(19)
(11)EP 3 378 507 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
10.06.2020 Bulletin 2020/24

(21)Application number: 18161793.7

(22)Date of filing:  10.10.2014
(51)International Patent Classification (IPC): 
A61M 5/00(2006.01)
A61M 5/24(2006.01)
A61M 5/32(2006.01)

(54)

INJECTION DEVICE WITH A NEEDLE CANNULA

INJEKTIONSVORRICHTUNG MIT EINER NADELKANÜLE

DISPOSITIF D'INJECTION COMPRENANT UNE CANULE D'AIGUILLE


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 31.10.2013 EP 13191052
04.11.2013 US 201361899413 P

(43)Date of publication of application:
26.09.2018 Bulletin 2018/39

(62)Application number of the earlier application in accordance with Art. 76 EPC:
14781911.4 / 3062836

(73)Proprietor: Novo Nordisk A/S
2880 Bagsværd (DK)

(72)Inventors:
  • BENGTSSON, Henrik
    2880 Bagsværd (DK)
  • EILERTSEN, Lars
    2880 Bagsværd (DK)
  • JENSEN, Casper Bo
    2880 Bagsværd (DK)
  • KIRK, Frederik Kaae
    2880 Bagsværd (DK)


(56)References cited: : 
WO-A1-96/11026
US-A- 5 894 015
US-A- 4 416 663
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    THE TECHNICAL FIELD OF THE INVENTION:



    [0001] The invention relates to an injection device such as an injection pen preferably in combination with a needle cannula. The invention especially relates to such injection device wherein the same needle cannula is used for multiple successive injections and automatically cleaned between injections. Further, the invention relates to a method of preparing such injection device.

    DESCRIPTION OF RELATED ART:



    [0002] Shielded injection needle assemblies are known from e.g. WO 2008/077706 and US 5,292,314. Further, a syringe having a manually operational telescopic shield is disclosed in EP 252,644 (figure 11-13). When the user needs to purge this syringe, a variable quantum of the drug contained in the syringe is ejected into a purging chamber forming the telescopic shield. Prior to purging the syringe, the user must manually manipulate the telescopic shield into the correct position. When purging the syringe, the user determines the volume ejected into the chamber of the shield.

    [0003] Injection devices having an injection needle for repetitive use is disclosed in US 3,354,881 and US 4,416,663. These injection devices for repetitive use have a telescopic movable shield which covers the tip of needle cannula between injections. The telescopic shield is pushed to its initial covering position by resilient means, which in US 4,416,663 is identified as being a spring. Further, the telescopic shield is provided with a reservoir containing a cleaning agent for cleaning the tip of the needle cannula between injections. The cleaning agent is in both US 3,354,881 and US 4,416,663 referred to as a sterilizing fluid.

    [0004] However, as the injection needle is maintained attached to the injection device between injections, the sterilizing fluid can flow through the lumen of the needle cannula and into the interior of the cartridge and thus be mixed with the pharmaceutical liquid drug contained in the cartridge and thus contaminate the drug. The result being that next time an injection is performed, the sterilizing fluid that has flown into the cartridge is injected into the body of the user together with the pharmaceutical liquid drug of the cartridge.

    DESCRIPTION OF THE INVENTION:



    [0005] It is an object of the present invention to provide an injection device with a needle cannula for repetitive use and wherein the liquid pharmaceutical drug contained in the cartridge is not contaminated by the cleaning liquid contained in the reservoir of the telescopic shield and which operates without the use of cumbersome physical valves or the like.

    [0006] The invention is defined in the claims. Accordingly, in a first aspect the present invention relates to an injection device comprising the following details:
    • a housing holding a cartridge having an interior chamber containing the pharmaceutical liquid drug to be injected. The pharmaceutical liquid drug contains a preservative maintaining the liquid drug biostatic i.e. prevents the growth or multiplication of an organism especially a microorganism in the liquid drug.
    • a needle cannula usable for multiple injections having a front part and a back part. The back part is adapted to be in liquid communication with the interior chamber of the cartridge and the front part has a sharp tip adapted to penetrate the skin of a user, and
      • a telescopic needle covering shield which distally is provided with a reservoir holding a predetermined volume of a liquid for cleaning at least the tip of the needle cannula between subsequent injections. The telescopic needle shield is urged in a distal direction by a resilient member, preferably a compression spring operational located between the telescopic needle shield and the housing


    [0007] The telescopic movable needle covering shield is axially and telescopic movable in relation to the needle cannula between a first position and a second position. The first and the second position being defined as;
    • a first position in which the tip of the front part of the needle cannula is maintained inside the reservoir, and
    • a second position in which the tip of the front part of the needle cannula (10) is located outside the reservoir and distally to the reservoir.


    [0008] In order to prevent contamination of the pharmaceutical liquid drug contained inside the cartridge, the liquid in the cleaning reservoir of the shield contains the same preservatives as present in the pharmaceutical preservative containing liquid drug inside the cartridge. In this way a backflow of liquid through the lumen of the needle cannula from the reservoir of the telescopic shield and back into the chamber of the cartridge will not contaminate the liquid drug inside the cartridge as the same preservatives are present in both liquids. The backflow will thus only very marginally raise the concentration of preservatives inside the chamber of the cartridge.

    [0009] The volume of liquid in the reservoir of the telescopic shield is predetermined by the manufacture of the injection device and is preferably predetermined such that the tip of the needle cannula is fully submerged in the liquid between subsequent injections. This implies that the level to which the reservoir of the shield is filled must be sufficient to maintain at least the tip of the needle cannula submerged in the liquid in all situations.

    [0010] The injection device can be any kind of pre-filled injection device. The drive mechanism of the injection device can be either manual or spring-loaded. By manual is meant that the user delivers the force needed to press the liquid drug out of the cartridge and by spring-loaded is meant that a spring, compression or torque, is provided in the injection and utilized, fully or partly, to press the liquid drug out through the lumen of the attached needle cannula.

    [0011] The liquid in the reservoir of the telescopic shield is either phenol or metacresol or any combination thereof. The preservatives can also be provided inside the reservoir of the telescopic shield in a solution of sterile injectable water. However, most beneficial is to use the pharmaceutical preservative containing liquid drug in the injection device as the cleaning liquid in the reservoir. In a preferred example, the liquid drug is a blood sugar regulating drug such as insulin, insulin analogue, GLP-1 or GLP-2. In a further example the pharmaceutical preservative containing liquid drug could be a growth hormone. The pharmaceutical preservative containing liquid drug could in an example be any commercially available liquid drug from the company Novo Nordisk A/S, e.g., NovoRapid®, NovoLog®, Levemir®, NovoMix®, Tresiba®, Ryzodeg®, Xultophy®, Victoza®, Saxenda® or Norditropin®, which all contains a preservative maintaining the liquid drug biostatic.

    [0012] The needle cannula is permanently secured to the injection device. Alternatively the needle cannula can be secured in a hub by gluing, welding or the like. The hub is then either permanently secured to the injection device, or provided with connecting means for detachable connecting the hub to the injection device. In the example wherein the hub is detachable coupled to the injection device, the telescopic shield could be provided in conjunction with the hub to form a part of the needle assembly. When the needle cannula is permanently secured to the injection device, either directly or via a hub, the preferred device is a so-called pre-filled injection device.

    [0013] In one example, the reservoir of the telescopic shield is made as a through-going opening in the telescopic shield which distally is covered by a distal membrane and proximally covered by a proximal membrane. These membranes or septums are preferably made from a rubber composition as known from standard septums generally used in cartridges.

    [0014] In an example one of these membranes or septums and preferably the proximal septum of the reservoir could be movable in relation to the telescopic shield. This movement of the proximal septum is preferably in a proximal direction thus allowing the reservoir to be filled. In the initial position when the proximal surface of the distal septum abuts the distal surface of the proximal septum a carved-out portion in one or both of the septums is preferred such that the lumen of the needle cannula is not covered by the septum material in the initial position. When such carved-out portion is present, a reservoir is so to speak formed even in the abut situation such that the liquid pharmaceutical drug has a space to flow into when an initial quantum is ejected into the reservoir.

    [0015] The filling of the reservoir is preferably done fully automatically and preferably by automatically moving the proximal septum in a proximal direction such that a vacuum is created inside the so expanding reservoir of the telescopic shield. In this context automatically means that the injection device is provided with means which generates the movement of the proximal septum. The means generating this proximal movement is preferably resilient means such as spring or like element. The proximal septum can in one particular embodiment be moved axially in the proximal direction by a pull spring which is e.g. released upon first use of the injection device.

    [0016] The axial movement of the proximal septum and thus the vacuum created and the filling volume of the reservoir in the telescopic shield is determined by the manufacture of the injection device. It can be inherent in the force of the spring or various stops can be provided limiting the distance the proximal septum can move. In any way, the volume of liquid filled into the reservoir is solely determined by the manufacture of the injection device such that the injection device is delivered to the user with this predetermination being inherent in the injection device. The user thus only has to take the injection device into use following the instructions from the manufacturer where after, the reservoir will be automatically filled with the predetermined volume.

    [0017] In one example, the proximal septum is preferably secured to an axial movable element which moves axially under influence of the second spring. The movable element preferably moves proximally from a locked position to a position engaging the telescopic shield when a user operates a release mechanism which again can be automatically released first time a user sets a dose.

    [0018] Alternatively, the injection device automatically ejects a predetermined volume of the pharmaceutical preservative containing liquid drug into the reservoir upon first use of the injection device. In one embodiment, the cap of the injection device can be coupled to a mechanism which automatically slides the cartridge proximally such that the rubber piston inside the cartridge is relatively moved to press out a predetermined volume. This ejection mechanism could e.g. be coupled to the cap such that it is activated upon rotation of the cap.

    [0019] The disclosure further includes a method of preparing the injection device prior to performing a series of injections i.e. the method is preferably executed when a new injection device is taken into use. The injection device is preferably a pre-filled injection device which is only taken into use once and discarded when the cartridge is empty after a series of injections.

    [0020] In order to take the pre-filled injection device into use, the user needs to perform two simple operations. The method according to the invention therefore comprises of at least the following two steps:
    1. i) holding the injection device with the telescopic shield in the first position such that the tip of the needle cannula is located inside the reservoir of the telescopic shield, and
    2. ii) automatically transferring a predetermined volume of the pharmaceutical preservative containing liquid drug contained inside the chamber of the cartridge into the reservoir of the telescopic shield.


    [0021] According to this method the user must first secure that the tip of the needle cannula is inside the reservoir of the telescopic shield where after the release mechanism must be activated such that the predetermined volume is automatically transferred from the compartment of the cartridge and into the reservoir of the telescopic shield.

    [0022] The release mechanism can be a movable element that the user must physically remove in order to activate the release or it can be integrated with the dose setting mechanism such that it is released first time the user sets a dose to be injected.

    [0023] The volume automatically filled into the reservoir is determined by the manufacture of the injection device. It can be decided by the size of the vacuum generated which again can be a result of the spring force of the spring used to generate the vacuum. Alternatively it can be one or more physical stops provided in the injection device; stops which e.g. limits the axial movement of the proximal septum.

    [0024] This method is in a further embodiment performed by releasing the movable element such that the second spring drives the movable element and the proximal septum in the proximal direction thereby creating a vacuum inside the reservoir. As the proximal septum moves further in the proximal direction, this vacuum grows and the pharmaceutical preservative containing liquid drug is automatically sucked through the lumen on the needle cannula from the chamber of cartridge and into the reservoir of the telescopic shield.

    DEFINITIONS:



    [0025] An "injection pen" is typically an injection apparatus having an oblong or elongated shape somewhat like a pen for writing. Although such pens usually have a tubular cross-section, they could easily have a different cross-section such as triangular, rectangular or square or any variation around these geometries.

    [0026] The term "Needle Cannula" is used to describe the actual conduit performing the penetration of the skin during injection. A needle cannula is usually made from a metallic material such as e.g. stainless steel and connected to a hub to form a complete injection needle also often referred to as a "needle assembly". A needle cannula could however also be made from a polymeric material or a glass material. The hub also carries the connecting means for connecting the needle assembly to an injection apparatus and is usually moulded from a suitable thermoplastic material. The "connection means" could as examples be a luer coupling, a bayonet coupling, a threaded connection or any combination thereof e.g. a combination as described in EP 1,536,854.

    [0027] The term "Needle unit" is used to describe one single needle assembly carried in a container. Such container usually has a closed distal end and an open proximal end which is sealed by a removable seal. The interior of such container is usually sterile such that the needle assembly is ready-to-use. Needle units specially designed for pen injections systems are defined in ISO standard No. 11608, part 2, and are often referred to as "pen needles". Pen needles have a front part for penetrating into the user and a back part for penetrating into the cartridge containing the drug.

    [0028] As used herein, the term "drug" is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension. Representative drugs includes pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form. Further, the term "Preservative containing liquid drug" is meant to encompass any flowable drug containing any amount of a preservative. In one example the preservative could be a phenol or a metacresol or any combination thereof. However, the wording preservative containing should not be limited to only these substances but should indeed mean any combination of a flowable drug and a preservative.

    [0029] "Cartridge" is the term used to describe the container containing the drug. Cartridges are usually made from glass but could also be moulded from any suitable polymer. A cartridge or ampoule is preferably sealed at one end by a pierceable membrane referred to as the "septum" which can be pierced e.g. by the non-patient end of a needle cannula. Such septum is usually self-sealing which means that the opening created during penetration seals automatically by the inherent resiliency once the needle cannula is removed from the septum. The opposite end is typically closed by a plunger or piston made from rubber or a suitable polymer. The plunger or piston can be slidable moved inside the cartridge. The space between the pierceable membrane and the movable plunger holds the drug which is pressed out as the plunger decreased the volume of the space holding the drug. However, any kind of container - rigid or flexible - can be used to contain the drug.

    [0030] Since a cartridge usually has a narrower distal neck portion into which the plunger cannot be moved not all of the liquid drug contained inside the cartridge can actually be expelled. The term "initial quantum" or "substantially used" therefore refers to the injectable content contained in the cartridge and thus not necessarily to the entire content.

    [0031] The term "Permanently secured" as used in the description is intended to mean that the parts, which in this application is embodied as the needle cannula and the injection device, requires the use of tools in order to be separated and should the parts be separated it would permanently damage at least one of the parts.

    [0032] By the term "Pre-filled" injection device is meant an injection device in which the cartridge containing the liquid drug is permanently embedded in the injection device such that it cannot be removed without permanent destruction of the injection device. Once the pre-filled amount of liquid drug in the cartridge is used, the user normally discards the entire injection device. This is in opposition to a "Durable" injection device in which the user can himself change the cartridge containing the liquid drug whenever it is empty. Pre-filled injection devices are usually sold in packages containing more than one injection device whereas durable injection devices are usually sold one at a time. When using pre-filled injection devices an average user might require as many as 50 to 100 injection devices per year whereas when using durable injection devices one single injection device could last for several years, however, the average user would require 50 to 100 new cartridges per year.

    [0033] All headings and sub-headings are used herein for convenience only and should not be constructed as limiting the invention in any way.

    [0034] The use of any and all examples, or exemplary language (e.g. such as) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

    [0035] The citation and incorporation of patent documents herein is done for convenience only and does not reflect any view of the validity, patentability, and/or enforceability of such patent documents.

    [0036] This invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law.

    BRIEF DESCRIPTION OF THE DRAWINGS:



    [0037] The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:
    Figure 1
    show a cross sectional view of part of the injection device prior to use.
    Figure 2
    show a cross sectional view of part of the injection device during filling of the reservoir of the telescopic shield.
    Figure 3
    show a cross sectional view of part of the injection device during dose ejection.
    Figure 4
    show a cross sectional view of part of the injection device of a second embodiment prior to use.
    Figure 5
    show a cross sectional view of part of the injection device of a second embodiment during filling of the reservoir of the telescopic shield.
    Figure 6
    show a cross sectional view of part of the injection device of a second embodiment during dose expelling.
    Figure 7
    show a cross sectional view of part of the injection device of a second embodiment between successive injections.
    Figure 8
    show a cross sectional view of another embodiment prior to use.
    Figure 9
    show the embodiment of figure 8 during filling of the reservoir of the telescopic shield.


    [0038] The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.

    DETAILED DESCRIPTION OF EMBODIMENTS:



    [0039] When in the following terms as "upper" and "lower", "right" and "left", "horizontal" and "vertical", "clockwise" and "counter clockwise" or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.

    [0040] In that context it may be convenient to define that the term "distal end" in the appended figures is meant to refer to the tip 13 of the needle cannula 10 actually penetrating the skin of the user whereas the term "proximal end" is meant to refer to the opposite end pointing away from the user during injection and penetrating into the cartridge 20.

    [0041] Figure 1 to 3 discloses the first embodiment in which an injection device carries a needle cannula 10. The needle cannula 10 is in the depicted embodiment secured in a hub 15 which is removable connected to a housing 1 of the injection device by a thread 16. However, the needle cannula 10 could be secured to the housing 1 in many different ways. The needle cannula 10 could e.g. be formed permanently attached to the housing 1.

    [0042] The needle cannula 10 has a front part 11 provided with a grinded tip 13 for easy piercing of the skin of a user and a back part 12 for penetrating into a chamber 21 of a cartridge 20. The opposite cannula end could also be grinded, and the two ends are connected through a lumen 14.

    [0043] Distally the housing 1 is provided with a telescopic shield 30 which is urged in the distal direction by a first resilient element such as a first spring 40 such that the telescopic shield 30 conceals the tip 13 of the needle cannula 10 in a non-use situation i.e. when not injecting.

    [0044] The telescopic shield 30 is further provided with a reservoir 31 which in the disclosed embodiment is depicted as a cylindrical through-going opening which distally is sealed by a distal septum 32 and proximally is sealed by a proximal septum 33 such that the through-going opening forms the reservoir 31.

    [0045] Either the distal septum 32 or the proximal septum 33, or both septums 32, 33, can on the surface pointing towards the reservoir 31 be provided with a carved-out portion 34 which in the first position could make up the reservoir 31 as depicted in figure 1.

    [0046] Further, a pull spring 35 is encompassed between, and connected to, the proximal septum 33 and a wall 36 which again is secured to the telescopic shield 30. The wall 36 could also be moulded as an integral part of the telescopic shield 30. This wall 36 together with the proximal septum 33 also supports and guides the needle cannula 10 thus preventing the front part 11 of the needle cannula 10 from bending when passing through the distal septum 32.

    [0047] In figure 1, the injection device is depicted with the telescopic shield 30 positioned in the first position. The telescopic shield 30 is urged in the distal direction by the spring 40 and the tip 13 of the needle cannula 10 is located inside the reservoir 31 (represented by the carved-out portion 34).

    [0048] The pull spring 33 is in figure 1 depicted in its cocked position where it is held stretched out by a not-shown release mechanism. When this release mechanism is released, preferably by the user, the pull spring 36 pulls the proximal septum 33 in a proximal direction as disclosed in figure 2. This movement creates a vacuum inside the reservoir 31, which vacuum moves a part of the pharmaceutical preservative containing liquid drug from the chamber 21 of the cartridge 20 to the reservoir 31via the lumen 14 of the needle cannula 10.

    [0049] Alternatively, the proximal septum 33 could be in a permanent position thus defining the reservoir 31 with a fixed volume. In this case, the drive mechanism of the injection device could be set to inject a predetermined amount of pharmaceutical preservative containing liquid drug into the reservoir 31 the first time the injection device is taken into use. It would then be preferred if one of the septums 32, 33 were provided with a venting area through which the air trapped in the reservoir 31 could escape during filling of the reservoir 31.

    [0050] The tip 13 of the needle cannula 10 is in figure 2 submerged into a quantum of the pharmaceutical liquid drug and since a pharmaceutical liquid drug usually contains preservative substances, these preservatives will clean the tip 13 of the needle cannula 10 whenever the tip 13 is inside the reservoir 31.

    [0051] When a user presses the injection device against the skin as indicated by arrows "A" in figure 3, the telescopic shield 30 is pushed in the proximal direction into its second position against the bias of the first spring 40. The front part 11 of the needle cannula 10 and especially the tip 13 of the needle cannula 10 thus penetrates through the distal septum 32 and an injection can be performed either manually or automatically.

    [0052] Following the injection when the user removes the telescopic shield 30 from the skin, the telescopic shield 30 is urged into the first position by the first spring 40 which makes the tip 13 of the needle cannula 10 once again enter into its submerged position inside the reservoir 31 as depicted in figure 2.

    [0053] In a second embodiment disclosed in the figures 4 to 7, the same elements are numbered using the same numbers as in the first embodiment.

    [0054] Figure 4 discloses the injection device with the telescopic shield 30 in the first position. The needle cannula 10 is mounted in a telescopic movable hub 15 and the telescopic shield 30 is urged in a distal direction by the first spring 40. The tip 13 of the needle cannula 10 is located inside the reservoir 31 which in figure 4 is limited to the carved-out portion 34. In the depictured embodiment this carved-out portion 34 is formed in the proximal septum 33 but it could easily be provided in the distal septum 32 or in both septums 32, 33.

    [0055] The proximal septum 33 is carried by a movable element 50 which is urged in the proximal direction by a second spring 45. A not disclosed release mechanism secures the movable element 50 and prevents it from moving proximally before the user actually activates the injection device. This release mechanism could in a simple form e.g. be a tab (indicated as "T" in figure 4) that the user must remove before first use of the injection device. A similar tab could be provided in the first embodiment to secure the pull spring 35 in its stretched condition. The release mechanism could alternatively be coupled to the dose dial, such that once a dose is being dialled, the movable element 50 is released and moves automatically in the proximal direction under the influence of the second spring 45. This proximal movement presses the hub 15 over the distal end of the cartridge 20 such that the back part 12 of the needle cannula 10 enters into liquid communication with the chamber 21 of the cartridge 20.

    [0056] The coupling between the hub 15 and the cartridge 20 is in the depicted embodiment designed such that the back part 12 of the needle cannula 10 thereafter remains in this liquid communicating position as will be explained.

    [0057] As the movable element 50 slides in the proximal direction so does the proximal septum 33 thus creating a vacuum inside the reservoir 31. This vacuum draws a predetermined quantum of the pharmaceutical liquid drug from the chamber 21 of the cartridge 20 and through the lumen 14 of the needle cannula 10 into the reservoir 31 which in this way is automatically filled.

    [0058] Figure 5 discloses the movable element 50 in its proximal position in which a radial ridge 51 provided on the movable element 50 is locked in a similar groove 36 provided internally in the telescopic shield 30 such that the movable element 50 thereafter moves telescopic together with the telescopic shield 30.

    [0059] When a user performs an injection by pressing the distal end of the telescopic shield 30 against the skin as indicated by the arrows "A" in figure 6, both the telescopic shield 30 and the movable element 50 retracts together thus maintaining the reservoir 31 with the same constant volume.

    [0060] Once the injection has been given, either manually by pressing home an extended element or automatically by an electric- or spring motor, the user removes the telescopic shield 30 from his or hers skin where after the first spring 40 urges the telescopic shield 30 and the movable element 50 distally such that the tip 13 of the needle cannula 10 re-enters into the reservoir 31 where it is maintained submerged in the cleaning liquid until the next injection.

    [0061] When the telescopic shield 30 moves axially from the second position disclosed in figure 6 to the first position disclosed in figure 5, the tip 13 of the needle cannula 10 once again enters into the reservoir 31 to be cleaned and be kept clean until next injection.

    [0062] Yet another embodiment is disclosed in figure 8-9 in which the same numbering of the various elements have been maintained.

    [0063] The pharmaceutical liquid preservative containing drug is pressed out through the lumen 14 of the needle cannula 10 by moving a rubber piston 25 forward inside the cartridge 20 thereby decreasing the volume of the chamber 21. In order to move the rubber piston 25 forward a piston rod 26 is driven in the distal direction by a not-shown drive mechanism.

    [0064] In figure 8, the distal end of the injection device is located inside a protective cap 2 as is common with injection devices. This cap 2 is coupled to the injection device such that when a user rotates the cap 2, the distal part of the injection device is forced to move proximally. However, the rubber piston 25 remains in its previous position due to the piston rod 26 which is locked against any proximal movement by the drive mechanism.

    [0065] As the cap 2 is rotated the injection device moves the distance "X" in the proximal direction as depicted in figure 9. This movement also moves the cartridge axially a distance "Y" in relation to the rubber piston 25 thereby ejecting a predetermined amount of the pharmaceutical liquid preservative containing drug into the reservoir 31.

    Example of a pharmaceutical preservative containing liquid drug:



    [0066] In one specific example, the liquid pharmaceutical drug contained in the chamber 21 of the cartridge 20 and in the reservoir 31 of the telescopic shield 30 could be NovoLog®, which is manufactured and sold by Novo Nordisk A/S.

    [0067] NovoLog® is a sterile, aqueous, clear, and colourless solution that contains:
    • insulin aspart 100 Units/mL
    • glycerin 16 mg/mL
    • phenol 1.50 mg/mL
    • metacresol 1.72 mg/mL
    • zinc 19.6 mcg/mL
    • disodium hydrogen phosphate dehydrate 1.25 mg/mL
    • sodium chloride 0.58 mg/mL
    • water for injection


    [0068] NovoLog has a pH of 7.2-7.6 and Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

    [0069] The preservatives (phenol and metacresol) are simultaneously present both in the chamber 21 of the cartridge 20 and in the reservoir 31 of the telescopic shield 30. Since the liquid in the chamber 21 and in the reservoir 31 is the same pharmaceutical preservative containing liquid drug, the exchange of liquid through the lumen 14 of the needle cannula 10 has no influence on the pharmaceutical preservative containing liquid drug to be injected as only the identical same pharmaceutical preservative containing liquid drug is present in the chamber 21 of the cartridge 20 and in the reservoir 31 of the telescopic shield 30.

    [0070] Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims


    Claims

    1. A prefilled injection device for injecting a pharmaceutical liquid drug containing a preservative, comprising:

    - a housing (1) supporting a cartridge (20) permanently embedded in the injection device and having an interior chamber (21) containing the pharmaceutical preservative containing liquid drug to be injected,

    - a needle cannula (10) permanently secured to the injection device and usable for multiple injections and having a front part (11) with a tip (13) and a back part (12), which back part (12) is adapted to be in liquid communication with the interior chamber (21) of the cartridge (20), and

    - a telescopic needle covering shield (30), which distally is provided with a reservoir (31) confining a predetermined volume of a liquid for cleaning at least the tip (13) of the needle cannula (10) between subsequent injections, and which telescopic needle covering shield (30) is urged distally into a first position by a first resilient member (40) and moved proximally against the bias of the first resilient member (40) into a second position during injection;

    - the first position being a position in which, the tip (13) of the front part (11) of the needle cannula (10) is located inside the reservoir (31), and

    - the second position being a position in which, the tip (13) of the front part (11) of the needle cannula (10) is located outside the reservoir (31) and distally to the reservoir (31),

    and wherein, the predetermined volume of liquid confined in the reservoir (31) of the telescopic needle covering shield (30) is either phenol or metacresol or any combination thereof, being the same preservative as present in the pharmaceutical preservative containing liquid drug contained in the chamber (21) of the cartridge (20).
     
    2. A drug delivery device according to claim 1, wherein the pharmaceutical preservative containing liquid drug is a blood sugar regulating drug such as insulin, insulin analogue, GLP-1 or GLP-2.
     
    3. A drug delivery device according to any of the claims 1 or 2, wherein the needle cannula (10) is secured in a hub (15), which is permanently secured to the injection device.
     
    4. A drug delivery device according to any of the previous claims, wherein the reservoir (31) of the telescopic shield (30) distally is provided with a distal septum (32) and proximally with a proximal septum (33).
     


    Ansprüche

    1. Vorbefüllte Injektionsvorrichtung zum Injizieren eines pharmazeutischen flüssigen Medikaments, das ein Konservierungsmittel enthält, umfassend:

    - ein Gehäuse (1), das eine Patrone (20) trägt, die dauerhaft in die Injektionsvorrichtung eingebettet ist und eine Innenkammer (21) aufweist, die das zu injizierende flüssige Medikament enthält, welches das pharmazeutische Konservierungsmittel enthä lt,

    - eine Nadelkanüle (10), die dauerhaft an der Injektionsvorrichtung befestigt und für Mehrfachinjektionen verwendbar ist und einen vorderen Teil (11) mit einer Spitze (13) und einen hinteren Teil (12) aufweist, wobei der hintere Teil (12) derart angepasst ist, dass er in Flüssigkeitsverbindung mit der Innenkammer (21) der Patrone (20) ist, und

    - einen Teleskopnadelabdeckschild (30), der distal mit einem Vorratsbehälter (31) versehen ist, welcher ein vorbestimmtes Volumen einer Flüssigkeit zur Reinigung von mindestens der Spitze (13) der Nadelkanüle (10) zwischen aufeinanderfolgenden Injektionen einschließt, und wobei der Teleskopnadelabdeckschild (30) durch ein erstes elastisches Element (40) distal in eine erste Position gedrängt wird und während der Injektion proximal gegen die Vorspannung des ersten elastischen Elements (40) in eine zweite Position bewegt wird;

    - wobei die erste Position eine Position ist, in der sich die Spitze (13) des vorderen Teils (11) der Nadelkanüle (10) innerhalb des Vorratsbehälters (31) befindet, und

    - die zweite Position eine Position ist, in der sich die Spitze (13) des vorderen Teils (11) der Nadelkanüle (10) außerhalb des Vorratsbehälters (31) und distal zu dem Vorratsbehälter (31) befindet,

    und wobei das vorbestimmte Flüssigkeitsvolumen, das in dem Vorratsbehälter (31) des teleskopischen Nadelabdeckschilds (30) eingeschlossen ist, entweder Phenol oder Metakresol oder eine beliebige Kombination davon ist, welches das gleiche Konservierungsmittel ist, wie es in dem dem flüssigen Medikament, welches pharmazeutische Konservierungsmittel enthält, vorhanden ist, das in der Kammer (21) der Patrone (20) enthalten ist.
     
    2. Medikamentenabgabevorrichtung nach Anspruch 1, wobei das flüssige Medikament, welches das pharmazeutische Konservierungsmittel enthält, ein blutzuckerregulierendes Medikament wie Insulin, ein Insulinanalogon, GLP-1 oder GLP-2 ist.
     
    3. Medikamentenabgabevorrichtung nach einem der Ansprüche 1 oder 2, wobei die Nadelkanüle (10) in einer Nabe (15) befestigt ist, die dauerhaft an der Injektionsvorrichtung befestigt ist.
     
    4. Medikamentenabgabevorrichtung nach einem der vorstehenden Ansprüche, wobei der Vorratsbehälter (31) des Teleskopschilds (30) distal mit einem distalen Septum (32) und proximal mit einem proximalen Septum (33) versehen ist.
     


    Revendications

    1. Dispositif d'injection prérempli pour l'injection d'un médicament liquide pharmaceutique contenant un conservateur, comprenant :

    - un logement (1) soutenant une cartouche (20) incorporée de manière permanente dans le dispositif d'injection et disposant d'une chambre intérieure (21) contenant le conservateur pharmaceutique contenant du médicament liquide à injecter,

    - une canule d'aiguille (10) fixée de manière permanente au dispositif d'injection et utilisable pour plusieurs injections et ayant une partie avant (11) avec un embout (13) et une partie arrière (12), laquelle partie arrière (12) est adaptée pour être en communication liquide avec la chambre intérieure (21) de la cartouche (20), et

    - un écran de protection d'aiguille télescopique (30), qui est pourvu distalement d'un réservoir (31) confinant un volume prédéterminé d'un liquide pour le nettoyage au moins de la pointe (13) de la canule d'aiguille (10) entre les injections ultérieures, et lequel écran de protection d'aiguille télescopique (30) est poussé distalement dans une première position par un premier élément élastique (40) et déplacé proximalement contre le biais du premier élément élastique (40) dans une deuxième position pendant l'injection;;

    - la première position étant une position dans laquelle l'embout (13) de la partie avant (11) de la canule d'aiguille (10) est situé à l'intérieur du réservoir (31), et

    - la deuxième position étant une position dans laquelle l'embout (13) de la partie avant (11) de la canule d'aiguille (10) est situé à l'extérieur du réservoir (31) et distalement du réservoir (31),

    et dans lequel, le volume prédéterminé de liquide confiné dans le réservoir (31) de l'écran de protection d'aiguille télescopique (30) est soit du phénol, soit du métacrésol, soit toute combinaison de ceux-ci, étant le même conservateur que celui présent dans le conservateur pharmaceutique contenant le médicament liquide contenu dans la chambre (21) de la cartouche (20).
     
    2. Dispositif de délivrance de médicament selon la revendication 1, dans lequel le conservateur pharmaceutique contenant du médicament liquide est un médicament de régulation de la glycémie comme l'insuline, l'analogue de l'insuline, le GLP-1 ou le GLP-2.
     
    3. Dispositif de délivrance de médicament selon l'une quelconque des revendications 1 ou 2, dans lequel la canule d'aiguille (10) est fixée dans un moyeu (15), qui est fixé de manière permanente au dispositif d'injection.
     
    4. Dispositif de délivrance de médicament selon l'une quelconque des revendications précédentes, dans lequel le réservoir (31) de l'écran de protection télescopique (30) est fourni de manière distale avec un septum distal (32) et proximale avec un septum proximal (33).
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description