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WO2010029371A2 - Dispositif médical - Google Patents

Dispositif médical Download PDF

Info

Publication number
WO2010029371A2
WO2010029371A2 PCT/GB2009/051179 GB2009051179W WO2010029371A2 WO 2010029371 A2 WO2010029371 A2 WO 2010029371A2 GB 2009051179 W GB2009051179 W GB 2009051179W WO 2010029371 A2 WO2010029371 A2 WO 2010029371A2
Authority
WO
WIPO (PCT)
Prior art keywords
spike
cartridge
passageway
outlet port
infusion container
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2009/051179
Other languages
English (en)
Other versions
WO2010029371A3 (fr
Inventor
Philip Bickford-Smith
Alan Wagstaff
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
B-LINK (UK) Ltd
Original Assignee
B-LINK (UK) Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B-LINK (UK) Ltd filed Critical B-LINK (UK) Ltd
Publication of WO2010029371A2 publication Critical patent/WO2010029371A2/fr
Publication of WO2010029371A3 publication Critical patent/WO2010029371A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1094—Tube connectors; Tube couplings at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • NPSA National Patient Safety Agency
  • 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.
  • 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.
  • an infusion container for a medication 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.
  • a cartridge for use with an infusion container 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”.
  • the cartridge forms the outlet port of the infusion container.
  • said cartridge and said container are formed into a single unit.
  • an infusion container for a medication 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.
  • a cartridge for use with an infusion container 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.
  • the passageway comprises a bore adapted for receiving a spike.
  • the bore is adapted for receiving a head section of a spike.
  • the passageway comprises a channel for receiving a spike.
  • the channel is adapted for receiving a piercing section of a spike.
  • the passageway is adapted to prevent insertion of a standard ISO closure-piercing spike into the bore, most preferably, the channel.
  • the internal diameter of the channel is substantially less than the cross sectional diameter of a standard ISO closure-piercing spike.
  • a standard ISO closure-piercing spike has a cross sectional diameter of between 5.2 to 5.6mm in accordance with ISO 8536-4:2007.
  • the internal diameter of the channel is substantially less than the internal diameter of the bore.
  • the ratio of the internal diameter of the channel to the internal diameter of the bore is substantially 1 :3, preferably substantially 1 :2.
  • the channel has an internal diameter of substantially 3.5mm and the bore has an internal diameter of substantially 7mm, or preferably substantially 8mm.
  • the length of the channel is approximately equal to the length of the bore.
  • the channel is substantially 6mm in length and, preferably, the bore is substantially 7mm in length.
  • a membrane is located in the passageway.
  • the membrane is located in the channel.
  • the membrane is located at an end of the passageway remote from an opening of the passageway.
  • the membrane is located towards an end of the channel adjacent the bore.
  • the membrane is located substantially less than 5mm from the bore, preferably from an end section of the bore.
  • the membrane is located substantially 4mm from the bore.
  • the membrane comprises a concave face.
  • the membrane is adapted to be punctured by a spike.
  • an infusion container for a medication 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.
  • a cartridge for use with an infusion container 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.
  • 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.
  • At least one ridge is provided on the bore.
  • a plurality of ridges is provided on the bore, preferably arranged circumferentially about the bore.
  • a spike for puncturing an infusion container 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.
  • said blocking means comprise at least one blocking member.
  • at least one blocking member is located on the head section of the spike.
  • a plurality of blocking members is provided.
  • said blocking members are arranged circumferentially about the spike, preferably the head section.
  • said blocking members are adapted to engage with the at least one ridge of the cartridge, preferably in a screw thread fitting.
  • the blocking means comprises a diameter of at least substantially 1 mm.
  • the head section is of a substantially equal length to the bore of the passageway.
  • 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.
  • the head section can be screwed into the passageway by the blocking members locking with the ridges in a screw fixing manner.
  • 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.
  • the provision of a screw thread ensures the spike is correctly aligned in the cartridge.
  • a collar is located on the spike.
  • the collar is adapted to abut against a portion of the cartridge.
  • the collar is adapted to abut against an abutment wall of the cartridge.
  • the collar comprises a taper portion.
  • the taper portion is dimensioned to taper from substantially 12mm diameter to substantially a 10mm diameter, preferably tapering towards the piercing portion.
  • the taper portion tapers outwardly at an angle of substantially 45 degrees.
  • 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.
  • two cut-outs are provided, preferably being spaced diametrically opposite to each other.
  • the spike comprises a gripping part adapted to be gripped by a care-giver during use.
  • the gripping part comprises a series of undulations preferably corresponding to a particular neuraxial NeuraxTM or enteral feed connector.
  • the gripping part is configured to resemble the anatomical shape of ribs or the spine.
  • the gripping part is configured to resemble loops of the gut.
  • the spike comprises nodules being adapted to prevent a fluid tight connection between the spike and an ISO luer hypodermic syringe.
  • the nodules are located at an end of the spike, preferably remote from the head section.
  • said nodules are located on a periphery of said end.
  • said end is adapted to substantially prevent a fluid-tight connection being achieved with an ISO594-compliant luer syringe or other medical device.
  • the collar 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.
  • kits of parts comprising an infusion container and a spike, as hereinbefore described.
  • kits of parts comprising an infusion container, a cartridge, and a spike, as hereinbefore described.
  • the kit further includes a connector tubing, said tubing comprising a spike as hereinbefore described.
  • the tubing is fixed to the spike by suitable fixing means, for example, adhesive.
  • an assembly comprising an infusion container and spike as hereinbefore described.
  • the assembly further comprises a cartridge as hereinbefore described.
  • an infusion container comprising the steps of,
  • 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;
  • the seal is an aluminium foil seal.
  • 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.
  • a method of delivering an infusion medication comprising the steps of, 1 .
  • the spike 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
  • a seal is provided on the container.
  • the seal is adapted to be removed, preferably before step 2.
  • the seal is manufactured from a suitable material for example, aluminium foil.
  • the medication is a neuraxial medication, preferably an epidural anaesthetic or an enteral feed.
  • the container is manufactured from plastics materials, preferably semi- rigid plastics materials.
  • the cartridge and/ or preferably the spike are manufactured from plastics materials, preferably rigid plastic materials.
  • the care-giver is not able to pierce the chamber with the standard ISO spike.
  • provision of the spike of the present invention prevents a care-giver from piercing the chamber of a standard ISO infusion container .
  • a kit comprising an infusion container having the adapted passageway and the spike comprising the head section.
  • the passageway is adapted to only receive said spike.
  • the chamber of the infusion container can only be pierced with the described spike.
  • the risk of a care-giver administering the wrong medication is reduced.
  • 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;
  • 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.
  • 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
  • FIGS. 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.
  • 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.
  • FIGs 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.
  • the configuration of the gripping part 52 mimics the anatomical shape of the ribs and spine.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the container 2 is 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.
  • the cartridge 16 may be fitted to the container 2 in a push fit manner.
  • 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 .
  • the container must be supported with one hand, whilst the user attempts to pierce the outlet port with the spike in the other hand.
  • 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.
  • Figures 17 to 25 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.
  • FIGS 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.
  • the spike 146 comprises a collar 158 having a tapered body portion 180 which is configured to taper by 45° (shown as ⁇ in Figure 18a) from substantially 12mm in diameter to substantially 10mm diameter, towards the piercing section 162.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne une cartouche destinée à être utilisée avec un récipient pour perfusion. La cartouche comprend un corps ayant une première extrémité et une deuxième extrémité et un passage entre celles-ci. Le passage est adapté pour empêcher qu’un perforateur de fermeture tel que spécifié dans les normes ISO n’accède à la chambre dudit récipient.
PCT/GB2009/051179 2008-09-12 2009-09-11 Dispositif médical Ceased WO2010029371A2 (fr)

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GB0816704A GB0816704D0 (en) 2008-09-12 2008-09-12 Medical device
GB0816704.1 2008-09-12

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WO2010029371A2 true WO2010029371A2 (fr) 2010-03-18
WO2010029371A3 WO2010029371A3 (fr) 2010-05-06

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FR2960155A1 (fr) * 2010-05-21 2011-11-25 Technoflex Connecteur pour un circuit de liquide
WO2016018552A1 (fr) * 2014-07-31 2016-02-04 Smiths Medical Asd, Inc. Système à perfusion de médicament et ensemble pompe destiné à être utilisé en son sein
EP3357527A1 (fr) * 2017-02-03 2018-08-08 B. Braun Melsungen AG Élément piqueur pour un système de perfusion médicale, chambre de goutte-à-goutte et système de perfusion
EP3650059A1 (fr) * 2012-11-30 2020-05-13 Becton Dickinson and Company Limited Adaptateur de perfusion pour ensemble de transfert de médicament

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US4650475A (en) * 1985-07-18 1987-03-17 Carol Smith Method and apparatus for the injection of pharmaceuticals
US5137527A (en) * 1990-09-20 1992-08-11 Clintec Nutrition Co. Enteral-specific spike/bag port system
FR2731621B1 (fr) * 1995-03-13 1997-09-05 Clintec Nutrition Co Dispositif de perforation et ensemble de raccordement pour systeme d'alimentation par voie enterale et procede de raccordement
US5971972A (en) * 1996-06-27 1999-10-26 Rosenbaum; Jay D. Failsafe intravenous transfusion system for typed blood
GB9907014D0 (en) * 1999-03-27 1999-05-19 Smithkline Beecham Biolog Novel device
WO2006071781A2 (fr) * 2004-12-23 2006-07-06 Hospira, Inc. Systeme de fermeture d'orifices pour recipient de fluide intraveineux
US20070060898A1 (en) * 2005-09-07 2007-03-15 Shaughnessy Michael C Enteral medical treatment assembly having a safeguard against erroneous connection with an intravascular treatment system

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2960155A1 (fr) * 2010-05-21 2011-11-25 Technoflex Connecteur pour un circuit de liquide
EP2388042A3 (fr) * 2010-05-21 2013-08-14 Technoflex Connecteur pour un circuit de liquide
EP3650059A1 (fr) * 2012-11-30 2020-05-13 Becton Dickinson and Company Limited Adaptateur de perfusion pour ensemble de transfert de médicament
WO2016018552A1 (fr) * 2014-07-31 2016-02-04 Smiths Medical Asd, Inc. Système à perfusion de médicament et ensemble pompe destiné à être utilisé en son sein
EP3174574A4 (fr) * 2014-07-31 2018-02-28 Smiths Medical ASD, Inc. Système à perfusion de médicament et ensemble pompe destiné à être utilisé en son sein
EP3357527A1 (fr) * 2017-02-03 2018-08-08 B. Braun Melsungen AG Élément piqueur pour un système de perfusion médicale, chambre de goutte-à-goutte et système de perfusion
DE102017201755A1 (de) 2017-02-03 2018-08-09 B. Braun Melsungen Ag Einstechteil für ein medizinisches Infusionssystem, Tropfkammer und Infusionssystem
US10953152B2 (en) 2017-02-03 2021-03-23 B. Braun Melsungen Ag Piercing part for a medical infusion system, drip chamber and infusion system

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GB0816704D0 (en) 2008-10-22

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