US20080134418A1 - Garments, Such As Gowns, Face Masks, Gloves And Headwear For Personnel Involved In Surgical Operations And The Use Of An Adhesive In Such Garments - Google Patents

Garments, Such As Gowns, Face Masks, Gloves And Headwear For Personnel Involved In Surgical Operations And The Use Of An Adhesive In Such Garments Download PDF

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Publication number
US20080134418A1
US20080134418A1 US11/794,954 US79495406A US2008134418A1 US 20080134418 A1 US20080134418 A1 US 20080134418A1 US 79495406 A US79495406 A US 79495406A US 2008134418 A1 US2008134418 A1 US 2008134418A1
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United States
Prior art keywords
adhesive
garment
skin
accordance
test
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Abandoned
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US11/794,954
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English (en)
Inventor
Helena Johansson
Fredrik Wallefors
Ann-Catherine Ericson
Karl Erikson
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Molnycke Health Care AB
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Molnycke Health Care AB
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Assigned to MOLNLYCKE HEALTH CARE AB reassignment MOLNLYCKE HEALTH CARE AB ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ERICSON, ANN-CATHERINE, JOHANSSON, HELENA, WALLEFORS, FREDRIK, ERIKSON, KARL
Publication of US20080134418A1 publication Critical patent/US20080134418A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A42—HEADWEAR
    • A42B—HATS; HEAD COVERINGS
    • A42B1/00—Hats; Caps; Hoods
    • A42B1/012—Sanitary or disposable, e.g. for use in hospitals or food industry
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A41D13/1161—Means for fastening to the user's head
    • A41D13/1169—Means for fastening to the user's head using adhesive
    • A41D13/1176—Means for fastening to the user's head using adhesive forming a complete seal at the edges of the mask
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/0002—Details of protective garments not provided for in groups A41D13/0007 - A41D13/1281
    • A41D13/0005—Joints
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A41D13/1161—Means for fastening to the user's head
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A41D13/1161—Means for fastening to the user's head
    • A41D13/1169—Means for fastening to the user's head using adhesive
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/12—Surgeons' or patients' gowns or dresses
    • A41D13/1209—Surgeons' gowns or dresses
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D19/00—Gloves
    • A41D19/0055—Plastic or rubber gloves
    • A41D19/0082—Details
    • A41D19/0089—Joints between glove and cuff or garment
    • A—HUMAN NECESSITIES
    • A42—HEADWEAR
    • A42B—HATS; HEAD COVERINGS
    • A42B7/00—Fastening means for head coverings; Elastic cords; Ladies' hat fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
    • A61B42/10—Surgical gloves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/58—Adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/20—Surgical drapes specially adapted for patients
    • A61B2046/205—Adhesive drapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/40—Drape material, e.g. laminates; Manufacture thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for

Definitions

  • the present invention relates to a garment of a disposable kind, such as gowns, face masks, gloves and headwear for health care personnel.
  • the garment may be sterile or non-sterile.
  • the personnel involved in surgical operations wear sterile garments.
  • the garment has two functions; on the one hand, it must prevent microorganisms from the surgical personnel from reaching the operation wound and, on the other hand, it must prevent the surgical personnel from becoming contaminated and possibly infected by the patient.
  • the risk of complications is present in every operation.
  • the majority of post-operative infections in surgical wounds occur during that period of the operation when it is possible for microorganisms to reach the open wound.
  • the source of microorganisms is either exogenous, that is to say from surgical personnel and instruments, or endogenous from the patient on whom the operation is being performed.
  • Parts of surgical garments are difficult to seal, however, for example around necklines and around the edge of surgical headwear. These areas are often in contact with and chafe against the skin, with the associated increased risk of skin particles becoming detached and then contaminating the patient's operation wound. A healthy person can shed thousands of skin particles, which carry bacteria on them, every minute when moving around.
  • the skin beneath the surgical gown, the face mask and the surgical headwear is heated up, and this makes it easier for air-borne particles to find their way up from the non-sterile area under through the gap between the garment and the skin and to constitute a potential risk of contamination of the operation wound.
  • One object of the present invention is to reduce the risk of fluid-borne or air-borne bacteria gaining entry via openings.
  • a further object is to prevent condensation on spectacles and to reduce the risk of mechanical wear of the garment.
  • Yet a further object of the invention is to bring about the reduction in this risk without impairing the convenience for the wearer of the garment.
  • the adhesive In order to achieve a secure barrier, the adhesive must adhered tightly to the skin, and the strength of the adhesive must be sufficiently high for the adhesive to withstand the movements that occur as a result of movements in the face or by the body.
  • Comfort is an important characteristic of surgical gowns, face masks and other garments intended for operating personnel. As it may be difficult to find the right positioning for the garment at the first attempt, it is an important characteristic for the garment to be capable of being reapplied without losing its adhesive strength. If the level of adhesion of the adhesive is significantly lower in the event of reapplication, there is a considerable risk of the barrier function being impaired.
  • the object of the present invention is to solve these problems and to make available a surgical garment which adheres securely around openings, provides a secure barrier, is removable without the risk of damage being caused to the skin, is capable of reattachment to the skin without the risk of the adhesive strength of the adhesive having reduced excessively, and offers increased comfort to the wearer.
  • a garment such as gowns, face masks, gloves and headwear, for personnel involved in surgical operations, characterized by a skin friendly adhesive for the sealing attachment of parts of the garment to the skin of a person wearing the garment.
  • a skin friendly adhesive for the sealing attachment of parts of the garment to the skin of a person wearing the garment.
  • the part of the garment provided with adhesive is leakproof in accordance with the MHC Leakage Test with a groove depth of 50 micrometres, 75 micrometres, 150 micrometres and 200 micrometres.
  • the adhesive also has a weight per unit area of 50 g/m 2 or more and a softness greater than 10 mm. In a preferred variant, the adhesive has a weight per unit area of 80 g/m 2 or more and a softness greater than 10 mm. The adhesive can have a weight per unit area of 200 g/m 2 or more and a softness greater than 10 mm. The adhesive can with advantage have a softness greater than 12 mm, and preferably greater than 14 mm.
  • the adhesive preferably consists of a hot-melt adhesive or a silicon elastomer.
  • the strength of the attachment of the adhesive to the skin is greater than 0.5 N/25 mm, preferably greater than 1.0 N/25 mm, and more preferably greater than 1.5 N/25 mm, and in the case of reapplication to the skin, the adhesive strength of the adhesive is reduced by less than 40%, preferably by less than 30%, and best of all by less than 15%.
  • damage to the Stratum Corneum following the removal of a garment attached to the skin is less than 40%, preferably less than 30%, preferably less than 20%, and more preferably less than 10%, on that part of the skin that was covered by the adhesive.
  • the invention also relates to the use of a skin friendly adhesive for the removable and re-attachable attachment of a face mask to a wearer.
  • a skin friendly adhesive for the removable and re-attachable attachment of a face mask to a wearer.
  • the risk of air-borne bacteria being able to exit from or enter the area inside the face mask is radically reduced.
  • the elastic bands that are used to attach the face mask around the ears of a wearer are superfluous in conjunction with the use of such an adhesive, which increases the convenience for the wearer.
  • the formable elements of the face mask, which are used to fit the face mask to the shape of the nose of a wearer can also be replaced by a skin friendly adhesive, which further increases the convenience for the wearer.
  • the invention also relates to the use of a skin friendly adhesive for the attachment of an item of surgical headwear to a wearer in a manner that is sealed to the skin and re-attachable, the use of a skin friendly adhesive for the attachment of the neckline and/or the ends of the sleeves of a surgical gown to the skin of a wearer in a manner that is tightly sealing and re-closable, and the use of a skin friendly adhesive for the attachment of a part of a surgical glove, which extends around the forearm of a wearer, to the skin of the wearer in a manner that is tightly sealing and re-closable.
  • FIG. 1 illustrates schematically a surgical gown in accordance with a first preferred embodiment of the invention
  • FIG. 2 illustrates schematically a face mask in accordance with a second preferred embodiment of the invention
  • FIG. 3 illustrates schematically the measurement of the strength of the adhesive attachment to the skin
  • FIG. 4 illustrates a cone used for the measurement of the softness
  • FIG. 5 illustrates a method of measurement for measuring the softness
  • FIGS. 6-12 illustrate the MHC Leakage Test
  • FIG. 13 shows a graph indicating the relationship between the weight per unit area and the softness in order to obtain sealing in accordance with the MHC Leakage Test
  • FIGS. 14-16 show the MHC Leakage Test performed on known products and on a product in accordance with the invention for different groove depths.
  • the surgical gown 1 illustrated schematically in FIG. 1 is constructed in a conventional manner and differs from conventional surgical gowns only in the respect that it is coated on the inside with a skin friendly adhesive in the areas 2 , 3 and 4 .
  • the area 2 in this case extends around at least the front part of the neckline of the gown, and the areas 3 and 4 extend around the ends of the sleeves of the gown.
  • the adhesive coatings seal the openings leading in to the wearer's body constituted by the sleeves and the neckline.
  • FIG. 2 Illustrated schematically in FIG. 2 is a face mask 5 in a plan view with its outside facing towards the observer.
  • the face mask comprises in a conventional fashion a number of folds 6 , which are sealed at the outer edges of the face mask.
  • the fold 6 can be folded out in a manner resembling a bellows, so that the face mask assumes a three-dimensional, triangular form.
  • the face mask also comprises a peripheral coating 7 of a skin friendly adhesive.
  • a skin friendly adhesive for the purpose of attaching the face mask makes it possible to dispense with the elastic bands that are fitted to face masks for attachment around the ears in order to support the face mask by that means.
  • Metal wires or the like are no longer required, moreover, in order to form the upper part of the mask to the shape of the root of the nose, and this is now effected with the help of that part of the peripheral adhesive coating that extends transversely over and past the root of the nose of a wearer.
  • a face mask in accordance with the invention makes closer contact with the wearer's skin than is the case with currently available face masks, and it functions more effectively as a result.
  • a further, not insignificant advantage is that a face mask in accordance with the invention is more comfortable to wear than currently available face masks.
  • the whole of the upper edge of the face mask will be caused to seal against the wearer's skin by the agency of the adhesive, which prevents exhaled air from being able to flow upwards and cause condensation to form on the spectacles of a wearer.
  • the adhesive attached to the skin counteracts friction and reduces the risk of skin particles becoming detached and contaminating the patient's operation wound. A healthy person can shed thousands of skin particles, which carry bacteria on them, every minute when moving around.
  • the adhesive in the coating must, as previously mentioned, be skin friendly and in addition must permit the removal of the garment without causing damage to the skin around the attachment area.
  • These requirements mean that those types of pressure-sensitive adhesives that are customarily used as adhesive coatings for surgical drapes and wound care products cannot be used.
  • Such adhesives often attach themselves to the skin so strongly that parts of the Stratum Corneum, that is to say the uppermost layer of the skin, become stuck to the adhesive and are pulled away from the skin when the attachment of the product is released. Certain of these adhesives are attached so strongly that even hairs are pulled out when the attachment is released.
  • the adhesive coating intended for sealing can exhibit different appearances and can consist of solid or broken lines, points or patterns of various kinds. It can also be executed as an unbroken strip.
  • the angle of removal that is to say the obtuse angle that is formed between the surface of the skin and the removed part of the strip A, must be 135°.
  • the force of adhesion to the skin of the measured adhesive comprises the mean value of the force F 1 .
  • Adhesives suitable for use in products in accordance with the invention must exhibit an adhesive strength of at least 0.5 N/25 mm.
  • the damage to the Stratum Corneum after the removal of a draping product attached to the skin shall, when measured by means of the SCT (Spectroscopic Colour Test), be less than 30%, preferably less than 20%, and more preferably less than 10%, on that part of the skin that was covered by the adhesive.
  • the SCT measurement shall be performed by the method described in detail in P. J. Dykes, R. Heggie, S. A. Hill, “Effects of adhesive dressings on the stratum corneum of the skin”, Journal of Wound Care, February, Vol. 10, No. 2, 2001, to which reference is made for more detailed information.
  • the SCT measurement must be performed on at least ten persons of different sexes and with healthy skin, and must proceed by the following method.
  • the skin at the centre of the test area is first stained by the application of a 12 mm Finn chamber of aluminium containing an 11 mm filter paper disc moistened with 0.03 ml of a 1% aqueous solution of methylene blue.
  • the Finn chamber is held against the skin for 60 minutes.
  • test strips are then applied to the stained areas of the skin on the test individuals and are left in place for 72 hours. Once the test strips have been removed after 72 hours, the stratum corneum is removed by means of the “skin surface biopsy procedure”, as described in R. Marks, R. P. R. Dawber, “Skin surface biopsy: an improved technique for the examination of the horny layer”, Br J Dermatol 1971: 84:117-123, and to which reference is made for more detailed information.
  • the biopsies are then cut into quite small pieces and placed in glass test tubes containing 2 ml of dimethylsulfoxide (DMSO).
  • DMSO dimethylsulfoxide
  • the glass test tubes are then shaken every 10-15 minutes during a period of 2 hours in order to ensure that the colour extraction is complete.
  • the dimethylsulfoxide extract is then centrifuged at 1000 g for 10 minutes in order to remove all fragments of the stratum corneum.
  • One millilitre of the dimethylsulfoxide is then transferred to a plastic vessel for measurement of the optical density.
  • the optical density is measured with a spectrophotometer.
  • a reference vessel containing dimethylsulfoxide is first scanned within the range 550-800 nm.
  • An extracted skin biopsy from a stained area of the skin is then scanned to determine the maximum absorption. All subsequent measurements are performed at the wavelength for maximum absorption.
  • the results are indicated as units of optical density and are stated as a percentage of damaged Stratum Corneum compared with a reference sample of adjacent undamaged Stratum Corneum.
  • Table 1 below illustrates the damage caused to the Stratum Corneum by the removal of adhesive from the skin, measured by the above-mentioned spectroscopic staining method (SCT) for a number of different, previously disclosed products provided with adhesive: Allevyn from Smith & Nephew, Hull, Great Britain; Tielle hydropolymer dressing from Johnson & Johnson, Gargrave, Great Britain; Duoderm Extra Thin from ConvaTec Ltd., Deeside, Great Britain; Mepilex Border from Mölnlycke Health Care AB, Gothenburg, Sweden, and Biatain from Coloplast, Humleb ⁇ k, Denmark.
  • SCT spectroscopic staining method
  • Mepilex Border which consists of a silicon adhesive, Silgel 612 elastomer from Wacker Chemie GmbH, Germany, meets the requirements stipulated above.
  • the negative value of the skin damage measured by the SCT test method on skin with Mepilex Border adhesive is probably an effect of the distribution of the measurement data, although it may also relate to the fact that the adhesive acts as a means of protection against the natural abrasion of skin cells compared with the reference sample that is only covered by gauze during the measurement period.
  • strips of an adhesive which possesses an adhesive strength of 0.5 N/25 mm and, when measured by means of the SCT (Spectroscopic Colour Test), reveals a level of damage to the Stratum Corneum, after removal of a draping product attached to the skin, of less than 10% on that part of the skin that was covered by the adhesive, can also be applied to sensitive skin and removed therefrom without causing damage or irritation to the skin.
  • Measurement of the strength of adhesion to the skin with re-application is performed by the following method. Test strips are applied to the back of ten persons of varying ages and sexes with healthy skin. After two minutes, the strips are pulled off in the same way as described above with reference to FIG. 3 at a rate of 25 mm/sec, and the removal force Ffirst is measured. The angle of removal must be 135°. The strip is then applied to the skin once more in an untouched area on the back, and measurement of the removal force is repeated after two minutes, in conjunction with which the removal force Fsecond is obtained.
  • the reduction in the removal force in conjunction with the second and the first removals must be less than 40%, preferably less than 30%, and more preferably less than 20%, and the removal force Fsecond in conjunction with the second removal must exceed 0.5 N/25 mm, preferably 1.0 N/25 mm, and more preferably 1.2 N/25 mm.
  • Silgel 612 is able to function excellently as an adhesive for a product in accordance with the invention.
  • the strength of the adhesive attachment to the skin of the adhesive coating is with advantage greater than 1.0 N/25 mm, and preferably greater than 1.2 N/25 mm.
  • Adhesives that are suitable for use in accordance with the present invention must exhibit a softness that exceeds 10 mm measured by means of a method based on ASTM D 937 and ASTM D 51580. Certain deviations, as can be appreciated below, have been made.
  • FIGS. 4 and 5 illustrate this modified method of measuring the softness of an adhesive by causing a cone B with a weight of 62.5 g to penetrate downwards by the effect of gravity into a 30 mm thick test piece C of the adhesive of which the softness is to be determined.
  • the test piece is produced by filling a cylindrical glass container having an internal diameter of 60 mm, and an internal height of 35-40 mm, with adhesive to a depth of 30 mm.
  • the cone used is illustrated in FIG.
  • the cone B is first lowered down into a position I, which is illustrated with broken lines in FIG. 5 , and in which the tip of the cone just touches the surface of the test piece C. The cone B is then released, so that it is able to penetrate downwards into the test piece C by the effect of gravity. The number of millimetres by which the tip B of the cone C has penetrated into the test piece C after 5 seconds is measured and constitutes the penetration value P, the value of which is greater in proportion to the softness of the test piece.
  • the penetration value P represents the softness index used in the present invention.
  • a PNR 10 penetrometer supplied by Sommer & Runge KG, Germany, is used in the performance of the method.
  • the method described below with reference to FIGS. 6-12 was developed by the applicants for the purpose of determining whether or not a coating of a soft, skin friendly adhesive is leakproof.
  • a coloured test fluid is prepared by mixing 0.2% by weight of Patentbl ⁇ tt V (from VWR International, Sweden) and 0.1% by weight of Teepol Gold (from Teepol Products, UK) with de-ionized water.
  • An aluminium test plate having dimensions of 15 ⁇ 50 ⁇ 50 mm and provided with 15 milled grooves is made; see FIG.
  • FIG. 8 section through the plate, viewed from the side. Illustrated in FIG. 8 are grooves with a depth of 75 micrometres, although other groove depths can be used in the test depending on what depth of cracks or folds in the skin the product is intended to seal.
  • a specimen is then carefully positioned centrally above the grooves of the test plate in such a way that no air bubbles are produced between the test plate and the specimen; see FIG. 9 .
  • No pressure may be exerted on the sample when it is positioned against the plate, so that, in the event that air bubbles are produced, these must not be forced away with the help of the fingers, but the sample must be raised and repositioned, or scrapped.
  • a piece of polyurethane foam (L00562-6, 1.6 mm from Rynel, Inc., Boothbay, Me., USA) having dimensions of 50 ⁇ 50 mm is then placed above the sample and the test plate.
  • the piece of foam is removed from the sample, and 65 ⁇ l of the test fluid are placed in the hole on the specimen with the help of a pipette.
  • the test fluid is distributed uniformly in the hole with the help of the tip of the pipette, so that the fluid reaches every point on the edge of the sample.
  • a stop watch is started as soon as all the test fluid is uniformly distributed in the hole. After 30 minutes, a picture is taken with a digital camera of the specimen and the test fluid placed on the test plate together with a calibrated ruler.
  • the photograph is used to measure the following distances. For all the grooves that are in contact with the hole on the sample, that is to say in all the grooves into which fluid may be expected to penetrate, the distance d from the edge next to the hole to the edge on the end of the sample is measured, see FIG. 11 , which indicates this distance d 1 for one of the grooves. All these distances d are then added together, and they constitute the total distance for which it is possible for the sample to leak. After this, the distance e for which the test fluid has leaked in all the grooves on the plate is measured; see FIG. 12 , which shows the distance e 1 for one of the grooves. The combined length of all the distances e represents the total leakage distance.
  • the leakage is obtained by dividing the combined leakage distance by the total distance for which it is possible for the sample to leak. This quotient is then converted into a percentage by multiplying it by 100.
  • the evaluation of the sealing is performed as follows: Result >10% leakage, regarded as leakage. Result ⁇ 10% leakage, regarded as sealing.
  • the plate between each measurement on the test plate, the plate must be cleaned in the following way.
  • the plate is first rinsed with water, and it is then washed with n-heptane. It is important to ensure that no adhesive residues remain in the grooves on the plate, and a soft material of the nonwoven compress type (Mesoft, Mölnlycke Health Care) can be dipped in n-heptane and used to rub away adhesive residues in the grooves on the plate. Finally, the plate must be left to dry in the air before it can be reused.
  • solvents may be used for adhesives that are not soluble in n-heptane.
  • a transparent plastic film is coated with the adhesive which the product contains, after which specimens with an area of 30 ⁇ 30 mm are punched from this material.
  • the abovementioned plastic film must be selected so that its bending length corresponds to the bending length of the carrier in the non-transparent product that is to be tested measured in accordance with the “Determination of bending length” method, ISO 9073-7:1995.
  • the MHC Leakage Test is then performed, as described above.
  • the MHC Leakage Test with a groove depth of 75 micrometres was performed on a polyurethane film with a thickness of 25+/ ⁇ 5 micrometres, which was coated with a Silgel 612 silicon elastomer supplied by Wacker Chemie GmbH, Germany, with different softness values and weights per unit area. The results are shown in FIG. 13 .
  • the carrier is an important part of the product, and this, too, has a major effect on the degree of sealing, especially in the case of low weights per unit area for the adhesive coating.
  • a rigid carrier thus requires a higher weight per unit area for the adhesive coating than a less rigid carrier in order to produce sealing.
  • Shearing forces which act on the self-adhesive attachment can also give rise to a separation between the different layers of skin. This results in the formation of a blister, that is to say a well-defined accumulation of serous fluid.
  • the blisters occur along the self-adhesive attachment and are usually located at different depths in the epidermis or at the boundary between the epidermis and the dermis.
  • the shearing forces which act on the attachment can arise, on the one hand, from external loading, but also as a result of a swelling occurring during the operation.
  • FIGS. 14-16 illustrate different products tested by means of the MHC
  • Leakage Test with groove depths of 50, 75 and 150 micrometres respectively and illustrate the leakage after 1 minute, 5 minutes and 30 minutes.
  • the tested products were 3MTM Hi-Tack Double Coated Medical Tape, Product Number 1517 supplied by 3M, USA; MED 6370U, Avery DennisonTM, Acrylic Adhesive supplied by Avery Dennison, USA; Barner Flex supplied by Neschen AG, Germany; MED 6370U Avery DennisonTM, Wetstick Adhesive supplied by Avery Dennison, USA; Foliodrape®, Hartmann, Transparent OP-tape, No. 258 542, LOT 348 01705, Exp. Date 2008 December supplied by Hartmann, Germany, and DISPOMELT 70-4647, 200 gsm ⁇ 20 gsm supplied by National Starch & Chemical, USA, PE-carrier (15 ⁇ m).
  • the products proposed in the present invention are often supplied packed in sterile conditions, which means that the adhesives used must be capable of being sterilized, as must other components of such articles, of course.
  • a skin friendly adhesive coating can naturally also be used to attach types of garments other than gowns and face masks for personnel involved in surgical operations to the skin of the wearer.
  • Examples of other applications are headwear and gloves.
  • the coating is applied to the inside in that part of the glove that extends above the wrist around the forearm of the wearer.
  • the primary function of the adhesive coating is to prevent that part of the glove that extends above the hand from slipping down from the forearm.
  • Face masks are also used by persons other than the personnel involved in surgical operations, for example by dentists, where sterility is not a requirement. Under such conditions, tightness against leakage is not as important, and skin friendliness and resealability are the critical factors for the functionality of the face mask.
  • Skin friendly adhesive coating can also be used for the attachment of a visor or protective goggles.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Textile Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Food Science & Technology (AREA)
  • Professional, Industrial, Or Sporting Protective Garments (AREA)
  • Gloves (AREA)
  • Devices For Medical Bathing And Washing (AREA)
US11/794,954 2005-01-11 2006-01-09 Garments, Such As Gowns, Face Masks, Gloves And Headwear For Personnel Involved In Surgical Operations And The Use Of An Adhesive In Such Garments Abandoned US20080134418A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE0500060-9 2005-01-11
SE0500060A SE0500060L (sv) 2005-01-11 2005-01-11 Klädsel, såsom rockar, munskydd, handskar och mössor, för personal vid kirurgiska operationer
PCT/SE2006/000022 WO2006075947A1 (en) 2005-01-11 2006-01-09 Garments, such as gowns, face masks, gloves and headwear for personnel involved in surgical operations and the use of an adhesive in such garments

Publications (1)

Publication Number Publication Date
US20080134418A1 true US20080134418A1 (en) 2008-06-12

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US11/794,954 Abandoned US20080134418A1 (en) 2005-01-11 2006-01-09 Garments, Such As Gowns, Face Masks, Gloves And Headwear For Personnel Involved In Surgical Operations And The Use Of An Adhesive In Such Garments

Country Status (14)

Country Link
US (1) US20080134418A1 (sv)
EP (1) EP1835822B1 (sv)
JP (1) JP5001175B2 (sv)
CN (1) CN101102687B (sv)
AT (1) ATE514347T1 (sv)
AU (1) AU2006205239B2 (sv)
BR (1) BRPI0606665A2 (sv)
CA (1) CA2594401A1 (sv)
ES (1) ES2366956T3 (sv)
MX (1) MX2007008390A (sv)
PL (1) PL1835822T3 (sv)
RU (1) RU2007126320A (sv)
SE (1) SE0500060L (sv)
WO (1) WO2006075947A1 (sv)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2470272A1 (en) * 2009-09-11 2012-07-04 Ronald D. Matich Face mask with seal within seal and optional bridging seal
WO2014023588A1 (en) 2012-08-07 2014-02-13 Sca Hygiene Products Ab Disposable absorbent product with temporary adhesive attachment and related methods
USD736883S1 (en) * 2011-09-28 2015-08-18 Swimways Corporation Swimming assistance shirt with inflatable sleeve
US9464213B2 (en) 2014-12-30 2016-10-11 Jamal Taha Surgical glove tape
US10004282B2 (en) 2014-12-30 2018-06-26 Jamal Taha Surgical glove tape

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US5514435A (en) * 1993-03-10 1996-05-07 New Oji Paper Co., Ltd. Adhesive sheet

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US6177482B1 (en) * 1996-12-23 2001-01-23 The Proctor & Gamble Company Adhesive for secure topical attachment to the skin and comfortable removal
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JP2002249917A (ja) * 2001-02-23 2002-09-06 Ishii Hirokazu 人毛等の着衣外部への放出防止装置及び方法
US7017577B2 (en) * 2002-01-18 2006-03-28 Matich Ronald D Face mask with seal and neutralizer
SE0200886L (sv) * 2002-03-22 2003-09-23 Moelnlycke Health Care Ab Uppdukningsprodukt med adhesiv kant för kirurgiska ingrepp
JP2003319967A (ja) * 2002-05-02 2003-11-11 Daio Paper Corp 貼付シートまたはテープ
US6945249B2 (en) 2002-09-24 2005-09-20 Kimberly-Clark Worldwide, Inc. Easy gripping face mask
US6767632B2 (en) * 2002-09-27 2004-07-27 Axelgaard Manufacturing Company, Ltd. Dermal fastener

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US4621029A (en) * 1984-01-17 1986-11-04 Fuji Systems Corporation Medical sealant for skin
US5514435A (en) * 1993-03-10 1996-05-07 New Oji Paper Co., Ltd. Adhesive sheet

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2470272A1 (en) * 2009-09-11 2012-07-04 Ronald D. Matich Face mask with seal within seal and optional bridging seal
EP2470272A4 (en) * 2009-09-11 2014-12-24 Breathe Safely Llc GASKET FACIAL MASK INSIDE SEALS AND OPTIONAL JOINT JOINT
US10674776B2 (en) 2009-09-11 2020-06-09 Breathe Safely, Inc. Face mask with seal within seal and optional bridging seal
USD736883S1 (en) * 2011-09-28 2015-08-18 Swimways Corporation Swimming assistance shirt with inflatable sleeve
WO2014023588A1 (en) 2012-08-07 2014-02-13 Sca Hygiene Products Ab Disposable absorbent product with temporary adhesive attachment and related methods
US8870843B2 (en) 2012-08-07 2014-10-28 Sca Hygiene Products Ab Disposable absorbent product with temporary adhesive attachment and related methods
US9464213B2 (en) 2014-12-30 2016-10-11 Jamal Taha Surgical glove tape
US10004282B2 (en) 2014-12-30 2018-06-26 Jamal Taha Surgical glove tape

Also Published As

Publication number Publication date
PL1835822T3 (pl) 2011-11-30
ATE514347T1 (de) 2011-07-15
AU2006205239B2 (en) 2011-03-24
MX2007008390A (es) 2007-09-06
JP5001175B2 (ja) 2012-08-15
SE0500060L (sv) 2006-07-12
WO2006075947A1 (en) 2006-07-20
JP2008527189A (ja) 2008-07-24
EP1835822A1 (en) 2007-09-26
BRPI0606665A2 (pt) 2009-07-07
RU2007126320A (ru) 2009-01-20
AU2006205239A1 (en) 2006-07-20
CN101102687B (zh) 2011-04-13
CA2594401A1 (en) 2006-07-20
CN101102687A (zh) 2008-01-09
SE0500060D0 (sv) 2005-01-11
ES2366956T3 (es) 2011-10-27
EP1835822B1 (en) 2011-06-29
EP1835822A4 (en) 2010-05-05

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STCB Information on status: application discontinuation

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