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WO2017039668A1 - Dispositif de prévention d'escarre de décubitus - Google Patents

Dispositif de prévention d'escarre de décubitus Download PDF

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Publication number
WO2017039668A1
WO2017039668A1 PCT/US2015/048249 US2015048249W WO2017039668A1 WO 2017039668 A1 WO2017039668 A1 WO 2017039668A1 US 2015048249 W US2015048249 W US 2015048249W WO 2017039668 A1 WO2017039668 A1 WO 2017039668A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure ulcer
ulcer prevention
substrate
prevention article
skin
Prior art date
Application number
PCT/US2015/048249
Other languages
English (en)
Inventor
Myungwon SONG
WonYeong SOHN
Jin Heo
JeongKyung KIM
Hyoungkun Park
Daegun Kim
Rob D. Everett
Matthew VALASKEY
Nathaniel T. HOLLINGSWORTH
Yiming WENG
Original Assignee
Kimberly-Clark Worldwide, Inc.
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 Kimberly-Clark Worldwide, Inc. filed Critical Kimberly-Clark Worldwide, Inc.
Priority to PCT/US2015/048249 priority Critical patent/WO2017039668A1/fr
Publication of WO2017039668A1 publication Critical patent/WO2017039668A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00387—Plasters use skin protection
    • A61F2013/00408—Plasters use skin protection shield for protection against hypodermic needles

Definitions

  • Pressure ulcer prevention articles and a method of use are described.
  • the pressure ulcer prevention article includes a skin adhesive layer disposed on the body facing surface and the skin adhesive layer covers between 60% and 95% of the cushioning layer area.
  • the cushioning layer is disposed between the bonding layer and the skin adhesive layer.
  • the pressure ulcer prevention article has a moisture vapor transmission rate ranging from 2,400 gm/m 2 *day to 10,000 gm/m 2 *day.
  • FIG. 1 representatively illustrates a pressure ulcer prevention article.
  • FIG. 2A representatively illustrates a bonding layer on an inner substrate surface of the pressure ulcer prevention article of FIG. 1 .
  • FIG. 2B representatively illustrates a cross section of the bonding layer and the substrate taken at line 2B-2B of FIG. 2A.
  • FIG. 4A representatively illustrates another aspect of a pressure ulcer prevention article.
  • FIG. 4B representatively illustrates a perspective view of the pressure ulcer prevention article shown in FIG. 4A.
  • compression refers herein to aligned forces pushing a first object in one direction and a second object in the opposite direction against the first object; for example such that the first object and the second object are being pushed against each other.
  • film refers herein to a thermoplastic film made using an extrusion and/or forming process, such as a cast film or blown film extrusion process.
  • the term includes apertured films, slit films, and other porous films which constitute liquid transfer films, as well as films which do not transfer fluids, such as, but not limited to, barrier films, filled films, breathable films, and oriented films. The term may even include liquid absorbent films.
  • shear refers herein to unaligned forces pushing a first object in one direction and a second object in the opposite direction against the first object; for example such that the first object and the second object are being slid against each other.
  • spunbonded fibers refers herein to small diameter fibers which are formed by extruding molten thermoplastic material as filaments from a plurality of fine, usually circular-capillaries of a spinneret with the diameter of the extruded filaments then being rapidly reduced to fibers as by, for example, in U.S. Patent No. 4,340,563 to Appel et al.; U.S. Patent No. 3,692,618 to Dorschner et al.;
  • thermoplastic refers herein to a material which softens and which can be shaped when exposed to heat and which substantially returns to a non-softened condition when cooled.
  • the present disclosure relates to a pressure ulcer prevention article 10 that controls skin moisture and mitigates pressure, friction, and shear forces on pressure-prone and shear-prone areas of the body as well as on existing pressure ulcers.
  • a pressure ulcer prevention article 10 that controls skin moisture and mitigates pressure, friction, and shear forces on pressure-prone and shear-prone areas of the body as well as on existing pressure ulcers.
  • a non-breathable covering is placed over a pressure-prone or shear-prone area, a micro-climate of the skin is created such that heat and moisture may by trapped near the skin thus exacerbating conditions for a pressure ulcer to form. It is essential that the pressure ulcer prevention article 10 is breathable to allow excessive moisture to move away from the skin.
  • the pressure ulcer prevention article 10 should have low friction on the outer surface to reduce shear forces when the pressure-prone or shear-prone area is moved against a surface such as for example, clothing, furniture, the seat of a wheelchair, or a bed sheet. Additionally, the pressure ulcer prevention article 10 reduces pressure by dissipating and absorbing shear and compression forces by cushioning the pressure-prone or shear-prone areas.
  • the pressure ulcer prevention article 10 includes a substrate 12, a bonding layer 18, a cushioning layer 22, and a skin adhesive layer 28.
  • the substrate 12 includes an inner substrate surface 14 and an opposite outer substrate surface 16.
  • the cushioning layer 22 includes a body facing surface 24 and an opposite substrate facing surface 26.
  • the bonding layer 18 is disposed between the inner substrate surface 14 of the substrate 12 and the substrate facing surface 26 of the cushioning layer 22 such that the substrate 12 and the cushioning layer 22 are attached to the bonding layer 18.
  • the skin adhesive layer 28 is disposed on the body facing surface 24 of the cushioning layer 22.
  • the skin adhesive layer 28 may be protected with a release paper or peel strip (not shown) as is known in the art.
  • the substrate 12 is intended to dissipate shear forces upon the skin and thus should have low friction.
  • the substrate 12 is breathable.
  • Suitable materials for the substrate 12 can include woven or nonwoven materials.
  • suitable woven materials may be surface treated to have low friction.
  • the cushioning layer 22 is intended to dissipate and absorb compressive and shear forces. Additionally, the cushioning layer is breathable and may also be hydrophobic. The breathable and hydrophobic properties of the cushioning layer 22 contribute towards controlling the micro-climate of the skin by allowing moisture to move away from the skin while not holding moisture near the skin.
  • Suitable materials for the cushioning layer 22 can include, although may not be limited to a variety of nonwoven materials such as fibrous nonwovens or foam.
  • a suitable fibrous, nonwoven material may be a corrugated material that remains flexible and soft while resisting compressive forces and is described in U.S. Published Application No. 2003/0022584 to Latimer et al., which is incorporated by reference in a manner that is consistent herewith.
  • Foams can be open or closed cell foams.
  • a suitable foam may be hydrophobic and have a thickness of less than about 10 mm, and more specifically from about 2 mm to 5 mm.
  • An exemplary open-celled, polyester foam is 100 PPI Natural Regicell and is available from Woodbridge FoamPartner Company, Chattanooga, TN, USA.
  • the substrate 12 and the cushioning layer 22 can be attached to one another using means known in the art such as adhesive, heat and/or pressure bonding, ultrasonic bonding and other suitable attachments. Referring to FIG. 1 , in one aspect, the substrate 12 and the cushioning layer 22 are attached to one another with a construction adhesive that is the bonding layer 18.
  • the skin adhesive layer 28 is applied to the cushioning layer 22 to allow for the pressure ulcer prevention article 10 to be adhered to the skin of the pressure-prone area.
  • any pressure sensitive adhesive known to those skilled in the art may be used as the skin adhesive layer 28, although preferably the pressure sensitive adhesive is not a known irritant to human skin and preferably the adhesive is not so aggressive that it causes pain to the wearer when the pressure ulcer prevention article 10 is removed from the skin and/or hair. It is also desirable that the skin adhesive layer 28 is selected such that the adhesive does not leave a substantial amount of an adhesive residue on the surface of the skin of the wearer when the pressure ulcer prevention article 10 is removed from the wearer after use. Particularly suitable pressure sensitive adhesive materials are disclosed in commonly assigned U.S. Pat. No.
  • Suitable application of the bonding layer 18 and of the skin adhesive layer 28 is critical for the pressure ulcer prevention article 10 to contribute towards controlling the micro-climate of the skin.
  • the bonding layer 18 and the skin adhesive layer 28 are advantageously applied in a pattern.
  • the patterning of the bonding layer 18 and skin adhesive layer 28 avoid occlusion of the breathable aspects of the substrate 12 and/or the cushioning layer 22.
  • the substrate 12 includes a width 32 and a length 30 defining a substrate area.
  • the bonding layer 18 may be disposed on the inner substrate surface 14 to cover less than 99% and more than 35%, and more specifically between 95% and 60% of the substrate area of the substrate 12.
  • the bonding layer 18 may be applied as, although not limited to, a non-uniform layer, such as a patterned layer, a sprayed pattern, or any of separate lines, stripes, swirls, or dots that may or may not be uniformly distributed on the inner substrate surface 14.
  • stripes may be curved or substantially straight, and/or deposited as intersecting or non-intersecting stripes, and swirls and/or dots may intersect. The illustrated embodiment in FIGS.
  • the bonding layer 18 disposed on the inner substrate surface 14 as an adhesive in a series of uniform dots that covers more than approximately 50% of the substrate area. It should be understood that while the illustrated embodiment shows the bonding layer 18 as being disposed on the inner substrate surface 14 of the substrate 12, the bonding layer 18 may also be disposed on the substrate facing surface 26 of cushioning layer 22 as another option of disposing the bonding layer 18 between the substrate 12 and the cushioning layer 22.
  • the cushioning layer 22 includes a width 32 and a length 30 defining a cushioning layer area.
  • the skin adhesive layer 28 may be disposed on the body facing surface 24 to cover less than 99% and more than 35%, and more specifically between 95% and 60% of the cushioning layer area of the cushioning layer 22.
  • the skin adhesive layer 28 may be applied in patterns as those previously described for the bonding layer 18.
  • FIGS. 3A and 3B show the skin adhesive layer 28 disposed on the body facing surface 24 of the cushioning layer 22 as a series of uniform, dome-shaped dots that covers approximately 50% of the cushioning layer area. It should be understood that the skin adhesive layer 28 is not limited to the dome-shaped dots as shown in FIGS. 3A and 3B and may include other patterns that provide the specified coverage area.
  • the bonding layer 18 pattern and the skin adhesive layer 28 pattern may be arranged where the patterns of each layer completely overlap, partially overlap or do not overlap.
  • a bonding layer 18 pattern may cover 95% of the substrate area and a skin adhesive layer 28 pattern may cover 5% of the cushioning layer area, such that: i) complete overlap of the patterns allows for 95% coverage of the substrate area and the cushioning layer area that is within the specified range of coverage of less than 99% and more than 35% and allows moisture from the skin to pass through the pressure ulcer prevention article 10, ii) partial overlap of the patterns may allow for between 96% to 99% coverage of the substrate area and the cushioning layer area that is within the specified range of coverage of less than 99% and more than 35% and allows moisture from the skin to pass through the pressure ulcer prevention article 10, and iii) no overlap of the patterns may allow for 100% coverage of the substrate area and the cushioning layer area that is outside of the specified range of coverage and does not allow moisture to pass through the pressure ulcer prevention article 10. It should be understood that various patterns of the bonding layer 18 and of
  • the pressure ulcer prevention article 10 may include a cushioning layer 22 that is of a smaller length 30 and a width 32 than the length 30 and the width 32 of the substrate 12.
  • the substrate 12 extends beyond the cushioning layer 22 forming a border 40.
  • the border 40 provides less bulk near the perimeter 50 of the pressure ulcer prevention article 10. The reduced bulk of the border 40 allows the substrate 12 to adhere closely to the wearer's skin such that the skin adhesive layer 28 on the border 40 has less propensity of lifting from the wearer's skin and ultimately prevents the pressure ulcer prevention article 10 from completely coming off of the wearer.
  • the dimensions and shape of the pressure ulcer prevention article 10 should be such that it is appropriately sized for its intended use. Generally, the size and shape of the pressure ulcer prevention article 10 is selected such that the pressure-prone area and some surrounding skin will be covered.
  • the shape of the pressure ulcer prevention article 10 could be symmetrical or asymmetrical. Shapes may include and are not limited to circles, ovals, squares, rectangles, or shapes that may accommodate a particular part of the body better than those previously listed, such as for example, hourglass-like or triangular-like.
  • the shape of the pressure ulcer prevention article 10 can generally be any operative shape, or combination of shapes that may especially be capable of adapting to the curvature of a wearer's body during use.
  • the pressure ulcer prevention article 10 may be different sizes to accommodate pressure- prone and shear-prone areas for people of different sizes and/or for use in different areas of the body. For example, a smaller sized pressure ulcer prevention article 10 could be for an elbow while a larger sized pressure ulcer prevention article 10 could be for the lower back.
  • the pressure ulcer prevention article 10 may be available in sheets that could be cut to size or in prepared sizes. For example, sheets may be 20.32 cm X 25.4 cm, 20.32 cm X 27.94 cm, 22.86 cm X 30.48 cm, or any size suitable for consumer user.
  • Prepared sizes may include 4.45 cm X 6.98 cm, 5.08 cm X 7.62 cm, 10.16 cm X 10.16 cm, or any other dimensions that provides an area of coverage suitable to the pressure prone area and the immediate surrounding skin.
  • the border 40 dimensions may vary based on the particular pressure ulcer prevention article 10 use.
  • the bonding layer 18 is a known construction adhesive such as Bostik Findley H2525A and is disposed between the inner substrate surface 14 of the polypropylene bonded carded material and the opposite substrate facing surface 26 of the foam, cushioning layer 22 such that the substrate 12 and the cushioning layer 22 are attached to the bonding layer 18.
  • the bonding layer 18 is disposed in a pattern that covers 60% of the substrate area.
  • the skin adhesive layer 28 is a DermaMed, medical grade, pressure-sensitive acrylic that is disposed on the body facing surface 24 of the foam, cushioning layer 22 in a pattern that covers 60% of the cushioning layer area.
  • the bonding layer 18 pattern and the skin adhesive layer 28 pattern are arranged in such a way that the total adhesive coverage is 60%.
  • the pressure ulcer prevention article 10 includes a border 40.
  • the pressure ulcer prevention article 10 codes include: 1 ) pressure ulcer prevention article 10 having a 30 gsm substrate 12 and 100% adhesive coverage (referred to as “High BW Full”), 2) pressure ulcer prevention article 10 having a 30 gsm substrate 12 and 60% adhesive coverage (referred to as “High BW Pattern” and is also the embodiment indicated as the exemplary aspect), 3) pressure ulcer prevention article 10 having a 17 gsm substrate 12 and 100% adhesive coverage (referred to as “Low BW Full”) and , 4) pressure ulcer prevention article 10 having a 17 gsm substrate 12 and 60% adhesive coverage (referred to as "Low BW Pattern").
  • the commercial codes include: 1 ) ALLEVYN (Life Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, available from Smith & Nephew Inc., Andover, MA, USA), 2) AQUACELL (Foam Dressing Sacral, available from ConvaTec Inc., Bridgewater, NJ, USA), 3) MEPILEX (Border Sacrum Self Adherent, available from Molnlycke Health Care, Norcross, GA, USA), and 4) SHEARBAN (sheets, available from Tamarack Habilitation Technologies, Blaine, MN, USA).
  • the exemplary pressure ulcer prevention article 10 (High BW Pattern) has MVTR values from about 8,600 g/m 2 /24 hrs to about 10,000 g/m 2 /24 hrs.
  • the ALLEVYN product has a MVTR from about 2,200 g/m 2 /24 hrs to about 2,600 g/m 2 /24 hrs.
  • the AQUACEL product has a MVTR from about 2,300 g/m 2 /24 hrs to about 2,400 g/m 2 /24 hrs.
  • the MEPILEX product has a MVTR of less than about 500 g/m 2 /24 hrs.
  • the SHEARBAN product has a MVTR of less than about 500 g/m 2 /24 hrs. Referring to FIG.
  • the exemplary pressure ulcer prevention article 10 (“High BW Pattern”) and the “Low BW Pattern” pressure ulcer prevention article 10 (MVTR ranging from about 4,000 g/m 2 /24 hrs to about 5,800 g/m 2 /24 hrs) provide a greater moisture vapor transmission rate than several current, commercial products such that some of the commercial pressure ulcer products provide little to no ability for moisture to transfer from the skin.
  • a low friction outer substrate surface 16 can aid in the prevention of pressure ulcers by reducing shear forces on the pressure-prone and shear-prone areas.
  • the coefficient of friction (COF) of the outer surface 16 of the was determined using a low thread count ( ⁇ 300), white cotton sheet, similar to those found in hospitals (available from Target Corporation, Minneapolis, MN, USA). Test samples for all codes were prepared from the center portion of each product where the thickness of the product was greatest.
  • the dynamic COF is indicative of a material being able to reduce shear forces against a pressure-prone or shear-prone area.
  • the term "dynamic COF” as used herein refers to the ratio of the force required to move one surface over another to the total force applied normal to those surfaces, once that motion is in progress.
  • the exemplary pressure ulcer prevention article 10 (High BW Pattern) has a dynamic COF ranging from about 0.356 to about 0.375.
  • the ALLEVYN product has a dynamic COF ranging from about 0.632 to about 0.815.
  • the AQUACEL product has a dynamic COF ranging from about 0.410 to about 0.498.
  • the MEPILEX product has a dynamic COF ranging from about 0.378 to about 0.469.
  • the SHEARBAN product has a dynamic COF of about 0.185 to about 0.190.
  • the exemplary pressure ulcer prevention article 10 (High BW Pattern) provides a lower dynamic COF than several of the current, commercial products. Lower dynamic COF values provide for less resistance against another surface than higher dynamic COF values. As such, dynamic COF values for the pressure ulcer prevention article 10 that range from about 0.1 to about 0.9, and more specifically from about 0.1 to about 0.6 can provide for reduced shear forces against pressure-prone and shear-prone areas.
  • the term "static COF” as used herein refers to the ratio of the force required to move one surface over another to the total force applied normal to those surfaces, at the instant motion starts.
  • the exemplary pressure ulcer prevention article 10 (High BW pattern) has a static COF ranging from about 0.791 to about 0.876.
  • the ALLEVYN product has a static COF ranging from about 0.714 to about 0.922.
  • the AQUACEL product has a static COF ranging from about 0.472 to about 0.553.
  • the MEPILEX product has a static COF ranging from about 0.439 to about 0.546.
  • the SHEARBAN product has a static COF of about 0.21 1 to about 0.219. Referring to FIG. 7, the MVTR and the dynamic COF values were charted for the pressure ulcer prevention article 10 codes and the commercial ALLEVYN, AQUACEL, MEPILEX, and
  • the exemplary pressure ulcer prevention article 10 (High BW Pattern) delivers a combination of MVTR and COF values that address the moisture and friction factors related to the formation of pressure ulcers at a level that is not seen with current commercial products.
  • unexpected technical effects of the pressure ulcer prevention article 10 having a fibrous nonwoven substrate 12 include delivering comparable or lower COF values and comparable or higher MVTR values than commercial products having film substrates.
  • the pressure ulcer prevention article 10 codes can be non-absorbent with a hydrophobic cushioning layer 22; whereas the commercial product codes are designed for wound management and are absorbent (except for SHEARBAN).
  • the pressure ulcer prevention article 10 can dissipate and absorb compressive and shear forces primarily through the cushioning layer 22.
  • the compressive properties of an article may include: LC: Compression Linearity - a measure of the resistance to compression force; higher LC indicates higher resistance to compression,
  • WC Compression Energy - a measure of the absorbed energy during compression force; higher WC indicates better absorption in compression energy
  • RC Compression Resilience - a measure of the degree of recovery after compression force deformation; higher RC indicates lower energy absorption and thus better recovery
  • EMC Compression Strain - an indication of the compressibility of the material; higher EMC indicates ease of compression.
  • the following codes were evaluated and are compared in Table 1 : A) pressure ulcer prevention article 10 - High BW Full, B) pressure ulcer prevention article 10 - High BW Pattern C) pressure ulcer prevention article 10 - Low BW Full, D) pressure ulcer prevention article 10 - Low BW Pattern, E) ALLEVYN, F) AQUACELL, G) MEPILEX, and H) SHEARBAN.
  • the four pressure ulcer prevention article 10 codes include higher values than several of the competitive products for most of these properties.
  • the exemplary pressure ulcer prevention article 10 (High BW Pattern, Code B) includes higher values for all properties, LC, WC, RC and EMC, than all competitive codes.
  • the exemplary pressure article prevention article 10 code B (High BW Pattern) has better resistance to compressive forces than commercial codes E, G and H due to significantly higher LC values (based on Tukey-Kramer HSD analysis).
  • the exemplary pressure article prevention article 10 code B (High BW Pattern) has better absorption in compression energy than commercial codes E - H due to the significantly higher WC values (based on Tukey-Kramer HSD analysis).
  • the exemplary pressure article prevention article 10 code B (High BW Pattern) has better ease of compression than commercial codes E - H due to the significantly higher EMC values (based on Tukey-Kramer HSD analysis).
  • One intended purpose of the pressure ulcer prevention article 10 is to prevent the formation of pressure ulcers.
  • the pressure ulcer prevention article 10 should be applied to clean, unbroken skin including skin that is not cracked, does not have an open wound, is not weeping or exuding fluid, is not blistered, is unblemished, or any other condition that is not of the aforementioned nature.
  • the unbroken skin may be cleansed with, for example, a mild soap and water, premoistened body wipes, and water-less cleansers.
  • Cleansers that do not compromise the unbroken condition of the wearer's skin are most suitable.
  • the skin should be dry before the application of the pressure ulcer prevention article 10 to the skin.
  • a cloth or paper towel may be used to dry the skin.
  • Air dryers or other forms of drying that also do not compromise the unbroken condition of the skin may also be suitable.
  • the pressure ulcer prevention article 10 can now be disposed onto the unbroken skin by adhering the skin adhesive layer 28 to the skin.
  • the pressure ulcer prevention article 10 can be adhered to the skin in such a way to provide the maximum benefits of breathability, cushioning and low friction during wearer movement; that is, the pressure ulcer prevention article 10 is most suitably applied to the skin without gaps between the skin and the pressure ulcer prevention article 10, and/or without folds or bunching of the pressure ulcer prevention article 10 when applied to the skin.
  • the pressure ulcer prevention article 10 may be worn for about 6 hours to about 7 days, and more typically from about 8 hours to about 12 hours.
  • the actual wear time of the pressure ulcer prevention article 10 may be based on such factors related to the individual person including the condition of the skin in the pressure-prone and shear-prone area, mobility of the person, position changes of the affected area and/or body part, and the person's weight.
  • pressure ulcer prevention articles 10 can be worn during the wear time for a given person. While the pressure ulcer prevention article 10 has been described for use in the prevention and treatment of pressure ulcers, it should be understood that the pressure ulcer prevention article 10 embodiments may be applicable in other situations. For example, the control of moisture, pressure, shear, and frictional forces against the skin may also be advantageous in the prevention of blisters and calluses.
  • Test methods were completed under the following conditions: 23 ⁇ 2°C (73.4 ⁇ 3.6°F) and 50 ⁇ 5% relative humidity.
  • Moisture Vapor Transmission Rate A suitable technique for determining the MVTR value of a film of the present disclosure is the test procedure standardized by INDA (Association of the Nonwoven Fabrick Industry), number IST- 70.4-99 which is incorporated by reference herein.
  • the testing device which may be used for MVTR measurement is known as the Permatran-W Model 101 K manufactured by Mocon/Modern Controls, Inc., Minneapolis, MN, USA.
  • the INDA test procedure is summarized as follows. A dry chamber is separated from a wet chamber of known temperature and humidity by a permanent guard film and the sample material to be tested. The purpose of the guard film is to define a definite air gap and to quiet or still the air in the air gap while the air gap is characterized.
  • the dry chamber, guard film, and the wet chamber make up a diffusion cell in which the test film is sealed.
  • a first test is made of the MVTR of the guard film and the air gap between an evaporator assembly that generates 100 percent relative humidity. Water vapor diffuses through the air gap and the guard film and then mixes with a dry gas flow that is proportional to water vapor concentration.
  • the electrical signal is routed to a computer for processing. The computer calculates the transmission rate of the air gap and the guard film and stores the value for further use.
  • the transmission rate (TR) of the guard film and air gap is stored in the computer as CalC.
  • the sample material is then sealed in the test cell. Again, water vapor diffuses through the air gap to the guard film and the test material and then mixes with a dry gas flow that sweeps the test material. Also, again, this mixture is carried to the vapor sensor.
  • the computer calculates the transmission rate of the combination of the air gap, the guard film, and the test material. This information is then used to calculate the transmission rate at which moisture is transmitted through the test material according to the equation: test material- test material.guardfilm.airgap- guardfilm.airgap
  • the moisture vapor transmission rate (“MVTR") is then calculated as follows:
  • RH the relative humidity at specified locations in the cell
  • test side was skin adhesive layer.
  • Table 2 includes MVTR Values (g/m 2 /24 hrs) for the pressure ulcer prevention article 10 and for commercial products.
  • Table 3 includes static load, static COF, average load, and dynamic COF values for the SAWABOND substrate 12 of the pressure ulcer prevention article 10.
  • Table 4 includes static load, static COF, average load, and dynamic COF values for the SHEARBAN product.
  • Table 5 includes static load, static COF, average load, and dynamic COF values for the ALLEVYN product.
  • Table 6 includes static load, static COF, average load, and dynamic COF values for the MEPILEX product.
  • Table 7 includes static load, static COF, average load, and dynamic COF values for the AQUACEL product.
  • the compression properties of the four pressure ulcer prevention article codes and the four commercial codes are presented in Tables 1 1 - 18.
  • the codes were tested using the Kawabata Evaluation System Compression Tester, also referred to as KES FB3 associated with the data acquisition program KES-FB System Ver. 7.09E/For Win98/2000/XP, available from Kato Tech Co., Ltd., Kyoto, JP.
  • KES FB3 Kawabata Evaluation System Compression Tester
  • KES-FB3 associated with the data acquisition program KES-FB System Ver. 7.09E/For Win98/2000/XP, available from Kato Tech Co., Ltd., Kyoto, JP.
  • the measurements were performed according to the Kawabata testing procedure, with at least 3 samples cut to 10 cm X 10 cm in the material form.
  • the product can be tested as it is without cutting.
  • the results were averaged. Care was taken to not to overly handle and/or deform the samples.
  • the test equipment was set up according to the instructions in the Kawabata manual
  • Stroke 5 mm or 50 mm (on machine & computer program)
  • Compression Rate 1 mm / 50 seconds at 5 mm stroke and 1 mm / 5 seconds at 50 mm stroke (on computer program)
  • Gears Red gear and Yellow gear; Red gear for 5 mm stroke and Yellow gear for 50 mm stroke depending on the thickness of sample (on machine); Red gear used only for SHEARBAN code.
  • Pressure Levels 0.5 gf/cm 2 and 50 gf/cm 2 are used to determine the thickness at To and TM respectively and subsequent calculations of LC, WC, RC and EMC

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Abstract

La présente invention concerne un article de prévention d'escarre de décubitus et un procédé impliquant l'article de prévention d'escarre de décubitus. L'article de prévention d'escarre de décubitus comprend un substrat, une couche de liaison, une couche d'amortissement, et une couche adhésive à la peau. Le substrat peut être un matériau cardé lié à du polypropylène et la couche d'amortissement peut être une mousse à alvéoles ouvertes. La surface externe du substrat peut présenter un coefficient de frottement dynamique compris entre environ 0,1 et environ 0,6. L'article de prévention d'escarre de décubitus peut présenter un taux de perméabilité à l'humidité compris entre environ 2 400 gm/m2*jour et environ 10 000 gm/m2*jour. L'article de prévention d'escarre de décubitus peut présenter une valeur d'énergie de compression d'environ 2 gfcm/cm2 à environ 5 gfcm/cm2.
PCT/US2015/048249 2015-09-03 2015-09-03 Dispositif de prévention d'escarre de décubitus WO2017039668A1 (fr)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020055329A1 (fr) * 2018-09-11 2020-03-19 Beta Medtech Pte. Ltd. Dispositif de prévention de plaies de pression
WO2020244924A1 (fr) 2019-06-04 2020-12-10 Carl Freudenberg Kg Timbre transdermique
WO2023166262A1 (fr) * 2022-03-03 2023-09-07 Urgo Recherche Innovation Et Developpement Pansement modulable

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050033211A1 (en) * 2003-08-08 2005-02-10 Samuel Scheinberg Friction reducing bandage
US8011041B2 (en) * 2007-09-19 2011-09-06 Persimmon Scientific, Inc. Devices for prevention of pressure ulcers
WO2011121394A1 (fr) * 2010-03-31 2011-10-06 Pharmaplast Sae Pansement pour soins des plaies, procédé et ligne de production pour la fabrication du pansement pour soins des plaies
US8093445B2 (en) * 2003-09-17 2012-01-10 Ossur Hf Wound dressing and method for manufacturing the same
WO2015020875A1 (fr) * 2013-08-05 2015-02-12 3M Innovative Properties Company Dispositif de support ayant un élément d'amortissement contenu

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050033211A1 (en) * 2003-08-08 2005-02-10 Samuel Scheinberg Friction reducing bandage
US8093445B2 (en) * 2003-09-17 2012-01-10 Ossur Hf Wound dressing and method for manufacturing the same
US8011041B2 (en) * 2007-09-19 2011-09-06 Persimmon Scientific, Inc. Devices for prevention of pressure ulcers
WO2011121394A1 (fr) * 2010-03-31 2011-10-06 Pharmaplast Sae Pansement pour soins des plaies, procédé et ligne de production pour la fabrication du pansement pour soins des plaies
WO2015020875A1 (fr) * 2013-08-05 2015-02-12 3M Innovative Properties Company Dispositif de support ayant un élément d'amortissement contenu

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020055329A1 (fr) * 2018-09-11 2020-03-19 Beta Medtech Pte. Ltd. Dispositif de prévention de plaies de pression
GB2591948A (en) * 2018-09-11 2021-08-11 Beta Medtech Pte Ltd Device for preventing pressure ulcers
GB2591948B (en) * 2018-09-11 2022-07-06 Beta Medtech Pte Ltd Device for preventing pressure ulcers
WO2020244924A1 (fr) 2019-06-04 2020-12-10 Carl Freudenberg Kg Timbre transdermique
WO2023166262A1 (fr) * 2022-03-03 2023-09-07 Urgo Recherche Innovation Et Developpement Pansement modulable
FR3133122A1 (fr) * 2022-03-03 2023-09-08 Urgo Recherche Innovation Et Developpement Pansement modulable

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