Adhesive film bandage for medical compression
The present invention relates to a transparent elastic compression bandage film composite for the treatment of venous diseases and tissue lesions, comprising a transparent film layer of 5-50 microns thickness, a medical adhesive coated on at least a portion of one surface of the film layer, which is preferably hypoallergenic, a first release liner for longitudinal detachment covering the adhesive film surface and, optionally, a second release liner for longitudinal detachment to serve as a carrier, wherein the effects of elasticity and of strong adhesion add to a compression quality superior to textile European standard compression media, in the main affecting superficial varicosities and long-term wearing.
1. A film compression bandage composite using elastic forces combined with adhesive forces, for compression treatment of venous diseases and tissue lesions, comprising
a. an elastic film with a modulus of elasticity of 5-400 N/mm 2 , when applying longitudinal expansions of 10-100%, and producing tensions of 1-40 N/mm 2 ,
b. a medical adhesive coated on at least a portion of a lower surface of the elastic film, which is pressure-sensitive and hypoallergenic, configured to adhere to an upper surface of the elastic film with an adhesive force of 0.12-2 N/25 mm, and configured to adhere to human skin with an adhesive force of 0.06-1 N/25 mm measured after 24 hours of wearing; and
c. a first release liner covering the medical adhesive coating, for longitudinal removal, wherein the lower surface of the elastic film is coated homogenously and in an uninterrupted manner by the medical adhesive coating, and wherein the elastic film is transparent to ultrasonic imaging.
2. The composite of claim 1 , further comprising a second release liner adhering to the upper surface of the elastic film, and configured to be removed prior to adhering of the medical adhesive coating.
3. The composite of claim 2 , wherein the second release liner
a. is inelastic, wherein the second release liner is configured to adhere to the upper surface of the elastic film with an adhesive force of 0.001-0.05 N/25 mm, or
b. is elastic, wherein the second release liner comprises an adhesive strength of 0.01-0.2 N/25 mm.
4. The composite according to claim 1 , wherein the elastic film has a modulus of elasticity of 10-200 N/mm 2 when applying longitudinal expansions of 10-100% and producing tensions of 1-40 N/mm 2 .
5. The composite of claim 1 , wherein a tensile strength of the elastic film is 5-50N/25 mm.
6. The composite of claim 1 , wherein the elastic film is 5-50 microns in thickness.
7. The composite of claim 1 , wherein the elastic film is vapor permeable with a moisture vapor transmission rate (MVTR) of 100-2000 g/m 2 /24 hrs/37° C. (10%-100% relative humidity) when measured according to the test methods for primary wound dressings set forth in European Standard EN 13726.
8. The composite of claim 1 , wherein the elastic film or the medical adhesive coating comprises elastic fibres or elastomeric elements in a longitudinal orientation.
9. The composite of claim 1 , wherein the elastic film comprises an indicator for stretching.
10. The composite of claim 1 , wherein the first release liner comprises an adhesive strength of 0.001-0.05 N/25 mm.
11. The composite of claim 1 , wherein the first release liner has separation means running along the width of the first release liner to provide separately removable release liner portions with a length of 1-12 times of the width of the first release liner.
12. The composite of claim 1 , wherein the first release liner is non-elastic.
13. A dispenser comprising a roll of the film compression bandage composite according to claim 1 .
14. A method of treating a condition, comprising applying the film compression bandage composite of claim 1 to a patient.
15. A method of treating venous diseases, tissue lesions or varicose veins, the method comprising applying the film compression bandage composite of claim 1 to a patient.
16. A method for treating varicose veins, comprising applying the film compression bandage composite of claim 1 to a patient.