HRP20161254A2 - Sterile urinary catheter - Google Patents

Abstract

The invention relates to a sterile urinary catheter (2.1), which, as a rule, is already inserted during production into suitable sealed medical plastic packaging (2.3) so that the remaining available space in the packaging is completely filled with the corresponding antiseptic agent (2.2), octenidine chloride, octenidine hydrochloride and octenidine dihydrochloride, the chemical formula of which is C36H62N4 x 2HCI, given the IUPAC name: N - octyl - 1 - [10 - (4 - octyliminopyhdin - 1 - yl) decyl] pyridine - 4 - imine, dihydrochloride , in gel or solution form. <BR/> The procedure for inserting a urinary catheter through the urethra into the bladder is performed shortly after removal from the packaging (2.3) of the urinary catheter (2.1). <BR/> Alternatively, the urinary catheter (2.1) is inserted into one chamber (4.4) of suitable hermetically sealed medical plastic packaging, while the other separate chamber (4.5) is filled with the corresponding gel-like antiseptic agent (2.2). or solution. These two chambers of medical plastic sealed packaging are constructed as two separate chambers but so that they are adjacent to each other, for example with a common wall (4.1), which allows the immersion of the catheter into the gel or solution antiseptic agent (2.2) or by removing that common wall (4.1).

Description

1. The field to which the invention relates

This invention relates to a sterile urinary catheter which, according to the International Patent Classification (IPC), is classified as: A61M 25/00 - catheters.

2. Technical problem

The technical problem that is solved by the subject invention is the contamination of the urinary catheter that occurs during the implementation of the urinary catheterization procedure, i.e. before and during the application of the catheter, which consequently results in bacterial inflammation of the urinary bladder and the entire urinary tract.

3. State of the art

In conditions that prevent complete physiological emptying of the bladder, urinary catheterization is indicated, which includes intermittent and permanent catheterization, which is carried out after urological and other surgical procedures, but also during diagnostic tests such as urodynamics and micturition cystourethrography, in which, through a permanent catheter, introduces a contrast agent or physiological solution into the bladder. The intermittent catheterization procedure is performed independently by the patient, if necessary, several times a day, while the permanent catheterization procedure is performed by a healthcare professional, usually a nurse, and in exceptional cases even a surgeon or urologist. The application of the urinary catheter is performed by inserting it into the bladder through the urethra 1.5 (urinary tube in the genital area) or through a surgically constructed stoma positioned in a suitable place on the surface of the skin.

A urinary catheter is a specially designed tube through which urine flows, and urinary catheterization is a procedure in which a urinary catheter 1.6, actually a suitable tube made of a suitable flexible plastic material (silicone or siliconized material in the case of a permanent catheter) is introduced through the urethra 1.5 into the patient's bladder 1.3, in which way the patient's urine 1.4 is allowed to flow freely from the neurogenic bladder through the catheter 1.6, in which the urine was left behind and collected there as a result of the disturbance of the possibility of natural emptying, i.e. the appearance of residual urine, i.e. urine remaining in the bladder, which occurs as a consequence of various pathophysiological conditions.

Urinary catheters can be permanent (permanent) or intermittent, which is removed after each emptying of the bladder, with a large number of different designs, where the differences are primarily in terms of dimensions, which are otherwise determined by the French catheter scale, thanks to which it is possible to choose a catheter from a large offer suitable for each individual case, and even according to the gender of the patient, which means that regardless of whether the catheter is introduced into the urinary tract through the penis or through the urethral meatus, the free flow of urine through the catheter is always enabled in order to prevent leakage of urine past the catheter .

Suppressing the occurrence of infection, even of the smallest scale and intensity, of any part of the entire urinary system when performing urinary catheterization is an absolute requirement and criterion for the success of its implementation, which means that catheterization must be an unquestionably sterile medical procedure, regardless of whether it is performed by qualified personnel using equipment designed for this purpose or the educated patient himself.

A number of elementary rules are prescribed as mandatory and self-explanatory preventive measures to prevent infection during urinary catheterization, such as hand washing before performing the urinary catheterization procedure, application of suitable antiseptic agents, most often by application in the form of a spray of octenidine chloride in combination with phenoxyethanol or another base, e.g. water in the area of the urethra, i.e. the place where the catheter enters the body, as well as in its environment, in order to prevent the transfer of bacteria from the skin to the urethra, but all this together does not solve the problem of contamination of the catheter itself, but only the problem of contamination of the perioperative region.

Today, the global problem of bacterial infections of the urinary system, which occurs when a urinary catheter is inserted into the bladder, is well known. The most common reason for this is that the catheter is not sterile before the application itself, since contamination of the catheter occurs even immediately before the urine catheterization procedure, which according to the known state of the art is almost impossible to avoid in everyday conditions. This is confirmed by randomized clinical studies, which state that when using today's known catheter designs as well as performing catheterization procedures, there is no statistically significant difference in the incidence of bacteriuria between sterile and clean intermittent catheterization, whereby sterile catheterization is 277% more expensive. (King RB, Carlson CE, Mervine J, VVu Y, Yarkony GM. Clean and sterile intermittent catheterization methods in hospitalized patients with spinal cord injury. Archives of physical medicine and rehabilitation. 1992; 73(9): 798-802.)

The known state of the art includes numerous solutions in attempts to solve the indicated technical problem. Thus, among other things, the use of oligodynamic metal ions, which are located in the hydrophilic layer on the surface of the catheter and are gradually released from the substrate, is envisaged as a means of preventing contamination of the ureter. The production process and raw materials are expensive, while the biggest problem lies in the absorption of metals into tissues.

Furthermore, in some technical solutions contained in the known state of the art, a solution using antiseptic agents was also proposed, whereby the highlighted antiseptic agents were hydrogen peroxide (in volume concentrations of 1% and 3%), iodine and chlorhexidine, and some other agents were also mentioned, which can be found in the catheterization set in combination with up to three antimicrobial substances.

In the known state of the art, there are also combinations in which metal salts and organic acids are used as antimicrobial substances. Some of the previously mentioned agents are included in the composition of the substrate of the hydrophilic layer, where they are activated by solvents such as water and ethanol. At the same time, in one of the solutions, the hydrophilic polymer coating is cross-linked to the mentioned substrate by irradiation. The problem lies in the fact that the aforementioned antiseptic agents, ie ethanol as a solvent, must not come into contact with the mucous membrane of the urethra due to absorption into the tissue.

In addition, in some known solutions to the technical problem, the use of antibiotics such as penicillin, amoxicillin, rapromycin, and their combinations was mentioned. The use of these antibiotics solves the problem only partially, because the mentioned antibiotics work only on certain types of bacteria, while other types of bacteria are resistant, and therefore the problem of contamination remains unsolved. Likewise, due to the irrational use of antibiotics, where the preventive and not the curative value of antibiotics is meant, resistance to them develops.

It is important to point out that the occurrence of bacterial infections of the urinary tract during the implementation of the urinary catheterization procedure is absolutely not excluded, even if the unquestionable sterility of the catheter is ensured in the production process, for example, the implementation of radiation sterilization, whereby sterile catheters are invested in adequate medical plastic packaging and storage and preservation such packaged sterile catheters until the actual implementation of the urinary catheterization procedure, which is a consequence of the fact that contamination of the catheter also occurs from the air as soon as the catheter is removed from the packaging in medical plastic, i.e. just before the actual application of the urinary catheter.

Therefore, there is a basis for the conclusion that despite the solutions known up to now according to the known state of the art as well as the use of existing medical aids, safety against the occurrence of urinary tract infection during the implementation of the urinary catheterization procedure in patients, especially in persons with disabilities and the elderly, has not yet been achieved. age and small children.

4. The essence of the invention

The essence of the subject invention aims to prevent and even completely eliminate the contamination of the urinary catheter that occurs during the implementation of the urinary catheterization procedure, i.e. when the urinary catheter is inserted into the bladder, thereby preventing and even eliminating the possibility of bacterial infection of the urinary system, which would occur as consequence of contamination of the urinary catheter.

As is known from the state of the art, the indicated goal of the subject invention has not been achieved so far despite the fact that the urinary catheterization procedure is carried out with the provision of a series of preventive measures. Thus, one of these measures consists in the fact that the urinary catheterization procedure is carried out as an unquestionably sterile medical procedure, regardless of whether it is performed by qualified personnel or the educated patient himself, using in both cases equipment designed for this purpose, within which sterility is ensured of the urethral area, i.e. the perioperative region, thus including the place where the catheter enters the body, as well as in its environment, how to prevent the transfer of bacteria from the skin of the urethral area through the urethra and catheter into the urethra and further into the bladder 1.3 through the ureter 1.2 all to the kidneys 1.1.

Of essential importance is the fact that the indicated goal of the subject invention has not been achieved so far even when ensuring the sterility of the catheter itself, which is regularly and routinely achieved already in the production process, in which the sterilization of the catheter is carried out, for example, by radiation, after which the sterile catheters are invested in an adequate packaging made of medical plastic and store and keep them packaged until they are used during the urinary catheterization procedure.

All the above-mentioned measures, during the implementation of the urinary catheterization procedure, including the use of sterile catheters, can nowadays be considered to represent an unquestionable standard, practice and prerequisite for further measures to prevent and/or eliminate bacterial infections of the urinary system, but which is only partially or in some favorable combination of circumstances, contributes to the prevention of bacterial infections of the urinary system that occur during the implementation of urinary catheterization, i.e. when the urinary catheter is inserted into the bladder, but the mentioned measures, each by itself and all together, do not form a whole solution existing problem.

The failure to achieve a complete and satisfactory solution to the indicated technical problem, which would reliably and without exception prevent and even eliminate the possibility of bacterial infection of the urinary system, stems from the fact that there is a possibility of contamination even of an initially sterile catheter, except in the mentioned ways, and bacteria from the surrounding air, which is particularly pronounced during the urinary catheterization procedure when bacteria settle on the surfaces of part or the entire surface of the initially sterile catheter itself. The possibility of this happening exists for the entire time from the moment after the sterile catheter is removed from the medical plastic packaging, until the moment when the urinary catheter is applied, that is, until the urinary catheter is inserted into the bladder.

Therefore, the actual prevention and even elimination of the possibility of bacterial infection of the urinary system, which occurs during the implementation of the urinary catheterization procedure, can only be achieved with the solution according to the subject invention.

The essence of the solution to the technical problem according to the subject invention consists in achieving the sterility of the urinary catheter not only with the preventive measures indicated above, but also for the entire time from the removal of the sterile catheter from the hermetic packaging made of medical plastic until the catheter is finally inserted into the bladder, which is achieved so that on all surfaces of the entire surface of the catheter, a layer of appropriate antiseptic agent according to the invention is established, that is, a layer of the appropriate antiseptic agent according to the invention is established, regardless of whether it is a disposable or permanent one, including all their types and designs, but above all disposable catheters, which are included and initially sterile catheters, in which way the established layer of an appropriate antiseptic agent on all surfaces of the entire area of the catheter eliminates the possibility of contamination of the urinary catheter with bacteria from any surrounding environment, not even bacteria from the surrounding air, as part of the catheter application procedure, the end result of which is elimi avoiding any possibility of bacterial infection of the urinary system during the implementation of the urinary catheterization procedure.

The antiseptic agent according to this invention means octenidine chloride, octenidine hydrochloride and octenidine dihydrochloride, whose chemical formula is C36H62N4 x 2HCI2, and the name according to IUPAC: N - octyl - 1 - [10 - (4 - octyliminopyridin -1- yl) decyl] pyridine - 4 - imine, dihydrochloride, whereby the above-mentioned antiseptic agent primarily has reliable and safe antiseptic properties, but it also has further multiple favorable properties that come to full expression in particular with disposable urinary catheters, in particular the property of being on all surfaces parts that make up the entire surface of the catheter, on which there is normally a hydrophilic layer initially, which contributes to and enables the reliable establishment of a suitable permanent and sufficient layer of antiseptic agent, in which way it is possible to reliably achieve the sterility of urinary catheters.

Furthermore, octenidine dihydrochloride, in addition to its absolutely satisfactory antiseptic properties, also has additional properties as part of achieving the sterility of the catheter as well as the urinary catheterization procedure, namely the properties of mobility, expansion, dispersion, adhesion and permanent retention on the walls of the overall surface of the material from which the catheters are made, mainly materials from which the catheter tube is made, on the total surfaces of which there is a hydrophilic layer.

Urinami catheter already from the moment it is produced, on its total surfaces contains a hydrophilic layer that is applied to the surface of the catheter during the production process and which serves as a base to which a suitable solution of the appropriate antiseptic agent according to this invention is attached, primarily octenidine dihydrochloride. The hydrophilic layer is a conditio sine qua non because the antiseptic agent in the form of a solution cannot bind to the surface of the catheter without it.

The antiseptic agent according to the invention, primarily octenidine dihydrochloride, can also be used in the form of a gel that has all the physical properties necessary for the successful binding of octenidine dihydrochloride to the surface of the catheter, and therefore in this case it is not necessary to have a hydrophilic layer on all surfaces of the entire catheter surface.

So, even in the case when for some reason there is no hydrophilic layer on the surface of the catheter, regardless of whether it was not initially applied at all or after application it was decomposed due to some processes, using octenidine dihydrochloride in the form of a gel as an antiseptic agent ensures the retention of its layer on the surface of the catheter all the time while it is in the hermetic packaging, but also after removing the catheter from the packaging until the catheter is inserted into the urethra. Otherwise, octenidine dihydrochloride as an antiseptic agent, regardless of whether it is in the form of a solution attached to a hydrophilic layer, or in the form of a gel, also serves as a lubricant during catheterization.

Eliminating the possibility of contaminating the urinary catheter within the catheter application procedure according to the subject invention is achieved by establishing a layer of the antiseptic agent according to the invention, primarily octenidine dihydrochloride with the aforementioned properties, on all the walls of the overall surface of the materials from which the catheters are made, especially the materials from which a catheter tube is made which, during application, is inserted through the urethra into the bladder.

The purpose of coating the catheter with an antiseptic agent according to the invention, primarily octenidine dihydrochloride, is to create a complete barrier between the surface of the catheter and harmful microorganisms (bacteria) from the environment. The solution implemented in this way ensures catheterization without the risk of contamination and consequent infections. Bacteria cannot settle on the surface of the catheter because the antiseptic agent according to the invention, primarily octenidine dihydrochloride, applied to all the walls of the entire surface of the material from which the catheters are made just before the application itself (or in the case of a gel immersed with the catheter in the same package) immediately destroys and bacteria, so during the urinary catheterization procedure there is no possibility of bacteria entering the body.

Achieving and maintaining the condition that a layer of the antiseptic agent according to the invention, primarily octenidine dihydrochloride, is established on the walls of the entire surface of the material from which the catheter is made, especially on the material from which the catheter tube is made, can be achieved in at least two ways, depending on the form in which the antiseptic agent according to the invention is, primarily octenidine dihydrochloride, which is most often found in the form of a gel or in the form of a solution.

When the antiseptic agent according to the invention is octenidine dihydrochloride in the form of a gel, the sterility of the catheter is achieved by immersing the catheter, regardless of whether it was previously sterilized or not, and keeping it in the octenidine dihydrochloride in the form of an antiseptic agent, a layer of the antiseptic agent is established, so octenidine dihydrochloride in the form of a gel with the aforementioned properties, on all the walls of the entire surface of the material from which the catheters are made, especially the material from which the catheter tube is made, which is inserted into the urinary bladder during application through the urethra.

This practically means that the urinary catheter 2.1 is placed in hermetic packaging made of medical plastic of the appropriate shape, volume and configuration, with the corresponding thickness and strength of the wall 2.3 so that it is possible to place the catheter, while the remaining available space in the packaging is completely filled with the corresponding antiseptic 2.2 according to the invention, primarily with octenidine dihydrochloride in the form of a gel or solution.

Removing the urinary catheter 2.1 from the packaging, on all the walls of the total area of the material from which the catheters are made, especially the material from which the catheter tube is made, a layer of the antiseptic agent according to the invention, primarily octenidine dihydrochloride in the form of a solution or gel, has been established, which is carried out with the aim of carrying out the urinary catheterization procedure, it is achieved in a suitable way, for example by rotating in opposite directions the base/fingertip of the catheter 2.6 and the packaging with the wall 2.3, to achieve their separation in the belt 2.7 and then to remove the catheter from the hermetic packaging made of medical plastic , after which the introduction of the urinary catheter through the urethra 1.5 into the bladder 1.3 is carried out, in which way the contamination of the urinary catheter 2.1 is prevented during the entire time from the opening of the packaging 2.3 with a wall made of medical plastic in which the sterile catheter 2.1 is stored after production and the removal of the catheter from until the insertion of the catheter into the urethra 1 .5 and bladder 1.3.

Urinary catheter sterility 2.1 so that on all walls of the entire surface of the material from which the catheters are made, especially the material from which the catheter tube is made, a layer of the antiseptic agent according to the invention, primarily octenidine dihydrochloride in the form of a gel or solution, is effectively and without exception established , it is possible to achieve immediately before the actual implementation of the urinary catheterization procedure, and this by placing the urinary catheter 4.6 as well as the corresponding antiseptic 4.7 in two separate chambers, so that the urinary catheter is stored in one chamber 4.4 while the corresponding antiseptic according to the invention, for example octenidine dihydrochloride in the form of a gel or solution, placed in another, separate chamber 4.5, but so that these two chambers are located next to each other, and have a common wall 4.1.

Coating all the walls of the entire surface of the material from which the catheters are made, especially the material from which the catheter tube is made, in which way a layer of the antiseptic agent according to the invention is established on these surfaces, primarily octenidine dihydrochloride in the form of a gel or solution, is achieved by immersion of the urinary catheter 4.6 in a suitable antiseptic 4.7, for example octenidine dihydrochloride in the form of a gel or solution, which is carried out before the actual application of the urinary catheter and in such a way as to remove the common wall 4.1 in a suitable manner, in which way the possibility is achieved that the appropriate the antiseptic according to the invention, for example octenidine dihydrochloride in the form of a gel or solution, spontaneously overflows from chamber 4.5 into chamber 4.4, in which way the connection of the antiseptic agent and the urinary catheter is realized, which makes it possible to cover all the walls of the entire surface of the materials from which they are made catheters, especially the materials from which the catheter tube is made, how a layer of the antiseptic agent according to the invention is established on these surfaces, primarily octenidine dihydrochloride in the form of a gel or solution.

The removal of the common wall 4.1, in order to achieve the possibility that the appropriate antiseptic of the invention, for example octenidine dihydrochloride in the form of a gel or solution, from the chamber 4.5 spontaneously overflows into the chamber 4.4, can be achieved, for example, by turning the base/tip 2.6 of the catheter in relation to chambers 4.4 and 4.5 as a unified whole, which results in the destruction or removal of the common wall 4.1, after which the separation in the zone 2.7 of the base/tip of the catheter 2.6 and the packaging with the wall 2.3 occurs.

Reliable, complete and without exception coating of all the walls of the total surface of the material from which the catheters are made can be improved by turning the packaging, whose outer wall 4.3 is the united chambers, 4.4 and 4.5, several times by 180° after removing the common wall 4.1.

5. Short list of drawings

Figure 1. Presentation of the basic components of the urinary tract

Position 1.1: Kidneys;

Position 1.2: Ureter;

Position 1.3: Bladder;

Position 1.4: Urine in the bladder;

Position 1.5: Urethra;

Position 1.6: Catheter;

Figure 2. Presentation of the assembly of the urinary catheter together with an antiseptic in a medical plastic package;

Position 2.1: Urinary catheter immersed in an antiseptic agent according to the invention;

Position 2.2: Antiseptic agent according to the invention;

Position 2.3: The wall of the packaging chamber in which the catheter and antiseptic perma-invention agent are placed;

Position 2.4: Openings in the catheter tube for the entry of urine;

Position 2.5: Sealer of packaging;

Position 2.6: Catheter base/pinch;

Position 2.7: Belt connecting the base of the catheter and the walls (2.3) of the packaging;

Figure 3. View of the distal part of the plug with indentations for gripping with fingers

Position 3.1: Catheter tube;

Position 3.2: Distal zone (corridor sanitaire) between base/pincer and tube;

Figure 4. Presentation of the urinary catheter assembly and an antiseptic agent, for example, octenidine dihydrochloride, which are placed in separate and separate chambers of the medical plastic packaging, whereby the urinary catheter assembly is placed in one of these chambers and an antiseptic agent, for example, octenidine dihydrochloride, is placed in the other

Position 4.1: Common wall of the combined two (4.4) and (4.5) chambers, which also separates these chambers;

Position 4.2: Connection of the common wall (4.1) and the base (2.6) of the catheter;

Position 4.3: Outer wall of united chambers, (4.4) and (4.5);

Position 4.4: The chamber in which the catheter is placed;

Position 4.5: The chamber in which the antiseptic is placed;

Position 4.6: Urinary catheter in a separate chamber (4.4);

Position 4.7: Antiseptic agent according to the invention, placed in a separate chamber (4.5);

6. Description of the method of realization of the invention

The realization of the subject invention is achieved by the usual procedures, procedures and methodologies that are known and have been classics in the field of medicine for decades, especially the part of it commonly known as urology.

7. Method of application of the invention

The application of the subject invention represents an essential advance in the field of urology, and its application does not differ from previously known ones in the method itself, but in the effectiveness of eliminating contamination of the urinary catheter that occurs during the implementation of the urinary catheterization procedure, i.e. during the introduction of the urinary catheter into the bladder, which prevents and even and eliminates the possibility of bacterial infection of the urinary system, which would occur as a result of contamination of the urinary catheter.

Claims (4)

1. Sterile urinary catheter for the implementation of the urinary catheterization procedure, indicated by the fact that the urinary catheter (2.1) was immersed for a certain time in the antiseptic agent (2.2) octenidine chloride, octenidine hydrochloride and octenidine dihydrochloride, whose chemical composition is formula C36H62N4 x 2HCI, and name according to IUPAC: N - octyl - 1 - [10 - (4 - octyliminopyridin -1- yl) decyl] pyridin - 4 - imine, dihydrochloride, in the form of a gel or solution, in such a way that the urinary catheter (2.1) was placed in hermetic packaging made of medical plastic of the appropriate shape, volume and configuration, with the associated thickness and strength of the packaging wall (2.3), so that the urinary catheter (2.1) can be placed in that packaging, while the remaining available space in the container with a wall (2.3), completely fill with the corresponding antiseptic agent (2.2) in the form of a gel or solution. 2. Sterile urinary catheter according to the 1st patent claim, on all the walls of the entire surface of the material from which the catheters are made, especially the material from which the catheter tube is made, which is inserted into the bladder through the urethra during application, a layer of an appropriate antiseptic agent has been established, in the form of a gel or solution, indicated by the fact that the procedure of introducing the urinary catheter through the urethra into the bladder is carried out immediately after the removal of the urinary catheter (2.1) from the packaging with a wall (2.3), which is achieved in a suitable way, for example by turning it in the opposite direction directions of the base/pinch of the catheter (2.6) and the packaging with the wall (2.3), achieve their separation in the belt (2.7). 3. Sterile urinary catheter according to patent claim 1, characterized in that the immersion of the urinary catheter (2.1) in the antiseptic agent (2.2) is carried out immediately before the use of the catheter (2.1) for the implementation of the urinary catheterization procedure, which immersion is achieved in such a way that the urinary catheter is (4.6) as well as the corresponding antiseptic (4.7) placed in two separate chambers, whereby the urinary catheter is stored in one chamber (4.4) while the corresponding antiseptic in the form of a gel or solution is placed in another, separate chamber (4.5), whereby these two chambers are located next to each other, so that they have a common wall (4.1), and the urinary catheterization procedure by introducing the urinary catheter through the urethra into the urinary bladder is carried out just after the connection of the antiseptic agent (4.7) and the urinary catheter (4.6) is achieved. , which is achieved by removing the common wall (4.1), which creates the possibility that the corresponding antiseptic, in the form of a gel or solution, from the chamber (4.5) spontaneously p rally into the chamber (4.4), thereby achieving the connection and coating of the urinary catheter (2.1) with an antiseptic agent (4.7), which can be facilitated by removing the common wall (4.1), the packaging of the united chambers, (4.4) and (4.5) ) whose outer wall is (4.3), turn several times by 180 °. 4. Sterile urinary catheter according to patent claim 3, characterized by the fact that the removal of the common wall (4.1), in order to achieve the possibility that the appropriate antiseptic, in the form of a gel or solution, from the chamber (4.5) spontaneously overflows into the chamber (4.4), is possible can be achieved, for example, by turning in opposite directions the base/fingertip (2.6) of the catheter in relation to the chambers (4.4) and (4.5) as a unified whole, which first causes the destruction or removal of that common wall (4.1), after which the separation in to the belt (2.7) of the catheter base/tip (2.6) and the packaging with the wall (2.3).