FR2951638A1 - Interfacing device for connecting syringe and bottle e.g. vial, containing drug that is injected into patient in hospital, has rigid shells defining interior compartment isolated from and/or connected with exterior compartment - Google Patents

Abstract

The device has a connection base (107) connected to a bottle to be perforated. The connection base comprises a removable air reservoir connected to the bottle to be perforated via an air circulation unit. The air reservoir has rigid shells (122, 123) associated with a flexible membrane (124), where the shells define an interior compartment (125) isolated from and/or connected with an exterior compartment (126). A non-return valve (130) is connected to the air reservoir.

Description

TECHNICAL FIELD The invention relates to the field of interfacing devices with bottles for the medical field. STATE OF THE ART Document 2928539 discloses an interfacing device for connecting a syringe and a drug-containing perforating bottle for the preparation of liquids for infusion into a patient. This device comprises means of air circulation and filtration, 15 allowing a double effect: - protect the medical staff from possible projections of liquid, - protect the liquid from any external elements. Figure 1 shows the device described further in FR 2928539. This figure shows an interfacing device 1 associated with a vial 2 to be perforated, in order to prepare liquids intended to be perfused in a patient. The interfacing device 1 comprises: a clipping plug 10, a distal connection base 100 comprising a through orifice 108 on which are arranged filtration means 109, a storage and handling device, not shown, a hollow perforation needle 30 and a cannula 102, a deformable membrane 40, a proximal connection base 50, a membrane connector 3, a filtration device 60.

The piercing bottle 2, also called Vial, comprises a neck closed by a membrane, thus isolating the contents of the Vial 2 from the outside. Vial 2 contains a compound for therapeutic use, for example in the form of particles intended to be solubilized in order to be injected into a patient. When using the interfacing device 1, it is assembled with the Vial 2, previously closed; the hollow perforation needle 30 then perforates the membrane closing the neck of the Vial 2. An air inlet in the Vial 2 then takes place; this air inlet passes through air circulation means, comprising the filtration means 109 of the opening orifice 108 and a functional clearance between the hollow perforation needle 30 and the cannula 102, in order to enter the Vial 2.

Once the Vial 2 has been assembled with the interface device 1, the preparation personnel connects a syringe filled with liquid to be infused to the membrane connector 3 if it is present, or directly to a Luer or Luer type connection. -lock of the filter device 60. The user then injects the liquid to be infused into the Vial 2, which pushes the air contained in said Vial 2 outside. The air pushed outward then takes the opposite path, and passes through the functional clearance between the hollow perforation needle 30 and the cannula 102, then by the filtration means 109.

Once the contents of the syringe injected into the Vial 2, the user removes the syringe. It can then remove the storage and handling device and lower the hollow perforation needle 30 until it reaches the bottom of the Vial 2. The user can then suck the mixture contained in the Vial 2 with the syringe. , then reinject it into the Vial 2, and repeat this operation several times to homogenize the mixture. During these aspiration and reinjection operations, air enters and leaves the Vial 2, borrowing the air circulation means in the same manner as previously described.

The use of this device therefore causes several air inlets and outlets in the Vial 2 during the various operations performed by the user. Such air inlets and outlets in the vial to be punctured pose security concerns; it is necessary to prevent unsolubilized particles in the Vial 2 from escaping and being released into the open air, and it is also necessary to prevent foreign elements in the open air from contaminating the atmosphere. In the known embodiments, the opening orifice 108 allowing air inlet / outlet is provided with filtration means 109, thus filtering the particles carried by the displacements of air, which this or particles of liquid or unsolubilized particles to prevent them from affecting the user, or external particles so that they do not introduce impurities in the liquid to be injected.

The filtration system of this device, however, has disadvantages, the filter does not seem sufficiently effective for users.

PRESENTATION OF THE INVENTION

The invention proposes an improvement of this device in the form of an interfacing device for connecting a syringe and a puncture bottle containing a medicament, comprising a base for connection to the flask to be perforated, said base comprising a air tank connected to the flask to be perforated via air circulation means, and adapted to allow inflow and outflow of the flask to be perforated, characterized in that the air reservoir comprises a rigid shell associated with a flexible membrane, defining a compartment isolated from the outside.

According to several particular embodiments, the invention may comprise one or more of the following characteristics: said rigid shell associated with said flexible membrane further defines a compartment in connection with the outside, an anti-return valve is connected to the reservoir of air, the air tank is removable, the rigid shell comprises two hemispherical elements, the connection base to the flask to be perforated comprises opening means for opening the non-return valve when a use of the device, - the air tank comprises a hole in the rigid shell, so as to connect one of said compartments to the open air, the other compartment being connected to the flask to be perforated, - a sliding needle in a cannula , characterized in that said cannula has a beveled end adapted to perforate a membrane closing the neck of a flask to be perforated, and in that the needle comprises an end emo Ussée intended to cooperate with stops disposed in the cannula to limit the displacement of said needle in the cannula.

This improved air circulation system is a substitute for the filter present in conventional devices, and allows air circulation in the Vial, while maintaining said Vial isolated from the outside, and thus isolated risks of contamination by external elements.

PRESENTATION OF FIGURES

Other characteristics, objects and advantages of the invention will emerge from the description which follows, which is purely illustrative and nonlimiting, and which should be read with reference to the appended drawings, in which:

Figure 1 shows a known interfacing device as described above. Figure 2 shows a sectional view of an interfacing device provided with an air tank according to the invention. Figure 3 shows an exploded view of an air tank according to the invention. Figure 4 shows a sectional view of the non-return valve associated with an air tank according to the invention.

Figure 5 shows a detailed view of the cannula and the hollow needle.

DETAILED DESCRIPTION FIG. 2 shows a view of an air tank according to the invention associated with an interfacing device as described above.

An air reservoir 120 according to the invention is connected to the interfacing device 1 at the opening orifice 108 which comprises a connection base 107, via an anti-return valve 130. The air reservoir represented comprises two rigid shells 122 and 123, which trap a membrane of flexible elastomeric material 124. The two rigid shells 122 and 123 define an inner space, which is therefore separated into two compartments, isolated from each other by the flexible membrane 124 - an inner compartment 125, - an outer compartment 126. 520 The outer compartment 126 is connected to the outside air via a hole in the corresponding shell, while the inner compartment 125 is isolated from the outside and is connected to the outside. the opening opening 108 via a non-return valve 130, having for example here a Luer lock connection. The rigid shell 125 or 126 connected to the anti-return valve 130 is also provided with a connection of the same type, for example here Luer-lock type, to assemble it with the non-return valve 130.

As mentioned above, the flexible membrane 124 isolates these two compartments from each other, preventing any passage from one of the compartments to the other. Other embodiments are possible: the hole in the shell may for example be replaced by several holes of reduced diameter, or by slots of various shapes. The rigid shell 122 or 123 may also be associated with the flexible membrane 124 to define only the inner compartment 125. The outer compartment 126 is not defined, which has the consequence that the deformation of the flexible membrane 124 n is not limited. The inner compartment 125, however, remains isolated from the outside because of the presence of the flexible membrane 124.

FIG. 3 shows an exploded view of the air tank 120. This figure shows the first rigid shell element 123 provided with the hole 140, the rigid shell element 124 provided with a connection interface 142, for example here of the type Luer lock, and the flexible membrane 130 disposed between the two rigid shells 123 and 124, here shown as having a rounded shape to illustrate its deformation.

FIG. 4 shows a detailed view of the non-return valve 130 associated on the one hand with the connection base 107 of the opening orifice 108, and on the other hand with a rigid shell 122.

The check valve 130 has a pusher 132 which actuates the valve when the air tank is connected. It cooperates for this with the connection base 107 of the opening orifice 108, which has for example a male cone 111 adapted to actuate the pusher 132 when the non-return valve 130 is associated with the interfacing device 1, and so open valve 133. Therefore, check valve 130 is turned in both directions when the air tank is connected, allowing air to enter and exit air tank 120, while air is disconnected, it prevents air and particles trapped in the inner compartment 125 of the air tank 120 out of said air tank.

The operation of the air reservoir 120 when using the interfacing device 1 is described below.

The flexible membrane 124 is deformed according to the movements of air. More specifically, the flexible membrane 124 is initially in the rest position, with an identical (or substantially identical) pressure in the inner compartment 125 and the outer compartment 126. During the use steps during which an air inlet in the Vial 2 takes place, for example during the perforation of the diaphragm closing the neck of said Vial 2, or during the suction of the liquid to be injected into the perforating syringe, it is the air initially present in the inner compartment 125 which will be injected into the Vial 2. There is a pressure difference that is created, and which deforms the flexible membrane 124 so that it reduces the volume of the inner compartment 125, thereby injecting the air initially present in the inner compartment 125 in the Vial 2.

In the opposite case where air leaves the Vial 2, for example when liquid is injected into said Vial 2, the air is sent into the internal compartment 125 which is then overpressurized relative to the outer compartment 126. This causes a deformation of the flexible membrane 124, so that it increases the volume of the inner compartment 125.

In both cases, the deformation of the flexible membrane 124 is limited because of the presence of the two rigid shells 122 and 123, the maximum deformation of the flexible membrane 124 being achieved when it is pressed against said rigid shell, and that the volume of the inner compartment 125 or outer compartment 126 occupies the entire internal space.

The compartment 125 is therefore connected to the Vial 2 via air circulation means, comprising the non-return valve 130 and the functional clearance between the needle 30 and the cannula 102.

The air reservoir 120 thus makes it possible to inject or extract air from the Vial 2 via the air circulation means, without there being any intrusions of foreign elements into the liquid to be injected. or there is a product coming from Vial 2 that escapes. The air tank 120 thus secures both the liquid to be injected contained in the Vial 2 and the user.

It should be noted that the fact of limiting the expansion of the flexible membrane 124 makes it possible to avoid any risk of explosion or tearing of the flexible membrane 124 in the event of excessive expansion of the latter. Indeed, an explosion, a tear, or anything that could damage the flexible membrane 124, and thus allow the passage of air and / or particles between the inner compartment 125 and the outer compartment 126 represents a risk for the user and for the liquid to be injected, and therefore for the patient to whom this liquid to be injected is intended.

Once the use of the interfacing device 1 is completed, the air tank 120 can be removed. The user disconnects the assembly constituted by the air tank 120 and the non-return valve 130 of the interfacing device 1. The non-return valve 130 ensures that any particles coming from the Vial 2 located in the internal compartment 125 are kept there, and can not be expelled to the open air. The opening opening 108 of the interfacing device 1 can then be closed by a plug, preferably allowing a tight closure.

The interfacing device 1 and the assembly consisting of the air tank 120 and the non-return valve 130 can then be stored individually, which has advantages in terms of space relative to an interface device in which the air tank are non-removable or permanently.

The fact of limiting the expansion of the flexible membrane 124 via the rigid shells 122 and 123 also makes it possible to limit the bulk of the air tank 120 with respect to a case where the expansion of said flexible membrane 124 would not be limited.

In addition, the rigid shells prevent any risk of perforation during disposal of the device, which could then endanger non-user personnel and external to the hospital (during the collection or treatment of waste for example) ).

As previously described, in the known embodiments the hollow perforation needle 30 has a beveled end to perforate the membrane closing the neck of the Vial 2.

This needle is then provided with retaining means to prevent it completely out of the cannula 102, which would present a risk for the user. Conventionally, these retaining means take the form of a spherical boss made on said needle. The resulting needle, however, is complex and expensive.

Another embodiment is shown in Figure 5, which shows a detailed view of the needle 30 and the cannula 102 in the device according to the invention. In this particular embodiment, the cannula 102 has a beveled end, which therefore gives it a pointed shape, adapted to perform the perforation of the membrane closing the neck of the Vial 2.

The needle 30 therefore no longer needs to have a beveled end, the perforation function being performed by the cannula 102. On the contrary, the end of the needle 30 is here of blunt shape, and stops 103 are arranged in the cannula 102. Thus, when the needle 30 moves in the cannula 102, the blunt end of the needle 30 will cooperate with the stops 103 of the cannula to limit the movement of the needle 30 in the cannula 102, and thus prevent the needle 30 completely out of the cannula 102.

In addition, the blunt form of the needle has an advantage over the beveled shape, allowing to suck more effectively (closer to the wall of the Vial) the liquid to be perfused in a patient. Such products are indeed very expensive, and such a shape of the needle makes it possible to minimize the quantity of product remaining in the Vial.

The needle thus produced is thus simpler and more economical, while maintaining its safe appearance.

Claims (8)

Revendications1. Interfacing device (1) for connecting a syringe and a drug-containing perforating bottle (2), comprising a connection base (107) to the perforating bottle (2), said base (107) comprising a reservoir of air (120) connected to the flask to be perforated (2) via air circulation means (130, 30, 102), and adapted to allow air inlets and outlets of the flask to be perforated (2), characterized in that the air reservoir (120) comprises a rigid shell (122, 123) associated with a flexible membrane (124), defining a compartment isolated from the outside (125). 2. Device (1) according to the preceding claim, characterized in that said rigid shell (122, 123) associated with said flexible membrane (124) further defines a compartment in connection with the outside (126). 3. Device (1) according to one of the preceding claims, characterized in that an anti-return valve (130) is connected to the air tank (120). 4. Device (1) according to one of the preceding claims, characterized in that said air tank (120) is removable. 5. Device (1) according to one of the preceding claims, characterized in that said rigid shell (122, 123) comprises two elements (122, 123) of hemispherical shape. 30 6. Device (1) according to one of claims 3 to 5, characterized in that the connection base (107) to the flask to be perforated (2) comprises opening means (111) for opening the valve anti -return (130) when using the device. 7. Device (1) according to one of the preceding claims, characterized in that said air tank (120) comprises a hole (140) in the rigid shell (122, 123), so as to connect one of said compartments ( 123) in the open air, the other compartment (122) being connected to the flask to be perforated (2). 8. Device (1) according to one of the preceding claims, comprising a sliding needle (30) in a cannula (102), characterized in that said cannula (102) has a beveled end adapted to perforate a membrane closing the neck of a vial to be perforated (2), and in that the needle (30) comprises a blunt end for cooperating with abutments (103) disposed in the cannula (102) to limit movement of said needle (30) in the cannula (102).