DE202024100800U1 - Unilateral implant for spreading one nostril - Google Patents

Abstract

Implant (10; 20; 30; 40; 50; 60) for spreading at least one nostril, which can be fastened in the human nose, in the implanted state lies fully on at least one inner surface of a nostril and is constructed from a blank made of thin sheet metal provided with a plurality of continuous perforations (15),
characterized,
that the initially flat cut is bent before implantation into a spatial shape curved out of the sheet metal plane, which follows the natural curvature of the inner side of the soft nasal side wall;
that the implant (10; 20; 30; 40; 50; 60) in the implanted state rests fully on only one inner surface of one of the two nostrils; and
that the implant (10; 20; 30; 40; 50; 60) has a triangular base body (11; 21; 31; 41; 51; 61), in which two catheti edges (12',13';22',23';32',33';42',43';52',53';62',63') starting from a triangle tip (S) are arranged against each other at a triangular angle (cp), each lead away from the triangle tip (S) and run on both sides in the direction of a hypotenuse edge (14';24';34';44';54';64') opposite the triangle tip (S).

Description

The invention relates to a rhinological implant for spreading at least one nostril, which can be fastened in the human nose, in the implanted state lies completely on at least one inner surface of a nostril and is constructed from a blank made of thin sheet metal provided with a plurality of continuous perforations.

Such a rhinological implant for spreading the nostrils is based on the applicant’s generic prior art EN 10 2006 023 058 B3 ~ EP 1 857 078 B1 (= Reference [1]) or from DE 203 07 058 U1 ≈ EN 20 2004 021 075 U1 ~ EP 1 475 056 B1 (= Reference [2]).

Background of the invention

• Referenz [3a] (Prof. Dr. á Wengen) https://breatheimplant.com/de/
• Referenz [3b] (die Anmelderin Firma Kurz) https://www.kurzmed.com/de/produkte/rhinologie/breathe-implantawengen.html
• Referenz [3c] (Firma Bess) https://bess.eu/rhinologie/breathe-implant-awengen

In general, implants for spreading the nostrils and their handling are described in great detail, for example on the following websites (accessed on January 30, 2024):

• Reference [3a] (Prof. Dr. á Wengen) https://breatheimplant.com/de/
• Reference [3b] (the applicant company Kurz) https://www.kurzmed.com/de/produkte/rhinologie/breathe-implantawengen.html
• Reference [3c] (Bess company) https://bess.eu/rhinologie/breathe-implant-awengen

The implantation of an implant, i.e. a piece of tissue or substance that is usually foreign to the body, into the human body is a long-known procedure in medical technology that is carried out in many variations to correct functional disorders of various parts of the body and/or psychological impairments.

Spreading of the nostrils may be indicated, for example, in the case of a narrowing of the nasal valve or a collapse of the soft tissues of the nostrils.

• Die Spreizung der Nasenflügel zielt ausschließlich darauf ab, den Naseninnenraum dauerhaft zu vergrößern und damit die Luftzufuhr über die Nase zu optimieren. Es handelt sich also um rein funktionelle Chirurgie. Hierzu gibt es eine Reihe von chirurgischen Techniken, die über Nähte und Transplantate zum Ziel führen sollen. Unterschiedliche und im Wesentlichen von der Erfahrung und dem Geschick des Operateurs abhängige Verfahren kommen hierfür in Betracht. Disartikulationstechniken bis hin zu gezielten Knorpelinzisionen können mehr oder weniger eine Rolle spielen.

In the following, the main differences between a procedure to spread the nostrils and the well-known Columella Strut technique will be explained:

• The sole purpose of spreading the nostrils is to permanently enlarge the nasal cavity and thus optimize the air supply through the nose. It is therefore purely functional surgery. There are a number of surgical techniques that aim to achieve this using sutures and transplants. Different procedures can be considered, which essentially depend on the experience and skill of the surgeon. Disarticulation techniques and even targeted cartilage incisions can play a greater or lesser role.

In contrast, the columella strut technique aims to elevate the nasal tip for cosmetic reasons. A strut is inserted between the two ends of the two alar cartilages to elevate the tip of the nose. The graft/implant is placed in a pocket between the medial crura of the alar cartilages over the anterior nasal spine and secured between the medial crura with through sutures.

This is described, for example, in the US 2012/0078367 A1 (= Reference [4]). This is an implant that is biodegradable and is therefore not intended for long-term use. The target region is the lower third of the nose, mainly the region around the tip of the nose. There is also talk of connecting the implant to the septum, but not to straighten it, but to lengthen it if the septum has been shortened by external influences or for cosmetic reasons. The curved parts of the implant described are at most about 20mm long, i.e. if they are placed on the base of the spina nasalis and take up the two limbs of the alar cartilage, they just reach the end of the septum.

The position of this implant in its implanted state would already be completely unsuitable for nasal ala spreading.

The implant according to reference [4] is therefore in no way intended for spreading the nostrils, and cannot be attached to either side 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 nostrils. Reference [4] does not address or mention an aid for such spreading at all.

Also in the WO 2008/153263 A1 (= Reference [5]) only describes techniques that aim to lift the tip of the nose. The septum is mentioned there. For example, the technique that the implant must be attached to the upper border of the septum cartilage is described. However, this also happens here again only to stabilize the nasal tip implant.

The known implantation systems according to reference [4] and reference [5] attempt to use the end of the septum for stabilization or lengthening. However, neither of the two systems aims at or would be suitable for permanently spreading one or both nostrils away from the septum.

CN 21 538 4901 U (= Reference [6]) discloses a rhinoplasty 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 tip corner and a columella nasi with a clamping groove at the support end, a clamping groove at the head end of the nasal septum extension and a U-shaped groove.

US11,241,306 B2 (= Reference [7]) describes nasal implants with a planar profile that has partially open spaces. Such a nasal implant can 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 nostrils and therefore serves a completely different, independent supply field.

A simple and frequently used method for spreading the nostrils is to use a nasal support patch, which is used by top athletes in particular to improve nasal breathing. However, this method is not suitable for long-term use. If the nasal patches are used regularly, the adhesive can cause skin problems. In addition, a nasal patch affects a person's external appearance.

Surgical methods are also known for permanently spreading the nostrils, in which cartilage is used to stabilize the lateral nasal soft tissue. However, the results are not always visually and functionally satisfactory. This procedure also has other disadvantages. Since the body's own cartilage is preferably used for stabilization, the cartilage must be removed before this step, preferably from the patient's ear or nasal septum, which is time-consuming and poses an additional risk for the patient. It is often found that the inserted part has too little inherent tension to keep the caudal air space of the nose open in a satisfactory manner. The procedure can even prove counterproductive because the inserted parts press the soft tissue inwards and can lead to further narrowing of the nose.

Metallic implants are also used to spread the nostrils. To do this, an opening is surgically made in the area of the alar edge of the nose, through which the implant is inserted and attached to the triangular cartilage. Metallic implants are much stronger and more elastic than cartilage and have enough inherent tension to keep the nasal air space open in a permanent and satisfactory manner.

The triangular cartilage of the human nose is known to have a relatively flat or at most very slightly curved plateau area. The disadvantage of many known implants is that they are so strongly curved around the bridge of the nose that, when implanted, a cavity is created between the triangular cartilage and the implant in the area of this plateau of the triangular cartilage, which can lead to poor healing after implantation and possibly to uncontrolled growth of tissue. Furthermore, many known implants are geometrically designed in such a way that they do not fit optimally on the flanks of the triangular cartilage in the area of the nostrils.

Another roof-shaped implant for spreading the nasal wings, which, when implanted, runs over the back of the septum like the implants according to the references cited above [1] and [2], is in US6,322,590 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 both ends and is bent from the plane into a spatial V-shaped roof shape, but with a "round tip" of the spatial V.

Implants according to the reference mentioned above [1], in which the flat strip is also bent out of the plane into a spatial V-shaped roof shape, but already has an angular or trapezoidal contour in the plane, enable geometrically more favorable implantation arrangements in the nose and represent an improvement over the rhinological implant according to reference [8]:

In reference [1] it is suggested that a dorsal portion of the implant above the nasal bridge should be flat or only very slightly angled against the plateau area of the triangular cartilage with a spreading angle ω>160° or barrelled. shaped with a radius of curvature r>4cm, preferably r>10cm, curved around the plateau area of the triangular cartilage, and that two side sections of the implant on either side of the nostrils run essentially parallel to the respective nostril at an angle φ of more than 50° each, bent downwards against the flat back section. This achieves a particularly good geometric adaptation of the implant to the (normal) shape of the human triangular cartilage without major manufacturing effort. In particular, after the operation, no cavities arise between the implant and the triangular cartilage, neither in the area of the plateau of the triangular cartilage nor on its flanks. Rather, the implant lies closely against the triangular cartilage over its entire surface facing the triangular cartilage, which also ensures a particularly good mechanical hold of the implant on the triangular cartilage.

Object of the invention

The present invention is based on the task of modifying a rhinological implant of the generic type according to reference [1] or [2] with the features defined at the beginning using inexpensive technical means so that the device does not have to be placed over the part of the septum on the bridge of the nose and attached to both sides of the nasal septum, but rather a one-sided application is possible. In addition, the manufacturing effort is to be significantly reduced and a considerable amount of material and weight is to be saved. Finally, the implant should be as permanently secure as possible when the device is implanted.

Brief description of the invention

This relatively complex task is solved in a surprisingly simple and cost-effective manner by bending the initially flat blank into a spatial shape curved out of the sheet metal plane before implantation, which follows the natural curvature of the inside of the soft nasal side wall; that the implant, when implanted, rests fully on only one inner surface of one of the two nostrils; and that the implant has a triangular base body in which two catheti edges are arranged against each other at a triangular angle φ, starting from a triangle tip, each leading away from the triangle tip and running on both sides in the direction of a hypotenuse edge opposite the triangle tip.

Like the generic rhinological implants, the implant according to the invention serves in particular to stabilize, support and expand the soft nasal side wall in the area between the lower end of the triangular cartilage of the human nose, the bony nasal entrance "apertura piriformis", the bridge of the nose and the nasal entrance on one side (or even on both sides if the implant is used multiple times). The implant according to the invention thus helps to reduce or eliminate the suction of the nasal side wall and thus facilitate and therefore improve nasal breathing.

The novel basic idea of the invention is to present an implant that can only be inserted on one side and is only applied to one side of the septum on the inner wall of the corresponding nostril. This makes the implantation operation much easier because to insert the implant, surgery only needs to be performed on one side of the septum on the inner surface of a nostril. In particular, the nasal mucosa no longer needs to be lifted off the cartilage of the septum. Instead, the slightly curved, essentially rigid implant according to the invention is immediately inserted into its desired position on the inner wall of a nostril.

Theoretically, two implants can be used on both sides of the septum on the inside of both nostrils, for example to achieve particularly high mechanical stability or to be able to correct asymmetrical deformations of the nasal septum more sensitively and better. Even in such cases, however, the lack of a nasal bridge section on the implant according to the invention makes the operation significantly less complex and therefore less stressful for the patient.

The special geometric structure of the implant according to the invention with an essentially triangular base body creates a relatively large contact surface on the inside of the nostril, which can guarantee a secure, stable fit of the implant even during long-term use and during the numerous mechanical movements of the patient's nose that are to be expected (e.g. when blowing the nose).

The material savings in the manufacture of the implant according to the invention compared to the generic state of the art discussed above are also considerable: Due to the omission of the previously always obligatory nasal bridge section and the opposite further side part, 60-70% less material is required, which of course also leads to a great weight saving in the implant according to the invention.

• Das Implantat wird nach dem Ausstanzen des ursprünglichen flachen, ungebogenen Zuschnitt in eine lediglich sehr leicht gekrümmte, der natürlichen Biegung der Innenseite der weichen Nasenseitenwand folgende Raumform aufgebogen. Damit lässt sich das erfindungsgemäße Implantat besser in die vorhandene Struktur der Patienten-Nase einbringen. Ein sehr starkes Aufbiegen (wie etwa bei den generischen Implantaten gemäß Referenz [1] oder [2] jeweils zwingend erforderlich, schon wegen der Ausformung des dort immer vorhandenen Nasenrückenteils relativ zu den beiden dort ebenfalls immer vorhandenen Seitenabschnitten in eine Dachform) entfällt nun vollständig, was wiederum zu einer deutlichen Arbeitsersparnis bei der Herstellung, aber nachfolgend auch beim Einsetzen des erfindungsgemäßen Implantats während der Implantation beiträgt.

Finally, the manufacturing process is also significantly simplified:

• After punching out the original flat, unbent blank, the implant is bent into a spatial shape that is only very slightly curved and follows the natural curvature of the inside of the soft side wall of the nose. This makes it easier to insert the implant according to the invention into the existing structure of the patient's nose. Very strong bending (as is absolutely necessary with the generic implants according to reference [1] or [2], because the part of the bridge of the nose that is always present there is shaped into a roof shape relative to the two side sections that are also always present there) is now completely eliminated, which in turn contributes to a significant saving of work during production, but also when inserting the implant according to the invention during implantation.

Despite the significantly lower manufacturing effort compared to the state of the art, this achieves a particularly good geometric adaptation of the implant to the current, possibly also severely deformed nose situation of the respective patient and a particularly good attachment of the implant to one of the inner surfaces of the nostrils. In particular, no cavities can form between the implant and the septum after the operation (as is entirely possible and sometimes even unavoidable with the state of the art). Instead, the essentially flat, only very slightly curved implant according to the invention lies closely against the nostril over its entire surface facing the nostril after the operation, which also ensures a particularly good fit and mechanical hold of the implant in the nose.

Prefabricated implants according to the invention allow the procedure to be carried out in a particularly reproducible, standardized and plannable manner. If a certain number of different sizes and different shapes of the implant according to the invention are kept in stock, the surgeon can respond particularly precisely and sensitively to the individual geometric conditions in the respective patient's nose. A main task is always to permanently stabilize the soft side wall of the nose.

Preferred embodiments of the invention

In practice, embodiments of the rhinological implant according to the invention have proven useful in which at least one of the two catheti edges and/or the hypotenuse edge opposite the triangle tip does not run in a straight linear manner, but follows a curved curve.

This allows particularly “soft” outer contours of the implant to be realized and ensures optimal adaptation to the actual geometric conditions on the inside of the nostril.

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 catheti edges by two side sections each extending from the triangle tip beyond the hypotenuse edge, wherein the outer edges of the two side sections each run in alignment with their respective catheti edge.

The cutting for such implants is not significantly more complicated to manufacture and the protruding side sections increase the contact surface and improve the fit when implanted.

Alternative embodiments of the invention are also advantageous, which are characterized in that at least one, preferably both, base tips of the triangular base body, where a catheti edge meets the hypotenuse edge opposite the triangle tip, are shortened or chopped off, so that the end of the respective catheti edge facing away from the triangle tip is connected to one end of the hypotenuse edge via a further edge line.

This creates a kind of compact “boomerang” shape that fits particularly well and optimally across the entire inside of the nostril.

Very particularly preferred are embodiments of the implant according to the invention which are characterized in that the triangular tip and preferably also all other, at least the outer corner structures of the implant are rounded.

This prevents the implant from getting caught or even impaled during implantation, and also eliminates or at least minimizes the risk of injury from any post-operative movement of the implant relative to its surroundings. This also prevents the implant from growing into the human tissue. facilitated and improved coverage by the soft tissues of the nasal lateral wall.

In a class of particularly preferred embodiments, the implant is constructed symmetrically 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 is particularly easy and precise to manufacture.

Alternatively, a further class of embodiments of the invention is characterized in that the implant is constructed asymmetrically, wherein a first catheti edge has a greater length extension away from the triangle tip of the triangular base body than the second catheti edge.

In this way, in a range of different shapes and sizes, special consideration can be given to individual characteristics and unusual deformations of the respective patient's nose, which could not be optimally treated with a symmetrical shape of the implant.

Advantageous variants of the implant according to the invention are therefore also characterized by the fact that one or more spikes are incorporated into the triangular base body.

The latter claw into the nostrils during implantation, ensuring an excellent and extremely long-lasting hold of the implant. This type of attachment can of course also be combined with other attachment methods described above to ensure that the implant sits particularly securely on the nostrils.

As already described above, the implant according to the invention has a large number of perforations. This reduces the mass of the implant and thus its weight, and also minimizes the amount of foreign material introduced into the human body through the implant as much as possible. In addition, the perforations promote the growth of the implant into the tissue. The perforations are particularly important in order to ensure the supply of the soft tissue on both sides of the implant, to enable tissue to grow through and thus secure and permanent fixation of the implant in the tissue, to enable the implant to be sewn onto the bone of the piriform aperture and to enable fixation to the outermost part of the alar cartilage.

The perforations are preferably present both on the triangular base body and on the two side sections of the implant and can be designed, for example, as circular holes, as elongated holes or as differently shaped openings.

Furthermore, these perforations also serve to securely fix the implant by sewing it in place using a surgical suture. This also ensures that the affected tissue is adequately supplied with nutrients.

However, creating a permanent attachment of the implant by sewing it on is usually time-consuming and sometimes somewhat complicated due to the spatial conditions.

In further advantageous embodiments of the invention, the perforations of the implant can together have a larger surface area than the solid sections of the implant surrounding the perforations, in particular those which are designed in the shape of a web.

This allows the mass and therefore the weight of the implant according to the invention to be significantly minimized while still maintaining high mechanical stability. This also ensures that the tissue is adequately supplied with nutrients.

Preferably, in variants of the invention, at least some of the perforations can be polyhedral-shaped or honeycomb-shaped.

This enables high stability even with minimal use of materials.

However, at least some of the perforations can also be slit-shaped, preferably by elongated slits running parallel to one another.

Among other things, this makes suture placement easier for the implanting surgeon.

Particularly preferred are embodiments of the implant according to the invention in which all edges of the implant, at least all outer edges, are rounded.

This minimizes the risk of injury, makes it much easier to grow into human tissue and prevents the soft tissue from covering the skin, such as cartilage. and the nasal mucosa is noticeably improved.

In practice, embodiments of the invention have proven useful in which 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 take up to a maximum extent of the entire inner surface of a human nasal wing and has a maximum length extension in the cutting plane between 2 mm and 7 mm, preferably about 5 mm.

For the vast majority of conceivable applications of the implant according to the invention, embodiments are suitable in which the triangular 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 strengthen the implant and thus reduces the occurrence of bending due to external forces in the sense of a gusset plate.

For some applications, it can be advantageous if the implant is made entirely or partially of metal. Metals and their alloys are ideal materials for surgical and orthopedic implants that are intended to remain in the body permanently because, in addition to very good biocompatibility, they have high fatigue strength and elasticity. Despite a relatively low density, implants made of materials such as pure titanium or titanium compounds have excellent mechanical properties with a long service life. Non-magnetizable metals or alloys are also well suited for the purposes mentioned, as they can also take MRI safety aspects into account.

Preferred embodiments are those in which the implant is made of a material with memory effect and/or superelastic properties, preferably of nitinol, so that, for example, optimal spring properties relative to the septum can be introduced 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, in particular of polymer material, preferably of a material that has a similar flexibility to the human nostrils, but has sufficient rigidity to guarantee a permanent spreading of the corresponding nostril 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 tuned shape of the implant, it can be conveniently manufactured using 3D printing technology and/or laser technology.

Depending on the individual requirements, the implant according to the invention can also be manufactured using machining technology, in particular by means of milling technology and/or by means of grinding technology, preferably vibratory grinding, magnetic vibratory grinding or satellite centrifugal grinding, and/or by means of polishing technology, preferably electropolishing, or by etching technology.

Finally, in further advantageous embodiments of the invention, the implant is manufactured by injection molding using the Micro Injection Molding (=MIM) process, which is used, for example, in the WO 00/06327 A2 (= Reference [9]) is known per se. This allows extremely cost-effective production of very large quantities with consistent quality, whereas conventional implants are usually hand-made like jewelry and are therefore relatively expensive to produce on the one hand, and can vary individually in terms of dimensional accuracy on the other.

Further features and advantages of the invention will become apparent from the following detailed description of embodiments of the invention with reference to the figures of the drawing, which show details essential to the invention, and from the claims.

Detailed description of the invention based on the drawing

The schematic drawing shows embodiments of the invention, which are explained in more detail in the following description.

• 1 eine schematische Draufsicht in stark vergrößerter Darstellung senkrecht von oben auf die Zuschnitts-Ebene einer symmetrischen Ausführungsform des erfindungsgemäßen Implantats mit exakt spiegelbildlich zueinander ausgebildeten Seitenabschnitten in großer L-Größe;
• 2 eine Draufsicht auf den Zuschnitt für eine Ausführungsform des erfindungsgemäßen Implantats mit symmetrisch ausgreifenden Seitenabschnitten;
• 3 eine Ausführungsform mit asymmetrischen Seitenabschnitten;
• 4 eine asymmetrische Ausführungsform mit einem ausgreifenden Seitenabschnitt auf der einen Seite und einer abgehackten Basisspitze auf der anderen Seite;
• 5a eine schematische Draufsicht senkrecht von oben auf die Zuschnitts-Ebene einer asymmetrischen Ausführungsform des erfindungsgemäßen Implantats mit beiderseits abgehackten Basisspitzen sowie mit einer gekrümmten Katheten-Kante und einer gekrümmten Hypothenusen-Kante;
• 5b die Ausführungsform von 5a in gekrümmter räumlicher Darstellung;
• 6a eine ähnliche Ausführungsform des erfindungsgemäßen Implantats wie in 5a als räumliche Draufsicht auf den -bereits leicht gekrümmten- Zuschnitt;
• 6b die Ausführungsform von 6a mit Blickrichtung in der Ebene des gekrümmten Zuschnitts;
• 6c die Ausführungsform von 6a in räumlicher Darstellung schräg von der Seite;
• 7a eine schematische Draufsicht senkrecht von oben auf die Zuschnitts-Ebene einer asymmetrischen Ausführungsform ähnlich wie in den 5 und 6 mit Bemaßung; und
• 7b die Ausführungsform von 7a mit Blickrichtung in der Ebene des gekrümmten Zuschnitts mit Bemaßung.

Show it:

• 1 a schematic plan view in a greatly enlarged representation vertically from above onto the cutting plane of a symmetrical embodiment of the implant according to the invention with side sections in a large L size that are exactly mirror images of each other;
• 2 a plan view of the blank for an embodiment of the implant according to the invention with symmetrically extending side sections;
• 3 an embodiment with asymmetrical side sections;
• 4 an asymmetrical design with a protruding side section on one side and a chopped base tip on the other side;
• 5a a schematic plan view vertically from above onto the cutting plane of an asymmetrical embodiment of the implant according to the invention with chopped base tips on both sides and with a curved cathetus edge and a curved hypotenuse edge;
• 5b the embodiment of 5a in curved spatial representation;
• 6a a similar embodiment of the implant according to the invention as in 5a as a spatial top view of the -already slightly curved- cut;
• 6b the embodiment of 6a with a view in the plane of the curved cut;
• 6c the embodiment of 6a in spatial representation obliquely from the side;
• 7a a schematic plan view vertically from above onto the cutting plane of an asymmetrical embodiment similar to that in the 5 and 6 with dimensions; and
• 7b the embodiment of 7a with viewing direction in the plane of the curved cut with dimensions.

The rhinological implant 10; 20; 30; 40; 50; 60 shown in all figures of the drawing for spreading at least one nostril can be attached to the human nose. When implanted, it lies completely on at least one inner surface of a nostril and is made of a cut-out made of thin sheet metal provided with a large number of continuous perforations 15.

The perforations 15 can be polyhedral or honeycomb-shaped, as shown in the figures of the drawing, but in embodiments not specifically shown they can also be circular holes or elongated holes. They help to reduce the weight of the implant on the one hand and to reduce the amount of foreign material in the patient's body as much as possible on the other. The perforations 15 also promote the growth of the implant 10; 20; 30; 40; 50; 60 with the surrounding tissue.

The perforations 15 have the 1 to 4 and 6 have a larger surface area than the web-shaped, solid sections 15' of the implant 10; 20; 30; 40; 60 surrounding the perforations 15. Preferably, at least some of the perforations 15 are polyhedral or honeycomb-shaped. However, other shapes are also possible, such as elongated or circular holes.

The implant 10; 20; 30; 40; 50; 60 is surgically inserted into the human nose and secured by means of a suture. Several individual sutures are placed through the perforations 15 and fixed.

According to the invention, the implant 10; 20; 30; 40; 50; 60 is characterized, among other things, in that the initially flat cut is bent before implantation into a spatial shape curved out of the sheet plane, which follows the natural curvature of the inside of the soft nasal side wall.

In contrast to the previously known bilateral implants that span the septum, the implant 10; 20; 30; 40; 50; 60 according to the invention, when implanted, rests fully on only one inner surface of one of the two nostrils.

In applications not specifically shown in the drawing, however, implants according to the invention can also be fitted to both nostrils. In these cases, the two implants used will generally be mirror images of each other. Of course, applications are also conceivable where, due to individual asymmetry or other deviations in the geometry of the two nostrils of a patient, implants according to the invention of different sizes can be used in both halves of the nose. Compared to the known bilateral implants, the implant according to the invention, which can only be fitted in one half of the nose, offers the treating otologist significantly greater flexibility in order to optimally address the specifics of the individual case.

The implant 10; 20; 30; 40; 50; 60 according to the invention has an approximately triangular-shaped base body 11; 21; 31; 41; 51; 61, in which two catheti edges 12', 13';22',23';32',33';42',43';52',53';62',63' are arranged against each other at a triangular angle φ, each of which is inclined from the triangular point S and run on both sides in the direction of a hypotenuse edge 14';24';34';44';54';64' opposite the triangle point S.

In all embodiments of the invention shown in the drawing, the triangular tip S as well as all other, 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 approximately 100°.

The implant 10; 20; 30; 40; 50; 60 according to the invention can be made entirely 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 a memory effect and/or superelastic properties, preferably from nitinol. It will preferably have a biocompatible, antibacterial coating.

The implant 10; 20; 30; 40; 50; 60 can also be made entirely or partially from plastic sheet, in particular from polymer material, preferably from a material which has a similar flexibility to the human nostrils, but has sufficient rigidity to bring about a permanent and stable spreading of a nostril from the septum.

The implant 10; 20; 30; 40; 50; 60 can be manufactured using 3D printing technology and/or laser technology. It is also possible to manufacture and process the implant 10; 20; 30; 40; 50; 60 using machining technology, in particular using milling technology and/or using grinding technology, preferably vibratory grinding, magnetic vibratory grinding or satellite centrifugal grinding, and/or using polishing technology, preferably electropolishing, or using etching technology. In addition, the implant 10; 20; 30; 40; 50; 60 can also be manufactured, for example, using injection molding using the micro injection molding (=MIM) process.

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.

• So zeigen die 2 bis 4 Ausführungsformen des erfindungsgemäßen Implantats 20; 30; 40, bei welchen der Dreiecks-förmige Grundkörper 21; 31; 41 an einer oder beiden Katheten-Kanten 22',23'; 32',33'; 43' durch zwei jeweils von der Dreiecksspitze S weg über die Hypothenusen-Kante 24'; 34'; 44' hinausgreifende Seitenabschnitte 22a,23a; 32a,33a; 43a verlängert ist, wobei die Außen-Kanten 22a', 23a'; 32a', 33a'; 43a' der beiden Seitenabschnitte 22a,23a; 32a,33a; 43a jeweils in Flucht mit ihrer jeweiligen Katheten-Kante 22', 23'; 32', 33'; 43' verlaufen.

In other embodiments of the invention, parts of the base body can also be shortened or lengthened:

• The 2 to 4 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 catheti edges 22', 23';32',33';43' by two side sections 22a, 23a; 32a, 33a; 43a, each extending 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 run in alignment with their respective catheti edge 22', 23';32',33';43'.

In the 1 and 2 In the embodiments of the invention shown, the implant 10; 20 is constructed symmetrically 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.

Embodiments for an asymmetrical structure of the implant 30; 40; 50; 60 according to the invention are shown in the 3 to 6c shown. There, the first cathetus edge 32';42';52';62' has a greater length extension away from the triangle tip S of the triangular base body 31; 41; 51; 61 than the second cathetus edge 33';43';53';63'.

As can be seen from the embodiments of the 4 to 6c can be seen, at least one, possibly also both of the base tips of the triangular base body 41; 51; 61, where a respective catheti edge 42';52',53';62',63' meets the hypotenuse edge 44';54';64' opposite the triangle tip S, can be shortened or chopped off, so that the end of the respective catheti edge 42';52',53';62',63' facing away from the triangle tip S is connected to one end of the hypotenuse edge 44';54';64' via a further edge line 42x';52x',53x';62x',63x'.

• Die 5a bis 6c zeigen Ausführungsformen der Erfindung, bei welchen zumindest eine der beiden Katheten-Kanten 53'; 63' und/oder die der Dreiecksspitze S gegenüberliegende Hypothenusen-Kante 54'; 64' nicht geradlinig linear, sondern einer gekrümmten Kurve folgend verläuft.

Furthermore, the edge lines of the implant according to the invention do not necessarily have to be linear:

• The 5a to 6c show embodiments of the invention in which at least one of the two catheti edges 53';63' and/or the hypo thenuse edge 54';64' does not run linearly but follows a curved line.

As in the case of 6c As can be seen from the spatially illustrated embodiment, in the implant 10; 20; 30; 40; 50; 60 according to the invention, some or all of the 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 of the outer edges, can be rounded in the sheet metal plane of the blank.

Not specifically shown in the drawing are embodiments of the invention 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 22a, 23a; 32a, 33a; 43a.

Typical designs of the dimensions of the blank for the boomerang-shaped embodiments of the implant 50; 60 according to the invention are shown in the 7a and 7b In particular, one can see in 7a the respective radii of curvature of the non-linear hypotenuse and cathetus edges and in 7b the radius of the small curvature from the cutting plane.

The main purpose of the implant according to the invention is to permanently separate a nostril from the nasal septum. Indications can be, for example, deviations as a result of trauma, congenital deviation, etc. or simply breathing difficulties of the patient as a result of a nostril located too close to the septum and the resulting constriction of the flow of breathing air.

List of reference symbols:

10; 20; 30; 40; 50; 60

rhinological implant

11; 21; 31; 41; 51; 61

Triangular-shaped base body

12', 13'; 22', 23'; 32', 33'; 42', 43'; 52', 53'; 62', 63'

Catheti edges

14'; 24'; 34'; 44'; 54'; 64'

Hypotenuse edge

22a, 23a; 32a, 33a; 43a

extending side sections

22a', 23a'; 32a', 33a'; 43a'

Outer edges of the side sections

42x'; 52x', 53x'; 62x', 63x'

further edge line

15

Perforations

15'

fixed sections

S

triangular tip

φ

Triangular angle

Reference list:

• [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] Internetseite von Prof. Dr. á Wengen vom 30.01.2024 https://breatheimplant.com/de/
• [3b] Internetseite der Firma Kurz vom 30.01.2024 https://www.kurzmed.com/de/produkte/rhinologie/breatheimplant-awengen.html
• [3c] Internetseite der Firma Bess vom 30.01.2024 https://bess.eu/rhinologie/breathe-implant-awengen
• [4] US 2012/0078367 A1
• [5] WO 2008/153263 A1
• [6] CN 21 538 4901 U
• [7] US 11,241,306 B2
• [8] US 6,322,590 B1
• [9] WO 00/06327 A2

Publications considered for the assessment of patentability:

• [1] EN 10 2006 023 058 B3 ≈ EP 1 857 078 B1
• [2] DE 203 07 058 U1 ≈ EN 20 2004 021 075 U1 ≈ EP 1 475 056 B1
• [3a] Website of Prof. Dr. á Wengen from 30.01.2024 https://breatheimplant.com/de/
• [3b] Website of the company Kurz from January 30, 2024 https://www.kurzmed.com/de/produkte/rhinologie/breatheimplant-awengen.html
• [3c] Website of the company Bess from 30.01.2024 https://bess.eu/rhinologie/breathe-implant-awengen
• [4] US 2012/0078367 A1
• [5] WO 2008/153263 A1
• [6] CN 21 538 4901 U
• [7] US11,241,306 B2
• [8th] US6,322,590 B1
• [9] WO 00/06327 A2

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions.

Cited patent literature

• DE 102006023058 B3 [0002, 0096]
• EP 1857078 B1 [0002, 0096]
• DE 20307058 U1 [0002, 0096]
• DE 202004021075 U1 [0002, 0096]
• EP 1475056 B1 [0002, 0096]
• US 2012/0078367 A1 [0008, 0096]
• WO 2008/153263 A1 [0011, 0096]
• CN 215384901 U [0013, 0096]
• US 11241306 B2 [0014, 0096]
• US 6322590 B1 [0019, 0096]
• WO 0006327 A2 [0068, 0096]

Claims (15)

Implant (10; 20; 30; 40; 50; 60) for spreading at least one nostril, which can be fastened in the human nose, in the implanted state lies fully on at least one inner surface of a nostril and is constructed from a cut made of thin sheet metal provided with a plurality of continuous perforations (15), characterized in that the initially flat cut is bent up before implantation into a spatial shape curved out of the sheet metal plane, which follows the natural curvature of the inner side of the soft side wall of the nose; that the implant (10; 20; 30; 40; 50; 60) in the implanted state lies fully on only one inner surface of a single one of the two nostrils; and that the implant (10; 20; 30; 40; 50; 60) has a triangular base body (11; 21; 31; 41; 51; 61), in which two catheti edges (12',13';22',23';32',33';42',43';52',53';62',63') starting from a triangle tip (S) are arranged against each other at a triangular angle (cp), each lead away from the triangle tip (S) and run on both sides in the direction of a hypotenuse edge (14';24';34';44';54';64') opposite the triangle tip (S). Implant after Claim 1 , characterized in that at least one of the two catheti edges (53';63') and/or the hypotenuse edge (54';64') opposite the triangle vertex (S) does not run in a straight linear manner, but follows a curved curve. Implant after Claim 1 or 2 , characterized in that the triangular base body (21; 31; 41) is extended at one or both catheti edges (22',23';32',33';43') by two side sections (22a,23a; 32a,33a; 43a) each extending from the triangle tip (S) beyond the hypotenuse edge (24';34';44'), the outer edges (22a',23a';32a',33a';43a') of the two side sections (22a,23a; 32a,33a; 43a) each running in alignment with their respective catheti edge (22',23';32',33';43'). Implant according to one of the preceding claims, characterized in that at least one, preferably both, base tips of the triangular base body (41; 51; 61), where a respective catheti edge (42';52',53';62',63') meets the hypotenuse edge (44';54';64') opposite the triangle tip (S), are shortened or chopped off, so that the end of the respective catheti edge (42';52',53';62',63') facing away from the triangle tip (S) is connected to one end of the hypotenuse edge (44';54';64') via a further edge line (42x';52x',53x';62x',63x'). Implant according to one of the preceding claims, characterized in that the triangular tip (S) and preferably also all other, at least the outer, corners of the implant (10; 20; 30; 40; 50; 60) are rounded. Implant according to one of the Claims 1 until 5 , characterized in that the implant (10; 20) is constructed symmetrically 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 the Claims 1 until 5 , characterized in that the implant (30; 40; 50; 60) is constructed asymmetrically, wherein a first catheti edge (32';42';52';62') has a greater longitudinal extension away from the triangular tip (S) of the triangular base body (31; 41; 51; 61) than the second catheti 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 larger surface area than the fixed partial sections (15') of the implant (10; 20; 30; 40; 50; 60) surrounding the perforations (15), in particular those which are web-shaped, and that preferably at least some of the perforations (15) are polyhedral or honeycomb-shaped. 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 in the sheet metal plane of the blank. Implant according to 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 triangular angle (cp) at the triangular 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 the Claims 1 until 13 , characterized in that the implant (10; 20; 30; 40; 50; 60) is constructed from sheet metal, in particular from pure titanium or a titanium alloy, or from a material with memory effect and/or superelastic properties, preferably from nitinol. Implant according to one of the Claims 1 until 13 , characterized in that the implant (10; 20; 30; 40; 50; 60) is made entirely or partially from plastic sheet, in particular from polymer material, preferably from a material which has a similar flexibility to the human nostrils, but has sufficient rigidity to bring about a permanent and stable spreading of a nostril from the septum.

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