WO2010029371A2

WO2010029371A2 - Medical device

Info

Publication number: WO2010029371A2
Application number: PCT/GB2009/051179
Authority: WO
Inventors: Philip Bickford-Smith; Alan Wagstaff
Original assignee: B-Link (Uk) Ltd
Priority date: 2008-09-12
Filing date: 2009-09-11
Publication date: 2010-03-18
Also published as: WO2010029371A3; GB0816704D0

Abstract

The invention provides a cartridge (16) for use with an infusion container (4). The cartridge comprises a body having a first end and a second end and a passageway (17) therebetween. The passageway is adapted to prevent a standard ISO-specified closure-piercing spike from accessing the chamber of said container.

Description

Medical Device

The invention relates to a medical device. Particularly, but not exclusively, the invention relates to a medical device for the administration of a neuraxial medication.

Many patients receiving hospital treatment are given medication as a fluid typically in liquid form via tubing sets typically fitted with connectors. The tubing set may, for example, be in the form of an intravenous 'drip' whereby the medication is delivered into a vein of the patient, or intended for neuraxial blockade whereby local anaesthetic medication is delivered to a site around the nerves within the central nervous system. Alternatively the medication may be given into the alimentary tract via one or several tubular devices. The medication is generally contained within an infusion container which is hooked onto a stand positioned alongside the patient. The infusion container and tubing set are connected together by a care-giver, for example a member of a medical team or a patient's carer, puncturing an outlet port in the infusion container with a standard 'closure-piercing spike', complying with ISO 8536-4:2007 'Infusion sets for single use', which form part of and is attached to a drip chamber and tubing set. The medication is thus able to flow from the infusion container through into the tubing set and thence into the patient. The medication may be delivered to the patient by gravity feed or by the use of a pump. Alternatively, medication may be drawn into a syringe which can be attached to the base of the infusion container using a 'closure-piercing spike' with dimensions complying with ISO 8536-4:2007 inserted into the outlet port of the infusion container.

Infusion containers are manufactured to comply with ISO 15747:2003 'Plastics containers for intravenous injection'. Said containers are designed to contain varying volumes of liquid. Said containers comprise a chamber containing medication, a loop connector to allow the bag to be hooked onto a stand, and at least one outlet port. Often only a label on the outer surface of the container identifies the volume, type and strength of the medication contained therein. An ISO 8536-4:2007 'spike' comprises a hollow body of set dimensions, having a pointed end for piercing the outlet port of the infusion container.

Due to the standard configuration of both the ISO 15747:2003 infusion container and the ISO 8536-4:2007 'closure-piercing spike', it is a known problem that an incorrect container can be mistakenly connected to a drip line of a patient. This is because ISO-compliant infusion containers may be filled with drugs not intended for intravenous administration. Since any ISO-compliant 'closure-piercing spike' can pierce any ISO-compliant infusion container, such an arrangement presents a significant risk to the patient, particularly if a drug within the container was intended for enteral or neuraxial administration, and is instead given intravenously; this may result in fatality. The UK National Patient Safety Agency (NPSA) has recognised that a number of incidents have occurred where medicines, in infusion containers, and intended for enteral (see NPSA Safety Alert 19) or epidural (see NPSA Safety Alert 21 ) administration, have been accidentally administered by the intravenous route due to the standard configuration of the ISO infusion container and ISO spike. There have also been reported instances of intravenous medicines being administered by the epidural route. In order to minimise these risks, the NPSA has recommended that the NHS and independent sector organisations in England and Wales clearly label infusion containers , for example, by labelling epidural containers and syringes "For Epidural Use Only", storing epidural infusions in separate cupboards or refrigerators from those holding intravenous and other types of infusions, and training staff in safe practices for administering epidural infusions. However, each one of the recommended steps does not prevent human error whereby the care-giver inadvertently chooses the wrong infusion container . The risk of administration of an incorrect medication therefore remains.

It is an object of the present invention to provide a medical device which minimises the risk of administration of fluid medication by the incorrect route, particularly those medications intended for neuraxial, enteral or intravenous administration.

According to an aspect of the invention there is provided an infusion container for a medication, the container comprising a chamber for containing the medication, and at least one outlet port through which the medication may exit the chamber, wherein a passageway is provided in the outlet port, the passageway being adapted to prevent a standard ISO-specified spike accessing the chamber.

According to a further aspect of the present invention there is provided a cartridge for use with an infusion container, the cartridge comprising a body having a first end and a second end and a passageway therebetween, wherein the passageway is adapted to prevent a standard ISO- specified closure-piercing spike accessing the chamber of the infusion container.

A standard ISO closure-piercing spike is a spike complying with ISO 8536-4:2007 "Infusion sets of single use - gravity feed".

Preferably, in use, the cartridge forms the outlet port of the infusion container. Preferably, said cartridge and said container are formed into a single unit.

According to an aspect of the invention there is provided an infusion container for a medication, the container comprising a chamber for containing the medication, and at least one outlet port through which the medication may exit the chamber, wherein a passageway is provided in the outlet port, the passageway having an internal diameter of substantially equal to or less than 3.5mm.

According to a further aspect of the present invention there is provided a cartridge for use with an infusion container, the cartridge comprising a body having a first end and a second end and a passageway therebetween, the passageway having an internal diameter of substantially equal to or less than 3.5mm.

Preferably, the passageway comprises a bore adapted for receiving a spike. Preferably, the bore is adapted for receiving a head section of a spike.

Preferably, the passageway comprises a channel for receiving a spike. Preferably, the channel is adapted for receiving a piercing section of a spike. Preferably, the passageway is adapted to prevent insertion of a standard ISO closure-piercing spike into the bore, most preferably, the channel.

Preferably, the internal diameter of the channel is substantially less than the cross sectional diameter of a standard ISO closure-piercing spike. Such an ISO closure-piercing spike has a cross sectional diameter of between 5.2 to 5.6mm in accordance with ISO 8536-4:2007.

Preferably, the internal diameter of the channel is substantially less than the internal diameter of the bore. Preferably, the ratio of the internal diameter of the channel to the internal diameter of the bore is substantially 1 :3, preferably substantially 1 :2. Preferably, the channel has an internal diameter of substantially 3.5mm and the bore has an internal diameter of substantially 7mm, or preferably substantially 8mm.

Preferably, the length of the channel is approximately equal to the length of the bore. Preferably, the channel is substantially 6mm in length and, preferably, the bore is substantially 7mm in length.

Preferably, a membrane is located in the passageway. Preferably, the membrane is located in the channel. Preferably, the membrane is located at an end of the passageway remote from an opening of the passageway. Preferably, the membrane is located towards an end of the channel adjacent the bore. Preferably, the membrane is located substantially less than 5mm from the bore, preferably from an end section of the bore. Preferably, the membrane is located substantially 4mm from the bore. Preferably, the membrane comprises a concave face. Preferably, the membrane is adapted to be punctured by a spike. According to a further aspect of the invention there is provided an infusion container for a medication, the container comprising a chamber for containing the medication, at least one outlet port through which the medication may exit the chamber, and a passageway provided in the outlet port, wherein a membrane is located in the passageway, the membrane located substantially less than 5mm from an end section of a bore of the passageway.

According to a further aspect of the present invention there is provided a cartridge for use with an infusion container, the cartridge comprising a body having a first end and a second end and a passageway therebetween, wherein a membrane is located in the passageway, the membrane located substantially less than 5mm from an end section of a bore of the passageway.

Most preferably, the passageway comprises a bore and a channel, the bore having a diameter two times greater than the diameter of the channel wherein the membrane is located in the channel adjacent the bore.

Preferably, at least one ridge is provided on the bore. Preferably, a plurality of ridges is provided on the bore, preferably arranged circumferentially about the bore.

According to a further aspect of the present invention there is provided a spike for puncturing an infusion container, the spike comprising a body having a piercing portion, the piercing portion being adapted for piercing an outlet port of an infusion container, wherein the spike further comprises blocking means to prevent the spike being inserted into the outlet port of a standard ISO infusion container.

Preferably, said blocking means comprise at least one blocking member. Preferably, at least one blocking member is located on the head section of the spike. Preferably, a plurality of blocking members is provided. Preferably, said blocking members are arranged circumferentially about the spike, preferably the head section. Preferably, said blocking members are adapted to engage with the at least one ridge of the cartridge, preferably in a screw thread fitting. Preferably, the blocking means comprises a diameter of at least substantially 1 mm.

Preferably, the head section is of a substantially equal length to the bore of the passageway. Preferably, the piercing portion is of a substantially equal length to the channel of the passageway. The length of the piercing portion in relation to the channel is such that when the membrane is pierced, the piercing portion is substantially flush with an opening of the channel adjacent the chamber.

In this arrangement, the head section can be screwed into the passageway by the blocking members locking with the ridges in a screw fixing manner. In so doing, the spike is secured in the cartridge in a locked position. The spike cannot therefore be simply pulled out of the locked position by a care-giver or a patient. Further, and advantageously, the provision of a screw thread ensures the spike is correctly aligned in the cartridge.

Preferably, a collar is located on the spike. Preferably, the collar is adapted to abut against a portion of the cartridge. Preferably, the collar is adapted to abut against an abutment wall of the cartridge. Preferably, the collar comprises a taper portion. Preferably, the taper portion is dimensioned to taper from substantially 12mm diameter to substantially a 10mm diameter, preferably tapering towards the piercing portion. Preferably, the taper portion tapers outwardly at an angle of substantially 45 degrees. Preferably, at least one cut-out is provided on the collar, preferably being located on a periphery of the collar, preferably on the 12mm diameter portion. Preferably, two cut-outs are provided, preferably being spaced diametrically opposite to each other.

Preferably, the spike comprises a gripping part adapted to be gripped by a care-giver during use. Preferably, the gripping part comprises a series of undulations preferably corresponding to a particular neuraxial Neurax™ or enteral feed connector.

Preferably, when the spike if for neuraxial use, the gripping part is configured to resemble the anatomical shape of ribs or the spine.

Preferably, when the spike is for enteral use, the gripping part is configured to resemble loops of the gut.

Preferably, the spike comprises nodules being adapted to prevent a fluid tight connection between the spike and an ISO luer hypodermic syringe. Preferably, the nodules are located at an end of the spike, preferably remote from the head section. Preferably, said nodules are located on a periphery of said end. Preferably, said end is adapted to substantially prevent a fluid-tight connection being achieved with an ISO594-compliant luer syringe or other medical device. Advantageously, when the head section is screwed into the bore, the collar abuts against the portion of the cartridge to provide a seal. Such an arrangement negates the need for additional sealing components, for example, elastomeric seals.

According to a further aspect of the present invention there is provided a kit of parts comprising an infusion container and a spike, as hereinbefore described.

According to a further aspect of the present invention there is provided a kit of parts comprising an infusion container, a cartridge, and a spike, as hereinbefore described.

Preferably, the kit further includes a connector tubing, said tubing comprising a spike as hereinbefore described. Preferably, the tubing is fixed to the spike by suitable fixing means, for example, adhesive.

According to a further aspect of the present invention there is provided an assembly comprising an infusion container and spike as hereinbefore described. Preferably, the assembly further comprises a cartridge as hereinbefore described.

According to a further aspect of the present invention there is provided a method of manufacturing an infusion container comprising the steps of,

1 . Moulding a cartridge comprising a body having a first end and a second end, and a passageway therebetween, wherein the passageway is adapted to prevent a standard ISO spike accessing the chamber;

2. Applying a seal, to the cartridge, to provide an airtight seal; and 3. Moulding a chamber for an infusion container around the cartridge.

Preferably, the seal is an aluminium foil seal.

Preferably, at step 3, the moulding step includes fixedly attaching the chamber to the cartridge, preferably as part of the moulding process. In this manner, the cartridge and chamber are joined together.

According to a further aspect of the present invention there is provided a method of delivering an infusion medication, comprising the steps of, 1 . Providing an infusion container for a medication, said container comprising a chamber for containing the medication, and at least one outlet port through which the medication exits the chamber, wherein a passageway is provided in the outlet port, the passageway being adapted to prevent a standard ISO closure-piercing spike accessing the chamber; 2. Inserting a spike into the outlet port of the infusion container to cause the medication to flow from the chamber, the spike comprising a body having a piercing portion, the piercing porting being adapted for piercing the outlet port, wherein the spike further comprises blocking means adapted to prevent the spike being inserted into the outlet port of a standard ISO infusion container; and

3. Directing the medication from the spike to the site of entry in a patient.

Preferably, a seal is provided on the container. Preferably, the seal is adapted to be removed, preferably before step 2.

Preferably, the seal is manufactured from a suitable material for example, aluminium foil.

Preferably, the medication is a neuraxial medication, preferably an epidural anaesthetic or an enteral feed.

Preferably, the container is manufactured from plastics materials, preferably semi- rigid plastics materials. Preferably, the cartridge and/ or preferably the spike are manufactured from plastics materials, preferably rigid plastic materials.

Provision of an infusion container having a passageway which is configured such that a standard ISO closure-piercing spike cannot be inserted into the chamber of the infusion container, minimises the risk of a care-giver administering the wrong medication to a patient. The care-giver is not able to pierce the chamber with the standard ISO spike. Similarly, provision of the spike of the present invention prevents a care-giver from piercing the chamber of a standard ISO infusion container .

Most preferably, a kit is provided comprising an infusion container having the adapted passageway and the spike comprising the head section. The passageway is adapted to only receive said spike. In this configuration, the chamber of the infusion container can only be pierced with the described spike. Advantageously, the risk of a care-giver administering the wrong medication is reduced.

All of the features described herein may be combined with any of the above aspects, in any combination.

An embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings, wherein:

Figure 1 shows a schematic front view of a medical device according to the invention; Figure 2 shows a schematic prospective view of a medical device according to the invention;

Figure 3 shows a schematic plan view of a medical device of Figure 2;

Figure 4 shows a schematic prospective view of a medical device of Figure 2;

Figure 5 shows a schematic side view of a medical device of Figure 2;

Figure 6 shows a schematic rear view of a medical device of Figure 2;

Figure 7 shows a schematic perspective view of a medical device of Figure 2;

Figure 8 shows a schematic exploded sectional view of a medical device of Figure 7;

Figure 9 shows a schematic perspective view of a medical device according to the invention;

Figure 10 shows a schematic perspective view of a medical device according to the invention;

Figure 1 1 shows a schematic side view of a medical device according to the invention;

Figure 12 shows a schematic front view of a medical device of Figure 9;

Figure 13 shows a schematic front view of a medical device of Figure 9;

Figure 14 shows a schematic side view of a medical device according to the invention;

Figure 15 shows a schematic sectional side view of a medical device of Figure 14;

Figure 16 shows a schematic perspective view of a medical device according to the invention;

Figures 17a and 17b show a schematic perspective rear and front view respectively of an embodiment of a medical device according to the invention;

Figures 18a, 18b and 18c show a schematic sectional side view, a schematic sectional plan view, and a further schematic sectional side view of the medical device of Figures 17;

Figure 19 shows a schematic exploded partial sectional view taken from Figure 18c; Figure 20 shows a schematic plan view of the medical device of Figures 17;

Figure 21 shows a schematic rear view of the medical device of Figures 17;

Figures 22a and 22b show a schematic perspective front and rear view respectively of an embodiment of a medical device according to the invention;

Figures 23a and 23b show a schematic side view and a schematic sectional side view of the medical device of Figures 22;

Figures 24a and 24b show a schematic front view and a schematic rear view respectively of the medical device of Figures 22; and

Figure 25 shows a schematic sectional side view of a part of the medical device of Figures 22.

Figure 1 shows an infusion container 2 having a chamber 4 in which is contained a medication to be administered to a patient. The container 2 comprises an attachment member 6 located towards an upper end of the chamber 4. A slot 8 is provided in the attachment member 6 to enable a care-giver to hook the container 2 onto a stand to allow the container 2 to be positioned alongside and above a patient. At an end of the body 4 remote from the attachment member 6, there is provided a first outlet port 10 and a second outlet port 12. A cap 14 is provided on the first outlet port 10. The first outlet port 10 may be used for container filling and then is permanently sealed. A cartridge 16 is provided in the second outlet port 12, as will be described in greater detail below. A passageway 17 is located between the cartridge 16 and the chamber 4. A seal 18 is located on an inner surface 30 of the cartridge 16. The cartridge 16 may be manufactured as an integral part of the moulding of the container 2. Alternatively, the cartridge 16 may be supplied as a separate part of the container 2 being adapted to be inserted into the outlet port 12.

Figures 2 to 8 show the cartridge 16 in more detail. The cartridge 16 is manufactured as a one piece moulding and comprises an outer member 20 which is generally circular in section, a shoulder portion 22 located adjacent the outer member 20, and a neck portion 24 located adjacent the shoulder portion 22. A membrane 26 is provided in the neck portion 24. The membrane 26 is located towards the shoulder portion 22. The membrane 26 is positioned towards a bore 34 of the cartridge 16. The membrane 26 is located less than 5mm from an end section 37 of the bore 34. The membrane 26 is approximately 1 .5mm from the end section 37. The membrane 26 is adapted to be pierced by a spike. A wall 28 extends downwardly from the outer member 20 by approximately 7mm. As can be seen in Figure 4, the cartridge 16 comprises the inner surface 30, having an abutment wall 32 located thereon. The abutment wall 32 extends downwardly towards the wall 28 to a depth of approximately 1 mm. A bore 34 is provided through the shoulder portion 22. The bore 34 is approximately 7mm in length and 7mm in diameter and extends from the abutment wall 32 towards a lower end 35 of the neck portion 24. A plurality of ridges 36 is located on the bore 34 as shown in Figure 7. The ridges 36 are arranged circumferentially around the bore 34, in a screw-thread configuration.

A channel 38 is provided in the neck portion 24 of the cartridge 16 as shown in Figures 7 and 8. The channel 38 is approximately 6mm in length and 3.5mm in diameter. The channel 38 is sealed towards an end adjacent the bore 34 by the membrane 26. The membrane 26 has a concave face 42 which is adapted to be pierced by a spike 46. An opening 44 is provided adjacent the membrane 26.

The seal 18, as shown in Figure 1 , is secured to the inner surface 30 of the cartridge 16 to ensure the cartridge 16 is kept sterile prior to use. The seal 18 is manufactured from a suitable material, for example, aluminium foil, to act as a bacteriological barrier, and is adapted to be removed prior to use by a user pulling said seal away from the cartridge.

Figures 9 to 16 show a spike 46 according to the invention. The spike 46 comprises an elongate member 48 which is approximately 40mm in length. The elongate member 48 comprises a head section 50 and a gripping part 52. The gripping part 52 is located remote from the head section 50 and shaped to enable a user to grip the spike 46. The gripping part 52 as shown in Figures 9 to 16 comprises a cuboidal shaped body on which is located a series of longitudinal and radial ridges. In the case of a spike intended for neuraxial use, the configuration of the gripping part 52 mimics the anatomical shape of the ribs and spine. For the enteral use, the gripping part mimics the loops of gut. The shape and colour of the gripping part 52 also offers 'affordance' to the user as to which route into the body the spike/container assembly is to be connected; for example, enteral (lilac) or neuraxial (yellow).

A first portion 53 of the elongate member 48 separates the head section 50 and the gripping part 52. The first portion 53 is approximately 9mm in length.

An end 56 of the spike 46 is adapted to receive tubing, or a syringe fitting. In the arrangement shown, two nodules 57 are provided on the end 56. The nodules 57 are arranged to prevent a fluid-tight connection being achieved to an ISO luer hypodermic syringe. When the medical device is used for neuraxial applications, the configuration of the end 56 of the spike 46 is such that said end 56 will only receive a neuraxial syringe manufactured under the trade name NEURAX. Advantageously, the provision of the nodules 57 prevents a luer hypodermic syringe being attached to the spike 46. In the event that a user attempts to force such a syringe into the assembly, fluid leaks from the end 56 of the spike 46.

The head section 50 of the spike 46 comprises a collar 58, a thread portion 60 and a piercing section 62. The thread portion 60 comprises a number of circumferential upstanding members 61 which are dimensioned to be received by the bore 34 of the cartridge 16. The thread portion 60 is designed to be compatible with a corresponding bore of a cartridge. Thus the thread portion 60 on a spike 46 intended to be connected to an outlet port 10 of a container 2 for enteral feed will not engage with the bore 34 on an outlet port on a container 2 for neuraxial solutions and vice-versa.

In the configuration shown in the Figures, the collar 58 of the spike 46 abuts against the abutment wall 32 of the cartridge 16 when the spike 46 is screwed into the cartridge 16. The piercing section 62 is shaped to pierce through the membrane 26 in the channel 38 of the neck portion 24. As can be seen in Figure 15, a passageway 64 is provided along the length of the elongate member 48, to allow medication to travel from the infusion container 2 through the elongate member 48 and into, for example, tubing or a syringe fitting.

Figure 16 shows a spike 46 having tubing 66 attached thereto. The tubing 66 is connected to the spike 46 by, for example, gluing, to prevent the tubing 66 from detaching from the spike 46. The tubing 66 can be a specific coloured tubing 66, appropriate to the type of fluid medication to be delivered, for example yellow tubing is used for epidural anaesthetic, lilac is used for enteral feed.

In use, a care-giver brings the spike 46 to meet the bore 34 in the cartridge 16 by inserting the spike 46 upwardly and inwardly into the inner surface 30 of the outer member 20. The head section 50 of the spike marries with the ridges 36 of the bore 34 and the care-giver screws the spike 46 inwardly until the collar 58 abuts against the abutment wall 32. In so doing, the piercing section 62 pierces through the membrane 26 to create a hole in the membrane 26 in neck portion 24. Medication contained in the infusion container 2 is thus allowed to flow through the passageway 64 and into the tubing 66.

Advantageously, due to the configuration of the cartridge 16 an ISO standard closure-piercing spike is prevented by dimensional incompatibility from entering the opening 44 in the neck portion 24 of the cartridge 16. Thus, a care-giver is prevented from accidentally piercing the chamber of the infusion container 2. Provision of the ridges 36 on the cartridge 16 and the thread portion 60 on the spike 46, enables the correct alignment of the spike 46 in the cartridge 16. Advantageously, the correct alignment ensures that there is no obstruction to the flow of medication through the passageway 64. The collar 58 provides a seal between the cartridge 16 and the spike 46 without the need for additional sealing components, for example, elastomeric seals.

It is a known disadvantage that elastomeric compounds leach when in contact with fluids. This is a particular problem for delivery of pharmaceuticals because the degree of leaching of the elastomeric components must be tested prior to authorisation for use. Advantageously, the present invention does not need to undergo such extensive testing. Preferably, the container 2, the cartridge 16 and the spike 46 are manufactured from plastics materials. The container 2 is most preferably manufactured from semi rigid plastics material having the cartridge 16 as an integral part thereof. Alternatively the cartridge 16 may be fitted to the container 2 in a push fit manner.

Advantageously, the screw thread action of the spike 46 and the cartridge 16 ensures that said parts are locked in place during use. The provision of a screw thread allows for ease of use because the care-giver simply holds on to the gripping part 52 and screws the elongate member 48 into the cartridge 16, unlike known container and spike arrangements wherein the care-giver must hold the container to provide leverage when forcing the spike through the outlet port of the container . In known arrangements, the container must be supported with one hand, whilst the user attempts to pierce the outlet port with the spike in the other hand. Conversely, the present invention negates the need for the care-giver to provide this level of support to the container because the screw thread action allows for ease of location of the spike 46 and immediate attachment to the cartridge 16.

An embodiment of the invention is shown in Figures 17 to 25. Figures 17 to 21 show an embodiment of a spike 146; Figures 22 to 25 show an embodiment of a cartridge 1 16.

Figures 17a to 17c show the spike 146 comprising like parts to those hereinbefore described in relation to Figures 9 to 16; said like parts having corresponding numerals. In contrast to the spike 46 shown in Figure 9, the spike 146 comprises a collar 158 having a tapered body portion 180 which is configured to taper by 45° (shown as β in Figure 18a) from substantially 12mm in diameter to substantially 10mm diameter, towards the piercing section 162. Further, the collar 158 comprises cut-outs 182. Two cut-outs 182 are located on the collar 158 being positioned diametrically opposite each other. Each cut-out 182 is 0.5mm deep by 1 mm wide. Provision of the cut-outs 182 help to ensure leakage of fluid in the event that the spike 146 is inadvertently jammed into an orifice of a container having an outlet diameter of 9-12mm. Such containers may exist in the medical field. The apparatus of the present invention guards against misuse. In addition to the embodiment of the collar 158, the spike 146 also comprises upstanding members 161 having a thread size of at least 1 mm in diameter.

Table 1 below lists the specific dimensions of the embodiment of the spike 146 shown in Figures 17 to 21 . It will be understood by the reader that said dimensions relate to the embodiment of Figures 17 to 21 and that other alternative spikes may comprise alternative dimensions but will be in keeping with the overall object of the invention.

Table 1

Figures 22 to 25 show an alternative embodiment of the cartridge 1 16. The cartridge comprises cartridge apertures 190 located in the shoulder 122 thereof. Said apertures 190 further ensure that the correct cartridge is used with the correct combination of container. It will be understood by the reader that said dimensions relate to the embodiment of Figures 22 to 25 and that other alternative cartridges may comprise alternative dimensions but will be in keeping with the overall object of the invention.

Table 2 below lists the specific dimensions of the cartridge 1 16 shown in Figures 22 to 25.

Table 2

The medical device of the present invention provides an infusion container incorporating a cartridge 16 which is configured to prevent insertion of a standard ISO spike. The configuration of the cartridge 16 and spike 46 provides an alternative way for a care-giver to give safe infusion into the body or drawing up into a dedicated syringe for injection. The invention provides an infusion container and spike delivery system which ensures the correct medication will only be administered to the correct part of the body for which it is intended.

The medical device of the present invention is suitable for the delivery of medication to humans and animals.

The medical device of the present invention is suitable for use with fluid medication, for example, neuraxial or enteral medication.

The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1 . A cartridge for use with an infusion container, the cartridge comprising a body having a first end and a second end and a passageway therebetween, wherein the passageway is adapted to prevent a standard ISO-specified closure-piercing spike accessing the chamber of said container.

2. A cartridge as claimed in claim 1 , characterised in that the passageway comprises an internal diameter of substantially equal to or less than 3.5mm.

3. A cartridge as claimed in claims 1 or 2, characterised in that the cartridge forms the outlet port of the infusion container.

4. A cartridge as claimed in any one of the preceding claims characterised in that said cartridge and said container are formed into a single unit.

5. A cartridge as claimed in any one of the preceding claims characterised in that the passageway comprises a bore adapted for receiving a head section of a spike.

6. A cartridge as claimed in any one of the preceding claims characterised in that the passageway comprises a channel, the channel being adapted for receiving a piercing section of the spike.

7. A cartridge as claimed in claim 6, characterised in that the internal diameter of the channel is substantially less than the cross sectional diameter of a standard ISO closure- piercing spike.

8. A cartridge as claimed in claim 7, characterised in that the internal diameter of the channel is substantially equal to or less than 3.5mm.

9. A cartridge as claimed in any one of claims 6 to 8, characterised in that the internal diameter of the channel is substantially less than the internal diameter of the bore.

10. A cartridge as claimed in any one of claims 6 to 9, characterised in that the ratio of the internal diameter of the channel to the internal diameter of the bore is substantially 1 :2.

1 1 . A cartridge as claimed in any one of claims 5 to 10, characterised in that the bore has an internal diameter of substantially 8mm.

12. A cartridge as claimed in any one of the preceding claims characterised in that a membrane is located in the passageway.

13. A cartridge as claimed in claim 12, characterised in that the membrane is located in the channel, at an end of the passageway remote from an opening of the passageway.

14. A cartridge as claimed in claim 13, characterised in that the membrane is located towards an end of the channel adjacent the bore, substantially less than 5mm from the bore.

15. A spike for puncturing an infusion container, the spike comprising a body having a piercing portion, the piercing portion being adapted for piercing an outlet port of an infusion container, characterised in that the spike further comprises blocking means to prevent the spike being inserted into the outlet port of a standard ISO infusion container.

16. A spike as claimed in claim 15, characterised in that said blocking means comprise at least one blocking member, located on a head section of the spike.

17. A spike as claimed in claims 15 or 16, characterised in that a collar is located on the spike.

18. A spike as claimed in claim 17, characterised in that the collar is adapted to abut against a portion of the cartridge.

19. A spike as claimed in claims 17 or 18, characterised in that at least one cut-out is provided on the collar, being located on a periphery of the collar.

20. A spike as claimed in any one of claims 15 to 19, characterised in that the spike comprises a gripping part adapted to be gripped by a care-giver during use, the gripping part comprising a series of undulations.

21 . A spike as claimed in any one of claims 15 to 20, characterised in that the spike comprises nodules being adapted to prevent a fluid tight connection between the spike and an ISO luer hypodermic syringe.

22. An infusion container for a medication, the container comprising a chamber for containing the medication, and at least one outlet port through which the medication may exit the chamber, wherein a passageway is provided in the outlet port, the passageway having an internal diameter of substantially equal to or less than 3.5mm.

23. A kit of parts comprising an infusion container and a spike, the container comprising a chamber for containing the medication, and at least one outlet port through which the medication may exit the chamber, wherein a passageway is provided in the outlet port, the passageway having an internal diameter of substantially equal to or less than 3.5mm, and a spike for puncturing an infusion container, the spike comprising a body having a piercing portion, the piercing portion being adapted for piercing the outlet port of the infusion container, characterised in that the spike further comprises blocking means to prevent the spike being inserted into the outlet port of a standard ISO infusion container..

24. A kit of parts comprising an infusion container, a spike, and a cartridge, the container comprising a chamber for containing the medication, and at least one outlet port through which the medication may exit the chamber, wherein a passageway is provided in the outlet port, the spike for puncturing the infusion container, the spike comprising a body having a piercing portion, the piercing portion being adapted for piercing the outlet port of the infusion container, characterised in that the spike further comprises blocking means to prevent the spike being inserted into the outlet port of a standard ISO infusion container, and the cartridge comprising a body having a first end and a second end and a passageway therebetween, wherein the passageway is adapted to prevent a standard ISO-specified closure-piercing spike accessing the chamber of said container.

25. An assembly comprising an infusion container and spike, the container comprising a chamber for containing the medication, and at least one outlet port through which the medication may exit the chamber, wherein a passageway is provided in the outlet port, the passageway having an internal diameter of substantially equal to or less than 3.5mm, and a spike for puncturing an infusion container, the spike comprising a body having a piercing portion, the piercing portion being adapted for piercing the outlet port of the infusion container, characterised in that the spike further comprises blocking means to prevent the spike being inserted into the outlet port of a standard ISO infusion container..

26. A method of manufacturing an infusion container comprising the steps of,

27. A method of delivering an infusion medication, comprising the steps of,

1 . Providing an infusion container for a medication, said container comprising a chamber for containing the medication, and at least one outlet port through which the medication exits the chamber, wherein a passageway is provided in the outlet port, the passageway being adapted to prevent a standard ISO closure-piercing spike accessing the chamber;

2. Inserting a spike into the outlet port of the infusion container to cause the medication to flow from the chamber, the spike comprising a body having a piercing portion, the piercing porting being adapted for piercing the outlet port, wherein the spike further comprises blocking means adapted to prevent the spike being inserted into the outlet port of a standard ISO infusion container; and

3. Directing the medication from the spike to the site of entry in a patient.

28. An infusion container, or a spike, or a cartridge, or a kit, substantially as hereinbefore described with reference to any one of the accompanying drawings.