专利摘要:
Contention band which is in the form of a knit obtained by the jersey knit technology based on synthetic threads which consists of two textile surfaces whose textile structure is different interconnected by struts son, each surface comprising elastic yarns, characterized in that said knit fabric has: - a face which has a textile structure which is a net - a longitudinal elongation measured according to the EN 14704-1 standard of between 50 and 160% - a higher shear threshold stress or equal to 3000 Pa.
公开号:FR3044217A1
申请号:FR1561402
申请日:2015-11-26
公开日:2017-06-02
发明作者:Celine Cohade;David Grange;Serge Lecomte;Magali Roblot
申请人:Laboratoires Urgo SAS;
IPC主号:
专利说明:

GENERAL TECHNICAL FIELD
The present invention relates to an optimized compression band, whose longitudinal elongation is between 50% and 160%, which is a 3D knit, obtained according to the "knit stitch" technology, without latex or adhesive, which does not stretch not what keeps its therapeutic effectiveness and prevent its sliding over time.
STATE OF THE ART The use of various compression systems is known to treat pathologies of venous origin, such as for example venous insufficiency, the treatment of varicose veins and leg ulcers, or to prevent venous thrombosis or venous thrombosis. treatment of lymphedema. These systems consist of one or more bands that apply pressure to the limb to be treated.
To be effective this system must make it possible to apply simultaneously: on the one hand, a relatively low pressure called "resting pressure", when the muscle is released to be conformable and in particular bearable during the night; and on the other hand, a relatively high pressure called "working pressure", when the muscle is tight or during movement, especially during walking.
This differential pressure between working pressure and resting pressure must be sufficient to promote venous reflux. It is generally considered that a pressure differential of 24 hours between 15 and 25 mm of mercury is necessary to restore a correct venous flow.
However, depending on the pathology, whether it is a treatment on legs without severe ulcers, a difficult treatment on legs damaged by edema, or treatment of a mixed arterial and venous ulcer, this range can range from 10 to 35 mm of mercury or even 10 to 40 mm of mercury.
The compression bands used are classified by the compression specialists in two major categories according to the extent of their elongation; the so-called short stretching strips and those said long stretching strips.
This classification is based on measuring the longitudinal elongation of the band as defined in method A §9.1 of EN 14704-1 when the 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 test material of 50 mm width and 250 to 300 mm length is cut and positioned without prestress in the jaws of an electronic dynamometer (for example an MTS brand dynamometer) so as to have a width of 50 mm and a reference length of 200mm. The dynamometer stretches the specimen at a speed of 100 mm / min to a maximum force of 6 N / cm and then the crosshead returns to its initial position at the same return speed of 100 mm / min. This cycle is carried out 5 times and the elongation obtained in the fifth cycle, expressed as a percentage, is directly calculated by the apparatus. The operation is repeated on 5 test pieces, then the average value which defines the longitudinal elongation of the band is calculated. The transverse elongation of the band can be evaluated according to the same protocol.
Short stretch strips
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 "short stretch" band if its longitudinal elongation is less than or equal to 100%.
These bands exert a low resting pressure and a high working pressure. They therefore have a large differential pressure especially during movement, for example during walking.
Long stretch strips
On the basis of the previous test according to standard EN 14704-1 taken as a reference, it is considered that a band is a "long elongation" band if its longitudinal elongation is greater than 100%.
These strips are easier to install because they have greater extensibility.
The long lengthening strips lead to small pressure variations between rest and work, and a small pressure variation during movement, for example during walking. They are less effective than short stretching strips. On the other hand, because of this low pressure differential, they are subjected during movements to lower force stresses than short-stretched bands, and they therefore have a risk of slackening and therefore slipping along the weaker leg. than short-stretched strips.
It is recognized today that the most effective compression systems in terms of ease and speed of application and in terms of therapeutic efficacy are those which comprise a maximum of 2 bands and at least one so-called compression band short elongation. By way of example, mention may be made of the products marketed under the names ACTICO, K2 and Coban 2 by the companies ACTIVA, Laboratoires URGO and 3M, respectively.
The ACTICO system consists of a self-adhering short stretching tape that is wrapped on a cotton band previously wrapped around the leg. The wadding is intended to distribute the pressures on the limb surface, and / or to protect the bone projections by its thickness, and to absorb any exudates if the band is placed on an open wound, for example in the case of ulcers. legs.
The K2® system marketed by Laboratoires URGO consists of a first band (marketed under the name Ktech®) which is a short-stretched strip consisting of a wadding layer coming into contact with the skin and needle-punched at a rate of elastic knit and a second elastic band (commercialized under the name KPress®) which is elastic and self-adherent which is a long stretching band which serves to hold the first band in place and to apply the complementary pressure with respect to the first band to obtain the desired pressure.
The Coban 2 system consists of a first non-extensionally laid band which is formed by the combination of a skin contacting foam associated with a self-adhering band and a second self-adhering band which is a short stretch band. which applies the desired pressure and serves to maintain the system.
A disadvantage of these systems is that to ensure their maintenance and effectiveness the self-adhesion of the strips is obtained using adhesive or latex which complicates their development and can lead to risks of allergy to contact with the skin, especially in the case of natural rubber latex.
The role of the adhesive or the latex is however essential because it is it which makes it possible to maintain the band or the system after its winding around a member and to reduce their intrinsic relaxation which leads to their loss of effectiveness and their sliding over time along the limb.
On the other hand, the incorporation of the adhesive or the latex complicates the production of the products because it modifies the pressure and pressure differential properties of the strip to which it is applied.
In order to improve patient and carer acceptability and to obtain a product that is easier to manufacture, it therefore appears desirable to have a restraining system that uses strips without adhesive or latex.
The so-called 3D knits are products that come in the form of two independent textile surfaces (knits) interconnected by strut threads, hence their "3D" name. Such products are for example used in the field of automotive seats for their compression capacity. But to get this ability these knits are thick, stiff and very elastic. Similarly they are used in the textile field for example for bra cups. These knits are very soft to the touch but again very elastic to ensure the maintenance. In both cases they are not adapted to fulfill the properties of a band of contention. Other 3D knits adapted for contention have been proposed in the patent application WO 95/16416.
The problem that proposes to solve this application WO 95/16416 is the suppression of the wadding. Indeed the settlement of the latter over time induces a game between the leg and the band during movement which can cause the slide of the whole. The objective is to compensate for this settlement phenomenon thanks to the 3D structure and the thickness of the knit that allow to obtain a good damping effect (padding) and to remove the wadding. To achieve this result the 3D knits described have heavy weights and thicknesses. This leads to the production of larger compression tapes therefore less easy to handle because they are in the form of coils thicker. They are also heavier which increases the risk that they slide more easily over time.
Thus, it is to overcome this defect and the absence of latex or adhesive that the document WO 2009/71894 proposes to incorporate an adhesive or a latex to the 3D knits proposed in the document WO 95/16416, which poses therefore also the aforementioned problems vis-à-vis the adhesive or latex in terms of development and risk of allergy.
Patent application GB 2473321 proposes the production of 3D knits always with high weights to approach the cushioning role of the wadding while applying pressures and pressure differentials adapted to the therapeutic objectives. However all the knits described are manufactured according to the technology "mesh picked". From the industrial manufacturing point of view this technology is not suitable for the production of compression tape because the cutting of a tablecloth of 3D knits leads to unraveling of the product. The problem of sliding over time also arises with respect to products obtained in accordance with the teaching of this document.
To remedy this, GB 2473321 proposes to perform the "cohesivation" of 3D knits by adding silica derivatives alone or in combination with latex or acrylates to ensure the maintenance over time, as mentioned on page 14 of this document. document, which also raises the aforementioned problems in terms of development and risks of allergy.
The slippage of a band is caused by 3 primary factors.
The first factor is related to the quality of the break. If a band is placed at an elongation too low it may slip because the pressure applied to the member will be insufficient to hold it in place. A calibration device makes it possible to solve this problem and to avoid that, conversely, if the band is too stretched, a too high pressure is applied which could lead to forming a tourniquet. Similarly it is necessary to secure the last turn to prevent the band relaxes at its end and on the entire winding which will result in a loss of therapeutic efficiency or even sliding along the leg. Various devices are used to reinforce this fixation.
The second factor is related to the ability of the tape to resist slippage on the skin which is dependent on its surface state coming into contact with it. This aspect is difficult to compensate because it is desired to have a face in contact with the skin which has a touch the least unpleasant possible to promote adherence to the wearing of the band by the patient.
The third factor is related to the mode of operation of the band. It consists in finding a balance between the force applied by the band in extension during the variation of the diameter of the calf and its capacity to avoid the lateral sliding turn on turn which is illustrated by their intrinsic relaxation and which translates the fact that they are relax in relation to the pose. We then find the same phenomenon as during a deficient pose that is to say a loss of therapeutic efficiency or even in case of transmission of this lateral slip of spiral turn in the course of time a vertical slip of the band that can again lead to his fall. This phenomenon is amplified by the weight of the band.
This third factor, cause of slippage, is particularly important and is also the main reason for the loss of efficiency of restraint systems over time.
Paradoxically this cause of slip has not been thoroughly studied so far. To solve this problem and oppose this intrinsic loosening, we "cohesive" bands that is to say privileged the incorporation of adhesive or latex on the compression bands. Thus, in all the short-elongation band-based compression systems for which this phenomenon is the most important, at least one "cohesive" band is nowadays incorporated, again posing the problems defined above.
In the absence of cohesivation or any other means to avoid this slip phenomenon if the first 2 factors are controlled the third factor then becomes essential. The therapeutic efficacy and intrinsic relaxation of the band which increases the possibility of sliding are closely related to this balance and its evolution over time
In conclusion, although the use of a 3D knit as a compression band has been proposed for almost 20 years, no solution appears totally satisfactory to obtain a 3D knit that exhibits the behavior of a short elongation to obtain the good pressure differential and, in the absence of latex or adhesive, to keep it and to avoid the risk of sliding along the member over time.
To solve this very complex specification with contradictory properties the applicant has studied the friction forces that apply at the level of a strip in contact with itself under the effect of a pressure corresponding to the treatment pressure. therapeutic sought for example in the case of a leg ulcer of the order of 35 to 50 mm of mercury. Indeed the sliding of the turns of the band is related to the micro-displacements of the latter on itself imposed by its weight because of gravity and repetitive frictional forces induced by variations in calf diameter during movement.
To perform the measurement, which had never been considered, of these micro-displacements of the tape on itself which are very weak the applicant has used a rheometer which is a device which conventionally serves to measure the rheological properties of soft materials. This apparatus, in addition to making it possible to determine very low forces, also makes it possible to apply a shearing torque, that is to say a torsion, in order to be representative of the friction constraints that apply to one band at a time. in the longitudinal and transverse directions of the latter. The technique thus developed has made it possible to determine the minimum shear stress responsible for the first micro-displacement experienced by the band wound on itself which will lead to lateral sliding of the turns and loosening of the band. This shear stress is called the shear threshold stress because it measures the first micro-displacement and is expressed in Pascal.
This measurement made it possible to better understand the phenomena involved and to determine the essential characteristics that a 3D knit must exhibit to fulfill the properties listed above, and in particular the shear threshold stress that it must possess in order to avoid intrinsic relaxation. band to maintain its therapeutic effectiveness and not slip.
The present invention therefore relates to a strip whose longitudinal elongation is between 50% and 160%, which is a 3D knit, obtained according to the "knit stitch" technology, without latex or adhesive, which does not slip at least during 48 hours and better at least for 3 days or more. In fact in the context of the treatment of leg ulcers that have very exudative wounds these minimum durations of 48 and 72 hours correspond to the usual times of change of the dressings which are arranged under the compression bands. It is therefore essential that the band remains in place for at least 2 or 3 days without slipping.
PRESENTATION OF THE INVENTION
The present invention therefore relates to a compression band which is in the form of a knit made by knit stitch technology, based on synthetic yarns which consists of two textile surfaces whose textile structure is different interconnected by spacers son, each textile surface having elastic son, characterized in that said knit has a face which has a textile structure which is a net, a longitudinal elongation measured according to EN 14704 -1 standard between 50 and 160 % and a shear threshold stress greater than or equal to 3000 Pa.
Tests described hereafter have demonstrated that a band possessing such a characteristic of a single shear stress makes it possible to ensure that the compression strip is not slipped on a turn and thus to prevent its intrinsic release and thus to preserve its therapeutic efficacy and to prevent its slipping.
According to the present invention the 3D knit may be disposable or reusable and therefore washable.
After the knitting operation, in order to stabilize the 3D knit, in particular in order to obtain a washable product, its structure will be fixed using the technologies commonly used for this purpose such heat-setting by heat or a steaming treatment. These operations consist of passing in an additional step, in line with the knitting or separated from the latter, at a given speed and a fixed temperature the knit in an oven for the heat-fixing and through a stream of water vapor for the steaming.
In order to promote precise positioning by the nursing staff, the compression band may be provided with a calibration means. This calibration means may be visual, such as a set of pictograms regularly spaced, printed on the tape or made by means of a calibration system. Information on recommended laying elongations may be provided with the calibration means. Calibration can also be done by the caregiver in the form of a stencil. This type of stencil or the explanations necessary to make it can be incorporated into the packaging of the tape. A kit comprising several strips of different constitutions, of different widths, of different lengths and / or with different calibrations to apply specific pressures may be used.
The kit may further comprise one or more dressings intended to be placed on the wound before the laying of the band.
In order to promote ease of handling during the laying, a knitwear having a longitudinal elongation as defined in the EN 14704-1 standard will be chosen which is between 50 and 160%, or more precisely between 50 and 120%, or even more precisely between 55 and 100%.
The knit has for example a thickness of between 1 and 2 mm, or more precisely between 1 and 1.5 mm.
The knitted fabric has, for example, a grammage of from 160 to 370 g / m 2, or more precisely from 180 to 300 g / m 2, or even more specifically from 200 to 250 g / m 2.
Also preferably the knit has for example a gap between the two textile faces between 0.4 and 1.5mm, or more precisely between 0.5 and 1.1mm.
These low weight and thickness properties ensure easy use with the shoes of the compression band. The compression band can thus also be more easily used with a wadding if necessary.
The presence of a mesh face also promotes the breathability of the band. This thread face will typically be in contact with the skin.
According to a particular embodiment, said knit has a face which has a textile structure of drape type (also called charmeuse structure), half-single with open or closed meshes, atlas under one or more rows, or open-knit, closed chain or alternating closed and open meshes, opposite the face adapted to be brought into contact with the skin which has a textile structure which is a net.
In order to facilitate the passage of the heel and to avoid a necking of the band during the laying, it is possible to use 3D knits which have a transverse elongation greater than 120% as measured according to method A § 9.1 of the standard EN 14704-1, or for example between 120% and 300%, or between 120% and 250%.
The knits according to the invention are for example made using yarns commonly used in the production of textile products and in particular knits. These son are for example synthetic. These yarns are divided into two main categories: elastic yarns and thermoplastic yarns.
Among the elastic yarns, for example, yarns based on polyurethane fibers may be mentioned, such as elastane yarns sold under the name LYCRA, yarns based on elastodiene or yarns based on triblock polymers (styrene-ethylene-butylene). styrene).
Among the thermoplastic yarns that may be mentioned are yarns made from synthetic materials that are not elastomers, for example polyester, polyamide, polypropylene or polybutylene terephthalate (PBT).
All these thermoplastic yarns can be gimped or not, textured or not.
The two textile surfaces of the 3D knit are for example made from elastic yarns and thermoplastic yarns. These threads can be monofilaments or multifilaments. These textile surfaces may be made from identical or different threads. The two surfaces will preferably comprise similar elastic threads.
The elastic yarns present on these textile surfaces have, for example, titers of the order of 40 to 80 dtex and thermoplastic yarns of 40 to 90 dtex.
If it is desired to promote the transfer of moisture from the knitted fabric to the outside, non-synthetic yarns, such as cotton or viscose, may be used on one of the two faces, in particular that in contact with the skin.
Elastane yarns are used for example as elastic yarn and polyamide or polyester yarns as thermoplastic yarn.
The son of struts are monofilament thermoplastic yarns, for example polyester or polyamide yarns which have, for example, a titre of between 20 and 80 dtex, or between 40 and 70 dtex, or even more specifically a monofilament polyester which has a title between 44 and 55 dtex.
For the realization of 3D knitting, it is possible for example to use a single bar for knitting the spacer thread which links the two textile surfaces. The invention also relates to a kit comprising one or more compression bands as defined above, and one or more dressings adapted to be placed on a wound prior to one of the compression bands.
DETAILED DESCRIPTION The invention will be illustrated by the following Examples and Comparative Tests, as well as Figures 1 and 2.
Example of implementation of the invention
A knit fabric approximately 10 cm wide according to the invention was made on a Raschel knit loom double needle gauge gauge 22.
To make the knit, 6 bars were used according to the mesh diagram shown in FIG. 1 with the following threads and conditions:
Nature of the yarns - Fl: polyamide yarn sold by the company Radici under the reference 78/18/1 dtex S Beige
F 2: 44 dtex elastane yarn marketed by ASAHI KASEI GROUP
F3: yarn which is a 55 dtex polyester monofilament marketed by the company FILVA
F4: 44 dtex elastane yarn marketed by ASAHI KASEI GROUP
F5: polyamide 66 yarn marketed by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE BE MM
F6: polyamide 66 yarn marketed by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE MM Settings for the knitting machine - Fl: feed 2500 mm of threads consumed for the production of 480 stitches - full threading - F2: supply 1500mm of threads consumed for the production of 480 meshes - threading lplein / 1 empty - F3: feeding 3500 mm of threads consumed for the realization of 480 meshes - full threading - F4: supply 1600mm of consumed son for the realization of 480 stitches - threading lplein / 1 empty - F5: feeding 2250 mm of threads consumed for the production of 480 stitches - threading 3 full / empty - F6: feeding 2250 mm of threads consumed for the production of 480 mailes - threading 3 full / lvide
Mesh scheme
FIG. 1 shows the graph of an example of a mesh structure for producing a knit according to a particular embodiment of the invention.
In this figure, the front edge is represented by the reference F, and the rear edge by the reference B. The mesh patterns of the wires F1 to F6 are then illustrated.
It is understood that this example and the following examples are purely illustrative, and they should not be interpreted in a limiting manner as to the scope of the invention.
The knit fabric thus produced undergoes a heat treatment step in line.
During this step, the knit passes in one go between two rollers formed of heating rolls so that each face undergoes this treatment at a speed of 5.5 meters per minute. The temperature of the rolls before the passage of the knit is set to be of the order of 190 ° C.
The following techniques were used to evaluate the parameters of the knit obtained.
Weight measurement
The grammage is measured according to standard NF EN 12127. Five test pieces with an area of 100 cm2 (measurement = +/- 1%) are weighed with a balance whose accuracy is at most 1 mg.
The weighing is carried out at a temperature of 21 ° C + 1-2 ° C and 60% +/- 15% RH.
The final measurement is an average of the 5 test pieces.
Thickness measurement
The thickness is measured according to standard NF EN ISO 9073-2. A KEYENCE laser micrometer (equipped with a LK-G87 CCD laser sensor head and a LK-G3001PV CCD laser displacement sensor) is used. The application pressure is set at 0.5kPa and the surface of the steel disk is 2500mm2.
Measuring the gap between the faces
This measurement is carried out as follows. With the aid of a KEYENCE digital microscope (optics x 100 or x 200) the space between the two planes of the two textile surfaces is determined.
The average plane of the two surfaces is represented by a horizontal line estimated by the operator and the distance between the two lines is determined automatically by the software. The measurement is reproduced several times in order to increase the precision and an average is made. measurements obtained.
Measurement of the shear threshold stress
The measurements are carried out using a DHR2 rheometer marketed by TA Instruments.
They are carried out at a temperature of 35 ° C. (so as to be close to the temperature of the strips in contact with the skin), said temperature being regulated by a Peltier plane which equips the rheometer.
2 discs 25 mm in diameter were cut from the analyzed 3D knit.
These 2 discs are glued respectively using a thin and rigid double-sided adhesive marketed by Plasto under the reference P753 on the metal face of the movable plate and the peltier plane of the rheometer. The two 3D knit disks, charming structure face (also called drape structure) face mesh surface, are put in contact by applying a pressure of 5.3 k Pa (equivalent to 40 mm of mercury). The rheometer control program generates a stress ramp (torque) that varies from 100 to 10,000 Pa in 600 seconds. The apparatus records the first micro-displacement it detects which corresponds to the shear threshold stress expressed in Pa.
The instrumental uncertainty on this measure is considered to be plus or minus 6%.
The parameters of the knit obtained are as follows (Example 1): - Weight: 232 g / m2 - Thickness: 1.23 mm - Shear threshold stress: 3080 Pa - Difference between the faces: 0.64 mm - Longitudinal elongation according to the standard EN 14704 - 1: 56% - Crosswise extension according to EN 14704 - 1: 128%
Several other examples of knitting have also been realized, which are detailed below.
These other examples are made using a mesh pattern identical to that detailed for Example 1 (unless otherwise indicated). The nature of the yarns and the adjustment of the knitting machine, as well as the characteristics obtained, are described below.
Example 2: corresponding for example to a product having a solid face in contact with the skin of a subject, and an opposite face which is a net:
Nature of the yarns: Fl: polyamide yarn sold by the company Radici under the reference 78/24/1 dtex S Beige
F 2: 44 dtex elastane yarn marketed by ASAHI KASEI GROUP
F3: yarn which is a 55 dtex polyester monofilament marketed by the company FILVA
F4: 44 dtex elastane yarn marketed by ASAHI KASEI GROUP
F5: polyamide 66 yarn marketed by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE BE MM
- F6: polyamide 66 yarn marketed by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE MM Setting of the knitting machine: - Fl: feeding 2000 mm of threads consumed for the production of 480 meshes - threading full - F2: supply 1500 mm of yarn consumed for the production of 480 stitches - threading 1 full / 1 empty - F3: feeding 3500 mm of threads consumed for the production of 480 stitches - full threading - F4: feeding 1600mm of threads consumed for the production of 480 meshes - threading 1 full / 1 empty - F5: feeding 2150 mm of threads consumed for the realization of 480 meshes- threading 3 full / 1 empty - F6: feeding 2250 mm of threads consumed for the realization of 480 mailes - Threading 3 full / 1 empty
The knit fabric thus produced undergoes a heat treatment step in line.
During this step, the knit passes in one go between two rollers formed of heating rolls so that each face undergoes this treatment at a speed of 5.5 meters per minute. The temperature of the rolls before the passage of the knit is set to be of the order of 190 ° C.
Characteristics of the obtained product: (Example 2) - Weight: 231g / m2 - Thickness: 1.22 mm - Threshold shear stress: 3027 Pa - Gap between the faces: 0.52 mm - Longitudinal elongation according to EN 14704 - 1 : 62% - Crosswise extension according to EN 14704-1: 173%
Example 3: corresponding for example to a product which is a long elongation:
Nature of the threads:
Fl: polyamide yarn 66 sold by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE BE MM
F 2: 44 dtex elastane yarn marketed by ASAHI KASEI GROUP
F3: yarn which is a 55 dtex polyester monofilament marketed by the company FILVA
F4: 44 dtex elastane yarn marketed by ASAHI KASEI GROUP
F5: polyamide 66 yarn marketed by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE BE MM
F6: polyamide 66 yarn marketed by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE MM
The mesh diagram is here distinct from that of the other examples, and is represented in FIG. 2. Adjustment of the knitting machine: - Fl: feeding 2100 mm of threads consumed for the production of 480 stitches - full threading - F2: 2050 feed mm of yarn used to make 480 stitches - full threading - F3: feeding 3700 mm of yarn consumed for making 480 stitches - full threading - F4: feeding 2300 mm of yarn consumed for making 480 stitches - full threading - F5: supply 2150 mm of threads consumed for the production of 480 stitches- threading 3 full / 1 empty - F6: feed 2150 mm of threads consumed for the production of 480 mail-threading 3 full / 1 empty
The knit fabric thus produced undergoes a heat treatment step in line.
During this step, the knit passes in one go between two rollers formed of heating rolls so that each face undergoes this treatment at a speed of 5.9 meters per hour. The temperature of the rolls before the passage of the knit is set to be of the order of 70 ° C.
A strip of product thus obtained was then subjected to 5 successive washes, without drying between the washes, in a washing machine at 40 ° C. and 800 rpm, with a laundry marketed under the trademark "Le Chat machine".
Characteristics of the product obtained: (Example 3) - Weight: 367 / m2 - Thickness: 1.9 mm - Threshold shear stress: 4077 Pa - Spread between the faces: 1.08 mm - Longitudinal elongation according to EN 14704 - 1 : 111% - Crosswise extension according to EN 14704 - 1: 191%
Example 4: corresponding, for example, to a product having a spacer wire of 22dtex:
Nature of the yarns: Fl: polyamide yarn sold by the company Radici under the reference 78/18/1 dtex S Beige
F 2: 44 dtex elastane yarn marketed by ASAHI KASEI GROUP
F3: yarn which is a 55 dtex polyester monofilament marketed by the company FILVA
F4: elastane yarn of 44 dtex marketed by ASAFII KASEI GROUP
F5: polyamide 66 yarn marketed by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE BE MM
- F6: polyamide 66 yarn sold by the company EMILE TARDY under the reference PA 66 1/44/34 / FT BE MM Setting the knitting machine: - Fl: supply 2400 mm of yarn consumed for the production of 480 meshes - threading full - F2: supply 1600 mm of yarn consumed for the production of 480 stitches - threading 1 full / 1 empty - F3: feeding 3900 mm of threads consumed for the production of 480 stitches - full threading - F4: feed 1600 mm of consumed yarn for the realization of 480 meshes - threading 1 full / 1 empty - F5: feeding 2000 mm of threads consumed for the realization of 480 meshes- threading 3 full / 1 empty - F6: feeding 2000 mm of threads consumed for the realization of 480 mailes - Threading 3 full / 1 empty
The knit fabric thus produced undergoes a heat treatment step in line.
During this step, the knit passes in one go between two rollers formed of heating rolls so that each face undergoes this treatment at a speed of 5.5 meters per minute. The temperature of the rolls before the passage of the knit is set to be of the order of 190 ° C.
Characteristics of the product obtained: (Example 4) - Weight: 199 / m2 - Thickness: 1.1 mm - Threshold shear stress: 3007 Pa - Gap between the faces: 0.57 mm - Longitudinal elongation according to EN 14704 - 1 : 54% - Crosswise extension according to EN 14704 - 1: 192%
The in vitro pressure performance, according to the test described below, was then compared between the examples according to the invention and the bilayer containment system marketed under the name K2 by Laboratoires URGO.
In vitro test
The performance of the 3D knitting of Examples 1 to 4 and of the two-layer compression system sold under the name K2 by Laboratoires URGO were evaluated in terms of working and rest pressures and pressure differential over time.
The in vitro test method and apparatus described in patent application WO 2007/113430 page 17 line 26 to page 19 line 18 was used. According to this method, the strip is placed around a cylinder with a total recovery of 100%, then the circumference of the cylinder is varied at a speed imposed continuously between a so-called rest position (the smallest diameter) and a so-called working position (largest diameter) to mimic muscle contraction. Pressure sensors measure the values of the resting pressures and working pressures over time. The time difference between the measurements of the working pressure and the resting pressure is 5 seconds and the frequency of the measurements of these two successive parameters is 0.2 Hz.
To test the compression bands according to the invention, the elongation at the laying of the band was determined as a function of the desired working pressure, for example using the tensile break curve as defined in the EN ISO standard. 13934-1. According to Laplace's law, the elongation to be carried out corresponds to the desired pressure.
A rectangular strip of sufficient width is cut by fraying it if necessary to obtain a final width sample of 50 mm. This sample is placed in the jaws of a dynamometer 200mm apart. The tensile test is carried out until the sample is broken at a speed of 100 mm / min. The test for 5 samples is repeated. Packaging, hygrometry and temperature conditions are defined in EN ISO 13934-1.
An elongation at laying of 40% for the strip according to Examples 1 to 3 and 45% for Example 4 of the invention was thus determined so as to apply to the laying a maximum pressure of the order of 50.degree. at 70 mm Hg.
To lay the strip appropriately, the strips were calibrated with a stencil as described in patent application WO 2007/113340 page 13, line 18 to page 14, line 6.
The results obtained for the band obtained according to the examples of the invention and the bilayer containment system marketed by Laboratoires URGO under the name K2 size 18-25 cm are summarized in Tables 1 and 2 below.
The value "Max Pressure at T0" corresponds to the first working pressure recorded immediately after the installation, and "Delta at T0" corresponds to the pressure differential between the first working pressure and the first resting pressure recorded immediately after installation. The values "Max Pressure at T24" and "Delta at T24" correspond to the measurements recorded 24 hours after installation, measured in mm of mercury. Then we calculated the difference between T0 and T24 hours "Delta (T0 - T24h)".
Table 1
Table 2
These tables show that results are obtained in terms of pressures applied at 24 hours and differential pressure at 24 hours for both the two-layer system K 2 and the mono-strips according to the invention which are included in the ranges. intended to mean a maximum pressure at 24 hours between 35 and 50 mm of mercury
and a pressure differential at 24 hours between 15 and 25 mm Hg. The values of pressure differentials at 24 hours which are important for the efficiency of the treatment are even greater for the mono-strips according to the invention, namely from 21 to 26 mm of mercury against 17 mm of mercury for the bilayer system K2. It can also be seen that for all the products of Examples 1, 2 and 4 and the product K 2, which are all short elongations, this pressure differential varies little over time since the variation is between +3 and +6 for the knits according to the invention and + / 2 for the bilayer system K2.
Surprisingly Example 3 which is a long elongation, therefore supposed to be less effective in terms of pressure differential, also has an excellent pressure differential of 21mm of mercury. Moreover, this pressure differential improves over time and is much better at 24 hours than at T = 0; 21 against 15 mm of mercury.
In conclusion, the strips according to the invention make it possible to obtain therapeutic properties equivalent to those of the product K2 or even higher, and to preserve the latter over time and this with a single band and without the addition of latex or adhesive.
In the same way, the in vivo test described hereinafter in Example 1 was compared with the product K2 to evaluate the intrinsic release of the strips over time.
The procedure of this in vivo test is as follows.
The bands are wrapped around the leg according to the recommendations described in the instructions for the K2 bilayer system.
As a reminder, this leaflet recommends the following method of application: 1) Hold the foot at 90 °, toes upwards. Apply KTECH to the base of the toes by making two all anchors, making sure that the fleece side is in direct contact with the skin and that the pressure gauge is located on the upper side of the band. Continue making an "8" figure around the ankle, without applying excessive tension on the foot and covering the heel well. 2) Raise to the knee by spiraling and stretching the band appropriately: the pressure indicator printed on the bands should form a circle. To obtain a correct overlap, the pressure gauge must be just covered (50% overlap). Finish 2cm below the knee and cut off the excess tape. Secure with a plaster. 3) Apply KPRESS on KTECH using the same technique by starting a finger over KTECH and finishing 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 a good hold of the system.
It is well understood that this last step 3) is not necessary for a compression band according to the invention.
For the example according to the invention, a stretching elongation is used as previously for the in vitro test of 40% and the knit is calibrated in the same way. The bands are wrapped around the foot, heel and along the leg to the knee with a 50% layer overlap. The last turn is fixed on itself with a metal clip or tape. If it is desired to check the pressure applied by the band, it is possible to have at a point B1, corresponding to the zone where the Achilles tendon is transformed into calf muscle, generally about 10 to 15 cm above the malleolus. , an interface pressure measuring sensor such as, for example, the sensor referenced KKH-01 from the company KIKUHIME. With a thin, non-erasable marker, a vertical line is drawn on at least 3 turns on the axis of the tibial crest, from the last coiled coil. This mark is used as a reference to evaluate using a ruler graduated to mm, the horizontal offset of the line at the end of the test duration. During the movements, this feature loses its rectilinear character and is in echelons all the more offset as the spiral turns are important. If the slip turns on a turn is very weak or nonexistent, the vertical line remains intact or varies very little mainly on the first turn which is located under the last coiled coil.
This offset of the vertical line is representative of the slackening of the strip and illustrates its potential slip over time.
This test was carried out during 6 hours on 5 people. Each person wears on one leg a band according to Example 1 of 10 cm in width and 2.6 m in length, face thread in contact with the skin, calibrated at 40% at the laying and on the other leg the bilayer system K2.
After 6 hours, the offset of the vertical line is measured on the first 3 turns.
The results are as follows:
K2 bilayer system: no offset of the line on any turn.
Such a result is coherent, because of the "cohesivation" of the band which blocks the sliding of the turns on each other.
Contention band according to Example 1: no offset of the line on the turns 2 and 3 and a slight average offset of 4 mm on the first turn which is located under the last coiled coil.
This average value is negligible and represents the randomness of measurements related to the variation of the calves of the testers, the reproducibility of the pose and the manufacturing variabilities of the bands.
It can therefore be considered that the strip according to the invention has a resistance to spin-on-turn slip equivalent to that of the cohesive system.
This test shows that in terms of performance the 2 products are equivalent. All of these tests demonstrate that it has been obtained with a single strand a restraint device that has the good therapeutic properties and that does not slip over time without the addition of additional substances on the latter.
权利要求:
Claims (11)
[1" id="c-fr-0001]
claims
1. Compression band which is in the form of a knit obtained by the knitted stitch technology based on synthetic threads which consists of two textile surfaces whose textile structure is different, connected to each other by stringer threads, each surface comprising elastic threads, said knit being characterized in that it has - a face which has a textile structure which is a net, - a longitudinal elongation measured according to the standard EN 14704 -1 of between 50 and 160%, - a shear threshold stress greater than or equal to 3000 Pa.
[2" id="c-fr-0002]
2. Strap of contention according to claim 1 characterized in that the spacer wire is a monofilament having a title between 20 and 80 dtex, or more precisely between 40 and 70 dtex.
[3" id="c-fr-0003]
3. Strap of contention according to one of the preceding claims, wherein said knit has a face which has a textile structure from the list below, - charmeuse; - half-single with open or closed meshes; - altas under one or more rows; - chain with open, closed or alternating meshes of closed and open meshes; said face being opposed to the face adapted to be brought into contact with the skin which has a textile structure which is a net.
[4" id="c-fr-0004]
4. Strap of contention according to one of the preceding claims characterized in that the knit has a thickness between 1 and 2 mm, or more precisely between 1 and 1.5 mm.
[5" id="c-fr-0005]
5. Strap of contention according to one of the preceding claims characterized in that the knit has a gap between the faces between 0.4 and 1.5mm, or more precisely between 0.5 and 1.1mm.
[6" id="c-fr-0006]
6. Strip contention according to one of the preceding claims characterized in that the knit has a basis weight between 160 and 300 g / m2, or more precisely between 160 and 370 g / m2.
[7" id="c-fr-0007]
7. Strap of contention according to one of the preceding claims characterized in that the knit has a longitudinal elongation as defined in EN 14704-1 between 50 and 120%.
[8" id="c-fr-0008]
8. Strap of contention according to one of the preceding claims characterized in that the knit is manufactured using a single bar for the spacer wire which connects the two textile faces.
[9" id="c-fr-0009]
9. Strap of contention according to one of the preceding claims characterized in that the elastic thread has a title between 40 and 80 dtex.
[10" id="c-fr-0010]
10. Strap of contention according to one of the preceding claims characterized in that the textile surfaces comprise thermoplastic son having titles of 40 to 90 dtex.
[11" id="c-fr-0011]
11. Kit which comprises one or more compression bands according to one of the preceding claims and one or more dressings adapted to be placed on a wound prior to the compression band.
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同族专利:
公开号 | 公开日
EP3380660A1|2018-10-03|
WO2017089731A1|2017-06-01|
AU2016360847B2|2021-12-09|
EP3380660B1|2022-02-16|
US20180344531A1|2018-12-06|
CN108603316B|2020-06-16|
AU2016360847A1|2018-06-21|
FR3044217B1|2017-12-29|
CN108603316A|2018-09-28|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题
WO1995016416A1|1993-12-16|1995-06-22|Seton Healthcare Group Plc|Bandages|
DE19821687A1|1998-05-14|1999-11-18|Medi Weihermueller & Voigtmann|Textile bandage material with a three-dimensional compression|
DE19910785A1|1999-03-11|2000-09-28|Titv Greiz|Three-dimensional ventilating structure for use in sports wear, shoes and medical aids|EP3508630A4|2016-08-31|2020-04-15|Toray Industries, Inc.|Shell fabric with motion followability|US5385036A|1993-05-24|1995-01-31|Guilford Mills, Inc.|Warp knitted textile spacer fabric, method of producing same, and products produced therefrom|
GB0724028D0|2007-12-07|2008-01-16|Medlock Medical Ltd|Improved compression bandage structures|FR3089406B1|2018-12-07|2020-11-20|Urgo Rech Innovation Et Developpement|Restraint device and restraint system comprising a restraint article and such a restraint device|
FR3089405A1|2018-12-07|2020-06-12|Urgo Recherche Innovation Et Developpement|Restraint device and restraint system comprising a restraint article and such restraint device|
FR3099986B1|2019-08-22|2021-09-03|Urgo Rech Innovation Et Developpement|Contention band with optimized surface.|
法律状态:
2016-11-25| PLFP| Fee payment|Year of fee payment: 2 |
2017-06-02| PLSC| Publication of the preliminary search report|Effective date: 20170602 |
2017-06-02| EXTE| Extension to a french territory|Extension state: PF |
2017-11-23| PLFP| Fee payment|Year of fee payment: 3 |
2017-12-22| TP| Transmission of property|Owner name: URGO RECHERCHE INNOVATION ET DEVELOPPEMENT, FR Effective date: 20171120 |
2019-11-25| PLFP| Fee payment|Year of fee payment: 5 |
2020-11-25| PLFP| Fee payment|Year of fee payment: 6 |
2021-11-24| PLFP| Fee payment|Year of fee payment: 7 |
优先权:
申请号 | 申请日 | 专利标题
FR1561402A|FR3044217B1|2015-11-26|2015-11-26|OPTIMIZED CONTENT TAPE|FR1561402A| FR3044217B1|2015-11-26|2015-11-26|OPTIMIZED CONTENT TAPE|
AU2016360847A| AU2016360847B2|2015-11-26|2016-11-25|Optimised compression bandage and kit using said bandage|
PCT/FR2016/053105| WO2017089731A1|2015-11-26|2016-11-25|Optimised compression bandage and kit using said bandage|
EP16815888.9A| EP3380660B1|2015-11-26|2016-11-25|Optimised compression tape and a kit using same|
US15/778,406| US20180344531A1|2015-11-26|2016-11-25|Optimized compression bandage and kit using said bandage|
CN201680080034.3A| CN108603316B|2015-11-26|2016-11-25|Optimized compression bandage and kit using same|
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