TECHNICAL FIELD

The invention relates to a chemical formulation coating to be applied to health apparatus and products such as injectors, especially nasogastric tubes (NGT) to be used in the medical field, in other words to areas where antibacterial/antifungal effect is desired.

BACKGROUND

Enteral nutrition (EB) can be applied directly, with a tube, percutaneous interventions, or by surgical method to different parts of the system from the mouth to the jejunum. Enteral nutrition is the continuous or intermittent administration of macro and micronutrients to the patient by nasogastric or nasoenteric, gastrostomy, or jejunostomy in patients with a functional gastrointestinal (GI) system. While nasogastric tube (NGT) and nasoenteric tube (NET) are the most commonly used tools in short-term nutrition such as four to six weeks, gastrostomy or jejunostomy is opened for long-term nutrition.

Nasogastric tube (NGT) is applied to hundreds of thousands of hospitalized patients every year for diagnostic, preventive, or therapeutic purposes as a complement to medical and surgical applications. Nasogastric tube (NGT) application is the insertion of a plastic catheter into the stomach by inserting it through the nostril and esophagus. Nasogastric tube application is an invasive application that is frequently used for enteral nutrition and concomitant drug administration, and stomach decompression and is under the responsibility of healthcare professionals. It is also used for irrigation and diagnostic applications of the stomach.

Today, NGTs are made of materials such as polypropylene, polyvinylchloride, latex, silicone, or polyurethane. Tubes made of polyvinylchloride are generally suitable for short-term feeding that will last less than seven days. Polyurethane tubes are especially suitable for enteral nutrition. These tubes are made of polyurethane, which can remain soft and flexible, which is a nonreactive substance. When tubes are used for long periods, they may cause esophageal and gastric erosions in patients. The polyvinyl chloride tubes should be replaced every three to five days, and the silicone or polyurethane tubes after eight weeks.

Microorganisms such as methicillin-resistant Staphylococcus aureus (MRSA), which increase the mortality rate by 2-2.5 times, cause microbial colonization and contamination in NGT and these microorganisms use NGT as a reservoir. Contamination of NGT with microorganisms leads to the development of many complications such as abdominal distension, bacteremia, diarrhea, pneumonia, and even death. Studies have shown that bacterial contamination develops 15 minutes after NGT placement; biofilm is formed in 60% of the tubes at the end of 24 hours and in all of them at the end of 48 hours, and the microorganisms that cause contamination on the outer surface of the NGT are also located inside the tube.

Nano-silver particles are known to be used to eliminate undesirable microorganisms and to prevent contamination due to their effective and wide-spectrum antibacterial activities. Even bacteria and viruses remain giant structures alongside nano-silver particles, and as soon as they come into contact with nanosized (0-200 nm) silver particles, their cellular structures deteriorate and die. Nano-silver has been attracting the attention of the scientific community for many years due to its antibacterial potency and the inability of bacteria to develop resistance to antibiotics against silver. Because of its nanoscale, when silver particles are coated on the surface of any material, the surface area increases several million times, providing a very strong antibacterial effect.

As mentioned above, enteral nutrients are ideal environments for reproduction, and when contamination occurs, bacteria proliferate rapidly, and contamination of the gastrointestinal tract may lead to diarrhea. In order to prevent bacterial contamination in patients who are fed enterally, it is recommended to follow hand hygiene, wipe the formula box opening cover with an alcoholic cloth, change the bedside formula set and bag routinely every 24 hours, to re-prepare the nutritional formulas every four hours, and to store the open formulas in the refrigerator. However, all of these are insufficient in solving the problems in the art.

In document numbered “US10695269B2”, the invention is described as “A nasogastric tube comprising at least one main lumen and at least one vacuum lumen comprising at least one suction port for sealing the inner wall of an esophagus against it, wherein the said at least one suction port includes a unique concave structure that significantly prevents tissue damage.” Small complications of NGTs of the present application include nosebleeds, sinusitis, and sore throat. Sometimes, the emergence of more important complications such as abrasion, esophageal perforation, pulmonary aspiration, intracranial placement of a collapsed lung or tube in the nose where the tube is fixed has addressed the technical problem and it is claimed that there is a need for improved NGTs with suction ports that can pull the inner wall of an esophagus towards themselves without causing tissue damage due to the applied suction force. Therefore, it is far from our current technical problem and the solution we offer.

In the document numbered “CN201329127Y”, the invention is a useful model, and discloses a nasogastric tube with a double tube cavity, including a perfusion tube cavity, wherein a guide wire tube cavity is provided in the tube body to guide the guide wire, the guide wire tube cavity end is a dead end, and the diameter of the pipe cavity of the guide wire is equivalent to that of the guide wire. The advantages of the nasogastric tube are as follows: 1 it reduces the possibility of infection contamination by effectively solving the problem of direct contact of guide wire and exudates in vivo; 2 it greatly enhances the strength of the nasogastric tube body to properly place and position the tube into the body by adjusting the diameter of the nasogastric tube equivalent to that of the guide wire, thus finishes the process once with insertion, avoids repetitive procedures, and reduces patients' pain. However, the present application is far from the solution we have presented.

As a result, the need to eliminate the deficiencies and disadvantages of the embodiments and applications that exist in the current art and are used today makes it necessary to improve in the relevant technical field.

DESCRIPTION OF THE INVENTION

The present invention relates to an antibacterial nanomaterial-coated nasogastric tube developed to eliminate the above-mentioned disadvantages and to bring new advantages to the related technical field.

The object of the invention is to provide an effective solution to show antibacterial/antifungal activity against pathogens on the surface of the NGT with the coating developed with the composition containing antibacterial/antifungal nano-silver ions. Nano-silver used in the invention does not harm human health, pets, or plants, in other words, multicellular organisms. During its function, nano-silver does not react in any way, is not deformed and the continuity in its function continues. In this way, the antibacterial effect will be provided on the surfaces contacted by NGTs without harming the living organisms, and thus, negative effects that may occur due to the presence of various bacteria during patient treatment will be eliminated.

Another object of the invention is to expect the antibacterial cover to be applied on the nasogastric tube to show strong activity on different microorganisms such as both bacteria and fungi. At the same time, the fact that it is odorless, stain-free, non-toxic, and washable is one of the innovations that the product will bring. With this study, "antibacterial coatings" will be obtained by using "Sol-Gel Coating" techniques, which is one of the most important applications of nano-coating technology.

Thanks to this invention, currently used NGTs will provide an antibacterial effect in the patient treatment process. In this way, antibacterial effects will be provided on the surfaces contacted by the Nasogastric Tubes, thus, negative effects that may occur due to the presence of various bacteria during patient treatment will be eliminated.

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the preferred alternatives of the embodiment of the present invention are merely explained for a better understanding of the subject of the present invention, which is not intended to be limiting in any way.

The nano solution, which has been tested for antibacterial activity in accordance with the standards, will be coated directly on the nasogastric tubes with spray, immersion, and brush application techniques and dried. For industrial applications, production can be carried out in series with a spraying method and subsequent effective drying phase in such a way that nasogastric tubes are homogeneously coated in a production line.

Sodium borohydride is used for antibacterial nanomaterial-coated NGTs. This compound is made of boron mineral and one of the most important purposes of its use in this invention is that it is a strong reducing agent. Sodium borohydride is used in the range of 30-45% by weight. In this way, it can store hydrogen in nanostructures at the appropriate pressure and temperature ranges and easily store them. Polyvinylpyrrolidone (PVP) is then added to this composition. The nanoparticles prepared by using this will have a homogeneous distribution in the solution. There will be equal concentrations of nano-silver particles everywhere. PVP is added in the range of 0.5-4.0% by weight. 0.5-2.0% oleic acid by weight is also added to the composition. With this addition, moisture is provided on the surface in the nano-silver solution. In addition, for antibacterial activity as the most important main compound, silver nitrate, which will be reduced to the nano-size, is added between 30-35% by weight and the nano solution is prepared. The nanosized solution, which is mixed with a mechanical stirrer for 24 hours in an extremely homogeneous manner, is applied on NGTs by spraying, immersion, and brush application methods and allowed to dry. (Parts 1 and 2).

The reason for using deionized water in the invention is that it is completely free of all organic, inorganic components and minerals within its framework. In addition, since deionized water has no taste, smell, color, and conductivity, it does not affect the chemicals or solutions it comes into contact with.

The invention is a formulation applied to the antibacterial nanomaterial-coated nasogastric tube for use in the medical field; it comprises 30-45% Sodium Borohydride, 0.5-4% PVP, 0.5- 2% Oleic Acid, 30-35% Silver Nitrate, and 14-39% Deionized Water in the combination of the whole formula by weight.

The production method of the invention comprises the process steps; - Dissolving all chemicals separately in deionized water,

- Adding PVP (Polyvinylpyrrolidone) to Sodium Borohydride,

- Adding oleic acid to the resulting chemical mixture,

- Adding silver nitrate to the resulting mixture,

- Mixing the resulting mixture homogeneously preferably with a mechanical stirrer for 24 hours,

- Applying the nano-sized solution on the apparatus to be directly applied by spraying or immersion or brush application methods or preferably on a hydrophobic nonwoven fabric by immersion, spraying or brush application methods,

- Allowing the applied process to dry preferably at 75-100 degrees in the oven.

From the temperature values used in the invention, the maximum efficiency is 85 degrees and it can be preferred between 75-100 degrees.

The nonwoven fabric used is hydrophobic and repels the existing water.

The PVP and Sodium Borohydride used in the invention were used as reducing agents. While Silver Nitrate provides antibacterial properties, it acts as a stabilizer in oleic acid in the present invention.