EP3227891A1 - Sterilisierbarer und strahlenundurchlässiger verbundwerkstoff sowie mit diesem material hergestelltes produkt - Google Patents

Sterilisierbarer und strahlenundurchlässiger verbundwerkstoff sowie mit diesem material hergestelltes produkt

Info

Publication number
EP3227891A1
EP3227891A1 EP15823385.8A EP15823385A EP3227891A1 EP 3227891 A1 EP3227891 A1 EP 3227891A1 EP 15823385 A EP15823385 A EP 15823385A EP 3227891 A1 EP3227891 A1 EP 3227891A1
Authority
EP
European Patent Office
Prior art keywords
radio
opaque
sheet
layers
attenuating
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.)
Granted
Application number
EP15823385.8A
Other languages
English (en)
French (fr)
Other versions
EP3227891B1 (de
Inventor
Alberto Franceschini
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Servizi Ospedalieri SpA
Original Assignee
Servizi Ospedalieri SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Servizi Ospedalieri SpA filed Critical Servizi Ospedalieri SpA
Publication of EP3227891A1 publication Critical patent/EP3227891A1/de
Application granted granted Critical
Publication of EP3227891B1 publication Critical patent/EP3227891B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
    • G21F3/00—Shielding characterised by its physical form, e.g. granules, or shape of the material
    • G21F3/02—Clothing
    • 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
    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
    • G21F3/00—Shielding characterised by its physical form, e.g. granules, or shape of the material
    • G21F3/02—Clothing
    • G21F3/025—Clothing completely surrounding the wearer

Definitions

  • 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 .
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • the sterile gown or sterilizable and radio-opaque or radio attenuating gown according to this invention 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the three layers which make up the comp multilayer material 16 according to this invention 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.
  • 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.
  • the invention as described above refers to a preferred embodiment .

Landscapes

  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • General Engineering & Computer Science (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Textile Engineering (AREA)
  • Professional, Industrial, Or Sporting Protective Garments (AREA)
  • Laminated Bodies (AREA)
EP15823385.8A 2014-12-01 2015-11-30 Sterilisierbarer und strahlenundurchlässiger verbundwerkstoff sowie mit diesem material hergestelltes produkt Active EP3227891B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITVR20140300 2014-12-01
PCT/IB2015/059216 WO2016088020A1 (en) 2014-12-01 2015-11-30 Sterilizable and radio-opaque composite material, as well as product manufactured with said material

Publications (2)

Publication Number Publication Date
EP3227891A1 true EP3227891A1 (de) 2017-10-11
EP3227891B1 EP3227891B1 (de) 2019-08-07

Family

ID=52464540

Family Applications (1)

Application Number Title Priority Date Filing Date
EP15823385.8A Active EP3227891B1 (de) 2014-12-01 2015-11-30 Sterilisierbarer und strahlenundurchlässiger verbundwerkstoff sowie mit diesem material hergestelltes produkt

Country Status (3)

Country Link
EP (1) EP3227891B1 (de)
ES (1) ES2751299T3 (de)
WO (1) WO2016088020A1 (de)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5419342A (en) * 1994-02-14 1995-05-30 Scott; Christina M. Adjustable radiation shield assembly for protecting the breast of a patient
DE102004002501A1 (de) * 2004-01-17 2005-08-11 Arntz Beteiligungs Gmbh & Co. Kg Strahlenschutzmaske
US20060041989A1 (en) * 2004-09-02 2006-03-02 Bushman Bradley J Liquid-proof sleeve and protective apparel incorporating same
WO2014071022A1 (en) * 2012-10-31 2014-05-08 Lite-Tech Inc. Flexible highly filled composition, resulting protective garment, and methods of making the same

Also Published As

Publication number Publication date
ES2751299T3 (es) 2020-03-31
EP3227891B1 (de) 2019-08-07
WO2016088020A1 (en) 2016-06-09

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