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    • 专利摘要:
    PISTON FOR A CARTRIDGE AND PISTON ROD FOR A DRUG RELEASE DEVICE. The present invention relates to a piston for a cartridge (24) for a drug delivery device comprising; at least one annular sealing surface (35) to radially abut against an inner side wall (24) of a cartridge (33), a distal surface (42) for confining a volume of drug reception from the cartridge (33), a surface receiving pulse (40) adapted to receive a pulse by exerting the plunger (10,32) of a drug release device to move the piston in a proximal direction in relation to the side wall (24), - where the surface of impulse receiving (40) comprises several centralizing elements (34) projecting from the impulse receiving surface (40) to the plunger (10, 32) and where the centralizing elements (34) comprise an external shape and geometry which correspond to a corresponding receptacle (38) of the plunger (10,32), and in which the centering elements (34) are arranged and aligned with the circumference of an imaginary or circular annular structure.
    公开号:BR112012014467B1
    申请号:R112012014467-7
    申请日:2010-12-16
    公开日:2020-11-03
    发明作者:Michael Jugl；Martin Otten
    申请人:Sanofi-Aventis Deutschland Gmbh；
    IPC主号:
    专利说明:

    description Field of the Invention
    [0001] The present invention generally relates to a piston being slidably disposed in a cartridge containing a medicament to be delivered by means of a drug delivery device, such as an injector-type pen. Furthermore, the invention relates to an impulse transfer interface between a piston and a cartridge piston of the drug delivery device to be adapted to exert an impulse to said piston. Background of the Prior Art
    [0002] User-operated drug delivery devices are as such known in the prior art. They are usually applicable in circumstances where people without formal medical training, that is, patients, need to administer an exact and predefined dose of a drug, such as heparin or insulin. In particular, these devices have an application, where a drug is administered on a regular or irregular basis over a short or long term.
    [0003] In order to accommodate these requirements, such devices must satisfy a number of requirements. First, the device must be robust in construction, even easier to use, in terms of handling and understanding by the user of its functioning and the release of the required dose or medication. Setting the dose should be easy and unambiguous. Where the device is to be disposable, rather than reusable, the device must be economical to manufacture and easy to dispose of. In addition, the device must be suitable for recycling. To satisfy these requirements, the number of parts required to assemble the device and the number of material types of the device is made from the need to be kept to a minimum.
    [0004] Such pen-type injectors are typically adapted to receive a replaceable and / or disposable cartridge containing the drug to be distributed through the device. The cartridge comprises an outlet to be coupled with a piercing element, for example, an injection needle, cannula or the like, in a fluid transfer mode. In addition, in order to expel a predefined dose of the drug, a plunger of a drug delivery device is adapted to act on the piston to move said plunger by a predefined distal distance, thus the dose delivery direction.
    [0005] Figure 1 shows a cross-sectional illustration of a piston 16 slidably disposed within a circumferential cylindrical wall 24 of a cartridge 23. The cartridge 23 is disposed within a drug delivery device comprising a component of the proximal housing 20 and a cartridge holder 22. The housing 20 accommodates a drive mechanism not illustrated further, which serves to drive a piston rod 10 and a rolling disc 12 in a distal axial direction, downwards, therefore, in the illustration in figure 1. For this purpose, the bearing disc 12 is rotatably mounted in a section of the lower end, hence distally located from the piston rod 10. The radial dimensions of the bearing disc 12 substantially coincide with the face size of the proximal end of the piston 16.
    [0006] Piston 16 comprises two annular sealing surfaces 25 radially adjacent against the inner side wall 24 of cartridge 23. In this way, piston 16 provides a durable and leak-proof seal for the medication contained in cartridge 23. How can seen in the cross-section of figure 1 and, as further illustrated in an illustration from the top view of figure 2, the pulse receiving surface comprises four distance elements in a rectangular shape, which, in the course of a production process in grease are adapted to prevent mutual adhesion of pistons, for example, in a feeding arrangement.
    [0007] In the illustration of figure 1, the bearing disc 12 and the face of the proximal end, the impulse receiving surface of the piston 16, are not yet in mutual contact. During the delivery of the dose, the piston rod 10 typically becomes subject to a rotary movement. Due to a threaded coupling, with a wire protruding radially inward 18, the piston rod 10 is displaced in the distal direction when rotated. Consequently, the rolling disc 12 comes into direct contact with the proximally located impulse receiving surface of piston 16 and, in response to an additional applied impulse, piston 16 is moved in the distal direction, which is downward in figure 1 .
    [0008] In practice, due to manufacturing and mounting tolerances, the radial position of piston rod 10 and / or bearing disc 12 can vary within certain limits. Thus, a piston rod 10 and / or a rolling disc 12 can be moved radially with respect to the center of piston 16. If not properly aligned, it may occur that the force provided by piston rod 10 and the bearing disc 12 is not centrally transferred to the piston 16. Such radial displacement can, in turn, lead to a scale or inclination of the piston 16, which is flexibly deformable to some extent. As a consequence, a displacement force required to displace piston 16 distally can increase substantially. In addition, dosing accuracy can also decrease when a driving force directed distally is not centrally transferred to the piston 16.
    [0009] Furthermore, since the distance elements 14 protrude from the face of the proximal end of the piston 16, the impulse to be applied to the piston 16 is entirely received by the distance element 14, which as a consequence can become compressed. However, such point stresses and pressing effects can still have a negative impact on the dosage accuracy of the drug delivery device and its drive mechanism. Objects of the Invention
    [00010] It is, therefore, an object of the present invention to provide an improved piston for a cartridge, as well as an improved plunger of a drug delivery device interacting with such pistons. In particular, the invention focuses on the cartridge piston / piston interface and drive mechanisms for drug delivery devices, preferably pen-type injectors. It is another objective of the present invention to prevent the transmission of non-centralized directed force to a cartridge piston. As another object, the invention aims to provide an improved dosing accuracy. Summary of the Invention
    [00011] The present invention provides a piston for a cartridge for a drug delivery device, wherein the piston comprises at least one annular sealing surface to abut radially against an inner side wall of a cartridge, typically being cylindrical in shape. The piston is adapted to be slidably arranged in the cartridge and to provide a durable and leak-proof seal. The cartridge itself is typically designed as carpules or flask, in which the piston is slidably disposed for the purpose of expelling a liquid content from the cartridge through an outlet located opposite, hence the distal end portion of the cartridge.
    [00012] The piston further comprises an impulse receiving surface, which is adapted to receive an impulse by exerting the plunger of a drug delivery device. When in the stop position, the plunger serves to move the piston in a proximal direction in relation to the side wall of the cartridge, thus expelling a predefined dose of the medical fluid. Opposite its impulse receiving surface, the piston comprises a distal surface adapted to confine a drug to receive the volume of the cartridge.
    [00013] The pulse receiving surface, which, in a cartridge assembly configuration within a drug delivery device faces a plunger, comprises several centralizing elements protruding from the pulse receiving surface towards the piston. Said centralizing elements further comprise an external shape and geometry that substantially coincide with a corresponding plunger receptacle. Typically, the axial and lateral shapes of the corresponding centering elements and receptacle correspond in such a way that the centering elements can be inserted almost entirely into the receptacle. In other words, the piston receptacle comprises such a shape and geometry that the centering elements protruding from the piston receiving surface of the piston can be fully received therein, thus providing mutual lateral alignment of the piston and the piston.
    [00014] Preferably, the position and radial orientation of the centering elements on the piston impulse receiving surface correspond to the position and radial orientation of the receptacle on the piston, since the piston and piston are mutually centered. In this way, any manufacturing or assembly tolerances can be inherently compensated after insertion of the centralizing element into its corresponding receptacle on the plunger. In the event that, after mounting the piston and plunger of the drug delivery device, they are positioned at a certain radial displacement, moving the plunger in the distal direction, the plunger and / or the cartridge preferably become subject to a movement centering direction directed radially when the centering elements correspond to the corresponding plunger receptacle.
    [00015] The centralizing elements are arranged and aligned with the circumference of an imaginary or circular ring structure in the plane of the impulse receiving surface.
    [00016] The circular structure can be circular symmetrical, but it can also be oval or elliptical. By making use of a circular arrangement, mutual centering and alignment of the piston and plunger can be easily achieved when the circular structure is inherently symmetrical to the center of the impulse receiving surface.
    [00017] In a preferred embodiment, the centralizing elements and / or the circular structure corresponds to a circular shape of the piston receptacle. In this way, not only the structure and shape of several centralizing elements, but also their mutual distance and alignment correspond to the piston receptacle.
    [00018] In this embodiment, the at least one centralizing element may also comprise a rectangular and / or arcuate shape in a plane parallel to the impulse receiving surface. In addition, it is especially advantageous when several centralizing elements are arranged at a distance from each other on the circumference of said imaginary circular or annular structure.
    [00019] Each of the centralizing elements may, for example, comprise a somewhat rectangular shape, in which each centralizing element is slightly curved according to the radius and circumference of the imaginary circular structure.
    [00020] By having a circular receptacle or groove in the piston and having numerous centralization elements distributed along the circumference of the imaginary circle, a mutual radial centralization of the piston and piston, as well as a mutual orientation in the transverse plane can be achieved regardless of the piston orientation and its centering elements in the plane of the impulse receiving surface.
    [00021] In addition, and according to another preferred aspect, the centralizing elements comprise an arcuate shape in a plane parallel to the pulse receiving surface. Thus, the shape of at least some, preferably of all the centering elements, corresponds to the shape and geometry of the ring or piston ring receptacle. In this way, when the piston and piston are arranged with a slight lateral displacement, almost all of the available centering elements contribute in a very similar way to mutual piston and piston alignment and centering.
    [00022] According to another preferred embodiment of the invention, the at least one centering element is integrally formed with a piston body. Typically, the piston is manufactured by injection molding. It can comprise thermoplastic materials and / or natural or synthetic rubber. At least one of the centralizing elements can also act as a spacer or distance element that serves to prevent pistons from sticking together during a mass production process. Said at least one particular centering element comprises a button-like shape.
    [00023] In another preferred embodiment, the at least one centralizing element is tapered in the direction of the plunger. Consequently, the receptacle provided on the plunger also comprises a corresponding tapered cross-section, which makes it possible to receive the centering element therein entirely.
    [00024] In yet another preferred embodiment, the at least one centering element comprises a side beveled surface. Since the receptacle is correspondingly formed, by means of such chamfered surfaces, a radial adjustment of the piston and plunger can be achieved when mutually corresponding to the chamfered surfaces of the receptacle and the centering element come into contact in the course of a displacement axial and distal direction of the plunger.
    [00025] Preferably, the side chamfered surface of the at least one centering element is oriented at an angle of 20 ° to 80 ° with respect to the plane of the pulse receiving surface. More preferably, the side beveled surface of the centering element is oriented at an angle between 30 ° to 60 °, more preferably, the angle is about 45 °.
    [00026] Furthermore, it is advantageous when at least one centralizing element is substantially triangular or convex in a plane perpendicular to the impulse receiving surface. Thus, the side chamfered surface does not necessarily have to be straight. It can be bent, as to facilitate the mutual radial alignment of the piston and piston, in the course of a distal directed movement of the piston.
    [00027] According to another preferred embodiment of the invention, the ratio of axial extension of the at least one centering element, i.e. the extension substantially perpendicular to the impulse receiving surface versus its radial expansion, which is the parallel expansion for the plane of the pulse receiving surface, is greater than or equal to 0.6. This relationship is particularly beneficial for the purpose of radial centralization of the piston and piston or cartridge, in the course of a movement directed distally from the piston towards the piston.
    [00028] In another independent aspect, the invention additionally relates to a plunger of a drive mechanism for a drug delivery device, such as a pen-type injector. The plunger comprises an end face adapted to, but against a piston-receiving surface of a piston being slidably arranged in a cartridge containing drug. The face of the piston end facing the piston comprises at least one receptacle being adapted to receive a centralizing element which projects from the piston receiving surface of the piston.
    [00029] The surface receptacle as well as the centering element protruding from the piston impulse receiving surface mutually correspond in size, shape and geometry. In addition, the receptacle comprises a somewhat circular or annular shape that corresponds with the position and / or alignment of the centering element provided on the pulse receiving surface. In this way, an eventual radial displacement in the position or orientation of the piston and / or piston or cartridge can be compensated, in the course of bringing the piston and piston in a mutual abutment configuration.
    [00030] When the shape and geometry of the receptacle corresponds to the shape and geometry and / or the alignment of the piston centering element, the piston end face can almost entirely, but against the piston receiving surface of the piston. In this way, the impulse provided by the piston can be evenly distributed through the piston - piston interface. In addition, spot stresses that result from the prior art and its negative impact on dosage accuracy can be effectively reduced.
    [00031] In the preferred embodiments, the receptacle disposed on the end face of the plunger comprises a substantially U or V-shaped groove or circular geometry in the plane of the end face. Having a symmetrical circular receptacle, a plurality of centering elements spaced from one another and being arranged over an imaginary circumference of a corresponding circle can be inserted into the receptacle, regardless of the piston orientation in the plane of its impulse receiving surface.
    [00032] According to yet another preferred embodiment, the piston comprises an axially displaceable piston rod and a radially extending bearing disc. The rolling disc is rotatably supported by a distal end portion of the piston rod. Preferably, the rolling disc comprises the receptacle on its end face pointing towards the piston, when the drug delivery device is finally assembled.
    [00033] In a further independent aspect the present invention also relates to a cartridge for a drug delivery device comprising a substantially cylindrical cartridge body providing a drug reception volume at least partially filled with a drug and being sealed by piston, as described above. The drug is usually intended for injection into a patient's biological tissue.
    [00034] In addition, the invention also relates to a drug delivery device for delivering a predefined amount of a liquid medicament and being further adapted to receive a cartridge with a piston, as described above. The drug delivery device further comprises a drive mechanism having a plunger comprising at least one receptacle to be adapted to receive a centralizing element protruding from a piston receiving surface of said cartridge.
    [00035] The term "medicine", as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound,
    [00036] in which, in one embodiment, the pharmaceutically active compound has a molecular weight up to 1500 Da and / or is a peptide, a protein, a polysaccharide, a vaccine, a DNA, an RNA, an antibody, an enzyme, an antibody, a hormone or oligonucleotide, or a mixture of the above pharmaceutically active compound,
    [00037] in which in an additional embodiment the pharmaceutically active compound is useful for the treatment and / or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, thromboembolic disorders, such as deep venous or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis,
    [00038] wherein in an additional embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and / or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy,
    [00039] wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, the glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.
    [00040] Insulin analogues are, for example, human insulin Gly (A21), Arg (B31), Arg (B32); human insulin Lys (B3), Glu (B29); human insulin Lys (B28), Pro (B29); human insulin Asp (B28); human insulin, where proline at position B28 is replaced by Asp, Lys, Leu, Vai or Ala and where at position B29 Lys can be replaced by Pro; human insulin Ala (B26); des human insulin (B28-B30); Des human insulin (B27) and des human insulin (B30).
    [00041] Insulin derivatives are, for example, human insulin B29-N-myristoil-des (B30); human insulin B29-N-palmitoyl-des (B30); human B29-N-myristoyl insulin; human B29-N-palmitoyl insulin; human insulin B28-N -miristoil LysB28ProB29; human B28-N-palmitoyl-LysB28ProB29 insulin; human insulin B30-N-myristoyl-ThrB29LysB30; human insulin B30-N-palmitoyl-ThrB29LysB30; B29-N- (N-palmitoyl-Y-glutamyl) - des (B30); human insulin B29-N- (N-lithocholyl-Y-glutamyl) -des (B30); and human insulin B29-N- (ω-carboxy-heptadecanoyl) -des (B30) and human insulin B29-N- (-carboxy-heptadecanoyl).
    [00042] Exendin-4, for example, means exendin-4 (1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu- Ser-Lys- GIn-Met-Glu-GluGlu-Ala-Val-Arg-Leu-Phelle-Glu-Trp-Leu-Lys- Asn-Gly-Gly-Pro-Ser-Gly-Ala-Pro-Pro-Ser-NH2.
    [00043] Exendin-4 derivatives are, for example, selected from the following list of compounds: H- (Lys) 4-des Pro36, Pro37 des Exendina-4 (1-39) -NH2, H- (Lys) 5-des Pro36, Pro37 des Exendina-4 (1-39) -NH2, des Pro36 [Asp28] Exendina-4 (1-39), des Pro36 [lsoAsp28] Exendina-4 (1-39), des Pro36 [Met (O) 14, Asp28] Exendina-4 (1-39), des Pro36 [Met (O) 14, lsoAsp28] Exendina-4 (1-39), des Pro36 [Trp (O2) 25, Asp28] Exendina-4 (1-39), des Pro36 [Trp (O2) 25, lsoAsp28] Exendina-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, Asp28] Exendina-4 (1-39) , des Pro36 [Met (O) 14 Trp (O2) 25, lsoAsp28] Exendina-4 (1-39), or des Pro36 [Asp28] Exendina-4 (1-39), des Pro36 [lsoAsp28] Exendina-4 ( 1-39), des Pro36 [Met (O) 14, Asp28] Exendina-4 (1-39), des Pro36 [Met (O) 14, lsoAsp28] Exendina-4 (1-39), des Pro36 [Trp ( O2) 25, Asp28] Exendina-4 (1-39), des Pro36 [Trp (O2) 25, lsoAsp28] Exendina-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, Asp28 ] Exendina-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25 , lsoAsp28] Exendina-4 (1- 39),
    [00044] wherein the Lys6-NH2 group can be attached to the -C terminus of the exendin-4 derivative;
    [00045] or a derivative of exendin-4 of the sequence H- (Lys) 6-des Pro36 [Asp28] exendin-4 (1-39) -Lys6-NH2, des Asp28 Pro36, Pro37, Pro38Exendina-4 (1-39 ) -NH2, H- (Lys) 6-des Pro36, Pro38 [Asp28] Exendina-4 (1-39) -NH2, H-Asn- (Glu) 5des Pro36, Pro37, Pro38 [Asp28] Exendina-4 (1 -39) -NH2, des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) - (Lys) 6- NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Asp28] exendina-4 (1- 39) - (Lys) 6-NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- ( Lys) 6-des Pro36 [Trp (O2) 25, Asp28] exendin-4 (1-39) - Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Trp (O2) 25] Exendin-4 (1- 39) -NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendina-4 (1-39) -NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendina-4 (1 -39) -NH2, des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendina-4 (1 -39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H-Asn- (Glu) 5 -des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6 -from Pro36 [Met (O) 14, Asp28] Exendin-4 (1 - 39) - Lys6-NH2, des Met (O) 14 Asp28 Pro36, Pro37, Pro38 Exendina-4 (1 - 39) -NH2, H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28 ] exendin-4 (1-39) -NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (0) 14, Asp28] Exendin-4 (1-39) -NH2, des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39) - (Lys) 6-NH2, H-Asn- (Glu) 5 des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39) - (Lys ) 6-NH2, H-Lys6-des Pro36 [Met (O) 14, Trp (O2) 25, Asp28] -exendin 4 (1 -39) - -Lys6 NH2, H-des Asp28 Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25] Exendin-4 (1-39) -NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1 - 39) -NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (0) 14, Trp (O2) 25, Asp28] Exendina-4 (1 -39) -NH2, des Pro36, Pro37 , Pro38 [Met (O) 14, Trp (02) 25 , Asp28] exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (S1 -39) - (Lys) 6-NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (0) 14, Trp (O2) 25, Asp28] Exendin-4 (1 -39 ) - (Lys) 6-NH2;
    [00046] or one. pharmaceutically acceptable salt or solvate of any of the aforementioned Exedina-4 derivatives.
    [00047] Hormones are, for example, for pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, as listed in Liste Rote, ed. 2008, chapter 50, as Gonadotropin (follitropin, Lutropine, Choriongonadotropin, menotropin), Somatropin (somatropin), desmopressin, Terlipresine, Gonadorreline, Triptorelin, leuprorelin, busherelin, nafarelin, goserelin.
    [00048] A polysaccharide is, for example, a glucosaninoglycan, hyaluronic acid, heparin, low molecular weight heparin or a derivative of the same ultra low molecular weight heparin or a derivative thereof, or a sulfate, for example, forms a polysulfate of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a low molecular weight polysulfate heparin is enoxaparin sodium.
    [00049] Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. The acid addition salts are, for example, HCI or HBr salts. Basic salts are salts, for example, having a cation selected from alkali or alkali, for example, Na + or K +, or Ca2 +, or an N + (R1) (R2) (R3) (R4) , where R1 to R4 regardless of the mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or a C6-C10 group -optionally substituted heteroaryl. Other examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., USA, 1985 and in the Encyclopedia of Pharmaceutical Technology.
    [00050] Pharmaceutically acceptable solvates are, for example, hyd rats.
    [00051] It will be evident to those skilled in the art that various modifications and variations can be made with the present invention without departing from its spirit and scope. In addition, it is to be noted that any reference signs used in the appended claims are not to be construed as limiting the scope of the present invention. Brief Description of Drawings
    [00052] Without limitation, the present invention will be explained in more detail below in connection with the preferred embodiments and with reference to the drawings in which:
    [00053] figure 1 illustrates a cross-section of a region of the piston-plunger interface inside a pen-type injector according to the prior art,
    [00054] figure 2 shows a top view of the piston according to figure 1,
    [00055] figure 3 shows a cross-section of a region of the piston-plunger interface according to the present invention,
    [00056] figure 4 in a perspective illustration shows a piston according to the present invention,
    [00057] figure 5 shows a triangular shape of the centering element in the cross section,
    [00058] figure 6 shows a configuration of centering elements with respect to the corresponding grooves in a mutual thrust bearing disc before,
    [00059] figure 7 is illustrative of the interface according to figure 6, in which the rolling disc is radially displaced, but in contact with the centralizing element and
    [00060] figure 8 shows the interface according to figures 6 and 7, when a final stop position has been reached. Detailed Description
    [00061] The enlarged illustration of figure 3 shows a drug delivery device in cross-section of an intermediate section, where a plunger touches against a face of the proximal end 40 of a piston 36. The drug delivery device, such as as illustrated it comprises a housing 20 and a cartridge holder 22. The cartridge holder 22 is adapted to receive a cartridge 33 having a substantially cylindrical side wall 24. Within the cartridge 33, a piston 36 is slidably arranged. Piston 36 comprises two sealing surfaces 35 radially adjacent against the inner side wall 24 of cartridge 33. In this way, piston 36 provides a durable, leak-proof seal for a volume of drug reception from cartridge 33, which is confined proximally by the face of the distal lower end 42 of the piston 36.
    [00062] Opposite its distal surface 42, the piston 36 comprises several centralizing elements 34, which according to the illustration of figure 4 are substantially rectangular in shape. The centralizing elements 34 are formed integrally with the piston body 36, for example, through injection molding. The centering elements 34 are also arranged on the circumference of an imaginary circle. Therefore, the centering elements 34 are slightly bent, so as to follow the circumference of the imaginary circle. The center point of the imaginary circle typically ideally corresponds and overlaps with the central point of piston 36 itself.
    [00063] As also illustrated in the cross-section of figure 3, the plunger of the drug delivery device comprises a piston rod 10 by being threaded with a thread 18 being integrally formed with the housing 20. At the lower end, distal a rolling disc 32 is rotatably mounted on the piston rod 10. On its distal surface, the rolling disc 32 comprises a circumferential groove 38, which is adapted to receive entirely the button-like centering elements 34 protruding from the surface of impulse reception 40 of piston 36
    [00064] In the illustrations of figures 3 and 4, the groove 38 is somewhat U-shaped and the corresponding centering elements 34 of the piston 36 feature a convex shape in a plane perpendicular to the impulse receiving surface 40. Since the shape and geometry of the centering elements 34 correspond to the shape and geometry of the receptacle 38, a radial mutual alignment of the piston 36 and the cartridge 33 with respect to the plunger 10, 32 can be achieved as soon as the piston rod 10 is brought for contact with piston 36.
    [00065] Since the receptacle 38 provided on the end face 44 of the bearing disc 32 is symmetrically circular, a mutual radial centering and alignment of piston 36 or cartridge 33 and / or bearing disc 32 and piston rod 10 can be achieved, regardless of the rotational orientation of the cartridge 33 or its piston 36.
    [00066] In figure 5, a centralizing element 34 is separated illustrated in the cross-section. Here, the centering element 34 is substantially triangular in shape. It comprises a radial extension x and an axial extension y. In the preferred embodiments, the ratio of axial dimensions y to radial dimensions x of the centering element 34 is greater than or equal to 0.6. In addition, as illustrated in figure 5, the centering element 34 in a triangular shape comprises two beveled side surfaces 46.
    [00067] Since the shape, size and geometry of the centering elements 34 and the corresponding receptacle 38 must coincide, in this case also the receptacle 38 of the rolling disc 32 comprises a V-shaped contour, as illustrated in figures 6 to 8.
    [00068] As shown in the course of figures 6 to 8, the centering element 34 and its corresponding receptacle 38 formed in the bearing disc 32 are slightly displaced in a radial direction, with a distance 48. When the piston rod 10 is still moved in the distal direction, from there to piston 36, mutually corresponding to the chamfered surfaces 46, 39 of the centering element 34 and the receptacle 38 come into contact, as shown in figure 7. An additional movement of the rolling disc 32 in the distal direction, from there in figure 7, then automatically leads to a mutual radial centering of the bearing disc 32 and piston 36. As indicated by the arrow pointing left in figure 7, the bearing disc 32 and / or its stem interconnected piston 10 is subject to movement to the left.
    [00069] Finally, when a final configuration has almost been reached, as shown in figure 8, the piston 36 and the bearing disc 32 are almost perfectly aligned in the radial direction in relation to each other. Since the depth of the receptacle 38 corresponds to the axial projection of the centering element 34, the distal end face 44 of the bearing disc 32 abuts directly against the impulse receiving surface 40 of the piston 36 through a surface area relatively large. Thus, when a centralized mutual configuration as shown in Figure 8 has been achieved, the thrust exerted by the plunger 10 can be uniformly and homogeneously transferred to the piston 36 across almost the entire impulse receiving surface 40.
    [00070] In this way the point stresses can be reduced and the plunger 36 is less prone to inadvertent tilt or scale during dose release. In this way, the driving force required to move piston 36 in the distal direction can be maintained over a relatively moderate range. List of reference numbers 10 piston rod 12 bearing disc 14 distance element 16 piston 18 thread 20 housing 22 cartridge holder 23 cartridge 24 cartridge wall 25 sealing surface 32 bearing disc 33 cartridge 34 centering element 35 seal 36 piston 38 receptacle 39 chamfered surface 40 final surface 42 distal surface 44 end face 46 chamfered surface 48 distance
    权利要求:
    Claims (12)
    [0001]
    1. Drug delivery device for delivering a predefined amount of a liquid drug, the drug delivery device comprising: a) a drive mechanism comprising a plunger (10), wherein the plunger comprises an end face (44) comprising at least one circular or ring-shaped receptacle (38), b) a cartridge (33) comprising a cylindrical body of the cartridge and a piston (36), wherein the body of the cartridge provides a volume of drug reception at least partially filled with medicine and sealed by the piston (36), in which the piston is slidably arranged in the cartridge, in which the piston comprises: aa) a body comprising natural or synthetic rubber, bb) at least one annular sealing surface (44) to abut radially against an inner side wall (24) of the cartridge (33), cc) a distal surface (42) to confine the volume of drug reception from the cartridge (33), dd) a surface for receiving impulse (40) adapted to receive the pressure piston (10, 32) to move the piston in a distal direction in relation to the side wall (24), ee) in which the impulse receiving surface (40) comprises numerous elements of centering (34) projecting from the impulse receiving surface (40) towards the plunger (10, 32) and where the centering elements (34) are arranged and aligned on the circumference of an imaginary ring or circular structure, c ) in which the centering elements (34) comprise an external shape and geometry corresponding to the circular or annular shape of the piston receptacle (38) (10, 32), d) in which the shape of the receptacle (38) corresponds to the alignment of the centralization elements (34) and in which the receptacle (38) is adapted to receive numerous centralization elements (34), characterized by the fact that: e) the centralization elements (34) comprise an arcuate shape in a parallel plane the impulse receiving surface o (40) and where, in the use of the cartridge (33) in the medication delivery device, the centering elements (34) are entirely received in the receptacle (38) so that a distal end face (44) of the plunger (10, 32) fully touch the pulse receiving surface (40).
    [0002]
    2. Drug delivery device according to claim 1, characterized in that the depth and geometric shape of the receptacle (38) are configured so that the plurality of centering elements (34) are completely received in the receptacle when the piston and plunger (10, 32) are adjacent.
    [0003]
    Drug delivery device according to claim 1, characterized in that the pattern of the plurality of centralizing elements (34) and the shape of the receptacle (38) are circular.
    [0004]
    Drug delivery device according to claim 1, characterized in that the pattern of the plurality of centralizing elements (34) and the shape of the receptacle (38) are semicircular.
    [0005]
    Drug delivery device according to claim 1, characterized in that at least one centering element is a spacer configured to prevent mutual adherence of similar pistons when the pistons are mass produced.
    [0006]
    6. Drug delivery device according to claim 1, characterized by the fact that at least one centralizing element is a button-like protrusion.
    [0007]
    Drug delivery device according to claim 1, characterized in that the receptacle (38) has a radius of curvature and the plurality of centering elements (34) comprises folded rectangles corresponding to the radius of curvature of the receptacle .
    [0008]
    8. Drug delivery device according to claim 1, characterized in that at least one centralizing element (34) is tapered in the direction of the plunger (10, 32).
    [0009]
    Drug delivery device according to claim 1, characterized in that at least one centering element (34) comprises a beveled lateral surface (46) oriented at an angle of 20 ° to 80 ° with respect to the plane of the pulse receiving surface (40).
    [0010]
    Drug delivery device according to claim 1, characterized in that the plurality of centralizing elements (34) is integrally formed with the piston body (36).
    [0011]
    Drug delivery device according to claim 1, characterized in that the piston comprises an axially displaceable piston rod (10) and a radially extending bearing disc (32).
    [0012]
    Drug delivery device according to claim 11, characterized in that the rolling disc (32) is rotatably supported on a distal end portion of the piston rod (10) and has a distal end face comprising the receptacle (38).
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    同族专利:
    公开号 | 公开日
    CN102781499B|2015-05-13|
    SG181790A1|2012-07-30|
    AU2010332862B2|2014-11-20|
    EP2512562B1|2018-09-12|
    CA2780417A1|2011-06-23|
    KR20120106756A|2012-09-26|
    ZA201203362B|2013-01-30|
    US20150190581A1|2015-07-09|
    RU2012130337A|2014-01-27|
    NZ600595A|2014-02-28|
    IL220246D0|2012-07-31|
    IL220246A|2015-03-31|
    CN102781499A|2012-11-14|
    DE202010018328U1|2015-08-18|
    AU2010332862C1|2015-12-24|
    AU2010332862A1|2012-07-05|
    MY162192A|2017-05-31|
    JP5943840B2|2016-07-05|
    BR112012014467A2|2017-03-14|
    WO2011073307A1|2011-06-23|
    EP2512562A1|2012-10-24|
    US20130018328A1|2013-01-17|
    JP2013514101A|2013-04-25|
    MX336689B|2016-01-28|
    US9370624B2|2016-06-21|
    MX2012006600A|2012-06-19|
    RU2552887C2|2015-06-10|
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2019-12-31| B06G| Technical and formal requirements: other requirements|
    2020-05-12| B07A| Technical examination (opinion): publication of technical examination (opinion)|
    2020-08-11| B09A| Decision: intention to grant|
    2020-11-03| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/12/2010, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    EP09180005.2|2009-12-18|
    EP09180005|2009-12-18|
    PCT/EP2010/069869|WO2011073307A1|2009-12-18|2010-12-16|Piston for a cartridge and piston rod for a drug delivery device|
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