WO2006077616A1

WO2006077616A1 - System for visualizing contaminated spots by using a film with a controlled release of coloured substances

Info

Publication number: WO2006077616A1
Application number: PCT/IT2006/000033
Authority: WO
Inventors: Giuseppe Chidichimo; Claudio Greco Gian; Maurizio Parise
Original assignee: Giuseppe Chidichimo; Claudio Greco Gian; Maurizio Parise
Priority date: 2005-01-24
Filing date: 2006-01-21
Publication date: 2006-07-27
Also published as: ITCS20050001A1

Abstract

The invention concerns a polymer film able to release progressively coloured substances or photonically colourable substances that can highlight the spots where the same film has been in touch with any kind of surfaces. In practical application the film will be supported by gloves, weared by the health operators during their usual activities. The film, applied to the gloves, will, therefore, highlight all the spots on the equipment and other structures that have been touched, also accidentally, by the health staff during surgical operations on their patients. The main function of this film will be that of eliminating the problem of transmitting infections to other patients because of an indirect contact with germs by health operators (crossed infections). The systems, which could be developed thanks to this film, object of this invention, will be able to highlight the spots that, in medical environment, should be disinfected after a surgical operation, before starting the next one on another patient.

Description

System for visualizing contaminated spots by using a film with a controlled release of coloured substances Technical Field of the invention

This invention concerns a system for visualizing contaminated spots, in medical and industrial environments, by using a film that gradually releases coloured substances.

The invention consists in a polymer film able to release gradually coloured substances or photonically colourable substances that can highlight the spots where the same film has been in touch with any kind of surfaces.

In practical application the film will be supported by gloves, weared by the health operators during their usual activities. The film, applied to the gloves, will, therefore, highlight all the spots on the equipment that have been touched, also accidentally, by the health staff during surgical operations on their patients.

The main function of this film will be that of eliminating the problem of transmitting infections to the patients because of an indirect contact with germs through health operators (crossed infections).

The systems, which could be developed thanks to this film and object of this invention, will be able to highlight the spots that, in medical environment, should be disinfected after a surgical operation, before starting the next one on another patient.

State of the art and way of realizing the invention

The invention, that is going to be presented in the following text, intends to eliminate, in health structures of any kind, the transmission of infections caused by germs that, come out from a patient during a surgical operation, could attach to the surfaces of equipment and other structures that the health staff could get in touch with during their surgical activities.

In many cases it is not possible to have recourse to a complete sterilization of the entire environment between an operation and the next one; so that it often happens that during the next operation on another patient the health staff could once again get in touch with the spots previously contaminated and could spread the germs there deposited.

This phenomenon is konw as "crossed infections' spread". Typical places where this kind of events can happen are dentists' surgeries, surgery-rooms and other surgeries in health structures both public and private.

Currently doesn't exist any system able to release visible or markable at control traces on surfaces that the health operators have to handle or, accidentally, get in touch with.

This method is certainly more efficient than the standard system of preventing the crossed infections, based on the disinfection of all the surgical equipment. This new strategy takes advantage of the possibility to highlight the spots that the health staff has been in touch with during its activities and, in a second step, to sterilize all the contaminated areas using an appropriate disinfectant.

The invention, therefore, consists of an integrated system including a plastic film able to highlight the previous contacts that the health staff have had with parts of the medical equipment or with any other structure (e.g. furniture) present in medical environment. The plastic film, highlighting the spots touched by the health staff during its activities, consists of a polymer film encompassing molecules coloured or colorable by exposition to radiation of wavelength 300-900 nm. This film could be fixed on the palm of the hand or on specific parts of the health gloves (e.g. the tops of the fingers) so that it could adhere and, subsequently, release gradually the coloring or colorable substanceTMTwiirhTghlight all the spots the health staff has been in touch with. In the following text we are going to describe the way of producing the film either directly on the health gloves or in the form of labels to be put on the gloves. A solution having the following components:

• One or more organic monomers polymerizable by thermal way or by U. V. beaming

• One or, eventually, more crosslinking agents. • A dyestuff or a photocromatic substance able to pass from a weak to a very intense coloration, by exposure to radiation of wavelength 300-900 nm.

• One or more solvents able to melt the dyestuff or the photochromatic substance, but unable to melt the health gloves' rubber.

• One activator for thermal or radical U.V. polymerization

• Eventually, other additives to improve the adherence or the reology both of the same solution and of the next polymer film.

Organic monomers that could be used for this invention are the monofunctional methacrylic esters such as: methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, ethylexyl methacrylate, glycidyl methacrylate, benzyl methacrylate, phenyl methacrylate, cyclohexyl methacrylate, isobornyl methacrylate.

Organic monomers that could be used for this invention are the hydrophilic ones. Among the hydrophilic monomers we mention hydroxyalkyl methacrylates, alkoxy derived from hydroxyalkyl methacrylates, aminoalkyl methacrylates, monovinyl ethers, N-vinyl lactams, hydroxylated vinyl ethers , amidic derivatives of methacrylates, oligomers of the above mentioned monomers. Other organic monomers are the crosslinking agents such as ethylenglycol dimethacrylate, diethylenglycol dimethacrylate, triethylenglycol dimethacrylate, tetraethylenglycol dimethacrylate, 1,6 esandiol dimethacrylate, glycerin methacrylate, 112,2-bis[4-(methacryloxy) phenyl]propan, and 2,2-bis[4-(methacryloxyethoxy) phenyl]propan.

Other monomers able to copolymerize with the monomers above mentioned are methyl acrylate, ethyl acrylate, n-butyl acrylate, ethylesil acrylate, cyclohexyl acrylate, benzyl acrylate, phenyl acrylate, isobornil acrylate, ethylene glyco diacrylate, triethylen glyco diacrylate, 1,6-esandiol diacrylate, trimethylolpropan triacrylate, 2,2-bis[4-(acryloxy) phenyl]propan, 2,2-bis[4- (acryloxyethoxy)phenyl]propan, and other acrylic esters; styrene, methylstyrene, dimethylstyrene, chlorostyrene, dichlorostyrene, bromostyrene, p-chloromethylstyrene, divinylbenzene, and other nucleus-substituted styrenes; alpha-methylstyrene, acrylonitryl, methacrylonitryl, maleic anidrid, and the N-substituted maleimide; diethylene glycol bis(allyl carbonates, diallyl phthalate, and other allylate compounds.

The dyestuffs can be choosen among natural dyestuffs used for colouring pharmaceutical preparations or food-stuffs' preparations. Some dyestuffs that could be employed for this invention belong to carotenes' family, such as 7',8'-dihydro-6-carotene or 7',8'-dihydro-y-carotene, ( see the patent WO03022071 ) or other carotenoids such as 3-carotene, canthaxanthin, 8'-apo-p-carotenal, ethyl 8'-apo-carotenoate, lycopene, astaxanthin, lutein and zeaxanthin.

References for the preparation of these compounds able to convey yellow or yellow-green coloration are contained in Carotenoids, ρ.774, O. Isler (ed.), Birkhauser Verlag Basel and

Stuttgart 1971; Chemistry in Britain3 (10), 424 (1967) e Pure and Appl. Chem. 14,265 (1967), both by B. C.L.Weedon; e R. Ruegg et al., HeIv. Chim. Acta 44, 994 (1961).

Other natural red dyestuffs of carotenoid kind that could be used in the present patent are cis-bixina

(C25H30O4), annatto seed extract, and norbixina.

These dyestuffs can be used alone, dispersed in solid form or in mixture in watery dispersions or in dispersions in natural triglycerides.

The photochromic substances can be choosen among well-known compounds such as spirooxazines and chromenes, already widely employed for contact-lens.

For the spirooxazines it is possibile to refer to the following patents: U.S. Pat. Nos. 5,139,707 e

^7hWτ^β2lπ(splfoχi53oline-quinazolineoxazines) and spiro(indoline-benzothiazoloxazines)), EP-A-

245,020 (spiro[indoline-[2,3']-benzoxazine]), JP-A-03251587 (spiro[indoline-[2,3']-benzoxazine] substituted in position & ) and WO-96/04590 (spiro[indoline-[2,3']-benzoxazine).

In regard to the chromenes, favourites are naphthopyran, benzopyran, indeno-naphthopyran, phenanthropyran, spiropyran derivatives ( see the patents: U.S. Pat. No. 5,066,818, WO 92/09593,

EP-A-401,958, EP-A-562,915 and WO 93/17071). Valuable series of naphthopyrans, that can be used, are the same ones used in the patent WO9748762 (Al), having the same structure.

Other naphthopyran compounds particularly important are those related to the patent WO9804937 (Al)

where -Rl, R2, R4 and R6 are alike or different and can indipendently represent hydrogen, halogens , linear or branched alkyl groups, linear or branched cycloalkyl or bicycloalkyl groups, linear or branched alkoxylic groups, linear or branched haloalkyl or haloalkoxylic groups and other else.

Among the several markable photochromic substances are preferred those which become active at wavelenght within a visible range in order to not get into difficulties linked with the use of ultraviolet highlighting light.

Among the solvents that can be added to the system in order to better release the dyestuffs or the electrochromic dyes particularly important are those which are not harmful to health such as: water, ethylic alcohol, ethylene glycol, glycerine and glycerolates. The activators for the radical or U. V. polymerization can be Irgacure 651 (Aldrich) or similar others;

Among the additives that can be added we mention fine-grained inert powders such as talcum. The solution can be deposited on any kind of supporting surface, or, eventually, in the form of a thin film, on specific parts of the health gloves so that it will be able to leave visibile traces on the surfaces of contact. Afterwards, this film will be heated at a suitable temperature, in case you would like to activate a thermal polymerization, otherwise it will be exposed at U. V. light, in case you would like to activate U.V. radical polymerization. The film, initially deposited in fluid form, will solidify remaining adhered to the gloves' surface. The concentration of polymerizable monomer and other compounds, in the first solution, will be such that the film will be able, getting in touch with other surfaces by health gloves, to release the solution holding the dyestuff. By this way the touched spots will be clearly highlighted and, in a second step, will be able to be sterilized using appropriate disinfectant solutions. Obviously, also the patient subjected to medical manipulation, will be coloured in the areas where the health staff will have touched him with the gloves containing the film object of this invention.

The dyestuff and the solvent, in which the dyestuff will be dispersed, will be selectioned in order to be easily washable and removable from the surfaces of contact, included those direct-related to the patient.

Commercially the invention could be used as follows:

Health gloves provided with system able to highlight the contacts, could be prepared directly by the health operators using conventional health gloves. The solution above described could be provided in an appropriate bin. The same solution could be spread on the usual health gloves or by an absorbent system, that releases it just for pressure, as it happens in fluid supply for stamps. To make this operation easier the gloves could be supported by apposite models of hand: After that they will be exposed under a U. V. lamp or in a thermostated device at the appropriate temperature in order to solidify the solution by polymerization and to fix the film on the gloves surface. Another way to prepare the contact detector gloves in loco consists in using a solution provided in appropriate nebulizer bins. The solution will be able to be sprayed on the gloves surface, properly supported by models of hand. Afterwards the polymerization of the film will proceed according to the above described method. Another way to prepare the contact detector gloves on site consists in the immersion of the gloves in the solution and in the successive polymerization of the fluid film remained adhered to the surfaces. The health gloves could be produced at industrial level according to processes similar to those already described and could be merchandized ready for use. The invention could be also realized in the form of prefabricated adhesive labels to be applied to the health gloves. The label will be preferably composed by three layers:

An adhesive layer, an inert flexible polymer layer and an external layer made of the marker film object of the present invention.

A further way to carry out the contact detector system is to add a ring layer of spongy material around the glove finger tip and a reservoir of a fluid solution of the marker dye on the upper side of the glove fingertips. In such a way the spongy layer will continuously suck the solution from the reservoir, transmitting it gradually to the bottom side. The amount of solution transmitted by contact to the touched surfaces, will be graduated by the size of the pores of the porous ring. The porous ring could be obtained by polymerising appropriate organic monomers. Examples of realizing the marker film Example 1:

Film highlighting contaminated spots Prepare a mixture containing:

• 25% hydroxymethyl methacrylate,

• 15% ethylene glycol dimethacrylate, • 29% 7',8'-dihydro-6-carotene,

• 30% water,

• 1% initiator Irgacure 651 (Aldrich);

The mixture is put on a substrate of rubber for health gloves and it is polymerized by exposure to ultraviolet light. After the polymerization on the rubber surface is generated a film layer able to release progressively the dyestuff by contact giving a red coloration.

Example 2:

Film highlighting contaminated spots

Prepare a mixture containing:

• 25% hydroxymethyl methacrylate,

• 15% ethylene glycol dimethacrylate,

• 29% 3-carotene,

• 30% tri-ethylglycerolate,

• 1% initiator Irgacure 651 (Aldrich);

Example 3

Film highlighting contaminated spots

Prepare a mixture containing:

• 5% monomer 1,4-phenylene bis[4-(6-acryloyloxyhexyloxy) benzoate)] having the following

structure formulation: 25% monomer Bisphenol A glycerolate diacrylate (Aldrich) 2% initiator Irgacure 651 (Aldrich); • 40% glycerin

• 28% di 7',8'-dihydro-6-carotene,

The mixture is put on a substrate of rubber for health gloves and it is polymerized by exposure to ultraviolet light. After the polymerization on the rubber surface is generated a film layer able to release progressively the dyestuff by contact giving a red coloration. Example 4

Film highlighting contaminated spots Prepare a mixture containing:

• 5% monomer 1,4-phenylene bis[4-(6-acryloyloxyhexyloxy) benzoate)] having the following structure formulation:

CH

25% monomer Bisphenol A glycerolate diacrylate (Aldrich)

• 2% initiator Irgacure 651 (Aldrich);

• 50% glycerin

• 18% spirooxazine or the above mentioned photochromies, that once enlightened has a gradual come-back to the uncoloured situation

Claims

1. System for visualizing contaminated spots comprising a film able to progressively release a colouring or photocromatic substance characterized by the fact that said film is made of:

• One or, eventually, more crosslinking agents.

• said colouring or photocromatic substance is able to pass from a weak to a very intense coloration, by exposure to radiation of wavelength 300-900 nm.

• One or more solvents able to melt said colouring or photocromatic substance, but unable to melt the health gloves' rubber.

• One activator for the thermal or radical U. V. polymerization

• Additives to improve the adherence or the reology both of the same solution and of the next polymer film.

2. System for visualizing contaminated spots including a film able to release progressively the dyestuff, according to claim 1, characterized by the fact that those organic monomers, in the solution, are monofunctional methacrylic monomer esters, hydrophilic monomers.

3. System for visualizing contaminated spots comprising a film able to progressively release a colouring or photocromatic substance, according to claim 1 or 2, , characterized by the fact that the solution is deposited on the conventional health gloves by a spray.

4. System for visualizingj^ntainmatexijφotsxompris^^ colouring or photocromatic substance, according to the previous claims, , characterized by the fact that the solution is deposited on the traditional health gloves by immersion of the gloves in the same solution.

5. System for visualizing contaminated spots comprising a film able to progressively release a colouring or photocromatic substance, according to claim 1 or 2, , characterized by the fact that this film able to release progressively the dyestuff is made in the form of label to be applied to the health gloves.

6. System for visualizing contaminated spots comprising a film able to progressively release a colouring or photocromatic substance, according to claim 1 or 2, where said substance is contained in a reservoir and is continuously fed to the film to be transmitted to touched surfaces.