DE202024100349U1 - Unilateral septal implant with splint - Google Patents

Abstract

Rhinological implant (10; 20; 30; 40; 50; 60; 70) for straightening the nasal septum, which can be fastened to an outer surface of the septum of the human nose in the left and/or right side of the nasal cavity and, in the implanted state, lies completely on this outer surface of the septum, wherein the implant (10; 20; 30; 40; 50; 60; 70) is constructed from a flat blank provided with several continuous perforations (15), characterized in that the implant (10; 20; 30; 40; 50; 60; 70) has a flat shape and, in the implanted state, lies completely flat on only one of the two outer surfaces of the septum; that the implant (10; 20; 30; 40; 50; 60; 70) has a triangular base body (11; 21; 31; 41; 51; 61; 71) in which two catheti edges (12a, 13a) are arranged at a triangular angle (cp) against each other starting from a triangle tip (S), lead straight away from the triangle tip (S) and run on both sides in the direction of a hypotenuse edge (14a) opposite the triangle tip (S); and that the triangular base body (11; 21; 31; 41; 51; 61; 71) is extended at the two catheti edges (12a, 13a) by two side sections (12, 13; 22, 23; 32, 33; 42, 43; 52, 53; 62, 63; 72, 73) each extending from the triangle tip (S) beyond the hypotenuse edge (14a), wherein the outer edges (12a', 13a') of the two side sections (12, 13; 22, 23; 32, 33; 42, 43; 52, 53; 62, 63; 72, 73) each run in alignment with their respective catheti edge (12a, 13a).

Description

The invention relates to a rhinological implant for straightening the nasal septum, which can be fastened to an outer surface of the septum of the human nose in the left and/or right side of the nasal cavity and, in the implanted state, rests fully on this outer surface of the septum, wherein the implant is constructed from a flat blank provided with several continuous perforations.

Such a rhinological implant for straightening the nasal septum is based on the generic state of the art EN 10 2022 120 193 B3 ≈ EP23 180 536.7 (= Reference [1]) or from EN 10 2012 107 123 B4 ≈ EP 2 692 313 B1 ≈ US9,895,252 B2 (= Reference [2]) of the applicant.

Background of the invention

In general, implants for septum straightening are described, for example, on the website dated 19.01.2024 https://bess.eu/rhinologie/septumschienen/septumschienen (= Reference [3])

The implantation of an implant, i.e. a piece of tissue or material 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.

As is well known, the cartilaginous part of the human nose consists of the nasal septum, the triangular cartilage and the alar cartilage. The present invention deals with the straightening of the septum. In many cases of functional, but also cosmetic, nose surgery, the aim is to straighten the septum in order to improve the airflow within the nasal passage or simply to cosmetically enhance the nose. This process is usually accompanied by changes to other structures. Currently, different suture or cartilage transplant techniques are used to straighten the septum.

• Die Septumplastik zielt ausschließlich darauf ab, das Septum zu begradigen 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.

The following will first explain the differences between a septoplasty and the columella strut technique:

• Septoplasty aims exclusively to straighten the septum 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.

Straightening a deviated septum can be one of the biggest challenges in rhinoplasty. Different procedures can be used, depending largely on the experience and skill of the surgeon.

Disarticulation techniques and even targeted cartilage incisions can play a greater or lesser role. Experts agree on one thing: straightening the septum, especially in the middle arch, is a difficult matter and by no means a simple operation.

In contrast to septal straightening, the columella strut technique aims to raise the tip of the nose for cosmetic reasons. A strut is inserted between the two ends of the two alar cartilages to raise 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-cut 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 latter is therefore never straightened. The position of the implant in the implanted state would be completely unsuitable for septum straightening.

The implant according to reference [4] is therefore in no way suitable for straightening the nasal septum, and cannot be attached to both sides of the septum of the human nose on the respective outer surface of the septum in the left and right sides of the nasal cavity. Rather, the implant according to reference [4] is a "columella strut", but not a generic septoplasty according to the present invention for straightening the nasal septum. Reference [4] does not address or mention an aid for straightening the septum 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 also mentioned there. For example, the technique that the implant must be attached to the upper border of the septal cartilage is described. However, this is again only done 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 straightening the septum.

Implants for spreading the nostrils are described in US6,322,590 B1 (= Reference [6]) or in EP 1 475 056 B1 (= Reference [7]) or in DE 2006 023 058 B3 (= Reference [8]). These implantation systems are also in no way designed or suitable for septum straightening.

For straightening the septum, however, techniques using PDS foils are known (described in: HNO.1999 Jun;47 (6):546-50
(= Reference [9])), which are cut to size and sewn onto the septum. The extremely thin film implants resorb after 10 to 25 weeks, leaving essentially no residue.

More stable - but also not permanent - implants for straightening the septum are the Reuter septum splints made of silicone, as described on the Bess website cited at the beginning. These implants are used to splint the septum and to minimize the risk of adhesion between the septum and the lateral nasal wall after rhinoplasty. They are slit to make them easier to insert and remove and have pre-punched holes for attaching sutures. The material is stated to be fluoroplastic. However, the splints must be removed from the nose after a few weeks, as silicone is not considered to be long-term stable and can potentially lead to infections.

CN 21 538 4901 U (= Reference [10]) 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 [11]) 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 the length of the planar profile.

Compared to the state of the art shown in references [3] to [11], the state of the art cited at the beginning according to reference [2] avoids the disadvantages of the septal splints according to Reuter and the implant lies permanently close to the nasal septum after the operation.

The basic idea of reference [2] is to simply straighten the septum with a specially shaped and thus mechanically permanently stable structure. It is important that the implant according to reference [2] is geometrically designed in such a way that the entire area of the septum is covered. This is achieved by the implant enclosing the free lower edge of the septum. Furthermore, both sides of the implant are perforated so that the implant can be easily and securely fixed to both sides of the septum. The thickness and associated rigidity of the implant is important in that the septal cartilage should adapt to the shape of the implant in the long term and not the other way around.

The two side sections of the implant according to reference [2] each have a first section that is directly connected to the central back section and runs essentially parallel to it, and the two side sections each have a second section towards their free ends that is connected to the respective first section and runs at an angle to it. These simple measures increase the long-term mechanical stability of the implant. In addition, the flat, firm fit of the implant on the two side surfaces of the nasal septum is improved.

A comparable geometric regulation in the state of the art according to references [3] to [11] does not lie within the functional scope of the columella strut technique and the nasal wing spreading described therein and therefore serves a completely different, independent field of care.

Finally, the state of the art according to reference [1], which has already been cited at the beginning, represents an improvement over the rhinological implant according to reference [2]: Here it is proposed that a third section is connected to an end of the respective first section according to reference [2] opposite the respective second section and that opposite the respective first section This enables even better long-term mechanical stabilization of the septum and further improves the flat, firm fit of the implant on both sides of the nasal septum. In particular, a very even distribution of the contact forces is achieved with the implant attached to the septum.

• Es muss kein Knorpel aus anderen Bereichen (normalerweise Rippe) entnommen werden. Dadurch verringert sich die Operationszeit und es besteht weniger Infektionsgefahr. Weiter ist bei Implantaten gemäß den Referenzen [1] oder [2] zu erwarten, dass eine Stabilisierung aus Metall deutlich länger die gewünschte Begradigung leistet als dies mit verformbarem Knochen wie bei einigen Implantaten nach dem Stand der Technik möglich wäre. Schließlich kann davon ausgegangen werden, dass ein Implantat gemäß den Referenzen [1] oder [2] deutlich dünner aufträgt als vergleichbar stabiler Knorpel, was sich positiv auf den gewünschten Luftdurchsatz auswirkt.

In most of the septal implants currently available for the correction of septal deviations or perforations of the septum, the implant structures are supported by cartilage. In contrast, the implants according to references [1] or [2] have many advantages:

• No cartilage needs to be removed from other areas (usually the rib). This reduces the operation time and reduces the risk of infection. Furthermore, with implants according to references [1] or [2], it can be expected that a metal stabilization will provide the desired straightening for significantly longer than would be possible with deformable bone, as would be the case with some state-of-the-art implants. Finally, it can be assumed that an implant according to references [1] or [2] will be significantly thinner than comparably stable cartilage, which has a positive effect on the desired air flow.

Object of the invention

In contrast, the present invention is based on the object 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 in such a way 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.

Brief description of the invention

This relatively complex task is solved in a surprisingly simple and cost-effective manner in that the implant has a flat shape and, when implanted, lies flat on just one of the two outer surfaces of the septum; that the implant has a triangular base body in which two catheti edges are arranged at a triangular angle φ against each other, starting from a triangle tip, lead straight away from the triangle tip and run on both sides in the direction of a hypotenuse edge opposite the triangle tip; and 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, with the outer edges of the two side sections each running in alignment with their respective catheti edge.

Like the generic rhinological implants, the implant according to the invention serves in particular for straightening, splinting, supporting as well as for building up and restoring the cartilaginous human nasal septum.

The new basic idea of the invention is to present an implant that can only be used on one side and is only sewn onto one side of the septum cartilage. This makes the implantation operation much easier because to insert the implant, the nasal mucosa only needs to be lifted off the cartilage of the septum on one side of the septum in order to then insert the flat and rigid implant.

Theoretically, two implants can be used on both sides of the septum, 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 material savings in the manufacture of the implant according to the invention compared to the generic prior art discussed above are also considerable. Due to the omission of the previously obligatory nasal bridge section and the opposite side part, 60-70% less material is required, which of course also leads to a large weight saving in the implant according to the invention.

Finally, the manufacturing process is also significantly simplified: the implant is always left in the original flat, unbent state of the blank. Subsequent straightening into a three-dimensional shape after punching out the flat blank (as is always mandatory with the generic implants according to reference [1] or [2]) is now completely eliminated, which in turn contributes to a significant labor saving in the manufacture of the implant according to the invention.

This allows for particularly good geometric adaptation despite the lower manufacturing effort. This is achieved by adapting the implant to the current, possibly severely deformed shape of the patient's septum and by ensuring that the implant is particularly well positioned on one of its outer surfaces. In particular, no cavities are created between the implant and the septum after the operation. Instead, the flat implant lies tightly against the septum over its entire surface facing the septum after the operation, which also ensures that the implant is held in place particularly well mechanically on the septum.

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 shapes of the implant according to the invention are kept in stock, the surgeon can respond particularly precisely to the individual geometric conditions of the respective patient's septum.

Preferred embodiments of the invention

Particularly preferred are embodiments of the implant according to the invention which are characterized in that the tip of the triangle and preferably all other, at least the outer corners of the implant are rounded. This safely prevents the implant from getting caught or even impaled during implantation, and also eliminates the risk of injury in the implanted state if the implant moves post-operatively relative to its surroundings.

In a further preferred embodiment of the invention, the two side sections of the implant each have an inner edge running parallel to their outer edge at a distance.

In this case, the side sections are geometrically designed as essentially rectangular-shaped “tongues” that extend on both sides of the triangular base body along the two catheti edges from the triangle tip beyond the hypotenuse edge and are particularly easy and precise to manufacture.

In a class of particularly preferred embodiments, the implant is constructed symmetrically to a height axis running from the triangle apex 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 side section has a greater length extension away from the triangle tip of the triangular base body than the second side section.

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 septum, which could not be optimally treated with a symmetrical shape of the implant.

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. In addition, the perforations promote the fusion of the implant with the tissue.

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 or as elongated holes.

Furthermore, these perforations also serve to securely fix the implant to the triangular cartilage of the septum by sewing the implant to the cartilage and/or the bony floor of the nose, particularly to the lower anterior nasal spur, using a surgical suture. This also ensures that the cartilage tissue and the cartilage membrane of the septum are adequately supplied with nutrients.

However, the production of a permanent attachment of the implant by sewing it onto the cartilage is usually time-consuming and sometimes somewhat complicated due to the spatial conditions. 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 and/or into the side sections. The latter dig into the septal cartilage during implantation and thus ensure an excellent and extremely permanent hold of the implant. This type of attachment can of course also be combined with other attachment types described above in order to achieve a to ensure a particularly secure fit of the implant on the septum.

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 cartilage tissue on the septum 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 noticeably improves coverage by the soft tissues of the cartilage and nasal mucosa.

In practice, embodiments of the invention have proven successful 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 an entire human nasal septum cartilage 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 120°, preferably about 100°.

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 and a long service life. Non-magnetizable metals or alloys, which can also take MRI safety aspects into account, are also well suited for the purposes mentioned.

Preferred embodiments are those in which the implant is made of a material with memory effect and/or superelastic properties, preferably 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, in particular of polymer material, preferably of a material which has a similar flexibility to the human septum, but has sufficient rigidity to straighten a deviated nasal septum in the long term, and without requiring a transection of the septum to cause weakening.

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 produced using machining technology, in particular by means of milling technology and/or grinding technology, preferably vibratory grinding, magnetic vibratory grinding or Satellites can be manufactured by centrifugal grinding and/or by polishing techniques, preferably electropolishing, or etching techniques.

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 [12]) is known per se. This allows extremely cost-effective production of even very large quantities with consistent dimensional accuracy, whereas conventional implants are usually hand-made like jewelry and are therefore relatively expensive to produce on the one hand, and dimensional accuracy can vary individually 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;
• 2a die Ausführungsform von 1, jedoch in etwas kleinerer (gegenüber der Realität aber immer noch stark vergrößerter) Darstellung;
• 2b die Ausführungsform von 2a, jedoch mit Blickrichtung von der Seite in der Zuschnitts-Ebene;
• 2c die Ausführungsform von 2a, jedoch als räumliche Darstellung mit Blickrichtung schräg von oben auf die Oberseite des Implantats;
• 3a-c eine ähnliche Ausführungsform wie 2a-c, jedoch mit einer Ausführungsform des erfindungsgemäßen Implantats in mittlerer M-Größe;
• 4a-c eine ähnliche Ausführungsform wie 2a-c, jedoch mit einer Ausführungsform des erfindungsgemäßen Implantats in kleiner S-Größe;
• 5 eine schematische Draufsicht in stark vergrößerter Darstellung senkrecht von oben auf die Zuschnitts-Ebene einer Ausführungsform des erfindungsgemäßen Implantats mit asymmetrischen Seitenabschnitten in großer L-Größe;
• 6 eine Ausführungsform des erfindungsgemäßen Implantats mit asymmetrischen Seitenabschnitten in mittlerer M-Größe; und
• 7 eine Ausführungsform des erfindungsgemäßen Implantats mit asymmetrischen Seitenabschnitten in kleiner S-Größe.

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;
• 2a the embodiment of 1 , but in a slightly smaller (but still greatly enlarged compared to reality) representation;
• 2 B the embodiment of 2a , but viewed from the side in the cutting plane;
• 2c the embodiment of 2a , but as a spatial representation with a view obliquely from above onto the top of the implant;
• 3a -c a similar embodiment as 2a -c, but with an embodiment of the implant according to the invention in medium M size;
• 4a -c a similar embodiment as 2a -c, but with an embodiment of the implant according to the invention in a small S size;
• 5 a schematic plan view in a greatly enlarged representation vertically from above onto the cutting plane of an embodiment of the implant according to the invention with asymmetrical side sections in a large L size;
• 6 an embodiment of the implant according to the invention with asymmetrical side sections in medium M size; and
• 7 an embodiment of the implant according to the invention with asymmetrical side sections in small S size.

The rhinological implant 10; 20; 30; 40; 50; 60; 70 shown in all figures of the drawing for straightening the nasal septum can be attached to an outer surface of the septum of the human nose in the left and/or right side of the nasal cavity. When implanted, the implant 10; 20; 30; 40; 50; 60; 70 then lies completely on this outer surface of the septum. It is constructed from a flat cut-out provided with several 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; 70 with the surrounding tissue.

In the embodiments of the invention shown in the drawing, the perforations 15 have a larger surface area overall than the web-shaped, solid sections 15' of the implant 10; 20; 30; 40; 50; 60; 70 surrounding the perforations 15.

The implant 10; 20; 30; 40; 50; 60; 70 is surgically inserted into the human nose using a so-called open rhinoplasty and is attached to the cartilage of the septum using a suture. Several individual sutures are placed through the perforations 15 and the septum and fixed.

According to the invention, the implant 10; 20; 30; 40; 50; 60; 70 is characterized in that it always has a flat shape and, in the implanted state, lies flat on only one of the two outer surfaces of the septum.

The implant 10; 20; 30; 40; 50; 60; 70 according to the invention has a triangular base body 11; 21; 31; 41; 51; 61; 71, in which two catheti edges 12a, 13a are arranged at a triangular angle φ against each other, starting from a triangle tip S, lead straight away from the triangle tip S and run on both sides in the direction of a hypotenuse edge 14a opposite the triangle tip S.

The triangular base body 11; 21; 31; 41; 51; 61; 71 is extended at the two catheti edges 12a, 13a by two side sections 12, 13; 22, 23; 32, 33; 42, 43; 52, 53; 62, 63; 72, 73, each extending from the triangle tip S beyond the hypotenuse edge 14a, whereby the outer edges 12a', 13a' of the two side sections 12, 13; 22, 23; 32, 33; 42, 43; 52, 53; 62, 63; 72, 73 each run in alignment with their respective catheti edge 12a, 13a.

In all embodiments of the implant 10; 20; 30; 40; 50; 60; 70 according to the invention shown in the drawing, the two side sections 12, 13; 22, 23; 32, 33; 42, 43; 52, 53; 62, 63; 72, 73 each have an inner edge 12b'' or 13b' running parallel to their outer edge 12a' or 13a' at a distance.

The thickness of the flat blank for the implant 10; 20; 30; 40 is usually between 0.2 mm and 1.2 mm, preferably about 0.8 mm, and the maximum longitudinal dimension is between 2 mm and 7 mm, preferably about 5 mm.

The triangular angle φ at the triangle tip S of the triangular base body 11; 21; 31; 41; 51; 61; 71 can be between 60° and 120°, in the embodiments shown it is approximately 100°.

In all embodiments 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; 70 are rounded.

In embodiments of the invention not shown in the drawing, some or all edges 12a, 13a, 14a, 12a', 13a', 12b', 13b' of the implant 10; 20; 30; 40; 50; 60; 70, in particular at least all outer edges, can be rounded.

Also 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; 71 and/or into the side sections 12,13; 22,23; 32,33; 42,43; 52,53; 62,63; 72,73.

The 1 to 4c The drawing shows embodiments of the invention in which the implant 10; 20; 30; 40 is constructed symmetrically to an imaginary height axis running from the triangle tip S at right angles to the hypotenuse edge 14a, which divides the implant 10; 20; 30; 40 laterally into two mirror-image halves.

As alternatives, the 5 to 7 the drawing shows embodiments of the invention in which the implant 50; 60; 70 is constructed asymmetrically, wherein the first side section 52; 62; 72 has a greater length extension away from the triangle tip S of the triangular base body 51; 61; 71 than the second side section 53; 63; 73.

The implant 10; 20; 30; 40; 50; 60; 70 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; 70 can also be made entirely or partially from plastic, in particular from polymer material, preferably from a material which has a similar flexibility to the human septum, but has sufficient rigidity to straighten a curved nasal septum in the long term, and without making it necessary to cut through the septum to cause a weakening.

The implant 10; 20; 30; 40; 50; 60; 70 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; 70 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; 70 can also be manufactured, for example, by injection molding using the micro injection molding (=MIM) process.

The main purpose of the implant according to the invention is to stabilize, splint and straighten the front (anterior) nasal septum up to the rear (dorsal) end of the implant. Indications can be, for example, septal deviations of the anterior septum of up to approx. 15mm as a result of trauma, congenital deviation, etc.

List of reference symbols:

10; 20; 30; 40; 50; 60; 70

rhinological implant

11; 21; 31; 41; 51; 61; 71

Triangular-shaped base body

12,13; 22,23; 32,33; 42,43; 52,53; 62,63; 72.73

extending side sections

12a, 13a

Catheti edges

14a

Hypotenuse edge

12a', 13a'

Outer edges of the side sections

12b', 13b'

Inner edges of the side sections

15

Perforations

15'

fixed sections

S

triangular tip

φ

Triangular angle

Reference list:

• [1] DE 10 2022 120 193 B3 ≈ EP 23 180 536.7
• [2] DE 10 2012 107 123 B4 ≈ EP 2 692 313 B1 ≈ US 9,895,252 B2
• [3] Internetseite vom 19.01.2024 https://bess.eu/rhinologie/septumschienen/septumschienen
• [4] US 2012/0078367 A1
• [5] WO 2008/153263 A1
• [6] US 6,322,590 B1
• [7] EP 1 475 056 B1
• [8] DE 2006 023 058 B3
• [9] HNO. 1999 Jun; 47(6):546-50
• [10] CN 21 538 4901 U
• [11] US 11,241,306 B2
• [12] WO 00/06327 A2

Publications considered for the assessment of patentability:

• [1] EN 10 2022 120 193 B3 ≈ EP23 180 536.7
• [2] EN 10 2012 107 123 B4 ≈ EP 2 692 313 B1 ≈ US9,895,252 B2
• [3] Website from 19.01.2024 https://bess.eu/rhinologie/septumschienen/septumschienen
• [4] US 2012/0078367 A1
• [5] WO 2008/153263 A1
• [6] US6,322,590 B1
• [7] EP 1 475 056 B1
• [8th] DE 2006 023 058 B3
• [9] ENT. 1999 Jun; 47(6):546-50
• [10] CN 21 538 4901 U
• [11] US11,241,306 B2
• [12] 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 102022120193 B3 [0002, 0086]
• EP231805367 [0002, 0086]
• DE 102012107123 B4 [0002, 0086]
• EP 2692313 B1 [0002, 0086]
• US 9895252 B2 [0002, 0086]
• US 20120078367 A1 [0010, 0086]
• WO 2008153263 A1 [0012, 0086]
• US 6322590 B1 [0014, 0086]
• EP 1475056 B1 [0014, 0086]
• DE 2006023058 B3 [0014, 0086]
• CN 215384901 U [0017, 0086]
• US 11241306 B2 [0018, 0086]
• WO 0006327 A2 [0063, 0086]

Cited non-patent literature

• https://bess.eu/rhinologie/septumschienen/septumschienen [0003]
• HNO. 1999 Jun; 47(6):546-50 [0086]

Claims (13)

Rhinological implant (10; 20; 30; 40; 50; 60; 70) for straightening the nasal septum, which implant can be attached to an outer surface of the septum of the human nose in the left and/or right side of the nasal cavity and, in the implanted state, lies flat on this outer surface of the septum, the implant (10; 20; 30; 40; 50; 60; 70) being constructed from a flat blank provided with several continuous perforations (15), characterized in that the implant (10; 20; 30; 40; 50; 60; 70) has a flat shape and, in the implanted state, lies flat on only one of the two outer surfaces of the septum; that the implant (10; 20; 30; 40; 50; 60; 70) has a triangular base body (11; 21; 31; 41; 51; 61; 71) in which two catheti edges (12a, 13a) are arranged at a triangular angle (cp) against each other starting from a triangle tip (S), lead straight away from the triangle tip (S) and run on both sides in the direction of a hypotenuse edge (14a) opposite the triangle tip (S); and that the triangular base body (11; 21; 31; 41; 51; 61; 71) is extended at the two catheti edges (12a, 13a) by two side sections (12, 13; 22, 23; 32, 33; 42, 43; 52, 53; 62, 63; 72, 73) each extending from the triangle tip (S) beyond the hypotenuse edge (14a), wherein the outer edges (12a', 13a') of the two side sections (12, 13; 22, 23; 32, 33; 42, 43; 52, 53; 62, 63; 72, 73) each run in alignment with their respective catheti edge (12a, 13a). Implant after Claim 1 , 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; 70) are rounded. Implant after Claim 1 or 2 , characterized in that the two side sections (12,13; 22,23; 32,33; 42,43; 52,53; 62,63; 72,73) each have an inner edge (12b' or 13b') running parallel to their outer edge (12a' or 13a') at a distance. Implant according to one of the Claims 1 until 3 , characterized in that the implant (10; 20; 30; 40) is constructed symmetrically to a height axis running from the triangle tip (S) at right angles to the hypotenuse edge (14a), which divides the implant (10; 20; 30; 40) laterally into two mirror-image halves. Implant according to one of the Claims 1 until 3 , characterized in that the implant (50; 60; 70) is constructed asymmetrically, wherein a first side portion (52; 62; 72) has a greater longitudinal extension away from the triangular tip (S) of the triangular base body (51; 61; 71) than the second side portion (53; 63; 73). 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; 71) and/or into the side sections (12,13; 22,23; 32,33; 42,43; 52,53; 62,63; 72,73). 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; 70) 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 (12a, 13a, 14a, 12a', 13a', 12b', 13b') of the implant (10; 20; 30; 40; 50; 60; 70), at least all outer edges, are rounded. Implant according to one of the preceding claims, characterized in that the thickness of the flat blank for the implant (10; 20; 30; 40) 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; 71) is between 60° and 120°, preferably about 100°. Implant according to one of the preceding claims, characterized in that the implant (10; 20; 30; 40; 50; 60; 70) has a body-compatible coating. Implant according to one of the Claims 1 until 11 , characterized in that the implant (10; 20; 30; 40; 50; 60; 70) 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 11 , characterized in that the implant (10; 20; 30; 40; 50; 60; 70) consists entirely or partially of is made of plastic, in particular polymer material, preferably of a material which has a similar flexibility to the human septum, but has sufficient rigidity to straighten a deviated nasal septum in the long term, and without requiring a severing of the septum to cause weakening.

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