WO2012000554A1 - Adaptateur pour système d'injection médicale - Google Patents

Adaptateur pour système d'injection médicale Download PDF

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Publication number
WO2012000554A1
WO2012000554A1 PCT/EP2010/059375 EP2010059375W WO2012000554A1 WO 2012000554 A1 WO2012000554 A1 WO 2012000554A1 EP 2010059375 W EP2010059375 W EP 2010059375W WO 2012000554 A1 WO2012000554 A1 WO 2012000554A1
Authority
WO
WIPO (PCT)
Prior art keywords
pen
adapter
injection
needle
connector
Prior art date
Application number
PCT/EP2010/059375
Other languages
English (en)
Inventor
Fritz Kirchhofer
Original Assignee
Tecpharma Licensing Ag
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 Tecpharma Licensing Ag filed Critical Tecpharma Licensing Ag
Priority to PCT/EP2010/059375 priority Critical patent/WO2012000554A1/fr
Publication of WO2012000554A1 publication Critical patent/WO2012000554A1/fr

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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • 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
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase
    • 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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/2474—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with movable piercing means, e.g. ampoule remains fixed or steady
    • 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
    • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors
    • 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
    • A61M39/12—Tube connectors; Tube couplings for joining a flexible tube to a rigid attachment
    • 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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • A61M5/345—Adaptors positioned between needle hub and syringe nozzle

Definitions

  • the present invention relates to an adapter for a medical injection of infusion system as well as a medical injection system or a medical infusion system.
  • injection pens are widely known for injecting a liquid medical product into subcutaneous tissue. Compared to simple syringes, these pens can have several advantages.
  • One option is an automated injection of the liquid medical product. This means that the user activates a trigger of the injection pen and the medical product is then automatically discharged without the need to push a piston rod during the whole injection.
  • Another option is setting the product dosage of the liquid medical product which is discharged during a single injection. Therefore, the application of an injection pen is easy and safe.
  • the present invention relates to an adapter for a medical injection or infusion system.
  • the adapter comprises a Luer taper for connecting the adapter to an injection or infusion device, such as a needle, a cannula or an infusion set.
  • the adapter further comprises a pen connector for mechanically connecting the adapter to an injection pen. Using the pen connector, the adapter can be attached to the injection pen, either permanently or detachably.
  • the adapter also comprises a needle hub fixedly holding a pen piercing needle protruding from the needle hub, the pen piercing needle piercing an antiseptic seal of the pen upon attachment of the adapter to the pen.
  • the pen connector and the needle hub have an invariable relative position between each other, and a fluid connection is established between the pen piercing needle and the Luer taper.
  • the pen can be connected to any injection or infusion device which has a Luer connector. This means that the pen cannot only be used with a subcutaneous needle, but also with longer needles such as an intramuscular needle or an intravenous needle.
  • the infusion pen also just referred to as "pen” can also be used with devices already attached to a body, for example any kind of catheter.
  • the needle hub and the pen piercing needle are fixedly connected such that a relative movement between the pen piercing needle and the needle hub is impossible.
  • the pen piercing needle protrudes from the needle hub, in particular on the same side on which the pen connector is provided.
  • the pen piercing needle does not protrude from the opposite end of the adapter. This means than the other end of the pen piercing needle ends in the adapter, for example in the needle hub.
  • the pen piercing needle is designed and placed in the needle hub such that it pierces an antiseptic seal of the pen when the adapter is attached to the pen.
  • the antiseptic seal is a plug or a disc placed within or on an opening or outlet of the pen to retain the liquid medical product within the pen.
  • the sealed opening can be at the pen itself or at a container holding the liquid medical product within the pen.
  • the seal can be made of a liquid-tight material such as rubber or silicon. Typically, this material is treated to have antiseptic properties.
  • a pen or container within a pen having a chamber for the liquid medical product and a second chamber for an antiseptic liquid, wherein the tip of the pen piercing needle, upon attachment of the adapter to the pen, first traverses the second chamber before it pierces into the chamber with the liquid medical product.
  • the pen connector and the needle hub have an invariable relative position between each other, which means that a relative movement between those two components is impossible.
  • the effect of this invariable relative position is that the pen piercing needle pierces the antiseptic seal directly upon attachment of the adapter to the pen without the need to perform any further action.
  • the needle hub and the pen connector are formed as a single unitary piece.
  • the pen connector and the needle hub are formed in the same moulding process step.
  • the needle hub and the pen connector are separate but immovably affixed pieces. This means that the needle hub and the pen connector are separate components, for example manufactured in separate production steps, but connected to each other such that a relative movement between the components is impossible.
  • the Luer taper can be either a Luer slip or a Luer lock (also referred to as Luer lok).
  • the male component is a Luer cone with a defined gradient angle, while the female component is a corresponding, conical recess.
  • the male and female components are held together by the frictional forces between the conical surfaces.
  • the female component or female fitting
  • the Luer taper and the needle hub have an invariable relative position between each other.
  • they are formed as single unitary piece or of separate but immovably affixed pieces.
  • the adapter then is a small device which is easy to manufacture.
  • the Luer taper and the needle hub are separate pieces connected by a flexible tube, or any other flexible fluid conduit, to provide the fluid connection. This means that the relative position between the Luer taper and the needle is variable. This is particularly advantageous if the Luer taper of the adapter is connected to a long needle or an infusion set. In this case, movement of the pen relative to the body to which the needle or infusion set is applied does not result in a movement of the needle or infusion set relative to the body, which would cause pain and irritate the tissue.
  • the male fitting can be on the adapter or on the injection or infusion device.
  • a female fitting on the injection or infusion device, such that the adapter has a male Luer fitting.
  • the pen connector is a sleeve, in particular a coaxial sleeve, around the pen piercing needle. The pen connector engages a counterpart on the pen or a container, such as an ampoule or a carpoule, held by the pen. If the sleeve and the pen piercing needle are coaxial, the pen piercing needle is automatically guided through the antiseptic seal into the medical product.
  • the pen connector comprises a thread to engage a counter-thread on the pen.
  • the adapter is screwed onto the injection pen. This provides a secure connection.
  • the pen connector comprises at least one latch to engage the pen to establish a snap-fit connection.
  • the adapter is easily clicked onto the injection pen. The latch engages a counterpart on the pen (or the container), such as a thread, a ring, a collar or a protrusion.
  • the present invention further relates to a medical injection system comprising an injection pen and an adapter as explained above.
  • the combination of the injection pen and the adapter can be connected to any injection or infusion device comprising a Luer fitting, such that the applicability of the injection pen is not limited to subcutaneous injections.
  • the pen comprises a container containing a medical product to be injected, the container comprising an outlet sealed by an antiseptic seal and a piston being driven by a piston rod. If the medical injection system is assembled, that is if the adapter is attached to the pen, the pen piercing needle of the adapter pierces the antiseptic seal such that the pen piercing needle pricks into the medical product. If the piston rod drives the piston towards the outlet of the container, the medical product is pushed through the adapter and out of the Luer taper.
  • the pen further comprises a driving mechanism for driving the piston rod.
  • the driving mechanism is a spring exerting a force on the piston rod.
  • other driving mechanisms such as pneumatic mechanisms, can be implemented. With the driving mechanism, it is sufficient to operate a trigger once to initiate the disbursement of the medical product. Once the trigger is activated, the driving mechanism automatically exerts a force on the piston rod without the need to continuously push the piston rod as in conventional syringes.
  • the trigger is a component which engages a driving member of the driving mechanism to act against the force of, for example, a spring until the trigger is activated and the connection between the trigger and the driving member is released.
  • the pen comprises a dosing mechanism for setting a product dosage by adjusting the travel length which the piston can move during administration of the product.
  • a dosing mechanism for setting a product dosage by adjusting the travel length which the piston can move during administration of the product.
  • the medical injection system further comprises an injection device, such as a needle, a cannula or an injection set which can be placed on the skin.
  • an injection device such as a needle, a cannula or an injection set which can be placed on the skin.
  • the injection device is suitable for intramuscular or intravenous injection.
  • the container provides an outer or inner thread or a protrusion to be engaged by the pen connector of the adapter.
  • This embodiment is particularly advantageous if the pen forms a casing for the container and the outlet of the container protrudes from the casing, in particular at a distal end of the casing.
  • the mechanical connection is then established between the adapter and the container.
  • the outlet of the container is within a neck of the container, while a shoulder of the container struts against a suitable counterpart of the pen casing.
  • Figure 1 a first embodiment of the adapter
  • Figure 2 the adapter of figure 1 and an injection pen
  • Figure 3 the adapter of figure 1 attached to the injection pen
  • Figure 4 a side view of the injection pen with the attached adapter
  • Figure 5 a sectional view of figure 4,
  • Figure 6 a variation of the adapter of figure 1 with a snap-fit connector
  • Figure 7 the adapter of figure 6 attached to an injection pen
  • Figure 8 an adapter according to a second embodiment
  • Figure 9 the adapter of figure 6 and an injection pen
  • Figure 10 the adapter of figure 6 attached to the pen
  • Figure 1 1 a side view of the pen with the adapter
  • Figure 13 the adapter of figure 6 with two caps
  • Figure 14 the adapter of figure 6 in a blister packing
  • Figure 15 an adapter of a third embodiment.
  • FIG. 1 shows a sectional view of an adapter 101 according to a first embodiment of the invention.
  • the adapter 101 comprises a Luer taper 102, a pen connector 103 and a needle hub 104.
  • the Luer taper 102, the pen connector 103 and the needle hub 104 are, in the present example, made of a single unitary piece, for example manufactured by injection moulding.
  • the pen connector 103 has an inner thread 119 to attach the adapter 101 to an injection pen having an appropriate outer thread.
  • the needle hub 104 holds a pen piercing needle 105 which protrudes from the needle hub 104 into the volume confined by the pen connector 103, but which does not protrude from the opposite end of the needle hub 104.
  • a recess 106 is provided in the prolongation of the pen piercing needle 105 to provide a fluid connection between the tip of the pen piercing needle 105 and the end of the Luer taper 102.
  • the adapter 101 further comprises an optional cylindrical sleeve 107 around parts of the Luer taper 102 for purposes of protection or assuring a safe connection between the adapter 101 and an injection or infusion device (not shown). With an optional inner thread 125 in the sleeve 107, the injection or infusion device can be locked to the adapter 101.
  • the Luer taper 102 is a conical member with a small inclination to a central longitudinal axis, for example an inclination of 3%.
  • the Luer taper 102 is to engage a counteipart at the injection or infusion device to provide a mechanical and fluid connection between the injection or infusion device and the adapter 101, and in the end between the injection or infusion device and the injection pen.
  • the adapter 101 is basically rotationally symmetric. Exceptions are the inner thread of the pen connector 103, the optionally tapered tip of the pen piercing needle 105 and the optional locking mechanism of the Luer connection.
  • the axis of symmetry is the centre axis of the conical Luer taper 102, of the pen piercing needle 105 and of the pen connector 103 with its inner thread 119.
  • a further asymmetry may be introduced by additional components of the adapter 101 which are not part of the present invention.
  • FIG. 2 shows a sectional view of the adapter 101 prior to attachment to an injection pen 110.
  • the adapter 101 is enclosed in a cap 108 having a cap seal 109.
  • the injection pen 110 comprises a housing 11 1 which holds a container 112 with a fluid medical product 1 14.
  • the container in the present embodiment and the following embodiments has a basically cylindrical wall with a step towards a smaller diameter towards an outlet, thus forming a shoulder.
  • the outlet of the container 112 is sealed by an antiseptic seal 115.
  • the seal is an element, such as a disc, externally placed on the container and held to the container by holder, such as a clamp 126.
  • the antiseptic seal could be a plug within a neck of the container 1 12. .
  • the outlet of the container 1 12 is accessible through an opening in the casing 111.
  • the pen 1 10 and the adapter 101 constitute a medical injection system.
  • This medical injection system can further comprise an injection or infusion device, such as a needle, a cannula or an infusion set, in particular if the adapter 101 is attached to the pen 110.
  • an injection or infusion device such as a needle, a cannula or an infusion set, in particular if the adapter 101 is attached to the pen 110.
  • the cap seal 109 is removed and the adapter 101 is screwed onto the pen 1 10 by the inner thread of the pen connector 103 engaging an outer thread 120 of the casing 11 1 of the pen 1 10.
  • the neck of the container 1 12 protrudes from the casing 111 and provides an outer thread for engagement with the thread of the pen connector 103.
  • FIG 3 shows the adapter 101 attached to the pen 110 with the cap 108 removed.
  • the pen piercing needle 105 has pierced the antiseptic seal 1 15, thereby disinfecting the tip of the pen piercing needle before it protrudes into the medical product 114.
  • the adapter 101 attached to the pen 1 10 the pen can now be used with any injection or infusion device having a Luer connector.
  • Figure 4 shows a side view of the adapter 101 connected to the pen 110.
  • the pen 110 comprises a transparent window 116 through which the medical product 114 in the container 112 can be seen. Through the window 116, a user of the pen can see how much product is left in the pen.
  • Figure 5 shows a sectional view of the pen 110 with the attached adapter 101.
  • a piston 1 17 in the container 112 is driven by a piston rod 118 to push the medical product 1 14 through the adapter 101 into an injection or infusion device.
  • the piston rod 1 18 is driven by a drive mechanism (not shown) which is pre-charged such that the activation of the trigger (not shown) activates the drive mechanism.
  • the medical product is then automatically administered without the need to continuously exert a manual force on the piston rod.
  • the drive mechanism comprises a pre-compressed spring directly or indirectly acting upon a piston rod 1 18. Activation of the trigger either couples the spring to the piston rod or releases a blocking of the piston rod.
  • the injection pen 1 10 further comprises a dosing mechanism for setting a product dosage, that is the amount of the medical product 114 administered during an injection.
  • the dosing mechanism adjusts the travel length which the piston 117 can move in the container 112 during administration of the medical product.
  • a dosing mechanism comprising a blocking member which limits the forward movement of the piston 1 17 (or the piston rod 1 18) after the predetermined travel length.
  • Another implementation is particularly useful for a pen which is manually charged before injection, for example by compressing a driving spring.
  • an intermediate member which acts upon the piston rod during injection, is moved relative to the piston rod during the charging process until the desired travel length is reached. Then, the intermediate member is decoupled from the charging process, while the drive mechanism is further charged.
  • the intermediate member, and therefore the piston can move only for the length it was displaced in the charging process before decoupling took place.
  • Figure 6 shows a variation of the adapter 101 in which the thread 119 is omitted and replaced by a protrusion 128, such as a nose or a latch.
  • This protrusion optionally has a slanted side facing towards the opening of the pen connector 103 and a non- slanting side facing the needle hub 104.
  • the protrusion preferably is resiliently supported such that it can be radially displaced while the adapter is attached to the pen.
  • FIG 6 which is in analogy to figure 2, the variation of the adapter 101 is shown before it is attached to the pen 1 10.
  • the housing 111 of the pen 110 optionally comprises a recess 129, which preferably is ring-shaped, instead of the thread 120.
  • the slanted side of the protrusion 128 reaches the housing 11 1 and is moved radially outwards such the protrusion 129 can slide over the housing 1 11.
  • the protrusion returns radially inwards to its original position relative to the pen connector 3 and engages the recess 129 or the thread 120 to provide a snap- fit connection between the adapter and the pen.
  • FIG 8 shows an adapter 201 according to a second embodiment of the present invention.
  • the adapter 201 comprises a conical Luer taper 202, a pen connector 203 and a needle hub 204.
  • the Luer taper 202, the pen connector 203 and the needle hub 204 are formed as a single unitary piece, for example by injection moulding.
  • the needle hub 204 fixedly holds a pen piercing needle 205.
  • the needle hub 204 has an optional, basically cylindrical extension surrounding parts of the pen piercing needle 205. At the end, the cylindrical extension has an optional conical recess.
  • the cylindrical extension extends from the basis of the needle hub 204 for the same distance as the pen connector 203, but could also be shorter.
  • the pen piercing needle 205 extends from the basis of the needle hub 204 for a distance larger than the length of the pen connector 203. This means that the tip of the pen piercing needle 205 protrudes from the pen connector 203.
  • a recess 206 in the Luer taper 202 is provided in the prolongation of the pen piercing needle 205. Through this recess 206, a fluid connection between the tip of the pen piercing needle 205 and the end of the Luer taper 202 is provided.
  • the pen piercing needle 205 has a length such that it does not protrude from the opposite side of the adapter 201, but ends in the recess 206.
  • the pen connector 203 has an outer thread 219 to engage a counter-thread of an injection pen. Instead of an outer thread, a protrusion as in the variation of the first embodiment can be provided.
  • the adapter 201 further comprises an optional, cylindrical sleeve 207 surrounding parts of the Luer taper 202 like in the first embodiment.
  • the sleeve 207 can have a protective function for the Luer taper 202 or provide a locking mechanism, such as a thread 225, a latch or a protrusion, to securely hold a Luer connector of an injection or infusion device attached to the adapter 201.
  • Figure 9 shows the adapter 201, provided with a cap 208, before it is attached to an injection pen 210.
  • the injection pen 210 has a housing 211 holding a container 212 filled with a liquid medical product 214.
  • the container 212 has an outlet closed by an antiseptic seal 215.
  • the housing 211 comprises an inner thread 220 to engage with the outer thread 219 of the adapter 201 and an opening through which the pen piercing needle 205 of the adapter 201 can reach into the container 212.
  • the adapter 201 is shown attached to the pen 210.
  • the adapter 210 is screwed into the housing 211 such that the thread 219 of the pen connector 203 fully engages the thread 220 in the housing 211.
  • the pen piercing needle 205 has pierced through the antiseptic seal 215, thereby being disinfected.
  • the tip of the pen piercing needle 205 now reaches into the container 212 such that the medical product 214 can flow through the pen piercing needle 205 and the recess 206 in the Luer taper 202.
  • the seal 215 is shown as a plug inside the outlet at a neck of the container 212.
  • the antiseptic seal could be an element, such as a disc, placed onto the outlet from the outside and held to the container by a holding element such as a clamp.
  • the inner thread for engaging the outer thread 219 of the pen connector 203 could be placed inside the container 212 instead of at the housing 211.
  • the mechanical connection between the adapter 211 and the pen 210 could be a snap-fit connection constituted by a latch and a protrusion instead of a screw connection.
  • Figure 1 1 shows a side view of the pen 210 with the attached adapter 201.
  • the pen 210 comprises a transparent window 216 through which the medical product 214 in the container can be seen.
  • Figure 12 is a sectional view of the pen 210 with the attached adapter 201.
  • a piston 217 within the container 212 is driven by a piston rod 218 to push the medical product 214 through the pen piercing needle 205 and the rest of the adapter 201.
  • the piston rod 218 can be acted upon as described with reference to the first embodiment, and a dosing mechanism can be provided as explained in the first embodiment.
  • Figure 13 shows the adapter 201 with the cap 208 covering parts of the Luer taper 202 and of the cylindrical sleeve 207.
  • the pen connector 203 and the pen piercing needle 205 are protected by a protective cap 221.
  • the protective cap 221 comprises a nose 227, or alternatively an inner thread, engaging the outer thread 219 of the adapter 201 to prevent the protective cap 221 from being unintentionally removed from the adapter 201.
  • the protective 221 is removed before the adapter 201 is attached to the pen 210.
  • the cap 208 resides on the adapter 201 during assembly. This has the advantage of enabling an improved grip of the adapter and of not contaminating the Luer taper 202.
  • One or both of the caps 208 and 221 could also be provided for the adapter 101 of the first embodiment or the adapter 301 of the third embodiment as explained below.
  • Figure 14 shows the adapter 201 of the second embodiment within a blister packing consisting of a body 222 and a seal 223.
  • the seal 223 is removed and the adapter 201 is attached to the pen 210 while the adapter 201 is still contained within the package body 222.
  • the package body 222 is made of an elastic material such that it can widen during assembly.
  • the pen 210 can be used with injection or infusion devices other than subcutaneous needles.
  • the pen 210 and the adapter 201 constitute a medical injection system.
  • This medical injection system can further comprise an injection or infusion device, such as a needle, a cannula or an infusion set.
  • FIG. 15 shows an adapter 301 according to a third embodiment of the present invention.
  • the adapter comprises a needle hub 304 and a pen connector 303.
  • the needle hub 304 and the pen connector 303 are formed as a single unitary piece, for example by injection moulding.
  • the needle hub 304 fixedly holds a pen piercing needle 305 protruding from the needle hub 304 into a volume encircled by the pen connector 303.
  • the needle hub 304, the pen connector 303 and the pen piercing needle 305 are rotationally symmetric, with the exception of the tapered tip of the pen piercing needle and an inner thread 319 of the pen connector 303.
  • the pen connector 303 and the pen piercing needle 305 are preferably arranged coaxially.
  • the needle hub 304 is connected to a Luer taper 302 by a flexible tube 324.
  • the flexible tube 324 provides a fluid connection between the tip of the pen piercing needle 305 and the narrow end of the Luer taper 302. Parts of the Luer taper 302 are surrounded by a cylindrical extension 307 having an inner thread 325.
  • the adapter 301 of the third embodiment is similar to the adapter 101 of the first embodiment with the only difference that the needle hub 304 and the Luer taper 302 are not formed as a single unitary piece, but as separate pieces connected by the flexible tube 324. A detailed description of the adapter 301 and how the adapter 301 is attached to an injection pen is omitted.
  • the Luer taper 302 and/or the pen piercing needle 305 can be covered by protective caps or a packing as shown in Figures 13 and 14 with reference to the second embodiment.
  • the Luer taper 302 is a rotationally symmetric Luer cone with a through-hole accommodating a first end of the flexible tube 324.
  • the flexible tube 324 axially extends through the whole Luer taper 302.
  • the flexible tube 324 could only extend into a part of the Luer taper 302 and end in a recess connecting the flexible tube 324 with the narrow end of the Luer taper 302.
  • the through-hole is coaxial with the axis of symmetry of the Luer taper 302.
  • the second end of the flexible tube 324 ends in the needle hub 304.
  • the end of the pen piercing needle 305 ends within the end of the flexible tube 324.
  • the ends of the pen piercing needle 305 and the flexible tube 324 could be adjoining or could be separated by a liquid-tight volume.
  • the recess within the needle hub which accommodates the second end of flexible tube 324 is coaxial with the pen piercing needle 305 and the centre of the pen connector 303.
  • segmented adapter 301 that is an adapter allowing relative movement between the Luer taper 302 and the pen connector 303
  • long needles such as intravenous or intramuscular needles can be used with an injection pen without the danger of moving the needle within the tissue or artery when the pen is operated.
  • the flexible tube 324 establishes the fluid connection between the pen piercing needle 305, and therefore the liquid medical product within a container of the injection pen, and the Luer taper 302, and therefore the injection or infusion device attached to the adapter.
  • a pen connector such as the variation of the first embodiment with a snap-fit connector or the pen connector 203 of the adapter 201 of the second embodiment can be used.

Abstract

La présente invention a pour objet un adaptateur (101, 201, 301) pour système d'injection ou de perfusion médicale, comportant a) une pointe de Luer en biseau (102, 202, 302) pour connecter l'adaptateur à un dispositif d'injection ou de perfusion, tel qu'une aiguille, une canule ou un ensemble de perfusion, b) un connecteur à pointe (103, 203, 303) pour connecter mécaniquement l'adaptateur à une pointe d'injection, et c) un raccord d'aiguille (104, 204, 304) maintenant fixement une aiguille de perçage à pointe (105, 205, 305) faisant saillie sur le raccord d'aiguille, l'aiguille de perçage à pointe perçant un opercule antiseptique (115, 215) de la pointe lors de la fixation de l'adaptateur sur la pointe, d) le connecteur à pointe (103, 203, 303) et le raccord d'aiguille (104, 204, 304) ayant l'un et l'autre une position relative invariable, et une connexion fluidique étant établie entre l'aiguille de perçage à pointe et la pointe de Luer en biseau.
PCT/EP2010/059375 2010-07-01 2010-07-01 Adaptateur pour système d'injection médicale WO2012000554A1 (fr)

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PCT/EP2010/059375 WO2012000554A1 (fr) 2010-07-01 2010-07-01 Adaptateur pour système d'injection médicale

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150073352A1 (en) * 2013-09-09 2015-03-12 Covidien Lp Single-use device for injection of cartridge drugs
WO2017037144A3 (fr) * 2015-06-08 2017-05-11 Peripal Ag Unité amovible pour un dispositif de liaison mécanique à usage médical, en particulier pour la dialyse péritonéale
RU2641314C1 (ru) * 2016-11-08 2018-01-17 федеральное государственное бюджетное образовательное учреждение высшего образования "Национальный исследовательский университет "МЭИ" (ФГБОУ ВО "НИУ "МЭИ") Устройство генерирования напряжения переменного тока постоянной частоты при переменной частоте вращения привода генератора
JP2018099515A (ja) * 2012-12-26 2018-06-28 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ ペン針アセンブリ
JP2019507626A (ja) * 2016-02-23 2019-03-22 ブレヴェッティ・アンジェラ・エッセ・エッレ・エッレ 予め充填された容器、それぞれの充填された容器ならびにそれらの実現方法のための開放および供給システム
CN110404143A (zh) * 2018-04-30 2019-11-05 贝克顿·迪金森公司 笔式针组件
US10603439B2 (en) 2013-09-09 2020-03-31 Kpr U.S., Llc Sealed self-activating injection device for delivery of medicine from a prefilled cartridge or vial
JP7019002B2 (ja) 2015-06-01 2022-02-14 ベクトン・ディキンソン・アンド・カンパニー 短縮された非患者側端部を含む使い捨てのペン注射針、および再使用可能なペンインタフェース

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WO2010042814A2 (fr) * 2008-10-10 2010-04-15 Deka Products Limited Partnership Ensemble pour pompe à perfusion

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US1746009A (en) * 1927-05-12 1930-02-04 Nat Drug Co Adapter needle
US3974832A (en) * 1975-01-07 1976-08-17 Vca Corporation Interchangeable hypodermic needle assemblage
US3989044A (en) * 1975-08-11 1976-11-02 Warner-Lambert Company Syringe
WO2009141003A1 (fr) 2008-05-20 2009-11-26 Tecpharma Licensing Ag Dispositif d'administration d'un produit injectable comportant un compteur de déversements
WO2010042814A2 (fr) * 2008-10-10 2010-04-15 Deka Products Limited Partnership Ensemble pour pompe à perfusion

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11246996B2 (en) 2012-12-26 2022-02-15 Becton, Dickinson And Company Pen needle assembly
JP2018099515A (ja) * 2012-12-26 2018-06-28 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ ペン針アセンブリ
US10561793B2 (en) 2013-09-09 2020-02-18 Kpr U.S., Llc Single-use device for injection of cartridge drugs
WO2015035378A1 (fr) * 2013-09-09 2015-03-12 Covidien Lp Dispositif à usage unique pour l'injection de médicaments en cartouche
CN105530964A (zh) * 2013-09-09 2016-04-27 柯惠有限合伙公司 用于注射药筒药物的单次使用装置
US20150073352A1 (en) * 2013-09-09 2015-03-12 Covidien Lp Single-use device for injection of cartridge drugs
US10603439B2 (en) 2013-09-09 2020-03-31 Kpr U.S., Llc Sealed self-activating injection device for delivery of medicine from a prefilled cartridge or vial
JP7019002B2 (ja) 2015-06-01 2022-02-14 ベクトン・ディキンソン・アンド・カンパニー 短縮された非患者側端部を含む使い捨てのペン注射針、および再使用可能なペンインタフェース
WO2017037144A3 (fr) * 2015-06-08 2017-05-11 Peripal Ag Unité amovible pour un dispositif de liaison mécanique à usage médical, en particulier pour la dialyse péritonéale
US11351350B2 (en) 2015-06-08 2022-06-07 Peripal Ag Apparatus for connecting a tube connector to a fitting and to fasten or unfasten closure caps
JP7001607B2 (ja) 2016-02-23 2022-01-19 ブレヴェッティ・アンジェラ・エッセ・エッレ・エッレ 予め充填された容器、それぞれの充填された容器ならびにそれらの実現方法のための開放および供給システム
JP2019507626A (ja) * 2016-02-23 2019-03-22 ブレヴェッティ・アンジェラ・エッセ・エッレ・エッレ 予め充填された容器、それぞれの充填された容器ならびにそれらの実現方法のための開放および供給システム
RU2641314C1 (ru) * 2016-11-08 2018-01-17 федеральное государственное бюджетное образовательное учреждение высшего образования "Национальный исследовательский университет "МЭИ" (ФГБОУ ВО "НИУ "МЭИ") Устройство генерирования напряжения переменного тока постоянной частоты при переменной частоте вращения привода генератора
CN110404143A (zh) * 2018-04-30 2019-11-05 贝克顿·迪金森公司 笔式针组件

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