WO2020115447A1

WO2020115447A1 - Retaining device and retention system comprising a retention article and such a retaining device

Info

Publication number: WO2020115447A1
Application number: PCT/FR2019/052950
Authority: WO
Inventors: Serge Lecomte
Original assignee: Urgo Recherche Innovation Et Developpement
Priority date: 2018-12-07
Filing date: 2019-12-06
Publication date: 2020-06-11
Also published as: FR3089405A1

Abstract

The invention relates to a retaining device for preventing slipping of a retention article on a limb of an individual, the retaining device comprising: - a flexible and inextensible film (5) having first (5a) and second (5b) faces which are located opposite each other, the first face (5a) having a base surface (6) and a plurality of hooking members (7), each extending from the base surface (6) to a free end (8), the hooking members (7) being configured to cooperate with loops of the retention article in order to retain said retention article on the first face (5a) of the film (5), the first face (5a) of the film (5) having a shore hardness A of greater than 55, preferably between 70 and 100, - an adhesive layer (15) which at least partially covers the second face (5b) of the film (5) and is adapted to retain the film (5) on the limb of the individual.

Description

Title of the invention: Restraint device and restraint system comprising a restraint article and such a restraint device Technical field

The invention relates to a restraint and a restraint system

comprising a restraining article and such a retaining device.

The invention relates, in particular, to a retaining device intended to prevent a sliding of a compression article on a member of an individual.

Prior art

The invention is particularly applicable to a textile-type compression article having surface loops, such as a textile compression band and in particular a short elongation compression band.

The use of a restraint system is known to treat pathologies

of venous origin, such as venous insufficiency, the treatment of varicose veins and leg ulcers or to prevent venous thrombosis or the treatment of lymphedema. These compression systems consist of one or more compression bands which apply pressure to the limb to be treated.

A recurring problem with these compression bands and, in particular, the short elongation compression bands is their sliding over time along the leg because of their weight and the movement of the patients.

The compression bands used are classified by compression specialists into two main categories according to the measure of their elongation; the so-called short stretch bands and those called the long stretch bands.

This classification is based on the measurement of the longitudinal elongation of the compression band as defined in method A §9.1 of standard EN 14704-1 when the compression band is subjected to a maximum tensile force of 6 N / cm.

The conditions for carrying out the measurement are as follows. A test piece of the compression band to be tested, 50 mm wide and 250 mm to 300 mm long, is cut and positioned without preload in the jaws of an electronic dynamometer (for example a dynamometer of the MTS brand) so as to have a width of 50 mm and a useful reference length of 200 mm. A crosspiece of the dynamometer stretches the test piece from an initial position at a speed of 100 mm / min to a maximum force of 6 N / cm then returns to its initial position at the same return speed of 100 mm / min. This cycle is performed 5 times and the elongation obtained in the fifth cycle, expressed as a percentage, is directly calculated by the dy- namometer. The operation is repeated on 5 test pieces, then the average value which defines the longitudinal elongation of the strip is calculated.

On the basis of this test according to standard EN 14704-1 taken as a reference, it is considered that a compression band is a band with "short elongation" if its longitudinal elongation is less than or equal to 100% and a band to "long elongation" if its longitudinal elongation is greater than 100%.

It is recognized today that the most effective compression systems in terms of ease and speed of installation and in terms of therapeutic effectiveness are those which include a maximum of 2 bands and at least one so-called compression band. short stretch. These compression bands exert a low resting pressure and a high working pressure. They therefore have a large pressure differential, in particular during movements, for example during walking.

But in return these short elongation strips are those which have the highest sliding potential.

The compression band which covers the calf is subjected to high pressures to be applied and, when walking, to rapid and repetitive variations in the diameter of the calf. The more the compression band is short, ie far from 100%, the less it will be stretchy and elastic and will adapt to variations in the diameter of the calf. It is then subjected to significant mechanical stresses which cause it to slide along the leg. This slip can result from a loss of contact with the calf. It can also result from an intrinsic loosening of the turns in relation to a tension exerted during installation.

To avoid this slipping, a solution which has often been envisaged is to coat all or part of the compression bandage with an adhesive which sticks to the skin and to the textile material of the compression bandage. But the presence of adhesive is often rejected by the patient and the compression band is no longer washable or reusable. In addition, the coating step modifies the properties of the compression bandage and complicates its development and manufacture.

Finally, the position of the adhesive on only part of the compression band is insoluble except to develop a multitude of compression bands to adapt to the morphology of each patient, whose legs are more or less long , and the position of the variable wound on the leg. In addition, in the case of the treatment of leg ulcers, a dressing is placed on the wound which the compression band comes to cover and it is necessary to avoid that the compression band does not stick to the dressing.

Document WO 2009/138672 describes and exemplifies a positioned adhesion

only at the end of a stocking and suggests the same solution for a compression band. However, this solution does not make it possible to solve the problems of developing and manufacturing the compression bandage, washing, rejection of the user and especially the size of the patient's leg and therefore the surface of the compression bandage to be made adhesive. This solution has never been implemented for a compression bandage.

To favor the absence of slippage, it was preferred to coat the two sides of the compression bandage with a product which adheres only to itself, generally latex, and especially not to the skin. The latter blocks the winding of the compression bandage in extension, avoids the turn-to-turn slip, its loosening and its slip.

However, the production of such a self-adhesive compression bandage is complex because again the coating of the latex modifies the elasticity and extensibility properties of the compression bandage and risks reducing its breathability. To simplify the development, in the most recent compression articles, the pressure has been distributed over two compression bands. The second compression band makes it possible to fix and maintain the first compression band. But in this case, thicker products, hotter and above all longer to lay are obtained. Finally, latex is likely to cause allergies in some patients.

The role of an adhesive or latex has long been essential to maintain the compression bandage or the compression system after it has been wrapped around a member and reduce their intrinsic loosening which leads to their loss of efficiency and their slip over time along the limb.

In order to improve the acceptability by the patients and the nursing staff and to obtain a compression system which is easier to manufacture, it therefore appears desirable to have a compression article which uses compression bands without adhesive. or latex. A first advantage is to allow washing and reuse of the compression bandage. A second advantage is, in the case of multi-layer compression systems, to obtain products which are thinner, less hot and above all quicker to apply due to the removal of the self-adhesive layer.

Application WO 2017/089731 proposes a 3D knitted fabric which has a shear threshold stress greater than or equal to 2800 Pa to avoid the turn-to-turn slip which induces the final slip of the compression band. But this specific solution is not applicable to other compression bands or 3D knitwear whose shear stress is less than 2800Pa.

None of the previous solutions is truly satisfactory to avoid the loose release and slippage of a non-specific compression bandage.

It is therefore desirable to find a more universal and simpler solution to

use only those proposed to avoid slipping of a non-self-adhesive compression bandage and, in particular, a compression band with short elongation. This solution could, if necessary, be applied to other articles of restraints that apply pressure.

The invention aims to propose such a solution.

Statement of the invention

To this end, according to a first aspect, the invention provides a retaining device intended to prevent a sliding of a compression article on a member of an individual, the compression article being of textile type and having surface loops, the retaining device comprising:

a flexible and inextensible film having a first face intended to be placed in contact with the compression article, and a second face opposite to the first face and intended to be placed facing the member of the individual, the first face comprising a base surface and a plurality of latching members each extending from the base surface to a free end, the latching members being configured to cooperate with the loops of the restraint to retain said compression article on the first face of the film, the first face of the film having a shore A hardness greater than 55, preferably between 70 and 100,

- an adhesive layer covering at least partially the second face of the film and adapted to retain the film on the limb of the individual.

The depositor has determined that, among all of the forces that interact on an adhesive-coated compression article placed in extension, the most critical point is the bond between the adhesive and the textile material of the compression article. . The textile material is stretchable so that the shear stresses on the compression article are directly transmitted to the adhesive. In the case of a compression band, these constraints are very high and the bond between the adhesive and the textile material then becomes very fragile.

The invention makes it possible to promote the link between the adhesive and the compression article even during variations in the extensibility of the latter. The depositor has determined that to protect this bond, it is necessary to inhibit or at least reduce the transmission of the shear stress imposed by the compression article during movements with the adhesive. To achieve this result, he interposed between an adhesive layer and the compression article, a film which, thanks to its inextensibility and its anchoring capacity in the compression band, opposes the shear stress.

The invention therefore combines the implementation of an adhesive layer with a film which, moreover, has a specific characteristic ensuring the attachment of the attachment members in the loops of the compression article: hardness shore A su greater than 55.

Indeed, hook films are known to be used in closures such as

commonly called "velcro", in which the hooks are anchored in a additional part in textile material which has loops. They are thus used in the closure of shoes, clothing, diapers or other.

They are manufactured by the companies Alfatex, Aplix or Velcro which offer wide ranges of such films suitable for various applications.

Films with adhesive hooks are also known. They are used as a fastener for an object on a wall. One or more films with hooks are stuck on the wall, one or more films with loops are stuck on the back of the object and the object is fixed by anchoring hooks in the loops. Such products are for example marketed by the company 3M.

In the context of the present invention, the film provided with the fastening members must fulfill a specification different from those defined in the previous applications. The retaining device is used only once and above all is subjected to non-static stresses, as for films with adhesive hooks for fixing or for films with closing hooks, but dynamic because of the repetitive variation. and quick calf diameter.

In the application considered for maintaining a compression bandage, the resulting specifications are complex. The film provided with the fastening members undergoes significant pressure imposed by the compression bandage in extension and tangential shear stresses in dynamic mode which do not exist in the fastening devices and in the closure systems. As the restraint device of the invention is independent of the compression band, the fastening members must be rigid enough to resist pressure and repetitive stresses, but also be able to anchor in the loops of the compression band. Finally, the film must be inextensible but remain flexible and flexible so as not to cause feelings of pain during use.

To meet this unusual specification, the applicant has determined that the films usable in the context of the present invention must have a specific characteristic, namely a Shore hardness greater than or equal to 55 on the face provided with the organs of 'hanging.

Furthermore, the use of hook films in association with a strip of

contention has already been proposed.

Document US 2009/0208698 proposes to replace the use of latex or

of adhesive in a compression band by fixing hook films all along the compression band, so as to block the turn-to-turn movement of the latter and prevent it from loosening and slipping.

This solution, considered 12 years ago, has never been used because the presence of hook films block the extensibility and elasticity of the compression band. It freezes like a plaster and can no longer adapt and follow rapid variations and petitive calf diameter during movements. Unable to stay in contact with the calf, it creates an interval and it eventually slips. It also becomes uncomfortable because it is too tight when the calf is at rest. If the number of hooked films is reduced, they lose in effectiveness with respect to the turn-to-turn slip and in too great a number, although these films are thin and flexible, they deteriorate the conformability and the breathability of the compression band and decreases patient acceptability. Finally, this complicates the manufacture of the compression bandage. In addition, since the hook films are fixed to the compression band and not independent, they are subjected to stresses different from those of the retaining device according to the invention in which the film with fastening members is independent of the compression band.

Document WO 2017/034462 proposes to use a compression bandage with a low pressure differential, therefore with long elongation, and to block the compression bandage according to the activity of the patient by adding on the outside of the latter, after its winding, large patches of hooked film patches which are anchored in the compression band. The compression band thus modified increases its efficiency and prevents slipping.

But the patches, numerous and thick, stiffen the compression band, reduce its breathability and lengthen the exposure time. In addition, this solution can only be applied for a long elongation compression bandage.

Document WO 2014/155014 uses, for its part, hook films at the end of the winding of the compression bandage in extension to secure the maintenance of the last two turns over time. Unlike the previous document, the films used here are very thin and very flexible. On the other hand, hung vertically on the last turns as illustrated in FIG. 2C, they detach from the compression band during movements and do not prevent sliding from turn to turn. With thicker films, we would come back to the disadvantages of the previous document.

None of the solutions proposed in these documents are satisfactory for avoiding the loosening and slipping of a compression band, in particular with short elongation.

Thus, the invention provides a non-slip retaining device for an article of restraint placed in extension, in particular on the leg. The retainer effectively and durably inhibits turn-to-turn slip and overall slip, particularly in the case of a non-self-adhesive, short-stretching compression bandage. The retaining device is independent of the restraint article so as to allow a reuse of this restraint article.

In addition, the retainer is easy to use and offers a greater choice of adhesive substance. It avoids modifying the contention band. Each attachment member can include:

a foot along a longitudinal axis, the foot being secured to the base surface,

- at least one attachment surface extending transversely to the longitudinal axis, facing the base surface.

The attachment surface can be arranged at the free end of the member

hanging.

The attachment members can be formed in one piece with the base surface.

Each attachment member can have a height between the base surface and

the free end between 0.2 mm and 1.2 mm.

The attachment members can be arranged in a network having a density between 120 attachment members / cm ² and 300 attachment members / cm ² .

The second face of the film may have a smooth surface.

The film can be produced from a thermoplastic polymer, in particular chosen from polypropylene, polyethylene, polyamide 6, polyamide 6.6, polyamide 4.6, polyester and, in particular, polyethylene terephthalate.

The film can have a basis weight between 90 g / m ² and 230 g / m ² .

The adhesive layer may have a tangential shear resistance t of at least 10 hours according to a creep test in which a first part of the retaining device is bonded via the adhesive layer to an inclined plate of an angle of 2 ° with respect to a vertical direction, leaving free a second part of the retaining device, a ballast being suspended from the second part of the retaining device, with: t = (L ² .l. h) / 2 .eMg

where L is a length of the adhesive layer of the first part of the retainer,

1 is a width of the adhesive layer of the first part of the retaining device, h is a viscosity of the adhesive layer,

e is a thickness of the adhesive layer,

M is a ballast mass, M being chosen as a function of a tangential stress exerted by the compression article,

g = 9.81 m / s ² .

The adhesive layer consists of an adhesive substance sensitive to pressure and in particular of an adhesive substance chosen from:

- acrylic adhesives based on acrylate polymers or copolymers of acrylic acid and esters of acrylic acid,

- high molecular weight poly-isobutylene adhesives,

- adhesives based on natural or synthetic polyisoprene,

- adhesives based on polymers or copolymers of siloxane and ta- cificants or silicone gels based on crosslinked polyxilosans,

- polyurethane adhesives or polyurethane gels,

- adhesives based on triblock copolymers, plasticizers and tackifying resins, in particular triblock polymers of the styrene- central block- styrene type in which the central block is unsaturated, for example isoprene or butadiene, or saturated, for example ethylene- butylene or ethylene-propylene, optionally mixed with diblock copolymers such as, for example, styrene-isoprene or styrene-butadiene copolymers.

The adhesive layer may include a single elementary adhesive layer.

The elementary adhesive layer may have a grammage of at least 50 g / m ² , preferably between 60 g / m ² and 120 g / m ² .

The elementary adhesive layer may have an adhesive force of between 0.5 N / cm and 5 N / cm measured by a peeling test in which the adhesive force at an angle of 90 ° to peel off the layer adhesive of a reference surface chosen from the second face of the film and a skin surface.

The adhesive layer can comprise:

- a first elementary adhesive layer intended to be brought into contact with the member,

a core having a first surface carrying the first elementary adhesive layer, and a second surface opposite the first surface,

- a second elementary adhesive layer to fix the second surface of the core to the second face of the film.

The first elementary adhesive layer may have a basis weight between 25 g / m ² and 120 g / m ² , preferably between 40 g / m ² and 80 g / m ² , and the second elementary adhesive layer may have a grammage between 20 g / m ² and 120 g / m ² , preferably between 30 g / m ² and 50 g / m ² .

The first elementary adhesive layer may have an adhesion force of between 0.5 N / cm and 5 N / cm and the second elementary adhesive layer may have an adhesion force of between 0.5 N / cm and 10 N / cm, the adhesive strength of each of the elementary adhesive layers chosen from the first and second elementary adhesive layers being measured by a peeling test in which the adhesive force at an angle of 90 ° to peel off said adhesive layer elementary of a reference surface chosen from the second face of the film and a skin surface.

According to a second aspect, the invention proposes a compression system comprising a compression article intended to be placed on a limb of a patient and a restraint device as defined above.

The compression article can be a textile compression band intended to be wrapped around the limb.

The compression band can be of short elongation.

Brief description of the drawings

Other characteristics, details and advantages of the invention will appear on reading the detailed description below, and on analysis of the appended drawings, in which:

[Fig.l]

- Figure 1 is a representation of a retaining device according to an embodiment of the invention, the retaining device comprising a film, a first face of which comprises a plurality of hooking members configured to cooperate with loops a textile compression article, and a second face is covered at least in part with an adhesive layer,

[Fig.2]

FIG. 2 is a representation of a retaining device according to a first variant of the embodiment of FIG. 1, the fastening members having a configuration different from that of the retaining device of FIG. 1,

[Fig.3]

FIG. 3 is a representation of a retaining device according to a second variant of the embodiment of FIG. 1, the fastening members having a configuration different from that of the retaining device of FIGS. 1 and 2,

[Fig.4]

- Figure 4 is a representation of a retaining device according to a fourth variant of the embodiment of Figure 1, the adhesive layer being of double-sided type,

[Fig.5]

- Figure 5 is a representation of an experimental device for carrying out a creep test measuring a tangential shear strength of the adhesive layer,

[Fig.6]

FIG. 6 is a representation of an in vivo test implementing a compression article in the form of a short elongation compression band wound on the leg of an individual, illustrating a sliding of the compression band,

[Fig.7]

- Figure 7 is a representation of an in vivo test implementing a compression system according to an embodiment of the invention comprising the retaining device and a compression article in the form of a compression band at al long short rolled up on the leg of an individual, illustrating less slippage of the compression bandage compared to the compression bandage wound in FIG. 6. Description of the embodiments In the figures, the same references designate identical or analogous elements.

FIG. 1 represents a retaining device 1 intended to prevent slipping of a compression article on a limb of an individual. The compression article is of textile type and has loops on the surface. It can in particular be a compression band 2 of textile material, with short elongation as defined in method A §9.1 of standard EN 14704-1, wound on a leg 3 of the individual.

The retaining device 1 comprises:

a flexible and inextensible film 5 having a first face 5a intended to be placed in contact with the compression article, and a second face 5b opposite the first face 5a and intended to be placed opposite the member of the individual, and

- An adhesive layer 15 covering at least in part the second face 5b of the film 5 and adapted to retain the film 5 on the limb of the individual.

In particular, the first face 5a of the film has a base surface 6 and a plurality of fastening members 7 each extending from the base surface 6 to a free end 8.

The fastening members 7 are configured to cooperate with the loops of

the compression article for retaining it on the first face 5a of the film 5. In the embodiment shown in FIG. 1, the hooking members 7 are formed in one piece with the base surface 6 and shaped as a hook double or anchor 9.

Each attachment member 7 includes:

- a foot 10 extending from the base surface along a longitudinal axis A,

- two attachment surfaces 11 arranged at the free end 8 of the attachment member 7, the attachment surfaces 11 extending transversely relative to the longitudinal axis A, facing the base surface 6 , in opposite directions.

The invention is not limited to such an embodiment and such a conformation of the fastening members. The invention extends to any attachment member formed in a single piece with the base surface 6 or attached to the base surface 6, and shaped to have at least one attachment surface extending transversely to the longitudinal axis, facing the base surface. Thus, in a first variant shown in FIG. 2, the retaining device 1 ’can comprise hooking members T in the form of a single hook 9’. In a second variant shown in FIG. 3, the retaining device 1 "can comprise hooking members 7" in the form of a mushroom 9 ". In other variants, hooking members in the form of harpoon, palm tree or the like can be provided.

Each attachment member 7 may have a height between the base surface 6 and the free end 8 between 0.2 mm and 1.2 mm. The hooking members can, moreover, be arranged in a network having a density between 120 hooking members / cm ² and 300 hooking members / cm ² .

In addition, the anchoring of the fastening members 7 in the compression band and the resistance to pressure and to shear forces implies that the first face 5a of the film has a specific characteristic: a higher shore A hardness. or equal to 55 and preferably between 70 and 100. This measurement is carried out on the first face 5a of the film 5 with a Shore A durometer, for example sold by the company Mitutoyo. Before the measurement, a preliminary calibration can be carried out with three reference materials which have increasing hardnesses: for example, a hardness of 33.1, a hardness of 61.8 and a hardness of 89.1. After this calibration, a series of three film hardness measurements is made and the average is calculated.

The second face of the film has a smooth surface.

The film can in particular be obtained by extrusion molding of thermoplastic polymer, in particular chosen from polypropylene, polyethylene, polyamide 6, polyamide 6.6, polyamide 4.6, polyester and, in particular, polyethylene terephthalate. Other thermoplastic polymers can be envisaged, but in the context of the present invention, polypropylene and polyamide will be preferred.

The film preferably has a basis weight between 90 g / m ² and 230 g / m ² .

Thanks to the use of such a film 5, a wider palette of adhesive substances for the adhesive layer 15 can be used in the context of the production of the retaining device 1.

In the context of the present invention, the adhesive substance is chosen to adhere to the skin and to the film. The adhesive substance is in particular a compatible organic adhesive substance commonly used to adhere to the skin or a wound in medical devices such as medical fixations, patches or dressings and cosmetic products.

The adhesive layer 15 consists of a pressure-sensitive adhesive substance designated under the term of PSA for Pressure Sensitive Adhesive. According to the PSTC (. Pressure Sensitive Tape Council), such an adhesive substance has the following characteristics:

- a permanent and measurable stickiness,

- a sticky power with a pressure hardly higher than that of the finger

- adhesion without any activation of any energy source,

- sufficient capacity to hold on the substrate,

- sufficient cohesion to remove the substrate without residue.

The adhesive substance can in particular be chosen from:

- acrylic adhesives based on acrylate polymers or copolymers of acrylic acid and acrylic acid esters; these adhesives are present in the aqueous phase or aqueous dispersion, they can also be obtained by photopolymerization of acrylic monomers with initiator photos, for example by UV crosslinking,

- high molecular weight poly-isobutylene adhesives,

- adhesives based on natural or synthetic polyisoprene,

- adhesives based on polymers or copolymers of siloxane and tackifying resins or silicone gels based on crosslinked polyxilosanes such as those described in document WO 2009/138642,

- polyurethane adhesives or polyurethane gels,

Various fillers can also be incorporated into the formulation of these adhesives such as, for example, antioxidants, dyes such as titanium dioxide or fatty substances such as petrolatum or lanolin.

These pressure-sensitive adhesive substances are generally hydrophobic but can incorporate, if necessary, hydrophilic compounds, such as, for example, hydrocolloids such as the sodium salt of carboxymethylcellulose, in an amount of the order of 1% to 40% and preferably from 2% to 25%.

By way of non-limiting example, the adhesive substance is an adhesive based on triblock co polymers of the styrene-central block-styrene type, plasticizers, tackifying resins and possibly fillers on normal skin. For fragile skin, the above formulation will be supplemented with, in dispersion in the adhesive, a small amount of hydrocolloids of 2% to 20% relative to the total weight of the adhesive or silicone or polyurethane gels.

If necessary, a treatment, in particular corona, can be provided on the film 5 or the adhesive layer 15 to facilitate the adhesion of the adhesive layer 15 to the film 5.

In FIGS. 1, 2 and 3, the adhesive layer 15 comprises a single elementary adhesive layer 16.

The grammage of the elementary adhesive layer 16 deposited on the second smooth face 5b of the film 5 is preferably at least 50 g / m ² and in particular between 60 g / m ² and 120 g / m ² , in order to stick to both the skin and the film.

An adhesive power of the adhesive layer 15 is defined by a peel test. This type of test is conventional and described, for example, in standard EN 1939. It consists in measuring an adhesion force to be provided for peeling off an adhesive layer 15 at an angle of 90 ° from a reference surface. Here, the adhesive force to peel off the adhesive layer 15 from the second face 5b of the film 5 or from a skin surface (for example example on the forearm).

The adhesion strength of the elementary adhesive layer 16 on the skin can be between 0.5 N / cm and 5 N / cm. Depending on the condition of the skin (normal, altered, fragile, parameters often linked to the patient's age and health), the morphology of the leg (muscular, fatty, conical or bony) and physical activity of the patient (mobile or not), the elementary adhesive layer 16 with the most suitable adhesive power is chosen. In the case of abnormal skin, an adhesive layer whose adhesion strength is between 0.5 N / cm and 1.5 N / cm is preferred.

According to another variant shown in FIG. 4, in the event of difficulties in adhering to both the skin and the film, the retaining device G "can have an adhesive layer 15 ′ of double-sided type comprising:

a first elementary adhesive layer 16a intended to be brought into contact with the member,

a core 17 having a first surface carrying the first elementary adhesive layer 16a, and a second surface opposite the first surface,

- a second elementary adhesive layer 16b for fixing the second surface of the core 17 to the second face 5b of the film 5.

The core is generally made of a film and / or a textile material. We prefer the use as a core of a thermoplastic film, a woven, a knit, a nonwoven or their combination.

The first elementary adhesive layer 16a can then have a grammage between 25 g / m ² and 120 g / m ² , preferably between 40 g / m ² and 80 g / m ² , and an adhesive force included between 0.5 N / cm and 5 N / cm, especially between 0.5 N / cm and 1.5 N / cm for fragile skin.

The second elementary adhesive layer 16b may have a grammage between 20 g / m ² and 120 g / m ² , preferably between 30 g / m ² and 50 g / m ² and an adhesive force between 0 , 5 N / cm and 10 N / cm.

In the case of a short elongation compression band, despite the reduction thus obtained in the transmission of shear stresses to the adhesive layer 15 by the film 5, the adhesive layer 15 remains subjected to cor shear forces. responding to the tangential forces applied by the compression band 2 on the retaining device 1. The risk is that these tangential forces cause, not a detachment of the skin or film 5 of the adhesive layer 15, but a cohesive rupture of the adhesive layer 15, that is to say that it separates into two parts glued one on the skin and the other on the film 5. In the case of an adhesive layer 15 ′ of double-sided type, this phenomenon of cohesive rupture can occur for the two elementary adhesive layers 16a, 16b.

The applicant therefore also studied the influence of these tangential forces and defined a additional parameter making it possible to improve the retaining device 1, namely a resistance t to tangential shear. The tangential shear strength t quantifies the ability of the adhesive layer to resist cohesive failure. The applicant has in fact found that several characteristics of the adhesive layer 15 come into play in its ability to resist a cohesive break: the thickness e of the adhesive layer 15, its viscosity and its surface.

The resistance t to tangential shear is measured by a creep test shown in FIG. 5. The principle of this creep test consists in determining the time required to obtain a cohesive rupture of the adhesive layer subjected to the action. of a determined weight which simulates the tangential forces applied to the device. This resistance t to tangential shear is defined by the time necessary to note the cohesive rupture.

A test piece of the retaining device 1 is cut. For example, the test tube is 10 cm long and 2.5 cm wide. A first part of this test piece is glued to a standard steel test plate 20, taking care not to include an air bubble between the adhesive layer 15 and the plate 20 to ensure intimate contact. The first part 1a, glued, has a length L, for example of 2.5 cm and a width 1 of 2.5 cm. Pressure is applied to the bonded surface in order to avoid premature detachment due to poor contact with the plate 20. A second part 1b of the test piece is left free. The test is carried out at 23 ° C after 24 hours conditioning of the plate plus test tube assembly at 23 ° C. The plaque

20 is installed on a support so that it is inclined at an angle a of 2 ° (degrees) relative to a vertical direction V, so that the oscillations at the start of the experiment after installation of the ballast do not disturb the results. Ballast

21 of mass M is suspended from the second part 1b of the test piece which hangs from the plate 20. This automatically triggers an hour meter. The cohesive rupture of the adhesive layer 15 which causes the ballast 21 to drop stops the hour meter. Three measurements are made and an average value is calculated.

The resistance t to tangential shear is then defined by:

t = (L ² .l. h) / 2.eMg

where L is the length of the first part la of the retaining device 1 bonded to the plate 20,

1 is the width of the first part 1a of the retaining device 1,

h is a viscosity of the adhesive layer 15 at 23 ° C.,

e is a thickness of the adhesive layer 15,

M is the mass of the ballast 21 suspended from the second part lb of the retaining device 1, M being chosen as a function of the tangential stress exerted by the compression article, g = 9.81 m / s ²

By way of nonlimiting example, for a compression band 2 with short elongation, the applicant has assessed that the tangential stresses are of the order of 2 kPa to 5 kPa depending on the interface pressure applied by the compression band 2, ie between 30 mm and 80 mm of mercury. On this basis, it determined that a ballast 21 of 1 kg is suitable for the shear stresses involved by the compression band 2 with a long length on the aforementioned test piece. The M / S ratio for a surface S of the retaining device 1 of between 20 cm ² and 50 cm ² (which corresponds to a preferred range of surface) leads to stresses between 2 kPa and 5 kPa and is therefore well representative of forces applied by the compression band 2 with a long short. For reasons of ease of implementation of the test, a square surface of 6.25 cm ² which corresponds to an M / S ratio of 16 kPa was chosen.

Those skilled in the art will however be able to adapt the mass of the ballast to the constraints of saliency applied by the compression article.

[0103] On the basis of these elements and after limit tests, for the substances

adhesives with the lowest viscosities and the lowest adhesive strengths, whatever the grammage of coating, it is possible to determine the creep limits for the adhesive layer.

It was thus determined that the adhesive layer 15 is preferably chosen to have a tangential shear strength t of at least 10 hours for the retaining device 1 to be functional.

The retaining device 1 according to the invention can be manufactured according to a manufacturing process having the following steps. The adhesive layer 15 is produced on a silicone temporary film and covered on a face opposite the temporary film with a silicone temporary protective film. After removal of the protective film, the adhesive layer 15 is transferred to the second smooth face 5b of the film 5. Coils of three layers are thus obtained and cut with the shape chosen for the retaining device 1. The temporary silicone film serves as a protector of the adhesive layer before it is removed and bonded to the skin.

The retaining device 1 can be in any suitable form, in particular geometric, rectangle, rectangle with rounded corners, bi or three-lobed, banana or other. Its dimensions are chosen to guarantee the retention of the compression article. Its dimensions are chosen so that the retaining device 1 has a surface of between 10 cm ² and 80 cm ² depending on the number and the position of the retaining devices 1 employed. Preferably, a single retaining device 1 of rec tangular shape, if necessary with very slightly rounded angles to minimize the risks of detachment, with an area between 20 cm ² and 40 cm ² will be used to retain a compression band 2 . In the case of a complex geometric shape (for example a three-lobed shape), the surface can be calculated as follows. The sheets of photocopiers of standard white A4 paper have a very precise grammage, indicated on the packaging which is 80 g / m ² . A 100 cm ² sample is cut and weighed to verify this value. The retaining device is placed with its temporary protector on an A4 sheet and its contours are drawn on the 80 g / m ² sheet of paper. The shape obtained is cut out and weighed. Knowing the weight of 100 cm ² we deduce the exact surface of the device.

To facilitate bonding on the skin and its retention on the leg 3, the retaining device 1 may have at least one axis of symmetry.

In the context of the attachment of a compression band 2, the retaining device 1 can be positioned under the knee horizontally approximately between 3 cm and 8 cm depending on the morphology of the patient. It can thus, for example, be in the form of a rectangular band with rounded edges which incompletely surrounds (like a bracelet) the leg below the knee at the level of the last turn of the compression band 2. As a variant , it can be arranged vertically on the tibial crest so as to be covered by several turns of the compression band 2. According to another variant, the "bracelet" can be replaced by several retaining devices 1 of dimensions smaller than those of " bracelet ”. It is also possible to combine several of the aforementioned retaining devices.

Although described in connection with an application to compression straps 2 with a long length, the retaining device can be applied for other compression articles to prevent slipping on a lower limb or any other part of the body where a slip would be likely to occur following the movements. Of course their positioning is then adapted accordingly.

Examples

The invention will be illustrated by the following examples and vivo tests.

MANUFACTURING OF THE RETAINER 1

Example 1

Preparation of the adhesive layer 15

An adhesive layer 15 was prepared by mixing in a MEL G-40 mixer.

Its composition, expressed as a percentage by weight relative to the total weight of the composition is as follows:

- Mineral oil sold by Shell Chemicals under the name Edelex 945: 9.76%,

- Block copolymer of poly (styrene-isoprene-styrene) (elastomer) sold by the company KRATON under the name KRATON® D 1111KT: WO 2020/115447 PCT / FR2019 / 052950

13.07%,

Block copolymer of poly (styrene-isoprene-styrene) (elastomer) sold by the company Exxon Mobil Chemical under the name VECTOR 4114A: 6.44%,

- Lanolin: 7.81%

- Antioxidant marketed under the name IRGANOX® 565 by the company CIBA SPECIALTY CHEMICALS: 0.1%,

- Tackifying resin sold by Parchem under the name Dertoline P2L: 39.03%,

- Perkacit ZDBC antioxidant sold by the company AKZO: 0.39%,

- Zinc oxide: 21.86%,

- Titanium dioxide sold by the company Cristal under the name TIONA 595: 1.54%.

The various constituents were introduced at a temperature between 130 ° C and 140 ° C with gentle stirring, so as to obtain a homogeneous mixture.

More specifically, the mineral oil, the two elastomers, the two antioxidants and the titanium dioxide were initially introduced, then the zinc oxide, then the ta ckifying resin and finally the lanolin.

Restraint 1 Preparation

This adhesive is coated at a basis weight of 80 g / m ² on a silicone temporary film and the adhesive layer 15 is covered with a silicone temporary protective film.

This adhesive layer 15 is transferred to a white film 5 provided with hooks from the company APLIX whose reference is 745 which has a shore A hardness of 90.6.

The final retaining device 1 is cut which is in a three-lobed form whose surface is 22.6 cm ² .

The resistance t to tangential shear of this retaining device 1 was evaluated according to the creep test described above. After 152 hours, no cohesive rupture of the adhesive layer 15 is observed. This retaining device 1 therefore fulfills the characteristic of tangential shear strength greater than 10 hours.

Example 2

Using an adhesive layer 15 ’of double-sided type for medical use marketed by the company ADHEX under the reference P754.

The “view” side of the double face is applied by pressure to the second smooth face 5b of a film 5 provided with hooks from the company ALFATEX, the reference of which is Gripper small F 511 and which has a shore A hardness of 87 , 6.

The final retaining device 1 is cut, which is in the form of a rec

tangular with rounded edges, 20 cm long and 2 cm wide, i.e. an area of 39 cm ² .

We evaluated the resistance t to tangential shear of this retainer 1 according to the creep test described above. After 144 hours, no cohesive rupture of any of the two elementary adhesive layers 16a, 16b is observed. This retaining device 1 therefore fulfills the characteristic of tangential shear strength greater than 10 hours.

Example 3

Using the same 15 ′ double-sided adhesive layer for medical use marketed by the company ADHEX under the reference P754 and the same film 5 with hooks as those of Example 2.

The final retaining device 1 is cut which is in a rec form

7.2 cm long and 5 cm wide, representing an area of 36 cm ² .

The resistance t to tangential shear of this retaining device 1 was evaluated according to the creep test described above. After 144 hours, no cohesive rupture of either of the two elementary adhesive layers 16a, 16b is observed. This retaining device 1 therefore fulfills the characteristic of tangential shear strength greater than 10 hours.

Example 4

Preparation of the adhesive layer 15

An adhesive layer 15 was prepared by mixing in a MEL G-40 mixer.

- Mineral oil marketed by Shell under the name Ondina @ 919: 39.7%,

- Sodium salt of carboxymethylcellulose (hydrocolloid) sold by the company AQUALON under the name CMC Blanose ®7H4XF: 14.8%,

- Block copolymer of poly (styrene-ethylene-butylene-styrene) (elastomer) sold by the company Kraton under the name Kraton® G 1651 E: 4.7%,

- Antioxidant marketed under the name IRGANOX® 1010 by the company CIBA SPECIALTY CHEMICALS: 0.2%,

- Tackifying resin marketed by the company EXXON CHEMICALS under the name ESCOREZ® 5380: 35.6%,

- Acid salt copolymer

2-methyl-2 [(1-oxo-2-propenyl) amino] -1-propanesulfonic acid and the ester

2-hydroxyethyl of propenoic acid sold by the company SEPPIC under the name SEPINOV® EMT 10: 5%.

The various constituents were introduced at a temperature between 105 and 115 ° C with stirring, so as to obtain a homogeneous mixture.

More specifically, the mineral oil, the hydrocolloid were initially introduced, and the elastomer then the antioxidant, SEPINOV® EMT 10 and finally the tackifying resin. Restraint 1 Preparation

This adhesive is coated at a basis weight of 100 g / m ² on a silicone temporary film and the adhesive layer 15 is covered with a silicone temporary protective film.

This adhesive layer 15 is transferred to a film 5 provided with hooks from the company APLIX, the reference of which is 745 and which has a shore A hardness of 90.6.

The final retaining device 1 is cut which is in a three-lobed form as in example 1.

The resistance t to tangential shear of this retaining device 1 was evaluated according to the creep test described above. We get a value of 21 hours. At this value, the cohesive rupture of the adhesive layer 15 is noted. This retaining device 1 therefore fulfills the characteristic of tangential shear resistance greater than 10 hours.

Example 5

The same hook film from the company ALFATEX is used here, the reference is Gripper small F 511 which has a shore A hardness of 87.6. However, the latter is not adhesive-coated and will be positioned outside the compression band as indicated in FIG. 2C of document WO 2014/155014. It is rectangular and its dimensions are 15.5 cm in length and 2.6 cm in width, or an area of 40.3 cm ² .

TEST IN VIVO

In FIGS. 6 and 7, the slip and the turn-to-turn offset over time of various compression bands 2 have been evaluated on the in vivo test described below.

The procedure for this in vivo test is as follows.

The compression bandage (s) 2 is wrapped around the leg 3 according to the recommendations described in the instructions for the K2 bilayer system.

As a reminder, this notice recommends the following method of application:

1) hold the foot at 90 °, toes up; apply KTECH to the base of the toes by making two turns of anchoring, ensuring that the padded face is in direct contact with the skin and that the pressure indicator is located on the upper side of the strip; continue by making a figure in "8" around the ankle, without applying excessive tension on the foot and covering the heel well;

2) go back up to the knee by making spirals and stretching the band appropriately: the pressure indicator printed on the bands must form a circle; to obtain correct recovery, the pressure indicator must be just covered (50% recovery); finish 2cm below the knee and cut the excess tape;

3) apply KPRESS on KTECH according to the same technique by starting a finger above KTECH and ending a finger under KTECH so that only KTECH is in direct contact with the skin; once applied, gently press the bandage with your hands to ensure that the system stays in place.

We understand that this last step 3) is not necessary if we do not use a second self-adhesive compression bandage. In this case, the last turn is fixed on itself with the help of a metal tie, a sticking plaster or, preferably, with the hook part of a velcro. However, the bandage is gently pressed again with the hands to ensure that the compression system stays in place.

Using a thin, non-erasable marker, a vertical line is drawn over at least three turns, on the axis of the tibial crest, from the last wound turn. This mark is used as a reference to assess using a ruler graduated to the mm, the horizontal shift of the line at the end of the test duration. During the movements, this line loses its rectilinear character and is presented in steps which are all the more offset as the slip turns on turns are important. If the turn-to-turn slip is very weak or non-existent, the vertical line remains intact or varies very little mainly on the first turn which is located under the last wound turn.

This vertical line offset is representative of the slackening of the strip and illustrates its potential slip over time. The test lasts 6 hours. We measure after 6 hours the offset of the vertical line on the first 3 turns.

One also draws with the help of the fine and non-erasable felt a horizontal line above the last wound coil. This mark is used as a reference to assess using a ruler graduated to the mm, the vertical offset between this line and the position on the leg of the last turn after the duration of the test. It is considered that if the difference between the ho rizontal line and the last turn is, after 6 hours, greater than 15 mm, the strip will slide completely before 24 hours.

If a strip is used with the retaining device according to the invention, the temporary protector is removed from the adhesive layer and the retaining device is glued either horizontally below the knee so as to be covered by the last whorl, or vertically on the tibial crest so as to be covered by several whorls. The strip is then wound as above on the leg. Thus the last turn or turns cover the retaining device.

This vivo test was carried out with the following bands.

The two-layer restraint system sold by the company Laboratoires

URGO under the name K2 size 18 cm-25 cm which consists of two compression bands. A first Ktech band which is a short elongation and applies the majority of the pressure and a second self-adhesive Kpress band which applies the residual pressure but above all fixes the first band and prevents it from slipping and shifting turn to turn. We also tested the Ktech tape alone without and with various devices. holdbacks of the invention. This Ktech strip is calibrated and installed according to the calibration pictogram.

A 3D knit, which is a short stretch, marketed in Germany by the

Neumed company. This knit based on synthetic fibers has a honeycomb face which comes into contact with the skin and an opposite solid face. The shear stress of this knitted fabric measured as described in document WO 2017/089731 is 2020 Pa. This compression band therefore has a large turn-to-turn offset which leads to its sliding. The compression band used is a band 5 m long, 8 cm wide and has a grammage of 219 g / m ² and a thickness of 1.44 mm.

To test this Neumed compression bandage, its elongation on installation was determined as a function of the desired working pressure, for example using the tensile rupture curve as defined in standard EN ISO 13934-1. . The principle of this standard is as follows.

[0149] A rectangular strip of sufficient width is thus cut out by unraveling it if necessary to obtain a sample of final width of 50 mm. This sample is placed in the jaws of a dynamometer 200 mm apart. The tensile test is carried out until the sample breaks at a speed of 100 mm / min. The test is thus repeated for five samples. The conditions of packaging, humidity and temperature are defined in standard EN ISO 13934 - 1.

According to Laplace’s law, the extension to be carried out corresponds to the pressure re

sought.

[0151] An elongation at installation of 45% was thus determined for the Neumed compression bandage so as to apply to installation a maximum pressure of the order of 60 mm to 70 mm of mercury.

To install the strip appropriately, this strip was calibrated at 45% using a stencil as described in document WO 2007/113340, page 13, line 18 to page 14, line 6.

The results obtained during these various tests are collated in Table 1.

[0154]

[Tables 1]

This table illustrates the advantages of the devices according to the invention.

For the K2 system, there is no vertical shift and no turn to turn offset. Such a result is consistent, due to the "cohesivation" of the second self-adhesive strip which blocks the sliding of the turns on each other and the vertical sliding. In the absence of the latter, the first Ktech strip has a significant vertical and turn-to-turn offset. It cannot stand alone and will slide quickly. Its use with the retainer of Examples 1 and 2 eliminates the turn-to-turn offset and eliminates the slippage of the compression band. The value of 2 mm horizontal offset of the first turn is negligible. It is considered that an average value over several people of the order of 4 mm to 5 mm is not representative of the potential for slip-on-turn slip of a compression band over time and represents the vagaries of measurements linked to the variation of the calves of testers, the reproducibility of the installation and the manufacturing variability of the bands. In addition, it is considered that a shift of 1 mm represents the uncertainty on the evaluation of the measurement of the thickness of the line, and is therefore negligible. The two retainers of Examples 1 and 2 which have different shapes, sizes and positions give identical results.

This is confirmed by the results with the Neumed compression bandage with the positive retention devices of Examples 3 and 4 with no turn-to-turn offset on turns 2 and 3 and negligible offsets for the first turn and vertically.

The test of this compression band with example 5 illustrates that positioning a film 5 with hooks on the outside of the compression band on three turns as shown in FIG. 2C of the document WO 2014/155014, although the retainer has the largest surface area, does not block the turn-to-turn or vertical offset. Results are obtained similar to those of the Neumed bandage alone. It is also noted after 6 hours that under the action of movements the retaining device undulates and tends to come off in part of the strip.

Finally, we tested with the Neumed compression bandage an adhesive-fastening Velcro fastener sold by the company 3M under the reference DualLock 3550. This product has a shore A hardness of 29 and as mushroom hooks. The second opposite smooth face is coated with an acrylic adhesive layer. A rectangular retainer identical to that of Example 3 was made and placed on the tibial crest. The device sticks well to the skin but it is very difficult to anchor the hooks in the compression band and very quickly the latter disconnects from the restraint. Finally its position under the compression band causes pain because it is too aggressive. This counter-example confirms the importance of the hardness characteristic in the production of a functional restraint.

In general, these results show that the retaining devices according to

the invention makes it possible to avoid the sliding of the short elongation compression bands and to use a single band of this type in place of a two-layer system with a self-adhesive band with latex. Obviously, such retaining devices can also be applied to other types of bands or compression articles and their positioning adapted to prevent the sliding of said articles.

Claims

[Claim 1] Restraint device (1,, 1 ”,”) intended to prevent slipping of a compression article on a limb of an individual, the compression article being of textile type and having loops on the surface , the retainer (1, G, 1 ”, G”) comprising:

- a flexible and inextensible film (5) having a first face (5a) intended to be placed in contact with the compression article, and a second face (5b) opposite the first face (5a) and intended to be placed in gaze of the limb of the individual, the first face (5a) comprising a base surface (6) and a plurality of fastening members (7, 7 ', 7 ”) each extending from the base surface ( 6) up to a free end (8), the fastening members (7, 7 ′, 7 ”) being configured to cooperate with the loops of the compression article to retain said compression article on the first face ( 5a) of the film (5), the first face (5a) of the film (5) having a shore A hardness greater than 55, preferably between 70 and 100,

- an adhesive layer (15, 15 ’) covering at least in part the second face (5b) of the film (5) and adapted to retain the film (5) on the limb of the individual.

[Claim 2] Restraint device (1, G, 1 ”, G”) according to claim 1, in which each fastening member (7, 7 ’, 7”) comprises:

- a foot (10) along a longitudinal axis (A), the foot (10) being integral with the base surface (6),

- at least one attachment surface (11) extending transversely relative to the longitudinal axis (A), facing the base surface (6).

[Claim 3] Restraint device (1, 1 ”,”) according to claim 2, in which the hooking surface (11) is arranged at the free end (8) of the hooking member (7 , 7 ', 7 ”).

[Claim 4] Restraint device (1, G, 1 ”, G”) according to any one of claims 1 to 3, in which the fastening members (7, 7 ', 7 ”) are formed in one single piece with the base surface (6).

[Claim 5] Restraint device (1, G, 1 ”, G”) according to any one of claims 1 to 4, in which each fastening member (7, 7 ', 7 ”) has a height between the base surface (6) and the free end (8) between 0.2 mm and 1.2 mm.

[Claim 6] Restraint device (1, G, 1 ”, G”) according to any one of claims 1 to 5, in which the fastening members (7, 7 ', 7 ”) are arranged in a network having a density between 120 fastening members / cm ² and 300 fastening members / cm ² .

[Claim 7] A retaining device (1, G, 1 ”, G”) according to any one of claims 1 to 6, wherein the second face (5b) of the film (5) has a smooth surface.

[Claim 8] Retaining device (1, G, 1 ”,”) according to any one of claims 1 to 7, in which the film (5) is made of thermoplastic polymer, in particular chosen from polypropylene, polyethylene, polyamide 6, polyamide 6.6, polyamide 4.6, polyester and, in particular, polyethylene terephthalate.

[Claim 9] Restraint device (1, G, 1 ”, G”) according to claim 8, in which the film (5) has a grammage between 90 g / m ² and 230 g / m ² .

[Claim 10] Restraint device (1, G, 1 ”, G”) according to any one of claims 1 to 9, wherein the adhesive layer (15, 15 ') has a tangential shear strength t '' at least 10 hours according to a creep test in which a first part (la) of the retaining device (1, G, 1 ”, G”) is bonded via the adhesive layer (15, 15 ') to a plate (20) inclined at an angle (a) of 2 ° relative to a vertical direction (V), leaving free a second part (lb) of the retaining device (1,, 1 ”,”), a ballast (21) being suspended from the second part (lb) of the retainer (1,, 1 ”,”), with: t = (L ² .l. h) / 2.eMg

where L is a length of the adhesive layer (15, 15 ’) of the first part (la) of the retaining device (1, G, 1”, G ”),

1 is a width of the adhesive layer (15, 15 ’) of the first part (la) of the retaining device (1,, 1”, G ”),

h is a viscosity of the adhesive layer (15, 15 ’), e is a thickness of the adhesive layer (15, 15’),

M is a ballast mass (21), M being chosen as a function of a tangential stress exerted by the compression article,

g = 9.81 m / s ² .

[Claim 11] A retaining device (1, 1 ”,”) according to any one of claims 1 to 10, wherein the adhesive layer (15, 15 ') consists of a pressure-sensitive adhesive substance and in particular of an adhesive substance chosen from:

- acrylic adhesives based on acrylate polymers or co-polymers of acrylic acid and esters of acrylic acid,

- high molecular weight poly-isobutylene adhesives - adhesives based on natural or synthetic polyisoprene

- adhesives based on polymers or copolymers of siloxane and tackifying resins or silicone gels based on crosslinked polyxilosanes,

- polyurethane adhesives or polyurethane gels,

[Claim 12] Retainer (1, G, 1 ”) according to claim 11, wherein the adhesive layer (15) has a single elementary adhesive layer (16).

[Claim 13] Restraint device (1, G, 1 ”) according to claim 12, in which the elementary adhesive layer (16) has a grammage of at least 50 g / m ² , preferably between 60 g / m ² and 120 g / m ² .

[Claim 14] Restraint (1, 1 ”) according to any of the reven

Dications 12 and 13, in which the elementary adhesive layer (16) has an adhesion force of between 0.5 N / cm and 5 N / cm measured by a peel test in which the adhesion force at an angle of 90 ° to peel off the adhesive layer (15) from a reference surface chosen from the second face (5b) of the film (5) and a skin surface.

[Claim 15] Restraint device (G ”) according to claim 11, in which the adhesive layer (15’) comprises:

- a first elementary adhesive layer (16a) intended to be brought into contact with the member,

a core (17) having a first surface carrying the first elementary adhesive layer (16a), and a second surface opposite the first surface,

- a second elementary adhesive layer (16b) for fixing the second surface of the core to the second face (5b) of the film (5).

[Claim 16] Restraint device (”) according to claim 15, in which the first elementary adhesive layer (16a) has a grammage between 25 g / m ² and 120 g / m ² , preferably between 40 g / m ² and 80 g / m ² , and the second elementary adhesive layer (16b) has a grammage between 20 g / m ² and 120 g / m ² , preferably between 30 g / m ² and 50 g / m ² .

[Claim 17] Retaining device (G ”) according to any one of claims 15 and 16, in which the first elementary adhesive layer (16a) has an adhesive force of between 0.5 N / cm and 5 N / cm and the second elementary adhesive layer (16b) has an adhesive force of between 0.5 N / cm and 10 N / cm, the adhesive force of each of the elementary adhesive layers chosen from the first (16a) and second (16b) elementary adhesive layers being measured by a peel test in which the adhesion force at an angle of 90 ° to peel said elementary adhesive layer from a reference surface chosen from the second face (5b) of the film (5 ) and a skin surface.

[Claim 18] Restraint system comprising a restraint article intended to be placed on a limb of a patient and a restraint device (1, 1 ', 1 ”, G”) according to any one of claims 1 to 17 .

[Claim 19] Restraint system according to claim 18, in which the restraint article is a textile restraint strip (2) intended to be wound on the member.

[Claim 20] A compression system according to claim 19, in which the compression band (2) is of short elongation.