Flexible adhesive element for external medical use in the treatm

Surgery: splint – brace – or bandage – Bandage structure – Skin laceration or wound cover

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450 81, A61F 1300, A41C 300

Patent

active

05998693&

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a flexible adhesive element for external medical use in the treatment of hypertrophic or cheloid scars following breast surgery.


BACKGROUND OF THE INVENTION

The state of the art is illustrated by document WO-A-88 06877 which describes an adhesive medical patch for protecting the nipple and the areolar zone of the breast following a surgical operation. The patch is circular and it is held in place by four adhesive tabs in a cross-configuration. As a result, the zone concerned of the breast is very limited.
To complete the state of the art, mention may also be made of other devices which are not for medical use, but which are designed to provide satisfactory support for the breast. These comprise, in particular, stick-on bra type devices (see for example documents FR-A-2 505 620 and U.S. Pat. No. 2,869,553) or devices of the molded shell type designed to serve as a stiffener that can be implanted in a traditional bra (see for example document BE-A-482 682).
Breast surgery, whether for repair purposes or for reconstruction purposes, requires the use of several types of surgical techniques, and the surgeon selects the technique which is most suited to the shape of the breast. Mention can be made of the peri-areolar technique which leaves a substantially circular scar in the areolar zone of the breast. There are also the L-technique and the T-technique which leave a scar formed by a first line going down from the peri-areolar zone of the breast to the fold under the breast, and a second line (straight or curved) extending along the fold under the breast, on one or both sides of the first line. The L- or T-technique can also be combined with the peri-areolar technique, in which case the first scar line is topped by a substantially circular scar.
Such scars are difficult to treat to obtain good appearance since the breast is a soft organ that is difficult to compress, particularly in its peri-areolar zone. Also, patients are naturally disinclined to use a rigid or semi-rigid element or a strap partially or completely surrounding the bust in order to exert localized pressure on the scar zones.
It can then be tempting to use a flexible element of the same type as is used already for the treatment of scars in a zone of the body having bony support, but that leads to several difficulties.
For example, flexible elements are known that are made from a non-adhesive gel based on silicone or on three-block copolymers, said gels for medical use generally being packaged in the form of patches, bands, or strips. Such patches, bands, or strips present advantageous flexibility, but they are thick (3 mm to 5 mm in general), which spoils appearance, and they require additional means to put them into position and to hold them in place (adhesive strips, etc.), such that applying such flexible elements to the treatment of breast scars would give rise to considerable risk of undesirable movement giving rise to poor positioning relative to the patient's bust, and consequently to reduced therapeutic effect. In addition, and particularly with bands, they also exert pressure on an area which is not limited to the scar zone that is to be treated, and that presents a major drawback of the element's occlusive effect and because of the resulting risk of maceration. Consequently, such a flexible element appears to be difficult to apply in treating scars following breast surgery.
Flexible elements are also known that are constituted by a silicone-based film having one face coated in an adhesive gel based on silicone (see for example document U.S. Pat. No. 4,991,574). These are dressings for applying to open wounds or to scars, which dressings are cut from a rectangular patch which is generally 10 cm.times.15 cm. However, that type of flexible element is also relatively thick (generally at least 3 mm to 4 mm), and of very limited flexibility; such that the traumatizing nature of wearing such an element is further reinforced because it is conspicuous. The poor flexibility of an element of that type makes it d

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