GB2495741A

GB2495741A - Container for a liquid drug

Info

Publication number: GB2495741A
Application number: GB1118035.3A
Authority: GB
Inventors: Kamran Zafar Khan
Original assignee: Individual
Current assignee: Individual
Priority date: 2011-10-19
Filing date: 2011-10-19
Publication date: 2013-04-24
Also published as: GB201118035D0

Abstract

A container for holding a liquid drug is described, having a vessel 1 and an opening 4 through which a liquid drug in the vessel 1 may be withdrawn. The container has a blocking means 8 for blocking the substantial insertion of a needle into the vessel 1 via the opening 4. Another container for holding a liquid drug is described, having a vessel 1 and a connector 2 in fluid connection with the vessel 1. The connector 2 is adapted to engage with a non-Luer type syringe fitting (not shown) and to thereby form a fluid connection with the syringe. A drug delivery system is also described, including a syringe and such a container adapted to engage with a fitting of the syringe and to form a fluid connection thereto.

Description

CONTAINER FOR A LIQUID DRUG

Technical Field of the Invention

The present invention relates to a container for a liquid drug.

Background to the Invention

Syringes, needles, and catheter tubing for drug delivery are commonly connectable to one another using a universal, system of compatible connectors known as Luer connectors, which are described in the international standards ISO 594-1 and ISO 94-2. However, injury, paralysis and death have been reported in cases where medication intended, for one drug administration route was inadvertently administered via another. This can be particularly serious in the case where a drug intended for intravcnous or othcr dclivcry routes is mistakcnly delivered via a spinal or epidura! injection or catheter that should only have been used to deliver a limited range of suitable anaesthetic drugs. A number of deaths have occurred following such errors. However, death has also occurred following the intravenous delivery of an epidural. anaesthetic.

It has been proposed that spinal aid epidural drug delivery should be performed using spinal' syringes, needles, and catheter fittings such as three-way-taps and adapters that are expressly designed not to interconnect with Luer connectors, so as to reduce the risk of such accidents occurring. Recent healthcare guidelines in the UK have urged healthcare professionals to perform epidural, spinal (intrathecal) and regional anaesthesia injections and infusions with devices that cannot he connected with intravenous equipment. Based on such guidance, healthcare manufacturers produce such equipment using so-called non-Luer' connections, which are generally understood to be interchangeably connectable with other non.-Luer connectors of a matching type but are incompatible with and cannot be connected to Luer connectors. Such non-Luer' connections typically have, for example, a tapered seal connector having a taper diameter less than 4 mm or greater than 5 mm. However, these proposals fail lo address the situation where a drug intended for other purposes is mistakenly drawn up into a spinal S syringe (e.g. using a needle to draw up an incorrect drug into a syringe provided with a non-Leur' connector). This would create the problem that die spinal syringe is supposed safe. due to its exclusive compatibility with other spinal devices only, hut now contains for example an intravenous drug that is lethal when intrathecally administered. Similarly, a spinal anaesthetic mistakenly drawn up into a standard (non-spinal) syringe (e.g. having a' Luer' connector) can be administered intravenously or otherwise with no significant safeguards.

This is a problem arising in part because drugs are commonl.y drawn up using a.

needle. Such a needle could be used to draw up any liquid from any ampoule, vial, or other container, into any type of syringe, without any preventative physical measures in place to stop this from occurring.

It is therefore an object of embodiments of the present invention to provide a means of reducing the risk of drawing tip drugs intended for one delivery route into syringes or other equipment designed or used in another delivery route. Specific delivery routes include intrathecal, Epidural, Caudal or local or regional Anaesthetic administration. It is another object of embodiments of the present invention to provide a closed' drug delivery system that is intuitively or physically incompatible with other drug delivery systems so that only suitable types of drug ma.y be used within that system.

Summary of the Invention

According to a first aspect of tile present invention, there is provided a container for holding a liquid drug, comprising a vessel and further comprising, or being arranged to form, an opcning through which a liquid drug in the vessel! may be withdrawn, the container also comprising a blocking means for blocking the substantial insertion of a needle into the vessel via thc opening.

The blocking means may ensure that a needle is not used for drawing up the liquid drug, or may make it awkward or counterintuitive to use a needle for this purpose, to that it is necessary or apparent that the drug must be drawn up by another means. This may in turn help healthcare establishments to prevent the accidental drawing up of unsuitable types of drugs into a certain type of specialist (e.g. Non-Luer) syringe by ensuring that supplies of drawing up needles cornpatfblc with that particular type of syringe are not stocked.

The container may comprise a connector adapted to engage with a syringe fitting to form a fluid connection between the vessel, and the syringe via the opening. The connector may be adapted to engage with a non-Luer type syringe fitting. Additionally, or alternatively, the connector may bc adapted to engage with a Luer type syringe fitting.

According to a second aspect of the present invention, there is provided a container for holding a liquid drug comprising a vessel and a connector in fluid connection, with the vessel, the connector being adapted to engage with a nonWuer type syringe fitting and to thereby form a fluid connection with the syringe.

Such a container may provide a means for separating drug provision within a drug administration system that is separate from and incompatible with the standard system that uses Luer connectors. This may help to reduce confusion between, for example. local spinal anaesthetics and other types of drug, so that local spinal anaesthetics kept exclusively in non-Luer fining containers are not inadvertently confused with, intravenous or other types of drug that are held in containers incompatible with a spinal syringe having a non-Luer connector.

The container may further comprise a blocking means for blocking the substantial insertion of a needle into thc vessel via the connector.

Both the first and second aspects of the invention, including any of their additional features as set out above, may benefit from each of the following features or any suitable combination thereof.

The blocking means may comprise a. kinked, angled, or tortuous connection between the vessel and the connector, may comprise a kinked, angled, or tortuous passage within the connector, or may comprise a kinked, angled, or tortuous portion of the vessel. Alternatively, or additionally, the blocking means may comprise a baffle.

The blocking means may he moveable between a first position, in which it acts to block th.e substantial insertion of a needle into the vessel via the opening and second position in which thc blocking means does not impede the flow of a liquid drug through the opening. This is advantageous in that when a syringe is attached to the container, to draw a liquid drug from the container, the blocking means can be moved to the second position so as to not impede the flow of the liquid drug into d.c syringe. The blocking means may be arranged such that, in the second position, the blocking means does not block the substantial insertion of a needle into the vessel via the opening. Preferably in the first position the blocking means comprises said kinked, angled, or tortuous connection and in the second position said kinked, angled, or tortuou.s connection is at least substantially removed, for example by straightening the connecting.

Conveniently, the connector may comprise an elongate conduit defining an axis and the blocking means comprises alignment of said conduit axis with a portion of a sidewall of the vessel, wherein the separation between the connector and the sidewall portion is substantially smaller than a major dimension of the vessel.

The connector may be adapted to releasably engage ith a syringe fitting, and may be adapted to form a substantially leak-proof seal with the syringe fitting. The connector may be a male' connector comprising an externally tapered tube, and may further comprise a substantially tubular surround with an internal helical thread.

Alternatively, the connector may be a female' connector comprising an internally tapered tube, and may comprise one or more external teeth for engagement with a helical thread. Conveniently, the connector is a non-Luer connector.

The container may comprise a removable seal. The connector and seal may be 1 5 contiguously fprmed as a single article, and the seal may adjoin the connector at a frangible region. The seal may be a snap-off or twist-off tab or cap, and may adjoin an end of the connector tube. The connector and vessel may be contiguously formed as a single article. The container as a whole may be formed from a single materiaL and may be substantially formed from a plastic material.

The container may be an ampoule, or may be a vial. The container may contain a liquid drug, which may be an anaesthetic drug, or its adjuvant, and may be a. liquid drug for intrathecal, intraspinal, peridural, or perineural administration or subcutaneous Local Infilteration.

The container and liquid drug may form a sealed unit fabricated using a simultaneous blow-moulding, filling and sealing (blow-fill-seal') technique.

The container may comprise a visual indication denoting an intended drug administration route or a subset of drug administration routes. For example, the container may feature a conspicuous symbol or colour (e.g. yellow in the case of intrathecal or peridural drugs) intended to denote compatibility with a selected drug delivery system.

According to a third aspect of the invention, there is provided a drug delivery system comprising a syringe and a container as set out above, the container being adupted to engage with a fitting of the syringe and to form a fluid connection thereto, At least a 1 0 portion of the syringe and at least a portion of the container may comprise a visual indication of mutual compatibility. These portions of the syringe and of the container may be fabricated or labelled in a matching colour, pattern, or texture. The portion of the syringe may be the syringe fitting, and the portion of the container may be the connector.

Detailed Description of the Invention

1.5 Tn ordcr that the invention may be more cleai-ly understood, embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which: Figure 1 is an ampoule according to an embodiment of the present invention; Figure 2 is an ampoule according to another embodiment of the present invention; and Figure 3 is a container according to a further embodiment of the present invention.

Figures 1 to 3 show a set of containers intended for storing spinal or epidLral anaesthetic drugs, although their use may extend to any sort of drug or other fluid intended to be used within a closed delivery system that is not compatible with other systems such as the standard Luer connection system, either for ensuring that the thugs used in such a closed system are not inadvertently administered via another system, or for ensuring that unsuitable drugs are not introduced into the closed system, or preferably both.

The a.mpoule of Figure 1 has a vessel (1) forming its body, a connector (2) at the neck of the vessel, and a tear-off, twist-off, or snap-off seal (3) that forms an integral part of the connector and frangibly seals its opening (4). The connector is a male locking connector, sudh as or similar to a Luer-T,ok' type connector, which has an intcrnally helically threaded drum (5) surrounding a male externally-tapered tube connection (6) for engaging with a corresponding female internally-tapered connection with external threads or teeth, such as the type of connector shown in Figure 2. In the current embodiment, the connection (6) protrudes from the drum (5). Howevcr, it will he appreciated that other arrangements may be used, for example the connection (6) may be entirely housed within the drum (5). Alternatively, the connector (2) may be a male type of non-locking connector which lacks thc threaded surround (5), such as a i;uer-SJip' type connecl:or.

The taper (6) should preferably be a 6-degree taper. In preferred embodiments, the connector is a non-Luer connector or another connection means that is incompatible with any type of Luer connector. Generally, a releasable connection which forms a leak-free seal is preferred, The male connector (2) may be preferable to a female connector, since it is most common for syringes to have a. male connector and needles to have a female connector, so that an ampoulc with a male connector would help to ensure that a limited range of syringe types with such a reverse' connection are connectable, even where Luer connections are used.

The vessel (1) is closed below its neck to form a baffle (8) which prevents the insertion of a needle into a substantial part of the vessel or by any more than a small distance. In particular, a rigid needle i.s prevented, by the tortuous path (9) required to pass around the baffle (8), from entering the main body of the vessel so that its tip cannot reach the bottom of the vessel where it would normally be directed for drawing up a liquid drug into*a syringe. Whilst it would in principle be possible to insertaneedle as far as the baffle (8) and to draw up a liquid by inverting the container until the liquid reaches 1.0 the vessel neck and the needle tip, this would be awkward and unintuitive for trained healthcare professionals used to handling other types of ampoule, to whom it would be immediately apparent that this is not the intended purpose of the drug or ampoule.

Instead of drawing up the drug via a needle, it is intended that the ampoule is connected, once the seal (3) is removed, to a corresponding connector of a syringe. The ampoule can then be inverted and the drug drawn directly into the syringe. The vessel may be flexibly collapsible, or the container may comprise a vent or further removable seal., so that the liquid may be drawn out of the vessel using relatively gentle suction from the syringe plunger.

It is envisaged that in use the ampoule would be fabricated using a blow-fill-seal method where the drug is encapsulated inside a sealed plastic vessel, although other methods maybe suitable. A separate connector or a portion of a connector, such as the helically threaded drum (5) of a male conn.ectoi, may be added a.flerwards, either for ease of fabrication or using an injeetion-moulded component, for example, to achieve better stiffiess and dimensional tolerances in the threaded portion of the connector or the connector as a whole..

Figure 2 shows another ampoule having similar function and usage to that shown in Figure 1. In this case, a female type of connector (12) is used, having an internal 6-degree taper (16) and optional teeth or threads (15) for engagement with a male locking connector similar to the one shown in Figure 1. This may be a. Luer-Slip or Luer-Lok type connector, but is preferably a non-Luer connector or another type of connection means that is incompatible with and cannot be connected to a Luer connector of any type.

A twist-off cap (13) keeps the contents sealed and sterile until use, anclan internal shelf (18) within the vessel (1) functions as a baffle for preventing needle insertion, in the manner described for the ampoule shown in Figure 1.

Figure 3 shows another ampoule or vial, or part of an ampoule, featuring a connector (2) mounted at an angle to the main body of the vessel (1). A seal (not shown) may he included and/or a tamper-evident sealed cap applied before sterilisation, The narrow bore of the tapered connector core (6), directed towards the proximal sidewall (20) or shoulder of the vessel, prevents insertion of a drawing-up needlc into the main body of the vessel a.nd keeps the needle tip well away from the distal end or base of the vessel. As described above, it may be possible to draw up a liquid drug from the vessel using a needle and tipping up the vessel, but this would be awkward. counterintoitive, and messy.

In use, it is intended that ampoules such as those descñbed above are used for the supply and storage of drugs in medical facilities where spinal' syringe and drug delivery systems are used that are separate from, and incompatible with, other delivery systems such as those using standard Luer connectors. It is envisaged that such healthcare facilities would avoid or prohibit stocking drawing-up needles compatible with their spinal syringe systems, so that oniy drugs suitable and safe for intrathecal or epidural delivery, such as certain anaesthetics. contained in ampoules or other containers according to the present invention, are usable with the spinal syringe/delivery system.

Such a system may be marked with symbols, colours, shapes, and/or textures, or may be fabricated in a unique or eye-catching colour so as to indicate distinctness from and incompatibility with a standard drug delivery system, and/or so as to indicate the compatibility of matching parts such as syringe, ampoule, and needle connectors within the same drug delivery system.

The above embodiments are described, by way of example only. Many variations and are possible without departing from the scope of the invention as defined in the appended claims,

Claims

<claim-text>CLAIMS1. A container for holding a liquid drug, the container comprising a vessel and further comprising, or being arranged to form, an. opening through which a liquid dru.g in the vessel may be withdrawn, the container also comprising a blocking means for blocking the substantial insertion of a needle into the vessel via the opening.</claim-text> <claim-text>2. A container according to claim 1 comprising a connector adapted to engage with a syringe fitting to form a fluid connection between the vessel and the syringe via the opening.</claim-text> <claim-text>3. A container according to claim 2 wherein the connector is adapted to engage with a non-Luer type syringe fitting.</claim-text> <claim-text>4. A container for holding a liquid drug, the container comprising a vessel and a connector in fluid connection with the vessel, the connector being adapted to engage v;ith a non-Luer type syringe fitting and to thereby form a fluid connection 1 5 with the syringe.</claim-text> <claim-text>5. A container according to claim 4 comprising a blocking means for blocking the substantial insertion of a needle into the vessel via the connector.</claim-text> <claim-text>6. A container according to any one of claims 2, 3 or 5 wherein the blocking means comprises a kinked, angled. or tortuous connection between the vessel. and the connector.</claim-text> <claim-text>7. A container according to any one of claims 2, 3 or 5 wherein the blocking means comprises a kinked, angled, or tortuous passage within the connector.</claim-text> <claim-text>8. A container according to any one of claims 2, 3 or 5 wherein the connector comprises an elongate conduit defining an axis and the blocking means comprises a portion of a sidewall of the vessel with which said axis intersects, and wherein the separation between the connector and the sidewall portion is substantially smaller than a major dimension of the vessel.</claim-text> <claim-text>9. A container according to any one of claims 2 to 8 wherein the connector is adapted to releasably engage with a syringe fitting.</claim-text> <claim-text>10. A container according to any one of claims 2 to 9 wherein th.e connector is adapted to form a substantially teak-proof seal with the syringe fitting.</claim-text> <claim-text>11. A container according to any one of claims 2 to 10 wherein the connector is a male' connector comprising an externally tapered tube.</claim-text> <claim-text>12. A container according to claim 11 wherein the connector comprises a substantially tubular surround with an internal helical thread.</claim-text> <claim-text>13. A container according to any of claims 2 to 10 whereinthe connector is a female' connector comprising an inl:ernally tapered tube.</claim-text> <claim-text>14, A container according to claim 13 wherein the tube comprises one or more external teeth for engagement with a helical thread.</claim-text> <claim-text>15. A container according to any one of claims 2 to 14 wherein the connector is a non-Luer connector.</claim-text> <claim-text>16. A container according to any one of claims 2 to 15 comprising a removable seal.</claim-text> <claim-text>17. A container according to claim 16 wherein the connector and seal are contiguously formed as a single article.</claim-text> <claim-text>18. Acontthcogtoclaiml6orl7whereinthesealadjoinstheconnectorata frangible region.</claim-text> <claim-text>19. Acontaineraccordingtoanyoneofclainis l6to l8whereinthesealisasnap-off or twist-off tab or cap.</claim-text> <claim-text>20. A contaizier according to any one of claims 16 to 19, where dependent on any one of claims 11 to 14, wherein the seal adjoins an end of the tube.</claim-text> <claim-text>2L Acontainccordingtoanyoneofclahns2to2owhereintheconnectorand vessel are contiguously formed as a single article.</claim-text> <claim-text>22. Acontaineraccordingtoanyoneofclaimslto3or5to8,oronanyoneof claims 9 to 21 where dependent on any one of claims Ito 3 or 5 to 8, wherein the blocking means comprises a kinked, angled, or tortuous portion of the vessel.</claim-text> <claim-text>23. Acontalneraccordingtoanyoneofclaimslto3or5to8,oronanyoneof claims 9 to 22 where dependent on any one of claims 1 to 3 or 5 to 8, wherein the blocking means comprises a baffle, 24. A container according to any preceding claim formed from a single material.25. A container according to any preceding claim substantially formed from a plastic material.26. A container according to any preceding claim wherein the container is an ampoule.27. A container according to any preceding claim containing a. liquid drug.28. A container according to any preceding claim containing a liquid drug for intrathecal, intraspinal, peridural, or perineural administration.29. A container according to any preceding claim comprising a visual indication denoting an intended drug administration route or a subset of drug administration routes.30. A container substantially as herein described with reference to the appended figures.31. A drug delivery system compnsing a syringe and a container according to any preceding claim adapted to engage with a fitting of the syringe and to form a fluid connection thereto.32. A drug delivery system according to claim 31 wherein at least a portion of the syringe and at least a portion of the container comprise a visual indication of mutual compatibility.33. A drug delivery system according to claim 32 wherein said portions of the syringe and of the container are fabricated or labelled in a matching colour, pattern, or texture.34. A drug delivery system according to claim 32 or 33 wherein the portion of the syringe is the syringe fitting.35. A drug delivery system according to any of claims 32 to 34 wherein the portion of the container is the connector.36. A drug delivery system substantially as herein described with reference to the appended figures.</claim-text>