(19)
(11)EP 2 506 892 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
13.05.2020 Bulletin 2020/20

(21)Application number: 10834873.1

(22)Date of filing:  03.12.2010
(51)Int. Cl.: 
A61M 5/00  (2006.01)
A61M 5/28  (2006.01)
(86)International application number:
PCT/US2010/003087
(87)International publication number:
WO 2011/068544 (09.06.2011 Gazette  2011/23)

(54)

CARTRIDGE FOR CONTAINING AND DISPENSING A MEDICAMENT

KARTUSCHE ZUR ABFÜLLUNG UND AUSGABE EINES MEDIKAMENTS

CARTOUCHE POUR CONTENIR ET DISTRIBUER UN MÉDICAMENT


(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: 04.12.2009 US 266616 P

(43)Date of publication of application:
10.10.2012 Bulletin 2012/41

(60)Divisional application:
13150403.7 / 2606927

(73)Proprietor: Becton, Dickinson and Company
Franklin Lakes, NJ 07417-1880 (US)

(72)Inventors:
  • CRONENBERG, Richard
    Mahwah, New Jersey 07430 (US)
  • VEDRINE, Lionel
    Palo Alto, California 94306 (US)
  • BEGLEY, Patrick
    Caldwell, New Jersey 07006 (US)

(74)Representative: dompatent von Kreisler Selting Werner - Partnerschaft von Patent- und Rechtsanwälten mbB 
Deichmannhaus am Dom Bahnhofsvorplatz 1
50667 Köln
50667 Köln (DE)


(56)References cited: : 
EP-A1- 1 437 150
WO-A1-2009/043000
US-A- 4 254 768
US-A1- 2001 021 820
US-A1- 2004 097 874
US-A1- 2007 088 288
US-A1- 2007 203 454
US-A1- 2008 116 105
US-A1- 2008 215 015
US-B1- 6 382 568
EP-A1- 2 022 523
WO-A2-2010/033778
US-A- 5 192 270
US-A1- 2002 045 865
US-A1- 2006 100 575
US-A1- 2007 088 288
US-A1- 2007 211 565
US-A1- 2008 215 004
US-A1- 2008 255 521
US-B2- 7 169 132
  
      
    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

    Cross-Reference to Related Application



    [0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 61/266,616, filed December 4, 2009 at the U.S. Patent and Trademark Office.

    Field of the Invention



    [0002] The present invention relates generally to a cartridge for containing and dispensing a medicament, and more particularly to a cartridge for containing and dispensing a medicament in conjunction with a pen injection device.

    Background of the Invention



    [0003] Medication delivery pens are hypodermic syringes used for self-injection of precisely measured doses of medication. Pens are widely used, for example, by diabetics to self-inject insulin. A typical prior art medication delivery pen includes a cartridge which contains a volume of liquid medication sufficient for several doses. The dose is injected into a tissue area, such as the intramuscular tissue layer, the subcutaneous tissue layer, or the intradermal tissue layer.

    [0004] The assembly and operation of a typical pen injection device is described in commonly-assigned U.S. Patent No. 7,645,264, issued on January 12, 2010, which is incorporated herein by reference in its entirety.

    [0005] Pen injection devices, such as the exemplary pen injector 50, as shown in FIGS. 1 and 2, typically comprise a dose knob/button 24, an outer sleeve 13, and a cap 21. The dose knob/button 24 allows a user to set the dosage of medication to be injected. The outer sleeve 13 is gripped by the user when injecting medication. The cap 21 is employed by the user to securely hold the pen injector 50 in a shirt pocket, purse, or other suitable location.

    [0006] FIG. 2 is an exploded view of the exemplary drug delivery pen 50 shown in FIG. 1. The dose knob/button 24 has a dual purpose and is used to both set the dosage of the medication to be injected and to inject the dosed medicament via a lead screw 7 and stopper 15 from a medicament cartridge 12, which is attached to the drug delivery pen through a lower housing 17. The lower housing 17 typically has dosage indicia on the exterior thereof. The medicament cartridge 12 is typically a glass tube sealed at one end with a septum 16 and at the other end with the stopper 15. In standard drug delivery pens, the dosing and delivery mechanisms are all found within the outer sleeve 13. Those mechanisms are not described in greater detail here as they are understood by those knowledgeable of the art.

    [0007] A pen needle 10 includes a hub 20, a patient needle 11 extending from a patient end of the pen needle, and a septum-penetrating needle cannula 18 disposed within the hub 20 on a non-patient side thereof. The septum-penetrating needle cannula 18 is in fluid communication with the patient needle 11. The hub 20 is preferably screwed onto the lower housing 17. In attaching the hub 20 to the lower housing 17, the septum-penetrating cannula 18 pierces the septum 16, but the septum 16 does not move with respect to the medicament cartridge 12. The stopper 15, however, is axially displaceable within the medicament cartridge 12 while maintaining a fluid tight seal. The distal movement of the plunger or stopper 15 within the medicament cartridge 12 (due to advancement of the lead screw 7) causes medication to be forced into the patient needle 11 of the hub 20.

    [0008] To protect a user, or anyone who handles the pen needle assembly 10, an outer shield 29, which attaches to the hub 20, covers the hub 20. The outer shield 29 can also be used as a handle or grip to screw hub 20 onto or off pen injector 50. An inner shield 28 covers the patient needle 11 within the outer shield 29. The inner shield 28 can be secured to the hub 20 to cover the patient needle 11 by any suitable means, such as an interference fit or a snap fit. The outer shield 29 and inner shield 28 are removed prior to use. The cap 21 fits snugly against outer sleeve 13 to allow a user to securely carry the pen injection device 50.

    [0009] FIG. 3 is a cross-sectional view of an exemplary cartridge 76 and a lower housing or cartridge retainer 78 for a drug delivery pen, such as the pen injector 50. As shown in FIG. 3, opposing ends of cartridge retainer 78 include threads 80 and 82 for respectively connecting the cartridge retainer 78 to pen needle assembly 10 and the outer sleeve 13. The lower housing 80 may be made of, for example, plastic. The cartridge 76 may be made of, for example, glass.

    [0010] A stopper 84 is movably disposed within an interior cavity of the cartridge 76. The stopper 84 is shown in phantom lines in a position for the beginning of an injection, and is shown in cross section in a position representing the end of the useful life of the cartridge 76. In other words, no more medicament 86 can be ejected from the cartridge 76. More specifically, the leading surface of the stopper 84 forms a substantially right angle with the side thereof. And during blowing or other elongation of the glass to form the cartridge 76, an end 88 of the interior cavity of the cartridge is radiused. Therefore, the stopper 84 can only be moved a certain distance in the interior cavity before the radius of the end 88 prevents further movement of the stopper 84. Accordingly, an uninjectable, or dead volume of medicament remains in the cartridge 76.

    [0011] A septum 92 is held on the end of the cartridge 76 by a crimping ring or band of metal 94. The septum 92 is made of, for example, rubber and the crimping ring 94 is made of, for example, aluminum or plastic. During installation of the septum 92 and crimping of the crimping ring 94, particles from the septum 92 and/or the crimping ring 94 may be generated and may enter the interior cavity of the cartridge 76.

    [0012] WO 2010/033778 describes a cartridge for containing and dispensing a medicament with a first reservoir with a first mixable substance and a second reservoir with a second mixable substance, wherein the first and second reservoir are separated by a movable stopper. Further, the cartridge comprises a recess wherein the first reservoir is in communication with the second reservoir via the recess if the movable stopper is at the position of the recess.

    [0013] US 2007/0088288, wherein all the features of the preamble of claim 1 and 14 have been disclosed, describes a dispensing device comprising an interior cavity and a movable stopper disposed within the interior cavity. Furthermore, the device comprises a mechanism for dispensing.

    [0014] US 2002/0045865 describes a cartridge for containing and dispensing a medicament comprising a reservoir for the medicament enclosed by a first stopper at a first end and a second stopper at a second end. Upon movement of the second stopper, the first stopper moves in unison into an end member attached to the first end. The end member comprises recesses through which the medicament is guided around the first stopper for dispensing.

    Summary of the Invention



    [0015] An aspect of the present invention is to provide cartridge for containing and dispensing a medicament in which the need for a cartridge retainer is obviated in accordance with claims 1 and 14.

    [0016] Additional and/or other aspects and advantages of the present invention will be set forth in part in the description that follows and, in part, will be apparent from the description.

    Brief Description of the Drawings



    [0017] The above and/or other aspects and advantages of embodiments of the invention will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, in which:

    FIG. 1 is a perspective view of an exemplary drug delivery pen of the prior art;

    FIG. 2 is an exploded view of the exemplary drug delivery pen of FIG. 1;

    FIG. 3 is a cross-sectional view of an exemplary cartridge for a drug delivery pen;

    FIG. 4 is a partial cross-sectional view illustrating integrated threads of a cartridge not being part of the present invention;

    FIG. 5 is a cross-sectional view illustrating a septum of a cartridge not being part of the present invention;

    FIG. 6 is a cross-sectional view illustrating dosage indicia on a cartridge not being part of the present invention;

    FIG. 7 is a perspective view of the cartridge of FIG. 6;

    FIG. 8 is a perspective view of a first embodiment of an attachment mechanism for a cartridge in accordance with an embodiment of the present invention;

    FIG. 9 is a perspective view of a second embodiment of an attachment mechanism for a cartridge in accordance with an embodiment of the present invention;

    FIG. 10 is a perspective view of a third embodiment of an attachment mechanism for a cartridge in accordance with an embodiment of the present invention;

    FIG. 11 is a perspective view of a fourth embodiment of an attachment mechanism for a cartridge in accordance with an embodiment of the present invention;

    FIG. 12 is a perspective view of a fifth embodiment of an attachment mechanism for a cartridge in accordance with an embodiment of the present invention;

    FIG. 13 is a perspective view of a sixth embodiment of an attachment mechanism for a cartridge in accordance with an embodiment of the present invention;

    FIG. 14 is a partial cross-sectional view illustrating a reduced dead volume feature of a cartridge not being part of the present invention;

    FIG. 15 is a partial cross-sectional view illustrating an embodiment of a reduced dead volume feature not being part of the present invention;

    FIG. 16 is a cross-sectional view illustrating a septum for a cartridge not being part of the present invention;

    FIG. 17 is a perspective view of a first embodiment of a lyophilization feature for a cartridge not being part of the present invention;

    FIG. 18 is a cross-sectional view of the cartridge of FIG. 17;

    FIG. 19 is a perspective view of a second embodiment of a lyophilization feature for a cartridge in accordance with an embodiment of the present invention;

    FIG. 20 is a cross-sectional view of a third embodiment of a lyophilization feature for a cartridge in accordance with an embodiment of the present invention;

    FIG. 21 is a perspective view of a fourth embodiment of a lyophilization feature for a cartridge in accordance with an embodiment of the present invention; and

    FIGS. 22 and 23 are cross-sectional views of a fifth embodiment of a lyophilization feature for a cartridge in accordance with an embodiment of the present invention.


    Detailed Description of Exemplary Embodiments



    [0018] Reference will now be made in detail to embodiments which form part, or do not form part of the present invention (as stated above), examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout. The descriptions of these embodiments exemplify the present invention, when they form part of the present invention (as stated above), by referring to the drawings.

    [0019] FIG. 4 is a partial cross-sectional view of a cartridge 100 for containing and dispensing a medicament. As shown in FIG. 4, the cartridge 100 includes a transparent cartridge body or body 104 that has an interior cavity 108 and a stopper 112 movably disposed therein. As discussed in greater detail below, the cartridge body 104 also has a septum 116 disposed at a front or user end thereof.

    [0020] At the front end, the cartridge 100 additionally has at least one connection thread 120 for connecting a pen needle assembly 10 directly to the cartridge body 104. For brevity, the pen needle assembly 10 will hereinafter be referred to as the pen needle 10. According to one embodiment, the body 104 is made of clear glass that does not react with the medicament. According to another embodiment, the body 104 is made of a transparent plastic material that does not react with the medicament. Examples of such a plastic material include, but are not limited to, cyclic olefin polymer (COP) and cyclic olefin copolymer (COC). One example of a COC is available from Zeon Chemicals, L.P., of Louisville, Kentucky under the designation "BD CCP Resin," and is listed by the U.S. Food and Drug Administration and DMF No. 16368. In addition, according to one embodiment, the body 104 is molded and the connection thread 120 is molded on the body 104 to be integrally formed as a unitary construction with the body 104.

    [0021] Because the pen needle 10 is connected directly to the body 104, it is not necessary to have a vial container or cartridge container, such as cartridge container 78, disposed between the body 104 and the pen needle 10. Therefore, a tolerance for the pen needle connection can be reduced. In other words, because the connection between the pen needle 10 and the body 104 is direct, without having to account for an intervening part, a looser fit between the pen needle 10 and the body 104 may be acceptable. Because users may have limited digital dexterity due to medical conditions, such as diabetes, this looser tolerance is beneficial in assembling the pen needle 10 to the cartridge body 104. According to one configuration, the connection thread 120 is male. According to another configuration, the connection thread 120 is female.

    [0022] As shown in FIG. 5, the septum 116 is made of an elastomeric material, such as rubber, that does not react with the medicament and is adhered directly to the body 104. Preferably, the material for the septum 116 has a self-sealing or self-healing property, allowing multiple punctures and resealings for successive connection of one or more pen needles 10. According to one embodiment, an adhesive is used to adhere the septum 116 to the body 104. According to another embodiment, the septum is made of a material that has an "adhesion" property that is compatible with the material of the body 104, so that the septum 116 can be co-injected with the body 104 during the molding thereof. In other words, the septum 116 is adhered to the body 104 during a molding process, thereby integrally forming the body 104 and the septum 116 as a unitary construction. According to yet another embodiment, the body 104 and the septum 116 are molded of the same material. Such a septum 116 that is adhered to the body 104 obviates the need for a crimping ring, such as crimping ring 94, and therefore eliminates the chance of particles entering the interior cavity 108 during a crimping process.

    [0023] FIG. 6 is a cross-sectional view illustrating dosage or volume indicia 124 disposed directly on the cartridge body 104. According to one embodiment, the dosage indicia 124 are "printed" directly on the body 104 using ink. According to another embodiment, the dosage indicia 124 are etched on the body 104.

    [0024] Using a plastic material represents a good alternative because of the precision achievable during molding. According to one embodiment, dosage indicia 124 are etched into the mold used for molding the body 104, and the dosage indicia 124 are formed on the body 104 during the molding process. According to another embodiment, an additive can be added to the plastic material of the body 104, so that the dosage indicia 124 can be formed by, for example, laser etching.

    [0025] FIG. 7 is a perspective view of the cartridge 100 illustrating a preferred configuration in which the body 104 is transparent, and thus the stopper 112, which is disposed in the interior cavity 108, is visible through the wall of the body 104. Progress of the stopper with respect to the dosage indicia 124 through the interior cavity 108, indicates a remaining volume of medicament.

    [0026] FIG. 7 (in addition to FIGS. 5 and 6) illustrates a connector 128 for directly connecting the cartridge body 104 to a dosing mechanism, such as an autoinjector, a spring driver, a manual driver, or the dosing mechanism contained in the outer sleeve 13 of the pen injector 50. As shown in FIG. 7, the connector 128 is disposed directly on the body 104. FIGS. 8-13 respectively illustrate first through sixth embodiments of connectors 128. As shown in FIGS. 7 and 8, according to one embodiment, the connector 128 includes a male protrusion disposed on the body 104. The wedge-shaped male protrusion corresponds to a female recess disposed on the dosing mechanism. The combination of the male protrusion and the female recess provides a snap-fit connection between the cartridge body 104 and the dosing mechanism. Conversely, FIG. 9 illustrates an embodiment in which the connector 128 includes a female recess disposed on the body 104. The female recess corresponds to a male protrusion disposed on the dosing mechanism to provide a snap-fit connection between the cartridge body 104 and the dosing mechanism.

    [0027] FIGS. 10 and 11 illustrate alternative connectors 128. In FIG. 10, the connector 128 includes a linear slot 132 disposed axially on the body 104. The connector 128 illustrated in FIG. 10 also includes a radial portion 136 disposed at an end of the axial slot 132 to form an L-shaped slot in combination with the axial slot 132. FIG. 11 illustrates an embodiment in which the connector 128 includes a linear protrusion that is substantially axially aligned on the body 104. In the embodiment of FIG. 10, an axially aligned linear protrusion similar to that shown in FIG. 11 is disposed on the dosing mechanism. Conversely, in the embodiment of FIG. 11, either a linear slot or and L-shaped slot similar to that shown in FIG. 10 is disposed on the dosing mechanism. To connect the body 104 to the dosing mechanism in the embodiments of FIGS. 10 and 11, the linear protrusion is inserted into the linear slot. And in the embodiments including the radial portion (for example, radial portion 136), the body 104 and the dosing mechanism are additionally rotated axially with respect to each other to engage the linear protrusion in the radial portion, thereby selectively locking the body 104 to the dosing mechanism.

    [0028] In the embodiment shown in FIG. 12, the connector 128 includes a male thread. In such an embodiment, the dosing mechanism includes a corresponding female thread for attaching the body 104 thereto. In FIG. 13, in addition to the male thread, the connector 128 additionally includes an anti-disassembly feature 140. According to the embodiment shown in FIG. 13, the anti-disassembly feature 140 includes a radially aligned wedge shape. In such an embodiment, in addition to a female thread, the dosing mechanism includes a radially oriented female recess (or series of female recesses to form a ratchet) to provide a snap-fit in combination with the radially aligned wedge shape 140. As will be appreciated by one skilled in the art, the male thread may be disposed on the dosing mechanism and the corresponding female thread may be disposed on the body 104 without departing from the scope of the present invention. Similarly, the wedge shape may be disposed on the dosing mechanism and the corresponding female recess(es) may be disposed on the body 104 without departing from the scope of the present invention. Additionally, one skilled in the art will appreciated that the connector 128 is not limited to the embodiments shown in FIGS. 8-13.

    [0029] The combination of the integral connection thread 120 and the connector 128 obviates the need for a cartridge retainer, such as cartridge retainer 78. The dosage indicia 124 on the cartridge body 104 further obviate the need for such a cartridge retainer.

    [0030] FIG. 14 illustrates a configuration in which the shape of the leading edge (or leading face) of the stopper closely corresponds to the shape of the end 144 of the interior cavity 108 closest to the septum 116. For example, as shown in FIG. 14, the shape of both the end 144 and the stopper 112 are substantially right angles. Accordingly, the stopper 112 can be moved until it contacts the end 144, thereby minimizing an uninjectable or dead volume of medicament. Similarly, in the configuration shown in FIG. 15, the shape of the end 144 and the stopper 112 are curved. More specifically, the stopper has a convex curve and the end 144 has as concave curve. One skilled in the art will appreciate the curves of the stopper 112 and the end 144 may be inverted without departing from the scope of the invention. Similarly, one skilled in the art will appreciate that the stopper and the end may have compound curves and/or straight portions without departing from the scope of the present invention. What is desired is that the shape of the stopper 112 corresponds to the shape of the end 144. In addition, according to one embodiment, a small nub or projection is disposed on the face of the stopper so that it enters the narrow nozzle area of the syringe and ejects all of the fluid in the dead space.

    [0031] FIG. 16 illustrates a configuration in which a septum 148 is inserted into an end of the cartridge body during manufacture of the cartridge 100. An example of a material for the septum 148 includes rubber. As shown in FIG. 16, the cartridge body 104 has a male protrusion 152 and the septum 148 has a corresponding female recess 156 to provide a snap-fit connection between the septum 148 and the cartridge body 104. To assemble the cartridge 100, the manufacturer inserts the septum into the end of the cartridge body 104 until the male protrusion 152 engages the female recess 156, thereby retaining the septum 148 in the cartridge body 104. It will be appreciated by one skilled in the art that the male protrusion 152 may be disposed on the septum 148 and the corresponding female recess 156 may be disposed on the cartridge body 104 without departing from the scope of the invention. One skilled in the art will also appreciate that corresponding pluralities of male protrusions and female recess may be employed without departing from the scope of the present invention. Similar to the septum 116 described above, the septum 148 obviates the need for a crimping ring, such as crimping ring 94, and therefore eliminates the chance of particles entering the interior cavity 108 during a crimping process.

    [0032] Lyophilization is a dehydration process used to preserve a material, such a medicament, and/or ease transportation of the medicament. During lyophilization, a liquid medicament is first frozen by lowering the temperature below the medicament's triple point (the lowest temperature at which the medicament can exist in a liquid phase). Subsequently, the pressure is lowered and the temperature is raised enough for the frozen water in the medicament to sublime directly from the solid phase to the gas phase. Subsequently, the lyophilized medicament can be reconstituted by adding water.

    [0033] Some factors of the lyophilization process are the convection (energy to sublimate the material), the ability to remove water vapor, and the packing density of containers in the lyophilization chamber for cycle time optimization (batch process). Some improvements to the process can be achieved by the use of specific materials (such as plastic) to increase the water vapor transmission or by the use of a coating to increase the convection factor, thereby improving the cycle time of the lyophilization.

    [0034] To use a known cartridge, such as cartridge 76, as a primary container during lyophilization, and thereby avoid having to use multiple containers, a separate vial stopper is employed in addition to the stopper 84. Such a vial stopper has a least a partial length groove. In use, the vial stopper is partially (removably) inserted into the interior cavity of the cartridge 76 so that the vial stopper groove communicates between the interior cavity and the outside of the cartridge 76, to provide a path for escape of sublimated water vapor. At the end of the lyophilization process, the vial stopper is removed and the stopper 84 is inserted into the interior cavity of the cartridge 76.

    [0035] For medicament stability reasons, each medicament may require a specific formulation of, for example, rubber for the vial stopper. This adds to the complexity of design, because each vial stopper formulation needs to be validated.

    [0036] FIGS. 17-23 illustrate embodiments in which a single stopper, such as stopper 112, can be employed with a single container (cartridge body 104) during a lyophilization process. For example, FIG. 17 is a perspective view of a cartridge body 104 having passageways 160 disposed at a second end of the body 104, opposite to the septum (for example, septum 116 or septum 148). The passageways provide venting from the interior cavity 108 during lyophilization.

    [0037] FIG. 18 is a cross-sectional view of the cartridge 100 of FIG. 17. In FIGS. 17 and 18, the passageways 160 are grooves or slots that axially extend from the second end of the body 104. As shown in FIG. 18, the slots 160 have an axial length greater than that of the stopper 112. Thus, after full insertion of the stopper 112, the slots 160 provide communication between the interior cavity 108 and the outside of the cartridge body 104 to provide venting during the lyophilization process. At the end of the lyophilization cycle, the stopper 112 is further inserted into the interior cavity toward the septum (116 or 148) so that the leading edge of the stopper (closest to the septum) is closer to the septum than the slots 160, thereby sealing or closing off the passageways 160. Such passageways 160 can reduce the time required for the lyophilization process because the stopper 112 is only inserted further, rather than being replaced.

    [0038] FIG. 19 illustrates an embodiment in which the passageways 160 are ribs 160 extending radially inwardly from an internal surface of the cartridge body 104. In FIG. 20, the passageways 160 are slots 160 extending radially through the wall of the cartridge body. FIG. 21 illustrates an embodiment in which the passageways 160 are holes extending radially through the wall of the cartridge body 104. One skilled in the art will appreciate that the passageways may be straight or may be curved without departing form the scope of the present invention.

    [0039] FIGS. 22 and 23 illustrate an embodiment in which the passageways 160 are slots 160 that extend from the second end of the cartridge body 104 and have an axial length that is les than that of the stopper 112. As shown in FIG. 22, the slots 160 provide venting from the interior cavity when the stopper 112 is partially inserted into the interior cavity 108. And as illustrated in FIG. 23, full insertion of the stopper 112 into the interior cavity 108 closes off the passageways 160.


    Claims

    1. A cartridge (100) for containing and dispensing a medicament, the cartridge (100) comprising:

    a cartridge body (104) having an interior cavity (108) therein;

    a stopper (112) movably disposed within the interior cavity (108);

    a septum (116) disposed at a first end of the interior cavity (108) for containing a medicament within the interior cavity (108);

    a connection thread (120) integrally formed as a unitary construction with the cartridge body (104), the thread being disposed at a first end of the cartridge body (104) for connecting a pen needle (10) directly to the cartridge body (104) to pierce the septum (116) and provide communication between the medicament and a patient end of the pen needle (10); and

    a connector (128) for directly connecting the cartridge body (104) to a dosing mechanism for moving the stopper (112) toward the septum (116) to dispense the medicament,

    characterized in that

    the cartridge body (104) comprises at least one passageway (160) for venting the interior cavity (108) during lyophilization subsequent to at least partial insertion of the stopper (112) into the interior cavity (108),

    wherein the passageway (160) comprises a slot recessed from a surface of the interior cavity (108), the slot axially extending from a second end of the cartridge body (104) opposite to the first end and having an axial length less than that of the stopper (112); or

    wherein the passageway (160) comprises a rib extending radially into the interior cavity (108) from an interior surface of the cartridge body (104), the rib axially extending from a second end of the cartridge body (104) opposite to the first end and having an axial length greater than that of the stopper; or

    wherein the passageway (160) extends radially through a wall of the interior cavity (108), the passageway (160) being disposed a distance greater than an axial length of the stopper (112) from a second end of the cartridge body (104) opposite to the first end.


     
    2. The cartridge according to claim 1 wherein the connector (128) comprises:

    a male protrusion disposed on one of the cartridge body and the dosing mechanism; and

    a corresponding female recess disposed on the remaining one of the cartridge body and the dosing mechanism.


     
    3. The cartridge according to claim 2, wherein the male protrusion comprises a wedge shape for providing a snap fit.
     
    4. The cartridge according to claim 2, wherein:

    the male protrusion comprises a substantially axially aligned linear protrusion; and

    the female recess comprises one of a substantially axially aligned slot and an L-shaped slot having a substantially axially aligned portion (132) and a radial portion (136).


     
    5. The cartridge according to claim 2, wherein:

    the male protrusion comprises at least one male thread; and

    the female recess comprises at least one female thread.


     
    6. The cartridge according to claim 2, further comprising an anti-disassembly feature (140).
     
    7. The cartridge according to claim 6, wherein the anti-disassembly feature comprises:

    a ratchet disposed on one of the cartridge body (104) and the dosing mechanism; and

    at least one tooth disposed on the remaining one of the cartridge body (104) and the dosing mechanism.


     
    8. The cartridge according any of the previous claims, wherein an end of the stopper (112) closest to the septum (116) has a shape corresponding to a shape of an end of the interior cavity (108) closest to the septum (116) for minimizing an uninjectable volume of medicament.
     
    9. The cartridge according to claim 8, wherein the shape of the end of the stopper (112) and the shape of the end of the interior cavity (108) comprise a substantially right angle.
     
    10. The cartridge according to claim 8, wherein the shape of the end of the stopper (112) and the shape of the end of the interior cavity (108) comprise a curved shape.
     
    11. The cartridge according to any of the previous claims, further comprising dosage indicia (124) disposed directly on the cartridge body, wherein one of:

    the dosage indicia (124) comprise ink printed directly on the cartridge body (104);

    the dosage indicia (124) comprise etched indicia;

    the cartridge body (104) comprises a plastic material that does not react with the medicament, and the dosage indicia (124) comprise an additive in the plastic material released by laser etching; or

    the dosage indicia (124) are etched into a mold to be formed on the cartridge body (104) during molding thereof.


     
    12. The cartridge according to any of the previous claims, wherein the cartridge body (104) comprises a plastic material that does not react with the medicament; and
    wherein the septum comprises an elastomeric material that does not react with the medicament and is adhered directly to the cartridge body.
     
    13. The cartridge according to claim 12 wherein the plastic material comprises cyclic olefin polymer (COP) or cyclic olefin copolymer (COC).
     
    14. A method of manufacturing a cartridge (100) for containing and dispensing a medicament, the method comprising:

    forming a cartridge body (104) having an interior cavity (108) therein;

    inserting a stopper (112) into the interior cavity (108) to be movable therein;

    at a first end of the interior cavity, providing a septum (116) for containing a medicament within the interior cavity (108); forming a connection thread (120) integrally formed as a unitary construction with the cartridge body (104), the thread being disposed at a first end of the cartridge body (104) for connecting a pen needle (10) directly on the cartridge body (104) to pierce the septum (116) and provide communication between the medicament and a patient end of the pen needle (10); and

    forming a connector (128) for directly connecting the cartridge body (104) to a dosing mechanism for moving the stopper (112) toward the septum (116) to dispense the medicament,

    characterized in that

    the cartridge body (104) comprises at least one passageway (160) for venting the interior cavity (108) during lyophilization subsequent to at least partial insertion of the stopper (112) into the interior cavity (108),

    wherein the passageway (160) comprises a slot recessed from a surface of the interior cavity (108), the slot axially extending from a second end of the cartridge body (104) opposite to the first end and having an axial length less than that of the stopper (112); or

    wherein the passageway (160) comprises a rib extending radially into the interior cavity (108) from an interior surface of the cartridge body (104), the rib axially extending from a second end of the cartridge body (104) opposite to the first end and having an axial length greater than that of the stopper (112); or

    wherein the passageway (160) extends radially through a wall of the interior cavity (108), the passageway (160) being disposed a distance greater than an axial length of the stopper (112) from a second end of the cartridge body (104) opposite to the first end.


     


    Ansprüche

    1. Kartusche (100) zum Aufnehmen und Ausgeben eines Medikaments, wobei die Kartusche (100) aufweist:

    einen Kartuschenkörper (104) mit einem darin ausgebildeten Innenhohlraum (108);

    einen Stopfen (112), der innerhalb des Innenhohlraums (108) beweglich angeordnet ist;

    ein Septum (116), das an einem ersten Ende des Innenhohlraums (108) zum Aufnehmen eines Medikaments in dem Innenhohlraum (108) angeordnet ist;

    ein Anschlussgewinde (120), das als eine einteilige Konstruktion einstückig mit dem Kartuschenkörper (104) ausgebildet ist, wobei das Gewinde an einem ersten Ende des Kartuschenkörpers (104) angeordnet ist zum direkten Verbinden einer Pen-Nadel (10) mit dem Kartuschenkörper (104), um das Septum (116) zu durchstehen und eine Verbindung zwischen dem Medikament und einem Patientenende der Pen-Nadel (10) herzustellen; und

    ein Verbindungsteil (128) zum direkten Verbinden des Kartuschenkörpers (104) mit einem Dosiermechanismus, um den Stopfen (112) zum Ausgeben des Medikaments in Richtung des Septums (116) zu bewegen;

    dadurch gekennzeichnet, dass

    der Kartuschenkörper (104) mindestens einen Durchgang (160) aufweist zum Belüften des Innenhohlraums (108) während einer Gefriertrocknung, nachdem der Stopfen (112) zumindest teilweise in den Innenhohlraum (108) eingesetzt wurde,

    wobei der Durchgang (160) einen von einer Oberfläche des Innenhohlraums (108) ausgesparten Schlitz aufweist, wobei sich der Schlitz axial von einem zweiten Ende des Kartuschenkörpers (104) entgegengesetzt zu dem ersten Ende erstreckt und eine axiale Länge aufweist, die geringer als die des Stopfens (112) ist; oder

    wobei der Durchgang (160) eine Rippe aufweist, die sich von einer Innenfläche des Kartuschenkörpers (104) radial in den Innenhohlraum (108) hinein erstreckt, wobei sich die Rippe axial von einem zweiten Ende des Kartuschenkörpers (104) entgegengesetzt zu dem ersten Ende erstreckt und eine axiale Länge aufweist, die größer als die des Stopfens ist; oder

    wobei sich der Durchgang (160) radial durch eine Wand des Innenhohlraums (108) erstreckt, wobei der Durchgang (160) in einem größeren Abstand als eine axiale Länge des Stopfens (112) von einem zweiten Ende des Kartuschenkörpers (104) entgegengesetzt zu dem ersten Ende angeordnet ist.


     
    2. Kartusche nach Anspruch 1, wobei das Verbindungsteil (128) aufweist:

    einen männlichen Vorsprung, der auf einem aus dem Kartuschenkörper und dem Dosiermechanismus angeordnet ist; und

    eine entsprechende weibliche Ausnehmung, die auf dem Verbleibenden aus dem Kartuschenkörper und dem Dosiermechanismus angeordnet ist.


     
    3. Kartusche nach Anspruch 2, wobei der männliche Vorsprung eine Keilform zum Bereitstellen einer Schnappverbindung aufweist.
     
    4. Kartusche nach Anspruch 2, wobei:

    der männliche Vorsprung einen im Wesentlichen axial ausgerichteten linearen Vorsprung aufweist; und

    die weibliche Ausnehmung eines aufweist aus einem im Wesentlichen axial ausgerichteten Schlitz und einem L-förmigen Schlitz mit einem im Wesentlichen axial ausgerichteten Abschnitt (132) und einem radialen Abschnitt (136).


     
    5. Kartusche nach Anspruch 2, wobei:

    der männliche Vorsprung mindestens ein Außengewinde aufweist; und

    die weibliche Ausnehmung mindestens ein Innengewinde aufweist.


     
    6. Kartusche nach Anspruch 2, ferner mit einer Anti-Demontage-Vorrichtung (140).
     
    7. Kartusche nach Anspruch 6, wobei die Anti-Demontage-Vorrichtung aufweist:

    eine Rastung, die auf einem aus dem Kartuschenkörper (104) und dem Dosiermechanismus angeordnet ist; und

    mindestens einen Zahn, der auf dem Verbleibendem aus dem Kartuschenkörper (104) und dem Dosiermechanismus angeordnet ist.


     
    8. Kartusche nach einem der vorstehenden Ansprüche, wobei ein Ende des Stopfens (112), das dem Septum (116) am nächsten ist, eine Form aufweist, die der Form eines Endes des Innenhohlraums (108), das dem Septum (116) am nächsten ist, entspricht, um ein nicht injizierbares Volumen eines Medikaments zu minimieren.
     
    9. Kartusche nach Anspruch 8, wobei die Form des Endes des Stopfens (112) und die Form des Endes des Innenhohlraums (108) einen im Wesentlichen rechten Winkel aufweisen.
     
    10. Kartusche nach Anspruch 8, wobei die Form des Endes des Stopfens (112) und die Form des Endes des Innenhohlraums (108) eine gewölbte Form aufweisen.
     
    11. Kartusche nach einem der vorstehenden Ansprüche, ferner mit Dosiermarkierungen (124), die sich direkt auf dem Kartuschenkörper befinden, wobei eines aus Folgendem gilt:

    die Dosiermarkierungen (124) weisen direkt auf dem Kartuschenkörper (104) gedruckte Tinte auf;

    die Dosiermarkierungen (124) weisen eingeätzte Markierungen auf;

    der Kartuschenkörper (104) weist ein Kunststoffmaterial auf, das nicht mit dem Medikament reagiert, und die Dosiermarkierungen (124) weisen in dem Kunststoffmaterial ein Additiv auf, das durch Laserätzung freigegeben wird; oder

    die Dosiermarkierungen (124) werden in eine Form eingeätzt, um während des Formens auf den Kartuschenkörper (104) aufgebracht zu werden.


     
    12. Kartusche nach einem der vorstehenden Ansprüche, wobei der Kartuschenkörper (104) ein Kunststoffmaterial aufweist, das nicht mit dem Medikament reagiert; und
    wobei das Septum ein Elastomermaterial aufweist, das nicht mit dem Medikament reagiert und direkt auf dem Kartuschenkörper haftet.
     
    13. Kartusche nach Anspruch 12, wobei das Kunststoffmaterial ein Cycloolefin-Polymer (COP) oder ein Cycloolefin-Copolymer (COC) aufweist.
     
    14. Verfahren zur Herstellung einer Kartusche (100) zum Aufnehmen und Abgeben eines Medikament, wobei das Verfahren umfasst:

    Bilden eines Kartuschenkörpers (104) mit einem darin ausgebildeten Innenhohlraum (108);

    Einsetzen eines Stopfens (112) in den Innenhohlraum (108), um darin beweglich zu sein;

    Vorsehen eines Septums (116) an einem erste Ende des Innenhohlraums zum Aufnehmen eines Medikaments in dem Innenhohlraum (108);

    Bilden eines Anschlussgewindes (120), das als eine einteilige Konstruktion einstückig mit dem Kartuschenkörper (104) ausgebildet ist, wobei das Gewinde an einem erste Endes des Kartuschenkörpers (104) angeordnet ist zum direkten Verbinden einer Pen-Nadel (10) auf dem Kartuschenkörper (104), um das Septum (116) zu durchstehen und eine Verbindung zwischen dem Medikament und einem Patientenende der Pen-Nadel (10) bereitzustellen; und

    Bilden eines Verbindungsteils (128) zum direkten Verbinden des Kartuschenkörpers (104) mit einem Dosiermechanismus, um den Stopfen (112) zum Ausgeben eines Medikaments in Richtung des Septums (116) zu bewegen,

    dadurch gekennzeichnet, dass

    der Kartuschenkörper (104) mindestens einen Durchgang (160) aufweist zum Belüften des Innenhohlraums (108) während einer Gefriertrocknung, nachdem der Stopfen (112) zumindest teilweise in den Innenhohlraum (108) eingesetzt wurde,

    wobei der Durchgang (160) einen von einer Oberfläche des Innenhohlraums (108) ausgesparten Schlitz aufweist, wobei sich der Schlitz axial von einem zweiten Ende des Kartuschenkörpers (104) entgegengesetzt zu dem ersten Ende erstreckt und eine axiale Länge aufweist, die geringer als die des Stopfens (112) ist; oder

    wobei der Durchgang (160) eine Rippe aufweist, die sich von einer Innenfläche des Kartuschenkörpers (104) radial in den Innenhohlraum (108) hinein erstreckt, wobei sich die Rippe axial von einem zweiten Ende des Kartuschenkörpers (104) entgegengesetzt zu dem ersten Ende erstreckt und eine axiale Länge aufweist, die größer als die des Stopfens (112) ist; oder

    wobei sich der Durchgang (160) radial durch eine Wand des Innenhohlraums (108) erstreckt, wobei der Durchgang (160) in einem Abstand, der größer als eine axiale Länge des Stopfens (112) ist, von einem zweiten Ende des Kartuschenkörpers (104) entgegengesetzt zu dem ersten Ende angeordnet ist.


     


    Revendications

    1. Cartouche (100) pour contenir et distribuer un médicament, la cartouche (100) comprenant :

    un corps de cartouche (104) ayant une cavité intérieure (108) dans celui-ci ;

    un bouchon (112) disposé de manière mobile dans la cavité intérieure (108);

    un septum (116) disposé au niveau d'une première extrémité de la cavité intérieure (108) pour contenir un médicament dans la cavité intérieure (108) ;

    un filetage de raccordement (120) formé d'un seul tenant comme une construction monobloc avec le corps de cartouche (104), le filetage étant disposé au niveau d'une première extrémité du corps de cartouche (104) pour raccorder une aiguille de stylo (10) directement au corps de cartouche (104) pour percer le septum (116) et assurer une communication entre le médicament et une extrémité côté patient de l'aiguille de stylo (10) ; et

    un raccord (128) pour raccorder directement le corps de cartouche (104) à un mécanisme de dosage pour déplacer le bouchon (112) vers le septum (116) afin de distribuer le médicament,

    caractérisée en ce que

    le corps de cartouche (104) comprend au moins un passage (160) pour mettre à l'air libre la cavité intérieure (108) pendant la lyophilisation suite à une insertion au moins partielle du bouchon (112) dans la cavité intérieure (108),

    où le passage (160) comprend une fente en retrait par rapport à une surface de la cavité intérieure (108), la fente s'étendant axialement à partir d'une deuxième extrémité du corps de cartouche (104) opposée à la première extrémité et ayant une longueur axiale inférieure à celle du bouchon (112) ; ou

    où le passage (160) comprend une nervure s'étendant radialement dans la cavité intérieure (108) à partir d'une surface intérieure du corps de cartouche (104), la nervure s'étendant axialement à partir d'une deuxième extrémité du corps de cartouche (104) opposée à la première extrémité et ayant une longueur axiale supérieure à celle du bouchon ; ou

    où le passage (160) s'étend radialement à travers une paroi de la cavité intérieure (108), le passage (160) étant disposé à une certaine distance supérieure à une longueur axiale du bouchon (112) d'une deuxième extrémité du corps de cartouche (104) opposée à la première extrémité.


     
    2. Cartouche selon la revendication 1, dans laquelle le raccord (128) comprend :

    une saillie mâle disposée sur l'un du corps de cartouche et du mécanisme de dosage ; et

    un évidement femelle correspondant disposé sur l'élément restant entre le corps de cartouche et le mécanisme de dosage.


     
    3. Cartouche selon la revendication 2, dans laquelle la saillie mâle comprend une forme de coin pour fournir une adaptation par encliquetage.
     
    4. Cartouche selon la revendication 2, dans laquelle :

    la saillie mâle comprend une saillie linéaire alignée essentiellement axialement ; et

    l'évidement femelle comprend l'une d'une fente alignée essentiellement axialement et d'une fente en forme de L ayant une partie alignée essentiellement axialement (132) et une partie radiale (136).


     
    5. Cartouche selon la revendication 2, dans laquelle :

    la saillie mâle comprend au moins un filetage mâle ; et

    l'évidement femelle comprend au moins un filetage femelle.


     
    6. Cartouche selon la revendication 2, comprenant en outre un élément anti-démontage (140).
     
    7. Cartouche selon la revendication 6, dans laquelle l'élément anti-démontage comprend :

    un cliquet disposé sur l'un du corps de cartouche (104) et du mécanisme de dosage ;

    et

    au moins une dent disposée sur l'élément restant entre le corps de cartouche (104) et le mécanisme de dosage.


     
    8. Cartouche selon l'une des revendications précédentes, dans laquelle une extrémité du bouchon (112) qui est la plus proche du septum (116) a une forme correspondant à une forme d'une extrémité de la cavité intérieure (108) qui est la plus proche du septum (116) pour minimiser un volume non injectable de médicament.
     
    9. Cartouche selon la revendication 8, dans laquelle la forme de l'extrémité du bouchon (112) et la forme de l'extrémité de la cavité intérieure (108) comprennent un angle essentiellement droit.
     
    10. Cartouche selon la revendication 8, dans laquelle la forme de l'extrémité du bouchon (112) et la forme de l'extrémité de la cavité intérieure (108) comprennent une forme incurvée.
     
    11. Cartouche selon l'une des revendications précédentes, comprenant en outre des indices de dosage (124) disposés directement sur le corps de cartouche, où :

    les indices de dosage (124) comprennent de l'encre imprimée directement sur le corps de cartouche (104) ; ou

    les indices de dosage (124) comprennent des indices gravés ; ou

    le corps de cartouche (104) comprend un matériau plastique qui ne réagit pas avec le médicament, et les indices de dosage (124) comprennent un additif dans le matériau plastique libéré par gravure au laser ; ou

    les indices de dosage (124) sont gravés dans un moule pour être formés sur le corps de cartouche (104) pendant son moulage.


     
    12. Cartouche selon l'une des revendications précédentes, dans laquelle le corps de cartouche (104) comprend un matériau plastique qui ne réagit pas avec le médicament ; et
    où le septum comprend un matériau élastomère qui ne réagit pas avec le médicament et adhère directement au corps de cartouche.
     
    13. Cartouche selon la revendication 12, dans laquelle le matériau plastique comprend un polymère d'oléfine cyclique (COP) ou un copolymère d'oléfine cyclique (COC).
     
    14. Procédé de fabrication d'une cartouche (100) pour contenir et distribuer un médicament, le procédé comprenant le fait :

    de former un corps de cartouche (104) ayant une cavité intérieure (108) dans celui-ci ;

    d'insérer un bouchon (112) dans la cavité intérieure (108) pour être mobile dans celle-ci ;

    de fournir, au niveau d'une première extrémité de la cavité intérieure, un septum (116) pour contenir un médicament dans la cavité intérieure (108) ; de former un filetage de raccordement (120) formé d'un seul tenant comme une construction monobloc avec le corps de cartouche (104), le filetage étant disposé au niveau d'une première extrémité du corps de cartouche (104) pour raccorder une aiguille de stylo (10) directement sur le corps de cartouche (104) pour percer le septum (116) et pour assurer une communication entre le médicament et une extrémité côté patient de l'aiguille de stylo (10) ; et

    de former un raccord (128) pour raccorder directement le corps de cartouche (104) à un mécanisme de dosage pour déplacer le bouchon (112) vers le septum (116) afin de distribuer le médicament,

    caractérisé en ce que

    le corps de cartouche (104) comprend au moins un passage (160) pour mettre à l'air libre la cavité intérieure (108) pendant la lyophilisation suite à une insertion au moins partielle du bouchon (112) dans la cavité intérieure (108),

    où le passage (160) comprend une fente en retrait par rapport à une surface de la cavité intérieure (108), la fente s'étendant axialement à partir d'une deuxième extrémité du corps de cartouche (104) opposée à la première extrémité et ayant une longueur axiale inférieure à celle du bouchon (112) ; ou

    où le passage (160) comprend une nervure s'étendant radialement dans la cavité intérieure (108) à partir d'une surface intérieure du corps de cartouche (104), la nervure s'étendant axialement à partir d'une deuxième extrémité du corps de cartouche (104) opposée à la première extrémité et ayant une longueur axiale supérieure à celle du bouchon (112) ; ou

    où le passage (160) s'étend radialement à travers une paroi de la cavité intérieure (108), le passage (160) étant disposé à une certaine distance supérieure à une longueur axiale du bouchon (112) d'une deuxième extrémité du corps de cartouche (104) opposée à la première extrémité.


     




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    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description