Instrument and use of instrument for correcting the shape of...

Surgery – Instruments – Surgical mesh – connector – clip – clamp or band

Reexamination Certificate

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C606S001000

Reexamination Certificate

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06517557

ABSTRACT:

BACKGROUND ART
The invention concerns an instrument for correcting the shape of an external ear.
Quite a lot of people have shape external ear shapes which deviate from the average. The deformaties are of different kinds which each give the ear a characteristic shape, such as e.g. jug ears, lop ears, cop ears or Stahl's ears.
Most people with deformed ears suffer a lot from the fact that they differ from other people in such an unfortunate and conspicuous way.
Thus, jug ears can result in bantering and psychosocial problems among children and in some cases cause low self esteem. Among adults, jug ears can be a cosmetic and/or psychological problem.
Problems with protruding ears can also be of purely physical kind. Some people experience that their ears get burnt in the summer. Others have problems wearing bicycle or motorcycle helmets.
Deformed ears can be corrected surgically which also do takes place to a grear extent. About 2,000 patients with jug ears undergo operations each year in Denmark alone.
There are many different ways to operate for jug ears. Some are relatively simple, others more complicated. However, the surgical operations involve pain or soreness to some extent, this can last for a period of time of a few months to several years after the operation is performed.
Another disadvantage is that the patients after the operation must wear a bandage, which looks like a turban, for ten days in order to give the cartilage time to heal in the wanted position. Some patients furthermore have to sleep with a kind of nightcap for three weeks before the result turns up to be satisfactory.
Furthermore, an operation is usually accompanied by adverse effects. Irregular anthelix and small left cartilage prominences can thus be formed. These can be painfull and cosmetically unsatisfactory to the patient. There is furthermore a risk of infection and embarrassing scars.
A number of researches have shown that it is possible to, during the neonatal period and early childhood, permanently correct jug ears and other deformaties on the auricula in a few days merely by means of surgical tape. It is assumed that it i.a. is because of the high content of oestrogen in the blood of small children that the ear cartilage is soft and relatively easy to shape.
In order to avoid the above-mentioned disadvantages of surgically correcting jug ears, means have been developped for drawing jug ears closer to the side of the head. In these cases, any actual treatments are not done. Only a temporary, cosmetic amelioration of the ear's appearance takes place.
By way of example, a method may be mentioned in which two discs are used, the discs are attached behind the auricula and on the side of the head, respectively. When the discs then are pressed together, the ears are drawn closer to the head. This method is disclosed in the patent document WO 94/09731.
Cosmetic means of the above-mentioned kind are furthermore known from U.S. Pat. Nos. 516,135, 543,455, 1,062,654, 1,338,090, 2,339,572, 2,896,613, 3,154,071, 3,238,938, 3,695,256, 4,187,838, and 1,050,744.
The object of the invention is to provide a instrument of the kind mentioned in the opening paragraph whereby a deform ear more easily and effectively than known per se can be corrected non-invasive.
SUMMARY OF THE INVENTION
The novel and unique features according to the invention, whereby this is achieved, is the fact that correction takes place by, from two sides, affecting a chosen zone of the ear for a relatively long period of time with forces for giving the cartilage of that zone a permanent deformation.
The stress affections generates bending, stretching, and squeezing forces in the cartilage of the zone. Thereby, ruptures in the perichondrium of the cartilage are made with a subsequently appositional cartilage growth which corresponds to the perichondrium on the convex side of the bending. The cartilage thereby increases in thickness and a permanent folding of the cartilage is obtained. This effect is best obtained in early childhood.
The invention also concerns the use of an instrument for correcting the shape of an external ear. The novel and unique features according to the invention are the fact that the instrument comprises a first and a second part which are interconnected by a swing connection, and which is made to, from each side, interactingly affect a chosen zone of the ear for a relatively long period of time with forces for giving the cartilage of that zone a permanent deformation.
This instrument will stress exactly the cartilage in the chosen zone without surgical intervention whereby the aspired deformation of the ear is effectively obtained. The instrument is so easy to operate that the patient easily and conveniently can attach it to his ear himself and take it off again as required.
The instrument can furthermore be used postoperatively in stead of the conventional turban-like bandage for patients who have chosen to undergo an operation for e.g. a jug ear.
In an especially advantageous embodiment, the swing connection can be shaped as a hinge with arms which at one end are connected to either the first or the second part and at the other has a swing bed for a mutual joint pivot. The pivot can furthermore be shaped as a screw while one of the hinge beds has a female thread which fits the screw. On opposite surfaces of at least two adjacent beds, radial grooves and ribs for, when tightening up the screw, locking the arms in a chosen mutual angle position can furthermore be made alternately.
When the instrument is to be applied, the two parts are by a light manual pressure fixed around the zone where e.g. an anthelix is to be made. The position is then locked by tightening the screw. The instrument is now securely fixed on the ear. During this, its two parts are exerting a constant pressure on the cartilage of the correcting zone which thereby gradually change structure. After a space of time which can vary from a few weeks to a couple of months, the zone has thereby been forced to permanently assume the desired new shape. The ear has been corrected and the instrument can be taken off.
Naturally, the instrument can also be taken off during the correcting period for example in order to tend to the personal hygiene. Thereby, the pressure is temporarily relieved in the correcting zone but when the instrument is reattached on the ear, the above-mentioned successively structurel change process continues.
The instrument fits tightly on the ear without looking conspicuous and blemishing the appearance of the ear. The patient can therefore wear the instrument everyday without cosmetic inconveniences and even have ears which already have the desired resulting shape.
The two parts of the instrument can appropiately be a patrix and a matrix respectively for interactingly affecting the zone with forces from each side of the ear. By, from the posterior side of the ear, folding a zone between helix and concha into the matrix, which is acting on the anterior side of the ear, a permanent anthelix can be made with this construction. Cop ears can be corrected in the same way, and lop ears and Stahl's ears can be corrected by a process affecting reversely.
The cartilage in the correcting zone can have slightly different thicknesses, and it will therefore be an advantage if the above-mentioned matrix is made of a relatively thin, elastic material which allows the matrix to elastically adapt itself to the dimensions of the cartilage of the zone.
To ensure the blood supply to the ear cartilage, the inside of the matrix and the outside of the patrix can furthermore have different patterns in the shape of e.g. elevations. The best result is obtanied when the pattern on the matrix is symmetrical to the patterne of the patrix when the instrument is in its position of use.
In an especially simple embodiment, the swing connection can be a mainly U-shaped spring which advantageously can be shaped as an ear ring so that the instrument looks like an ornament.
When the two legs of the U at the same time form the first and the second part respe

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