• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to an elastic venous compression orthosis indicated in the case of venous affection of a lower limb of a patient, said lower limb having an ankle, a calf and a thigh, said orthosis comprising an ankle portion (14). for wrapping the ankle and a calf portion (16) for wrapping the calf, said orthosis having a textile pressure profile such that: - the textile pressure measured at the ankle is less than 10 mmHg, and - the measured textile pressure calf is less than 35 mmHg and greater than 25 mmHg.
    公开号:FR3050928A1
    申请号:FR1654103
    申请日:2016-05-06
    公开日:2017-11-10
    发明作者:Francois Cros；Amina Ouchene；Joel Mathieu
    申请人:Laboratoires Innothera SAS；
    IPC主号:
    专利说明:

    BACKGROUND OF THE INVENTION The invention relates to an elastic venous compression orthosis, or CVE, hereinafter "orthosis", indicated in the case of venous disease of a lower limb of a patient.
    State of the art
    Elastic venous compression orthoses, formerly known as "compression stockings" or "compression stockings", are textile medical devices that produce a therapeutic effect by compressing the lower limbs as opposed to the lower stockings. maintenance "(or" low support "or" low anti-fatigue ") and" low mode ", which are not medical devices for therapeutic purposes.
    To allow strong compression of the lower limbs, the elastic venous compression orthoses are conventionally made from a knitted mesh incorporating an elastic weft yarn, generally a gimped elastane. The orthosis is threaded, to a service position, on the lower limb of the patient to be treated. The restoring force of the elastic fibers then exerts compression.
    The mesh and the yarns, as well as the sizing of the rows of stitches, are chosen so as to apply predetermined textile pressures at different altitudes of the lower limb, for example at the height of the ankle, at the start of the calf, at the level of the calf. , popliteal hollow, etc. up to the thigh, conventionally noted altitudes B to G.
    These different textile pressures are defined for each class with reference to metrological templates such as the leg-model of the French standard NF G 30-102 part B, appendix B, corresponding to the leg-model "type Hohenstein" according to the German reference system. RAL-GZ 387, or as defined in European Experimental Standard XP ENV 12718: 2001.
    Measuring points of the lower limb are defined by the European Compression Standardization Commission (C. Gardon-Mollard, A. Ramelet, The Medical Compression, Ed Masson, 2nd Edition).
    As shown in FIG. 1, the altitudes of the lower limb are defined by the standard morphological reference. They have been represented, using standardized notation: - B: ankle, at the point of its minimum circumference; - B1: junction point between the Achilles tendon and the calf muscles; - C: calf, at the point of its maximum circumference; - D: just below the tibial tuberosity (that is, just below the knee); - E: in the center of the patella and above the back of the knee (that is to say at the level of the popliteal fossa); - F: in the middle of the thigh; and - G: at the top of the thigh.
    The calf is the limb segment between levels B1 and D, and the ankle is the limb segment extending from level B to the instep.
    The textile pressure profile, that is to say the evolution, along an orthosis, of the textile pressure exerted by the orthosis threaded onto the morphological template, is decisive on its therapeutic effectiveness. WO2010 / 037609 describes examples of textile pressure profiles.
    To promote venous return in an orthostatic situation, the textile pressure profile is classically degressive.
    To promote venous return when the patient walks, the textile pressure profile is instead progressive upwards from the ankle. Such a profile indeed improves the effectiveness of the "musculo-aponeurotic calf pump" (PMAM), which, thanks to physiological muscular contractions of the calf, causes a centripetal venous hunting on the muscle and deep venous network.
    In addition, to improve compliance, an orthosis must be practical and comfortable.
    There is a constant need to improve the efficiency and comfort of orthoses.
    An object of the invention is to respond, at least partially, to this need. Summary of the invention
    According to the invention, this goal is achieved by means of an elastic venous compression orthosis indicated in case of venous disease of a lower limb of a patient, said orthosis having a textile pressure profile such as: - the pressure textile measured at the ankle, that is to say at altitude B, is less than 10 mmHg (or substantially 13.3 hPa, the mmHg is however commonly used as a unit of measurement of textile pressure in the field phlebology and medical compression), preferably less than 7 mmHg (ie substantially 9.3 hPa), preferably less than 5 mmHg (or substantially 6.7 hPa), and preferably greater than 3 mmHg ( or 4 hPa), and the textile pressure measured at calf, that is to say at altitude C, is less than 35 mmHg (or substantially 46.7 hPa), preferably less than 33 mmHg (or substantially 44 hPa), preferably less than 30 mmHg (40 hPa), and greater than 25 mmHg (ie substantially 33.3 hPa), preferably greater than 28 mmHg (ie substantially 37.3 hPa).
    The inventors have found that an orthosis according to the invention is effective, and particularly comfortable. In particular, donning is easy and the therapeutic efficacy remarkable.
    An orthosis according to the invention may also comprise one or more of the following optional and preferred characteristics: the textile pressure measured in the middle of the thigh, that is to say at the altitude F, is less than 10 mmHg (substantially 13.3 hPa), preferably less than 7 mmHg (ie substantially 9.3 hPa), preferably less than 5 mmHg (or substantially 6.7 hPa), and preferably greater than 3 mmHg (ie 4 hPa); the ankle portion and / or the calf portion exhibit, at any altitude, a constant structure along the circumference of said orthosis at said altitude; - The mesh height of the calf portion is greater than 400, 450 or 500 and the mesh height of the ankle portion is greater than 700, 750 or 800; - The mesh height of the ankle portion is greater than the mesh height of the calf portion, the increase is preferably progressive.
    BRIEF DESCRIPTION OF THE FIGURES Other features and advantages of the invention will become apparent on reading the detailed description which follows, and on examining the appended drawing in which: FIG. 1 represents an orthosis according to the invention threaded on a lower limb of a patient; FIG. 2 diagrammatically represents the standard morphological reference frame; and - Figures 3 and 4 illustrate the test result. Definitions - The terms "compression" and "contention" define very different effects, although they are sometimes confused in the common language.
    "Compression" is the effect produced by an elastic orthosis, both at rest and during effort, on a limb segment due to the more or less powerful forces of the elastic fibers of this orthosis. These forces act almost constantly on the limb: at rest, the compression is present at the value of nominal pressure, and at the effort the effect of this compression is slightly increased by the contraction of the muscular masses. Conversely, "contention" is the effect produced by an orthosis that acts in a differentiated manner (effort / rest) on a limb segment under the action of a structure considered to be inelastic (but deformable), for example a non-elastic bandage, also referred to as a "short stretch bandage". At rest, this type of band exerts little or no pressure. On the other hand, during the muscular contraction, it is opposed to the local increases of the volume of the muscle, which abuts on the inelastic structure, the pressure thus being greatly increased. The compression is therefore effective and active during exercise, and almost inactive at rest. It is common practice in the scientific literature to consider an orthosis to be "rigid" when it produces an increase of at least 10 mmHg (13 hPa) per centimeter increase in circumference. limb at the point where the Achilles tendon meets the calf muscles. "Rigidity" is understood here in the sense of the definition of the European prestandard XP ENV 12718: 2001, that is to say, "the increase in compression per centimeter of increase in circumference of the leg, expressed in hectopascals. per centimeter and / or in millimeters of mercury per centimeter ". - "Altitude", or "level", corresponds to a level in the vertical direction V when the orthosis is worn by a patient standing upright, as shown in Figure 2. - The French standard NF G 30 -102, part B, defines and provides the protocol for measuring a pressure called "compression pressure" This standard also applies to the measurement of compression pressures.To this end, this standard uses a leg-model "type Hohenstein "At a determined altitude, the circumference of an orthosis threaded on such a leg-model, that is to say along a contour corresponding to a horizontal section of the limb, is circular. .
    Conventionally, at a determined altitude, the structure of the orthosis is constant along its circumference. The section being circular, the compression pressure measured at a point of this circumference is therefore constant, regardless of the point considered.
    In a generic way, the term "textile pressure" is the pressure in the sense of the NF G30102 standard, that is to say the pressure exerted by a textile stretched on a jig with a circular section.
    detailed description
    In FIG. 1, reference numeral 10 generally designates an orthosis according to the invention. The orthosis 10 is shaped to cover the ankle and the calf, that is to say that it extends at least from the altitude B to the altitude D. The orthosis 10, knitted, present the general shape of a deformable sleeve, adapted to be threaded on a lower limb of a patient. In anatomical form, the orthosis comprises, successively from the end of the foot, - optionally, a foot portion 12 wrapping the foot; a leg portion 13 comprising an ankle portion 14 wrapping around the ankle and a calf part 16 wrapping around the calf; optionally, a thigh part wrapping around the thigh, and optionally a terminal knitted part called odds "18, which ends below the knee. The orthosis 10 shown extends to an altitude below the knee, in the case where the orthosis is a sock "mid-low" (or "low-hock").
    The sock-shaped configuration is not limiting, and the orthosis 10 can also be made in the form of a "lower-thigh", the leg portion 13 being extended by the thigh portion 20 compressive. The orthosis 10 may also be made in the form of a pantyhose, and / or without a foot part 12 (low or "open foot" type).
    The various adjoining parts of the orthosis 10 are preferably knitted continuously on a circular loom, according to conventional methods. Advantageously, the realization of the orthosis 10 does not require any preparation step for the assembly of the different parts, with the exception of sewing operations of the tip at the foot portion 12, if the latter is present.
    The structure of the orthosis conventionally comprises a network of stitches made by means of a knit yarn, a weft yarn being interwoven between said stitches. The orthosis 10 is conventionally made by knitting a knit yarn and a weft yarn, the sizing and the nature of the knit and weft yarns and the knit structure being chosen so as to exert in the circumferential direction. after the orthosis has been placed on the lower limb, an elastic restoring force capable of producing compression of the limb at the desired therapeutic pressure level.
    In a preferred embodiment, all parts of the orthosis are compressive.
    Depending on the altitude, the knitted mesh may be more or less tight texture.
    Preferably, the weft yarn is elastic, preferably is a double spandex elastane yarn. The adaptation of the elastic restoring force to obtain a given textile pressure profile does not pose any particular difficulty to those skilled in the art.
    The graph shown above the drawing of Figure 2 shows the pressure zone (shaded area) in which the textile pressure profile of an orthosis according to the invention is preferably contained.
    The curve Pr (a) represents an example of a textile pressure profile giving the textile pressure P as a function of the altitude a.
    The textile pressure profile may have inflection points or, as shown, vary continuously.
    It may have pressure levels, the textile pressure being constant over part of the height of the orthosis, for example over more than 1 cm more than 3 cm or more than 5 cm. On the contrary, the textile pressure profile may vary over the entire height of the orthosis. For example, the calf part can be made by a knitting with four falls: - 1st fall = mesh jersey place all needles with 2 ends of (lycra 17 dtex type 175C gimped by air with polyamide 66 1/44 / 13 FTS mid-mast); - 2nd fall = load 1 needle out of 2 with 1 end of (lycra 940 dtex type 136C double gimped with polyamide 66 1/78/23 FT mid-mat); - 3rd fall = stitch stitch all needles with 2 ends of (175c17 dtex lycra type air-capped with polyamide 66 1/44/13 FTS mid-mat); - 4th fall = load 1 needle out of 2 with 1 end of (lycra 570 dtex type 902C double gimped with polyamide 66 1/22/7 FT mid-mat).
    The mesh height for the calf portion can be 500.
    The same knitting can be applied for the ankle part, increasing the mesh height to 800. The increase in the mesh height is preferably progressive, for example in the region between the altitudes B and B1.
    Tests have shown that textile pressure profiles according to the invention lead to remarkable efficiency and comfort performances.
    In particular, an expert panel of 7 women (whose ankle perimeters were between 19 and 22 cm), regularly trained and trained in sensory analysis techniques, evaluated 9 descriptors defining the ease of donning, the discomfort felt to the movement and tightening sensation of 5 degressive or progressive compression shanks according to a methodology developed by IFTH in collaboration with Innothera Laboratories based on ISO 11035, ISO 11036, BP X10 040 and BP X10 sensory analysis standards 041. The objective was to compare the ease of donning, the discomfort with the movement and the feeling of tightening of low compression shank of classes 1 to 3 and products delivering a progressive compression.
    The results are given in the figures in appendices.
    In these figures, the bars or braces denote statistically equivalent products according to the Duncan test at 5%. In the IFTH report, the code / product correspondences are: - A: Innothera Comfort 1 - B: Innothera Comfort 2 - C: Innothera Gauss 5-30 (progressive), according to the invention - D: BV Sport ProRecup (progressive) - E: Innothera Actys 25
    Tests show that the easiest product to thread globally is Comfort 1 and then Gauss. Statistically equal ProRecup, Actys 25 and Comfort 2. The products causing the least inconvenience to movement and tightening are Comfort 1 and Gauss, statistically equal. In contrast, statistically equal, Comfort 2, Actys 25 and ProRecup, in terms of comfort to wear. The therapeutic efficacy of the product GAUSS is also superior to that of the product Comfort 1. The latter is indeed a class 1 product, indicated for the early stages of venous disease. The Gauss product advantageously has an efficacy of a class 3 product.
    An orthosis according to the invention is suitable for the therapeutic treatment of chronic venous affections, and in particular for the treatment of venous insufficiencies less than or equal to C3 in the CEAP classification (C: clinical manifestation; E: etiology factors; A: anatomy distribution P: pathophysiologic dysfunction).
    Of course, the invention is not limited to the embodiments described and shown, provided for illustrative purposes only.
    权利要求:
    Claims (9)
    [1" id="c-fr-0001]
    1. An elastic compression elastic venous orthosis, having the shape of a deformable sheath, and indicated in case of venous disease of a lower limb of a patient, said lower limb comprising an ankle, a calf and a thigh, said orthosis comprising an ankle portion (14) for wrapping the ankle and a calf portion (16) for wrapping the calf, said orthosis having a textile pressure profile such that: - the textile pressure measured at the ankle is less than at 10 mmHg, and the textile pressure measured at the calf is less than 35 mmHg and greater than 25 mmHg, the textile pressure being the pressure within the meaning of standard NF G30102.
    [2" id="c-fr-0002]
    2. An orthosis according to the immediately preceding claim, wherein: the textile pressure measured at the ankle is less than 7 mmHg, and the textile pressure measured at the calf is less than 33 mmHg and greater than 28 mmHg.
    [3" id="c-fr-0003]
    3. An orthosis according to any one of the preceding claims, wherein: the textile pressure measured at the ankle is less than 5 mmHg, and the textile pressure measured at the calf is less than 30 mmHg.
    [4" id="c-fr-0004]
    4. An orthosis according to any one of the preceding claims, wherein: the textile pressure measured at the ankle is greater than 3 mmHg.
    [5" id="c-fr-0005]
    5. Orthosis according to any one of the preceding claims, said orthosis comprising a leg portion (20) for wrapping the thigh, said orthosis having a textile pressure profile such that: - the textile pressure measured in the middle of the thigh is lower at 10 mmHg.
    [6" id="c-fr-0006]
    6. An orthosis according to the immediately preceding claim, wherein: the textile pressure measured in the middle of the thigh is less than 5 mmHg.
    [7" id="c-fr-0007]
    7. An orthosis according to the immediately preceding claim, wherein: the textile pressure measured in the middle of the thigh is less than 3 mmHg.
    [8" id="c-fr-0008]
    An orthosis according to any one of the preceding claims, wherein the mesh height of the ankle portion is greater than the mailing height of the calf portion, the increase preferably being progressive.
    [9" id="c-fr-0009]
    9. An orthosis according to any one of the preceding claims, selected from the group consisting of a sock "mid-bottom", a "bottom-thigh", and a tights.
    类似技术:
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    JP2008543404A|2008-12-04|Knitted compressible prosthesis for lower limbs to treat chronic venous insufficiency
    FR2780637A1|2000-01-07|COMPRESSIVE ORTHESIS OF THE LOW OR TIGHTING TYPE
    FR2588184A1|1987-04-10|LOW THERAPEUTICS FOR THE TREATMENT OF BLOOD CIRCULATION DISORDERS IN A LEG
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    JP2016065342A|2016-04-28|Hose
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    同族专利:
    公开号 | 公开日
    US20170319395A1|2017-11-09|
    CA2965945A1|2017-11-06|
    RU2017115695A|2018-11-06|
    FR3050928B1|2018-06-01|
    DE102017109689A1|2017-11-09|
    RU2017115695A3|2020-05-28|
    RU2734815C2|2020-10-23|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    FR2588184A1|1985-09-11|1987-04-10|Kendall & Co|LOW THERAPEUTICS FOR THE TREATMENT OF BLOOD CIRCULATION DISORDERS IN A LEG|
    EP0934043A1|1996-10-25|1999-08-11|BV Sport|Support stocking|
    US20090240279A1|2005-06-16|2009-09-24|Francois Becker|Knitted Compressive Orthosis of the Lower Limb for Treating Chronic Venous Insufficiency|
    WO2010037609A1|2008-10-01|2010-04-08|Pierre Fabre Medicament|Compression stocking for moderate to severe chronic venous insufficiency|FR3108251A1|2020-03-18|2021-09-24|Laboratoires Innothera|Compression product for the treatment of OSAHS|FR2749754B1|1996-06-14|1998-12-11|Innothera Topic Int|COMPRESSIVE ORTHESIS FOR SINGLE USE|
    WO2000015139A2|1998-09-16|2000-03-23|Circaid Medical Products, Inc.|Compression device with compression measuring system|
    FR2805459B1|2000-02-29|2002-10-18|Innothera Topic Int|PLACEBO-TYPE CONTAINMENT ORTHESIS|
    US8172782B2|2008-11-25|2012-05-08|Mmi-Ipco, Llc|Compression garments|
    WO2011143489A2|2010-05-13|2011-11-17|Vazales Brad E|Variable compression stockings|
    AU2012328481A1|2011-10-28|2013-05-23|Ing Source, Inc.|Compression foot garment, and therapeutic method for reducing heel pain|FR2995525B1|2012-09-19|2014-10-10|Thuasne|METHOD FOR MANUFACTURING A TUBULAR COMPRESSION ARTICLE AND ARTICLE THUS OBTAINED|
    FR3040125B1|2015-08-20|2020-02-28|Laboratoires Innothera|METHOD FOR DETERMINING A SIZE GRID|
    法律状态:
    2017-03-30| PLFP| Fee payment|Year of fee payment: 2 |
    2017-11-10| PLSC| Search report ready|Effective date: 20171110 |
    2018-03-30| PLFP| Fee payment|Year of fee payment: 3 |
    2019-04-30| PLFP| Fee payment|Year of fee payment: 4 |
    2020-04-27| PLFP| Fee payment|Year of fee payment: 5 |
    2021-03-31| PLFP| Fee payment|Year of fee payment: 6 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1654103A|FR3050928B1|2016-05-06|2016-05-06|VENOUS COMPRESSION ORTHESIS WITH VARIABLE PRESSURE PROFILE|
    FR1654103|2016-05-06|FR1654103A| FR3050928B1|2016-05-06|2016-05-06|VENOUS COMPRESSION ORTHESIS WITH VARIABLE PRESSURE PROFILE|
    CA2965945A| CA2965945A1|2016-05-06|2017-05-01|Venal compression orthotic with variable pressure profile|
    RU2017115695A| RU2734815C2|2016-05-06|2017-05-04|Venous compression orthesis with variable pressure profile|
    DE102017109689.2A| DE102017109689A1|2016-05-06|2017-05-05|Venous compression orthosis with variable pressure profile|
    US15/589,012| US20170319395A1|2016-05-06|2017-05-08|Venous compression orthosis with variable pressure profile|
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