Adhesive film bandage for medical compression

Abstract

To provide a transparent elastic compression bandage film composite for the treatment of venous diseases and tissue lesions.SOLUTION: The present invention relates to an elastic compression bandage film composite comprising a transparent film layer of 5-50 microns thickness, a medical adhesive B coated on at least a portion of one surface of the film layer, which is preferably hypoallergenic, a first release liner C for longitudinal detachment covering the adhesive film surface and, optionally, a second release liner D for longitudinal detachment to serve as a carrier, where 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.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention is in the field of medicine and cosmetics, in particular in the field of venous disease, edema, and tissue damage. The present invention is also in the field of drugs / medical devices for treating such diseases. [Background technology]

[0002] Several conditions, such as venous insufficiency, edema, and tissue injury, are commonly treated with compression. The purpose of compression is to limit blood or fluid extravasation, hematoma, and tissue swelling, to reduce pain, or to act as a prophylaxis against thrombosis by increasing the flow rate within the vessel while decreasing its diameter. Compression bandages can also be used to secure resorbable media in wound management.

[0003] For example, compression strategies after venous surgery are intended to prevent bleeding from wounds and locations where blood vessels or tissue have been excised. Secondly, the reduction in vessel diameter increases flow velocity, thus preventing thrombosis. An additional benefit is the prevention of post-traumatic swelling. In a similar manner, compression has been applied after other types of surgery, such as liposuction.

[0004] Varicose veins are enlarged, intricate veins. Although the term generally refers to veins in the legs, varicose veins can occur elsewhere. They are most common in the superficial veins of the legs, which are exposed to high pressure when standing. In addition to cosmetic problems, varicose veins are often painful due to congestion, especially when standing or sitting. Oxygen transfer is restricted, metabolic products become locally concentrated, and skin changes such as inflammation, induration, and discoloration commonly occur after years of disease. Ulcers are a typical late manifestation of varicose veins and venous insufficiency. Spider veins are small varicose veins. They are considered merely a cosmetic problem unless accompanied by other symptoms.

[0005] Treatment of varicose veins and venous insufficiency has shifted to catheter-based interventional techniques using laser light, radiofrequency or steam energy, or chemical agents. The veins remain in place but are occluded, and continuous regression occurs over weeks and months until only visible strands of connective tissue remain. Superficial varicose veins, once surgically removed, are now often treated with interventional techniques, particularly foam sclerotherapy. Postinterventional compression is essential for several weeks after these treatments to aid and enhance the vein regression process. In superficial varicose veins, compression also prevents symptomatic phlebitis, inflammatory responses, noticeable clots, or discoloration due to the excessive metabolism of clotted venous blood.

[0006] In current medical routine, venous or tissue compression is achieved with stockings or bandages made from textiles containing elastic elements, such as rubber or polymer fibers. Long-stretch compression bandages have a long-stretch property, meaning that their high compression force can be easily adjusted. Long-stretch compression bandages also exert higher pressure during rest, typically requiring removal at night to avoid pain and discomfort. Therefore, short-stretch compression bandages are generally preferred for the treatment of venous disease. Typical stretchability is 60–90%. However, due to the low content of elastic elements, the recovery force is weak during the first few centimeters of stretch, then suddenly increases, quickly becoming nearly rigid due to the inelastic elements (Figure 7). This property contributes to a lack of comfort, especially during work or sports.

[0007] Woven bandages must be renewed daily or every few days. For the long-term treatment of venous insufficiency, compression stockings, made of elastic fibers or a woven composite of woven and elastic fibers, have been developed. Unlike traditional dressings, athletic stockings, and socks, compression stockings use stronger elastic to create significant pressure in the legs, ankles, and feet. However, compression stockings usually must be removed overnight because they are simply uncomfortable or even lead to ischemic pain. This presents a drawback for their initial use after intravenous treatment, as the loss of pressure allows the treated veins to refill with blood, resulting in a longer healing period.

[0008] In a study of venous diameter after intraluminal occlusion treatment, the inventors discovered a specific ultrasound pattern not previously reported or described: cross-sectional ultrasound images of occluded vessels showed a single circular structure of moderate signal intensity within the venous equivalent circle (Figure 5). This specific pattern was present in up to 80% of cases at week 4 but was not observed in subsequent examinations. A homogeneous cross-sectional signal intensity is usually considered to represent a thrombus within the tissue. By focusing on patients undergoing weekly examinations, we were able to confirm that this specific pattern was generated during the phase when pressure was reduced, such as after bandage removal. When pressure on the treated vein was relieved, non-coagulated blood entered the vein, filling the space between the existing thrombus and the vein wall, increasing the vein diameter. Due to its high water content, the newly entering blood subsequently coagulated and appeared at low signal intensity for a period of 1 to 3 weeks. By examining several patients daily after occluded vein treatment, we were able to confirm that the reduction in pressure during nighttime rest from work could lead to an increase in venous diameter. The conclusion is that an optimal compression modality after intraluminal obstruction treatment must provide sufficient compression under working conditions as well as under resting conditions to avoid re-expansion of the vein diameter. To this end, the optimal compression medium must be different from all known fibrous or woven media. In particular, it should be able to be worn day and night for several weeks without interruption or discomfort.

[0009] Although their diameters may be larger than those of corresponding arteries, veins have thinner walls than arteries. In particular, the muscle layer of veins is rather weak. Therefore, venous diameter is primarily determined by blood load, or venous blood pressure. For this reason, superficial veins are rarely seen in elevated limbs, whereas they are larger in hanging limbs and are commonly found in areas with little fatty tissue, such as the backs of the hands and feet. Veins with reduced or absent valve capacity, commonly referred to as "deficient," show increased diameter. In a vicious cycle, valve insufficiency leads to increased blood filling (congestion), which further dilates the venous wall, including the valve area, inducing further valve insufficiency. These are the reasons why varicose veins grow and become more visible over time. Even very large and unsightly varicose veins appear to normalize when the limb is elevated above heart level for a few minutes. Normalized venous diameter reduces space consumption and therefore reduces pressure on adjacent tissues, including sensitive nerves (e.g., in the skin) that support normal (intact) valves. If the vein that has been treated for occlusion can normalize in diameter, the symptoms caused by the original increased vein size will no longer occur.

[0010] When an affected vein is closed with interventional tools or injections, the amount of blood remaining in or returning to the vein determines the duration of tissue transformation. All of these methods, except for intravenous adhesion, do not fix the vein size during treatment; they only induce chemical or physical changes to the vein's innermost layer, the endothelium. Occlusions with degenerated endothelium potentially lose their vascular structure and transform into connective tissue fibers. The higher the intravenous blood volume, the more blood must be organized and removed by the body, resulting in reactions such as inflammation. Therefore, patients rarely feel these changes in small veins, but more in large veins. Because the distance to nerve-containing structures determines the intensity of pain, large superficial varicose veins, particularly those close to the skin, are particularly susceptible to symptomatic venous reactions after intravenous treatment. This relationship is the primary reason why new compression modalities are needed for venous occlusion modalities other than adhesions. The use of compression stockings or bandages after any type of venous treatment is generally recommended to address the risk of thrombosis or phlebitis and for other purposes, such as preventing bleeding and edema. This does not meet the requirements of interventional, ultrasound-based treatments. In particular, patients often want to remove the compression medium at least overnight or while bathing or showering, so the benefits of continuous wear are often lost. During these periods, even if brief, blood can return to the treated vein, enlarging it and prolonging the duration and increasing the symptoms of venous involution. Therefore, compression mediums that can be worn constantly may help avoid these problems.

[0011] Common compression media have several other drawbacks. Appropriate medical pressure stockings are difficult to put on, and many patients cannot achieve this without assistance. Bandages, on the other hand, are easy to apply but take time, and the pressure depends on the tension applied. Stockings and bandages remove fluid and fat from the skin, making it more vulnerable to lesions, inflammation, or infection. Therefore, stockings are usually removed at night to allow the skin to heal. Compression stockings, pants, or bandages are generally less comfortable (pain from pressure, skin abrasion from migratory wrinkles; displacement, allergic reactions). Even stockings tailored to individual patients often do not fit optimally. Bandages are often too thick to wear under regular shoes. Heat congestion is common in summer, making compression media more uncomfortable. This is the main reason why venous surgery is not typically performed in summer. Finally, another drawback is the ugly appearance of the bandages and medical stockings, which makes the patient embarrassed to wear skirts or shorts or to participate in sports, swimming or beach activities. As a result of all these drawbacks, patient compliance is poor.

[0012] The compressive effect of woven textile materials on veins in upright individuals cannot be measured by imaging techniques, except in rare vertical MRTs. If the compression medium could be manufactured as a transparent film, the effect on superficial veins could be estimated visually. If the material were also transparent to ultrasound, the compressive effect of specific veins could be measured directly in ultrasound images. This would be an advantage after vein treatment or as a follow-up control before the patient is released.

[0013] When transparent plastic wrap sheets are used and tightly wrapped around the affected leg, the film visibly reduces the space available for the veins to expand. The film immobilizes superficial varicose veins at approximately skin level. The more varicose veins that were previously above skin level, the smaller their lumen size is. However, even when secured with adhesive tape, plastic wrap sheets can slip off and crumble during patient movement.

[0014] The inventors unexpectedly found that when a thin, elastic, semipermeable film and a medical adhesive were used to firmly secure the film on the skin of humans with varicose veins for two weeks, the reduction in the diameter of the affected veins was significantly greater than when a typical woven compression bandage was used (Table 1).

[0015] [Table 1]

[0016] We investigated this effect on varicose veins and found that there are three forces that contribute to vein compression by adhesive elastic films. A) The perpendicular force is determined by the adhesive strength of the adhesive alone, limiting the available space. This is especially true for superficial veins (Fig. 3, 8). For a precise physical explanation, it must be noted that the adhesive's space-limiting effect is reduced by a small percentage due to the extensibility of the film. For example, when a compression tape is applied to an elevated leg, the varicose vein is fixed in a collapsed state, even if the film has no elastic properties.

[0017] B) The force is determined by the film's resistance to adhesive shear stress, since the adhesive film cannot slide on the skin. This can be explained using the previous example: when the leg circumference increases when changing from an elevated to a suspended position in response to blood inflow, any conventional bandage will slide on the skin to adapt its length. However, an adhesive film bandage does not slide on the adhesive and therefore withstands shear stress (de in Figure 3).

[0018] C) The well-known centripetal force due to concentric compression depending on the pretension of the compression medium during application (Figs. 2b, 3e). This force is different for conventional media and compression films because compression films can be made entirely from elastic materials, while woven fiber media only contain a certain percentage of elastic medium.

[0019] For these reasons, the desired effect of a compression film bandage must consist of these three components and can only be achieved by the specific mechanical properties of the adhesive and the film of the present invention. Furthermore, in most embodiments, compression film bandages require a specific backing or release liner for storage and shipping, because the thin adhesive film is too soft to be manually handled without a supporting medium.

[0020] The effects of adhesive compression film bandages and conventional fiber media are different. With these familiar media, the material does not adhere to the skin, so the compression effect is solely due to the elastic properties of the tissue. Using a self-adhesive compression film bandage creates a composite of the film and skin (Figure 3e). The material cannot slide over the skin or itself, as would be the case with a fiber bandage. As soon as the film is adhered to the skin, the elastic properties of the film and skin—along with the influence of the underlying connective tissue—are added. For this reason, the effect of pressure on target structures, such as veins, must always be understood as a result of the properties of the skin and connective tissue, in addition to the properties of the film and adhesive. As a result, when using a compression film bandage, there is an additional general contractile force (C) due to the adhesive properties of the film (A, B) and a specific contractile force for superficial varicose veins above skin level.

[0021] This quality can be best defined by the resulting change in vein size, summarizing the effect of adhesive and film elasticity (Figures 2 and 3). Similar to the concentric effect of conventional compression stockings or bandages, the general compression effect due to elastic properties is best defined by the achieved increase in tissue pressure. This is also the common standard for defining conventional compression media and "compression classes," even though nomenclature varies between countries (Table 2).

[0022] [Table 2]

[0023] While elastic film bandages have not been described for general tissue compression purposes, several elastic dressings have been proposed for different localized purposes, such as preventing venous or arterial bleeding, or as wound dressings. WO 2004 / 112666 discloses a dressing with an elastic compression means. The disclosure relates to a dressing comprising a swab that can be placed against a wound to absorb secretions therefrom, a means for pressing the dressing against the wound, and a fastening means for locally securing the dressing. The pressing means is embodied as an open-pore or closed-pore foam material that is elastically reversible and capable of deforming in a delayed manner and is contained within the dressing between the swab and an outer cover layer overlying the swab.

[0024] The specific mechanical characteristics of the elastic film and adhesive composite of the present invention define an application in which the compression bandage film behaves better than traditional textile bandages and stockings and differently from medical films manufactured for wound management (Figures 6 and 7).

[0025] Band-Aids or patches made from film materials have been used in drug therapy as sterile, transparent wound coverings, usually with or without additional resorbable areas, in different sizes depending on the size of the wound to be treated. The use of transparent film materials is primarily intended to allow continuous visualization of the wound and, secondarily, to provide a more flexible patch for securing to uneven substrates. In the most common film patch (TEGADERM®, 3M), a patch of the desired size is removed from the sterile cover, the non-adhesive paper covering the adhesive at the bottom of the film is removed laterally, the film patch is placed on the wound, and finally, the second sheet is removed from the top of the film. In this case, the top cover is removed by grasping the two paper flags and pulling the two halves of the patch cover sideways. This type of application is laborious and cannot be converted for use as a compression bandage, which requires positioning the film over the body part one turn at a time, with a slight overlap, while holding the film under constant tension. Furthermore, the elastic properties of such film patches are weak and are intended simply to conform to any part of the body surface. They are not intended to provide concentric pressure and will fail if attempted (Figure 6).

[0026] The present invention is not related to the prevention or treatment of arterial or venous bleeding or to the treatment of wounds, but rather to the reduction of vein diameter and fixation of treated reduced diameter superficial veins. Summary of the Invention [Problem to be solved by the invention]

[0027] The present invention relates to an adhesive film compression bandage composite and dispenser thereof, as described herein. The adhesive composite and dispenser can be used for compression of human tissue, particularly human veins. Therefore, they can be used as a medicament, particularly for the treatment of venous or vascular diseases, such as varicose veins. Preferably, the composite is for use in areas of veins that have been treated by interventional means, such as physical or chemical closure. Another application is any type of soft tissue lesion where external compression is thought to be useful to aid healing. Examples include areas following muscle fiber rupture or liposuction. More preferably, the composite is for use in treating varicose veins, including spider veins. [Means for solving the problem]

[0028] The transparent compression film bandage composite described herein includes a thin elastic film layer, a preferably pressure-sensitive and hypoallergenic adhesive coated on at least a portion of the underside of the layer, a first release liner for longitudinal removal covering the adhesive side of the film, and, optionally, a second release liner for longitudinal removal adhering to the top of the film, which acts as a carrier. The adhesive provides strong adhesion to the top side of the film and adequate adhesion to human skin. The film is vapor permeable, transparent, and ultrasonically transmissive. The optional dispenser includes a roll carrying the adhesive film and release liner composite, as well as a mechanism for appropriately unfolding the film. [Brief explanation of the drawings]

[0029] [Figure 1]Layers of the compression film bandage composite: a film layer (A), a medical adhesive (B) preferably pressure-sensitively coated on at least a portion of the surface of the film layer, a first release liner (C) coating the adhesive, optionally a second release liner (D) reversibly attached to the top film side and acting as a carrier, and optionally perforations (e1, e2) and tab means (e2) in one or both of the release liners to facilitate longitudinal removal. [Figure 2a] Cross-sectional patterns of a leg with varicose veins (A) with concentric compression (B) applied by any medium. Conventional media such as compression stockings and bandages and the novel adhesive compression bandage film have similar concentric compression effects, but the summary results differ depending on the adhesive effect of the film. Furthermore, the compression film bandage can be worn for more than two weeks without interruption or replacement. [Figure 2b] When using the compression film bandage of the present invention, the leg cross-sectional pattern has an additional compression effect due to the adhesive which is discernible from the reduced vein diameter. [Figure 3a] Detailed pattern of superficial varicose veins that extend above skin level. [Figure 3b] Blood pressure (white arrow) enlarges varicose veins in a standing patient, resulting in gap areas (black arrows) along superficial veins when using a non-adhesive dressing medium. Strong adhesion can prevent this loss of effectiveness. [Figure 3c] The same superficial venous pattern when the leg is elevated. Blood leaves the vein by gravity, causing the vein to shrink to a minimum, which may be less than 20% of its size in a standing patient. It is a well-known phenomenon that even legs with severe varicose veins appear fine when the leg is elevated. [Figure 3d] When the adhesive compression film dressing is secured to the elevated leg, it keeps the affected vein small and below skin level, even when the patient is in an upright position. [Figure 3e]Detailed pattern of adhesive elastic film bandage that firmly adheres to the skin and forms a functional unit with it, a) performing concentric compression (dashed arrows) that increases tissue pressure, and b) effectively restricting the space for the diseased vein to expand due to the strong adhesive connection between the film and the skin (grey arrow). [Figure 4] Typical strain-elongation diagram (B) of a compression film bandage of the present invention, y-axis: tension in N / mm²; x-axis: % elongation. Dashed line: example for linear elasticity between 20 and 50%. For the present invention, the deviation of strain values from linear progression should preferably not differ by more than 30% between 20 and 50% elongation (working range for film application, shaded area). [Figure 5] Seven days after intraluminal occlusive venous therapy, A) ultrasound findings and corresponding scheme showing the initial thrombus (*) formed at maximum compression effect with a fibrous bandage (short extension, standard in venology) and evidence of secondary re-entry of blood and increase in diameter. Possible reasons: cessation of bandaging, bandage change, loss of elasticity. Result: delayed vein retraction. B) shows the same vein after the use of the compression film bandage of the present invention, showing a homogeneous echo signal with no signs of re-entry of blood. [Figure 6] Comparison of strain-elongation diagrams between a conventional elastic wound dressing (10x10cm patch, burst at 56% elongation) and the adhesive compression film bandage (acfb) of the present invention. Y-axis: tension in N / mm2; x-axis: % elongation. [Figure 7] Comparison of the elastic behavior of a 25 cm long sample of a conventional short-stretch bandage (A) and an adhesive compression film bandage of the present invention in (B) strain-elongation diagram. Y-axis: tension in N / mm2; x-axis: elongation in cm. [Figure 8] Photographs of varicose veins before treatment (A), after 7 days with adhesive compression bandage (B), and final result (C). [Figure 9]Polyurethane film on the lower leg: brown discoloration along the original vein course above the edge of the film (arrow), no discoloration within the film-compressed area. The entire leg was covered with German, class II medical compression stockings. The film was worn for 10 days, and the patient showered 7 times. The edge of the film was slightly damaged by friction mediated by the stockings while walking. [Figure 10] Identical spot of the lower limb in ultrasound images: a) uncompressed vein before application of compression film bandage, b) vein after placement of a 25 micron thick, 100 mm wide, single closed circle, polyurethane film bandage with acrylic adhesive, tension applied during application: 16-18 N / mm2. DETAILED DESCRIPTION OF THE INVENTION

[0030] The optimal compression bandage modality for body parts, especially after intravenous medical treatments including sclerotherapy, should be transparent to allow optical and ultrasonic control of the compression effect. It should be highly flexible to accommodate the patient's movements and tightly adhere to the skin to avoid skin irritation. It should be very thin and vapor-permeable to provide high comfort even when worn constantly, day and night, for several weeks. It should be sufficiently elastic and strong to meet common venous compression criteria, such as a pressure of 10–32 mmHg at the ankle, decreasing toward the thigh. For specific application to superficial veins that bulge above skin level, it should exceed the diameter reduction achieved by textile bandages at the same pressure.

[0031] The present invention provides a solution to all these needs for compression, especially after interventional vein treatment. The present invention relates to a compression bandage film composite and dispenser thereof that can be applied by wrapping around the target area or in a closed circle like a traditional compression bandage, with minimal overlap. In particular, the present invention discloses a novel combination of elastic and adhesive properties of the material that add to their effectiveness for improved compression, especially of superficial veins.

[0032] The present invention can be used for compressing human veins or tissues. Therefore, it can be used as a medicine, especially for the treatment of venous or vascular diseases such as varicose veins. Preferably, it is for use in areas with veins that have been treated by intravenous means, such as physical or chemical occlusion. Another application is any type of soft tissue lesion where external compression is thought to be useful to aid healing. Examples include areas with muscle fiber rupture or after liposuction. More preferably, it is for use in treating varicose veins, including spider veins.

[0033] The adhesive compression film dressing according to the present invention is a transparent composite that stores elastic and adhesive strength for the treatment of venous or vascular disease and tissue injury.

[0034] The film of the present invention is defined as a thin, continuous polymeric material consisting of one or several components. The term compression bandage composite includes an elastic film, an adhesive, and one or several release liners. The term "compression film bandage" or "compression bandage film" refers to the layers to be applied to the patient, i.e., the film and adhesive, without any release liner or application aid. Depending on the practical application of the adhesive compression film bandage, the side that adheres to the skin is referred to as the "lower side," "underside," or "bottom side" of the film, and the opposite side of the film is referred to as the "upper side," "surface," or "top side."

[0035] The composites disclosed herein comprise several layers disposed on top of one another (Figure 1). The layers are: (A) a thin, elastic, semipermeable film layer; (B) a medical adhesive covering at least a portion of the underside of the film layer; and (C) a first release liner for longitudinal removal covering the adhesive side of the film. Optionally, there may be (D) a second release liner for longitudinal removal adhered to the non-adhesive side of the film, which acts as a carrier, and means (e1, e2) for longitudinal separation of one or both liners.

[0036] (1a) When designed for compression, the most important property of the film is its elasticity. Elasticity is the physical behavior of an object that reversibly deforms under stress. When an elastic material is deformed by an external force, it experiences an internal force that opposes the deformation and restores it to its original state when the external force is no longer applied. In some articles, such as metal springs, elasticity is linear according to Hooke's law, which means that the restoring force is proportional to the elongation. The restoring force is the force that causes an expanded article to return to its original size or shape.

[0037] The elastic behavior of an expanded article is described by its modulus, which is defined as the ratio of expansion to strain. Another expression for strain is tension.

[0038] The elastic modulus E is defined as the slope of the graph of the tension-elongation curve under uniaxial tension: E = σ / ε (σ: tension; ε: elongation). Elongation or elongation is defined as the ratio of change in length compared to the original length (units: dimensionless, or %). E is linear for articles that follow Hooke's law. For other articles, such as polymeric materials, elasticity is typically nonlinear but curvilinear (Figure 4). For compression film bandages of the present invention, the elastic modulus has approximately linear behavior within the recommended application range, which is between 20% and 50%, and even between 10% and 75% elongation. "Approximately linear" is defined as a deviation from the linear ratio of less than 30% (Figure 4).

[0039] The elastic modulus E is derived from tension-elongation measurements. Measurements were performed on film samples of 100 mm width and different lengths from 100 to 200 mm. The force per cross-sectional unit (e.g., N / mm 2 ), so the sample width has no effect on the elastic modulus E or the tension-elongation relationship.

[0040] For tension-elongation measurements, as described in the text and similarly in Figures 4, 6, and 7, 100 mm wide film samples were fixed on one side to a rigid plate and clamped on the other side to a 100 mm wide fixture equipped with ball bearings that allowed the plate to rotate nearly frictionlessly. A horizontal tension was then applied while the elongation (cm) was measured on a centimeter scale and the force (N) was measured using a digital dynamometer.

[0041] In the film of the present invention, when applying an extension of 10 to 100%, preferably 20 to 75%, and more preferably 30 to 50%, the elastic modulus is 5 to 400 N / mm 2 and more preferably 10 to 200 N / mm 2 and most preferably 20 to 50 N / mm 2 and 1 to 40 N / mm 2 , more preferably 2.5 to 25 N / mm 2 and most preferably 5 to 10 N / mm 2 This generates tension.

[0042] The elastic properties of the film bandage are referred to in both the transverse and longitudinal directions to allow for conformity to the body anatomy and helical wrapping. For this purpose, the transverse modulus is defined as 25-100% of the longitudinal modulus.

[0043] After the external strain on the polymeric material is terminated, the original length may not be fully regained. This is called hysteresis. For the compression film bandages of the present invention, the hysteresis-related loss of recovery force is defined as less than 10% over a 20-50% extension range. Over the time and conditions used for follow-up treatment, typically 7-28 days at temperatures between 0-40°C, the bandage film material does not substantially lose its tendency to return to its original length.

[0044] The definition of the elastic modulus of the material of the present invention addresses the requirement to establish the necessary compression without exerting a great deal of physical effort and to use an elongation that is comfortable when applied by medical staff.

[0045] (1b) The second important property of the compression film bandage is the specific adhesive, which is essential for the function of the compression film bandage. The medical adhesive (B) is preferably pressure-sensitive and hypoallergenic. Suitable adhesives can be selected from the group of acrylates, polyacrylates, polyvinyl ethyl ethers, silicones, or others.

[0046] The underside containing the adhesive is preferably sterile, as contact with the surgical site or rupture site is possible.

[0047] The force required to remove the adhesive strip is called the adhesive strength. It is often measured on 25mm wide strips and therefore has the units N / 25mm.

[0048] Adhesive strength is usually measured on a 25 mm wide strip, so it has the unit N / 25 mm (mentioned in the text), and it is exactly this sample width that was used to measure the films of the present invention: a 25 mm wide, 100 mm long strip was attached over 50% of its length with the adhesive of the present invention to various human skin surfaces or to a film sample inseparably fixed to a plate. Then, a perpendicular force was applied and monitored by a digital dynamometer until the adhesive dissolved. The force required to remove the adhesive strip is called the adhesive strength.

[0049] Once applied, the composite should adhere firmly to the skin and adequately follow any movement of the body surface without peeling or wrinkling. It should provide sufficient adhesive strength to prevent bulging of superficial veins, especially in standing patients (Figure 3). Bulging refers to the protrusion of the vein above the skin level. Superficial refers to at least a portion of the vein extending beyond the skin level. However, the adhesive should allow painless removal of the film bandage at the end of the wearing period. Therefore, for the purposes of this invention, adhesion to human skin is defined as achieving an adhesive force of 0.06 to 1 N / 25 mm, more preferably 0.1 to 0.5, and most preferably 0.12 to 0.25 N / 25 mm, measured 24 hours after wearing. These adhesive forces are sufficient to compress superficial varicose veins even in the absence of any elastic properties of the bandage, even when blood pressure is abnormally elevated to 25 mmHg (Figures 3d and 3e).

[0050] The adhesive strength may change during prolonged wear due to temperature and moisture, and therefore may exceed the defined range. It also varies depending on skin factors such as surface oils and sweat. Therefore, it is recommended to remove grease and sweat before applying the bandage. Since the area of the body targeted for bandaging is also subject to invasive treatment, this is usually done routinely, and therefore it is cleaned and disinfected before treatment.

[0051] At the same time, the bandage film tends to adhere firmly to its own surface so that the bandage, once produced, behaves and conforms like a closed composite in the manner of a compression stocking.

[0052] This property is defined for the present invention to provide adhesion to the top side of the film with an adhesive force of 0.12-2 N / 25 mm, more preferably 0.2-1, and most preferably 0.25-0.5 N / 25 mm. The adhesive force required depends on two factors: 1) the adhesive, and 2) the type of film surface, which should preferably be very smooth and free of grease and removable particles.

[0053] It is preferable to use compression film dressings on hair-free (shaved) skin because they are easier to remove and adhere better. Furthermore, the film adheres to the skin close to the hairless skin, preventing water from seeping behind the film from the edges when the patient showers.

[0054] (1c) The first release liner (C) is used as a cover for the adhesive surface of the film. Its task is to protect the adhesive from dirty or infected particles and to maintain the quality of the adhesive. It also provides protection against accidental adhesion before the intended application. Furthermore, the release liner can function as a carrier for a very thin and flexible film. The release liner is designed so that it can be removed longitudinally during application of the dressing.

[0055] (1d) Optionally, a second release liner (D) is used as a carrier to aid in application of the film after removal of the first release liner. This film is necessary for embodiments that are too soft to be processed without the second carrier. The optional release liner is simply loosely adhered to the non-adhesive side of the film. Like the first release liner, it is also designed to be removable longitudinally. The second release liner is preferably transparent to allow visual control of the film and target area.

[0056] In one embodiment, the second release liner is not expandable and therefore separates from the film bandage before application to the skin or upon exiting the dispenser, hi another embodiment, the second release liner expands with the film and is removed after the adhesive film is applied to the skin and before subsequent circles of compression film bandage are applied.

[0057] The first and second release liners may be made of paper, preferably wax paper, or a polymer material. In some cases, both the first and second release liners may be made of paper. In some cases, both the first and second release liners may be made of plastic. In further cases, the first release liner may be made of paper and the second release liner may be made of plastic, or vice versa.

[0058] The adhesive compression bandages according to 1a-1d allow a new compression effect that establishes a reduction in the diameter of superficial veins that reaches or exceeds the reduction in diameter achieved in the same wrapping with venous woven short-stretch compression bandages or with appropriate compression stockings (Table 1).

[0059] The composite, particularly the adhesive and optional film layer, should be non-toxic, biocompatible, and non-allergenic. The composite may optionally further comprise a superabsorbent polymer capable of absorbing blood. This layer may be disposed between the adhesive and film layer. This layer may also comprise additives, such as hemostatic compounds that induce blood clotting or antibacterial properties, or substances that promote wound healing, prevent edema, or cause vein retraction.

[0060] Preferably, the adhesive layer is sterile. More preferably, the adhesive and film layer are sterile. Most preferably, the entire composite is packaged sterile. Preferably, the film material, especially the top surface, is sterile.

[0061] The composites according to 1a-d can exert a pressure of 6-32 mmHg, preferably 8-24 mmHg, and most preferably 10-18 mmHg, measured as pressure in the underlying tissue using a single layer closed loop of the composite, measured at the ankle of an average individual.

[0062] Because additional adhesive force must be applied, the applied pressure can be lower than according to conventional recommendations (Table 1). Compared to textile compression bandages used in phlebology, the recovery force of the film compression bandage is much higher, up to 75% of the elongation (Figure 7).

[0063] The circumferential pressure of a compression medium acting on a body part depends on 1) the elastic tension or strain of the medium and 2) the shape of the compressed surface. In use after venous treatment, compression is designed to decrease from distal to proximal to support physiological venous flow toward the heart. For conventional or inventive compression bandages, this refers to application to provide a constant pretension to a body part whose diameter increases from distal to proximal. In areas of decreasing diameter, the pretension should increase from distal to proximal. These considerations are based on Laplace's law, which describes the pressure exerted on a body part by an elastic material applied in a concentric manner that is inversely proportional to the square of the radius of curvature. Pretension is defined as the tension applied to the bandage film before it is attached to the skin.

[0064] In the compression bandage film of the present invention, the pretension corresponds to the desired longitudinal strain. Typical values are 1 to 40 N / mm 2 and more preferably 2.5 to 30 N / mm 2 and most preferably 5 to 20 N / mm 2 is.

[0065] According to the Laplace law, pressure increases with the inverted square of the surface radius. This is true for all compression media. In stocking products with a defined compression range, the compression is measured on a standardized solid model by a pressure sensor, but this may differ when worn by an actual patient. Furthermore, textile compression bandages do not have a means for controlling the compression after placement, and the compression effect depends on the experience of the medical professional.

[0066] Common compression stockings are classified as Class I, II, or III depending on the material's performance and the indication for its use. Severe venous hypertension, associated with edema, eczema, skin pigmentation, induration, and ulcers, is typically classified as Class III. Management of mild venous insufficiency and varicose veins requires Class II compression, while Class I is selected for preventing venous overload in healthy individuals. Compression class definitions may vary by country (Table 2). The primary indication for the novel compression film bandage is its application after intravenous procedures to reduce the diameter of the treated vein to accelerate its conversion to connective tissue. This indication requires lower pressure than surgical treatment. During research into compression media, the inventors found that a pressure of 12–22 mmHg was completely sufficient for this indication. Due to the additional effects of elasticity and adhesion, the required pressure when applying the compression film bandage is 10–18 mmHg, depending on the size and location of the treated vein.

[0067] Compression film bandages can be applied like traditional compression bandages by wrapping them around the target area in a spiral or multiple single circles (bamboo type), overlapping several times at the beginning, sides, and ends, and with at least one closed final circle. The term closed circle refers to the last part of the applied film piece that adheres to its own surface, not to the skin. A closed circle or spiral is essential when the goal is to relieve the skin from tension and place stress primarily on the bandage material.

[0068] An initial portion of the adhesive film bandage, several centimeters in length, is released from the first release liner and firmly attached to the distal portion of the target area. An additional portion of the adhesive film, approximately 1 / 2 to 1 lap in length, is then released from the first release liner, and the film bandage is manually stretched to the desired pretension, after which it is secured to the target area in a circular or spiral configuration. If a second release liner is included, it is removed before stretching if it is inelastic, and after application if it is elastic.

[0069] Preferably, the compression film dressing is applied in a single layer with a lateral overlap of 0.5 to 2 cm, or 5 to 15% of the film width, so that the majority of the area is covered with a single layer of the dressing film, allowing its semipermeable properties to take effect.

[0070] If necessary, compression film can be applied in several layers, using a shingle or patter technique, rather than just one. In this case, the elastic force of each layer is increased, providing a higher degree of compression while using the same pretension during positioning. In this way, ankle pressures of 32 mmHg and even greater can be achieved, which is required for post-surgical treatment (vein stripping, phlebectomy) or for patients with post-thrombotic syndrome. However, vapor permeability may be lost or limited.

[0071] The defined adhesive is strong enough to create a strong connection to a film surface that is resistant to everyday movement, including extreme sports, with a lateral edge overlap of only 0.5-2 cm, or 5-15% of the bandage width. Those skilled in the art will understand that there is no actual maximum adhesive strength for a film on its own surface. Even within the range defined in (1b), the adhesive film provides a stable composite that can withstand tangential stress. Adhesive bonding of a circular loop of an adhesive film bandage with only an edge overlap of 0.5-2 cm, or an overlap of 5-15% of the bandage, will cause the film to tear rather than the adhesive bond to loosen.

[0072] Tensile strength defines the maximum stress a material can withstand when stretched or pulled before failure or fracture. For compression film bandages, the tensile strength of a 0.5-2 cm longitudinal overlapping adhesive region is defined as being greater than the tear strength of a single film layer. This means that when pressure is applied beyond the tear strength limit, the film will break elsewhere except in the overlapping region. This function is related to achieving a uniform composite of several spiral or circular wraps with minimal overlap, depending on the adhesive strength when the film of the present invention is applied to its own surface. The overlapping area of the composite should not exceed 15% of the covered area.

[0073] The film layer preferably has a tensile strength of 5 to 50 N / 25 mm, more preferably 7.5 N / 25 mm to 40 N / 25 mm, and most preferably 10 N / 25 mm to 30 N / 25 mm.

[0074] The elongation at break indicates the percentage of stretch the tape can undergo before it breaks. The elongation at break of the film layer is preferably 100-400%, more preferably 125-300%, and most preferably 150-200%.

[0075] To provide maximum comfort and support semipermeability, the film must be as thin as technically possible, limited by the need to establish a constant pressure, depending on the specific amount of material. In particular, the resilience of the bandage corresponds to the cross-section of the elastic element. Based on current technology, the composite of the present invention preferably has a thickness of 5 to 50 microns, more preferably 6 to 30 microns, and even more preferably 7 to 20 microns. Future materials may provide even thinner layers. Because the bandage must be permeable to moisture, microhole or microporous technology can affect the film thickness. Any holes weaken the elastic properties, and thicker films make it more difficult to make them semipermeable.

[0076] Ideally, 90-100% of the underside of the film layer is covered with adhesive, preferably uniformly and uninterruptedly. In this context, the degree of coverage refers to the visual or technical appearance and refers to the adhesive area. If the adhesive is applied to the underside of the film by spray coating techniques, the micro-coverage may be much less than 90%, for example, 10-30%. If less than 100% of one side is visually covered with adhesive, this preferably refers to one or several non-adhesive edges.

[0077] Adhesive bandage films are preferably made of breathable materials or have numerous small or micropores sized to allow vapor transfer. More specifically, films containing adhesive layers should be vapor-permeable and liquid-impermeable. This means that the adhesive-containing film is semipermeable. Vapor permeability is essential to allow continuous wear of adhesive film bandages for days or even weeks. Otherwise, moisture and sweat can accumulate under the film, promoting adhesive debonding, skin maceration, and bacterial infection. Vapor permeability is usually determined as the moisture vapor transmission rate (MVTR). Because the film is impermeable to water droplets, patients can shower at any time after treatment, allowing for comfortable wear even for weeks.

[0078] Various techniques exist for measuring water vapor transmission rate (MVTR), also known as moisture vapor transmission rate (WVTR), ranging from gravimetric techniques that measure moisture gain or loss by mass to more sophisticated instrumentation techniques that can measure extremely low transmission rates in some designs. Note that special care must be taken when measuring porous materials, such as fabrics, as some techniques are not suitable. Similarly, due to the extremely low levels, many techniques will not have the resolution to provide reliable results. Numerous standard methods are described in ISO, ASTM, BS, DIN, etc.—these are often industry-specific. Instrument manufacturers often provide test methods developed to fully utilize the specific designs they sell. The conditions under which measurements are performed have a significant impact on the results. Both temperature and humidity gradients across the sample must be measured, controlled, and recorded along with the results. MVTR results without specifying these conditions are largely meaningless. Indeed, it is best not to compare two results unless the conditions are known. The most common international unit for MVTR is g / m². 2 / day. In the US, g / 100in 2 / day is also used, which is g / m 2 / day value is about 1 / 15 of the typical permeability of aluminum foil laminates is 0.001 g / m 2 / day, while the permeability through the fabric is several thousand g / m 2 The MVTR can be measured up to 1000 kJ / day. Often, the test is performed on a sheet of material. Calculations based on this can be useful when designing finished structures (packaging, clothing, etc.). Seams and seals are also very important to end-use performance; performance verification and evaluation of complete containers or irregular objects is often recommended. For the purposes of this invention, MVTR is measured according to German DIN EN 13726.

[0079] Those skilled in the art know how to achieve the semipermeable quality of thin films by technologically developing or adding very small perforations. For the purposes of this invention, the micropores must be large enough to allow vapor to pass through but too small to allow water to pass through. If a polymeric material is deformed to obtain micropores, it will lose stability and elasticity compared to a solid material, resulting in a loss of compressive strength. Therefore, the desired water vapor transmission rate must be reduced to a reasonable limit. Patients may need to be advised to avoid sports or sauna use while wearing the film dressing to avoid sweating that may exceed the MVTR of the film dressing.

[0080] To summarise the requirements for vapor transmission and compressive force, the film layer comprising the adhesive of the present invention should have a compressive force of 100 to 2000, preferably 300 to 1500, more preferably 500 to 1000 g / m2, measured according to DIN EN 13726. 2 It is defined as vapor permeable with a moisture vapor transmission rate (MVTR) of 10-100% relative humidity over 24 hours at 37°C.

[0081] Transparency, a physical property that allows light to pass through a material without being scattered, can be met to a large extent by polymeric materials. In practical terms, the transparency required for a polymeric film means that the details behind it can be clearly seen. In particular, the criterion may be the visibility of stratum corneum lines, epidermal ridges, or hair. The composites of the present invention are substantially transparent, so that changes in superficial target veins (skin irritation, varicose vein changes) or undesirable skin reactions (inflammation, hematoma) can be visually confirmed even with the film in place. This means that the film and adhesive are transparent. When a second release liner is used in certain embodiments, the second release liner should also be transparent to allow for viewing of the application site and the areas where the dressing has already been applied for proper placement. If elastic fibers are present, they are advantageously transparent as well. However, those skilled in the art will further understand that even non-transparent fibers, typically present in very small or low concentrations, can be included in the composite without losing overall transparency.

[0082] Due to their transparency, film bandages are virtually invisible. They are so thin that they can be worn invisibly even under tight clothing. Due to their minimal thickness and semipermeability, films do not accumulate heat, as bandages do. Furthermore, the waterproof nature of polymeric films is a welcome feature. This characteristic is preferably maintained even when microporous technology is applied during the manufacturing process. Furthermore, adhesives are preferably water-resistant. In this case, film bandages can be worn even when showering or swimming. This translates into excellent patient comfort. Cost and time savings are also achieved because film bandages do not require renewal. These comfort factors increase patient compliance, thereby improving compression outcomes (Table 1).

[0083] In most applications, it is desirable to have an adhesive bandage film that is compatible with ultrasound imaging. If ultrasound imaging can be applied while the bandage is in place, the compression effect and the underlying healing process can be examined. Ultrasound transparency means that the film material, including the adhesive, is transparent to ultrasound and transmits the signal without visible loss of energy. It also means that the bandage film can be firmly attached to the skin without gas or air inclusions that would degrade the ultrasound signal.

[0084] Woven compression bandages do not allow for inspection of the pressure effect underneath, whereas compression film bandages provide both visual and ultrasonic control. Those skilled in the art will appreciate that definition by effect is more accurate than definition by any mechanical parameter of the material.

[0085] For application as a wrappable bandage, the film material may have a width of 6 to 50 cm, preferably 8 to 30 cm, and more preferably 10 to 20 cm. For typical application to the human body, the length may be 30 to 250 cm, preferably 100 to 225 cm, and more preferably 150 to 200 cm. For application to very small body parts such as fingers or very large body parts such as the chest or waist, other dimensions may be required. The shape is typically rectangular, with the length several times greater than the width. The length-to-width ratio is preferably >10, more preferably >20. If the material is provided as a large, sliceable roll for individual bandage lengths, the bandage film may have any reasonable length, such as 5 or 10 meters.

[0086] The film layer may be made of a material selected from polymeric substances such as polyethylene, polypropylene, polyurethane, polyetherurethane, polyetherpolyurethane, polyesterurethane, polyether-polyamide copolymer, polyester, nylon, polyvinyl chloride, polyacrylate, biopolymers and their respective fibers or films.

[0087] The elasticity of the dressing film may be achieved by a single material or by a composite of two or more materials. The basic elastic plastic film may contain additional longitudinal structures (e.g., fibers, bands) of different materials. Thus, the film layer or adhesive may preferably contain longitudinally oriented elastic fibers. In another example, the film layer comprises or consists of an elastomer. Suitable elastomers are selected from the group of polymers mentioned above. Elastomers are generally viscoelastic (colloquially "elastic") polymers that have a low modulus and a high strain at break compared to other materials. The fibers are preferably transparent.

[0088] The film layer may include a stretch indicator. The indicator allows the degree of stretching of the film during application to be observed or measured, and the degree of compression to be estimated or measured. For example, a meter scale may be imprinted on the film layer and measured against a second external scale or a scale imprinted on a removable film carrier material. The stretch indicator may also include at least one release liner.

[0089] During application of an adhesive film compression bandage, the film must be separated from one or several release liners. For this purpose, the release liner covering the adhesive side of the film should be adhered with an adhesive strength of less than 0.5 N / 25 mm. If necessary, the first release liner may be provided with a non-adhesive medium, such as silicone oil or wax, for easy removal. During application of the compression film bandage, the adhesive layer must be exposed by removing the first release liner. This removal must occur longitudinally, since the film has the shape of a bandage and its placement is a more or less tight circle under longitudinal tension. During spiral wrapping of the body part, at least a portion of the film bandage must be exposed, usually less than one complete circle in length. The first release liner should only be loosely adhered to the underside of the film, since it does not need to resist the associated stresses except by adhering to the film during storage and unwinding for application. Conversely, any significant adhesion would impair easy application. Therefore, the optimum adhesive strength is in the range of 0.001 to 0.05, preferably 0.01 to 0.04, and even more preferably 0.015 to 0.03 N / 25 mm.

[0090] In one embodiment, the second release liner is removed longitudinally after placing the adhesive film on the target area. In this case, the adhesion requirements for the second release liner to the film surface are approximately the same as for the first release liner. In another embodiment, when an elastic second release liner is used, it must withstand higher stresses than the first release liner. The second release liner must adhere firmly to the film surface even when the film with the second release liner in place is stretched to full pretension before applying it to the target. The required adhesive strength is in the range of 0.01 to 0.2, preferably 0.02 to 0.15, and even more preferably 0.03 to 0.1 N / 25 mm.

[0091] In some applications, it is advantageous for the first release liner to have a separation means along the width of the first release liner, providing separately removable sections of the release liner that are 1 to 12 times, preferably 2 to 8 times, and more preferably 3 to 5 times the width of the release liner. The separation means may consist of a continuous cut line, perforations, or unconnected overlapping regions. Separation means are particularly useful for gradually peeling the release liner away during placement of the dressing film. For many applications, it is preferred that the first release liner include a tab means for facilitating removal of the release liner. This is particularly advantageous when a separation means, as described above, is present to facilitate removal of sections of the release liner. If present, the second release liner may also include one of the separation means described above.

[0092] At least one of the release liners may extend beyond the width or length of the transparent film layer or may include a tab means to facilitate longitudinal removal of the release liner or release liner portion.

[0093] While the first release liner is substantially inelastic, the second release liner can appear in different embodiments: in one embodiment, the second release liner is inelastic for longitudinal removal before adhering the film to the object, while in another embodiment, the second release liner is elastic and expandable for removal after placement on the object. In this case, the resilience of the elastic release liner is only 5-50%, preferably 10-25%, of the resilience of the film. This limitation allows for proper placement without requiring excessive force to achieve a defined pretension.

[0094] To fit any area of the human body, the film must be elastic in both the longitudinal and transverse directions. It must be thin and flexible. Therefore, the transparent film layer containing the adhesive, optionally including a second release liner, must conform to the surface of any anatomy.

[0095] To aid in easy storage and application, the composite may be wound into a roll or cylinder.

[0096] For the same purpose, a dispenser containing the composite described herein may be used. The dispenser contains a roll of the composite of the adhesive film and release liner of the present invention and a mechanism for appropriate film spreading. The dispenser preferably appears in the form of a cylinder or cylindrical body. The dispenser has at least one opening on one side that is large enough to allow the composite or a portion thereof to pass through, but small enough to allow the film composite roll to be held in the box.

[0097] (21) The dispenser may also include a means for providing a constant resistance to unwinding of the composite so that the composite can be wound at a desired tension. Preferably, unwinding is prevented up to a force of 3.0 N.

[0098] The dispenser may also include a means for separating the film from one or more backings, or portions thereof. The mechanism may include a means for retaining or collecting one or more release liners, or portions thereof. Additionally, the dispenser may include a cutting element for cutting off multiple single or excess portions of the film, release liners, or all components.

[0099] All claims relating to the compression film bandage and all claims relating to the dispenser also apply to their medicinal use. The claims further apply specifically to their use in the treatment of venous disease or tissue damage. Preferentially, they apply to their use in the treatment of varicose veins. [Example]

[0100] The use of transparent compression bandages in the treatment of varicose veins. The applied dressing is coated with a layer of acrylic adhesive, 25 microns thick, and has >50 pores / mm2 with a diameter of <30 microns. 2The film consisted of a polyurethane film of 1000 psi. The film was applied in separate circles, overlapping by approximately 2 cm. The tension during application was 4-5 N / mm. 2 The range was.

[0101] The patient was treated for 14 days (Figure 8). Similar optical results were obtained for <0.1g / 100cm 2 This was achieved using a 12 micron thick semipermeable polyethylene food wrap film to which a liquid bandage spray containing an acrylic copolymer of 2,4-dichloro-1,4-dichloro- ...

[0102] Compression bandages showed improved results compared with compression stockings (Figure 9). The results of using transparent compression bandages can also be seen on ultrasound images (Figure 10).

Claims

1. 1. A film compression bandage composite for the compression treatment of vascular and tissue disorders, which uses elastic forces in combination with adhesive forces, comprising: a. 5 to 400 N / mm when applying a longitudinal extension of 10 to 100% 2 and the elastic modulus is 1 to 40 N / mm 2 an elastic film that generates a tension of; b. a medical adhesive covering at least a portion of the surface of the underside of the film, the medical adhesive being preferably pressure-sensitive and hypoallergenic, and adhering to the upper side of the film with an adhesive force of 0.12 to 2 N / 25 mm and to human skin with an adhesive force of 0.06 to 1 N / 25 mm measured 24 hours after wear; c. a first release liner covering the adhesive surface of the film for longitudinal removal; d. A composite optionally including a second release liner, preferably transparent, adhered to the non-adhesive side of the film to serve as a carrier for longitudinal removal.

2. 10. The composite of claim 1, wherein the reduction in superficial vein diameter achieved by said adhesive compression bandage film approaches or exceeds the reduction in diameter achieved in the same wrap by a venous fiber short stretch compression bandage.

3. The elastic film has a compressive strength of 10 to 200 N / mm when subjected to a longitudinal extension of 10 to 100%, preferably 20 to 75%, and more preferably 30 to 50%. 2 , most preferably 20 to 50 N / mm 2 and has an elastic modulus of 1 to 40 N / mm 2 , more preferably 2.5 to 25 N / mm 2 , most preferably 5 to 10 N / mm 2 The composite of claim 1 or 2, which generates a tension of

4. 10. A composite according to any preceding claim, wherein a single layer closed loop of said composite achieves a tissue pressure of 6 to 32 mmHg, preferably 8 to 24 mmHg, most preferably 10 to 18 mmHg, measured at the ankle of an average individual.

5. 10. A composite according to any preceding claim, wherein the tensile strength of a single layer closed film loop is greater than the tear strength of the composite against a longitudinal strain of 0.5 to 2 cm or 5 to 15% of the bandage width of the longitudinal overlapping bonded area.

6. A composite according to any preceding claim, wherein the film is preferably 5 to 50 microns thick, more preferably 6 to 30 microns thick, even more preferably 7 to 20 microns thick.

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

8. 10. A composite according to any preceding claim, wherein the adhesive coated film layer is transparent to ultrasound images.

9. 10. A composite according to any preceding claim, wherein the film layer or the adhesive comprises longitudinally oriented elastic fibres or elements, which are preferably transparent.

10. 10. A composite according to any preceding claim, wherein the film layer comprises an orientation indicator.

11. 10. A composite according to any of the preceding claims, wherein a first release liner covering the adhesive side of the film adheres with an adhesive strength of 0.001 to 0.05 N / 25 mm, preferably 0.01 to 0.04 N / 25 mm, even more preferably 0.015 to 0.03 N / 25 mm, optionally comprising a non-adhesive medium such as silicone oil or wax to limit adhesion, while an optional second release liner adheres to the top surface of the film in the same range as the first release liner in a non-elastic embodiment, and with an adhesive strength of 0.01 to 0.2, preferably 0.02 to 0.15, even more preferably 0.03 to 0.1 N / 25 mm in an elastic embodiment.

12. 10. A composite according to any preceding claim, wherein at least one of the release liners has a separation means along the width of the release liner, providing separately removable sections of release liner having a length of 1 to 12 times, preferably 2 to 8 times, and more preferably 3 to 5 times the width of the first release liner.

13. 10. A composite according to any preceding claim, wherein the first release liner is substantially inelastic, while in one embodiment the second release liner is inelastic for longitudinal removal prior to adhering the film, and in another embodiment the second release liner is elastic and expandable with the film. The resilience of the elastic release liner is limited to 5 to 50%, preferably 10 to 25%, of the resilience of the film.

14. A dispenser comprising a roll of the composite of any preceding claim.

15. 15. The dispenser of claim 14, including means for resisting unwinding of the composite, wherein unwinding is prevented up to a force of 3.0 N.

16. A complex according to claims 1 to 13 or a dispenser according to claims 14 to 15 for use as a medicament.

17. A composite according to claims 1 to 13 or a dispenser according to claims 14 to 15 for use in the treatment of venous disease, tissue damage or varicose veins.

18. 1. A pharmaceutical composition for use in the treatment of varicose veins, comprising: a. a polymeric material; b. Contains a medical adhesive; The polymeric material has a strength of 5 to 400 N / mm when subjected to a longitudinal extension of 10 to 100%. 2 and the elastic modulus is 1 to 40 N / mm 2 forming an elastic film that generates a tension of The medical adhesive is preferably pressure-sensitive and hypoallergenic, and adheres to the top side of the film with an adhesive force of 0.12 to 2 N / 25 mm, and adheres to human skin with an adhesive force of 0.06 to 1 N / 25 mm measured 24 hours after wear.

Images