EP2694003A1 - Article de soin pour blessure ayant une enveloppe déformable dans une direction ciblée - Google Patents

Article de soin pour blessure ayant une enveloppe déformable dans une direction ciblée

Info

Publication number
EP2694003A1
EP2694003A1 EP12713952.5A EP12713952A EP2694003A1 EP 2694003 A1 EP2694003 A1 EP 2694003A1 EP 12713952 A EP12713952 A EP 12713952A EP 2694003 A1 EP2694003 A1 EP 2694003A1
Authority
EP
European Patent Office
Prior art keywords
wound
care article
wound care
article according
shell
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP12713952.5A
Other languages
German (de)
English (en)
Inventor
Birgit Riesinger
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BSN Medical GmbH
Original Assignee
BSN Medical GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by BSN Medical GmbH filed Critical BSN Medical GmbH
Publication of EP2694003A1 publication Critical patent/EP2694003A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A61F13/01042
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/45Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the shape
    • A61F13/01038
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive plasters or dressings
    • A61F13/0203Adhesive plasters or dressings having a fluid handling member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/0054Plasters use for deep wounds

Definitions

  • the invention relates to a wound care article having at least one absorption body and an outer shell according to claim 1.
  • Such a wound care article is particularly suitable for receiving wound fluid from highly exuding wounds, in particular chronic wounds, such as e.g. in diabetes, leg ulcers and similar diseases.
  • Surface wound dressings have long been known.
  • Flat wound dressings which contain superabsorbent substances, in particular polymers, are also known.
  • Such dressings may be a wound dressing for the absorption of wound exudates, e.g. in WO03094813, WO2007051599 and WO0152780 of the assignee of the present invention, the disclosure of which is incorporated herein by reference.
  • the wound dressing exerts some pressure on the wound due to the increased absorption of wound exudate or, if desired, the wound dressing diverts the collected exudate away from the wound, thus leaving a slight void over the wound Wound surface is formed.
  • the object of the present invention is therefore to provide a wound care article in which the volume increase is directed in a predetermined direction. This object is achieved by the wound care article according to the main claim. Further preferred embodiments are given by the features of the dependent claims.
  • the present invention discloses a wound care article having at least one absorbent body surrounded by an outer shell, characterized in that the shell comprises means designed and / or selected such that the shell is at least partially supplemented by a fluid intake increase in volume
  • Absorbent body is targeted deformable.
  • wound care article is intended in particular to designate a wound dressing, preferably a flat wound dressing or a wound care cloth.
  • targetably deformable means that the outer shell around the absorbent body directs the volume increase during the absorption process in a certain direction, which can be achieved both by expansion of the absorbent body in the direction of the wound and away from the wound, ie, depending on the arrangement vertical
  • the shell has a wound-facing, liquid-permeable side and a side facing away from the wound, wherein at least one of the two sides is elastically and / or plastically deformable at least in some areas. It goes without saying that the Shell at least on the side facing the wound, is permeable to liquid.
  • the sheath forms a barrier against solid precipitates, but at the same time allows the passage of other leaked substances to the material portion of absorbent material disposed within the sheath.
  • partial area means that at least a partial area of the corresponding side is elastically and / or plastically deformable, which is of particular relevance if the wound care article is placed in such a way that the absorption process is carried out by the natural
  • Gravity is influenced, e.g. in a leg bandage in the form of a cuff.
  • the upper portion in the applied state is the
  • the wound care article according to the invention may moreover have a form adapted to the anatomical conditions.
  • he may be the shape of the cuff designed so that it can be slipped over an arm, a leg or a joint.
  • the wound care article may be in the form of a heel, an elbow joint, or the like.
  • the wound care article is bounded by the shell around the absorbent body, an expansion margin, the dimensions of the
  • Adjusted volume increase of the absorbent body and in the initial state 3 to 90 vol% is greater than the absorption body.
  • the absorption body in plan view of its flat side on a surface (Fl), which is in the non-wetted state by 3% to 90% smaller than the surface (F2) of the flattened shell and is freely movable or fixed in the shell.
  • Fl surface
  • the expansion margin is thus preferably an expansion margin peripheral to the perimeter
  • arranged absorption body is located.
  • At least one lining layer is arranged between the absorption body and the sheath.
  • the laminating layer serves that through to conduct the wound exudate received to the absorbent body while preventing backflow of wound exudate into the wound.
  • the lining layer is preferably adapted to the inner dimension of the shell and accordingly in the area slightly larger than the underlying absorption body, so that leaks from the
  • Absorbent body can be intercepted.
  • the lining layer is exactly adapted to the expansion edge around the absorbent body.
  • the absorbent body can both only from one side by a laminating layer, or by a
  • Sandwich assembly be covered by one or more Kasch michslagen from both sides.
  • the lamination layer is preferably made of cellulose fleece without further
  • one side of the shell can be elastically and / or plastically deformable.
  • elastically deformable is understood to mean a reversible deformation, that is to say
  • the term "plastically deformable” is understood to mean an irreversible deformation. The degree of deformation depends on the particular material from which the shell is made.
  • the shell is made of hydrophobic material or of a hydrophobically-finished natural material, preventing the hydrophobic properties of the shell bonding to the wound surface and helping the wound exudate particles to enter the shell more rapidly
  • the deformable material is a woven or nonwoven fabric having at least one elastic or plastic component, preferably one
  • Chemical fibers particularly preferably a polyaddition fiber, most preferably a polyurethane fiber.
  • Polyurethane fibers have the property of high elastic extensibility. Polyurethane is available as fiber under the trade names Elasthan, Lycra or Dorlestan is known and consists of at least 85% polyurethane. Because it is well dyeable compared to rubber, it is usually used in conjunction with other fibers for stretchable fabrics.
  • the chemical fibers formerly also referred to as synthetic fibers, but not only include fibers from synthetic, but also from natural polymers, such as rubber fibers. These fibers of natural polymers can also be used as elastic components for the sheath in the wound care article of the invention. In addition, some natural fibers are suitable, provided they have a minimum of elasticity or plasticity.
  • the fabric or fleece can be made entirely from the elastic or plastic
  • the sheath is preferably made of a woven or non-woven material which has at least a surface-specific weight of 20 g / m 2 .
  • the deformable material is a plastic film.
  • Suitable materials are all types of films with a certain flexibility, so that the film is elastically or plastically deformable.
  • Suitable plastic films are preferably made of polyethylene or polyurethane.
  • films of polystyrene, polyvinyl chloride, polyester or polycarbonate are possible or made of artificial spider silk.
  • the films may be wholly or partly pored, especially on the side facing the wound, so that the wound exudate reaches the absorption body via the pores.
  • the sheath wholly or partially on a uniform perforation.
  • the material of the sheath may be structured such that the sheath has a rough inner surface and a smooth outer surface.
  • the rough inner surface of the shell is formed by funnel-shaped perforations, each tapering towards the inner surface and terminating in a free opening edge ("protrusion"), this rough inner surface counteracting the displacements of the contents of the shell, thus providing adhesion with adhesive dots
  • the smooth outer surface of the casing material may be formed by curved sections of material extending between the perforations, Such a casing material may be referred to as "three-dimensional" in contrast to a bilaterally planar one and is known from, for example, DE 102006017194 Applicant of the present application, the disclosure content of which is fully referenced here.
  • the pores are adapted to the size of the SAP particles so that the SAP particles can not escape from the shell.
  • the pores or meshes of the sheath are preferably 0.05 mm to 1.0 mm, preferably 0.20 mm to 0.50 mm in size. Furthermore, it can preferably be provided that the pores or meshes are delimited by the filament or fiber sections, which are approximately arcuate in section through the envelope and point outwards with their arc crests.
  • the sheath has on at least one side a peripheral seam, preferably an ultrasonic seam, for limiting the deformation of the sheath.
  • a peripheral seam preferably an ultrasonic seam
  • the shell in plan view of its flat side has a circumferential, projecting beyond the seam top and the absorbent body is free of hard, sharp edges and corners. The seam is held together by the seam. At the same time, so will the
  • the seam may in some cases be elastically and / or plastically deformable.
  • the sheath in the regions with elastic and / or plastically deformable seams causes a great extensibility, whereas in the other regions with rigid seams no expansion is possible.
  • seams are particularly suitable ultrasonic seams or welds.
  • the seam is crimped by e.g. a stretchable crimping tape with a rubber band incorporated therein is used. As a result, the shell is slightly curled and gets at the seams a high elasticity.
  • the deformable shell has color-contrasting means which, upon targeted deformation of the
  • the suitable agent is selected from the group of thread, ribbon and wire.
  • these agents are incorporated visibly into the sheath and may tear by the expansion of the absorbent body, so that the number of broken points and / or the distance between two torn ends represent an indication of the increase in volume of the absorbent body.
  • a change in color takes place in that the incorporated thread loses color intensity as a result of the stretching during the volume increase of the absorption body and thus provides an indication of the status of the absorption process.
  • such means may also be attached to the non-stretchable, outside of the shell facing away from the wound and, for example by a compression of the shell on the side facing away from the wound lead to a visible change in the indicator, in particular by an increase in color intensity.
  • the absorption body is essentially made of a sheet-like absorption material.
  • the absorption body may additionally be surrounded by an inner, liquid-permeable casing.
  • this inner shell does not have to have the same properties with regard to the targeted deformability as the outer shell.
  • Liquid-permeable shell materials are well known in the wound care sector in connection with commercially available absorption bodies.
  • the wound care article according to the invention the wound care article according to the invention
  • Nonwoven refers to a textile fabric of individual fibers which, unlike woven fabrics, knitted fabrics and knitted fabrics, is not made of yarns Nonwovens tend to retain their structural integrity as a result of the adhesion of the individual fibers and are referred to as "nonwovens". and eg made by swaging the fibers.
  • the individual layers of the absorbent body preferably have a surface-specific weight of at least 300 g / m 2 , wherein the basis weight of the evenly distributed therein proportion of osmotically active substances is at least 100 g / m 2 .
  • the absorption body has additional distribution layers. These distribution layers provide for distributing the wound exudates the entire receiving surface of the absorbent body and thus improve the overall absorption process.
  • the absorbent body has at least partially superabsorbent substances, preferably in the form of particles, granules, powder, bedding and / or fibers.
  • the superabsorbent substances may also be in the form of compact bodies in the form of a compact, a foam, a fiber knitted fabric, a nonwoven fabric and / or a fiber wadding, or be incorporated into such.
  • Particularly preferred are superabsorbent polymers (SAP).
  • SAP superabsorbent polymers
  • Superabsorbent polymers are plastics that are able to absorb many times their own weight - up to 1000 times - in liquids.
  • this is a copolymer of acrylic acid (propenoic acid, C 3 H 4 O 2 ) and sodium acrylate (sodium salt of acrylic acid, NaC 3 H 3 0 2 ), wherein the ratio of the two monomers to each other may vary.
  • a so-called core crosslinker core-crosslinker, CXL is added to the monomer solution which forms the long-chain
  • polymer molecules are joined together by chemical bridges (see
  • the absorbent body is an airlaid.
  • Airlaid refers to a special nonwoven fabric made from cellulose and polyolefin fibers, in which superabsorbent polymers may be embedded.
  • the superabsorbent substances may be incorporated into one or more of the layers of the absorbent body, or may consist entirely of them. Particularly preferred is provided that the individual layers to more than 40 wt .-% of
  • the wound care article according to the invention for attachment to the patient or for compressing the wound care article prior to attachment to the patient connectable to each other fasteners, preferably Velcro and / or adhesive surfaces.
  • the fastening means can therefore have several functions: For quick attachment or for quick application to the patient, the
  • wound Care Articles Quick-release closures such as those known from diapers. Alternatively, however, tapes or adhesive strips are possible. If the wound space or the edema is to be filled with the wound care article, the fastening means can also be arranged so that it in their use to a compression or a
  • the wound care article comes so that the wound care article can be optimally adapted to the wound.
  • fasteners are useful for specific body parts such as legs, knees or joints, as the wound care products are designed here mostly in the form of cuffs.
  • the wound care article also at least one nutritive, at least one disinfecting or
  • the disinfecting agent and / or complex may be e.g. to be a composition of at least one vitamin or vitamin derivative, a metal ion, and a detergent. It can also be an BLIS
  • the nutritive active ingredient and / or complex drug may be a composition containing at least the components of an enteral and / or parenteral dietetics. Likewise, it may be at least one active element selected from the group consisting of insulin, recombinant insulin, proinsulin, an insulin-like growth factor (IGF), an insulin mimetic and / or a diabetic-specific, non-glucose or sucrose-based
  • the protease-inhibiting active substance and / or active substance complex may be at least one active element selected from the group comprising protease inhibitors, superabsorbent polymers, divalent cation chelators, collagen, coated magnetic particles, acids, buffers, non-pathogenic acid-producing microorganisms, probiotics and / or symbiotics. Further relationships and background to the nutritive, a disinfecting or decontaminating and / or proteases inhibiting agents and / or
  • DE102007030931 also contains other nutritive, disinfecting or decontaminating and / or protease-inhibiting active ingredients and / or active substance complexes
  • wound care article according to the invention can also be used in a
  • Wound care system for wound drainage may be introduced using negative pressure.
  • Such systems are e.g. in the publications DE202004017052, WO2006048246 and
  • a device for wound treatment using negative pressure comprising a gas-tight wound covering element which, in the state applied to the patient's body, interposes between the respective wound and the wound
  • the wound care article is at least one layer of a superabsorbent enriched textile section, which is surrounded by a liquid-permeable shell, and the layer has a surface in plan view of its flat side, which is 3% to 90% smaller than that of the sheath so that the wound care article can approach a circular shape in the vicinity of its total filling capacity in cross-section.
  • a multi-component dressing for wound treatment of the human or animal body using negative pressure comprising: a wound covering element for attachment to the skin and mucosal surface, at least one connection point which is in contact with the wound space and over which the substances located in the wound space can be evacuated .
  • the latter having superabsorbent polymers, wherein the absorbed wound secretions remain bound to polymers in the wound space until they are removed from the wound space, the polymers, by virtue of their binding capacity, assisting mutual synergies with the subatmospheric pressures.
  • a drainage device for wound treatment using negative pressure comprising a gas-tight, sheet-like material wound covering element which is adhesively attached to the skin surface around the wound area in the body applied to the patient and one between the respective wound and the wound covering element remaining, sealed space forms, at least one drainage tube, which can be used in the space through which the substances in the room can be evacuated, and at least one disposed within the room, the wound secretions absorbent wound care article, the at least one layer of superabsorbent enriched textile section which is surrounded by a liquid-permeable sheath, wherein the absorbed wound secretions within the wound care article and thus below the wound-covering element until removal of the wound care article from the body of the Patients remain, and wherein the wound covering element has a gas-tight sealable treatment opening, through which the wound care article can be inserted into the room and removed from the room.
  • the wound care article of the invention may moreover have a form adapted to anatomical conditions.
  • a form adapted to anatomical conditions e.g. be designed in the form of a cuff; which can be slipped over the one arm or a leg or a joint, or in the form of an adapted to the heel, the elbow joint or the like Association.
  • the wound care article according to the invention may also be designed so that it is suitable for transfer around a surgically applied line.
  • the wound care article may have at least one slot which makes it possible to transfer the dressing around the body of a patient by a line (eg a drainage line or a catheter), wherein the wound care article is associated with a second, likewise planar wound care article, which is at a distance from the first wound care article,
  • Such a wound care article is e.g. from the DE202006005966 the applicant of the present invention, the contents of which should be fully added to the disclosure of the present description.
  • the wound care article has at least one agent which can limit the bleeding or bleeding tendency.
  • Said agent may be at least one chemical and / or
  • physiologically acting active substance or active substance complex or act at least one physically acting active element.
  • the wound care article for example, the wound care article
  • substantially flat material section comprising absorbent material which consists of an absorbent fleece with superabsorbent polymers distributed therein and at least one chemically and / or physiologically active substance or
  • the superabsorbent As a combination of a primary, non-insubstantially or only insubstantially absorbent wound dressing having at least one chemically and / or physiologically active agent or drug complex, and a secondary wound dressing circumferentially disposed of this primary wound dressing, the superabsorbent
  • Active substance complex and a winding section arranged on the wound dressing which has at least partially superabsorbent polymers, and / or
  • the material section having a longitudinal extent comprising absorbent material, the material section having elastically deformable properties, and wherein the material section has superabsorbent polymers and optionally at least one chemically and / or physiologically acting active substance or active substance complex
  • the chemically and / or physiologically active agent or active substance complex is preferably at least one substance or a composition which
  • Hemostats Hemostatic properties. These substances are known by the generic term "hemostats”.
  • the physically acting active element is e.g. a binding, a pressure pad, a compression bandage or a compression bandage.
  • FIG. 1 shows a wound care article according to the invention with an absorbent body 1 in an inner, liquid-permeable sheath 8 and a targeted deformable
  • the absorption body 1 is indicated by the hatched rectangle in the middle, which is surrounded by a partially elastic sheath with a peripheral seam 6.
  • the seam 6 may also be in partial areas, e.g. right and left, be elastic, so that the sheath can expand in use in both the vertical and in the horizontal direction.
  • Incorporated on the outer side of the sheath facing away from the wound are 3 threads 4, which are connected to attachment points 5 with the sheath.
  • the absorption body expands, the shell around it also expands. There is an expansion in the vertical direction, i. away from the wound, and in the horizontal direction, i. in the partial areas with elastic seams.
  • Fig. 3 shows exactly also a wound care article according to the invention
  • FIG. 4 shows the wound care article according to the invention as already illustrated in FIG. 3, but with the broken thread 4 and the spacing 7 formed between the two thread ends.
  • FIG. 5a shows the wound care article according to the invention in cross-section from the side.
  • the absorption body 1 is surrounded by an inner liquid-permeable casing 8, which adapts to the volume increase of the absorption body 1. That is why the
  • the wound care article can be used either facing the top of the wound or away from the wound, depending on the direction in which the expansion of the absorbent body 1 is desired.
  • FIG. 5b shows the wound care article according to the invention as already illustrated in FIG. 5a, but after the absorption process.
  • the envelope has increased the volume of the
  • Absorbent body 1 adjusted and extended upwards targeted.
  • FIG. 6 shows the wound care article according to the invention with the absorbent body 1 and a seam in the periphery of the sleeve, which is elastic in partial regions 10 and inelastic in other partial regions 9.
  • a crimping tape with rubber portion can be used for the elastic part seams 10.
  • the targeted expansion of the wound care article is indicated by the arrows on the sides, in which the envelope is held together by the elastic seams 10. Accordingly, there is no expansion in the areas with inelastic seams 9 - represented by the crossed-out arrows above and below the wound care article.
  • a similar behavior can also be achieved with unidirectionally elastic covering material, that is, a material which is extensible in one direction, but not in the direction orthogonal thereto. Such materials are for example from WO2005087159, in which they are used in a joint bandage.
  • Fig. 7a shows another wound care article according to the invention in cross-section from the side.
  • the absorbent body 1 is surrounded by a liquid-permeable sheath having an elastic portion 11 (indicated by the dashed line) and an inelastic portion 12 (indicated by the non-dashed line).
  • Fig. 7b shows said wound care article in position on the wound leg 13 of a patient.
  • said combination of elastic and non-elastic shell materials ensures that absorbed by the absorbent body liquid (exudate) from the wound not following the shearing force sags in the lower region of the absorption body and there leads to a bag-like training - which is sometimes uncomfortable for the patient may be, as this Aussackung for others may be recognizable as bulging on the trouser leg of the patient, possibly disturb him while walking and possibly even burst.
  • Fig. 8 shows another wound care article according to the invention in cross section of the
  • the absorption body 1 is surrounded by a liquid-permeable casing 14, which in the example shown consists entirely of an elastic material (indicated by the dashed representation).
  • the shell lies closely against the intermediate layers 15, 16, which are arranged on both sides of the absorption body 1 and preferably consist of a non-elastic material, for example a cellulose fleece without
  • the two intermediate layers project over the absorption body on at least two sides, thus concealing it as it were and rendering it invisible from the outside, thus defining an expansion space which the absorption body can use for its volume increase when it absorbs liquid. If the
  • Absorbent body has filled the space thus provided, the further volume increase is defined by the expansion properties of the elastic shell.

Abstract

L'invention concerne un article de soin pour blessure comportant au moins un corps absorbant qui est entouré d'une enveloppe extérieure. L'enveloppe comporte des moyens qui ont une forme et/ou sont choisis de sorte que l'enveloppe soit déformable au moins en partie et dans une direction ciblée par un apport volumique déterminé du corps absorbant par prélèvement de liquide.
EP12713952.5A 2011-04-06 2012-04-04 Article de soin pour blessure ayant une enveloppe déformable dans une direction ciblée Withdrawn EP2694003A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102011001832A DE102011001832A1 (de) 2011-04-06 2011-04-06 Wundpflegeartikel mit zielgerichtet verformbarer Hülle
PCT/EP2012/056170 WO2012136707A1 (fr) 2011-04-06 2012-04-04 Article de soin pour blessure ayant une enveloppe déformable dans une direction ciblée

Publications (1)

Publication Number Publication Date
EP2694003A1 true EP2694003A1 (fr) 2014-02-12

Family

ID=45953121

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12713952.5A Withdrawn EP2694003A1 (fr) 2011-04-06 2012-04-04 Article de soin pour blessure ayant une enveloppe déformable dans une direction ciblée

Country Status (4)

Country Link
US (1) US20140100542A1 (fr)
EP (1) EP2694003A1 (fr)
DE (1) DE102011001832A1 (fr)
WO (1) WO2012136707A1 (fr)

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US20140100542A1 (en) 2014-04-10
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