Adhesive Film Bandage for Medical Compression

Abstract

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.

Claims

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.sup.2, when applying longitudinal expansions of 10-100%, and producing tensions of 1-40 N/mm.sup.22, b. a medical adhesive coated on at least a portion of the lower surface of said film, which is preferably pressure-sensitive and hypoallergenic, adhering to the upper side of the film with an adhesive force of 0.12-2 N/25 mm, and adhering to human skin with an adhesive force of 0.06-1 N/25 mm measured after 24 hours of wearing; c. a first release liner covering the adhesive surface of the film, for longitudinal removal; d. optionally, a second release liner, adhering to the non-adhesive side of the film, to serve as a carrier, for longitudinal removal, which is preferably transparent.

2. A composite according to claim 1, wherein the diameter reduction in superficial veins obtainable by the adhesive compression bandage film reaches or exceeds the diameter reduction achieved by phlebological textile short-stretch compression bandages in identical wrappings.

3. A composite according to claim 1 or 2, wherein the elastic film has a modulus of elasticity of 10-200 N/mm.sup.2, most preferably 20-50 N/mm.sup.2, when applying longitudinal expansions of 10-100%, preferably 20-75% and even more preferably 30-50% and producing tensions of 1-40 N/mm.sup.2, more preferably 2.5-25 N/mm2, most preferably 5-10 N/mm2.

4. The composite of any of the preceding claims, wherein a single layer closed loop of the composite achieves tissue pressures of 6-32 mmHg, preferably 8-24 mmHg, most preferably 10-18 mmHg, measured at the ankle of an average individual.

5. The composite of any of the preceding claims wherein the tensile strength of a longitudinal overlapping adhesive zone of 0.5-2 cm or of 5-15% of the bandage width in a single closed film loop to longitudinal strain is larger than the tear strength.

6. The composite of any of the preceding claims wherein the film is preferably 5-50 microns in thickness, more preferably 6-30 microns, even more preferably 7-20 microns;

7. The composite of any of the preceding claims, wherein the adhering film layer is vapor permeable with a moisture vapor transmission rate (MVTR) of 100-2000, preferably 300-1500, more preferably 500-1000 g/m.sup.2/24 hrs/37 C. (10%-100% relative humidity) when measured according to DIN EN 13726.

8. The composite of any of the preceding claims, wherein the film layer coated with adhesive is transparent to ultrasonic imaging.

9. The composite of any of the preceding claims, wherein the film layer or the adhesive comprises elastic fibres or elastomeric elements in longitudinal orientation, which are preferably transparent.

10. The composite of any of the preceding claims, wherein the film layer comprises an indicator for stretching.

11. The composite of any of the preceding claims, wherein the first release liner covering the adhesive side of the film is adhering with an adhesive strength of 0.001-0.05 N/25 mm, preferably 0.01-0.04 N/25 mm, even more preferably 0.015-0.03 N/25 mm, optionally provided with non-stick media, like silicon oil or wax to limit the adhesion, while the optional second release liner in an inelastic embodiment adheres to the films upper surface either in the same range like the first release liner, and in an elastic embodiment it adheres with an adhesive strength of 0.01-0.2, preferably 0.02-0.15, even more preferably 0.03-0.1 N/25 MM.

12. The composite of any of the preceding claims, wherein at least one of the release liners has separation means running along the width of the release liner to provide separately removable release liner portions with a length of 1-12 times of the width of the first release liner, preferably 2-8 times and more preferably 3-5 times.

13. The composite of any of the preceding claims, wherein the first release liner is substantially non-elastic, while the second release liner in one embodiment is non-elastic for longitudinal removal prior to adhering the film, while in another embodiment the second release liner is elastic and expandable together with the film. The restoration force of the elastic release liner is limited to 5-50%, preferably 10-25% of the film's restoration force.

14. A dispenser comprising a roll of the composite according to any of the preceding claims.

15. The dispenser of claim 14 comprising means for exercising resistance against winding off the composite, wherein winding off is prevented up to 3.0 N.

16. The composite according to claims 1 to 13 or the dispenser according to claims 14-15 for use as a medicament.

17. The composite according to claims 1 to 13 or the dispenser according to claims 14-15 for use in treating venous diseases, tissue lesions or varicose veins.

18. A pharmaceutical composition for use in the treatment of varicose veins comprising: a. a polymeric substance; b. a medical adhesive; wherein the polymeric substance forms a. an elastic film with a modulus of elasticity of 5-400 N/mm2, when applying longitudinal expansions of 10-100%, and producing tensions of 1-40 N/mm22; wherein the medical adhesive is preferably pressure-sensitive and hypoallergenic, adhering to the upper side of the film with an adhesive force of 0.12-2 N/25 mm, and adhering to human skin with an adhesive force of 0.06-1 N/25 mm measured after 24 hours of wearing.

Description

FIGURE CAPTIONS

[0110] FIG. 1: Layers of the compression film bandage composite: a film layer (A), a medical adhesive (B) which is preferably pressure-sensitive coated on at least a portion of one surface of the film layer, a first release liner (C) covering the adhesive, and optionally, a second release liner (D) reversibly adhered to the upper film side to serve as a carrier, and optionally, perforations (e1, e2) and tab means (e2) of one or both release liners to ease the longitudinal removal.

[0111] FIG. 2a: Pattern of a leg cross section with varicose vein (A), with concentric compression (B) applied by arbitrary media. Conventional media like compression stockings or bandages and the novel adhesive compression bandage film do not differ much in the concentric compression effect, but they differ in the summary result due to the adhesive effect of the film. Furthermore, the compression film bandage can be worn 2 weeks or longer without interruption or exchange.

[0112] FIG. 2b: Pattern of a leg cross section with additional compression effect by the adhesive, discernible from the decreased vein diameter, when using a compression film bandage according to the invention.

[0113] FIG. 3a: Detailed pattern of a superficial varicose vein bulging over skin level.

[0114] FIG. 3b: Gap areas (black arrows) resulting along superficial veins when using non-adhesive bandage media, due to the blood pressure (white arrow) enlarging varicosities in the standing patient. Strong adhesion could prevent this loss of effectivity.

[0115] FIG. 3c: Pattern of the same superficial vein when the leg is elevated. The blood leaves the vein due to gravitation, and the vein shrinks to a minimum. This may be less than 20% of the size in the standing patient. The phenomenon is well known, as even legs severely diseased with varicosities look nicely when the leg is elevated.

[0116] FIG. 3d: When the adhesive compression film bandage is fixed on the elevated leg, it will keep the diseased vein small and under skin level even when the patient is in upright position.

[0117] FIG. 3e: Detailed pattern of the adhesive elastic film bandage, sticking firmly to the skin, forming a functional unit with the skin, executing a) concentric compression (dashed arrows) increasing the tissue pressure, and b) by the tight adhesive connection between film and skin (grey arrows), effectively limiting the space of the diseased vein to expand.

[0118] FIG. 4: Typical strainelongation diagram of a compression film bandage according to the invention (B) in a. Y-axis: tension in N/mm.sup.2; x-axis: elongation in %. Dashed straight line: Example for linear elasticity between 20 and 50% elongation. For the invention, the deviation of strain values to a linear progression should preferably not differ for more than 30% between 20 and 50% elongation (working range for film application, shaded area).

[0119] FIG. 5: ultrasound findings and corresponding scheme, 7 days after endoluminal occlusive vein therapy, A) when using textile bandage (short-stretch, standard in phlebology), showing a first thrombus formed at maximum compression effect (*), and evidence of a secondary re-entering blood and increase of diameter. Possible reasons: Discontinuation of bandage wearing, bandage exchange, loss of elasticity. Consequence: delay in vein regression. B) shows a similar vein after using a compression film bandage according to the invention, showing a homogenous echo signal without signs of re-entered blood.

[0120] FIG. 6: Comparison of a common elastic wound dressing (patch 10 x 10 cm, ruptured at 56% elongation) and an adhesive compression film bandage (acfb) according to the invention in a strain-elongation-diagram. Y-axis: tension in N/mm.sup.2; x-axis: elongation in %.

[0121] FIG. 7: Comparison of the elastic behavior of common short-stretch bandages (A) and a compression film bandage according to the invention, 25 cm long samples each, (B) in a strainelongation diagram. Y-axis: tension in N/mm.sup.2; x-axis: elongation in cm.

[0122] FIG. 8: Photograph of a varicose vein before treatment (A), after 7 d (of 14) with adhesive compression bandage (B), final result (C).

[0123] FIG. 9: Polyurethane film at lower limb: Brownish discolorations along former vein course above film edge (arrows), no discolorations within film compressed zone. The whole leg had been covered by a medical compression stocking German class II. The film was worn for 10 days, patient took showers 7 times. Film edge was slightly damaged by friction mediated by stocking while walking.

[0124] FIG. 10: Identical spot of of lower limb in ultrasound imaging: a) non-compressed vein before application of compression film bandage, b) vein after positioning a polyurethane film bandage of 25 microns thickness and 100 mm width, one closed circle, acrylic glue, tension applied during application: 16-18 N/mm.sup.2