FR2980971A1 - Stopper for screwing on neck of standard water bottle for enteral nutrition system, has chimney projecting from transverse wall and receiving enteral nutrition tube, and flange receiving hydrophobic filter and allowing passage of air - Google Patents

Abstract

The stopper (1) has a disk shaped transverse wall (4) forming a peripheral skirt (6) having an internal thread (7). An opening (9) is provided in the transverse wall and surrounded by a chimney (12) projecting from the transverse wall opposite to the peripheral skirt, where the chimney receives an enteral nutrition tube (26). Another opening is provided in the transverse wall and surrounded by a flange (19) projecting from the transverse wall in the same direction as the peripheral skirt, where the flange receives a hydrophobic filter (27) and allows passage of air. An independent claim is also included for an enteral nutrition system.

Description

The present invention relates to a plug for enteral nutrition system. Enteral nutrition is a method of artificial nutrition for people with total or partial inability to eat by mouth. It consists in bringing into the digestive tract nutrients to cover the daily nutritional needs of the person concerned, or to fight against undernutrition. This contribution can be made by a probe, for example a nasogastric tube, that is to say a probe entering the nose and going into the stomach.

An enteral nutrition system comprises a tubing whose proximal end is connected to an enteral nutrition bag and whose distal end has a tip that is inserted into the tip fitted to the probe, for example at the nose of the patient. Until 1998, enteral and parenteral (ie non-digestive) nutrition tubings were not necessarily differentiated, and accidents related to the confusion of the two tubings were regularly identified. in the hospital environment. Indeed, a bag of food provided for enteral nutrition could be accidentally injected by infusion, and thus have serious consequences for the patient.

This problem was solved by the NF EN 1615 standard of June 2001. This requires that the enteral nutrition administration devices are provided at the patient end of a connector that does not allow connection to a conical assembly. Luer female, Luer type fittings are almost always used for parenteral tubing. Thus, by imposing different and non-compatible connection systems, the risks of confusion and the consequences that result are avoided during the supply of food to the patient. However, this risk of confusion due to a connection error is still present when administering water to the patient. Water, most commonly conventional mineral water from the mainstream market, can be sent into the tubing of the enteral nutrition system for hydration of the patient, which is needed several times a day, or to rinse the tubing if it is blocked or if a drug has just been administered. The administration of water to the patient in the enteral tubing can be carried out: either batchwise, by means of a compatible or non-compatible syringe Luer; - or continuously, with a bag to fill with a non-compatible Luer enteral tubing.

But these methods are impractical, since they require the transfer of water from a first container to a syringe or pocket. Also, another method used to administer water to the patient, typically to hydrate it, is to hit the cap of a standard water bottle with a perfuser, which is easy and fast.

However, the infusers have a connector that is Luer compatible. Thus, nothing prevents the tubing connected to the infusor to be connected by mistake to the venous route, which would have serious consequences, the administration of water in the veins can lead to hemolysis or infectious problems that can lead to the patient's death.

The present invention aims at remedying the above-mentioned problems by providing a practical solution for improving the safety of the patient, particularly during enteral hydration. For this purpose, and according to a first aspect, the invention relates to a plug for enteral nutrition system. The plug has a disc-shaped cross wall from which a peripheral skirt with an internal thread protrudes, and is adapted to be screwed onto the neck of a standard water bottle. In addition, the plug further comprises: a first orifice formed in the transverse wall and surrounded by a chimney projecting from the transverse wall opposite the peripheral skirt and which is adapted to receive a nutrition tube; enteral; and a second orifice formed in the transverse wall and surrounded by a flange which projects from the transverse wall in the same direction as the peripheral skirt and which is adapted to receive a hydrophobic filter and to allow the passage of air. By "enteral nutrition system" is meant generally any system that can be used for both hydration and enteral nutrition, or only enteral hydration. This system can operate by gravity or by means of an enteral pump. Thus, the invention provides a stopper that can be adapted to the standard mineral water bottles on the market, due to its geometry and its dimensions, and which can be connected to an enteral nutrition tubing whose connection is incompatible Luer. Concretely, during the tubing rinsing or hydration phases of the patient, this cap is placed at the proximal end of the tubing and screwed onto the neck of a conventional water bottle, generally Still water. The invention thus makes it possible to avoid confusion between enteral and parenteral connections since the tubing associated with the stopper is not Luer compatible. Another advantage of the invention is to allow the administration of water to the patient in a very simple way, in particular without the need for transfer of water between several containers. The term "distal" refers to an element closer to the patient's body than a "proximal" element, when the enteral nutrition system is in a position of use, the fluid delivered to the patient thus flowing in the distal direction . According to a possible embodiment, the average internal diameter of the chimney is substantially identical to or slightly smaller than the outside diameter of an enteral feeding tube, and is typically between 3 and 5 mm, for example of the order of 4 mm. To facilitate retention of the enteral nutrition tubing in the chimney, it may be provided that the inner side face of the chimney is slightly conical and convergent toward the transverse wall. It can also be provided that the centers of the first and second orifices and the center of the transverse wall are substantially aligned. Advantageously, in order to improve the seal, the stopper may further comprise an inner skirt which projects from the transverse wall in the same direction as the peripheral skirt and which is intended to cooperate with the inner face of the neck of a standard water bottle. According to a second aspect, the invention relates to an assembly which comprises a plug as previously described, enteral nutrition tubing inserted into the chimney and adhered to the inner side face of the chimney, and a hydrophobic filter mounted in the collar. According to a third aspect, the invention relates to an enteral nutrition system which comprises an assembly as previously described, a dropper chamber mounted between two portions of the tubing, a control wheel of the fluid flow flowing in the chamber. tubing and, at the distal end of the tubing, a tip adapted to cooperate with the tip of a nutrition probe. This system may further comprise protective device adapted to cooperate with the cap when the latter is not screwed onto the neck 5 of a standard water bottle, to ensure the sterility of the system. The tubing may comprise at least one branch. It may be a rinsing branch. Alternatively, the proximal end of a branch of the tubing may include a striker device for an enteral nutrition bag. The system may also include a cap adapted to be placed on the nozzle of the tubing when the latter is not inserted into the tip of a nutrition probe. Several possible embodiments of the invention will now be described, by way of nonlimiting examples, with reference to the appended figures: FIG. 1 is a perspective view of a plug according to the invention; Figure 2 is a plan view of the outer face of the transverse wall of the plug of Figure 1; Figure 3 is a sectional view along line AA of Figure 2; Figure 4 is a partial view of the cap of Figure 1 screwed onto a standard water bottle in an enteral nutrition system; Figures 5 to 7 are schematic views of different enteral nutrition systems according to the invention. Figures 1 to 3 show a plug 1 for an enteral nutrition system 2. The plug 1, which has an axis 3, is typically made of plastic. It comprises a transverse wall 4 in the form of a disk, with a center 5. A peripheral skirt 6 provided with an internal thread 7 protrudes from the transverse wall 4. The stopper 1 also comprises an inner skirt 8 which projects from the wall transverse 4 in the same direction as the peripheral skirt 6. A first orifice 9 preferably substantially circular, axis 10 and center 11, is formed in the transverse wall 4. This orifice 9 35 is surrounded by a chimney 12 which protrudes from the transverse wall 4 opposite the peripheral skirt 6. In the embodiment shown, the stack 12 has, at the level of the transverse wall 4, an internal diameter dl2min greater than the diameter d9 of the first orifice 9, the wall transverse 4 thus forming an annular flange 13 at the base of the chimney 12 and inside thereof.

The inner side face 14 of the chimney 12 is slightly conical and convergent toward the transverse wall 4. Thus, the inside diameter d2max of the chimney 12 at its free end 15 is greater than the internal diameter d2min of the chimney 12 at the the transverse wall 4.

A second, preferably substantially circular, orifice 17, with axis 17 and with center 18, is also formed in the transverse wall 4. This orifice 16 is surrounded by a flange 19 which projects from the transverse wall 4 in the same direction as the peripheral skirt 6. In the embodiment shown, the inside diameter d19 of the flange 19 is substantially identical to the diameter d16 of the second orifice 16. As illustrated in FIG. 2, the centers 11, 18 of the first and second openings 9, 16 and the center 5 of the transverse wall 4 may be substantially aligned. According to an important feature of the invention, the cap 1 is designed to be screwed onto the neck of a standard water bottle. In particular, the dimensions of the plug 1 - which also includes its thread 7 and its optional inner skirt 8 - are adapted to the dimensions of the threaded neck of a conventional mineral water bottle of the consumer market. Thus, according to a possible embodiment, the inside diameter d6 of the peripheral skirt 6 is about 30.5 mm, and the height of the threads of the order of 0.7 mm, while the outside diameter d8 of the inner skirt 8 is about 25.2 mm. In Figure 4, we see the plug 1 screwed on the neck 20 of a standard water bottle 21, axis 22. The neck 20 comprises an external thread 23 which cooperates with the internal thread 7 of the plug 1. In screwed position, the inner skirt 8 cooperates with sealing with the inner face 24 of the neck 20. The bottle 21 is placed on a suitable support 25 of the enteral nutrition system 2, neck 20 downwards, preferably with its axis 22 35 substantially vertical, so as to allow the flow of water by gravity for the administration of water to a patient, in particular for its hydration.

An enteral feeding tubing 26 is inserted into the chimney 12 and adhered to the inner side face 14 of the chimney 12. In practice, the average internal diameter of the chimney 12 is substantially the same as or slightly smaller than the outside diameter d26 of the tubing 26, this average internal diameter being typically between 3 and 5 mm, for example of the order of 4 mm. Advantageously, it can be provided that the inner side face 14 of the chimney is slightly conical and convergent in the direction of the transverse wall. For example, the inside diameter dl 2max of the stack 12 at its free end 15 may be of the order of 4.1 mm, and the inside diameter dl 2min of the stack 12 at the level of the transverse wall 4 may be the order of 4 mm. Thus, the tubing 26 can be mounted slightly forcibly in the chimney 12. In addition, its retention can be reinforced by gluing, typically by means of a solvent allowing the materials constituting the stopper 1 and the tubing 26 to be intimately bonded together. In addition, a hydrophobic filter 27 is mounted in the collar 19, generally by force. This filter 27 prevents leakage of water through the second orifice 16 but allows the entry of air into the bottle 21 so as to allow a regular flow of water through the tubing 26. By way of example, the inner diameter d19 of the flange 19 may be of the order of 4.1 mm. Various enteral nutrition systems 2 will now be described with reference to FIGS. 5 to 7. The enteral nutrition system 2 comprises a tubing 26 whose proximal end 30 is inserted into the chimney 12 of a stopper 1 screwed onto a bottle 21. A dropper chamber 28 is mounted between two portions of the tubing 26 to allow adjustment and control of the flow. In addition, there is provided a wheel 29 - or "roller clamp" - for adjusting the flow of fluid flowing in the tubing 26. At the distal end 31 of the tubing 26 is mounted a tip 32 adapted to cooperate with a tip 33 of a nutrition probe 34 inserted into the patient. The enteral nutrition system 2 also comprises a cap 35 adapted to be placed on the tip 32 of the tubing 26 when the latter is not inserted into the tip 33 of the nutrition probe 34.

In the system 2 shown in Figure 6, the tubing 26 has a branch 36 that can be used to pass a cleaning liquid. In the system 2 illustrated in FIG. 7, the tubing 26 has a branch 36 which can be used to pass a cleaning liquid, and a branch 37 which is provided with a wheel 29, and whose proximal end comprises a striker device 38 for an enteral nutrition bag 39. In addition, the system 2 may comprise a protection device 40 adapted to cooperate with the stopper 1 when the latter is not screwed onto the neck 20 of a bottle of water 21 standard. Thus, the invention makes it possible to provide a sterile system allowing the hydration of a patient by the enteral route. It goes without saying that the invention is not limited to the embodiments described above as examples but that it includes all technical equivalents and variants of the means described and their combinations.

Claims (11)

REVENDICATIONS1. Cap for an enteral feeding system (2), characterized in that it comprises a disc-shaped transverse wall (4) from which a peripheral skirt (6) provided with an internal thread (7) projects, in that it is designed to be screwed onto the neck (20) of a standard water bottle (21), and in that it further comprises: - a first orifice (9) in the transverse wall (4) ) and surrounded by a chimney (12) projecting from the transverse wall (4) opposite the peripheral skirt (6) and adapted to receive enteral nutrition tubing (26); and a second orifice (16) formed in the transverse wall (4) and surrounded by a flange (19) which projects from the transverse wall (4) in the same direction as the peripheral skirt (6) and which is adapted to receive a hydrophobic filter (27) and allow the passage of air. The cap of claim 1, characterized in that the average inside diameter of the stack (12) is substantially the same as or slightly less than the outside diameter (d26) of an enteral nutrition tubing (26), and is typically included between 3 and 5 mm, for example of the order of 4 mm. 3. Stopper according to claim 1 or 2, characterized in that the inner side face (14) of the chimney (12) is slightly conical and convergent towards the transverse wall (4). 4. Stopper according to one of claims 1 to 3, characterized in that the centers (11, 18) of the first and second orifices (9, 16) and the center (5) of the transverse wall (4) are substantially aligned. . 30 5. Stopper according to one of claims 1 to 4, characterized in that it further comprises an inner skirt (8) which projects from the transverse wall (4) in the same direction as the peripheral skirt (6) and which is intended to cooperate with the inner face (24) of the neck (20) of a standard water bottle (21). 6. An assembly characterized in that it comprises a plug (1) according to one of claims 1 to 5, a tubing (26) of enteral nutrition inserted into the chimney (12) and glued against the inner side face (14). the chimney (12), and a hydrophobic filter (27) mounted in the flange (19). 7. enteral nutrition system, characterized in that it comprises an assembly according to claim 6, a dropper chamber (28) mounted between two portions of the tubing (26), a wheel (29) for adjusting the flow rate of fluid flowing in the tubing (26) and, at the distal end (31) of the tubing (26), a tip (32) adapted to cooperate with the tip (33) of a nutrition probe (34). ). 8. System according to claim 7, characterized in that it further comprises a protection device (40) adapted to cooperate with the cap (1) when the latter is not screwed onto the neck (20) of a standard water bottle (21). 9. System according to claim 7 or 8, characterized in that the tubing (26) comprises at least one branch (36, 37). 20 10. System according to claim 9, characterized in that the proximal end of a branch (37) of the tubing (26) comprises a striker device (38) for an enteral nutrition bag (39). 25 11. System according to one of claims 7 to 10, characterized in that it comprises a cap (35) adapted to be placed on the tip (32) of the tubing (26) when the latter is not inserted. in the tip (33) of a nutrition probe (34).