HK1110766A - Implant for splaying alar wings of the nose - Google Patents

Description

The invention relates to a roof-shaped implant for spreading the nasal fins, which is attached to the triangular cartilage of the human nose and is made of a strip initially flat, curved into a roof shape.

Such an implant for the spread of the nasal fins has been made known, for example, by EP 1 475 056 A1.

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

A widening of the nostrils may be indicated, for example, by a narrowing of the nasal valve or by a collapse of the soft parts of the nostrils.

A simple and well-known method of spreading the nasal fins is to use a nasal patch, which is used by high-performance athletes to improve nasal breathing. However, this procedure is not suitable for permanent use. Regular use of the patches can cause skin problems due to the glue.

Since it is preferable to use cartilage from the patient's own body for stabilization, removal of cartilage, preferably from the patient's ear or nasal septum, must precede this step, which is time-consuming and an additional risk to the patient. Opening the nose shows that the part used has too little internal tension to open the nasal cavity in a satisfactory manner. The procedure even proves to be counterproductive because the narrow parts can keep themselves open and narrow after a narrowing of the nose.

Metal implants are also used to spread the nasal fins, by surgically opening an opening in the nasal wing area through which the implant is inserted and attached to the triangular cartilage. Metal implants are much firmer and more elastic than cartilage and have sufficient internal tension to keep the nasal air space open in a durable and satisfactory manner.

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Other nasal implant devices allow for implants according to EP 1 475 056 A1, in which the flat strip is also bent from the plane into a spatially V-shaped roof shape, but already has an angular contour in the plane, in particular a V-shaped or trapezoidal contour.

The triangular cartilage of the human nose is known to have a relatively flat or at least very slightly curved plateau area. The disadvantage of all known implants is that they are so strongly curved around the back of the nose that in the implanted state in the area of this plateau of the triangular cartilage a cavity is formed between the triangular cartilage and the implant, which can lead to an unfavorable healing behavior after implantation and possibly to uncontrolled growth of tissue accumulations.

The purpose of the invention is therefore to modify by simple technical means an implant of the type described at the outset in such a way as to avoid these disadvantages and to ensure that the implant is as close as possible to the triangular cartilage after surgery.

This task is solved in a surprisingly simple and cost-effective way by having a back section of the implant above the back of the nose flat or only very slightly angled against the triangular cartilage plane with a spreading angle ω> 160° or barrel-shaped with a radius of curvature r> 4 cm, preferably r> 10 cm, curved around the triangular cartilage plane and having two lateral sections of the implant on either side of the nasal fins essentially parallel to the respective nasal fins at an angle φ of more than 50° each to the flat back section.

This allows the implant to be fitted to the (normal) shape of the human triangular cartilage without any major manufacturing effort, and in particular, no cavities are created between the implant and the triangular cartilage after the operation, neither in the area of the triangular cartilage plateau nor on its flanks.

In a preferred embodiment of the invention, the two lateral sections of the flat strip are widened to their free ends, which allows the nostrils to be spread or stabilized over a large area.

Metals and their alloys are predestined as materials for surgical and orthopedic implants, because in addition to being very biocompatible, they have high durability and elasticity. Despite a relatively low density, implants made of such materials as titanium or titanium compounds have excellent mechanical properties with a long life. Also a good fit for the aforementioned purposes is stainless steel.

The flat band can be trapezoidal and/or have more complicated structures with branches that can be used to stabilize, for example, the back of the nose after the implant is bent into its final spatial shape.

In an advantageous design, the flat strip or the finished implant may have perforations, which on the one hand reduce the weight of the implant and on the other hand reduce the proportion of foreign material introduced into the human body by the implant as far as possible. In addition, the perforations promote the growth of the implant with the tissue. The perforations are preferably intended both on the lateral sections of the implant and on the back section between them and are formed, for example, as circular holes or as long holes.

The perforations also serve to secure the triangular cartilage with a suture.

In addition to the good biocompatibility of the material itself, the flat strip or implant may also have a special, body-compatible coating.

To obtain a finely tuned shape of the flat strip or implant, it may be appropriate to produce it by laser technology.

The most particularly preferred embodiments of the invention are characterized by the fact that the free ends of the two lateral sections of the implant are edged downwards at an even greater angle to the back than the other parts of the lateral sections, thus achieving a special attachment to the triangular cartilage.

In favourable extensions of these embodiments, the edge angles of the free ends of the two side sections are designed so that the side sections in the implanted state are in close spatial contact, in particular in a preferably symmetrical clamping with the triangular cartilage, which is under tension on both sides, which contributes to a particularly good implant position.

In other advantageous embodiments of the invention, the flat strip or the implant is manufactured in injection moulding using the Micro Injection Moulding (=MIM) process, which is known for example from WO 00/06327 A2. This allows extremely low cost production of very large quantities with the same precision, whereas conventional implants are usually handmade like jewellery and therefore relatively expensive to produce and can vary in precision.

Finally, embodiments of the invention in which the flat strip or implant is made of a material with superelastic properties, preferably nitinol, are also particularly desirable, so that, for example, by appropriate heat treatment, the implant can be given optimal spring properties relative to the triangular cartilage.

Further features and advantages of the invention are described in detail below, using the figures of the drawing showing the essential details of the invention, and the claims. The individual features may be realized individually or in any combination of several of them in the case of variants of the invention.

The schematic illustration shows examples of the invention, which are described in more detail in the following description.

It shows: Fig. 1a perspective view of a first embodiment of an implant of the invention with a flat back section;Fig. 2a schematic frontal view of the implant of Fig. 1 seen in a direction parallel to the upper edge of the nasal cavity;Fig. 2a schematic frontal view of a second embodiment of an implant of the invention with a back section slightly angled against the plateau area of the triangular cartilage; andFig. 3a schematic view of a flat sub-section for an implant of the invention.

Figure 1 shows in perspective a first possible embodiment of an implant according to the invention 11 This is made of a flat strip 10 as schematically shown in Figure 3 and curved into a roof-like space.

The stripe is curved in the plane 10 V and has a rounded tip. It has a series of regular perforations 15 which help to reduce the weight of the implant 11 on the one hand and to reduce the proportion of foreign material in the patient's body as much as possible on the other. In addition, the perforations 15 promote the growth of the implant 11 with the tissue. The implant 11 is operatively inserted into the nose by an open rhinoplasty under the wingtips and fixed on the triangular cartilage by a suture.

It is clear from Figures 1 and 2a that the embodiment of the implant 11 according to the invention shown therein has a flat back section 12 which is placed in the implanted state above the back of the nose. On either side of the nose wing two side sections 13, 14 of the implant 11 run essentially parallel to the respective nose wing at an angle φ of more than 50° each downwards from the flat back section 12, as shown in particular in Figure 2a. The free ends 16, 17 of the two side sections 13, 14 of the implant 11 run at an even greater angle to the back section 12 than the parts of the cut side 13, 14 of the implant, with the remaining ends of the implant 13 being in such a close contact with the implant, that the three ends, particularly the end of the cut side 13, 14 are in such a way that they are in free contact with the back section 13 at a narrow angle, so that the other three ends, 13 and 14 of the implant, are in such a way that they are in close contact with the implanted side, especially at the opposite corner.

The back section of the implant according to the invention does not have to be 100% flat, however. It may also have a very slight angle or a very slight curvature in the case of embodiments, without losing the advantages of the invention in general. On the contrary, in some people the plateau-shaped area of the triangular cartilage is also not completely flat, but very slightly arched, so that such embodiments can be used to make a particularly good geometric adaptation of the implant to the individual circumstances of the patient.

In Fig. 2b, therefore, an embodiment is shown in which the implant 11' has a very slightly angled back section12' against the triangular cartilage plane with a spreading angle ω > 160°. Here again the two lateral sections 13', 14' of the implant 11' run essentially parallel to the respective nose wing at an angle φ of more than 50° each downwards from the flat back section 12' and run again into free ends 16', 17' which are angled downwards from the back section 12' by an even greater angle than the other parts of the lateral sections 13', 14'.

In addition to the slight deflection shown in Fig. 2b, the back part of the implant of the invention may, in other embodiments not shown in the drawing, have a very slight barrel-shaped curvature with a relatively large radius of curvature r> 4 cm, preferably even r> 10 cm, around the triangular cartilage plane.

Claims (13)

1. A roof-shaped implant for spreading the nasal fins, which is attached to the triangular cartilage of the human nose and is made of a strip (10) which is curved at first flat into a roof shape, characterised by a back section (12; 12') of the implant (11; 11') above the back of the nose being flat or only very slightly angled against the triangular cartilage plane with a spreading angle ω> 160° or a tonne-shaped implant with a radius of curvature r> 4 cm, preferably r> 10 cm, curved around the triangular cartilage plane and by two lateral sections (13, 14; 13', 13' (114') '); the two sides of the implant running parallel to the nasal plane at an angle of more than 50° (12; 12') to the back of the nose, each running at a flat angle to the nose.
2. Implant according to claim 1, characterised by the widening of the two lateral sections (13, 14; 13', 14') of the flat strip (10) to their free ends.
3. Implant according to one of the above claims, characterised by the fact that the flat strip (10) or the implant (11; 11') is made of metal, in particular titanium, titanium alloy or stainless steel.
4. Implant according to one of the above claims, characterised by the fact that the flat strip (10) has an angular outline, in particular a V-shaped or trapezoidal outline with or without branches.
5. Implant according to one of the above claims, characterised by having flat strips (10) or perforations (15) on the implant (11; 11').
6. Implant as claimed 5, characterised by the perforations (15) being provided on both the lateral (13, 14; 13', 14') and the intermediate dorsal (12; 12') sections of the implant (11; 11').
7. Implant according to claim 5 or 6, characterised by perforations (15) in the form of circular or elongated holes.
8. Implant according to one of the above claims, characterised by a flat strip (10) or an implant (11; 11') with a body-compatible coating.
9. Implant according to one of the above claims, characterised by the fact that the flat strip (10) or the implant (11; 11') is produced by laser technology.
10. Implant according to one of the above claims, characterised by the free ends (16, 17; 16', 17') of the two lateral sections (13, 14; 13', 14') of the implant (11; 11') being edged downwards at an even greater angle to the dorsal section (12; 12') than the other parts of the lateral sections (13, 14; 13', 14').
11. Implant as claimed 10, characterised by the edge angles of the free ends (16,17; 16',17') of the two side sections (13, 14; 13',14') being such that the side sections (13, 14; 13',14') are in close spatial contact with the triangular cartilage in the implanted state, in particular in a preferably symmetrical clamping with tension on both sides.
12. Implant according to one of the above claims, characterised by the fact that the flat strip (10) or the implant (11; 11') is manufactured in injection moulding using the Micro Injection Moulding (=MIM) process.
13. Implant according to one of the above claims, characterised by the fact that the flat strip (10) or the implant (11; 11') is made of a material with a memory effect, preferably nitinol.