GB2080197A - Surgical drape fabric - Google Patents

Surgical drape fabric Download PDF

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Publication number
GB2080197A
GB2080197A GB8119924A GB8119924A GB2080197A GB 2080197 A GB2080197 A GB 2080197A GB 8119924 A GB8119924 A GB 8119924A GB 8119924 A GB8119924 A GB 8119924A GB 2080197 A GB2080197 A GB 2080197A
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United Kingdom
Prior art keywords
drape
fabric
pressure sensitive
sensitive adhesive
layer
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.)
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Application number
GB8119924A
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Smith and Nephew PLC
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Smith and Nephew Associated Companies PLC
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Filing date
Publication date
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Publication of GB2080197A publication Critical patent/GB2080197A/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/58Adhesives
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/22Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00Surgical drapes
    • A61B46/40Drape material, e.g. laminates; Manufacture thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B29/00Layered products comprising a layer of paper or cardboard
    • B32B29/02Layered products comprising a layer of paper or cardboard next to a fibrous or filamentary layer
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B29/00Layered products comprising a layer of paper or cardboard
    • B32B29/06Layered products comprising a layer of paper or cardboard specially treated, e.g. surfaced, parchmentised
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form
    • B32B3/26Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/02Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by structural features of a fibrous or filamentary layer
    • B32B5/022Non-woven fabric
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/18Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by features of a layer of foamed material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/22Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed
    • B32B5/24Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/22Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed
    • B32B5/24Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer
    • B32B5/245Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer another layer next to it being a foam layer
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/22Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed
    • B32B5/24Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer
    • B32B5/26Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer another layer next to it also being fibrous or filamentary
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04Interconnection of layers
    • B32B7/12Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2305/00Condition, form or state of the layers or laminate
    • B32B2305/02Cellular or porous
    • B32B2305/026Porous
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/70Other properties
    • B32B2307/714Inert, i.e. inert to chemical degradation, corrosion
    • B32B2307/7145Rot proof, resistant to bacteria, mildew, mould, fungi
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/70Other properties
    • B32B2307/724Permeability to gases, adsorption
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/70Other properties
    • B32B2307/726Permeability to liquids, absorption
    • B32B2307/7265Non-permeable
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00Medical equipment, e.g. bandage, prostheses, catheter

Abstract

A moisture vapour transmitting, water impermeable drape fabric which comprises an absorbent layer and a porous layer bonded together by a pressure sensitive adhesive which prevents the passage of bacteria between the two layers and methods for the production thereof and sterile surgical drapes and gowns made therefrom are described.

Description

1
GB2 080197A
1
SPECIFICATION
Surgical drape fabric and drapes
5 The present invention relates to absorbent surgical drapes and methods of their manufacture and to the fabric therefor.
Absorbent surgical drapes are used inter alia around operation sites where their func-10 tion is to form a barrier between the site and the surrounding skin areas to aid in preventing infection. The upper layer of the drape should be capable of absorbing fluids such as blood and the lower layer of the drape should 15 be capable of transmitting fluids such as perspiration. The central layer of the drape prevents communication of the two layers.
It is known from British Patent Specification No. 1061054 to form surgical drapes with 20 two absorbent layers laminated to a central layer of a polyethylene film. Unfortunately drapes using a polyethylene barrier prevent evaporation of perspiration and can cause a clammy feeling.
25 It is known from British Patent Specification No. 1341605 to form surgical drapes and gowns in which two absorbent layers are bonded to a central layer of a water vapour permeable film or sheet substrate which may 30 be made of non-adhesive material.
A surgical drape fabric has now been discovered that has good moisture vapour transmission rates while avoiding the use of an independent central film or sheet which could 35 reduce the flexibility of the fabric.
The present invention provides a moisture vapour transmitting, water impermeable drape fabric which comprises an absorbent layer, and a porous layer bonded together by a 40 pressure sensitive adhesive which prevents the passage of bacteria between the two layers.
When used herein the term 'porous layer' means a layer having pores or openings which 45 allow the transmission of moisture vapour through the layer.
The moisture vapour transmission rate of the drape of this invention is suitably not less than 200g/m2, more suitably not less than 50 250g/m2 and preferably bot less than
500g/m2/24hrs at 37°C at 100%-10% relative humidity difference.
The moisture vapour transmission rate may be measured by the Payne Cup method. The 55 method uses a cup 1.5 cm deep with a flanged top. The inner diameter of the flange is such as to provide an area for moisture vapour transmission of 10cm2. In this method 10ml. of distilled water is added to the cup 60 and a sample of the material under test, large enough to completely cover the flange, is clamped over the cup. The complete assembly is then weighed and placed in a cabinet where the temperature and relative humidity 65 are maintained at 37°C and 10% respe-
crtively. After 1 7 hours, the cup is removed from the cabinet and allowed to cool at room temperature. After re-weighing, the mass of water lost by vapour transmission is calculated 70 and the result expressed as g/m224hr. at 37°C, 100%-10% relative humidity difference.
In use the two external layers of surgical drape material can perform different func-75 tions. The outer layer should be capable of absorbing water and aqueous body fluids such as blood. The rate of absorption of this layer should be rapid enough to prevent liquids running off the surface of the surgical drape 80 fabric and thus contaminating other surfaces. It is advantageous that the outer absorbent layer should also have the ability to absorb other liquids such as isopropyl alcohol used at or around the operation site during certain 85 surgical procedures. It is also desirable that the outer absorbent layer should not shed particles or fibres and should have a "non-pilling" surface in the presence of moisture.
The inner layer which in use is adjacent to 90 the patients skin should be capable of transmitting perspiration in either liquid or vapour form, produced during the period of the operation, thereby reducing the "clammy" feeling caused by the build-up of moisture and heat 95 under the drape.
Suitable porous layers include non-woven fabrics, foams and porous or microporous films. The porous layer can be absorbent or non absorbent. Normally and preferably it is 100 absorbent.
In a favoured aspect the present invention provides a moisture vapour transmittingm water impermeable drape fabric which comprises of two absorbent layers bonded together by a 105 pressure sensitive adhesive which prevents the passage of bacteria between the absorbent layers.
It is preferred that in this form of the invention the inner absorbent layer should 110 have similar properties to that of the outer layer, although the absorbent capacity of the inner layer may be lower if desired.
In one preferred construction of the surgical drape fabric the two absorbent layers are 115 made of the same material.
In another preferred construction the absorbent layers are different. The two absorbent layers may have different chemical composition, physical construction or different weights 120 or thicknesses.
Suitable materials for the absorbent layers include nori-woven fabrics, foams and treated papers.
Especially suitable materials for the absor-125 bent layers include bonded non-woven fabrics containing viscose rayon fibres, their blends with wood pulp fibres and treated 'spun-bonded' polester fibre non-woven fabrics. An apt weight range for the non woven fabric for 130 the outer absorbent layer is 20-70gsm and
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GB2080197A
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preferred weight range is 25-45 gsm. Similar weight of material may be used for the inner absorbent layer but if desired a lower weight such as 15-20 gsm may be employed.
5 A suitable polyester 'spun-bonded' staple fibre non-woven fabric which is heat set and has been given an "anti-pill" finish is available as 'Sontara' (trade mark) from Dupont. Sontara 3008 which has a base weight of 10 approximately 70 gsm/sq. metre and Sontara 8000 which has a base weight of approximately 40 gsm are both apt.
A suitable apertured non-woven fabric made from spun-bonded viscose rayon filaments is 15 available as Bemliese (Trade Mark) from Asa-hai Chemical Industry Co. Ltd. Bemliese is available in weights ranging from 18-45gsm which are suitable for use in this invention.
A suitable bonded non-woven fabric made 20 from viscose rayon staple fibre is available as Paraprint (Trade Mark) from Lohmann GmbH & Co. KG. Grade OL 35 which has a base weight of 35gsm and grade OL 20 which has a base weight of 20gsm are both apt. 25 A suitable bonded non-woven fabric made from a blend of wood pulp fibres and viscose rayon fibres is available as Storalene from Stora Kopparsberg Bervik Ltd. Grades 509.17 and 71 5.45 have base weights of 18 gsm 30 and 43 gsm respectively are both apt.
A suitable bonded non-woven fabric made from a blend of viscose rayon and wood pulp fibres is available, Tamlon (Trade Mark) from Tampella. Grade K 267/40 has a base 35 weight of 44gsm and is apt for use in this invention.
Suitable non-absorbent porous layers include non-woven fibrous materials made by stretching melt embossed polymer blends. 40 One form of preferred non-woven fibrous reticulate material is disclosed in British Patent Specification No. 1531715. A second form of preferred non-woven fibrous reticulate material is disclosed in British Patent Specification 45 No. 1548865. A further form of a non-absorbent porous layer is disclosed in British Patent Specification No. 14951 51.
The pressure sensitive adhesive can be in any form providing it prevents the passage of 50 bacteria between the two layers and has a moisture vapour transmission rate of at least 200g/m2/24hrs. The pressure sensitive adhesive will also act as a barrier to liquid water and aqueous body fluids such as blood. It is 55 desirable that the pressure sensitive adhesive has some resistance to the penetration of isopropyl alcohol and preferable that it prevents the penetration of isopropyl alcohol.
Normally and preferably the pressure sensi-60 tive adhesive is continuous (as opposed to microporous; naturally the adhesive will always be macroscopically continuous).
Most aptly the adhesive has a moisture vapour transmission rate of at least 250g/m2 65 and preferably at least 500 g/m2/24hrs./at
37°C at 100%-10% relative humidity difference.
Suitable pressure sensitive adhesives which are moisture vapour permeable as a continu-70 ous coating include acrylate ester copolymers, polyvinyl ethyl ethers and polyurethanes. Examples of suitable adhesives are given in British Patent Specification No. 1280631.
The pressure sensitive adhesives can be 75 polymers per se, blends of polymers, mixtures of polymers with tackifying resins and optionally other materials such as fillers and antioxidants.
A preferred pressure sensitive adhesive 80 comprises a blend of high and low viscosity polyvinyl ethyl ethers in particular "adhesive composition A" disclosed in British Patent Specification No. 1280631.
Other preferred pressure sensitive adhesives 85 comprise copolymers of acrylate ester with acrylic acid and in particular a copolymer of 47 parts by weight of n-butyl acrylate, 47 parts by weight of ethylhexyl acrylate and 6 parts by weight of acrylic acid polymerised in 90 acetone according to the general method .. given in U.S. Specification No. 2884126 and with an intrinsic viscosity of at least 1.8 dl/g.
Another preferred pressure sensitive adhesive is a crosslinkable acrylate ester copolymer 95 available as a 55% solids aqueous emulsion and known as Primal N 580 (Trade Mark) may by Rohm and Haas. Primal N 580 is preferably used in a thickened form. An acrylic thickener known as Primal AS E60 * 100 (Trade Mark) made by Rohm and Haas is particularly suitable for thickening Primal N 580. A coating of Primal N 580 when dried gives a crosslinked pressure sensitive adhesive.
105 Crosslinked pressure sensitive adhesives will have a better resistance to solvents than the uncrosslinked adhesives and and therefore drape fabrics bonded with a crosslinked pressure sensitive adhesive are a preferred aspect 110 of the invention.
The weight range of the adhesive coating is generally from 1 5 to 90gsm, desirably 1 5 fo 70gsm and preferably from 20 to 45gsm.
The adhesive coating can be formed by any 115 convenient method including solution and emulsion coating, coating from a hot melt, by extrusion and also spray coating.
The present invention also provides a method of forming a moisture vapour trans-120 mitting surgical drape fabric as hereinbefore defined which comprises bonding together an absorbent layer and a porous layer with a pressure sensitive adhesive.
A favoured method of production of the 125 drape fabric is to form the adhesive on the surface of at least one layer by transfer coating process and to bond the other layer thereto by lamination under pressure.
To avoid random pinholes in the adhesive 1 30 which may occur when the adhesive is formed
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as a single coating on for example a release surface it is preferred that the continuous adhesive comprises two or more coatings.
A favoured method is to form separate 5 adhesive coatings on both non woven fabric layers for example by transfer coating and to bond the layers together at the adhesive surfaces under light pressure. In an alternative method the pressure sensitive adhesive can be 10 formed by applying two or more coatings for example by spraying to a non woven fabric layer. Combinations of both these methods can also be used.
Fig. 1 illustrates a process of making the 15 surgical drape fabric of the invention. A silicone release paper (1) is coated with a solution or emulsion of the pressure sensitive adhesive (2) by means of a coating head (3) and passed through a drying oven (4). The 20 dried continuous coating (5) of pressure sensitive adhesive on the release paper (1) is passed through the nip of pressure rollers (6) where it is transferred to a non-woven fabric (7) and stripped from the release paper. The 25 adhesive coated non-woven fabric is then passed through the nip of another set of pressure rollers (8) where it is laminated to a second non-woven fabric (9) to form the surgical drape fabric (10) of the invention. 30 The surgical drape fabric can be processed in the various forms and sizes and packaged.
Suitable forms of surgical drape include square or rectangular sheets with or without fenestration. Useful sizes are 71cm X 91cm 35 (small) 91cm X 91cm, 91cm X 142cm (medium) 142cm X 142cm (large) and 142cm X 178cm (extra large).
The surgical drape can be made up in a suitable form for particular surgical procedures 40 for example in the form of leggings for lithotomy.
The surgical drape can be provided with a pressure sensitive adhesive margin to enable the drape to be adhered to the patient. The 45 adhesive margin can be located at one or more outside edges of the drape or around the inner edge or edges of a fenestrated area of the drape.
When the surgical drape has a square or 50 rectangular shape it is desirable that the surgical drape has a pressure sensitive adhesive margin on one edge or on two opposed edges. It is also desirable that a fenestrated surgical drape should have a continuous pres-55 sure sensitive adhesive margn around the edge or edges of the fenestration.
The pressure sensitive adhesive margin can be formed by coating or laminating an additional pressure sensitive adhesive layer onto 60 the margins of the drape. Altenatively the pressure sensitive adhesive margin can be provided by exposing the surface of the pressure sensitive adhesive used to bond the layers together. In one form this is acheived 65 by bonding a first layer coated with the pressure sensitive adhesive to a second layer of lesser area than that of the first layer. For example surgical drapes of rectangular or square shape with a pressure sensitive adhe-70 sive margin on one edge or opposed edges can be made from a surgical drape fabric which is formed by bonding a first layer of a non-woven fabric coated with a moisture vapour transmitting pressure sensitive adhesive 75 to a second narrower layer of non-woven fabric.
In a second and preferred form this is achieved by removing a strip or strips of a tearable porous film used to form the porous 80 layer of surgical drape of the invention. Suitable tearable porous films include those described in British Patent Specification No. 14951 51. A preferred porous film is described in Example 1 of the above specifica-85 tion.
The width of the pressure sensitive adhesive margin can depend on the size of the surgical drape but a width of about 2.5cm to 7.5cm is desirable. It is desirable that the pressure 90 sensitive adhesive margins of the surgical drape should be covered by a removable protector.
The surgical drapes can be individually packaged in sealed paper bags or film/paper 95 pouches which are bacteria proof under dry conditions. Alternatively the drape can be part of a procedure pack.
It is preferable that the surgical drape is sterilised in its packaged condition. Any con-100 venient means of sterilisation may be employed such as steam autoclaving, gas sterilisation techniques and irradiation with elecron or gamma rays.
The use of a pressure sensitive adhesive to 105 bond the absorbent layers together has advantages that the surgical drape fabrics of this invention can be manufactured by a simple pressure laminating process and the resultant drape fabrics can be flexible and less 110 "boardy" than drape materials made with a preformed central film layer.
The surgical drape fabric of this invention is also suitable fof forming surgical gowns and other aseptic absorbent barrier materials 115 which are used in conjunction with the skin.
Gowns made from the surgical drape form an aspect of this invention.
Example 1
120 A polyvinyl ethyl ether based pressure sensitive adhesive composition ("Adhesive composition A" of British Patent Specification No. 1280631) was coated using a knife over flat bed coating unit onto a silicone release coated 125 paper (Steralease 77) and dried in an oven at 80°C to give a dry coating weight of 29gsm. The pressure sensitive adhesive coated release paper was then laminated to Tamlon grade 267/40 non-woven fabric by passage 130 through the nip of two rollers under pressure
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GB2 080197A
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and the release paper stripped off. The adhesive coated non-woven fabric was then laminated to Storalene grade 509/17 non-woven fabric by passing through the nip of another 5 set of rollers under pressure.
The surgical drape fabric of the Example had a moisture vapour transmission rate of 2000g/m2/24hrs at 37T at 100%-10% relative humidity difference.
10 The fabric had a weight of 90gsm and a thickness of 0.28 mm. The drape fabric rapidly absorbed water placed on either surface which did not penetrate to the other surface in either case.
15
Example 2
In a similar manner to Example 1 a surgical drape fabric was made using a pressure sensitive adhesive composition consisting of a co-20 polymer of 47 parts by weight of ethyl hexyl acrylate, 47 parts by weight of n-butyl acrylate, 6 parts by weight of acrylic acid polymerised in acetone according to the general method of U.S. Specification No. 2884126 25 with an intrinsic viscosity of 1.9 dl/g. A dry coating weight of 64 gsm was used.
The surgical drape fabric of the example had a moisture vapour transmission rate of 900g/m2/24hrs at 37°C at 100%-10% rela-30 tive humidity difference. The drape fabric had a weight of 125 gsm and a thickness 0.35mm.
The drape fabric rapidly absorbed water placed on either surface which did not pene-35 trate to the other surface.
Example 3
In a similar manner to Example 1 a surgical drape fabric was made using 30gsm of the 40 acrylate ester copolymer adhesive of Example 2 to bond together a Paraprint grade OL 35 absorbent non-woven fabric to a non-woven fibrous reticulate material as described in Example 1 of British Patent Specification No. 45 1548865.
The surgical drape fabric of the example had a moisture vapour transmission rate of about 1600 g/m2/24 hrs at 37°C at 100%-10% relative humidity difference. The 50 drape fabric had a weight of 77 gsm and a thickness of 0.25mm.
The drape fabric rapidly absorbed water placed on the absorbent non-woven fabric surface which did not penetrate to the outer 55 surface.
Example 4
An acrylate ester copolymer aqueous emulsion adhesive (Primal N 580 supplied by 60 Rohm and Haas (U.K.) Ltd.) thickened by the addition of an acrylic thickener (24 parts by weight per hundred parts of the adhesive emulsion of 10% aqueous solution of Primal ASE 60 supplied by Rohm and Haas (U.K.) 65 Ltd.) and maintained at a pH 9 by the addition of ammonium hydroxide was coated onto a silicone release polyethylene coated paper (Steralease 1 5 supplied by Sterling Coated Papers Ltd.) by a knife over flat bed coating 70 unit and dried in an oven at 95°C for 2 minutes to give a dry coating weight of 30g/m2. The Pressure sensitive adhesive coated release paper was then laminated to Storaline grade 509.17 non woven fabric by 75 passage through the nip of two rollers, heated to approximately 50°C under light pressure. In a similar manner another length of the pressure sensitive adhesive coated paper was laminated to Paraprint grade OL 25 non-80 woven fabric. The release paper was then removed from both non-woven fabric laminates and the adhesive coated non-woven fabrics bonded together at their adhesive surfaces by passage through the nip of two 85 rollers heated to 55°C under slight pressure.
The surgical drape fabric of the example had a moisture vapour transmission rate of approximately 1 550g/m2/24 hours at 37°C at 100%-10% relative humidity difference.
90
Example 5
In a similar manner to Example 4 a surgical drape fabric was made using the pressure sensitive adhesive of Example 2 instead of 95 emulsion adhesive Primal N 580. The surgical drape fabric of the example had a moisture vapour transmission rate of approximately 900g/m2/24 hours at 37°C at 100%-10% relative humidity difference.
100
Example 6
Lin a similar manner to Example 4 a surgical drape fabric was made using a polyvinyl ethyl ether pressure sensitive adhesive consist-105 ing of 32.3 parts by weight of polyvinyl ethyl ether K value 100 (Lutonal A 100, a 25% solution in hexane available from B.A.S.F.), 53.3 parts by weight of polyvinyl ethyl ether K value 50 (Lutonal A 50 a 70% solution in 110 petroleum solvent available from B.A.S.F.), 13.7 parts by weight of a zinc resinate (Kelrez 42-263, a polymerised gum derivative containing 7.9% to 8.5% zinc, available from Croda Resins Ltd.) and 0.7 parts by weight of 115 an antioxidant (Permanax W.S.L. available from Vulnax Limited) dissolved in a petroleum ether solvent (SBP2, boiling point range 72°C-95°C, available from BP Chemicals Limited) to give 40% solids.
120 The surgical drape fabric of the example had a moisture vapour transmission rate of approximately 1150 g/m2/24 hours at 37°C at 100%-10% relative humidity difference.
125 Isopropyl Alcohol Penetration Test
The resistance of a drape fabric to penetration by isopropyl alcohol was tested by placing a small drop of isopropyl alcohol at five locations on one side of a 10cm X 10cm 1 30 square sample of the drape fabric. After a
*
GB2 080197A
period of 1 minute the reverse side was examined for penetration of the liquid. Drape fabric samples from Examples 4, 5 and 6 were subjected to this test. No penetration of 5 the isopropyl alcohol was observed.
Bacteria Penetration Test
The resistance of a drape fabric to penetration by bacteria was tested by placing a J 0 10cm X 10cm test sample of the drape fabric onto the surface of an agar plate so that the sample overlapped the edge of the plate. 0.2ml. of a 24 hour broth culture of serratia marcescens (motile red pigmented organism 15 approximately 0.5 microns in diameter) was spread over the top surface portion of the test sample in contact with the agar plate so as to leave the edge margins of the sample un-coated and the test sample left at room tem-20 perature for 4 hours. The drape sample was then removed and the agar plate incubated at 28° to 30°C for 24 hours. Any penetration of the test organism through the drape sample is indicated by growth of the pigmented organ-25 ism on the agar plate.
Drape fabric samples of Examples 4, 5 and 6 were found to have good resistance to pentration by the test organism.
Drape fabric samples of Example 4 and 5, 30 sterilised by autoclaving at 1 34°C for 3.5 minutes, also showed good resistance to penetration by the test organism.

Claims (19)

  1. 35 1. A moisture vapour transmitting water impermeable drape fabric which comprises an absorbent layer and a porous layer bonded together characterised in that the absorbent layer and porous layer are bonded together by 40 a pressure sensitive adhesive which prevents the passage of bacteria between the two layers.
  2. 2. A drape fabric as claimed in claim 1 having a moisture vapour transmission of not
    45 less than 250g/m2/24 hours at 37°C at 100%-10% relative humidity difference.
  3. 3. A drape fabric as claimed in either of claims 1 or 2 in which the pressure sensitive adhesive is continuous.
    50
  4. 4. A drape fabric as claimed in claim 3 in which the pressure sensitive adhesive comprises an alkyl acrylate copolymer.
  5. 5. A drape fabric as claimed in claim 3 in , which the pressure sensitive adhesive com-55 prises a polyvinyl ethyl ether.
  6. 6. A drape fabric as claimed in any of claims 1 to 5 in which the pressure sensitive adhesive is crosslinked.
  7. 7. A drape fabric as claimed in any of 60 claims 1 to 6 in which the pressure sensitive adhesive has a coating weight of 15g/m2 to 70g/m2.
  8. 8. A drape fabric as claimed in either of claims 1 or 2 in which the porous layer
    65 comprises a non woven fibrous reticulate material.
  9. 9. A drape fabric as claimed in either of claims 1 or 2 in which the porous layer is also absorbent.
    70
  10. 10. A drape fabric as claimed in claim 9 in which one or both absorbent layer comprises a bonded non woven fabric.
  11. 11. A drape fabric as claimed in claim 10 in which the bonded non woven fabric has a
    75 weight of 25g/m2 to 45g/m2.
  12. 12. A drape fabric as claimed in either of claims 10 or 11 in which the bonded non woven fabric of the inner absorbent layer intended to be used adjacent to the patient's
    80 skin has a weight of 15g/m2 to 20g/m2.
  13. 13. A method for forming a moisture vapour transmitting surgical drape fabric as defined in any of claims 1 to 12 which comprises bonding together an absorbent
    85 layer and a porous layer with a pressure sensitive adhesive.
  14. 14. A method as claimed in claim 13 in which the pressure sensitive adhesive is formed on the surface of at least one layer by
    90 transfer coating and the other layer bonded thereto by lamination under pressure.
  15. 15. A method as claimed in either of claims 13 or 14 in which the pressure sensitive adhesive comprises two or more coatings.
    95
  16. 16. A sterile surgical drape or gown made from the drape fabric as defied in any one of claims 1 to 12.
  17. 17. A sterile surgical drape as claimed in claim 16 in which a pressure sensitive adhe-
    100 sive margin is provided at one or more edges of the drape.
  18. 18. A sterile drape as claimed in claim 17 in which the pressure sensitive adhesive margin is located around the edge of a fenes-
    105 trated area of the drape.
  19. 19. A sterile surgical drape as claimed in either of claims 17 or 18 in which the pressure sensitive adhesive margin is provided by exposing the surface of the pressure sensitive
    110 adhesive used to bond the layers together.
    Printed for Her Majesty's Stationery Office by Burgess & Son (Abingdon) Ltd.—1982.
    Published at The Patent Office, 25 Southampton Buildings.
    London, WC2A 1AY, from which copies may be obtained.
GB8119924A 1980-07-15 1981-06-29 Surgical drape fabric Withdrawn GB2080197A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8023036 1980-07-15
GB8030454 1980-09-20

Publications (1)

Publication Number Publication Date
GB2080197A true GB2080197A (en) 1982-02-03

Family

ID=26276219

Family Applications (1)

Application Number Title Priority Date Filing Date
GB8119924A Withdrawn GB2080197A (en) 1980-07-15 1981-06-29 Surgical drape fabric

Country Status (3)

Country Link
EP (1) EP0045137A3 (en)
AU (1) AU7263181A (en)
GB (1) GB2080197A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2199284A (en) * 1986-11-05 1988-07-06 Ueb Packaging Ltd Packaging material
GB2218241A (en) * 1988-04-19 1989-11-08 Arthur Leonard Lewis Liquid presence detector
NL8902742A (en) * 1989-06-30 1991-01-16 Peter Schuengel Dr Med COVERING CLOTH.

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2198971B (en) * 1986-09-20 1990-03-21 Smith & Nephew Ass Thin film adhesive dressings preparation and use
FR2662603B1 (en) * 1990-06-01 1994-05-27 Pont Audemer Papeteries COMPLEX MATERIAL IN THE FORM OF A SHEET, IN PARTICULAR FOR HOSPITAL PURPOSES.
DE4031943A1 (en) * 1990-10-09 1992-04-16 Silver Plastics Gmbh & Co Kg Sterilisable surgical cloth - with heat bonded absorbent outer thermoplastic layer, impermeable thermoplastic barrier layer and permeable thermoplastic base layer
FR2720234B1 (en) * 1994-05-24 1996-12-20 Hubert Copin Waterproof, absorbent and reusable textile drape.
EP0782504B1 (en) * 1994-09-20 2000-01-19 The University Of Tennessee Research Corporation Microporous film/nonwoven composites
US5673433A (en) * 1994-12-13 1997-10-07 Minnesota Mining & Manufacturing Company Garment having barrier layer adhered thereto
AU2001234571B9 (en) 2000-01-26 2004-09-23 Loma Linda University Method for the evaluation of implantable materials

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3667458A (en) * 1970-03-02 1972-06-06 Kimberly Clark Co Surgical drape sheet

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2199284A (en) * 1986-11-05 1988-07-06 Ueb Packaging Ltd Packaging material
GB2218241A (en) * 1988-04-19 1989-11-08 Arthur Leonard Lewis Liquid presence detector
GB2218241B (en) * 1988-04-19 1992-08-26 Arthur Leonard Lewis Apparatus for use in detecting the presence of liquid
NL8902742A (en) * 1989-06-30 1991-01-16 Peter Schuengel Dr Med COVERING CLOTH.

Also Published As

Publication number Publication date
AU7263181A (en) 1982-01-21
EP0045137A2 (en) 1982-02-03
EP0045137A3 (en) 1982-03-31

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