WO1993010422A1

WO1993010422A1 - Dosing apparatus for sterile and/or pharmaceutical solutions

Info

Publication number: WO1993010422A1
Application number: PCT/ES1991/000081
Authority: WO
Inventors: Pedro Casamira Camps
Original assignee: Industrias Palex, S.A.
Priority date: 1991-11-22
Filing date: 1991-11-22
Publication date: 1993-05-27
Also published as: EP0570378A1; CA2101049A1

Abstract

The dosing device for sterile and/or pharmaceutical solutions is comprised of a laminar body (10) which contains the solution, presenting a top neck wherein a tubular nozzle (20) may be inserted and which is covered by a cup (30) having a weakened area, with a fluted ring (40) which interconnects said parts. The device may be coupled to a rigid support (50) which has a base slidable on an axis in order to apply the solution by manually pressing on the base of said support.

Description

DOSING DEVICE FOR SOLUTIONS

STERILE AND / OR PHARMACEUTICAL

The present invention concerns a sterile and / or pharmaceutical solutions dosing device, formed by a single-use container containing the solution, provided with a nozzle and a cap covering it, a ring in function of closure and a rigid support for its support, which in turn, facilitates the use and handling of the device.

The dosing device object of the present invention of sterile and / or pharmaceutical solutions is of medical or surgical application, for use in human or veterinary functions.

FIELD OF THE INVENTION

As is already known, in some situations it is convenient to provide fixed amount of solutions on localized points, for curative or preventive purposes. These functions are performed through conventional means such as syringes or other similar ones, operating on the basis of sucking liquids from a sterile container through sterile means, such as syringes, and emptying the collected content on specific points of the human or animal body . This solution involves several problems, among them, the transfer from one medium to another, which although they are sterile, usually present problems of loss of sterility, as well as certain discomforts in their use and handling.

BACKGROUND OF THE INVENTION

Container devices of pharmaceutical and veterinary liquid solutions, such as ampoules, cartridges or vials, which are provided with needles are known or means for its coupling, which allows its direct use in its administration. Such a device is described in Spanish Patent No. 8801006, formed by a container of flexible synthetic material, being emptied by pressure exerted against the walls thereof.

More specific background of the current invention in the sector where it is affected, is first constituted by US Patent 2,319,383 of Merck & Co., Inc, and in particular the execution set forth in US Patent 3,989,045 of Illinm F. Van Eck, in which a syringe formed by a container and a needle is described, this container being in the form of a balloon and flexible walls, presenting a fastening means in the neck of the container. ^{* The} aforementioned device suffers from a first inconvenience in its use, as it does not comprise a flat base for its physical positioning on a surface, leading to the hole at the end of the needle coming into contact with the surface where it rests, thus losing its sterilization. dad

Also in the indicated position, part of the solution is spilled on the flat surface where the assembly rests, by principles of capillarity.

Thirdly, there is a notable lack of precision in the emptying of the container, since the necessary flexibility of the wall of the container requires a considerable pulse to accurately dose.

Other background of the invention can be found in British Patent 1573 514, of AB Helinos, of Sweden, and in German Patent 29 00 827, of Merck Patent GmbH, which describe devices formed by a flexible, closed and sealed container that contains the solution, applicable against rigid elements that involve a needle that pass through it, being able to pierce the indicated container by one of the ends of the needle and receive it in mind, while at the other end of the needle they allow the exit of the solution contained. These devices have the common disadvantage of requiring a coupling operation, a situation that involves handling, manually (in the Merck solution), the container and the rigid element by the end to be punched, thereby losing the optimum sealing conditions of the assembly , and consequently, his sterility.

As in previous solutions pointed out, the lack of precision in emptying the container is also notable, mainly in the Merck solution.

Finally, container cartridge systems of solutions that can be coupled to rigid structures are also known, such as that described in PCT Patent WO 89/02286, of Wolke, in which a device formed by a sealed container can be described. inside a hollow rigid structure, with one of its ends provided with a needle that pierces and communicates with the outside the solution contained in the container, dosable through a plunger located at the other end of the indicated hollow rigid structure.

Although this solution has greater reliability in terms of accuracy in emptying the contents of the package, it also requires manual handling of the packages to be placed inside the hollow rigid structure. Another important drawback is the large number of parts that the indicated device entails, with a high cost in its manufacture.

SUMMARY OF THE INVENTION

The device according to the present invention eliminates the aforementioned drawbacks, managing to dose and supply a sterile solution in optimal conditions, easy to use and high precision, as well as with a low cost in the industrial manufacturing process.

For this, the current device comprises a container containing the solution, consisting of: - a cylindrical general flexible laminar body with its wall in accordion bellows, with a blind base and the other axially extended in a cylindrical duct, which ends with an outer ring, - a cylindrical tubular nozzle, which has a relief external surrounding, flat, and presenting a bevel-like end, and its outer diameter being slightly smaller than that of the bore of the cylindrical duct that extends the bellows, c) a cap that covers a part of the nozzle, presenting on its wall a weakened surrounding line, and its mouth being extended in a wall, attached to the surrounding relief of the nozzle, and, d) a grooved ring that determines a circular race capable of perimetrically trapping the extension ring in the body a) with the wall of the cap, and laterally extending this ribbed ring into at least one fin.

The coupling between the flexible laminar body and the tubular nozzle is carried out at the end of the latter with the hole in the cylindrical duct that extends the bellows. Similarly, the cap covers the other end of the nozzle, resting its wall with the outer ring of the flexible laminar body. The described elements placed are secured by the grooved ring that perimetrically catches the ring of the extension of the flexible laminar body with the wall of the cap.

The set described is bearable in a rigid structure, as a support, formed by:

- a flat 'U' shaped area with two non-contiguous and parallel ends provided with a 'l.' , determining two longitudinal and parallel guides,

- a lower axis and perpendicular to said flat area and symmetrically arranged thereon,

- a circular base comprising a central recess, with a lateral extension that has a hole that the it passes, the perpendicular axis being tightly adjustable, and with a lower extension provided with perpendicular pressure means on said axis.

The axis perpendicular to the base of the rigid structure is capable of presenting a graduated scale.

The preceding elements include certain peculiarities that will be indicated below.

DESCRIPTION OF THE DRAWINGS

The attached drawings, by way of example only, will allow us to better understand the invention, the features that it presents and the advantages that it is susceptible to provide:

Figure 1 is a perspective view of the flexible laminar body, the tubular nozzle and the cap, in preassembly position,

Figure 2 is a cross-sectional view of the elements shown in Figure 1, coupled with each other and with the grooved ring joining them,

Figure 3 is a double view of a valve in section and in perspective with the three elements that compose it,

Figure 4 is a perspective view of the support structure of the assembly shown in Figure 2, Figure 5 is a cross-sectional view of the support structure, and,

Figure 6 is a perspective view of the support structure to which the assembly shown in Figure 2 has been attached. The elements designated with numbers in the drawings correspond to the parts indicated below.

CONCRETE EMBODIMENT OF THE INVENTION Figure 1 shows a device according to the present invention, formed by a laminar body 10, a nozzle 20 and a cap 30, represented in a preassembly position, on the same ideal axis. The laminar body 10, the nozzle 20 and the cap

30, preferably of plastic material, are obtained by molding.

The laminar body 10 has a generally cylindrical configuration inferiorly, with its side wall 11 in accordion bellows and its blind base. By its other base it extends axially in a cylindrical duct 12, which ends with an outer ring 13 defining a central hole 14 that communicates the inside of the body 10 with the outside. The nozzle 20 is tubular, with a longitudinal hole 21 that passes through it, presenting a general cylindrical configuration, with an external and flat surrounding relief 22.

The nozzle 20 of Figure 1 has an upper end 23 as a bevel. As will be described later, this end may have different shapes depending on applications.

The overall diameter of the nozzle 20, both above and below relative to the surrounding relief 22 has a diameter slightly less than that of the orifice ^'of the core 14 and cylindrical conduit 12 of the laminar body 10.

As already indicated above, the nozzle 20 is preferably realizable of plastic material. However, the thickness of the same must have a rigidity that eliminates any possible flexibility in its use.

The cap 30 is of elongated general configuration, with a central and hollow cylindrical section from which two diametrically opposed fins 31 and 32 emerge laterally, with their upper ends slightly inclined to finish off against their upper end. Inwardly, the cap 30 provides a blind cylindrical cavity, not shown in Figure 1, of a diameter substantially greater than that of the upper section of the nozzle 20. Lowerly, the cap 30 comprises on its outer wall a surrounding weakened line 31, prolonged rubbing its mouth on a wall 34 that determines a flat ring.

The internal cavity of the cap 30 is capable of receiving the upper section of the nozzle 20, thereby coinciding with the upper surface of the surrounding relief 22 against the lower surface of the wall 34 that determines the mouth of the cap 30.

Similarly, the lower section of the nozzle 20 is capable of being inserted inside the central hole 14 and penetrating the cylindrical conduit 12, thereby coinciding with the lower surface of the surrounding relief 22 with the upper surface of the outer ring 13 of the body 10. Figure 2 shows in section the body 10 and the cap 30 with the nozzle 20 inserted inside the cylindrical duct 12, and in turn inside the cap 30.

In the same Figure 2 the grooved ring 40 is shown, which determines a circular race 41 capable of perimetrically trapping the outer ring 13 of the body 10, with the wall 34 of the cap 30, and consequently the surrounding relief 22 of the nozzle 20.

The grooved ring 40 extends laterally in the example illustrated on a fin 42.

The grooved ring 40 allows the body 10, the nozzle 20 and the cap 30 to be held together in a stable manner. In an industrial application of the device according to the present invention, it is preferable to fill the solution inside the body 10 before proceed to the assembly of the parts that compose it.

Coupled the elements described on the body 10, the overlapping will allow, apart from joining the various parts, to keep the interior of the device tight, being able to sterilize the assembly by conventional procedures unrelated to the present invention. The described device consists of a closed single-use container that allows solutions to be supplied. To be able to practice its opening and proceed to dose it is necessary to hold the device with one hand by its fin 42 and with the other hand hold the cap 30, to proceed to tear it by axial rotation. In this operation the fins 31 and 32 of the cap 30 cooperate effectively, preventing the fingers from slipping during the opening of the device.

Subsequently, and with only one hand, the contained solution can be dosed by holding the cylindrical duct 12 with two consecutive fingers of the hand and pressing the blind base of the body 10 with the thumb. The lateral wall 11 of the body 10 will yield, allowing to be dosed by slight weakening of the accordion bellows, and / or to suction for its recovery.

The upper end 23 of the nozzle 20 has a beveled shape, for specific applications in terms of the use of the device. As indicated previously, the nozzle 20 may have different upper ends 23, such as that illustrated in Figure 3. Likewise, the inner duct that passes the nozzle 20 can provide elements that allow maintaining a unidirectional passage of the contained solutions. inside the body 10. In Fig. 3 a nozzle 20 is illustrated which has a cylindrical end 23.

The represented nozzle 20 is formed by the union of two halves, one upper and the other lower, comprising a hole 21 that communicates in an inner tubular duct 28 that passes it longitudinally, with a disc 29 which is located inside a cavity 27, exercising the valve functions, allowing with This is a unidirectional solution step. The described valve is conventional, oblivious to the present invention in terms of the particularities that it presents, and valves of different types can be used. As indicated previously, the ends 23 of the nozzle 20 may have different shapes according to the specific application to which the solution to be dosed is intended. Independently, valves or direct conduits can be used inside the nozzle 20.

The application of a non-return valve as described will allow to extract the air that may exist inside the body 10 and maintain this position in a stable manner. Similarly, the indicated valve will prevent any suction, and in turn, penetration of other liquid or gaseous materials inside the body 10.

The nozzle 20 may also present the convenient forms to be able to receive conventional tubes or fittings tightly against its outer surface and to ensure its retention. In all cases, the blind cavity of the cap 30 will have the appropriate shapes to be able to receive these ends and in turn keep the device in general tight.

The ribbed ring 40 extends laterally on a fin 42. The number of fins that the device can comprise are multiple.

This fin has clear functional applications, allowing to adhere a label with the identification of the solution contained in the device, such as a description, formula, expiration date or similar data. Apart from the function indicated above, in terms of facilitating the opening of the device, the utility of a fin allows to protect the fingers of the hand at the time of dosing the solution avoiding the contact of those with the element receiving the solution.

Likewise, in the non-use position of the device, the flap prevents the device from rolling on surfaces

apparently flat, and in turn collaborates in distancing the end 23 of the nozzle 20 from the surface where the device is placed.

The described device is capable of being used in isolation or through a rigid support. Figures 4 and 5 illustrate a rigid support 50. In Figure 6 the rigid support 50 is shown in which the dosing device has been engaged.

In the rigid support 50 a flat area 51 is provided with one of its sides presenting a recess 54, and with two non-contiguous and parallel ends provided with a shoulder 52 and 53 in L ^/ , which determine two longitudinal guides.

The rigid support 50 comprises a lower axis 55 and perpendicular to the flat area 51, arranged symmetrically thereon.

Lowerly, the support 50 comprises a base 56 that has a circular zone with a central recess 57 and a side hole 58 that passes through it. The side hole 58 of the base 56 is substantially larger in diameter than that of the shaft 55.

The base 56 has an extension inferiorly provided with an inner hole 65 perpendicular to the side hole 58 and communicated therewith, with pressure means constituted by a screw 59 that controls a spring 61 and in turn it collaborates on the cylinder 60.

Once the base 56 is placed on the shaft 55 through the side hole 58 thereof, the cylinder 60 exerts pressure by collaboration of the means indicated in the previous paragraph on the surface of the shaft 55. Thus, the base 56 is only movable to will along axis 55.

The base 56 on the axis 55 is limited superiorly by the flat area 51, and inferiorly by the recess 62, which has at its last end a slight step against which the cylinder 60 collaborates.

The external surface of the shaft 55 has a graduated scale 63, whose usefulness will be described later.

The different parts that make up the rigid support can also be obtained by molding, of plastic or metallic materials.

The dosing device is attachable in the rigid support 50. For this, the fin 42 must be placed on the flat area 51 with the guided collaboration of the 'L' projections 52 and 53 upon receiving the sides of the fin 42 itself. position, the neck 12 of the body 10 and the ring 40 are located in the recess 54. In the lower part, the blind base of the body 10 is located in the central recess 57 of the base 56 of the rigid support. Figure 6 illustrates the final positioning of the device on the rigid support.

The opening and operation of the dosing device coupled to the rigid support is identical to what has been described previously without it.

The application of the rigid support has clear advantages that allow dosing with greater precision, by collaborating with a greater rigidity of the whole device, and by understanding the graduated scale 63 on the axis 55. With this, it is possible to dose concrete amounts of solution.

Claims

1.- Dosing device for sterile and / or pharmaceutical solutions, of the type formed by a container containing the solution and which is provided with outlet connection means, and a rigid support against which the indicated container is characterized, characterized for comprising the following parts: a) a general cylindrical flexible laminar body with its wall in accordion bellows, with a blind base and the other axially extended in a cylindrical duct, which ends up topped by an outer ring, b) a cylindrical tubular nozzle , which has a surrounding external relief, flat, and having a bevel-like end, and its outer diameter being slightly smaller than the bore of the cylindrical conduit that extends the bellows, c) a cap covering a part of the nozzle, they have ¬ Taping on its wall a weakened surrounding line, and its mouth being extended in a wall, attached to the surrounding relief of the nozzle, and, d) a corrugated ring that det a circular regatta capable of catching the extension ring in the body a) with the wall of the cap perimeter ends, and this ribbed ring is extended laterally into at least one fin.

2.- Dosing device for sterile and / or pharmaceutical solutions, according to the preceding claim, characterized in that in a second embodiment, it is possible to place a non-return valve between the bellows body and the nozzle.

3.- Dosing device for sterile and / or pharmaceutical solutions, according to previous claims, characterized in that in another embodiment, the end of the nozzle is capable of ending in a beveled tip.

4.- Sterile solution dosing device les and / or pharmaceuticals, according to previous claims, characterized in that, in another embodiment, the tip of the nozzle itself is capable of finishing off in a cone of the 'Luer' type. 5.- Device for measuring sterile and / or pharmaceutical solutions, according to previous claims, characterized in that it comprises, in a second embodiment, the following parts: a) a cylindrical general flexible laminar body with an accordion bellows wall, with a blind base and the other axially extended in a cylindrical duct, which ends with an outer ring, b) a cylindrical tubular nozzle, which has an external, flat surrounding relief, and presenting a bevel-like end, and its outer diameter being slightly below that of the hole in the cylindrical duct that extends the bellows, c) a cap that covers a part of the nozzle, presenting a weakened surrounding line on its wall, and its mouth being extended in a wall, attached to the surrounding relief of the nozzle, d) a grooved ring that determines a circular regatta capable of perimetrically trapping the extension ring in the body a) with the v Alona of the cap, and laterally extending this ribbed ring into at least one flap, and, e) a rigid support capable of receiving the anterior assembly in a energetic manner, and in which they are provided:

- a flat U-shaped area with two non-contiguous and parallel ends provided with a "L" shoulder, determining two longitudinal and parallel guides,

- a circular base comprising a central recess, with a lateral extension that has a hole that passes through it, the perpendicular axis being adjustable, and with a lower extension provided with means perpendicular pressure on said axis.

5.- Dosing device for sterile and / or pharmaceutical solutions, according to the preceding claim, characterized in that the axis perpendicular to the base of the rigid structure is capable of presenting a graduated scale.