WO2024228140A1

WO2024228140A1 - Three-way connector for bladder catheters

Info

Publication number: WO2024228140A1
Application number: PCT/IB2024/054250
Authority: WO
Inventors: Greta TODESCHINI
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-05-02
Filing date: 2024-05-02
Publication date: 2024-11-07
Anticipated expiration: 2025-11-02

Abstract

The invention is a three-way connector (100) for urine collection and/or for washing a bladder catheter (C), comprising: a three-way valve (200), a first fitting (300) mounted on the first outlet (210) of said valve (200) and suited to be connected to a bladder catheter (C), a second fitting (400) mounted on the second outlet (220) of said valve (200) and suited to be connected to a tube (S1) of a urine collection bag, a third fitting (500) mounted on the third outlet (230) of said valve (200) and suited to be connected to a device or syringe (P) for injecting a liquid into the valve (200) and/or for drawing a liquid from the inside of the valve (200).

Description

THREE-WAY CONNECTOR FOR BLADDER CATHETERS DESCRIPTION

The present patent concerns medical devices for urinary catheterization, and in particular it concerns a new three-way connector for urine collection and/or for washing bladder catheters.

Bladder catheters with different characteristics, depending on the applications, are known.

Catheters for prolonged use are known, that is, catheters which are designed to remain applied in the patient's body for several days, or even for much longer periods.

Urinary catheterization is used to empty the bladder artificially, but can also be used to collect sterile urine samples, that is, taken directly from the bladder, or to administer drugs.

For example, the so-called “balloon” urethral catheters are known, which comprise a tube made of a soft, flexible material, suited to be inserted through the urinary canal into the bladder.

Said tube comprises a first end intended to be introduced into the bladder and provided with a balloon that is inflated when it is inside the bladder to prevent the tube from autonomously slipping out. At the opposite end of the tube, instead, there are two openings, one for the outflow of urine, which will be connected to a collection bag, and one for the injection of a saline solution to inflate the balloon.

Said urine outlet is then connected to the bag, which is usually attached to a support, for example to the bed for bedridden patients, or to the leg of walking patients. The bag must be periodically emptied by means of a special valve mounted on it.

Three-way catheters are also known, in which one larger channel is intended for the outflow of urine, a second channel is used for inflating the balloon, while the third channel is intended for injecting a liquid to wash the catheter. This type of three-way catheter has the drawback of having a large diameter, meaning that it cannot be used in all situations, in addition to being very uncomfortable to leave in place for long periods.

The use of bladder catheters can entail various risks, both for the patient and for the operator or person in charge of the patient’s care and handling the catheter.

Among these risks, health care-associated infections (HCAIs) are unfortunately very common, which include infections caused by pathogens already present within the body as well as infections transmitted from the outside, that is, due to bacteria and contaminating agents in general which get into the patient's body through the catheter.

When dealing with catheters, in fact, operations such as, for example, emptying the collection bag, replacing the catheter, taking urine samples and washing the catheter in case of obstruction, are frequently carried out.

In fact, up to 50% of catheterized patients experience occlusion of the catheter lumen.

All these operations require operators or the patients themselves to handle the catheter, the bag, syringes and other medical devices, and above all require that the catheter circuit be opened, very often by detaching it from the bag, which means opening a possible channel through which contaminants can be be introduced.

The washing procedure, as currently standardized, requires the following operations: detaching the bag from the catheter, taking care not to contaminate the catheter outlet and the bag connection cone; connecting a sterile cone syringe containing a washing liquid to the catheter;

- washing the catheter by injecting the washing liquid and drawing the sediment that obstructs the lumen; disconnecting the syringe containing contaminated fluid while trying to avoid uncontrolled spillage; in particular, if the catheter has been unblocked, urine flows copiously and the operator must therefore take great care to keep the catheter duct mechanically, often manually, closed until the catheter is properly connected to the collection bag; properly disposing of the syringe containing the contaminated material.

It can be easily understood that all these operations entail the risk of some contaminating agents getting into the catheter, and of the operator themselves being accidentally contaminated.

This operation often needs to be repeated several times, and to ensure due care it should be carried out by two operators.

For urine sampling, collection bags are known which, in proximity to the connection to the catheter, are equipped with a valve having a perforated membrane, which must be thoroughly disinfected before inserting the needle for aspiration. This procedure entails the risk of contamination of the sample and, above all, the handling of needles always involves risks for the operator. Document US2023/008738A1 describes a three-way valve, on which three rigid fittings of rather limited length are mounted, which do not allow the device to be adequately manoeuvred.

Document W02004/034953 Al describes a urine bag, inside which there is a three-way valve connected to the inside of the bag and to a bladder catheter, which sticks out of the bag and can also be connected to a syringe through a second duct that sticks out from the bag. Said valve, being positioned inside the bag, is difficult to manoeuvre, and furthermore is also immersed, like at least part of the bladder catheter, in the urine that is collected inside the bag. This causes serious problems related to the need to ensure that the catheter is sterile and to the safety of the operator and the patient.

Document WO2017/163092A2 describes a very complex device, also equipped with optical devices, lights and mirrors intended to enable selfcatheterization and administration of medical solutions in the bladder of female patients. Also in this case, the connections with the catheter, the urine bag and the syringe are rigid and rather short fittings, which do not allow the device to be easily manoeuvred, also due to the fact that it is further complicated by the presence of lights, cameras and mirrors.

Document CN204543058U describes a three-way connector that, like the previous devices, is difficult to handle due to the rigidity of the fittings.

In order to overcome all the above-mentioned drawbacks, a new type of thee- way connector for collecting urine and/or washing bladder catheters has been designed and constructed.

The main object of the present invention is to reduce the risk of infection in the patient, while also increasing safety for the operator, by keeping the urine outflow circuit always closed, thus limiting the risk of contaminants entering the patient's body through the catheter on the one hand, and the uncontrolled leakage of contaminated fluids from the patient's body on the other.

Another important object of the invention is to provide a connector that can be used on any type of bladder catheter, and in particular even on small catheters, catheters intended to remain in place for a long time, suprapubic catheters, etc.

Another important object of the invention is to ensure that the device is easy to use, also for non-professional operators, for example by a patient's family members or carers, or by the patient themselves.

Another important object of the invention is to ensure that the device can be easily used not only for periodic bladder catheter washing, but also for safe urine sampling by both patient and operator.

Another object of the invention is to also allow easy replacement of the urine collection bag.

These and other direct and complementary objects are achieved by the new three-way connector for urine sampling and/or for washing bladder catheters, which in its main parts comprises: a three-way valve, equipped with an on-off selector having a knob to selectively connect two ways or to open all ways, said valve thus having three outlets; at least one first fitting mounted on a first outlet of said valve, said first fitting being suitable for connection to a bladder catheter; at least one second fitting mounted on a second outlet of said valve, said second fitting being suitable for connection to a urine collection bag; at least one third fitting mounted on a third outlet of said valve, said third fitting being suitable for connection to a device for the injection of a liquid into the valve and/or for the suction of a liquid from within the valve.

In the preferred solution, said first fitting is mounted on said first outlet of the valve in a non-removable manner.

However, according to the invention said first fitting can be mounted on said first outlet of the valve in a removable manner, in order, for example, to allow the fitting itself or the valve to be replaced. Said first fitting also preferably comprises at least one flexible part, in order to ensure a certain degree of mobility of the entire system. For example, said first fitting is completely or partially made of rubber and/or latex and/or flexible plastic or in any case of a material that makes it possible to bend or curve said first fitting or part of the same to a non-negligible extent, which cannot be done with normal fittings made of a rigid material, plastic or the like.

The free end of said first fitting preferably comprises a cone for connection to a normal bladder catheter.

Said cone, in particular, is configured for connection to bladder catheters of the known type, having any diameter.

Said second connection is also preferably flexible, to ensure a certain degree of mobility of the collection bag to which it is connected, and is mounted in a removable or non-removable manner on said second outlet of the valve.

Said third fitting is mounted in a removable or non-removable manner on said third outlet of the valve and can comprise an anti-reflux valve or membrane or another device suited to prevent any uncontrolled leakage of liquid from the inside of the valve towards the outside.

According to the invention, furthermore, said third fitting can comprise connection means, for example of the type for syringes with Luer-Lock™ cones, that is, having a threaded part suited to be screwed into the cone of a syringe.

Alternatively, said third fitting can be configured for simple connection to a non-threaded cone of a syringe of the known type, for example of the type called “schizzettone” in Italian technical jargon.

Said syringe, whatever type it is, can be selectively used to inject washing liquid into the valve, for example to wash the bladder catheter, or to inject liquids in general, for example medical substances or other substances. Alternatively, said syringe, once correctly connected to said third fitting, can be used to draw liquid from inside the valve, for example for urine sampling and for collecting any sediment from the bladder catheter.

In both cases, it is preferable that said connection means of said third fitting be suitable for limiting or preventing the risk of uncontrolled liquid spillage. For this purpose, it has been observed that a connection of the Luer-Lock™ type is particularly effective and preferable.

The connector also preferably and conveniently comprises at least one cap suited to seal said third fitting while maintaining sterile and antiseptic conditions. In fact, it is of fundamental importance that said third fitting be always kept sealed and protected from external contamination, so as to prevent the leakage of liquids, on the one hand, but above all to prevent said third fitting from coming into contact with contaminants that could get inside the valve and thus inside the bladder catheter.

In this way, the catheter circuit actually remains always closed.

According to the invention, in order to make the new connector easier to handle, said third fitting is preferably long enough to allow easy connection to a syringe, that is, its length is such that its open end is in a forward position with respect to the knob of the three-way valve.

In the preferred and most effective embodiment of the device, said fittings are all mounted on said valve in a non-removable manner, so as to completely avoid the risk of accidental detachment that would affect the complete sterility of the system, and moreover said first fitting and/or said second fitting, and more preferably both, are flexible, in order to ensure a greater degree of mobility of the system, to the benefit of the patient's comfort, and to avoid accidental breakage or detachment, for example in the event of the patient having to move.

The operation of the new connector is described below.

1) Connection to the urine collection bag

Said second fitting is properly connected to the tube of the urine collection bag. For better handling, it is more practical to connect the valve to the collection bag before connecting the catheter. According to a possible option, the valve can be supplied in a kit pre-connected to the collection bag in a removable manner.

2) Connection to the bladder catheter.

The new connector must be connected to the catheter tube before applying the catheter in the patient’s urinary canal. Said first fitting is then correctly connected to the catheter. The on-off selector of the valve must be preferably positioned in such a way that said third outlet is closed, and it is also preferable that the antiseptic sealing cap is mounted at least on said third fitting. According to the invention, instead, said first and said second outlets are open, to allow the operator to check the correct position of the catheter, which is confirmed by the outflow if urine.

Alternatively, the new valve can be attached to an already placed catheter only in case of need, for example when it is necessary to wash the catheter in the event of lumen obstruction or to take samples.

3) Normal operation of the connector

During normal operation of the connector, that is, when the catheter has been correctly positioned and urine flows through it, said on-off selector of the valve is positioned so that said first outlet is connected to said second outlet, while said third outlet is closed.

In this way, urine flows out, through the catheter and the valve, and is collected in the bag. 4) Washing the bladder catheter

In the event that the bladder catheter needs to be washed, a syringe containing a washing liquid must be connected to said third fitting, after the sealing cap has been removed.

After connection to the syringe, said on-off selector of the valve is brought to the position in which said third outlet is connected to said first outlet, while said second outlet is closed. At this point, it is possible to inject a given quantity of liquid that will flow towards the first outlet and thus towards the catheter. Proceeding then with the suction operation with the syringe, it will be possible to draw the just injected washing liquid again. The catheter is washed by carrying out this operation once or several times. Once the washing operation has been completed, it is possible to proceed in two different ways.

According to a first preferred option and in order to ensure more safety for the operator, once the catheter washing procedures have been completed it is possible to rotate the on-off selector of the valve in such a way as to connect said third outlet to said second outlet, closing said first outlet, and to empty the syringe into the valve making its contents flow completely into the collection bag. At this point the on-off selector of the valve can be rotated in such a way as to connect the first outlet to the second outlet, closing the third one, and the syringe, now completely empty, can be removed and disposed of, while said sealing cap can be replaced on said third fitting in order to protect it.

According to a possible but not recommendable alternative, said on-off selector of the valve is rotated in such a way as to connect said first outlet to said second outlet again in order to allow the normal outflow of urine towards the collection bag, while the third outlet is closed. At this point, the syringe containing the contaminated washing liquid can be safely removed and disposed of, while said sealing cap can be replaced on said third fitting in order to protect it.

5) Urine sample collection

In drainage catheters, the bladder is emptied continuously and therefore in order to be able to collect a urine sample it is first necessary to close said first outlet, so that urine accumulates in the bladder and in the catheter. After a certain time interval, approximately 30 minutes to 1 hour, it will be possible to open the third outlet and proceed to collection.

It is possible to use a closed suction circuit similarly to what happens for blood sampling, by means of the known vacuum tubes which, connected for this purpose to the third outlet by means of a known device called “vacutainer”, collect the urine sample, which flows out spontaneously.

In this case, too, a standard Luer-Lock™ syringe can be used as an alternative. As described, all the above procedures are performed with maximum safety for both the operator and the patient.

The particular combination of the technical features claimed herein makes the device particularly effective in guaranteeing the sterility of the system and safety for the patient and the operator, in addition to making the device quick and easy to use.

The characteristics of the new connector and of the method for using it are better clarified in the following description, making reference to the drawings, which are attached by way of non-limiting example.

Figure 1 shows a view of the new connector (100) according to a possible embodiment.

The new connector (100) comprises a three-way valve (200), in turn comprising a first outlet (210), a second outlet (220) and a third outlet (230). The valve (200) is provided with an on-off selector with a knob (240) which can be manoeuvred to selectively connect said outlets (210, 220, 230) two by two, or to keep all the three outlets open at the same time, as is the case when said knob (240) is in the position shown in Figure 1.

The connector (100) also comprises a first fitting (300) mounted on said first outlet (210) of said valve (200), said first fitting being suitable for connection to a bladder catheter (C).

Said first fitting (300) can be mounted on said first outlet (210) of the valve (200) in a non-removable manner, thus constituting a single body with the valve (200).

Alternatively, said first fitting (300) can be mounted on said first outlet (210) in a removable manner.

Said first fitting (300) comprises a completely or partially flexible tubular duct (310) and has an end (320) preferably configured as a cone or in any case provided with means for connection to the end (Cl) of a catheter (C) of any type and diameter.

The new connector (100) comprises a second fitting (400) mounted on said second outlet (220) of said valve (200) and suitable for connection to a urine collection bag.

Said second fitting (200) preferably comprises a completely or partially flexible tubular duct (410) and is mounted on the valve (200) in a removable or preferably non-removable manner, in the latter case forming a single body with the latter.

Said second fitting (400) is thus configured, for example, for the simple engagement of a cone (SI) of a tube (S) of a urine bag, the latter not being shown in the figure.

According to the invention, said second fitting (400) can be completely cylindrical or have various shapes, for example a conical shape, to guarantee the optimal connection to the urine collection bag.

Finally, the connector (100) also comprises a third fitting (500) mounted on said third outlet (230) of said valve (200).

Said third fitting (500) is configured for connection to a device for the injection of a liquid into the valve and/or for the suction of a liquid from within the valve, for example by means of a syringe (P) with a Luer-Lock™ cone or any other type of syringe.

Said third fitting (500) can thus be configured with connection means for syringes of the Luer-Lock™ type or, in a larger size, for simple cone syringes. The latter are particularly useful when they need to be used as disposable syringes, for example in the presence of blood clots in the bladder.

Said third fitting (500) is mounted on said third outlet (230) of the valve (200) in a removable and more preferably non-removable manner and can comprise an anti-reflux valve or membrane or another device having the same function. The connector (100) also comprises at least one antiseptic cap (600) intended for sealing said third fitting (500) when it is not in use.

Figure 2 shows the connector (100) in its normal operating position (1), in which it is connected between said catheter (C) and said collection bag for urine outflow. In this normal operating position (1), the valve (200) is positioned in such a way that said first outlet (210) is connected to said second outlet (220), while said third outlet (230) is closed. To ensure even greater safety, said cap (600) is applied to seal the third fitting (500). The flow direction of the liquid, that is, urine, is indicated by the arrows in Figure 2.

Figure 3 shows the connector (100) during the washing (2) of the bladder catheter (C). In this situation, a syringe (P) is connected to said third fitting (500), after removing the cap (600), while the valve (200) is positioned in such a way that said first outlet (210) is connected to said third outlet (230), while said second outlet (220) is closed.

The washing liquid alternately flows in both directions, in order to carry out the washing operation repeatedly, and is indicated by the arrows in Figure 3. Figure 4 shows the condition (3) in which the syringe (P) is being emptied, with the valve (200) in the position in which said third outlet (230) is connected to said second outlet (220), closing said first outlet (210).

In this situation (3), the syringe can be completely emptied, injecting the contaminated liquid into the tube (S) of the collection bag. The liquid flow direction is indicated by the arrows in Figure 3.

Figure 2 also shows another possible situation, in which the syringe (P) is connected to the connector (100) to inject drugs into the catheter (C) or to take urine samples from the catheter (C).

These are the schematic outlines that are sufficient for the expert in the art to carry out the invention, consequently, on practical application variants may be obtained that do not affect the substance of the innovative concept introduced herewith.

Therefore, with reference to the above description and the attached drawings, the following claims are made.

Claims

1. Three-way connector (100) for urine collection and/or for washing a bladder catheter (C), characterized in that it comprises: a three-way valve (200) with a first outlet (210), a second outlet (220) and a third outlet (230) and a valve that can be operated at least to selectively connect said outlets (210, 220, 230) two by two or to open all outlets simultaneously; a first fitting (300) mounted on said first outlet (210) of said valve (200), said first fitting (300) being suited to be connected to a bladder catheter (C); a second fitting (400) mounted on said second outlet (220) of said valve (200), said second fitting (400) being suited to be connected to a tube (SI) of a urine collection bag; a third fitting (500) mounted on said third outlet (230) of said valve (200), said third fitting (500) being suited to be connected to a device or syringe (P) for injecting a liquid inside the valve (200) and/or for drawing a liquid from the inside of the valve (200) through at least one anti reflux valve or membrane or another device suited to prevent uncontrolled leakage of liquid from the inside of said valve (200) towards the outside, and wherein said first, second and third fitting (300, 400, 500) are mounted in a non-removable manner on said respective outlets (210, 220, 230) of said valve (200), and wherein at least said first fitting (300) comprises a completely or partially flexible duct (310).

2. Three-way connector (100) according to claim 1, characterized in that said second fitting (400) comprises a completely or partially flexible duct (410).

3. Three-way connector (100) according to claim 1, characterized in that it comprises at least one antiseptic sealing cap (600) suited to seal said third fitting (500) when not in use.

4. Three-way connector (100) according to claim 1, characterized in that said third fitting (500) comprises connection means for syringes with Luer- Lock™ cones.

5. Three-way connector (100) according to claim 1, characterized in that said third fitting (500) comprises connection means for cone syringes.