WO2011092513A2

WO2011092513A2 - An assembly for delivering a fluid drug and method

Info

Publication number: WO2011092513A2
Application number: PCT/GB2011/050152
Authority: WO
Inventors: Simon Jason Cohen
Original assignee: Innovate Uk Limited
Priority date: 2010-01-29
Filing date: 2011-01-31
Publication date: 2011-08-04
Also published as: WO2011092513A3; GB201001447D0

Abstract

An assembly for delivering a fluid drug including a container (1) defining an opening at one end closed by a pierceable resilient closure (7). A vent (12) is formed at an opposite end of the container and connects with a conduit (11) which extends along a side wall of the bottle and terminates adjacent the opening. A slidably movable insert (14) is mounted relative to the container. A first hollow needle (7) is mounted to the insert is connected to a fitting for engagement with a syringe and arranged to pierce the closure of the container (7). A second hollow needle or sharp point (23) is also mounted to the insert (14) and arranged to pierce the conduit (11) so as to open the vent.

Description

AN ASSEMBLY FOR DELIVERING A FLUID DRUG AND METHOD

The present invention relates to an assembly for delivering a fluid drug and to a method of use of the assembly. The assembly is particularly, but not exclusively, for use in filling needleless syringes with a liquid drug.

Needless syringes are widely used in the medical and veterinary fields for the delivery of drugs to patients. The syringes comprise a fitting, typically a Luer or tapered connector, to enable the syringe to be connected to a corresponding fitting, such as that provided on the hollow needle.

Fluid, typically liquid, drugs are usually supplied in single dose bottles. These comprise a single opening closed by a resilient pierceable closure which maybe pierced by a hollow needle. In use, fluid is drawn from the bottle via a hollow needle inserted into the bottle through its closure into a syringe for subsequent administration to a patient.

Best practice in the filling of a needleless syringe with a liquid drug from a bottle involves fitting a first hollow needle to the syringe, piercing the bottle's closure with the hollow needle and introducing the tip of the needle into the liquid to be drawn from the bottle, providing a second hollow needle, piercing the bottle's closure with the second hollow needle and introducing the tip of the second hollow needle into the space above the liquid in the bottle, withdrawing liquid from the bottle into the syringe, removing the first hollow needle from the syringe and fitting a fresh hollow needle or other apparatus to the syringe to enable the drug to be administered to a patient and safely disposing of the bottle and first and second hollow needles. The second hollow needle is provided to enable air to flow into the bottle as the drug is withdrawn, to enable the drug to be withdrawn. The tip of the second hollow needle should remain in the airspace above the drug so that incoming air does not bubble through the liquid which would risk contaminating or unnecessarily aerating the liquid. The overall process, even before a drug is administered, involves many steps, is time consuming and the use and subsequent disposal of two hollow needles carries a risk of needle stick injury.

To simplify the process, save time and consumables healthcare professionals often use a syringe fitted with a first hollow needle to inject air into a drug bottle before withdrawing liquid from the bottle through the same needle. This avoids the need to use a second hollow needle to vent the bottle but in practice increases the risk of contamination of the drug and introduces a risk of potential failure of the bottle.

Embodiments of the present invention have been made in consideration of this, and other, problems.

According to a first aspect of the present invention there is provided an assembly for delivering a fluid drug, the assembly comprising a container with an opening through which a fluid may be withdrawn from or introduced into the container and a vent means remote from the opening through which another fluid may flow into or out of the container as fluid is introduced or withdrawn through the opening.

Providing an opening and vent means remote from the opening enables fluid to be withdrawn from and introduced into the container efficiently with minimum interaction between a fluid of interest, such as a drug, and a vented fluid such as air.

The opening may be formed in a first end of the container. The vent means may be provided towards, in or adjacent a second end of the container. The first and second ends of the container may be opposite each other. The opening is preferably closed by way of a pierceabie closure. The container may be a bottle and the opening formed by a neck of the bottle.

The vent means is preferably normally closed, but arranged to be opened in use. The vent means may be closed by way of an openable closure such as a pierceabie closure. The vent means may be sealed by a seal which is arranged to be ruptured in use. Preferably, the vent means communicates with a conduit which extends to the end of the container where the opening is formed, and it preferably terminates at a position adjacent but spaced from the opening in the container.

A hollow needle is preferably movably mounted to the container.

The container is preferably moulded from a plastics material. The conduit is preferably moulded integrally with the container.

According to another aspect of the present invention there is provided an assembly for delivering a fluid drug comprising a container and a fitting, the fitting housing a hollow needle mounted for movement relative to the container.

The fitting may be moulded to the container. Moulding of a container to a fitting provides a convenient and cost effective method of manufacture.

The container may be blow moulded. The fitting may be moulded to the container such that it closes an opening in the container. The container may form a blow fill seal with the fitting. The fitting may be captured by the container.

Features of either aspect of the invention may be combined with the other aspect. In either aspect the hollow needle preferably comprises a sharp end and an opposite end connected to a coupling. The coupling may be arranged to connect to a syringe. The hollow needle is preferably mounted for movement between a first position in which the sharp end of the needle does not enter the container and a second position in which the sharp end of the needle enters the container through a closure closing the opening. The hollow needle may be mounted on a sliding member which is slidably mounted to the container, preferably via the fitting (where provided). Where a vent means is provided a second hollow needle or other sharp point may be provided on the slidable member for movement with the slidable member and hollow needle. The second hollow needle or sharp point is preferably arranged to open the vent means when the slidable member is moved such that the hollow needle is in its second position. When the hollow needle is in the second position the sharp point is preferably arranged to pierce part of the container to open the vent means or a conduit leading from the vent means.

According to another aspect of the present invention there is provided a method of using an assembly for delivery of a fluid drug, the assembly comprising a container with an opening through which a liquid may be withdrawn from or introduced into the container and a vent means remote from the opening through which another fluid may flow into or out of the container as fluid is introduced or withdrawn through the opening, the method comprising the steps of: inserting a hollow needle fitted to a syringe into a container; opening the vent means; orienting the container such that the tip of the hollow needle lies below the vent means and drawing the liquid from the container into the syringe via the hollow needle.

According to another aspect of the present invention there is provided a method of using an assembly for delivering a fluid drug comprising a container and a fitting, the fitting housing a hollow needle mounted for movement relative to the container, the method comprising the steps of: engaging a needleless syringe with the hollow needle, moving the hollow needle from a first to a second position such that the needle enters the container and drawing liquid from the container into the syringe via the hollow needle.

In order that the invention may be more clearly understood an embodiment thereof will now be described by way of example only with reference to the accompanying drawings of which:

Figure 1 is a perspective view of an assembly according to the invention;

Figure 2 is a cross-sectional view of the assembly of Figure 1 taken along the

Figure 3 is a perspective view of the bottle of the assembly of Figure 1 ;

Figure 4 is a perspective view of the collar of the assembly of Figure 1 ;

Figure 5 is a perspective view of the insert of the assembly of Figure 1 ; and Figure 6 shows a cross-sectional view of an assembly according to the

invention, as shown in Figure 2, in use with a syringe.

Throughout the drawings like reference numerals are used to denote corresponding features. The drawings are not to scale. The terms up, down, top, bottom and like terms are used to describe the assembly as illustrated and should not be taken as otherwise limiting. For the purposes of reference, the described assembly is shown in an upright configuration in Figures 1 and 2 and in an inverted configuration in Figure 6.

Referring to the drawings an assembly for delivering a liquid drug comprises a bottle 1 blow moulded from a plastics material. The bottle comprises a generally cylindrical lower portion 2 which reduces in diameter towards its top to form a neck 3 defining an opening. Moulded into the sidewall of the bottle is a conduit 11. The conduit 11 opens out into the bottle forming a vent 12 adjacent the bottom of the bottle. That is to say the opening is towards the opposite end of the bottle to the opening formed by the neck 3 of the bottle. The conduit 11 extends up the sidewall of the bottle and terminates in a position adjacent, but spaced from the opening in the neck 3 of the bottle. This end of the conduit is closed. As the bottle is moulded the end of the conduit is closed by the material from which the bottle is formed.

Attached to the opening in the neck 3 of the bottle is a collar 4. The collar comprises a sidewall with a generally cylindrical portion and a lobe extending from the cylindrical portion. The sidewall defines an opening 5 at the upper end of the collar. The opposite end of the collar is partially closed by an endwall 6 including a generally circular aperture closed by a pierceable resilient closure 7. Two generally rectangular apertures 8 are formed in respective opposed positions in the sidewall of the collar. A protrusion 9 is formed on the inside of the sidewall spaced above one of the rectangular apertures 8. Four elongate ribs 13 are also formed on the inside of the sidewall. They are generally evenly spaced around the sidewall and extend from the endwall 6 to the opposite end of the sidewall. An externally projecting rim 10 extends around the lower edge of the sidewall. In manufacture the bottle is blow moulded such that its neck extends around and captures the rim 10 forming a blow fill seal between the bottle and the collar 4.

A needle holding insert 14 is slidably mounted within the collar 4 and is arranged to move relative to the collar along an axis substantially parallel to the longitudinal axis of the collar in the directions shown by arrow 15. The insert 14 is shaped to have a close sliding fit within the collar 4. It comprises a generally circular disc 16 arranged to fit into the generally cylindrical part of the sidewall of the collar. The disc has four cut outs 17 in its outer edge to accommodate the ribs 13 in the collar. Engagement of the ribs 13 in the cut outs aids alignment between the insert 14 and collar 4. Above the disc 16 is formed a fitting 18 for receiving the corresponding fitting of a syringe. The fitting communicates with an aperture 19 in the opposite, lower, side of the disc, into which is fitted a hollow needle 20. An arm 21 extends from the insert 14 into the space defined by the lobe of the sidewall of the collar. An aperture 22 is formed on a lower surface of the arm into which another hollow needle 23 is fitted. The aperture extends through the lower part of the arm and opens out into a space 24 between the arm and the endwall 6 of the collar 6,.

A removable cap 25 is fitted over the collar 4.

The insert 14 is movable within the collar 4 between an uppermost first position (not shown) in which the disc 16 lies above the protrusion 9 on the sidewall of the collar 4 and a lowermost second position in which the disc 16 lies below the protrusion in the sidewall of the collar. In the first position, the protrusion 9 provides resistance to downward movement of the insert 14 and so effectively locks it in the first position. In the first position the lower, sharp end of the hollow needle 20 is spaced above the resilient piercably closure 7 and the lower sharp end of the hollow needle 23 is spaced above the closed end of the conduit 11.

The insert may be moved from the first to the second position by the application of force to the fitting 18 of the insert 14, urging the fitting towards the bottle 1. Force overcomes the resistance offered by the protrusion and the disc 16 "snaps" past the protrusion. In the second position the sharp end of hollow needle 20 pierces the closure 7 and extends into the bottle 1. The sharp end of hollow needle 23 pierces the closed end of the conduit 11 and extends into the conduit 11 connecting the vent 12 to the atmosphere outside the bottle. When the insert 14 is in the first position the rectangular apertures 8 in the sidewall of the collar are not obstructed. In the second position they are. This gives a visual indication that the insert 14 is in the second position and, hence, that the hollow needles have entered the bottle.

The primary purpose of assemblies according to the invention is to provide liquid drugs for filling syringes which do not have a fitted hollow needle. In use the cap 25 is removed and a syringe 26 to be filled, with its plunger fully depressed, is connected to the fitting 18 of the insert 14 and the bottle 1 inverted into the orientation shown in Figure 6. The syringe 26 and insert 14 are then urged together towards the bottle 1 moving the insert 14 from the first to the second position where the hollow needle 20 enters the bottle and the hollow needle 23 enters the conduit 11. As the bottle 1 is inverted liquid drug 27 in the bottle 1 will cover the hollow needle 20. The plunger of the syringe 26 is then withdrawn by a desired amount. This draws liquid drug through the hollow needle 20 into the syringe 26. As the open end of the hollow needle 20 is submerged no air or other gas should be drawn into the needle. As liquid is withdrawn from the bottle air can flow into the bottle via the conduit 11 and vent 12 to fill the space vacated by the liquid, equalizing pressure inside and outside the bottle, facilitating withdrawal of liquid and avoiding any outside air bubbling through the liquid. Air flows into the conduit from the open end of the collar 14 around the insert, via space 24 and through hollow needle 23. The complex path taken by the air is such that, in the event of any escape of liquid via the conduit and hollow needle 24, the liquid tends to be captured in space 24, and not leak out of the assembly. When the syringe 26 has been filled sufficiently it is disconnected from the connector 18 and may then be connected to a standard hollow needle or other apparatus to administer the drag to a patient. The cap 25 can then be replaced on the assembly and the assembly and its capture hollow needles safely disposed of. As the hollow needles are captive they do not present any risk of needle stick injury.

The above embodiment has been described by way of example only. Many variations are possible without departing from the invention.

Claims

1. An assembly for delivering a fluid drug, the assembly comprising a container with an opening through which a fluid may be withdrawn from or introduced into the container and a vent means remote from the opening through which another fluid may flow into or out of the container as fluid is introduced or withdrawn through the opening.

2. An assembly as claimed in claim 1 wherein the opening is formed in a first end of the container.

3. An assembly as claimed in claim 2 wherein the vent means is provided towards, in or adjacent a second end of the container.

4. An assembly as claimed in claim 3 wherein the first and second ends of the container are opposite each other.

5. An assembly as claimed in any preceding claim wherein the opening is closed by way of a pierceable closure.

6. An assembly as claimed in any preceding claim wherein the container is a bottle and the opening is formed by a neck of the bottle.

7. An assembly as claimed in any preceding claim wherein the vent means is normally closed, but arranged to be opened in use.

8. An assembly as claimed in claim 7 wherein the vent means is closed by way of a pierceable closure.

9. An assembly as claimed in claim 7 wherein the vent means is sealed by a seal which is arranged to be ruptured in use.

10. An assembly as claimed in any preceding claim wherein the vent means communicates with a conduit which extends to an end of the container where the opening is formed.

1 1. An assembly as claimed in any preceding claim wherein a hollow needle is movably mounted to the container.

12. An assembly for delivering a fluid drug comprising a container and a fitting, the fitting housing a hollow needle mounted for movement relative to the container.

13. An assembly as claimed in claim 12 wherein the fitting is moulded to the container such that it closes an opening in the container.

14. An assembly as claimed in claim 13 wherein the container is blow moulded and forms a blow fill seal with the fitting.

15. An assembly as claimed in any of claims 11 to 14 wherein the hollow needle comprises a sharp end and an opposite end connected to a coupling.

16. An assembly as claimed in claim 15 wherein the hollow needle is mounted for movement between a first position in which the sharp end of the needle does not enter the container and a second position in which the sharp end of the needle enters the container through a closure closing the opening.

17. An assembly as claimed in claim 16 wherein the hollow needle is mounted on a sliding member which is slidably mounted to the fitting.

18. An assembly as claimed in claim 17 wherein a second hollow needle or other sharp point is provided on the slidable member for movement with the sliding member and hollow needle.

19. An assembly as claimed in claim 18 wherein the second hollow needle or sharp point is arranged to open a vent means or a conduit leading from a vent means in the container when the slidable member is moved such that the hollow needle is in its second position.

20. A method of using an assembly as claimed in claim 1 with the container thereof being at least partially filled with a liquid drug, the method comprising the steps of:

inserting a hollow needle fitted to a syringe into the container;

opening the vent means;

orienting the container such that the tip of the hollow needle lies below the vent means and drawing liquid from the container into the syringe via the hollow needle.

21. A method of using an assembly as claimed in claim 12 with the container thereof being at least partially filled with a liquid the method comprising the steps of:

engaging a needleless syringe with the hollow needle,

moving the hollow needle from a first to a second position such that the needle enters the container and drawing liquid from the container into the syringe via the hollow needle.