Body fluid collection bag and valve

The present invention concerns a medical device comprising a bag for collecting body fluids, in particular urine, and a valve suitable for attachment to said bag.

It is known that body fluids, like for example urine or blood, drained living creature or taken from the human body but also from the body of any other, in many cases are directly conveyed into a bag with suitable capacity, generally 2 litres.

Urine is drained via catheterism following various types of surgery carried out on bedridden patients.

The bag comprises a sealed container made of a plastic material in the form of a film, usually in polyvinylchloride (PVC), a delivery tube, one end of which is connected to a catheter of external or urethral type, applied to the patient's body, more precisely to the point from which the body fluid must be taken.

The opposite end of the delivery tube communicates with the inside of the container, to which it is permanently joined via connection means constituted, for example, by a radio frequency weld or pinch carried out on the PVC film so that it envelops a section of the delivery tube.

The bag also comprises a discharge tube of the body fluid stored in the container, said discharge tube being connected to the container in the same way as the delivery tube, and therefore communicating with the internal volume of the container itself.

The bag also comprises a valve or stopcock associated with the discharge tube and used by the health worker to discharge the fluid outside the container, into an environment or structure suited for this purpose, in a comfortable, practical, hygienic and effective way.

Moreover, the valve makes it possible to carry out a controlled discharge of the fluid, avoiding sudden and abrupt outflows from the bag, which inevitably involve for the health worker the risk of undesired, unhygienic and sometimes extremely dangerous contacts with the fluid.

The drainage of the fluid from the bag must obviously take place when the sealed container is completely full or, in any case, at the end of a working day, independently of the level reached by the fluid.

For hygienic reasons, the manufacturers of the medical devices in question recommend to consider the bag as disposable: once the fluid has been discharged from the sealed container, the bag must be definitively thrown away.

A first type of collection bags of the type briefly described above and presently available on the market is disclosed in the Patent applications FR 2 199 969 A1 and US 4,055,179 A, and comprises a valve, known as "push-pull", constituted by two coaxial tubular bodies, a first one of which is fixed to the container with a first end.

The second tubular body is externally and slidingly coupled to the second end of the first tubular body, so that two stable positions of the valve, corresponding to two operating configurations, are defined.

These are the closed position, in which the second tubular body is coupled to the first one in such a way as to close its outlet, and the open position, in which the second tubular body, following the exertion of a traction force, protrudes from the first of a length that is greater than in the closed position, thus opening the outlet of the first tubular body and allowing the body fluid to flow out.

The reciprocal position of the tubular bodies in the two operating configurations mentioned above is defined by stop means, for example annular projections, obtained on both tubular bodies.

According to another embodiment of the collection bags carried out according to the known art, which is disclosed in the Patent application WO 2004/103229 A, the valve is T-shaped and comprises a first tubular body that defines a first longitudinal axis, one end of which is joined to the sealed container, while the opposite end is in communication with the external environment.

The valve also comprises a second tubular body that develops along a longitudinal axis orthogonal to the longitudinal axis of the first tubular body, slidingly arranged inside a cylindrical element carried out as a single body integral to the first tubular body.

The second tubular body is provided, near the intermediate area of its side surface, with two coaxial through holes that, with the valve in closed position, face the inner wall of the cylindrical element.

A thrusting force is exerted by the user on the second tubular body, so that the valve is brought to the open position in which the two through holes are positioned coaxial to the first tubular body, thus allowing the fluid contained in the sealed container to be discharged.

Also in this case, the reciprocal positions of the tubular bodies in the two operating conditions described above are defined by stop means properly obtained on their internal and external surfaces.

The Patent application US 5, 228, 646 A discloses a different embodiment of the above mentioned valve, in which the closing and opening of the second tubular body are determined by the action of, respectively, a spring and retaining teeth.

Nevertheless, the body fluid collection bags carried out according to the known art are not without drawbacks.

The main drawback of the collection bags of the known type is represented by the fact that the user, after using them for the first time, can use them again once the stored fluid has been drained.

It is the construction form of the valves, originally designed exclusively to facilitate the disposal of the body fluid, that facilitates this operating method.

All of the known construction variants described above and, more generally, any collection bag carried out according to the known art and provided with mechanisms for regulating and controlling the discharge of the body fluid are characterised in that they allow the valve to be closed again even after it has been opened.

It often occurs that, following a wrong procedure, the user, starting from the open condition, closes the valve by applying a simple compression force to the second tubular body.

In this way the health worker, once having emptied the collection bag, leaves it applied to the patient via the catheter, even for more than 24 hours.

This happens notwithstanding the recommendations of the manufacturers that, in compliance with the rules aimed at guaranteeing the user's safety and good hygienic conditions, suggest to use the collection bags only once and to throw them away when they are completely full or, in any case, at the end of a working day.

Considering the type of product in question, which from a technical point of view is rather simple, the operating method described above exposes the patient, the health worker and any other person to serious risks, since the bag is a source of bacteria, viruses and other infections.

Collection bags designed so that a part of the valve will break have been launched on the market, in order to prevent them from being used twice.

In any case, also this solution has serious drawbacks, due to the uncontrolled outflow of body fluid during the discharge phase, which involves conditions that are highly critical and risky for the health worker and, in general, for the whole environment where the operation is carried out.

The present invention intends to overcome the drawbacks posed by the prior art which have just been mentioned.

In particular, the main aim of the present invention is to carry out a collection bag equipped with means suited to regulate the discharge of the body fluid that prevent the user from using the bag again after discharging the body fluid previously stored therein.

At the same time, the invention aims to allow the health worker to discharge the body fluid from the bag in absolutely safe and good hygienic conditions, in any case exceeding those allowed by equivalent bags of the known type.

The above mentioned goals have been achieved through the implementation of a body fluid collection bag comprising:

• a sealed container defining an internal volume that cannot be reached by a user;
• a delivery tube in communication with said internal volume of said container, suited to convey said fluid inside said container;
• a discharge tube in communication with said internal volume of said container, suited to discharge said fluid outside said container;
• a valve suited to regulate the discharge flow of said fluid, comprising:

  • a first tubular element associated with said discharge tube;
  • a second tubular element slidingly coupled to said first tubular element;
  • stop means, interposed between said tubular elements, suited to define for said valve at least one closed and one open position,

characterized in that said valve comprises definitive locking means, cooperating with said tubular elements, suited to prevent the reciprocal movement of said tubular elements when said valve is in said open position.

The subject of the present invention is also a valve for body fluid collection bags, suited to be associated with the discharge tube of said bag to regulate the discharge flow of said fluid and having the construction characteristics described above.

Advantageously, the invention carries out a body fluid collection bag that can be used only once, thus keeping to the recommendations of the manufacturers and at the same time respecting the minimum safety and hygiene conditions required for this type of medical devices.

Still to advantage, the discharge of the body fluid stored in the sealed container when this is completely full, or in any case at the end of a working day, is carried out by the health worker with no risk of contact with the fluid, in safer conditions than allowed by the known art.

Differently from the bags of the known type, the bag subject of the invention, in fact, does not involve the breakage of any of its components, especially in correspondence with the valve, during the body fluid discharge phase.

Therefore, the invention combines the positive effects determined on one hand by the impossibility to reuse the bag by closing the valve after discharging the fluid, and on the other hand by the way the fluid flows out of the sealed container towards the outside.

Once opened, the valve of the bag subject of the invention remains definitively in this position and at the same time the outflow of the body fluid is completely controlled.

Still to advantage, the valve used in the bag subject of the invention is simple to construct.

The aims and advantages described above, as well as others illustrated below, will be highlighted in greater detail in the description of a preferred embodiment of the invention, given indicatively with reference to the enclosed drawings, wherein:

• Figure 1 is an axonometric view of the bag subject of the invention in a first operating condition;
• Figure 2 is an axonometric view of the bag of Figure 1 in a second operating condition;
• Figure 3 is an exploded axonometric view, truncated and partially sectioned, of an enlarged detail of Figure 1;
• Figure 4 is a plan view, seen from below, of a component of the enlarged detail of Figure 3;
• Figures 5 and 6 show a longitudinal section of the detail of Figure 4 in two different operating conditions.

The bag subject of the invention is shown in Figures 1 and 2, where it is indicated as a whole by 1, in two distinct operating conditions.

It is particularly suited to be used in hospitals, clinics and similar structures for collecting a body fluid L, for example urine.

As it can be observed, the collection bag 1 comprises:

• a sealed container 2, made of PVC, defining an internal volume that cannot be reached by a user;
• a delivery tube 3 in communication with the internal volume of the container 2, suited to convey the fluid L inside said container;
• a discharge tube 4 in communication with the internal volume of the container 2, suited to discharge the fluid L outside said container;
• a valve 5 suited to regulate the discharge flow of the fluid L, which in turn comprises:

  • a first tubular element 6, preferably but not necessarily made of PVC, associated with the discharge tube 4,
  • a second tubular element 7, preferably made of polyethylene, slidingly coupled to said first tubular element 6;
  • stop means, indicated as a whole by 8 and visible only in Figure 3, interposed between the tubular elements 6 and 7, suited to define for the valve 5 one closed and one open position.

According to the invention, the valve 5 comprises definitive locking means, indicated as a whole by 9 and visible starting from Figure 3, cooperating with the tubular elements 6 and 7 and suited to prevent the reciprocal movement of the tubular elements 6 and 7 when the valve 5 is in the open position.

The delivery tube 3 and the discharge tube 4 are made of a plastic material, preferably but not necessarily PVC, and are joined to the container 2 via connection means, not visible but of the type known per se in these medical devices, for example a radio frequency pinched edge made on two opposite sides of the tubes 3 and 4.

Figures 1 and 2 show that the first tubular element 6 is coupled to the discharge tube 4 at the level of the upper edge 6a of the first tubular element 6.

The tubular elements 6 and 7, each having in a cross section a circular profile, are coaxial to each other and to the longitudinal axis Y defined by the discharge tube 4.

As shown in Figure 3, the first tubular element 6 is provided with two articulated diametrically opposed grooves 10, 11 made on the outer wall 6c starting from the lower edge 6b of the first tubular element 6.

From this point onwards and where not specified otherwise, for the sake of simplicity reference will be made to the articulated groove 10 only, and the statements made will be considered valid also for the articulated groove 11, visible only partially in the figures.

The articulated groove 10 comprises:

• a first linear section 12 ending at the level of the lower edge 6b of the first tubular element 6;
• a second linear section 13 that develops parallel to the first linear section 12 and for a length L₂ smaller than the length L₁ of the first linear section 12;
• a transverse rectilinear section 14 that connects two ends 12a, 13a of the linear sections 12, 13, substantially obtained in the intermediate area 61c of the outer wall 6c of the first tubular element 6.

Viewed from the front, the articulated groove 10 has a substantially U-shaped profile and, in any cross section, a polygonal profile.

The linear sections 12, 13 of the articulated groove 10 develop according to corresponding longitudinal directions Y', Y" substantially parallel to the longitudinal axis Y of the discharge tube 4.

As to the stop means 8 that define the closed position of the valve 5, they are constituted by the perimeter wall 14a of the transverse rectilinear section 14 of the articulated groove 10.

The stop means 8 that define, on the other hand, the open position of the valve 5, are constituted by the upper wall 13b of the second linear section 13 of the articulated groove 10.

According to the preferred embodiment of the invention described herein, the locking means 9 comprise:

• two shaped wedges 15, 16 protruding from the bottom 10a of the articulated groove 10;
• two shaped teeth 17, 18, both visible in greater detail in Figure 4, protruding from the inner wall 7a of the second tubular element 7, slidingly arranged inside the articulated grooves 10, 11, respectively, and opposing the shaped wedges 15, 16 when a force is exerted on the second tubular element 7 in the direction opposite the direction according to which the shaped teeth 17, 18 previously overcame the shaped wedges 15, 16, according to the explanation provided below.

Practically, the locking means 9 comprise a first shaped wedge 15, arranged inside the rectilinear section 14 near the end 12a of the first linear section 12 of the groove 10, and a second shaped wedge 16, positioned in a substantially intermediate area 13c of the second linear section 13 of the groove 10.

Each one of the shaped wedges 15, 16 presents, according to a cross section, a substantially triangular profile, with the base associated with the bottom 10a of the groove 10 and the oblique sides diverging towards the outside starting from the bottom 10a itself.

Each one of said shaped wedges 15, 16 has:

• a main plane surface 15a, 16a that departs from the bottom 10a according to a direction diverging towards the outside and incident to the longitudinal axis Y and defines a sort of ramp allowing the shaped tooth 17 to slide in the groove 10;
• a secondary plane surface 15b, 16b that departs from the bottom 10a according to a direction substantially orthogonal to the bottom 10a itself and defines a barrier that prevents the shaped tooth 17 from sliding in the groove 10;
• two lateral plane surfaces opposite each other and in contact with the perimeter walls, for example that indicated by 14a, of the groove 10.

The shaped tooth 17 that fits into the articulated groove 10 and the shaped tooth 18 that fits into the articulated groove 11 are positioned near the end 7b of the second tubular element 7 that is coupled to the first tubular element 6.

The shaped tooth 17, as well as the shaped tooth indicated by 18, presents, according to a diameter section, a substantially triangular profile, with the base associated with the inner wall 7a of the second tubular element 7 and the oblique sides diverging towards the outside according to directions incident to the longitudinal axis Y.

The shaped tooth 17 is provided, at the level of the shorter oblique side, with a plane wall 17a positioned adjacent to the secondary plane surface 16b of the second wedge 16 to prevent the reciprocal translation of the tubular elements 6 and 7 along the longitudinal axis Y when a compression force is exerted on the second tubular element 7, starting from the open position of the valve 5.

Practically, the plane wall 17a of the shaped tooth 17 resting against the secondary plane surface 16b of the second wedge 16 stops any attempt to close the valve 5 after it has been opened to discharge the fluid L from the sealed container 2, in order to prevent the collection bag 1 from being used again.

Obviously, in the articulated groove 11 the shaped tooth 18 rests against a corresponding second wedge, not shown in the attached drawings.

The shaped tooth 17 is also provided with two lateral plane walls 17b, 17c opposite each other, one of which is positioned adjacent to the secondary plane surface 15b of the first wedge 15 when the second tubular element 7 is set rotating clockwise around the longitudinal axis Y starting from the closed position of the valve 5.

Figures 5 and 6 show that the second tubular element 7 is provided with a plug 19, protruding from the inner wall 7a of the second tubular element 7, inserted in the outlet 6d of the first tubular element 6 when the valve 5 is in the closed position.

In this case, the plug 19 is preferably connected to the second tubular element 7 via three radial ribs 20, 21, 22.

It is important to point out that in further embodiments of the invention, not shown herein, the first tubular element may be provided with a single articulated groove on its outer wall.

Consequently, in this case the second tubular element will be provided on its inner wall with a single shaped tooth belonging to the locking means.

In the assembly phase, the user couples the second tubular element 7 to the first tubular element 6 introducing the shaped teeth 17, 18 inside the corresponding articulated groove 10, 11.

More specifically, the shaped tooth 17 is inserted in the first linear section 12 until it meets the perimeter wall 14a of the transverse rectilinear section 14 of the articulated groove 10.

At this point, the user makes the second tubular element 7 rotate anticlockwise, so that during its movement inside the articulated groove 10 the shaped tooth 17 passes beyond the first wedge 15 and reaches the end 13a of the second linear section 13, remaining in any case within the transverse rectilinear section 14 of the groove 10.

The same happens on the diametrically opposed side of the outer wall 6a of the first tubular element 6 for the shaped tooth 18 inside the groove 11.

The valve 5 obtained in this way is thus in the closed position shown in Figure 5, that is, the position in which the collection bag 1 with which it is connected is delivered to the health worker for use. Observe the distance H₁ of the end 7b of the second tubular element 7 from the ring 23 protruding from the outer wall 6c of the first tubular element 6.

During the day the collection bag 1 is completely filled with fluid L, as shown in Figure 1, which must be discharged outside the bag.

The health worker exerts a traction force on the second tubular element 7 and makes it slide along the longitudinal axis Y, thus increasing the length of the valve 5 in its whole and removing the plug 19 from the outlet 6d of the first tubular element 6.

In this phase, the shaped tooth 17 slides inside the second linear section 13, passing beyond the second wedge 16 until reaching the upper wall 13b.

In this way, the valve 5 reaches the operating condition shown in Figure 6 and the fluid L is free to flow out of the sealed container 2 through the discharge tube 4, as shown in Figure 2, where it is possible to observe the distance H₂ of the end 7b of the second tubular element 7 from the ring 23.

The health worker's attempt to bring the valve 5 back to the closed position in order to reuse the collection bag 1 fails due to the fact that the sliding movement of the second tubular element 7 along the longitudinal axis Y in the direction opposite the direction that determines the opening of the valve 5 is prevented by the second wedge 16 as the plane wall 17a rests against the secondary plane surface 16b.

In this way the aim to make a collection bag definitively and effectively disposable is achieved, with no need for the health worker to run the risks connected with contact with the fluid while emptying the sealed container.

The invention also prevents the health worker from opening the valve 5 in a way different from the one proposed, that is, by first rotating the second tubular element 7 clockwise and then exerting a traction force on it, making the shaped teeth 17, 18 cover the opposite path with respect to the path described for the production phase during the coupling of the tubular elements 6 and 7.

In fact, the presence of the first wedge 15 locks the clockwise rotation around the longitudinal axis Y due to the opposition between the lateral plane wall 17b and the secondary plane surface 15b.

According to the above, it is therefore clear that the body fluid collection bag and the valve applied to it, which are the subject of the present invention, achieve the aims and offer the advantages mentioned above.

Upon implementation, modifications may be made to the collection bag that is the subject of the invention, consisting, for example, in a different shape of the tubular elements belonging to the valve.

Furthermore, the locking means may be of a type different from the one described as preferable, which does not affect the advantage offered by the present patent.

It is also important to point out that the first tubular element may be connected to the discharge tube via connection means, as in the embodiment described above, or may be carried out as a single body integral with it.

In the cases where the technical characteristics illustrated in the claims are followed by references, these have been added only with the aim to facilitate the comprehension of the claims themselves and therefore said references do not have any limiting effect on the degree of protection to be granted to each element they identify only by way of example.

All the variants described and mentioned, but not represented in the attached drawings, must be considered protected by the present patent, as they fall within the innovative concept expressed in the following claims.