WO2003101353A2

WO2003101353A2 - Body fluid drainage device and a collection bag fitted with said device

Info

Publication number: WO2003101353A2
Application number: PCT/FR2003/001641
Authority: WO
Inventors: Henri Holtermann
Original assignee: B. Braun Medical Sas
Priority date: 2002-05-31
Filing date: 2003-05-30
Publication date: 2003-12-11
Also published as: AU2003250351A1; FR2840194B1; WO2003101353A3; FR2840194A1

Abstract

The invention relates to a body fluid drainage device and a collection bag comprising one such device which is used to collect a body fluid, such as urine. The drainage device (20) is disposed around a hole in the fluid collection bag (14). Said device comprises: a first circular flap (30) which is fixed externally to a wall (12) of the bag (14) around the aforementioned hole; a second flap (40) which is articulated to the first flap (30) by means of a first hinge (C1) in order to move between a first down (closed) position in which it seals the hole in the first flap (30) and a second up (open) position in which the fluid can flow therethrough; and a third flap (50) which is articulated to the second flap (40) in order to move between a first down (closed) position in which it locks the second flap (40) in the down (closed) position on the first flap (30) and a second up (open) position in which it releases the second flap (40), such that said second flap can pivot. The device offers increased comfort to ostomy patients.

Description

Device for emptying a bodily fluid and collection bag provided with this device Technical field of the invention

The invention relates to a device for emptying a body fluid, such as urine, as well as a collection bag provided with this emptying device. Raw problem concerns the invention

After a surgical operation performed on a patient following a malformation, tumor or inflammation of the urethra or bladder, and in particular after a urostomy, urinary functions should be restored artificially, those -this cannot be performed normally by the body of the operated patient. A hygienic device, comfortable and not disturbing the occupations of the patient, such as work, sport or leisure, is therefore provided for this purpose.

For this, the ostomy patient is generally equipped with a pocket for collecting body fluid placed immediately after the operation, generally around an abdominal orifice for evacuating urine. This pocket, conventionally produced in the form of a bag of flexible woven material impermeable to the fluid it contains, can be removable or else be emptied of its contents. In this particular embodiment, it is common to use a draining device, usually connected in the lower part of the bag by a neck with reduced section, so that the urine flows under the effect of gravity when the emptying device is in an open position. PRIOR ART We already know closing devices with an articulated flap which are not intended for ostomy bags. For example, US Pat. No. 5,938,176 describes a shutter intended to close an orifice in a wall by a hinged flap provided with an end-piece intended to penetrate into the orifice in a first position and to release the latter in a second position. Likewise, US Pat. No. 5,938,056 describes a bottle stopper comprising a mouthpiece to be fixed on a neck and a cap articulated on the base and comprising two shutters, one close to the base and intended to close the opening of the base, and the other intended to close a ventilation opening of the part close to the base. This plug therefore allows an opening in two phases, first a removal of the internal pressure, then a real opening.

There are also known different types of bag emptying devices for collecting body fluid already existing on the market. Apart from ordinary clip-on systems which are impractical to use, there are systems which usually use a drain valve located in the lower part of the bag and which can be handled by the patient or a third party, such as a nurse, to open or close a urine drain. Such devices are notably described in international application WO-93 17 642. According to this document, the valve is of the rotary type and can in particular take alternately two positions substantially perpendicular to one another, depending on whether the patient wishes close the drainage channel or open it to drain the urine. FR-2,474,858 describes a complex valve system for closing or closing a drainage channel of a urine collection bag.

These devices are not satisfactory in terms of the hygiene of the patients or of the people who use them, the safety of the shutter, the ease of gripping, the degree of complexity of the manufacturing, the discretion or the comfort. use.

The object of the invention is therefore to resolve the drawbacks mentioned above.

General description of the invention

To do this, according to the invention, the emptying device is produced in the form of an articulated system ensuring good sealing, great safety, easy and quick operation, as well as excellent comfort of use in reduced overall dimensions.

More specifically, the invention relates to a device for draining a bodily fluid, arranged around a orifice for emptying a bag for collecting this fluid, and comprising three articulated flaps consisting of:

a first substantially annular flap fixed externally to a wall of the bag and provided with a central opening for the flow of the fluid out of the bag,

- a second flap hinged to the first by means of a first hinge, to pass from a first closed closed position, in which it closes the opening of the first flap by covering it tightly, a second open and raised position, in which it allows the fluid to flow through the opening thus released, and

a third flap articulated on the second flap to pass from a first closed folded position, in which it blocks the second flap in its closed folded position on the first flap, preventing it from pivoting, to a second open and raised position, in which it unlocks the second flap allowing it to pivot.

Thus, the second and third flaps form a sealed blocking system with a lever effect that is easy to open or close without it being necessary for the user to produce a significant force.

According to different preferred embodiments of the invention: the third flap is articulated on the second flap by means of a second hinge, arranged parallel to the first hinge common to the first and second flaps,

the first flap is provided with first blocking means cooperating with the second flap to keep it in its closed folded position,

- the pre-locking means are protuberances normally protruding from the annular part of the first flap, - the protuberances have a T shape and are constituted by a foot extended by an enlarged head provided with a first lobe engaged with the sides of the second flap to lock it in its closed folded position. the foot of each protrusion is elastically deformable laterally with respect to its direction of elevation,

- two identical protuberances are diametrically opposite on either side of the central opening of the first flap,

the third flap is equipped with second blocking means cooperating with the first blocking means of the first flap to maintain the third flap in its closed position folded over the second flap,

the second opposite lobe of the enlarged head is engaged with the second blocking means of the third flap to block the latter in its closed folded position,

the second locking means are lateral eyelets each having an opening intended to receive the corresponding protuberance,

the third flap has a hollowed-out central zone and is provided with a gripping tab, disposed opposite the second hinge relative to the central zone and oriented towards the hollowed-out zone of the third flap,

the emptying device is made in a single piece of injected plastic, and / or

- a discharge nozzle is adaptable to the drainage device when the latter is open. The invention also relates to a collection bag, intended to be placed on the abdomen of a patient who has undergone an ostomy operation. This pocket includes the emptying device defined above coupled to a fluid-tight bag through a drain orifice. Advantageously, the emptying device is welded externally to a film constituting a bag, in an area forming an elongated evacuation channel.

So that the bag is compact and comfortable to carry, the area forming a drain channel is foldable in the closed position under an external covering covering the film on which the drain device is welded. Brief description of the drawings

Other characteristics, details and advantages of the invention will emerge on reading the description made with reference to the accompanying drawings given by way of example and in which:

- Figure 1 is a perspective view of a urine collection bag provided with a drainage device disposed in a first extreme open position and on which is mounted a discharge nozzle, - Figure 2 is a view in perspective of the emptying device in its first extreme open position,

FIG. 3 is a perspective view of the emptying device arranged in a partially open intermediate position, FIG. 4 is a perspective view of the emptying device arranged in a second extreme closed position,

FIG. 5 is a sectional view along the arrows AA of FIG. 4, and

- Figure 6 is a sectional view along the arrows BB of Figure 4.

Figure 1 shows in perspective a pocket 10 of ileostomy collection according to the invention. Detailed description of the invention

This pocket 10 is formed by two thin films 12 spaced apart and welded to each other at their periphery to form a bag 14 impervious to the bodily fluid contained in the pocket, that is to say in the present case of excrement. fluids or pasty. A fabric, such as cotton, or a non-woven coating, usually covers the bag 14 for better wearing comfort, in particular in contact with the patient's stomach, and to avoid irritation due to friction and sweat. The bag 14 ends at a lower end with a zone 16 of reduced section forming an elongated drainage channel. This drainage channel 16 has a width less than the main width of the bag 14 and slightly greater than the overall width of a drainage device 20 welded externally to the bag 14 and making it possible to empty the contents of the bag 10. To this end, the emptying device 20, shown in FIG. 1 in a first raised open extreme position, receives a hollow evacuation tip 18 making it easier to empty the contents of the bag under the action of gravity, and possibly by pressing the bag 14.

The emptying device 20, shown in more detail in Figures 2 to 6, mainly comprises three flaps 30, 40 and 50 hinged on each other to allow or not the emptying of the bag.

The first flap 30 is welded externally to one of the films 12 of the bag 14. The welding is carried out around a conventional drain orifice (not visible in the figures), arranged in the thickness of the film 12. This first flap 30 is of annular shape and has, facing the emptying orifice of the bag 14, a substantially circular central opening 31 surrounded by a solid annular part 32, as shown in FIG. 2. This first flap 30 is also provided with first locking means 33 diametrically opposite on either side of the central opening 31, on the solid annular part 32.

These first blocking means 33 are in the form of protuberances 34 which protrude substantially normally from the surface of the annular part 32 of the first flap 30. Each protuberance 34 has a substantially straight foot 35 extended by an enlarged head 36 provided with two lobes 36a and 36b so as to have a substantially T shape, as illustrated in particular in FIGS. 2 to 6. The foot 35 is deformable elastically laterally to its main direction of elongation, as illustrated by the arrow F in FIG. 5.

The second flap 40 is articulated on the first flap 30 using a first hinge C1 situated on an edge of the second flap 40. This hinge allows the second flap 40 to pass alternately from a first closed closed position, in which it covers in a fluid-tight manner the central opening 31 of the first flap 30 using a membrane 42 as shown in the FIGS. 3 and 4, at a second raised open position in which it allows the fluid to flow through the opening 31, as shown in FIGS. 1 and 2.

To allow the second flap 40 to be held in the closed position on the first flap 30, as illustrated in FIG. 4, the sides 43 of the second flap 40 cooperate with the lobes 36a of the protrusions 34 with which they are engaged in order to form clips locking elastic. The third flap 50 is articulated on the second flap 40 using a second hinge C2 disposed on an edge opposite to that where the first hinge C1 is located. This second hinge C2 allows the third flap 50 to pass alternately from a first closed closed position in which it blocks the second flap 40 in its closed folded position on the first flap 30 by preventing it from pivoting, as illustrated in FIG. 4, to a second raised open position in which it unlocks the second flap 40 by allowing its pivoting, as illustrated in FIGS. 1 and 2.

The third flap 50, also of annular shape with a recessed central zone 56 to reduce the weight of the emptying device, is provided with second locking means 51. These second locking means 51 are constituted by lateral eyelets 52 projecting each having a central opening 53 for the passage of the first locking means 33, including the enlarged head 36. The opening 53 of the eyelets is bordered by a zone of material 54 substantially in the form of a handle, intended to come into engagement with the lobes 36b of the protrusions 34. The third flap 50 is thus blocked on the first flap 30, and the membrane 42 of the second flap 40 is compressed on the central opening 31 of the first flap 30. A good seal of the emptying device is then guaranteed. The third flap 50 is also provided with a gripping tab 55 disposed opposite the second hinge C2 and directed towards the hollowed out area 56. The discharge nozzle 18 shown in FIG. 1 can be temporarily fixed on the first flap 30, for example by cooperation with the first blocking means 32. The zone 16 forming an elongated drainage channel can, when the device drain 20 is completely closed, be folded under the coating covering the film 12 on which the drain device 20 is welded. Thus, the drain device 20 is protected by this coating, does not overflow from the bag 14 and therefore does not interfere the patient carrying the bag 10.

As can be seen in particular in FIGS. 5 and 6, the total thickness of the emptying device 20 is very small, of the order of a few millimeters, making it particularly compact and therefore easy to carry since it does not interfere with the patient. Furthermore, this emptying device 20 is made of a single plastic material, for example an injection molded polymer material, so that its manufacturing process is particularly rapid and economical.

The use of this emptying device 20 is very simple, hygienic and reliable. The patient wishing to empty the bag 10 grasps the grip tab 55 by passing a finger from below. He raises it to tilt the third flap 50 around the second hinge C2. The lower shape of the lobes 36b and the elasticity of the foot 35 are such that it suffices to pull hard enough on the gripping tab 55 so that the second locking means 51 separate from the lobes 36b. However, the effort to be provided by the patient is relatively low because the blocking force is distributed between the second and the third flap.

Once the third flap 50 has been raised, as illustrated in FIG. 3, the patient lifts the second flap 40 to tilt it around the first hinge C1. For this, the patient releases the first blocking means 33 so that the sides 43 are no longer in engagement with the lobes 36a of the protrusions 34. This operation is facilitated by the leverage and leverage effect provided by the third flap 50 on the second flap 40. The patient therefore does not have to make a significant effort to lift the second flap 40. In this raised position of the second flap 40, as illustrated in FIG. 2, the membrane 42 no longer closes the central opening 31 of the first flap 30 and the bodily fluid can be evacuated from the bag 14. This evacuation is preferably carried out after fitting the end piece 18 on the first locking means 33 of the first flap 30, as illustrated in FIG. 1.

It is understood, however, that this exemplary embodiment is given solely by way of illustration of the subject of the invention, of which it in no way constitutes a limitation. In particular, the central opening of the first flap 22 may be elliptical, oval or of any suitable elongated shape. Furthermore, the blocking means may have other forms and their number may vary. The emptying device as described above can also be used on a bag for collecting urine or other physiological effluents. Industrial application possibilities

The products according to the invention give patients who have undergone an ostomy surgery a comfort allowing them to go about their business normally.

Claims

CLAIMS 1. Device for draining (20) a bodily fluid, arranged around a drain orifice for a bag (14) for collecting this fluid, and characterized in that it comprises three articulated flaps consisting of:

- a first substantially annular flap (30) fixed externally on a wall (12) of the bag (14), around the drain orifice, and provided with a central opening (31) for the flow of the fluid out of the bag (14), - a second flap (40) articulated on the first flap (30) by means of a first hinge (Cl) to pass from a first closed closed position in which the second flap ( 40) closes the opening (31) of the first flap (30) by covering the latter in a sealed manner, at a second open and raised position, in which the second flap (40) allows the fluid to flow through the opening (31), and

- a third flap (50) articulated on the second flap (40) to pass from a first closed closed position, in which it blocks the second flap (40) in its closed position folded over the first flap (30 ) by preventing its pivoting, to a second open and raised position, in which it unlocks the second flap (40) by allowing it to pivot.

2. Draining device according to claim 1, characterized in that the second flap (40) is provided with a membrane (42) for closing the opening (31) of the first flap (30) in its closed folded position.

3. Draining device according to claim 1 or 2, characterized in that the first flap (30) is provided with first locking means (33) cooperating with the second flap (40) to maintain the latter in its closed folded position.

4. Draining device according to claim 3, characterized in that the first locking means (33) are protrusions (34) normally protruding from the annular part (32) of the first flap (30).

5. Draining device according to claim 4, characterized in that the protrusions (34) have a T shape and are constituted by a foot (35) extended by an enlarged head (36) provided with at least a first lobe ( 36a) engaged with the sides (43) of the second flap (40) to block the latter in its closed folded position.

6. Draining device according to one of claims 4 and 5, characterized in that the foot (35) of each protuberance (34) is elastically deformable laterally relative to its main direction of elongation.

7. Draining device according to any one of claims 4 to 6, characterized in that two identical protuberances (34) are diametrically opposite on either side of the central opening (31) of the first flap (30).

8. Draining device according to claim 7, characterized in that the third flap (50) is articulated on the second flap (40) by means of a second hinge (C2) parallel to the first hinge (Cl).

9. Emptying device according to one of claims 7 and 8, characterized in that the third flap (50) is equipped with second locking means (51) cooperating with the first locking means (33) of the first flap (30 ) to maintain the third flap (50) in its closed position folded over the second flap (40).

10. Draining device according to (a claim 9, characterized in that the second lobe (36b) opposite the enlarged head (36) is engaged with the second locking means (51) of the third flap (50) to block that -this in its closed folded position.

11. Draining device according to claim 11. characterized in that the second locking means (51) are lateral eyelets (52) each having an opening (53) intended to receive the corresponding protuberance (34) bordered by a zone of material (54) cooperating with the second lobe (36b) of each protuberance (34).

12. Emptying device according to any one of the preceding claims, characterized in that the third flap (50) has a hollowed-out central zone (56).

13. Emptying device according to any one of the preceding claims, characterized in that the third flap (50) is provided with a gripping tab (55).

14. Emptying device according to one of claims 12 and 13, characterized in that the gripping tab (55) is arranged opposite the second hinge (C2) and oriented towards the recessed area (56) of the third part (50).

15. Draining device according to any one of the preceding claims, characterized in that the draining device (20) is made in a single piece of injected plastic.

16. Draining device according to any one of the preceding claims, characterized in that the draining device (20) is welded externally to a film (12) constituting the bag (14) in an area forming a draining channel (16 ).

17. Draining device according to any one of the preceding claims, characterized in that a discharge nozzle (18) is adaptable to the draining device (20) when the latter is open.

18. Draining device according to any one of claims 3 to 16 and claim 17 taken together, characterized in that the discharge nozzle (18) is adaptable to the first locking means (33).

19. Pocket (10) for collecting a body fluid, intended to be placed on the abdomen of a patient who has undergone an ostomy operation and comprising the emptying device (20) according to any one of the preceding claims, coupled to a fluid tight bag (14) through a drain port.

20. Bag according to claim 19, characterized in that the emptying device is welded externally to a film (12) constituting the bag, in a zone (16) forming an elongated emptying channel.

21. Bag according to claim 20, characterized in that the zone (16) forming a drainage channel can be folded in the closed position under an external covering covering the film (12) on which the drainage device (20) is welded.