WO1995019195A1

WO1995019195A1 - Cartridge unit for the distribution of a liquid

Info

Publication number: WO1995019195A1
Application number: PCT/FR1995/000015
Authority: WO
Inventors: Frédéric Neftel; Bernard Bouvier
Original assignee: Debiotech S.A.
Priority date: 1994-01-12
Filing date: 1995-01-06
Publication date: 1995-07-20
Also published as: AU1457895A; FR2714824A1

Abstract

The invention relates to a cartridge unit for dispensing a liquid. It is characterized in that it comprises an external sleeve (12) presenting a first open extremity (44) and a second obturated extremity (30, 34) provided with a liquid passage hole (38), said sleeve comprising perforation means (40) of which the perforating extremity (42) projects outside said passage inside the sleeve, the perforation means presenting an internal channel which extends said passage; a cartridge (10) presenting a body (14) having a first extremity (16) provided with a piercable membrane (18) and a second extremity (22) closed by a piston (24) slidingly mounted inside the body of the cartridge, said cartridge, in a storage position, being engaged in said sleeve, the cartridge being intended to be pushed inside said sleeve so that the perforation means pierce said deformable membrane; and sealing means (48) provided between said sleeve and the body of the cartridge.

Description

CARPULE DEVICE FOR DISPENSING

LIQUID

The present invention relates to a cartridge device for the distribution of a liquid, in particular a liquid injectable to a patient.

To administer an injectable liquid to a patient, it is well known to use a cartridge containing the injectable liquid. The cartridge consists of a glass vial, one end of which is provided with a perforable membrane to thereby connect the cartridge to a flexible liquid delivery pipe via a needle perforating the membrane and the bottom of which is the most often replaced by a movable piston which thus permanently makes it possible to adapt the effective volume of the cartridge to the quantity of liquid actually contained as the liquid is distributed. Most often also, the flexible pipe comprises a pumping device, for example a roller pump, which makes it possible to precisely regulate the flow rate of the liquid. Conventionally, the establishment of the tubing on the carpule is done by providing at the end of the tubing a needle or a perforating member of the perforable membrane of the carpule. The establishment of the tubing on the cartridge therefore requires laborious and dangerous handling for the establishment of the tubing, in particular because of the presence of the needle. In addition, when the tubing is placed on the perforable membrane of the carpule, the aseptic conditions are not most often observed, which can of course be harmful for the patient treated.

An object of the present invention is to provide a cartridge device for the distribution of an injectable liquid which makes it possible, on the one hand, during the storage phase to maintain a high degree of asepsis and which, on the other hand, avoids , dangerous handling due to the presence of a needle.

To achieve this aim, the cartridge device according to the invention for the distribution of a liquid is characterized in that it comprises: an external sheath having a first open end and a second closed end provided with a passage orifice for the liquid, said sheath further comprising internally perforation means of which a first perforating end forms protruding from said end piece inside said sheath and the other end of which is integral with said passage, the perforation means having an internal channel which extends said passage; and a cartridge having a body having a first end provided with a perforable membrane and a second end closed by a piston mounted sliding inside the body of the cartridge and containing said liquid, said cartridge in the storage position being engaged in said sheath in such a way that the perforable membrane is arranged opposite the perforation means recessed with respect to the first end of the perforation means, said cartridge being able to be pressed into said sheath so that the perforation means perforate said membrane deformable; and sealing means between said sheath and the body of the adite carpule.

We understand that, in its storage phase, the cartridge is already in place _^ inside the sheath, which ensures the maintenance of asepsis, in particular of the perforable membrane and the perforating end of the needle , this maintenance of asepsis being made possible by the presence of sealing means between the sheath and the body of the carpule. In addition, the needle is already in place in the sheath, it can not present any danger when using the cartridge device.

Preferably, the sealing means are arranged inside the sheath and cooperates with the body of the cartridge during its entire travel in the sheath.

Other characteristics and advantages of the present invention will appear better on reading the following description of an embodiment of the invention given by way of non-limiting example. The description refers to the appended figures in which:

- Figure 1 is a longitudinal sectional view of the cartridge device in the storage position;

- Figure 2 is a view of the cartridge device of Figure 1 in the position of use; and - Figure 3 is a view of an improved embodiment of the cartridge device comprising a plug. Referring first to Figure 1, we will describe the general structure of a first embodiment of the cartridge device. This essentially consists of an actual cartridge 10 and an external sheath 12. The cartridge 10 consists of a bottle, preferably cylindrical and preferably made of glass 14, of which a first end 16 in the form of a neck is closed by a perforable membrane 18. The perforable membrane 18 is fixed to the neck 16 of the cartridge by any means such as a crimped metal capsule 20. The second end 22 of the cartridge is open. This end 22 is closed by a piece 24 forming a piston which can move freely inside the cartridge, as will be explained later.

In order to ensure a rigorous airtightness between the piston and the body of the cartridge, the side wall 24a of the piston 24 is provided with sealing lips such as 26. Preferably, there are three sealing lips 26 .

The external sheath 12, which is for example made of plastic material, preferably comprises a cylindrical body whose diameter is slightly greater than the external diameter of the body of the cartridge 14. The sheath 12 has a first end 30 of reduced diameter which is connected to the cylindrical part 28 of the sheath by a frustoconical portion 32. The internal diameter of the end 30 is slightly greater than the diameter of the neck 16 of the cartridge. The end 30 of the sheath ends in a portion of further reduced diameter 34 in which is fixed a tip 36 which seals this end. The end piece 36 is provided with an internal axial channel 38. A needle 40 is fixed in the internal face of the end piece 36 so that the tip 42 of this needle is opposite the perforable membrane 18 of the cartridge 10 when it is placed in the sheath as will be explained later. However, this point 42 is set back relative to the membrane 18.

It can also be seen that, near its open end 44, the sheath 12 in its cylindrical part 28 has an internal annular groove 46 in which is mounted an annular seal 48. This seal is dimensioned so as to provide a seal at the air between the sheath 12 and the cartridge 10 when the latter is introduced into the scabbard. The seal 48 is shaped in such a way that it provides not only a static seal but also a dynamic seal during the various phases of placing the cartridge in the sheath and when the cartridge is inserted into it. scabbard as will be explained later.

Preferably, a second annular seal 48 'is provided, mounted in a second annular groove 46'. The axial distance between the two joints is 1.

It can also be seen that, preferably, the internal face of the sheath 12 has internal guide ribs such as 50 to ensure axial centering of the cartridge inside the sheath during its movement.

Preferably, in the reduced diameter portion 30 of the sheath, there are provided clipping members such as 52 which ensure the imprisonment of the head 16 of the cartridge 10 when the latter is fully inserted into the sheath, as well as it will be explained later.

Before describing the mode of use of the cartridge device, we will describe the preferred steps for placing the cartridge inside the sheath.

Initially, the assembly of plastic material consisting of the sheath 12 and preferably the tubing which is connected to it and the pumping means is assembled and sterilized in the traditional way with ethylene oxide or by gamma radiation. Carpule 10 is prefilled with injectable liquid and autoclaved. It is then inserted into the sheath up to its storage position shown in FIG. 1. This operation is carried out under advanced aseptic conditions, for example under laminar flow. After the step of introducing the carpule into the sheath, the seal 48 maintains the asepsis of the medium thus created, in particular as regards the needle 42. The carpule device is stored as in the form shown in Figure 1.

One can also operate the sterilization after the introduction of the cartridge in the sheath. Sterilization is then carried out in a conventional manner by gamma radiation or using a sanitizing gas such as ethylene oxide. When it is desired to use the cartridge, it suffices to cause the insertion of the cartridge 10 inside the sheath 12 until the perforable membrane 18 comes into abutment or substantially abuts against part 54 of the end 30 of the sheath, which corresponds to a stroke equal to the. One can provide retractable stop means which prevent accidental insertion of the cartridge into the sheath in storage. During this insertion, it is understood that the needle 40 or more precisely its tip 42 punctures the perforable membrane 18 thus ensuring communication between the interior of the cartridge 10 and the channel 38 of the nozzle 36 via the needle 40. In this fully depressed position, the neck 16 is preferably secured irreversibly on the sheath 12 thanks to the presence of the clipping elements 52. This ensures that the cartridge 10 or the sheath 12 cannot be used subsequently to administer again an injectable product.

It will be understood that, as the liquid leaves the cartridge 10 under the effect of a pumping member, the piston 24 gradually sinks inside the cartridge under the effect of the depression created by the exit of the liquid. Preferably the sheath 12 has an orifice 70 which is closed by a microporous filter 72. This filter can advantageously have pores whose dimension is of the order of 0.22 microns. On the one hand, this filter allows air to exit the sheath as the penetration of the carpule, which greatly facilitates its establishment and its final depression to perforate the membrane. On the other hand, it allows the introduction of a sanitizing gas into the sheath after the initial insertion of the cartridge.

Also preferably, the distance 1 between the two seals 48 and 48 'is at least equal to the stroke Y of the cartridge in the sheath. Thus, the entire external face of the cartridge which lies beyond the second seal 48 'was already protected by the first seal 48 in the storage phase. As a variant, instead of providing two O'ring type seals, a single lip sealing ring could be fitted, the axial contact length of which with the cartridge would be equal to 1. FIG. 3 represents a preferred variant of the device carpule. This includes in addition to the carpule 10 and the sheath 12 a plug 60 which can be put in place at the open end 44 of the sleeve. This plug has a movable part 62 relative to its base 64 on which a pressure spring 66 acts. The end 62a of the movable part is applied to the piston 24. The stroke of the movable part, under the effect of the relaxation of the spring 66 is determined in such a way that it ensures, on the one hand, the purging of the pipe for distributing the injectable liquid and that it cancels, on the other hand, the friction forces which could have been created between the sealing lips of the piston and the internal face of the capsule during the storage period. On the other hand, the spring 66 makes it possible to create a slight suφression in the caφule facilitating if necessary the initial movement of the piston 24 or even during its entire stroke provided that the spring is given a sufficient stroke. It may further be noted that after it has been placed on the sheath 12, the plug 66 provides mechanical protection for the piston. It is also possible that the plug allows air to enter between itself and the piston 24.

Claims

1. Ca Dispositifule device for dispensing a liquid, characterized in that it comprises: an external sheath (12) having a first end (44) open and a second end (30, 34) closed provided with an orifice passage (38) for a liquid, said sheath further comprising internally perforation means (40), a first perforating end (42) protruding from said nozzle inside said sheath and the other end of which is integral with said passage , the perforation means having an internal channel which extends said passage; and a caφule (10) having a coφs (14) having a first end (16) provided with a perforable membrane (18) and a second end (22) closed by a piston (24) mounted sliding inside the coφs of the caφule and containing said liquid, said caφule in the storage position being engaged in said sheath so that the perforable membrane is disposed opposite the perforation means recessed relative to the first end of the perforation means, said caφule being able to be pressed into said sheath so that the perforation means perforate said deformable membrane; and sealing means (48, 48 ') between said sheath and the coφs of said caφule.

2. Caφule device according to claim 1, characterized in that said sealing means (48, 48 ') are arranged inside said sheath and are able to cooperate with the external face duc Oφs of caφule whatever driving the caφule into said sheath (12).

3. Caφule device according to any one of claims 1 and 2, characterized in that said sheath (12) internally comprises first clipping means (52) capable of cooperating with said caφule, when said caφule is in its position in which the perforable membrane is perforated.

4. Caφule device according to any one of claims 1 to 3, characterized in that it further comprises in the storage situation a liquid delivery tube including a end is connected to said passage and means for administering the liquid.

5. Caφule device according to any one of claims 1 to 4, characterized in that it further comprises a plug (60) capable of cooperating with the first end (44) of the sleeve (12) when said caφule is in position pressed.

6. Caφule device according to claim 5, characterized in that said plug (60) comprises elastic means (66) able to cooperate with the external face of the piston (24) of said caφule to cause a limited depression of the piston in the coφs of said caφule, whereby the purging of said tubing is carried out.

7. Caφule device according to claim 6, characterized in that said elastic means comprise a spring (66) whose stroke is at least equal to a part of the length of movement of said piston (24).

8. Caφule device according to any one of claims 1 to 7, characterized in that said sheath (12) comprises, between its first and its second end, an orifice (70) closed by a microporous filter (72).

9. Ca Dispositifule device according to any one of claims 1 to 8, characterized in that said sealing means (48, 48 ') have an axial length of contact with the caφule (14) at least equal to the stroke of the caφule inside the sheath (12) between its storage position and its depressed position.

10. Caφule device according to claim 9, characterized in that said sealing means comprise two annular seals (48, 48 ') offset axially, in the direction of displacement of the caφule, of said length 1.