Unilateral septal implant with splint

Abstract

A rhinological implant (10) for nasal septum straightening, which can be attached to an outer surface of the septum and is made from a flat blank with several continuous perforations (15), is characterized in that it has a flat shape and, in the implanted state, lies flat and fully in contact with only one of the two outer surfaces of the septum; it has a triangular base body (11) in which two catheti edges (12a, 13a) extending from a triangle apex (S) are arranged at a triangular angle (φ) to each other, extend straight away from the triangle apex and on both sides run in the direction of a hypotenuse edge (14a) opposite the triangle apex;and that the triangular base body is extended at both catheti edges by two side sections (12, 13) extending from the apex of the triangle beyond the hypotenuse edge, the outer edges (12a', 13a') of each side section being aligned with a catheti edge. The device is not erected from the flat blank into a three-dimensional form and placed over the dorsum-side part of the septum, but allows for unilateral application on one side surface of the septum. The manufacturing effort is significantly reduced, and considerable material and weight are saved.

Description

[0001] The invention relates to a rhinological implant for straightening the nasal septum, which 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 fully in contact with this outer surface of the septum, wherein the implant is constructed from a flat blank provided with several continuous perforations.

[0002] Such a rhinological implant for straightening the nasal septum is disclosed in the generic prior art DE 10 2022 120 193 B3 ≈ EP 23 180 536.7 (= Reference [1]) or in DE 10 2012 107 123 B4 ≈ EP 2 692 313 B1 ≈ US 9 895 252 B2 (= Reference [2]) of the applicant. Background of the invention

[0003] 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])

[0004] 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-established 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.

[0005] As is well known, the cartilaginous portion 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, nasal surgery, the goal is to straighten the septum to improve airflow within the nasal passage or simply to cosmetically enhance the nose. This procedure is usually accompanied by the modification of other structures. Currently, various suture or cartilage graft techniques are used to straighten the septum.

[0006] 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 airflow through the nose. It is therefore a purely functional surgery. A number of surgical techniques are available for this purpose, using sutures and grafts.

[0007] Straightening a deviated septum can be one of the most challenging aspects of rhinoplasty. Various procedures are possible, depending largely on the experience and skill of the surgeon.

[0008] Disarticulation techniques, including targeted cartilage incisions, can play a role to a greater or lesser extent. Experts agree on one thing: septal straightening, especially in the middle arch, is a difficult procedure and by no means a simple one.

[0009] In contrast to septal straightening, the columellar strut technique aims to elevate the nasal tip for cosmetic reasons. A strut is inserted between the two ends of the alar cartilages to elevate the tip. 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 penetrating sutures.

[0010] This is described, for example, in US 2012 / 0078367 A1 (= reference [4]). This document refers to an implant that is biodegradable and therefore not intended for long-term use. The target region is the lower third of the nose, primarily the area around the tip. While the document also mentions connecting the implant to the septum, this is not for straightening it, but rather for lengthening it if the septum has shortened due to external factors or for cosmetic reasons. The curved parts of the described implant are at most approximately 20 mm long; that is, if placed on the base of the nasal spine and the two crura of the alar cartilages are incorporated, they barely reach the end of the septum. The septum is therefore never straightened. The implant's position in its implanted state would be completely unsuitable for septum straightening.

[0011] The implant according to reference [4] is therefore in no way suitable for straightening the nasal septum, nor can it be attached to the respective outer surface of the septum on both sides of the human nose in the left and right sides of the nasal cavity. Rather, the implant according to reference [4] is a "columella strut," not a septoplasty of the type described in the present invention for straightening the nasal septum. Reference [4] does not address or mention any aid for straightening the septum at all.

[0012] WO 2008 / 153263 A1 (= Reference [5]) also describes exclusively techniques aimed at lifting the nasal tip. While the septum is mentioned there as well, and the technique described involves placing the implant at the upper border of the septal cartilage, this is again done solely to stabilize the nasal tip implant.

[0013] 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 system aims to, or would be suitable for, permanently straightening the septum.

[0014] Implants for widening the nasal alae are described, for example, in US 6 322 590 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 by no means designed or suitable for septum straightening.

[0015] For septal straightening, techniques using PDS foils are known (e.g., described in: HNO. 1999 Jun;47 (6):546-50 (= reference [9])), which are cut to size and sutured onto the septum. The ultra-thin foil implants are resorbed essentially without residue after 10 to 25 weeks.

[0016] More stable—though still not permanent—implants for septum straightening are the silicone septum splints developed by Reuter, as described on the Bess company website cited earlier. These implants serve to splint the septum and minimize the risk of adhesion between the septum and the lateral nasal wall after rhinoplasty. They are slotted for easier insertion and removal and have pre-punched holes for suture fixation. The material is listed as fluoroplastic. However, the splints must be removed from the nose after a few weeks, as silicone is not considered stable in the long term and can potentially lead to infections.

[0017] CN 21 538 4901 U (= Reference

[10] ) discloses a nasal support for plastic surgery comprising a columella nasi support section, a nasal septum extension section, plates of the columella nasi support section, plates of the nasal septum extension section, 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.

[0018] US 11 241 306 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 length of the planar profile.

[0019] 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.

[0020] The basic idea of ​​Reference [2] is to simply straighten the septum using a specially shaped and thus mechanically stable structure. It is important that the implant, according to Reference [2], is geometrically designed to cover the entire area of ​​the septum. This is achieved by the implant encompassing 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 either side of the septum. The thickness and associated stiffness of the implant is important in that the septal cartilage should adapt to the shape of the implant over time, and not vice versa.

[0021] The two lateral sections of the implant according to reference [2] each have a first subsection that connects directly to the central posterior section and runs essentially parallel to it, and each of the two lateral sections has a second subsection at its free ends that connects to the respective first subsection and runs at an angle to it. These simple measures increase the long-term mechanical stability of the implant. Furthermore, they improve the implant's firm, flat fit to both lateral surfaces of the nasal septum.

[0022] A comparable geometric specification in the prior art according to references [3] to

[11] is not within the scope of function of the columella strut technique and nasal alar spreading described therein and therefore serves a completely different, independent field of care.

[0023] Finally, the prior art already cited at the beginning, according to reference [1], represents an improvement over the rhinological implant according to reference [2]: Here, it is proposed that a third subsection be attached to the end of the respective first subsection opposite the respective second subsection, and that this third subsection is also angled relative to the respective first subsection. This enables even better long-term mechanical stabilization of the septum and further improves the firm, continuous fit of the implant to both lateral surfaces of the nasal septum. In particular, a very uniform distribution of the application forces is achieved for the implant attached to the septum.

[0024] Most currently available septal implants for correcting septal deviations or perforations are supported by cartilage. In contrast, the implants according to references [1] or [2] have numerous advantages: No cartilage needs to be harvested from other areas (usually the rib). This reduces the operating time and the risk of infection. Furthermore, with implants according to references [1] or [2], it can be expected that metal stabilization will provide the desired straightening for a significantly longer period than would be possible with deformable bone, as is the case with some state-of-the-art implants. Finally, it can be assumed that an implant according to references [1] or [2] is significantly thinner than comparably stable cartilage, which has a positive effect on the desired airflow. Object of the invention

[0025] In contrast, the present invention is based on the objective of modifying a rhinological implant of the generic type according to reference [1] or [2] with the features defined above, using simple technical means, such that the device does not need to be placed over the dorsum-side part of the septum and attached to both sides of the nasal septum, but rather enables unilateral application. Furthermore, the manufacturing effort should be significantly reduced, and a considerable amount of material and weight should be saved. Brief description of the invention

[0026] This relatively complex task is solved in a surprisingly simple and cost-effective manner by ensuring that the implant has a flat shape and, in the implanted state, lies flat and fully in contact with only one of the two outer surfaces of the septum; that the implant has a triangular base body in which two cadre edges are arranged at a triangular angle φ towards each other, extending straight away from the apex of the triangle and on each side running towards a hypotenuse edge opposite the apex of the triangle; and that the triangular base body is extended at the two cadre edges by two side sections, each extending from the apex of the triangle beyond the hypotenuse edge, with the outer edges of the two side sections each running in line with their respective cadre edge.

[0027] Like 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.

[0028] The novel basic idea of ​​the invention is to present a unilaterally usable implant that is sutured to only one side of the septum cartilage. This significantly simplifies the implantation surgery because, to insert the implant, the nasal mucosa only needs to be lifted from the cartilage of the septum on one side in order to then insert the flat and rigid implant.

[0029] While theoretically two implants can be used on either side of the septum, for example to achieve particularly high mechanical stability or to correct asymmetrical deformities of the nasal septum more sensitively and effectively, even in such cases the absence of a nasal dorsum section on the implant according to the invention makes the surgery significantly less complex and therefore less stressful for the patient.

[0030] 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 opposing side section, 60-70% less material is required, which naturally also leads to a significant weight saving in the implant according to the invention.

[0031] Finally, the manufacturing process is also significantly simplified: The implant is always left in its original flat, unbent state as a blank. Subsequent straightening into a three-dimensional shape after punching out the flat blank (as is always mandatory with generic implants according to reference [1] or [2]) is now completely eliminated, which in turn contributes to a significant saving of labor in the production of the implant according to the invention.

[0032] This results in a particularly good geometric adaptation of the implant to the current, potentially severely deformed, shape of the patient's septum, despite the reduced manufacturing effort, and ensures a particularly secure attachment of the implant to one of its outer surfaces. In particular, no gaps form between the implant and the septum after the operation. Rather, the flat implant lies tightly against the septum over its entire surface facing the septum, which also results in exceptionally good mechanical retention of the implant.

[0033] Prefabricated implants according to the invention allow the procedure to be performed in a particularly reproducible, standardized, and predictable manner. Having a certain number of different sizes and shapes of the implant according to the invention available allows the surgeon to optimally address the individual geometric conditions of the patient's septum with particular precision. Preferred embodiments of the invention

[0034] Particularly preferred are embodiments of the implant according to the invention which are characterized by the fact that the apex of the triangle, and preferably also all other, at least the outer, corners of the implant, are rounded. This reliably prevents snagging or even impaling during implantation, and also eliminates the risk of injury in the implanted state due to any postoperative movement of the implant relative to its surroundings.

[0035] 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 “tongues” that extend on both sides of the triangular base body along the two catheti edges from the triangle apex beyond the hypotenuse edge and are particularly easy and precise to manufacture.

[0036] In one class of particularly preferred embodiments, the implant is constructed symmetrically with respect to a vertical axis running perpendicularly from the triangle's apex to the hypotenuse edge, which divides the implant laterally into two mirror-image halves. This symmetrical shape is particularly simple and precise to manufacture.

[0037] Alternatively, another class of embodiments of the invention is characterized in that the implant is asymmetrically constructed, wherein a first side section has a greater length extension from the apex of the triangular base body than the second side section. In this way, 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, within a range of different shapes and sizes.

[0038] As described above, the implant according to the invention has a multitude of perforations. This reduces the mass of the implant and thus its weight, while simultaneously minimizing the amount of foreign material introduced into the human body through the implant. Furthermore, the perforations promote the integration of the implant with the tissue.

[0039] The perforations are preferably present on both the triangular base body and the two side sections of the implant and can be designed, for example, as circular holes or as elongated holes.

[0040] Furthermore, these perforations also serve to securely fix the implant to the triangular cartilage of the septum by suturing it to the cartilage and / or the bony nasal floor, particularly to the inferior anterior nasal spur, using a surgical suture. This also ensures that the cartilage tissue and the perichondrium of the septum are adequately supplied with nutrients.

[0041] Creating a durable fixation of the implant by suturing it to the cartilage is generally time-consuming and sometimes somewhat complicated due to spatial constraints. Advantageous variants of the implant according to the invention are therefore characterized by the fact that one or more spikes are incorporated into the triangular base body and / or the side sections. These spikes anchor themselves in the septal cartilage during implantation, thus ensuring excellent and extremely durable fixation of the implant. This type of fixation can, of course, also be combined with other fixation methods described above to guarantee a particularly secure fit of the implant to the septum.

[0042] In further advantageous embodiments of the invention, the perforations of the implant together can have a larger surface area than the solid sections of the implant surrounding the perforations, in particular those shaped like ribs.

[0043] This allows the mass and therefore the weight of the implant according to the invention to be significantly minimized while maintaining high mechanical stability. It also ensures an adequate supply of nutrients to the cartilage tissue at the septum.

[0044] Preferably, in variants of the invention, at least some of the perforations can be polyhedral or honeycomb-shaped. This enables high stability even with minimal material usage.

[0045] However, at least some of the perforations can also be slit-shaped, preferably by means of elongated slits running parallel to each other. This makes, among other things, the suture placement easier for the implanting surgeon.

[0046] 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, significantly facilitates ingrowth into human tissue, and noticeably improves coverage by the soft tissues of the perichondrium and nasal mucosa.

[0047] In practice, embodiments of the invention have proven successful in which the thickness of the flat cut for the implant is between 0.2mm and 1.2mm, preferably about 0.8mm.

[0048] The implant according to the invention can have a maximum extent equal to that of an entire human nasal septum cartilage and has a maximum length in the cutting plane of between 2mm and 7mm, preferably about 5mm.

[0049] For the vast majority of conceivable applications of the implant according to the invention, embodiments are suitable in which the triangle angle φ at the apex of the triangular base body is between 60° and 120°, preferably about 100°. This shape serves to reinforce the implant and thus reduces the occurrence of bending due to external forces, similar to a gusset plate.

[0050] For some applications, it may be advantageous for the implant to be made entirely or partially of metal. Metals and their alloys are ideal materials for surgical and orthopedic implants intended to remain permanently in the body because, in addition to excellent biocompatibility, they exhibit high fatigue strength and elasticity. Despite their relatively low density, implants made of materials such as pure titanium or titanium compounds possess excellent mechanical properties and a long service life. Non-magnetizable metals and alloys, which also allow for MRI safety aspects, are also well suited for these purposes.

[0051] Preferred embodiments include those in which the implant is made of a material with a memory effect and / or superelastic properties, preferably nitinol, so that, for example, optimal spring properties relative to the septum can be achieved through suitable thermal treatment of the implant.

[0052] For other applications, it may be advantageous if the implant is made entirely of plastic or triangular material, particularly polymer material, preferably a material which has a similar flexibility to the human septum but has sufficient stiffness to straighten a deviated nasal septum in the long term, and without requiring a severing of the septum to cause weakening.

[0053] In addition to the good biocompatibility of the material itself, the implant may also have a special, biocompatible and / or germ-repellent coating.

[0054] To achieve a finely tuned shape for the implant, it can be expediently manufactured using 3D printing technology and / or laser technology.

[0055] 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 grinding or satellite centrifugal grinding, and / or by means of polishing technology, preferably electropolishing, or by etching technology.

[0056] Finally, in further advantageous embodiments of the invention, the implant is manufactured by injection molding using the micro injection molding (MIM) process, which is known per se, for example, from WO 00 / 06327 A2 (reference

[12] ). This allows for extremely cost-effective production of even very large quantities with consistent dimensional accuracy, whereas conventional implants are generally handmade, like jewelry, and are therefore relatively expensive to manufacture and can vary in dimensional accuracy.

[0057] 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, as well as from the claims. Detailed description of the invention based on the drawing

[0058] The schematic drawing shows embodiments of the invention, which are explained in more detail in the following description.

[0059] They show: Fig. 1 a schematic top view in a highly enlarged representation perpendicular from above onto the cutting plane of a symmetrical embodiment of the implant according to the invention with side sections formed exactly as mirror images of each other in large L-size; Fig. 2a the embodiment of Fig. 1, but in a slightly smaller (but still greatly enlarged compared to reality) representation; Fig. 2b the embodiment of Fig. 2a, but viewed from the side in the cutting plane; Fig. 2c the embodiment of Fig. 2a, but as a spatial representation with a view obliquely from above onto the top of the implant; Fig. 3a-c a similar embodiment as Fig. 2a-c, however with an embodiment of the implant according to the invention in medium M size; Fig. 4a-c a similar embodiment as Fig. 2a-c, however with an embodiment of the implant according to the invention in a smaller S-size; Fig. 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 asymmetric side sections in a large L size; Fig. 6 an embodiment of the implant according to the invention with asymmetrical side sections in medium M-size; and Fig. 7 an embodiment of the implant according to the invention with asymmetrical side sections in small S-size.

[0060] The rhinological implant 10; 20; 30; 40; 50; 60; 70, depicted 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 on the left and / or right side of the nasal cavity. When implanted, the implant 10; 20; 30; 40; 50; 60; 70 lies in full contact with this outer surface of the septum. It is constructed from a flat blank with several continuous perforations 15.

[0061] 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 and to minimize the amount of foreign material in the patient's body. Furthermore, the perforations 15 promote the integration of the implant 10; 20; 30; 40; 50; 60; 70 with the surrounding tissue.

[0062] In the embodiments of the invention shown in the drawing, the perforations 15 have a total area larger than the solid, rib-shaped sections 15' of the implant 10; 20; 30; 40; 50; 60; 70 surrounding the perforations 15.

[0063] The implant 10; 20; 30; 40; 50; 60; 70 is surgically inserted into the human nose using a procedure called open rhinoplasty and attached to the cartilage of the septum with sutures. Several individual sutures are placed and secured through the perforations 15 and the septum.

[0064] 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.

[0065] 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 to each other starting from a triangle apex S, lead straight away from the triangle apex S and on both sides run in the direction of a hypotenuse edge 14a opposite the triangle apex S.

[0066] The triangular base body 11; 21; 31; 41; 51; 61; 71 is extended at the two leg 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 vertex 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 line with their respective leg edge 12a,13a.

[0067] In all embodiments of the implant according to the invention 10; 20; 30; 40; 50; 60; 70 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' that runs parallel to their outer edge 12a' or 13a' at a distance.

[0068] The thickness of the flat blank for the implant 10; 20; 30; 40 is generally between 0.2mm and 1.2mm, preferably about 0.8mm, and the maximum longitudinal extent is between 2mm and 7mm, preferably about 5mm.

[0069] The triangle angle φ at the vertex 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°.

[0070] 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.

[0071] 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, may be rounded.

[0072] Also not 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.

[0073] The Fig. Figures 1 to 4c of the drawing represent embodiments of the invention in which the implant 10; 20; 30; 40 is constructed symmetrically with respect to an imaginary vertical axis extending perpendicularly from the apex of the triangle S to the hypotenuse edge 14a, which divides the implant 10; 20; 30; 40 laterally into two mirror-image halves.

[0074] As alternatives, the Fig. Figures 5 to 7 of the drawing show embodiments of the invention in which the implant 50; 60; 70 is asymmetrically constructed, wherein the first side section 52; 62; 72 has a greater length extension from the apex S of the triangular base body 51; 61; 71 than the second side section 53; 63; 73.

[0075] The implant 10; 20; 30; 40; 50; 60; 70 according to the invention can be made entirely or partially of metal, in particular of titanium, preferably of pure titanium or a titanium alloy, or of stainless steel and / or of a material with memory effect and / or superelastic properties, preferably of nitinol. It will preferably have a biocompatible, antibacterial coating.

[0076] The implant 10; 20; 30; 40; 50; 60; 70 may also be 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 a weakening.

[0077] The implant 10; 20; 30; 40; 50; 60; 70 can be manufactured using 3D printing and / or laser technology. It is also possible to manufacture and process the implant 10; 20; 30; 40; 50; 60; 70 using machining techniques, in particular milling and / or grinding, preferably vibratory finishing, magnetic vibratory finishing, or satellite centrifugal grinding, and / or polishing, preferably electropolishing, or etching. Furthermore, 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.

[0078] The main purpose of the implant according to the invention is to stabilize, splint, and straighten the anterior nasal septum up to the posterior (dorsal) end of the implant. Indications may include, for example, anterior septal deviations of up to approximately 15 mm resulting from trauma, congenital deviation, etc. Reference symbol list: 10; 20; 30; 40; 50; 60; 70 rhinological implant 11; 21; 31; 41; 51; 61; 71 Triangular base body 12,13; 22,23; 32,33; 42,43; 52,53; 62,63; 72,73 extending side sections 12a, 13a Leg 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 triangle apex φ Triangular angle Reference list:

[0079] Publications considered for the assessment of patentability: [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] Website from January 19, 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 10 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

Claims

[1] Rhinological implant (10; 20; 30; 40; 50; 60; 70) for straightening the nasal septum, which 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 fully 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 bythat the implant (10; 20; 30; 40; 50; 60; 70) has a flat shape and, in the implanted state, lies flat over its entire surface 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 (φ) to one another starting from a triangular vertex (S), lead straight away from the triangular vertex (S) and run on both sides in the direction of a hypotenuse edge (14a) opposite the triangular vertex (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 apex (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) are each aligned with their respective catheti edge (12a,13a). [2] Implant according to claim 1, characterized by 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. [3] Implant according to claim 1 or 2, characterized by 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. [4] Implant according to one of claims 1 to 3, characterized by that the implant (10; 20; 30; 40) is constructed symmetrically to a height axis running from the triangle apex (S) at right angles to the hypotenuse edge (14a), which divides the implant (10; 20; 30; 40) laterally into two mirror-image halves. [5] Implant according to one of claims 1 to 3, characterized by that the implant (50; 60; 70) is constructed asymmetrically, wherein a first side section (52; 62; 72) has a greater longitudinal extension away from the triangular tip (S) of the triangle-shaped base body (51; 61; 71) than the second side section (53; 63; 73). [6] Implant according to one of the preceding claims, characterized by 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). [7] Implant according to one of the preceding claims, characterized bythat 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. [8] Implant according to one of the preceding claims, characterized by 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. [9] Implant according to one of the preceding claims, characterized by 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. [10] Implant according to one of the preceding claims, characterized bythat the triangular angle (φ) at the triangle apex (S) of the triangular base body (11; 21; 31; 41; 51; 61; 71) is between 60° and 120°, preferably about 100°. [11] Implant according to one of the preceding claims, characterized by that the implant (10; 20; 30; 40; 50; 60; 70) has a biocompatible coating. [12] Implant according to one of claims 1 to 11, characterized by 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. [13] Implant according to one of claims 1 to 11, characterized bythat the implant (10; 20; 30; 40; 50; 60; 70) 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 curved nasal septum in the long term, and without requiring a severing of the septum to cause a weakening.

Images