WO2008012443A2

WO2008012443A2 - Device for protection and/or healing

Info

Publication number: WO2008012443A2
Application number: PCT/FR2007/001291
Authority: WO
Inventors: Daniel Bourgeois; Jean-Jacques Mongold
Original assignee: Daniel Bourgeois; Jean-Jacques Mongold
Priority date: 2006-07-28
Filing date: 2007-07-26
Publication date: 2008-01-31
Also published as: DE112007001732T5; FR2904214A1; WO2008012443A3; FR2904214B1

Abstract

The invention relates to a flexible device (1) for protecting and/or healing a zone that is to be protected and/or treated, comprising at least one distal elastic film (2) based on film-forming polymer and a proximal elastic adhesive layer (3) based on a gel and comprising two longitudinal parts, an upper part (6) directed towards said film and a lower part (7) intended to be in contact with the zone that is to be protected and/or treated, said device (1) comprising an intermediate textile stretchable layer (4) which is located between the distal film (2) and the proximal layer (3) and is fixed at points (5) to said film (2), the upper longitudinal part (6) of the layer (3) passing through said textile layer (4) between the fixing points (5). The invention also relates to a process for obtaining a device of this type and to its uses.

Description

DEVICE FOR PROTECTING AND / OR HEALING

The present invention relates generally to a dressing, having a composite structure and having great flexibility and elasticity, to protect and / or effectively treat any area, including the human body, regardless of its area and location .

More particularly, the invention relates to a dressing comprising at least one layer intended to cover said zone, directly, and to adhere to it, that said layer is said to be proximal and provides both the protection and / or the treatment of said zone and the adhesion to said zone, and at least one layer intended to protect and / or maintain the proximal layer, this layer is said to be distal.

The effectiveness of currently commercially available dressings may vary during use, even to zero, depending on the thickness of the proximal layer, the location and extent of the area to be protected and treated. . By way of example, if the dressing is applied on the heel or toe, its permanent or repeated contact with a part of the shoe may cause its movement by creep of the adhesive, and thus clear the area to be protected from the dressing, may cause worsening of the wound. One solution may be the application of wide strips of dressing to securely maintain said area in contact with the proximal layer; however, it leads to often uncomfortable and unsightly protection.

US2003 / 040691 discloses a wound protection device comprising from the distal zone to the proximal zone:

a non-elastic and breathable layer, which may consist of a non-woven strip on which is fixed an air-permeable film, made of polyurethane for example,

an elastomer layer, for example consisting of filaments obtained by hot extrusion, and

a layer of a non-elastic and absorbent nonwoven, which may be in laminated form.

The described device has no elastic property. According to the document EP-B1 -370789, an occlusive and compressive device consisting of the following layers is known: an elastic fabric, an adhesive layer of a treating hydrocolloidal composition, interacting with the biological fluids, and optionally, a thin layer of latex reinforcing the cohesion between the elastic fabric and the adhesive layer, and a removable protective layer of the adhesive layer.

This device is obtained by coating the elastic fabric with latex, on the one hand, and preparing the layer and applying the protective layer, on the other hand, and then laminating the assembly.

This dressing is more intended for the bandaging of areas to be treated and compress ulcerated leg type, and is not used as a dressing for the protection of an area, in that it has no protective layer and cohesion the adhesive layer which can flow through the elastic fabric.

According to WO2005 / 048911A, there is known a device comprising a polyurethane-based distal film, a textile intermediate layer and a proximal layer of silicone gel. It is obtained by successive stratification of the different materials, starting with the constituent polymer of the distal film which is first deposited, in the liquid state, on a cardboard support, then the textile layer is glued on the distal film, by calendering to obtain, mechanically, a complete impregnation of the textile in the distal film. Then, the silicone of the proximal layer is applied to the textile layer.

The resulting dressing does not disadvantageously have the expected elasticity, that is to say that of the textile fabric because the latter is actually embedded in the polyurethane of the distal film and can then confer a very limited elasticity to the dressing . This dressing has a certain extensibility, but it is not reversible, and as soon as the elongation force is too great, white marks appear on the surface of the polyurethane film, characteristics of the damaging separation of the textile layer of the film . These disadvantages prevent the reuse of this dressing on the one hand, and limit its application, for example to the restraint, on the other hand. Finally, the method of manufacturing this dressing consists of successive stratification steps of the different layers, and under these manufacturing conditions, the polyurethane of the film passes through the textile layer and pollutes the silicone on contact, modifying its properties, particularly its stability. The invention provides a solution, with a protective and / or healing device, flexible, having elasticity close to that of the layer textile, and having a layer for holding, cohesion and protection of the adhesive adhesive layer.

Thus, a device which is the subject of the present invention comprises at least one distal elastic film based on a filmable polymer and a proximal elastic adhesive layer based on a gel and comprising two longitudinal portions, one of which is said to be superior. directed towards said film and the lower one intended to be in contact with the area to be protected and / or treated, said device comprising an extensible textile intermediate layer located between the distal film and the proximal layer and fixed in points on said film, the upper longitudinal portion of the layer passing through said textile layer, between the attachment points.

In the course of the description, the terms treatment and cicatrization will be used interchangeably.

The device resulting from the combination according to the invention of these three elements, distal film, intermediate layer and proximal layer, allows protection and / or treatment of the area to be treated, sustainable whatever the zone and whatever the typical constraints. Shear applied, and reusable. Indeed, this combination gives the device an elasticity that ensures both ease of placement, even in areas difficult to access and its perfect hold in place on the area, in use. Even over wide areas, the device provides a contention of said zone, the elasticity being obtained in the longitudinal, transverse and diagonal directions, regardless of the thickness of the distal protective layer and / or treatment. After removal and cleaning the device, it can be reused.

In this, the applications of a device of the invention are numerous and varied, such as in the fields of phlebology, the treatment of burns, in the prevention or protection of bedsores, the prevention or reduction of keloids, and of course in the prevention, protection and treatment of more or less deep skin lesions.

The method of attachment between the distal film and the intermediate layer allows the proximal layer to mechanically catch in the device of the invention, without risk of pollution of the materials by each other. Indeed, when the gel of the proximal layer is applied to the film and the textile, the gel of the upper longitudinal portion of the proximal layer passes through the interstices between the fibers constituting the textile and comes to rest between the attachment points of the textile layer to the distal film, without chemical interaction and therefore without risk of diminishing the properties of the materials of each of the film and layers.

The attachment points of the proximal layer to the distal film are also distributed or not, and are preferably 0.5 to 1 mm apart. To achieve the objectives described above, the distal film and the proximal layer of a device of the invention advantageously have an elasticity, identical or different, but which is greater than that of the textile layer. The device according to the invention has an elasticity which is generally not more than 10% less than that of the textile layer. Thus, depending on the destination of the device, the skilled person knows to select the appropriate elastic textile to manufacture said device.

The gel of the proximal layer will make it possible to obtain an occlusive treatment device. It is known that the closure of an area of the skin causes a defense mechanism of the body, by bringing blood and oxygen to said area, which will promote the strengthening of cellular tissue and healing. We therefore choose a gel that allows at least partial closure, or even the entire area to be treated. It is advantageously chosen from compounds which, in addition to their mechanical action above promoting healing, intrinsically participate in healing. Preferably, the gel is selected from silicones, hydrocolloid gels, caprolactone-based gels, and mixtures thereof.

To complete and improve the treatment of the zone, the gel of the layer may comprise at least one active principle, for example bactericidal, virucidal, fungicidal and / or antiseptic. This is preferably associated with a vehicle, resulting in the gradual release of said active ingredient, especially to the lesion, promoting the disinfection of the wound to be treated. By way of illustration, such a gel may be a silicone as described in FR-A-2768615. Preferably, a silicone having an adhesion strength of at least 500 g / cm ² is chosen. The gel may also include any other ingredient contributing to the protection and / or treatment of the zone, this ingredient being associated or not with the active principle (s) above. It may for example be an agent promoting cell reinforcement of the skin, such as vitamin A.

The constituent polymer of the adhesive layer, at least for the portion intended to cover the skin, must be stable, having a blocked chemical structure, to prevent any uncontrolled and undesirable release of molecules, eg oil molecules, that would cross the skin barrier. It is preferably permeable to oxygen.

The adhesive layer has a variable thickness which is determined according to the application of the device. As stated above, the adhesive layer comprises in the longitudinal direction, two parts, a portion directed towards the film which is designated by the upper longitudinal portion, and a portion directed towards the area to be protected and / or treated that the is designated lower longitudinal portion. So that the proximal layer is adhesive, it is preferable that said lower portion does not include fibers of the textile layer, the upper longitudinal portion corresponding to the portion of the adhesive layer in which the textile layer is embedded.

The thickness of the lower longitudinal portion of the adhesive layer may vary from 0.5 to 4 mm, the thickness of the upper longitudinal portion may vary from 0.05 to 0.1 mm. Likewise, the consistency of the gel which is determined during gel production is fixed in relation to the destination of the device, for example protection of an area subjected to friction or shear or protection / treatment of an area where the support of the body is concentrated. Thus, in the treatment of hallux valgus or the prevention of sacrum ulcers, the consistency of the gel will be higher, thus allowing the support pressures to be distributed over the entire surface of the device.

The distribution of the gel in the layer is also adaptable to use, it is generally at least 700 g / m ² .

Silicone is a polymer which combines all the aforementioned preferential qualities and is therefore the preferred polymer according to the invention for constituting the proximal layer.

The polymer of the distal film is preferably selected to be liquid-tight, tear-resistant, friction-resistant, shear-resistant. It is also advantageously microaerated. For this purpose, it may be chosen from polyurethanes, polyvinyl chloride, polyethylenes, and mixtures thereof. The thickness of the distal film can vary between 15 and 25 microns, depending on the use, particularly depending on the constraints that will be submitted.

According to a particularly preferred variant of the invention, the gel is a silicone and the film is a polyurethane film. As said above, the elasticity of the device is maintained even for large thicknesses of the proximal layer. This elasticity that it can be expressed as a percentage of elongation with respect to the device not subjected to stretching, can thus reach 250%, and this without the properties of the device are affected.

According to the invention, textile of the intermediate layer, a material consisting of synthetic fibers and / or natural, having elastic properties. This textile may be woven or non-woven, it is preferably of fibers selected from polyamide fibers, polyester fibers, mixtures thereof. The textile may thus be a Lycra ^®, whose elasticity is chosen according to the application of the device according to the invention, as said earlier. In a preferred embodiment, the device of the invention may comprise a removable protective layer of the adhesive layer, before use, paper, cardboard, other material or composite. Thus, this layer advantageously comprises a layer of polyethylene which is in contact with the gel, on a cardboard sheet. To facilitate the removal of this protective layer during the application of the device, the polyethylene is preferably embossed. The cardboard sheet of the protective layer has a basis weight of the order of 150 to 200 g / m ² .

Yet another advantage derived from the elasticity of the device of the invention lies in a mode of removal of this removable layer. The layer is advantageously precut for shrinkage, the shrinkage taking place by simple stretching of the device which leads to the separation of the pre-separated parts of the removable layer.

A device of the invention can adopt various presentations, for example in the form of strips to cut, roll, or individual dressings of varying sizes and shapes. These presentations can be obtained by simply cutting a device of the invention to the desired size and shape.

The applications of a device of the invention are multiple. Thus, it can be used as a dressing or protection device and / or treatment of burns, as a dressing or device for protecting and / or preventing bedsores, for example pressure ulcers of the heels, elbows, cheeks, sacrum, as a dressing or device for protecting and / or treating skin lesions, for example foot lesions, such as ampoules, as a dressing or device for preventing or reducing keloids, cartilage-poor areas, or any other cutaneous lesion such as varicose origin. According to an implementation of a device of the invention, the proximal layer of said device is covered with a textile layer, expandable. In this variant, a device finds particular interest for obtaining a plantar pad or for obtaining a sleeve for covering a stump, including tibial or femoral. In the first use, the device is cut into shape, and said textile layer advantageously only partially covers the proximal layer, the zone of contact with the arch is not covered as well as holding zones on the foot by adhesion of and others of said device. In the second use, the device of the invention promotes lymphatic drainage of the stump, while allowing a distribution of the supports. This device can also be used as a bandage for restraint purposes.

According to another implementation of a device of the invention, it is possible to obtain, by superposition of two devices described above, a device for distributing the pressing pressures. More specifically, this device has a sandwich structure superimposing a first protection / treatment device of the invention and a second protection / treatment device of the invention, said second device being identical to or different from said first device, the two devices implementing common their layer (3), respectively. This support pressure distribution device is not necessarily obtained by superposition of said first and second devices, and, according to an advantageous variant, it comprises only one and the same layer (3).

Such a support pressure distribution device has various applications, in particular in any pathology or any situation in which the support pressures of an area affected by this pathology or situation are restricted, which can cause or cause pain. Thus, according to preferred applications, such a device can be used to obtain a footpad, or to obtain a sleeve for covering a stump, including tibial stump or femoral stump. The plantar foot is a zone under the soles of the foot strongly solicited, by the standing, the sport, and its wear causes pain, the distribution of the pressures being reduced, as in the case of the stump whose contact with the prosthesis can be painful for the same reasons. A device according to the invention makes it possible to restore a distribution of pressures and to relieve pain, and to maintain lymphatic drainage. The elasticity of the device gives the latter a shape memory that will make it reusable, and in the In the case of the stump sleeve, this device makes it possible to provide restraint, facilitating its formation and guaranteeing lymphatic drainage.

The device is cut according to the desired application, and in particular size and shape. The invention also relates to a method for obtaining a protection and treatment device as described above; it includes the following steps:

Glue dots are deposited on the distal film

The textile layer is pressed onto the distal film to fix the textile layer on the distal film by point.

The polymer of the proximal layer is applied to the textile layer, by topping.

The method according to the invention which is not a stratification of the different layers, allows each material to retain its original properties, the interactions between each of them being very restricted.

A description of a device for protecting and / or healing the invention and a device for distributing the pressing pressures is hereinafter made with reference to FIGS. 1 and 2, respectively, showing a sectional view of devices of the invention. Figure 1 illustrates a device 1 for protection and / or healing. It comprises a distal film 2 of a fumable polymer, a proximal layer 3 having an upper longitudinal portion 6 directed towards the film 2 and a lower longitudinal portion 7 intended to be applied to the area to be protected and / or treated, and a layer 4 textile. The latter is embedded in the part 6 of the layer 3 and is fixed in points to the film 2. This figure perfectly illustrates the mode of attachment of the layer 4 to the film 2, leading to the indirect fixation of the layer 3 in the device 1 Part 7 of layer 3 is free of textile fibers. A removable protective layer 8 covers the layer 3.

FIG. 2 illustrates a device 9 for distributing the pressing pressures. It responds to a sandwich structure whose core consists of a layer 10 of a polymer chosen polymers suitable for obtaining the distal layer 3 of the device 1 shown in Figure 1. On each longitudinal side of the heart, the device comprises a layer 11, identical or different, then a film 12, identical or different, on which the layer 11 is fixed by points 5. The layer 10 comprises two longitudinal peripheral portions 13 directed towards the film 12, passing through the textile layer and a central longitudinal part 14.

Claims

1. Device (1) for protecting and / or healing a zone to be protected and / or treated, flexible, comprising at least one distal elastic film (2) based on a fumable polymer and a layer (3) proximal, elastic, adhesive, gel-based and having two longitudinal portions, upper (6) directed towards said film and lower (7) intended to be in contact with the area to be protected and / or treated, said device (1 ) being characterized in that it comprises an intermediate layer (4), textile, extensible, located between the film (2) distal and the layer (3) proximal and fixed by points (5) on said film (2), the upper longitudinal portion (6) of the layer (3) passing through said textile layer (4) between the points

(5) fixing.

2. Device according to claim 1, characterized in that the film (2) distal and the layer (3) proximal have an identical or different elasticity, which is greater than that of the layer (4) textile.

3. Device according to claim 2, characterized in that its elasticity is not more than 10% lower than that of the layer (4) textile.

4. Device according to any one of claims 1 to 3, characterized in that the gel of the layer (3) is selected from silicones, hydro colloidal gels, caprolactone-based gels, and mixtures thereof.

5. Device according to any one of claims 1 to 4, characterized in that the polymer of the film (2) is selected from polyurethanes, polyvinyl chloride, polyethylene, and mixtures thereof.

6. Device according to any one of claims 1 to 5, characterized in that the gel of the layer (3) is a silicone and the polymer of the film (2) is a polyurethane.

7. Device according to any one of claims 1 to 6, characterized in that the gel distribution of the layer (3) is at least 700 g / m ² .

8. Device according to any one of claims 1 to 7, characterized in that the textile of the layer (4) is woven or non-woven.

9. Device according to any one of claims 1 to 8, characterized in that the textile of the layer (4) is made of fibers selected from polyamide fibers, polyester fibers, and mixtures thereof.

10. Device according to any one of claims 1 to 9, characterized in that the film (2) is microaerated.

11. Device according to any one of claims 1 to 10, characterized in that the film (2) has a thickness ranging from 15 to 25 microns.

12. Device according to any one of claims 1 to 11, characterized in that the layer (3) adhesive is permeable to oxygen.

13. Device according to any one of claims 1 to 12, characterized in that the lower longitudinal portion (7) of the layer (3) has a thickness ranging from 0.5 to 4 mm.

14. Device according to any one of claims 1 to 13, characterized in that the portion (6) of the upper longitudinal layer (3) has a thickness ranging from 0.05 to 0.1 mm.

15. Device according to any one of claims 1 to 14, characterized in that the layer (3) comprises at least one active ingredient, for example bactericidal, virucidal, fungicidal and / or antiseptic.

16. Device according to any one of claims 1 to 15, characterized in that the layer (3) comprises at least one agent promoting cell reinforcement of the skin, for example vitamin A.

17. Device according to any one of claims 1 to 16, characterized in that the points (5) for fixing the layer (4) to the film (2) are spaced from 0.5 to 1 mm.

18. Device according to any one of claims 1 to 17, characterized in that it comprises a removable layer (8) for protecting the adhesive layer, before use.

19. Device according to claim 18, characterized in that the layer (6) comprises a layer of polyethylene in contact with the layer (3) and deposited on a cardboard sheet.

20. Device according to claim 19, characterized in that the polyethylene is embossed.

21. Device according to claim 19 or 20, characterized in that the cardboard sheet has a basis weight of the order of 150 to 200 g / m ² .

22. Device according to any one of claims 1 to 21, characterized in that it is in the form of strips to cut, roll, or individual dressings of varying sizes and shapes.

23. A dressing for protecting and / or treating burns, consisting of a device according to any one of claims 1 to 22.

24. A dressing for protecting and / or preventing bedsores, consisting of a device according to any one of claims 1 to 22.

25. Dressing for protecting and / or treating skin lesions, consisting of a device according to any one of claims 1 to 22.

26. Dressing for preventing or reducing keloids, consisting of a device according to any one of claims 1 to 22.

27. Device (9) for distribution of the pressing pressures, characterized in that it has a sandwich structure superimposing a first device according to any one of claims 1 to 22 and a second device according to any one of claims 1 22, identical or different from said first device, the two devices pooling their layer (3), respectively.

28. Device according to claim 27, characterized in that it comprises only one layer (10).

29. Use of a device according to any one of claims 1 to 22, for obtaining a dressing for the protection and / or treatment of burns.

30. Use of a device according to any one of claims 1 to 22, for obtaining a dressing for the prevention and / or protection of bedsores.

31. Use of a device according to any one of claims 1 to 22, for obtaining a dressing for the protection and / or treatment of skin lesions.

32. Use of a device according to any one of claims 1 to 22, for obtaining a dressing for the prevention or reduction of keloids.

33. Use of a device according to any one of the claims

1 to 22, for obtaining a plantar pad, the proximal layer of said device is covered with a textile layer, extensible.

34. Use of a device according to any one of claims 1 to 22, for obtaining a sleeve for covering a stump, in particular tibial or femoral, the proximal layer of said device is covered with a textile layer, extensible.

35. Use of a device according to claim 27 or 28, for obtaining a plantar pad.

36. Use of a device according to claim 27 or 28, for obtaining a sleeve for covering a stump, in particular tibial or femoral stump.

37. A method for obtaining a device according to any one of claims 1 to 22, characterized in that it comprises the following steps:

Glue dots are deposited on the distal film

The polymer of the proximal layer is applied to the textile layer, by topping.