EP3383341B1 - Perforating needle for flask with septum - Google Patents

Description

Object of the invention

The present invention relates to a device for transferring fluids between a container containing for example a drug or any ingredient (in solid or liquid form) for its preparation and an injection means. The invention relates more particularly to a perforating needle.

State of the art

In the field of pharmaceutical preparations, the ingredients are commonly supplied in containers. The product contained in a vial is transferred by means of a syringe or by pressure difference to the preparation device, for example a syringe or to a specific preparation or synthesis device, in order to constitute the drug or one of its precursors.

In some cases, the product is supplied in liquid form in a vial while in other cases it is in the form of a solid, for example powdered or freeze-dried. When it comes to a powder, it is most often deposited or evaporated on the bottom of the bottle. To recover this powder, a solvent must be introduced into the flask to dissolve the powder. The reconstituted product is then removed from the vial and transferred to the place of use.

These products are frequently taken from an inverted flask, that is, with an opening towards the bottom, having a septum (or elastomeric stopper) or other access means pierceable at the base of the vial. The vial is connected by piercing the vial stopper with a piercing needle. The vial is therefore "upside down" with the needle through the cap.

A hollow perforating needle as known from the state of the art provides a means of fluid communication with the contents of the vial. In particular, the tip can pierce the septum, to insert a solution or empty the contents of the vial.

A conventional needle is composed of a sharp tip and a hollow access tube allowing a fluid to flow for example from an infusion bag as described in the patent. US 6,261,267 B1 . The solution continues to flow until the meniscus of the fluid in the vial falls below the end of the tip, leaving a certain amount of residual liquid in the vial.

The products contained in containers in small quantity are dosed with a precision required by the method of preparation or the clinical indication. This precision can be important. Therefore, failure to recover all of the product contained in the vial may result in variations in the quality of the preparation or the amount transferred.

A conventional perforating needle, as presented at figure 1 , comprises a central channel 11 ending in an orifice which is in the extension of the channel. The piercing needle 1 of the figure 1 is shown in a bottle 2 after piercing the septum 6. This needle 1 comprises a cylindrical body 3, a stop 4, and a pointed end 5. The cylindrical body 3 extends from a distal end 9 of the needle to a proximal end 10. At its distal end 9 the cylindrical body 3 has a side wall 12 surrounding a central channel 11 terminated by an orifice at the pointed end 5.

Such a needle makes it possible to send a vertical jet of solvent which can reach the top of the flask (or the bottom of the flask as it is flipped over) and thus recover all the reagent present in the solvent, even if it is deposited in solid form on all the inner walls of the bottle. However, such a piercing needle does not empty the bottle in its entirety. There will always remain a fraction of unrecoverable fluid 7 below the level of the orifice of the tip 5 (see figure 1D ). Moreover, the piercing point is eccentric which causes misalignment of the vials with respect to the axis of the needle and is problematic in automated systems. Finally the eccentric points are generally less sharp.

The document WO 2009/029010 A1 discloses another needle comprising at least one lateral opening for emptying a vial completely. Such a perforating needle is represented at figure 2 . The piercing needle 1 has a central channel 11 that does not open and two lateral openings 8 at its distal end 9. The opening is located just above the septum 6 so that all the fluid contained in the bottle can flow to through the lateral opening 8 in the central channel 11.

However, even if such a needle makes it possible to empty the bottle in its entirety, the needle does not make it possible to produce a sufficiently vertical solvent jet to reach the bottom of the bottle and thus recover the entirety of the product deposited on the walls.

GB829383 and WO 2009/030788 describe hypodermic perforating needles.

Goals of the invention

The present invention aims to provide a perforating needle which does not have the disadvantages of the prior art.

The device of the invention is intended to allow both to optimally inject a liquid in a vial containing a product in solid form dispersed on the inner wall or in liquid form to recover it entirely in the liquid and extracting the solution or mixture thus formed from the vial by completely draining the liquid into the vial, leaving no residue.

Main characteristic elements of the invention

• une extrémité pointue configurée pour percer le bouchon ;
• un corps cylindrique comprenant un canal central par lequel le fluide peut entrer et sortir du flacon et une paroi latérale comprenant au moins un orifice latéral, ledit orifice étant en communication fluidique avec le canal central et l'extrémité inférieure de cet orifice étant, en utilisation, essentiellement au niveau de la face interne du bouchon, ledit orifice étant prolongé vers l'extrémité pointue par une cannelure dont la forme est déterminée pour être essentiellement tangente à l'écoulement du fluide en vue de le canaliser selon l'axe de l'aiguille ;

la paroi latérale comportant deux orifices latéraux diamétralement opposés et disposés de part et d'autre d'un îlot central, l'îlot central présentant une arête de séparation formant un angle compris entre 15° et 60°, de préférence entre 20° et 30°, l'arête de séparation pénétrant dans le canal central et les cannelures prolongeant les orifices débouchant à proximité de l'extrémité pointue.The present invention relates to a perforating needle, also called "spike", intended to be introduced into a bottle through a plug or septum to inject and extract a fluid, said needle comprising:

• a pointed end configured to pierce the plug;
• a cylindrical body including a central channel through which fluid can enter and exit the vial and a side wall including at least one side port, said port being in fluid communication with the central channel and the lower end thereof being in use , essentially at the inner face of the plug, said orifice being extended towards the pointed end by a groove whose shape is determined to be essentially tangent to the fluid flow in order to channel it along the axis of the needle ;

the lateral wall having two diametrically opposite lateral orifices arranged on either side of a central island, the central island having a separation edge forming an angle between 15 ° and 60 °, preferably between 20 ° and 30 °, the separation edge penetrating into the central channel and the grooves extending the orifices opening near the pointed end.

The perforating needle is intended to be introduced into a flask to be pierced in order to inject and / or extract a fluid. When the reagent is to be stored in solid form, it is generally deposited on the walls and more particularly on the bottom of the flask by evaporation or lyophilization techniques known to those skilled in the art.

During the process of use, the solid reagent is recovered by introducing a suitable solvent via the piercing needle and then aspirating the solution in which the solid reagent has dissolved or has been entrained. This requires to be able to fully wet the inner surface of the bottle.

• l'aiguille perforante est constitué de matière plastique rigide ;
• l'aiguille perforante est destinée à être introduite dans un flacon comprenant un bouchon en élastomère ou en matière plastique ;
• l'aiguille perforante comporte une zone d'élargissement de la paroi latérale appelée butée sur laquelle peut prendre appui un écrou configuré pour fixer fermement l'aiguille sur un dispositif de raccordement fluidique ;
• l'aiguille perforante est accompagnée en outre d'un accessoire de guidage configuré pour être fixé de façon irréversible sur l'aiguille perforante, le cas échéant par l'entremise d'un écrou, pour maintenir et guider le flacon ;
• l'accessoire de guidage comporte des crochets permettant de maintenir l'accessoire de guidage sur l'aiguille, directement ou par l'entremise d'un écrou;
• l'accessoire de guidage comporte des paires d'ailettes qui sont configurées pour maintenir le flacon de façon irréversible. De préférence, une première paire d'ailettes est placée en position haute en vue de maintenir le flacon au-dessus de l'aiguille avant perçage du bouchon alors qu'une seconde paire d'ailette est placée en position basse afin de maintenir le flacon enfoncé sur l'aiguille après perçage du bouchon.

Preferred embodiments of the invention further comprise in combination one or more of the following features:

• the piercing needle is made of rigid plastic material;
• the perforating needle is intended to be introduced into a bottle comprising a plug of elastomer or plastic;
• the perforating needle comprises a zone of widening of the lateral wall called abutment on which can be supported a nut configured to fix the needle firmly on a fluid connection device;
• the perforating needle is further accompanied by a guide accessory configured to be irreversibly fixed to the piercing needle, if appropriate by means of a nut, to hold and guide the bottle;
• the guide accessory comprises hooks for holding the guide accessory on the needle, directly or through a nut;
• the guide accessory has pairs of fins which are configured to hold the bottle irreversibly. Preferably, a first pair of fins is placed in a raised position to hold the vial above the needle before piercing the stopper while a second pair of vane is placed in the down position to hold the vial depressed on the needle after drilling the stopper.

Brief description of the figures

• The figure 1 , mentioned above, schematically shows the steps (A, B, C, D) of the operating principle of a perforating needle of the prior art comprising an orifice located in the axis of the central channel. Such a needle does not completely empty the bottle.
• The figure 2 , mentioned above, schematically shows the steps (A, B, C, D) of the operating principle of a perforating needle of the prior art comprising one or more lateral orifices. Such a needle does not produce a sufficiently vertical solvent jet to reach the bottom of the bottle and thus recover the entirety of the product deposited on the walls.
• The figure 3 shows schematically the steps (A, B, C, D) of the operating principle of a perforating needle according to the invention. After piercing the septum, a solution is introduced in an essentially vertical jet into a vial and the contents of the vial are completely emptied. The needle is shown provided with a nut and capped with a guide accessory of the vial.
• The figure 4 represents a perspective view of an example of perforating needle according to the invention.
• The Figure 5A represents a side view of the needle presented at figure 4 and the Figure 5B a sectional view of the needle represented on the Figure 5A according to section AA.
• The Figure 6A represents a side view of the needle of the invention pivoted at an angle of 90 ° with respect to the device shown in FIG. Figure 5A . The Figure 6B represents a sectional view of the needle represented on the Figure 6A according to section BB. The Figure 6C represents a detailed view of the encircled portion of the Figure 6B .
• The figure 7 represents an axial view of the piercing needle, the pointed end appearing in the foreground.
• The figure 8 represents two perspective views of an accessory guiding the vial on the perforating needle of the invention.
• The figure 9 represents two sectional views of the guiding accessory shown in FIG. figure 8 . These sectional views show pairs of fins holding the vial at the top and bottom positions of the guide accessory.
• The figure 10 represents two cross-sectional views of the perforating needle combined with the guide accessory, the left one with vial in the upper position before the septum is pierced (A) and the right one with the vial in the lower position after piercing the septum (B).
• The figure 11 represents perspective views of the mounting of the piercing needle on a connecting device for introducing a fluid (A), the positioning of a nut (B) against the stop of the needle, the positioning of the guiding accessory (C) on the needle with a nut and the finished assembly (D) ready to receive the bottle in the inverted position.

Detailed description of the invention

The present invention relates to a perforating needle designed to allow the creation of a substantially vertical jet of solvent in a vial from one or more lateral ports which also allow the vial to be completely emptied. The principle of working in four stages (A, B, C, D) is illustrated in figure 3 . The perforating needle 1 is shown in a bottle 2 after having pierced the septum 6. The lateral orifices are located just above the cap, at the same level as the internal face of the latter. In a first step (step A), the needle 1 is used to inject a fluid 7 vertically into the bottle to solubilize the contents, for example in the form of a powder adhering to the walls of the bottle, mainly in the bottom. The bottle is then completely emptied of its contents (steps B, C and D), the solution flowing through the lateral orifices 8 of the needle in the central channel 11.

The performance in the essentially vertical injection of liquid is obtained thanks to the particular shape of the flow surfaces of the rising liquid flow. The rising vertical flow can be divided or not. When the flow is not divided, the central channel 11 opens on a lateral orifice 8 extended towards the pointed end 5 by a groove 17 (shown on the figure 4 ). The shape of the groove ensures the flow of fluid to the tip and a substantially vertical jet is obtained along the axis of the piercing needle.

According to the method of execution presented figure 3 , the vertical flow is divided in two. The central channel 11 opens on two lateral orifices 8, each orifice being extended to the pointed end 5 by a groove 17. The flow of fluid is channeled around a central island 13 constituting a separation stop 14 (shown in FIG. Figure 6C ) for the rising liquid flow. The fluid 7 follows the central island 13 of substantially convex shape, the surrounding pressure does not allow the fluid to deviate. As a result, the needle makes it possible to project the fluid along its substantially vertical axis and to recover it completely via one or more lateral orifices 8.

A guide accessory 15 is also shown on the figure 3 . This accessory facilitates the vertical insertion of the bottle 2 on the piercing needle 1. A nut 19 is supported on the stop 4 of the needle for firmly fixing it on the connecting device. The guide accessory is positioned on this nut (see figure 10 ). The guide accessory 15 comprises hooks 16 which are wedged on the nut 19. This operation ensures a good alignment of the guide accessory relative to the needle. The guide accessory 15 also has a pair of lower fins 18a in the lower position for holding the bottle 2 down on the needle after it has pierced the septum. There is also a pair of upper fins 18b in the up position (visible on the figure 9 ) and to maintain the bottle in the guide accessory before drilling the septum.

The figure 4 is a perspective representation of the piercing needle according to the invention. This needle 1 comprises a cylindrical body 3, a stop 4, and a pointed end 5. The cylindrical body 3 extends from a distal end 9 of the needle towards a proximal end 10. At its distal end 9, the cylindrical body 3 has a central channel 11 which is subdivided into two lateral orifices 8 extending by two flutes 17 opening near the pointed end 5.

The Figure 5A represents a side view of the needle presented at figure 4 in which the lateral orifices 8 are situated on either side of the pointed end 5.

The Figure 5B is a sectional view corresponding to the Figure 5A according to section AA. In this sectional view, the cylindrical body 3 comprises a central channel 11 surrounded by a lateral wall 12 which extends from the proximal end of the needle but stops before reaching the distal end 9. The central channel 11 is subdivided at this level into two lateral orifices 8 around a central island 13.

The Figure 6A represents a side view of the needle of the invention pivoted at an angle of 90 ° with respect to the device shown in FIG. Figure 5A . A first lateral opening 8 is presented from the front and the other opening 8 is in the background, diametrically opposed to the first.

The Figure 6B represents a sectional view corresponding to the Figure 6A according to section BB. In this sectional view, the cylindrical body 3 has a central channel 11 surrounded by a side wall 12 which extends from the proximal end 10 of the needle to its distal end 9. Close to the end distal 9, the central channel 11 is divided into two lateral orifices 8 which are separated from each other by a central island 13. This island is disposed at the end of the central channel 11. It begins with a separation stop 14 which divides the incoming liquid flow in two, extends laterally by substantially straight forms and ends with the pointed end 5. The central island 13 is an extension of the side wall 12 in this plane as shown in FIG. Figure 5B .

The Figure 6C represents a detailed view of the encircled portion of the Figure 6B . Preferably, the angle formed by the separation stop 14 of the central island 13 is between 15 ° and 60 °. For example, it is 24 ° on the Figure 6C .

The figure 7 is an axial view of the piercing needle 1. From the first plane to the last plane can be seen successively: the pointed end 5, the lateral orifices 8, the side wall 12 of the cylindrical body 3 and the upper part of the stop 4 .

In order to facilitate the well-centered vertical insertion of the perforating needle 1 into the septum of the cap of the vial 2, a guide accessory 15 may be used. This accessory is configured to be fixed irreversibly on the piercing needle 1, directly or through a nut 19 (see figure 11 ).

An example of a guide accessory is shown at figure 8 . The drawing on the left shows the end of the accessory clinging to the nut 19 of the needle and the drawing on the right shows the end of the accessory through which the bottle 2 is inserted.

The guide accessory 15 comprises hooks 16 for attaching to the needle through a nut 19. The hooks 16 are clipped behind the nut 19 enclosing the needle as shown in FIG. figure 10 . The presence of these hooks 16 prevents the guiding accessory 15 from detaching from the needle once it is attached thereto. Once the guiding accessory and the piercing needle are assembled on the connecting device, the user only has to insert the vial into the guide accessory and push it to pierce the septum.

Two pairs of lower and upper fins 18a, 18b located at different depths in the guide accessory 15 hold the bottle in place, the first 18b in the unbored position, the second 18a in a depressed position on the needle. These pairs of fins 18a, 18b are visible on the figure 9 where are shown two sectional views of the guide accessory shown in FIG. figure 8 .

The figure 10 shows the principle of operation of the pairs of fins 18a, 18b in the presence of a bottle in the inverted position. The left sectional view shows the bottle not yet pierced, held in the upper position by the upper pair of fins. The right sectional view shows the bottle pressed down and held on the needle by the pair of lower fins 18b.

In an embodiment represented in figure 11 the proximal end 10 of the needle 1 forms a male "luer" fitting that can be fitted to any fluid transfer device with a female "luer" connector.

The figure 11 represents perspective views of mounting the piercing needle on a connecting device for introducing a fluid therein. In step (A), the needle 1 comprises a male "luer" fitting attached to a fluid transfer device comprising a female "luer" connector. In step (B), a nut 19 is introduced on the needle. This nut has a recess of complementary shape (essentially rectangular or square) to the upper part of the stop 4 of the needle so as to keep it firmly in the vertical position. In step (C), the guide accessory is positioned on the needle provided with a nut, the hooks 16 of the guide accessory being clipped behind the nut (see figure 10 ). Step (D) shows the finalized mounting, the accessory of guiding being ready to receive a bottle in an inverted position as shown in FIG. figure 10 .

Alternatively to the "luer" connection presented at figure 11 , the proximal end 10 of the needle may comprise another type of connection, grooved or welded for example. It is through this connection that the fluid enters or leaves.

In another embodiment, the needle may be used in a reduced pressure injection system to transfer fluid from a vial to a syringe or vice versa.

List of reference symbols

1.

Piercing needle

2.

Bottle

3.

Cylindrical body

4.

stopper

5.

Sharp end

6.

Stopper or septum

7.

Fluid

8.

Orifice

9.

Distal end

10.

Proximal end

11.

Central channel

12.

Side wall

13.

Central island

14.

Stop separation

15.

Guiding accessory

16.

Hook

17.

Groove

18a.

Lower wing

18b.

Upper wing

19.

Nut

Claims (8)

1. A perforating needle (1) intended to be inserted into a flask (2) through a stopper or septum (6) to inject and remove a fluid (7), said needle comprising:

   - a pointed end (5) configured to pierce the stopper (6);

   - a cylindrical body (3) comprising a central channel (11) through which the fluid (7) may enter and leave the flask (2) and a side wall (12) comprising at least one lateral orifice (8), said orifice (8) being in fluid communication with the central channel (11) and the lower end of this orifice (8) being, in use, essentially level with the inner face of the stopper (6), said orifice (8) being extended toward the pointed end (5) by at least one slot (17), the shape of which is determined to be essentially tangential to the flow of the fluid (7), for the purpose of channeling it along the axis of the needle;

   the side wall (12) comprising at least two diametrically opposite lateral orifices (8) arranged on either side of a central island (13), the central island (13) having a separating rim (14) that penetrates the central channel (11);
   characterized in that the separating rim (14) forms an angle comprised between 15° and 60°, preferably between 20° and 30°, and in that the slots (17) extending the orifices emerge near the pointed end (5).
2. The perforating needle (1) according to Claim 1, characterized in that it is made up of rigid plastic material.
3. The perforating needle (1) according to any one of the preceding claims, characterized in that it is intended to be inserted into a flask (2) comprising an stopper (6) made of elastomeric or plastic material.
4. The perforating needle (1) according to any one of the preceding claims, comprising a wider zone of the side wall (12) called stop (4) on which a nut (19) can bear configured to firmly attach the needle on a fluid connection device.
5. The perforating needle (1) according to any one of the preceding claims, further accompanied by a guiding accessory (15) configured to be irreversibly attached on the perforating needle to maintain and guide the flask (2).
6. The perforating needle (1) according to Claim 5, characterized in that the guiding accessory (15) comprises hooks (16) allowing to maintain the guiding accessory on the needle, directly or using a nut (19).
7. The perforating needle (1) according to Claim 5, characterized in that the guiding accessory (15) comprises pairs of fins (18a, 18b) that are configured to maintain the flask irreversibly.
8. The perforating needle (1) according to Claim 7, characterized in that a first pair of fins (18b) is placed in a high position in order to maintain the flask above the needle before the stopper is pierced, while a second pair of fins (18a) is placed in a low position in order to keep the flask pushed in on the needle after the stopper has been pierced.

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