WO2016088020A1

WO2016088020A1 - Sterilizable and radio-opaque composite material, as well as product manufactured with said material

Info

Publication number: WO2016088020A1
Application number: PCT/IB2015/059216
Authority: WO
Inventors: Alberto Franceschini
Original assignee: Servizi Ospedalieri S.P.A.
Priority date: 2014-12-01
Filing date: 2015-11-30
Publication date: 2016-06-09
Also published as: EP3227891A1; ES2751299T3; EP3227891B1

Abstract

A composite material (16) for manufacturing products (10) having radio-opaque and radio attenuating characteristics comprises a central layer consisting of a radio-opaque or radio attenuating sheet (17) enclosed between two layers (18, 19) made of fabric. Each of the two layers (18, 19) is made of trilaminate consisting of two outer polyester layers and an inner polyurethane membrane, each of the two layers (18, 19) being impermeable to liquids and permeable to steam, in such a way as to allow the repeated washing and industrial sterilisation of the sheet (17) using steam at a temperature of about 134 °C; moreover, said sheet (17) consists of a bicomponent thermosetting polyurethane film provided with predetermined radio-opaque or radio attenuating characteristics.

Description

STERILIZABLE AND RADIO-OPAQUE COMPOSITE MATERIAL, AS WELL AS PRODUCT MANUFACTURED WITH SAID MATERIAL

* * * * *

TECHNICAL FIELD

This invention relates to a composite sterilizable and radio-opaque or radio attenuating material, as well as a product, for example a gown which can be used in the health sector and in particular in surgical areas, such as in operating rooms or in other areas also subject to radiological type emissions such as industrial ones (electronic, pharmaceutical, food preparation, etc.).

The product according to this invention is made using a multilayer composite material which is able to provide high performance levels in terms of duration, firstly relative to radio-protection and secondly in terms of resistance to industrial washing and sterilizing in steam autoclaves .

More specifically, this invention relates to a product, such as, for example, a gown and further clothing accessories which can be reused in the health sector or designed for the same purpose, conceived for radio- protection in a recyclable fashion, that is, reusable, as it uses a material which is radio-opaque or radio attenuating and resistant to industrial washing and sterilization in steam autoclaves.

In view of the capacity of the radio-opaque material according to this invention to withstand high temperatures, is possible to make garments and sheets supplied in the sterile state.

The radio-opaque or radio attenuating product according to this invention applies mainly to the health sector and can be used mainly even if not exclusively in health structures, that is to say, in hospital wards and in operating rooms.

BACKGROUND ART

It is known that in the health sector and in particular in operating rooms and in hospital wards it may be necessary to carry out radiological investigations on patients during surgery or during therapeutic treatments.

In these cases, the current traditional protocol requires that the operators and the medical personnel wear X-ray aprons or X-ray vests if necessary combined with an X-ray skirt, which are worn by the surgical team, and which are of the non-sterile type.

In effect, these protective garments are worn before wearing the sterile surgical gowns, and therefore underneath the sterile gown and over the classic coat and trousers .

In other words, the traditional solutions currently adopted consist of vests or other accessories equipped with protection against radiation or X-rays, which are made of material which is not sterile and not sterilizable and in effect can be worn only underneath the sterile surgical gown, which in these cases is necessary as required by health protocols especially in surgical contexts .

The fact of using vests or other accessories which on the one hand are opaque to radiation but on the other hand are of the non-sterilizable type, and precisely for this reason can only be worn underneath sterile surgical gowns, results in obvious problems of a practical nature which have an effect on the surgery preparation procedures and clothing requirements. Patent document WO 2005/069309 Al describes a mask for protection against radiation comprising at least a film with an elastomeric matrix without lead and having radiation absorption features. This film is cut to size and inserted inside a fabric bag the edges of which are bonded or stitched except for an open area in which the film is inserted into the bag or removed from it. In order to re-use the . materials the film is removed and heat treated, and the bag is sterilized.

DESCRIPTION OF THE INVENTION

The aim of this invention is to provide a composite multilayer material for manufacturing products for health sector purposes, for example gowns or other similar accessories, which is radio-opaque or radio attenuating and which at the same time can be subject to numerous sanitizing and sterilizing cycles.

This material is described at claim 1. The dependent claims describe particularly advantageous embodiments of the material according to the present invention.

The aim of this invention is also to provide a product, for example a gown the characteristic of which is that of being made of a radio-opaque or radio attenuating resistant material, that is, at least partly impenetrable to "X" rays and which at the same time can be subjected to numerous sanitizing and sterilizing cycles, so as to overcome the above-mentioned problems.

This product is described at claim 8 and at the claims dependent thereon.

The product according to this invention is obtained by using a composite multilayer material which on the one hand can offer high performance in terms of duration with regard to radioprotection and which simultaneously guarantees the necessary resistance to industrial washing and sterilization in steam autoclaves, finally obtaining a product which is able eliminate or at least reduce the above-mentioned drawbacks.

The product according to this invention, in particular a gown, or other similar accessories for radio- protection, is relatively easy to make since it is based on the use of materials with high radio-opaqueness properties and at the same time has the capacity to withstand repeated sterilization and industrial washing treatments .

The main advantages of this invention, as well as all those which derive from a certain production simplicity if compared with the important result achieved, concern above all the fact that a sterilizable or sterile X-ray gown according to this invention is able to replace the current combination of sterile surgical gown plus non-sterile X- ray apron.

The advantage obtained also concerns the possibility of providing products, for example radio-opaque gowns, and to provide them sterile and, moreover, repeatedly sterilizable and washable with industrial processes, whilst currently the X-ray aprons are provided non-sterile and not even treatable for sterilization because they are made with material which can neither be sterilized nor, in most cases, washed with industrial processes.

Thanks to the characteristics of the fibers which make up the fabric with which the sterilizable radio-opaque product according to this invention has been made— it reaches the performance levels required without the use accessories or external means and without the need to be combined with traditional sterile gowns, keeping its characteristics unaltered for the entire duration of the product cycle life.

ILLUSTRATION OF DRAWINGS

Other features and advantages of the invention will become apparent on reading the following description of a form of embodiment of the invention, given as a non- limiting example, with the help of the figures illustrated in the annexed drawing sheets, in which:

Figure 1 is a schematic view of a product, in particular a gown according to this invention;

Figure 2 is a schematic and perspective view of the composition of the layers which make up a composite multilayer material according to the invention, the layers being separated;

Figures 3 and 4 are schematic views of the layers in cross section which make up the composite material according to the invention.

DESCRIPTION OF AN EMBODIMENT OF THE INVENTION

With reference to the accompanying drawings, the numeral 10 in Figure 1 indicates a product, in particular a gown or other similar surgical accessory according to this invention, the gown being made with a design concept such that it can be provided to medical surgeons in a sterile state, and at the same time is both radio-opaque or radio attenuating, that is, it contains a protection against X rays.

More specifically, the product according to this invention is made using radio-opaque or radio attenuating fabric parts and trilaminate fabric parts, all being provided in the sterile state reusable using washing and sterilizing processes which follow each use.

In more detail, the sterile gown or sterilizable and radio-opaque or radio attenuating gown according to this invention, denoted in its entirety by the numeral 10, is made up of several parts, including a front panel 11 and a rear panel 12, from the knees to the neck, made of fabric comprising at least one radio-opaque or radio attenuating layer, with different models depending on the size (XS-S- M-L-XL-XXL) and the level of attenuation or protection required, for example approximately 0.26 - 0.36 - 0.52 - 0.72 or other thicknesses which can be made to measure in equivalent millimetres of lead (Pb) .

The rest of the gown, that is to say, the sleeves 13 with the heat-sealed stitching, the side and the lower panel 15, is generally completed with reusable trilaminate technical fabric, thereby guaranteeing total protection.

With reference to an important feature,, the product according to this invention is made from a multilayer composite material having at least one radio-opaque or radio attenuating layer, denoted in its entirety by the numeral 16 in Figures 2 to 4, and comprises a central core 17 consisting of a sheet of radio-opaque or radio attenuating material between two layers of 100% polyester trilaminate, labelled, respectively, 18 and 19.

According to the invention, the sheet 17 comprises a bicomponent thermosetting polyurethane film having predetermined radio-opaque or radio attenuating characteristics which are obtained using known methods. This bicomponent thermosetting polyurethane film in particular withstands repeatedly steam sterilizing at 134°C.

According to this invention, the trilaminate polyester layers 18 and 19 which enclose the central sheet 17 in turn consist of a front part made of 100% polyester, a polyurethane membrane and a rear part made of 100% polyester with an approximate weight of 150 gr/m2 +/- 5% which is washable up to 90°C and sterilizable at a temperature of up to 134 °C.

The trilaminate is impermeable, as is the stitching or bonding around the central sheet 17, but allows the passage of steam.

According to a further advantageous embodiment of the invention, the central sheet 17, enclosed between two layers of polyester trilaminate 18 and 19, generally consists of a thermosetting polyurethane resin PU with a hardness Sh°A 50 +/-5, comprising radio-opaque or radio attenuating metals represented by Antimony and Bismuth. The basic weight of the central core may be typically between 3,000 and the 4,500 gr/m2 but may vary outside these values depending on the type of protection required.

According to experiments performed by the applicant, the sheet 17 is able to be steam sterilized at a temperature of 134 °C. Consequently, the product made with the material according to this invention is able to be repeatedly subjected to industrial washing and drying at a high temperature.

Listed below are the tests performed with X-ray tube IAE X50H - Control console CYGNUS-ODEL of certain attenuation values of the X-rays asa function of the intensity of the beam-values +/- 2.5%, of the central core

17 :

The three layers which make up the comp multilayer material 16 according to this invention, which consist of a first layer of trilaminate material impermeable to liquids but permeable to steam, a second layer comprising a sheet of radio-opaque or radio attenuating material and a third layer of trilaminate material impermeable to liquids but permeable to steam, are joined together by stitching or bonding, that is to say, with a laminating process. This material can be sanitized with the use of industrial washing processes, is sterilizable in steam autoclaves and is impermeable according to reference standard UNI EN 20811.

The lightness of the respective layers 18, 19 made of polyester/polyurethane/polyester trilaminate, applied outside the radio-opaque or radio attenuating sheet 17, allows a composite material to be made which is very malleable and more comfortable compared with the products currently on the market as well as making it sanitizable with the traditional machinery used in industrial laundries (continuous wash and centrifugal wash) and sterilizable with steam.

The material 16 may have different weights depending on the protection required by the client according to the various basic weights, of the radio-opaque sheets 17.

In its variants, the composite multilayer material 16 can also be made with processes for laminating the various fabrics directly on the radio-opaque or radio attenuating sheet 17.

With the material 16 it is possible to make further different articles, both traditional and innovative, such as :

• Vests;

• Skirts;

• Full aprons; • Parathyroid protection;

• Gonad protection;

• Mittens;

• Various types of protection for patients in the operating room and ward (e.g. aprons, gonad protection, breast protection, covers, etc.);

• Sterile surgical sheets with and without hole. As may be noted, the material described above enables the aims of the invention to be achieved, that is to say, to provide a product on the market which offers high performance in terms of duration, both relative to the radio-protection and resistance to industrial washing and sterilizing in steam autoclaves.

The invention as described above refers to a preferred embodiment .

It is nevertheless clear that the invention is susceptible to numerous variations falling within the scope of the disclosure, in the framework of technical equivalents .

Claims

1. A composite material (16) for manufacturing products (10) having radio-opaque or radio attenuating characteristics, the material comprising a central layer consisting of a radio-opaque or radio attenuating sheet (17) enclosed between two layers (18, 19) of fabric, characterised in that each of the two layers (18, 19) is made of trilaminate consisting of two outer polyester layers and an inner polyurethane membrane, each of the two layers (18, 19) being impermeable to liquids and permeable to steam, in such a way as to allow the repeated washing and industrial sterilisation of the sheet (17) using steam at a temperature of about 134 °C, and in that said sheet (17) consists of a bicomponent thermosetting polyurethane film provided with predetermined radio-opaque or radio attenuating characteristics.

2. The material (16) according to claim 1, characterised in that the two trilaminate layers (18, 19) are joined to the sheet (17) by stitching or bonding or laminating .

3. The material (16) according to claim 2, characterised in that the stitching is impermeable to liquids.

4. The material (16) according to any one of the previous claims, characterised in that each of the two layers (18, 19) has a weight of 150 gr/m2 +/- 5% and is washable up to 90 °C and sterilizable in steam at a temperature of up to 134°C.

5. The material (16) according to any one of the previous claims, characterised in that the bicomponent thermosetting polyurethane sheet (17) is composed of a PU thermosetting resin with a hardness Sh°A 50 +/-5, comprising radio-opaque or radio attenuating metals.

6. The material (16) according to claim 5, characterised in that the radio-opaque or radio attenuating metals consist of antimony and/or bismuth.

7. The material (16) according to any one of the preceding claims, characterised in that the sheet (17) has a weight of between 3, 000 and 4, 500 g/m2.

8. A product or garment (10) which can be used in the health sector, that is, in an industrial context subject to radiological type emissions, characterised in that it can be made of a material according to claims 1 to 7.

9. The product (10) according to claim 8, characterised in that it consists of a gown comprising a front panel (11) and a rear panel (12), from the knees to the neck.

10. The product (10) according to claim 9, characterised in that it also comprises a pair of sleeves (13) and a lower panel (15) made of trilaminate fabric.

11. The product according to any one of the preceding claims, characterised in that it consists of a vest or a skirt, or an apron, or a parathyroid or gonad protection, or a mitten or a protection for the breasts or a surgical cover or sheet.