WO2021258121A1 - Coated gloves and dispenser box for avoiding nosocomial infections - Google Patents

Abstract

The invention relates to medical gloves for single use and a corresponding dispenser box, the gloves according to the invention being coated with a disinfectant coating and the gloves being perfectly hygienically removable from the dispenser box. The gloves packaged in the dispenser box have disinfecting inner and/our outer surfaces so that pathogenic germs on their surfaces cannot proliferate.

Description

Coated gloves with a dispenser box to prevent nosocomial infections

The invention relates to medical gloves for single use including a dispenser box, wherein the gloves according to the invention have disinfecting coatings and the gloves can be removed from the dispenser box according to the invention in a hygienically perfect manner.

The gloves packed in the dispenser box are equipped with disinfecting surfaces on the inside and / or outside so that pathogenic germs can no longer multiply on their surfaces. The dispenser box according to the invention has one, but preferably two, removal openings which are positioned so that the gloves can only be gripped specifically at the cuff edge and external contamination of the unused gloves in the palm and finger area in the dispenser box from soiled hands of the user is avoided.

In the USA, every tenth hospital patient is currently infected with a hospital infection, generally known as a nosocomial infection. The 2 million patients affected each year cause additional costs in the US healthcare system of between US $ 4.5 billion and US $ 11 billion. Around 90,000 deaths are caused annually by these "hospital germs" in the USA and at least 35% of these infections are estimated to be easily preventable. The situation in Europe is similar: in Germany there are more than 500,000 nosocomial infections annually, with many thousands of deaths and additional costs of well over 2.5 billion euros.

The need for protection of nursing staff has led to a more than a hundredfold increase in the consumption of examination gloves worldwide over the past three decades. At the same time and against all expectations, however, the nosocomial infections, which often also affect the hospital staff themselves, multiplied. This is due to the fact that the use of examination gloves, on the one hand, leads to increased bacterial growth due to the occlusive inclusion of the human skin under the glove, and, on the other hand, it can be assumed that the nursing staff usually wears gloves when they come into contact with infected patients and contaminated waste, Gloved hands are washed and disinfected less often.

A significant proportion of nosocomial infections are spread through contaminated hands of hospital and nursing staff. This involves improper use and Taking off examination gloves combined with poor hand hygiene is a major factor. The germs are mostly brought to the outside of the unused gloves by the hands of the nursing staff contaminated from previous work and then to medical equipment and the patient's environment.

When examination gloves are removed, critical contamination of the freshly donned gloves or of unused gloves lying in the pack almost always occurs. Subsequent infections of patients, e.g. when placing catheters or infusions, are inevitable, in particular due to the fact that germs and pathogens that mainly grow on human tissue are transmitted.

The situation is aggravated by the fact that, in recent years, gloves, which are predominantly made of natural or synthetic rubber latex, have tended to have fewer chemical residues for reasons of skin compatibility, and so there are hardly any more bactericidal rubber chemicals such as dithiocarbamate accelerators in the rubber film, which is the survival rate of Germination on the rubber surface increased dramatically. Due to the fact that the proportion of powder-free examination gloves is increasing, no powder residue remains on the hands of the nursing staff after removing the gloves and the subjectively false impression of "clean, germ-free" hands arises, which leads to a further reduction in hand washing leads.

It is therefore an aim of the present invention to prevent the chains of contamination with pathogenic germs caused by the use of disposable medical gloves.

The object is achieved in such a way that the use of disposable gloves that are equipped with disinfecting surfaces on the inside and / or outside is proposed. This prevents the transmission or multiplication of pathogenic germs on the glove surfaces. The disposable gloves according to the invention should preferably be used in combination with dispenser boxes, where the gloves are not contaminated in the shaft area when they are removed. For this purpose, as described below, the surface properties of the gloves according to the invention are to be adapted accordingly. When using the gloves according to the invention (preferably in combination with optimized dispenser boxes), a significant reduction in the nosocomial infection rates in hospitals and care facilities can be expected.

The unsterile gloves used in health care are usually delivered in non-sterile form in so-called dispenser box packs with a filling quantity of typically 100 to 200 pieces of ambidextrous gloves. Due to fully automated production systems and GMP-compliant manufacturing and packaging methods, there is usually hardly any pre-germination of the gloves.

The usual way of interrupting the chain of contamination described is regular cleaning and disinfection of the hands of the nursing staff, combined with frequent glove changes. This is essentially a purely organizational measure, but from the point of view of skin tolerance it is not without problems because of the use of disinfectants that usually contain alcohol and long-lasting occlusive wearing conditions.

As mentioned in the introduction, it can be assumed that gloved hands are often not washed and disinfected sufficiently often, even in the hospital and care sector. When examination gloves are used, the occlusive inclusion of the human skin under the glove leads to increased perspiration and germ growth, and ultimately to undesirable germ transfer.

It is therefore proposed in the present invention that disposable gloves used in the health and food sector have surfaces with a disinfectant effect, which contain germicidal or germ-growth-inhibiting substances.

Such surfaces have already been described, for example, in WO 2009/073907 for the inner and outer surfaces of the gloves.

The Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the German Robert Koch Institute (RKI) regularly publishes recommendations for effective chemicals for hand hygiene in health care facilities (see e.g. Bundesgesundheitsbl. 2016 59: 1189-1220 DOI 10.1007 / s00103-016-2416- 6 © Springer-Verlag Berlin Heidelberg 2016). The use of generally known disinfecting active ingredients for the production of the glove surfaces according to the invention is according to the invention.

Thus, the following compounds are proposed here as examples of usable disinfectants for producing the disinfecting glove surfaces:

- Chlorhexidine (insoluble in water)

- Mecetronium methyl sulfate (water soluble)

- Triclosan (not soluble in water)

- Triclocarban (insoluble in water)

- Octenidine (insoluble in water)

- Chloramine T (water soluble)

- thymol (insoluble in water)

- Chlorxylenol (insoluble in water)

- Chitosan (polymer, insoluble in water)

- polyhexanide (polymer, water-soluble)

- zinc, copper, silver salts (preferably insoluble in water)

- Iodine compounds (e.g. polyvinylpyrrolidone-iodine)

Quaternary ammonium compounds (e.g. didecyldimethylammonium chloride, alkylamidopropyl betaine)

- 2-phenylphenol (insoluble in water)

- phenoxyethanol

- ethacridine salts and many more.

The disinfectants mentioned here are often used in health facilities in the form of alcoholic or aqueous solutions to disinfect hands, skin and medical products.

If disinfectants are used to treat the surface of examination gloves, however, the slipperiness of the outer and inner glove surfaces is often impaired, which leads to problems when peeling off from the molds in the manufacturing process, as well as the gloves sticking together in the dispenser box packaging, and ultimately also making the gloves difficult to put on User leads. In particular, in the case of packaging in dispenser boxes, where the gloves are stacked and only to be picked up by the glove shaft for hygiene purposes, a sufficient one must be used Surface slipperiness of the gloves must be guaranteed so that a secure individual removal from the dispenser box is always guaranteed.

It is therefore the object of the present invention to define surfaces of thin-walled disposable gloves, including associated products and processes, in such a way that the following properties are guaranteed:

Internal and / or external surfaces of the gloves must have germicidal or germ-growth-inhibiting properties.

The inner and outer surfaces of the gloves must have sufficient surface slipperiness to ensure that the gloves can be easily removed from the mold in the course of their manufacturing process and that the user of the gloves can easily put them on.

The outer surfaces of the gloves must be designed in such a way that the adhesion between two gloves pressed against one another is so low that easy removal from small dispenser box packaging with a stacked glove arrangement is guaranteed at all times, even with dispenser box packaging where, for reasons of hygiene, the gloves are only gripped by the shaft can be.

In an embodiment variant according to the invention, when the disinfectants are applied to the disposable gloves, they are applied to the glove surfaces together with silicone oil. According to the present invention, mixtures of siloxanes in the form of silicone oil, silicone oil solutions or silicone oil emulsions with the disinfectant to be applied or a solution or emulsion thereof are produced. These mixtures according to the invention are then sprayed onto the gloves or applied in a dipping process. The spraying is preferably carried out using rotating drying drums in the same way as laundry dryers, or, for example, as part of the pull-off process on the glove-making machines. The application in the dipping process takes place, for example, in dipping baths on the glove manufacturing machines.

Examples of silicones according to the invention are:

- Rhodorsil Oils 47 V 20 to V 1000, as well as associated emulsions and solutions

- Dow Corning (R) 1664 emulsion

- Silbione Emulsion 70001 SP

- and much more Mixtures according to the invention of disinfectants and silicone oils (polysiloxanes) for producing disinfecting surfaces on the gloves according to the invention are, for example:

- Dow Corning (R) 1664 Emulsion: alcoholic solution of mecetronium ethyl sulfate 0.2% (Sterillium) in a mixing ratio of 1: 1

- Silbione Emulsion 70001 SP: alcoholic solution of triclosan 0.1% in a mixing ratio of 1: 1

- and much more

In a variation according to the invention, when applied to the medical gloves, the disinfectants are applied to the glove surfaces together with, for example, fatty acid salts, chlorinated polyolefins, polyolefin, paraffin oil or wax suspensions or hydrogel mixtures. The substances mentioned act as lubricants and a mixture, solution or emulsion is used that contains both lubricant and the disinfectant to be applied. In particular, it can be provided that a lubricious coating was produced from a liquid or disperse mixture, which contains at least one lubricant and one or more germicidal or germ-growth-inhibiting substances. The mixtures according to the invention are applied in the course of the manufacturing process in the dipping or spraying process or applied to the gloves in a subsequent process step, e.g. by spraying.

In principle, every mixture and combination of disinfectant and lubricant which is used for the coating of thin-walled medical gloves is claimed as according to the invention.

Examples of mixtures according to the invention of disinfectants and lubricants are:

Aqueous coagulation baths containing calcium stearate in the dipping process of glove production, to which a non-water-soluble disinfectant has been added in small quantities (e.g. containing 1% calcium stearate and 0.05% triclosan)

- Mixture of magnesium stearate and octenidine dihydrochloride e.g. in the last wash dip as part of the glove manufacturing process on a chain diving machine (e.g. 0.5% magnesium stearate and 0.05% octenidine dihydrochloride)

- Mixture of e.g. paraffin oil and polyhexanide (PHMB) e.g. for use on the outer glove surfaces after removing the gloves from the dipping molds in front of an automatic stacking device (autolayering device) - Etc.

The preferred amount of the germicidal or germ growth inhibiting substances applied to the gloves is about 0.1 to 10 times the recommended value for hand disinfection or 0.01 to 5 times the recommended value for wound disinfection the active ingredient of the respective disinfectant type according to the manufacturer's instructions.

The preferred amount of lubricant applied is strongly dependent on the respective lubricant, the glove material and the type of application to the gloves, and must in most cases be determined individually for each individual case as part of the product and manufacturing process optimization.

The simultaneous use of gloves according to the invention with germicidal or germ growth-inhibiting surfaces in combination with dispenser boxes according to the invention, where stacked gloves can only be grasped at their shaft edges for removal, furthermore represents a new, synergistically effective method for combating nosocomial infections Mixtures of disinfectant and lubricant in particular make it easy to remove from dispenser box packs, where the gloves are in a stacked arrangement and can preferably only be grasped at their shaft edges for removal.

Of course, the lubricant / disinfectant mixtures described can also be used for the surface treatment of other medical products, such as catheters, stomas, cannulas, tubes, and others, as well as for the treatment of critical surfaces in the care and treatment area, etc.

The gloves according to the invention to be packaged in the dispenser boxes are described in more detail below with the aid of a few production examples: Powder-free latex examination gloves are usually produced on a continuously operated chain diving machine, with hand-shaped dipping molds made of ceramic material being moved through baths and hot air dryers by means of a revolving chain. According to the prior art, the process steps listed below are essentially run through, with manufacturing steps 1 to 18 on the continuously running immersion machine, manufacturing step 19 in continuous or discontinuous washing or chlorination drums, and manufacturing step 20 in drying drums equipped with a spray device , is carried out: 1. Immersion in mold cleaning baths.

2. Mold drying after mold cleaning.

3. Immersion in a coagulant dip which preferably contains calcium salts and a mold release agent (lubricant) / disinfectant mixture according to the invention (e.g. calcium nitrate / calcium stearate / mecetronium methyl sulfate in combination with surfactants and defoamers).

4. Industrial air drying after the coagulant bath.

5. Immersion in one or more natural or synthetic latex mixture baths to position the latex carrier layer.

6. Air drying after the latex baths.

7. Diving in one or more dilution water baths (Precure Leaching).

8. Optional industrial air drying after Precure Leaching.

9. Optional dipping in synthetic latex (PU / polyacrylate) for the later internal sliding layer.

10. Optional industrial air drying.

11. Attachment of the rolled edge.

12. Main drying with hot air (vulcanization oven, "curing").

13. Diving in water baths (postcure leaching) and optional online chlorination with chlorine water.

14. Optional further diving in water baths (postcure leaching).

15. Optional application of a lubricant / disinfectant mixture (e.g. zinc stearate / mecetronium ethyl sulfate).

16. Hot air drying.

17. Optional: Cooling before removing the latex gloves.

18. Removing the latex gloves while turning them inside out.

19. Optional: washing and possibly light chlorination of the gloves in washing drums, whereby in a preferred variant the gloves can be treated with a mixture of lubricant and disinfectant solution.

20.Optional: drying in warm air and spray treatment of the gloves in a rotating dryer, whereby the gloves are sprayed with a mixture of lubricant (e.g. silicone oil emulsion or calcium stearate emulsion) and disinfectant solution.

The above description of the manufacturing process for natural or synthetic latex gloves is only to be regarded as an example and only reflects the typical state of the art using chain diving machines. Changes or variations in the process sequences (eg positioning of process steps in the context of the manufacturing process) are quite common here and do not influence the essential content of the present disclosure.

According to the invention, the targeted combined application of lubricants and disinfectants results in the formation of disinfecting surfaces, (optionally) both on the outside and on the inside of the gloves.

The simultaneous application of the disinfectants together with the lubricants means that the disinfectants are distributed more homogeneously over the surfaces of the gloves. The lubricant content prevents the gloves from sticking and makes it much easier to remove the gloves from the dispenser box - especially in the case of dispenser boxes where the gloves are stacked and can only be picked up by the shaft edges.

The simultaneous use of gloves with germicidal or germ growth-inhibiting surfaces in combination with a dispenser box according to the invention represents a new, synergistically effective method for combating nosocomial infections.

To the representations:

Legend to the drawings:

2 side surface of the dispenser box

3 Top surface of the dispenser box

4 removal openings

5 Hand part of the gloves, consisting of fingers, palm or back of the hand

6 cuff edge or rolled edge

9 separating film, here in the shape of a sack

1 shows a dispenser box packaging of stacked examination gloves according to the prior art, the gloves usually not having any disinfecting surfaces and being gripped on their palms for removal.

2 shows an example according to the invention of a dispenser box packaging of examination gloves arranged in a stack. Here are stacks of gloves and Removal openings 4 are arranged on the dispenser box in such a way that the gloves can only be gripped by the upper edges of the glove or the cuff edges 6 to remove them. When using disinfectants on the glove surfaces, the application of lubricants is advantageous according to the invention at the same time in order to prevent the gloves from sticking together and to ensure safe, hygienic individual removal.

3 shows microbiological examinations on examination gloves, the surfaces of which have been treated with mecetronium ethyl sulfate / calcium stearate or triclosan / silicone oil mixtures.

The disinfectants mentioned are usually used in health facilities in the form of alcoholic or aqueous solutions for disinfection. Despite the fact that the gloves were well dried after application of the disinfectant mixture and did not have a low molecular weight alcohol content on the surfaces, a significant growth inhibition of Staphylococcus aureus could be demonstrated around the treated glove pieces and thus the effectiveness of the concept according to the invention could be proven.

Gloves, the surfaces of which had been treated with the mixtures according to the invention mentioned here, were always very easy to remove from the stacked packs according to the invention, in contrast to gloves that were free of lubricant and treated with disinfectant.

Claims

Patent claims: 1. Flexible, preferably powder-free, object with a flexible carrier layer made of polymeric material, in particular made of natural or synthetic latex or soft PVC, preferably made by the immersion process, at least part of which is designed to come into contact with or to rest against human skin , in particular a work, examination, surgical glove, a catheter, a condom or the like, for single use, which is provided with a lubricious coating at least in a partial area of the inner or outer surface, characterized in that the lubricious coating has one or more Contains germicidal or germ growth inhibiting substances. 2. Flexible object according to claim 1, characterized in that it is a glove for single use, the glove having on the inner surface and / or on its outer surface, germicidal or germ growth-inhibiting lubricant-containing coatings, it being provided in particular that the glove has germicidal or germ growth-inhibiting lubricant-containing coatings according to the invention both on the inner surface and on its outer surface. 3. A method for producing disposable gloves according to one of claims 1 or 2, characterized in that germicidal or germ growth inhibiting mixtures are applied to the gloves as part of the manufacturing process, which lubricants from the group of polysiloxanes, fatty acid salts, polyolefins, paraffin oils, waxes or Hydrogels included. 4. A method for the production of disposable gloves from natural or synthetic latex according to claim 3, characterized in that the gloves are produced in the dipping process, and that germicidal or germ-growth-inhibiting substances in combination with lubricants, from the group of fatty acid salts, polyolefins, paraffin oils, waxes , are applied to the gloves as part of the manufacturing process before the first latex dip, with the germicidal or germ-growth-inhibiting substances are preferably not water-soluble and are present in disperse form together with the lubricants in the immersion bath. 5. A method for producing disposable gloves from natural or synthetic latex according to claim 3 or 4, characterized in that the gloves are produced in the dipping process, and that in the course of the production process before the first latex bath Coagulant dip is used which, in addition to water-soluble calcium salts, contains germicidal or germ growth inhibiting substances in combination with lubricants, preferably from the group of fatty acid salts, polyolefins, paraffin oils, polysiloxanes, waxes, both germicidal and germ growth inhibiting substances as well as the lubricants are not water-soluble and are in disperse form. 6. Liquid or disperse mixture for the surface treatment of flexible Objects according to claim 1 or 2, characterized in that these germicidal or germ growth-inhibiting substances in combination with lubricants, in particular from the group of polysiloxanes, fatty acid salts, Has polyolefins, paraffin oils, waxes or hydrogels. 7. Liquid or disperse mixture for the surface treatment of flexible Objects according to claim 5 or 6, characterized in that the germicidal or germ growth-inhibiting substances come from the group of wound or hand disinfectants, particularly preferably Chlorhexidines, Mecetronium Ethilsulfat, Triclosan, Triclocarbane, Octenidines, Chloramine T, Thymol, Chlorxylenol, Chitosan, Polyhexanid, Quaternary Ammoniumverbindungen, 2-Phenylphenol, Phenoxyethanols, Zinc-, copper-, silver salts, iodine compounds. 8. Use of gloves for single use according to one of claims 1 or 2, characterized in that they are used in combination with a dispenser box in which the gloves according to the invention are in a parallel stacked arrangement. 9. Use of gloves for single use according to claim 8, characterized in that the glove stacks and removal openings (4) are arranged so that the gloves can only be gripped at the upper edges of the glove for their removal. 10. Gloves, in particular according to one of claims 1 or 2, to avoid nosocomial infections in combination with a donor box, wherein the donor box contains at least one stack of gloves, the stack of gloves with an associated removal opening (4) is arranged so that the gloves to their Removal only from the upper edges of the glove or Cuff edges (6) can be gripped, characterized in that the gloves have surfaces which contain germicidal or germ-growth-inhibiting substances in combination with lubricants.