• 专利附录
  • 专利说明
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    • 专利摘要:
    DRIVE SET FOR A DRUG RELEASE DEVICE AND DRUG RELEASE DEVICE The present invention relates to a drive set for a drug release device (100), comprising: a housing (10) with a proximal end ( 11) and a distal end (12), and a longitudinal axis (A) extending between the proximal end (11) and the distal end (12); a rotation sleeve (40), which is rotatable relative to the housing (10); and a piston rod (50), which is axially movable relative to the housing (10). The piston rod (50) is in mechanical cooperation with the rotation sleeve (40), to be rotatable and movable in the distal direction, relative to the housing (10), when the rotation sleeve (40) rotates in a first direction ( D1), and is stationary in the axial direction relative to the housing (10), when the rotation sleeve (40) rotates in the second direction (D2) opposite the first direction (D1).
    公开号:BR112012013769B1
    申请号:R112012013769-7
    申请日:2010-12-06
    公开日:2021-03-02
    发明作者:Steffen RAAB；Uwe Dasbach
    申请人:Sanofi-Aventis Deutschland Gmbh；
    IPC主号:
    专利说明:

    [0001] The present invention relates to an actuation set for a drug delivery device, and a drug delivery device.
    [0002] Such drug delivery devices, for example, those disclosed in WO 00/62847 A1, WO 2008/148864 A1, WO 2010/066796 A1, EP 2 292 286 A1 or WO 2010/139630 A1, may have an application in which a user, without formal medical training, needs to administer an accurate and predefined dose of a medication or drug. In particular, these devices may have an application in which a medication is administered regularly or irregularly, based on a short or long period of time.
    [0003] It is an objective of the invention to provide an actuation set that provides improved operability. It is another object of the invention to provide a drug delivery device that is simple to use and provides an accurate drug release.
    [0004] This objective is achieved by a drive assembly, according to claim 1, and a drug delivery device, according to claim 13. Advantageous embodiments are the subject of the dependent claims.
    [0005] According to a first aspect, an actuation set, suitable for a drug delivery device, comprises a housing. The housing comprises a proximal end and a distal end. A longitudinal axis extends between the proximal end and the distal end. The drive assembly also comprises a rotation sleeve. The rotation sleeve is rotatable relative to the housing. The drive assembly comprises a piston rod. The plunger rod is axially movable in relation to the housing. The plunger rod is in mechanical cooperation, for example, in coupling with the rotation sleeve in the distal direction, relative to the housing, when the rotation sleeve rotates in a first direction relative to the housing, for example, to release a dose of medication . The plunger rod is in mechanical cooperation with the rotation sleeve, so that it is stationary or essentially stationary in the axial direction relative to the housing, when the rotation sleeve rotates in a second direction, opposite the first direction, for example, to adjust or select a dose of medication. An axial movement can be a movement along the longitudinal axis of the housing.
    [0006] The advantage of this drive set is that, due to the axial movement of the piston rod, relative to the housing, a very high mechanical stability of the piston rod, relative to the rotation sleeve, can be achieved. Consequently, a very high mechanical stability of the drive assembly can be achieved.
    [0007] The rotation sleeve can be fixed against axial displacement with respect to the housing. The plunger rod can be fixed against rotary movement in relation to the housing.
    [0008] In an advantageous embodiment, an actuating element is axially movable in relation to the housing. The drive element can be part of the drive set. The rotation sleeve is in mechanical cooperation, for example, in coupling, with the drive element, so that it is rotating relative to the housing, when the drive element is moved in the axial direction relative to the rotation sleeve.
    [0009] The rotation sleeve is arranged to be rotating relative to the housing, when the drive element is moved in the distal or proximal direction by mechanical interaction of the drive element and the rotation sleeve. Preferably, the drive element is axially oriented. The drive element can be grooved in the housing. An axial force, exerted on the drive element, for example, by a user, is transformed into a rotating movement of the rotation sleeve with respect to the housing. This force can be transformed into a distal movement of the piston rod with respect to the housing, when the rotation sleeve is rotating in the first direction.
    [00010] This has the advantage that a simple transformation of an axial force in the drive element in a rotating movement of the rotation sleeve, with respect to the housing, is possible. Furthermore, the axial movement of the drive element can be controlled in a very precise way. Therefore, an exact dose of the medication is facilitated. Furthermore, this can be convenient for the user of the drug delivery device, as there is no rotating movement of the drive element, necessary during its operation.
    [00011] In another advantageous embodiment, the rotation sleeve rotates in the first direction relative to the housing, when the drive element is moved in the distal direction, and rotates in the second direction, when the drive element is moved in the proximal direction.
    [00012] This has the advantage that a selection of a dose of the drug can be conducted in a simple way, when the actuating element is moved in the proximal direction. Furthermore, drug delivery can be conducted in a simple manner, when the drive element is moved in the distal direction. In addition, the axial movement of the proximal end allows control of the dose selection, as well as the injection of the dose very simply. Therefore, a very accurate dose of the medication, with a very low risk of applying the wrong dose, is facilitated.
    [00013] In another advantageous embodiment, the drive element and the rotation sleeve are coupled by a thread. Preferably, the drive element has an internal thread, which is coupled with a rotating sleeve coupling device. Alternatively, the rotation sleeve may have an external thread, which is coupled with a drive element coupling device.
    [00014] The thread is a suitable means for coupling the drive element and the rotation sleeve for a transformation of the axial movement of the drive element into a rotational movement of the rotation sleeve with respect to the housing.
    [00015] According to another advantageous embodiment, the rotation sleeve comprises a radial protrusion. The protrusion is arranged in the axial direction, between two sections of the housing. The two sections prevent axial movement of the rotation sleeve.
    [00016] This has the advantage that an axial movement of the rotation sleeve can be prevented in a simple way, and only a rotational movement of the rotation sleeve is possible.
    [00017] According to another advantageous embodiment, the piston rod has an external surface provided with at least one guide track disposed on the external surface. The rotation sleeve comprises a guide piece, which is arranged and movable on the guide track. Preferably, a guide track is arranged on the outer surface of the piston rod.
    [00018] This has the advantage that the guide track and guide piece can be designed in a simple way, to cooperate as a split guide, which has good mechanical coupling characteristics.
    [00019] According to another embodiment, the guide trail forms a zigzag type line on the external surface of the piston rod. The zigzag type line extends in the axial direction.
    [00020] This has the advantage that the plunger rod is movable in the distal direction relative to the housing, when the rotation sleeve is rotating in the first direction and is stationary in the axial direction relative to the housing, when the rotation sleeve is rotating in the second direction opposite the first direction for the accommodation.
    [00021] According to another advantageous embodiment, the guide track comprises primary sections and secondary sections. The primary sections are perpendicular to the longitudinal axis. The secondary sections are oblique relative to the longitudinal axis.
    [00022] This has the advantage that the plunger rod is movable in the distal direction, relative to the housing, when the rotation sleeve is turning in the first direction and is stationary in the axial direction relative to the housing, when the rotation sleeve is turning in the second direction opposite the first direction for the accommodation.
    [00023] According to another advantageous embodiment, the primary sections are designed to prevent axial movement of the piston rod. The primary sections can have a perpendicular extension relative to the longitudinal axis, which limits the rotational angular movement of the rotation sleeve. In particular, the rotational movement of the rotation sleeve, in the second direction with respect to the piston rod, can be limited by the angular extension of the primary sections.
    [00024] According to another advantageous embodiment, the secondary sections are designed to convert rotational movement of the rotation sleeve, in the first direction, into axial movement of the piston rod, for example, by mechanical interaction of the rotation sleeve and the rod plunger in the secondary sections.
    [00025] In another advantageous embodiment, the guide trail comprises at least one initiation section. The initiation section is arranged between one of the primary sections and one of the secondary sections.
    [00026] This has the advantage that an initiation operation can be conducted after the dose selection has started, and before the medication is dispensed. This facilitates an exact mechanical alignment between the different parts of the drug delivery device, and, consequently, can increase dose accuracy.
    [00027] In another advantageous embodiment, the guide track comprises at least one end section. The at least one end section is designed to limit the axial movement of the piston rod.
    [00028] This has the advantage that another distal movement of the piston rod can be prevented.
    [00029] In another advantageous embodiment, the piston rod is grooved in the housing.
    [00030] This has the advantage that the movement of the piston rod, in the axial direction, can be conducted in a very accurate manner.
    [00031] According to a second aspect, a drive assembly, suitable for a drug delivery device, comprises a housing. The housing comprises a proximal end and a distal end. A longitudinal axis extends between the proximal end and the distal end. The drive assembly also comprises a rotation sleeve. The rotation sleeve is rotatable relative to the housing. The drive assembly comprises a piston rod. The plunger rod is axially movable relative to the housing.
    [00032] The plunger rod has an outer surface with a guide track disposed on the outer surface. The rotation sleeve comprises a guide piece, which is arranged and movable on the guide track. The guide track and guide piece are designed to cooperate like a split guide.
    [00033] This has the advantage that the guide track and the guide piece can be designed in a simple way, to cooperate as a grooved guide, which provides a good orientation of the piston rod relative to the rotation sleeve.
    [00034] According to a third aspect, a drug delivery device comprises a drive assembly. The drug delivery device comprises a cartridge containing medication. The plunger rod interacts with a plug, which is disposed in the medication-containing cartridge, to dispense the medication.
    [00035] The terms "medication", "drug" and "drug" are used as equivalent expressions in this context.
    [00036] The terms "medication", "drug" and "drug", as used in this specification, preferably mean a pharmaceutical formulation containing at least one pharmaceutically active compound: in which, in one embodiment, the compound pharmaceutically active substance has a molecular weight of up to 1,500 Da and / or is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody, hormone or oligonucleotide, or a mixture of the pharmaceutically active compound mentioned above; wherein, in another embodiment, the pharmaceutically active compound is useful in the treatment and / or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, thromboembolism disorders such as pulmonary or deep vein thromboembolism, acute coronary syndrome (CHA), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis; wherein, in another embodiment, the pharmaceutically active compound comprises at least one peptide for treatment and / or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy; wherein, in another embodiment, the pharmaceutically active compound comprises at least one human insulin or a human insulin analog or derivative, a glucagon-like peptide (GLP-1), or an analog or derivative thereof, or exendin-3 or exendin-4, or an analogue or derivative of exendin-3 or exendin-4.
    [00037] Insulin analogs are, for example, Gly (A21), Arg (B31), Arg (B32) human insulin Arg (B32); Lys (B3), human insulin Glu (B29); Lys (B28), human insulin Pro (B29); human insulin Asp (B28); human insulin, where proline at position b28 is replaced by Asp, Lys, Leu, Val or Ala, and where, at position B29, Lys can be replaced by Pro; human insulin Ala (B26); human insulin Des (B28-B30); human insulin Des (B27) and human insulin Des (B30).
    [00038] Insulin derivatives are, for example, human insulin B29-N-myristoil-des (B30); human insulin B29-N-palmitoyl-des (B30); human insulin B29-N-myristoil; human B29-N-palmitoyl insulin; human B28-N-myristoil insulin LysB28ProB29; human insulin B28-N-palmitoyl-LysB28Pro B29; human insulin B30-N-myristoyl-ThrB29LysB30; human insulin B30-N-palmitoyl-ThrB29LysB30; human insulin B29-N- (N-palmitoyl-Y-glutamyl) -des (B30); human insulin B29-N- (N-litocolyl-Y-glutamyl) -des (B30); human insulin B29- N- (w-carboxy-heptadecanoyl) -des (B30) and human insulin B29-N- (w-carboxy-heptadecanoyl).
    [00039] Exendin-4 means, for example, Exendin-4 (1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu- Ser-Lys- Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu- Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro- Pro-Ser-NH2.
    [00040] Exendin-4 derivatives are selected, for example, from the following list of compounds: H- (Lys) 4-des Pro36, des Pro37 Exendin-4 (1-39) -NH2, H- (Lys) 5 -des Pro36, des Pro37 Exendin-4 (1-39) -NH2, des Pro36 [Asp28] Exendin-4 (1-39), des Pro36 [IsoAsp28] Exendin-4 (1-39), des Pro36 [Met ( O) 14, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14, IsoAsp28] Exendin-4 (1-39), des Pro36 [Trp (O2) 25, Asp28] Exendin-4 ( 1-39), des Pro36 [Trp (O2) 25, IsoAsp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, IsoAsp28] Exendin-4 (1-39); or des Pro36 [Asp28] Exendin-4 (1-39), des Pro36 [IsoAsp28] Exendin-4 (1-39), des Pro36 [Met (O) 14, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14, IsoAsp28] Exendin-4 (1-39), des Pro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39), des Pro36 [Trp (O2) 25, IsoAsp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, IsoAsp28] Exendin-4 (1-39), wherein the -Lys6-NH2 group can be attached to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence: H- (Lys) 6-des Pro36 [Asp28] Exendin-4 (1-39) -Lys6-NH2, des Asp28 Pro36, Pro37, Pro38Exendin-4 (1-39) - NH2, H- (Lys) 6-des Pro36, Pro38 [Asp28] Exendin-4 (1-39) -NH2, H-Asn- (Glu) 5des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39 ) -NH2, des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Asp28] Exendin-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] Exendin-4 (1-39) - NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin- 4 (1-39) -NH2, des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-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-des P ro36 [Met (O) 14, Asp28] Exendin-4 (1-39) -Lys6-NH2, des Met (O) 14 Asp28 Pro36, Pro37, Pro38 Exendin-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 (O) 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 (O) 14, Trp (O2) 25, Asp28 ] Exendin-4 (1-39) -NH2, des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 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, P ro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2; or a pharmaceutically acceptable salt or solvate of any of the Exendin-4 derivatives mentioned above.
    [00041] Hormones are, for example, pituitary hormones or hypothalamic hormones, or regulatory active peptides and their antagonists, as listed in Rote Liste, ed. 2008, chapter 50, such as Gonadotropin (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropin (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
    [00042] A polysaccharide is, for example, a glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin, or a derivative of it, or a sulfated form, for example, polysulfated polysaccharide mentioned above, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of an ultra-low polysulfated molecular weight heparin is enoxaparin sodium.
    [00043] Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. The acid addition salts are, for example, the HCl or HBr salts. Basic salts are, for example, salts having a cation selected from alkali or alkali, for example, Na + or K +, or Ca2 +, or an N + (R1) (R2) (R3) (R4) ammonium ion, where R1 to R4 independently mean: hydrogen, an optionally substituted C1 - C6 alkyl group, an optionally substituted C2 - C6 alkenyl group, an optionally substituted C6 - C10 heteroaryl group, or an optionally substituted C6 - C10 group. Other examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17 ed. Alfonso R. Genaro (Ed), Mark Publishing Company, Easton, Pa, U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology.
    [00044] Pharmaceutically acceptable solvates are, for example, hydrates.
    [00045] The exemplary embodiments of the invention are explained below, with the help of schematic drawings. These are as follows: Figure 1 - shows schematically parts of a drive set, according to an embodiment, in a perspective view; Figure 2 - shows schematically an actuating element, a rotation sleeve and a piston rod of the actuation set, according to an embodiment, in a perspective view; Figure 3 - schematically shows a section of the drug delivery device with the actuation set, according to one embodiment, in a longitudinal section view; Figure 4 - schematically shows a section of the piston rod, according to one embodiment, in a side plan view; Figure 4A - schematically shows a section of the piston rod, according to another embodiment, in a side plan view; Figure 4B - schematically shows a section of the piston rod, according to another embodiment, in a side plan view; Figure 4C - schematically shows a section of the piston rod, according to another embodiment, in a side plan view; Figure 4D - schematically shows a section of the piston rod, according to another embodiment, in a side plan view; and Figure 5 - schematically shows a drug delivery device.
    [00046] Figures 1 and 2 show a drive set. The drive assembly is preferably part of a drug delivery device 100 (see figure 5). Preferably, the drug delivery device 100 is a pen-type drug delivery device, which can inject drugs. Preferably, the drug delivery device 100 is a fixed dose device, which is configured to dispense preset doses. The drive assembly comprises a housing 10 (see figures 3 and 5). Furthermore, the drive assembly comprises a drive element 20 and a rotating sleeve 40. Additionally, the drive assembly comprises a piston rod 50.
    [00047] Preferably, the housing 10 extends between a proximal end 11 and a distal end 12. The housing 10 may have a hollow cylindrical shape. Preferably, housing 10 comprises a first section 14 and a second section 16. The first section 14 is shaped like a glove. The second section 16 is shaped like a disc. The second section 16 is firmly coupled to the first section 14.
    [00048] The housing 10 may comprise a coupling means at the distal end 12. The housing 10 may comprise a coupling means at the 2x 12. The coupling means at the distal end 12 may be for coupling the housing 10 with a cartridge retainer. 102 (figure 5). The cartridge retainer 102 interacts with the second section 16. The second section 16 acts as an intermediate element for the cartridge retainer 102, to obtain a defined position of the cartridge retainer 102.
    [00049] A longitudinal axis A extends between the proximal end 11 and the distal end 12. The longitudinal axis A extends basically through the center of the housing 10. The surfaces of the housing 10 extend basically along the longitudinal axis A. The housing 10 may comprise an opening, for example, to provide a display, which may show the number of dispensed or remaining doses of drug.
    [00050] The drive element 20 preferably comprises an internal thread 21, which extends in the axial direction (figure 3). The internal thread 21 of the drive element 20 follows a helical path, with a central axis of its path being the longitudinal axis A, or an axis parallel to the longitudinal axis A. In alternative embodiments, the rotation sleeve 40 has an external thread, which engages with a coupling device for the actuation element 20. The actuation element 20 is axially displaceable with respect to the housing 10, and thus provides for a rotational movement of the rotation sleeve 40 by the thread 21. Preferably, any axial movement of the drive element 20, relative to the rotation sleeve 40, is converted into a rotary movement of the rotation sleeve 40.
    [00051] The drive element 20 is preferably grooved in the housing 10. The drive element 20 preferably comprises at least one groove 22, which extends in the axial direction. The groove 22 is coupled with the housing 10, for example, with a flap. The flap is a part of the housing 10, or is locked in the housing 10. The groove 22, being in contact with the housing 10, can guarantee an axial movement of the drive element 20 relative to the housing 10. In alternative embodiments, the housing 10 it comprises a groove, and the drive element 20 has a flap, which is coupled with the groove.
    [00052] The drive element 20 preferably comprises a coupling means for coupling the drive element 20 with other elements. For example, a dosing knob 24 is coupled with the actuating element 20. The dosing knob 24 can transfer a force exerted on the dosing knob 24, in the distal or proximal direction with the actuating element 20. The pressing knob 24 can be pushed in the distal direction with respect to accommodation 10, to administer a dose of medication. The dosing knob 24 can be pulled in the proximal direction, with respect to the housing 10, to adjust a dose of medication. In another embodiment, the force to deliver a dose of medication is exerted directly on the drive element 20. In this embodiment, no separate dosing button 24 is required. The force can be a force being exerted manually on the dosing button 24 by a user.
    [00053] The rotation sleeve 40 has an outer surface 42. The outer surface 42 comprises a coupling device 43, which extends in the axial direction and is coupled with the thread 21 of the driving element 20. The thread 21 and the coupling device 43 provides for a transformation of an axial movement of the driving element 20 into a rotary movement of the rotation sleeve 40. A rotational movement of the rotation sleeve 40 can be conducted in a first direction D1, or in a second direction D2, which is counterclockwise with the first direction D1. In particular, a rotary movement of the rotation sleeve 40, in the first direction D1, can be obtained by a movement of the driving element 20 in a distal direction D3, relative to the housing 10, which is a distal movement of the driving element 20. Consequently, a rotational movement of the rotation sleeve 40, in the second direction D2, can be obtained by a proximal axial movement of the driving element 20, relative to the housing 10 in a proximal direction D4.
    [00054] The rotation sleeve 40 further comprises a protrusion 44, for example, a flange directed radially outwards, extending in the radial direction. As the protrusion 44 is arranged in the axial direction, between the first section 14 and the second section 16 of the housing 10 (see figure 3), an axial movement of the rotation sleeve 40, relative to the housing 10, can be prevented. Therefore, the rotation sleeve 40 conducts a rotary movement only in the first direction D1 and in the second direction D2.
    [00055] The rotation sleeve 40 has a guide piece 45 protruding from an internal surface of the rotation sleeve 40 in the radial direction, in particular, in the direction of the longitudinal axis A of the housing 10. The guide piece 45 is in coupling with the plunger rod 50.
    [00056] The plunger rod 50 has an outer surface 52. A guide track 53 is arranged on the outer surface 52 of the plunger rod 50. Preferably, the guide piece 45 of the rotating sleeve 40 is arranged on the guide track 53. Preferably, the guide piece 45 is movable on the guide track 53. The coupling of the guide piece 45 and the guide track 53 provides a secure connection connection between the rotation sleeve 40 and the piston rod 50.
    [00057] Preferably, the guide piece 45 has a circular square section, as shown in figures 4 and 4A. This provides a uniform and safe movement of the guide piece 45 on the guide track 53.
    [00058] Figure 4 shows in a detailed view the guide track 53 of the piston rod 50. The guide piece 45 and the guide track 53 are coupled. The guide track 53 extends on the outer surface 52 of the plunger rod 50, which can be curved. To illustrate the function of the rotation sleeve 40 and the piston rod 50, the path of the guide track 53 is shown in a plan view in figure 4. The guide track 53 can be moved along the guide piece 45, when the plunger rod 50 is moved in the distal direction.
    [00059] As can be seen particularly in Figures 4, 4A and 4B, the guide track 53 is preferably formed as a zigzag-shaped line on the outer surface 52 of the plunger rod 50. Preferably, the The zigzag-shaped line extends in the axial direction, in particular, as far as a major direction of the extension of the guide track 53 is considered.
    [00060] Guide track 53 has consecutive segments, and each consecutive segment of guide track 53 comprises a first section 54 and a second section 55. Each consecutive segment of one of the primary sections 54 and one of the secondary sections 55 is formed as a "V". A single of these consecutive segments, formed as a "V", is shown in figures 4B, 4C and 4D. The primary sections 54 conveniently extend perpendicular or essentially perpendicular to the longitudinal axis A and act as dose adjustment sections. Guide piece 45 moves in primary sections 54 during dose adjustment. Secondary sections 55 extend obliquely to the longitudinal axis A and act as dose-dispensing sections. If the first section 54 of a segment is oblique with respect to axis A, the second section 55 of that segment is preferably more oblique with respect to axis A. However, it is preferred that the primary sections 54 extend perpendicular with respect to axis A. Guide piece 45 moves in secondary sections 55 during dose dispensing. Secondary sections 55 define primary paths P1, and primary sections 54 define secondary paths P2. Primary paths P1 and secondary paths P2 are designed to guide guide piece 45. In general, primary sections 54 and secondary sections 55 are arranged alternately along guide track 53, thereby forming the line in zigzag to guide track 53.
    [00061] In an alternative embodiment, the guide track 53 has the secondary sections 56, 57 with different axial extensions. The angle of one 56 of the secondary sections, as seen in the projection on the A axis, may be different from the angle of the other 57 of the secondary sections, as seen in the projection on the A axis. Consequently, the length of one 56 of the secondary sections may be different. the length of the other 57 of the secondary sections. As the axial extension of the second oblique section 55 defines the axial displacement of the plunger rod 50, the length of the secondary sections 56, 57 determines the dose of drug injected during the displacement of the guide piece 45 in the second section 55.
    [00062] In the embodiment of figure 4, between an end of one of the primary sections 54 and an adjacent end of one of the secondary sections 55, an initiation section 58 is arranged. The initiation section 58 allows a small axial movement of the guide track 53 with respect to the guide piece 45, during the transition of the guide piece 45 from an interaction with the first section 54 to an interaction with the second section 55. The small axial movement can be promoted by converting the rotation of the rotation sleeve 40, in the first direction D1, into axial movement, when the guide piece 45 interacts with the initiation section 58. Due to the small axial movement, which can be small, if compared to the axial movement of the piston rod 50, during dose release, the guide piece 45 and the guide track 53 can be positioned relatively to each other, so that the guide piece 45 can interact with the second section 55 of the segment of moment, during a subsequent rotation of the rotation sleeve 40, in the second direction D2.
    [00063] The guide track 53 further comprises two end sections 59, one at the upper end and another at the lower end of the guide track 53, with respect to figures 4 and 4A.
    [00064] The piston rod 50 furthermore comprises a guide element 60. Therefore, the piston rod 50 is grooved in the housing 10. This facilitates a precise movement of the piston rod 50 in the axial direction, without a rotation.
    [00065] In the embodiment of figure 4A, the initiation section 58 is arranged at the lower end of the guide track 53 and is shaped as an oblique section. The initiation section 58 provides an axial movement of the guide track 53 with respect to the guide piece 45. This axial movement can be done by converting the rotation of the rotation sleeve 40, in the first direction D1, into an axial movement, when the guide piece 45 interacts with the initiation section 58, before the first dose release. Due to this axial movement, which may be small compared to the axial movement of the piston rod 50, during dose release, the guide piece 45 and the guide track 53 can be positioned relatively to each other, so that the guide 45 can interact with the second section 55 of the moment segment, during a subsequent rotation of the rotation sleeve 40, in the second direction D2.
    [00066] In the embodiment of figure 4A, the end end 59 is disposed at the proximal end of the second uppermost section 55, in relation to figure 4A. This makes it possible to prevent a further adjustment movement of the plunger rod 50 immediately after the last permissible dose has been dispensed. In the embodiment of figure 4, a subsequent dose adjustment movement is allowed, while the subsequent dose dispensing movement, which would have to be performed, is prevented.
    [00067] In the embodiment of figures 4B and 4C, the guide piece 45 has an almost circular square section, with an oblique cut at its proximal end. The angles of the oblique cuts are different in figures 4B and 4C. The oblique cut allows a uniform and safe movement of the guide piece 45 on the guide track 53.
    [00068] In the embodiment of figure 4D, the guide piece 45 has a quadrilateral square section. This shape of the guide piece 45 provides a safe movement of the guide piece 45 on the guide track 53.
    [00069] Furthermore, in the embodiment of figures 4B, 4C and 4D, the first section 54 of the guide track 53 has a wedge-shaped projection 62, extending from the proximal wall of the first section 54. The projection 62 can be elastically deformable. The projection 62 reduces the cross section, in particular the axial extension of the first section 54. The first section 54 can taper in the direction from right to left in the view of figures 4B, 4C and 4D. The projection 62 is in mechanical cooperation with the guide piece 45. The shape of the guide piece 45 of figures 4B, 4C and 4D, in particular in combination with the wedge projection 62, can prevent an unintended backward movement of the guide piece 45 on the guide track 53. The reason for this is that, after the guide piece 45 has passed through the projection 62, during its movement from the first section 54 to the second section 55, the shape of the guide piece 45, with its upper right edge, and the shape of the projection 62 result in the guide piece 45 attaching to the second section 55, and therefore preventing movement of the guide piece 45 of the second section 55 back to the first section 54.
    [00070] Additionally or alternatively, in the embodiment of figures 4A, 4C and 4D, a recess 64 is disposed between the first section 54 and the second section 55, adjacent to the projection 62. The recess 64 increases the flexibility of the projection 62, in the case in which the guide piece 45 passes through the projection 62, during its movement from the first section 54 to the second section 55. Consequently, a safe passage from the guide piece 45, from the first section 54 to the second section 55, is possible without the interference from impeding the movement of the guide piece 45, from the second section 55 back to the first section 54.
    [00071] Figure 5 shows the drug delivery device 100. The drug delivery device 100 can be a fixed dose device, in particular, a device for dispensing fixed doses, not variable by the user, for example, constant. The drug delivery device 100 comprises a cartridge containing medication 101, which is disposed in the cartridge retainer 102 (figure 3). Cartridge 101 holds a medication 103. The medication and the drug are used as equivalent expressions in this context. The drug delivery device 100 further comprises a needle device 104. The needle device 104 is disposed at the distal end of the cartridge containing medication 101, and is preferably attached to it. Medication 103 may be dispensed by needle device 104. Medication 103 may comprise insulin, growth hormones, low molecular weight heparins and / or their analogs and / or derivatives. Medication 103 can be a fluid.
    [00072] A plug 105 is disposed inside the cartridge 101. The plug 105 is capable of being moved inside the cartridge 101. A displacement of the plug 105, in the distal direction relative to the cartridge 101, results in a dispensing of medication. The movement of the plug 105 is actuated by the piston rod 50. The piston rod acts on the plug 105 by means of a bearing 70. Preferably, the bearing 70 is arranged axially between the piston rod 50 and the plug 105. Alternatively, the bearing 70 can be eliminated.
    [00073] At the proximal end of the cartridge containing medication 101, the drive set is arranged. The medication-containing cartridge 101 is preferably attached to the housing 10, on the side of the distal end of the housing 10.
    [00074] Next, the function of the drive set and the drug delivery device will be described in detail, in particular in view of the embodiment of figure 4.
    [00075] An actuation of the dosing knob 24, preferably a manually actuated movement of the dosing knob 24 in relation to the housing 10, causes linear displacement of the actuating element 20, which is part of the actuating set. The drive element 20 is moved linearly in the distal direction, for example, towards the distal end 12 and the needle device 104, respectively. The linear displacement of the driving element 20 causes a rotational movement of the rotation sleeve 40 in one of the secondary directions D1, D2 and a corresponding displacement to the piston rod 50. The displacement of the piston rod 50, in the injection phase, is, preferably linear.
    [00076] During a dose adjustment, the user pulls the actuation element 20 in the proximal direction D4. As the movement of the driving element 20 in the proximal direction D4, relative to the housing 10, is correlated with the rotational movement of the rotation sleeve 40, in the second direction D2, the guide piece 45 of the rotation sleeve 40 moves along the first section 54 of the guide track 53 in the second path P2, from left to right, with respect to figure 4. In another embodiment not shown, with a guide track in a mirror image arrangement with respect to figure 4, the Guide piece can move along the first section of the guide track, from left to right on the second path. The movement of the guide piece 45 is restricted by two limiting walls of the guide track 53. The guide piece 45 moves along the second path P2, until the guide piece 45 contacts the wall of the guide track 53, for example, a wall to the left of the guide track 53, close to the transition area or in the transition area between the first section 54 and the second section 55 of the moment segment of the guide track 53.
    [00077] During the transition of the guide piece 45, from one of the primary sections 54 to one of the secondary sections 55, the guide piece 45 passes through the initiation section 58. Thereby, a small axial movement of the plunger rod 50 , in the distal direction, is obtained. In addition to this small axial movement of the plunger rod 50, the plunger rod 50 may not move in the axial direction relative to the housing 2, during the dosing adjustment process. The small axial movement of the plunger rod 50 can achieve an exact mechanical alignment of the plunger rod 50, relative to the housing 10 and the cartridge 101. Consequently, an exact dosage of medication 103, during the next dispensing phase, is facilitated. Furthermore, the initiation section 58 can prevent movement of the guide piece 45 along the second path P2 back to the starting point, during the next process step, as another wall, for example, the wall on the right of the guide track 53, it will mechanically cooperate with the guide piece 45, to prevent the reentry of the first section 54 previously passed. At the end of the second path P2, the dosage adjustment process is completed.
    [00078] To dispense the dose, the user pushes the actuating element 20 of the drug delivery device 100 in the distal direction D3. As the movement of the driving element 20, in the distal direction D3, relative to the housing 10, is correlated with a rotational movement of the rotation sleeve 40, in the first direction D1, the guide piece 45 of the rotation sleeve 40 follows the first path P1 of the second section 55, from left to right with respect to figure 4. The movement of the guide piece 45 is again restricted by the two limiting walls of the guide track 53. The guide piece 45 then cooperates with the right wall of the guide track 53. Therefore, the guide piece 45 moves along the first path P1, until the guide piece 45 reaches the transition area, between the second section 55 of the moment segment and the first section 54 of a subsequent segment of the guide track 53. During this movement, the plunger rod 50 is moved in the distal direction, due to the interaction of the guide piece 45 with the oblique wall of the second section 54. In this way, medication 103 can be dispensed from cartridge containing medication 101.
    [00079] After a described dose adjustment and dispensing cycle has been carried out, a user can carry out the described dose adjustment and dispensing steps in consecutive steps, in which the guide piece 45 of the rotation sleeve 40 is oriented by the consecutive segment of the primary sections 54 and one of the secondary sections 55. In this way, multiple doses of a drug can be dispensed.
    [00080] The end sections 59 of the guide track 53 limit the movement of the guide piece 4, and, consequently, the movement of the plunger rod 50 relative to the housing 10. The two end sections 59 define the maximum number of sections consecutive and, consequently, the dose adjustment and dose dispensing cycles, which can be conducted by the user. In particular, the end section 59, at the proximal end of the guide track 53, can prevent a dispensing movement of the plunger rod 50, after the last permissible dose has been dispensed.
    [00081] The function of the drive assembly and the drug delivery device of the embodiment of figure 4A differs from the function of the embodiment of figure 4 in that the initiation section 58 is arranged at the lower end of the guide track 53 and is shaped like an oblique section. Therefore, the exact mechanical alignment of the plunger rod 50, relative to the housing 10 and the cartridge 101, is carried out only once in conjunction with the first dosage adjustment, before the first dose dispensing, so that an exact dosage of the medication 103, during the first dose dispensing phase, can be obtained. Furthermore, the different position of the end section 59, at the proximal end of the guide track 53, may prevent another adjustment movement of the piston rod 50, after the last permissible dose has been dispensed.
    [00082] The function of the drive set and the drug delivery device of the embodiment of figures 4B, 4C and 4D differs from the function of the embodiment of figure 4 in the fact that the mechanical cooperation between the guide piece 45 and the projection wedge-shaped 62, it can prevent movement of the guide piece 45 along the second path P2 back to the starting point during the next process step. After the guide piece 45 has passed through the wedge projection 62, the guide piece 45 attaches to the second second section 55, and a reentry in the first section 54 previously passed can be prevented by the wedge projection 62, which blocks the passage from the second section 55 back to the first section 54. LIST OF REFERENCE NUMBERS 10 - housing 11 - proximal end 12 - distal end 14 - first section 16 - second section 20 - actuating element 21 - thread 22 - groove 24 - button 40 - rotation sleeve 42 - outer surface 43 - coupling device 44 - protrusion 45 - guide piece 50 - piston rod 52 - outer surface 53 - guide track 54 - first section 55 - second section 56 - second section 57 - second section 58 - initiation section 59 - end section 60 - guide element 62 - projection 64 - recess 70 - bearing 100 - drug delivery device 101 - cartridge containing medication 102 - cartridge retainer 103 - med ication 104 - needle device 105 - plug A - longitudinal axis D1 - first direction D2 - second direction D3 - distal direction D4 - proximal direction P1 - first path P2 - second path
    权利要求:
    Claims (11)
    [0001]
    1. Drive assembly for a drug delivery device (100), comprising: - a housing (10) with a proximal end (11) and a distal end (12), and a longitudinal axis (A) extending between the proximal end (11) and distal end (12); - a rotation sleeve (40), which is rotatable with respect to the housing (10); characterized by the fact that the drive set for the drug delivery device (100) comprises: - a drive element (20) is axially movable with respect to the housing (10), and the rotation sleeve (40) is in mechanical cooperation with the drive element (20) to be rotatable with respect to the housing (10) when the drive element (20) is moved in the axial direction with respect to the rotation sleeve (40), where the rotation sleeve ( 40) rotates in a first direction (D1) in relation to the housing (10) when the drive element (20) is moved in the distal direction and rotates in a second direction (D2) when the drive element (20) is moved in the proximal direction, and - a plunger rod (50), which is axially movable with respect to the housing (10), in which the plunger rod (50) is implemented to be in mechanical cooperation with the rotation sleeve (40), to be mobile in the distal direction, in relation to the housing (10), when the rotation sleeve (40) rotates a in the first direction (D1), and is stationary in the axial direction in relation to the housing (10), when the rotation sleeve (40) rotates in the second direction (D2) opposite the first direction (D1), and in which the rod plunger (50) has an outer surface (52) provided with at least one guide track (53) arranged on the outer surface (52), and the rotation sleeve (40) comprises a guide piece (45) being arranged and being mobile on the guide trail (53).
    [0002]
    2. Drive assembly, according to claim 1, characterized by the fact that the guide track (53) forms a zigzag type line on the outer surface (52) of the piston rod (50), the line of the zigzag type extending essentially in axial direction.
    [0003]
    3. Drive assembly according to claim 1 or 2, characterized by the fact that the guide track (53) comprises first sections (54) and second sections (55), the first sections (54) being perpendicular to each other to the longitudinal axis (A) and the second sections (55) being oblique in relation to the longitudinal axis (A).
    [0004]
    4. Drive assembly according to claim 3, characterized by the fact that the first sections (54) are designed to prevent axial movement of the piston rod (50) and have a perpendicular extension in relation to the longitudinal axis (A ) which limits the rotation movement of the rotation sleeve (40).
    [0005]
    5. Drive assembly according to claim 3 or 4, characterized in that the second sections (55) are designed to convert rotational movement of the rotation sleeve in the first direction into an axial movement of the piston rod (50) .
    [0006]
    Piston assembly according to any one of claims 3 to 5, characterized in that the guide track (53) comprises at least one initiation section (58) being arranged between one of the first sections (54) and one of the second sections (55).
    [0007]
    Piston assembly according to any one of claims 1 to 6, characterized in that the guide track (53) comprises at least one end section (59) being designed to limit the axial movement of the piston rod (50).
    [0008]
    Drive assembly according to either of Claims 1 or 7, characterized in that the drive element (20) and the rotation sleeve (40) are coupled by a thread (21).
    [0009]
    9. Drive assembly according to any one of the preceding claims, characterized by the fact that the rotation sleeve (40) comprises a radial protuberance (44), being arranged in the axial direction between the two sections (14, 16) of the housing (10), the two sections preventing an axial movement of the rotation sleeve (40).
    [0010]
    10. Drive assembly according to any one of the preceding claims, characterized by the fact that the piston rod (50) is grooved in the housing (10).
    [0011]
    11. Drug delivery device (100) with a drive assembly as defined in any of claims 1 to 10, the drug delivery device (100) characterized by the fact that it comprises a cartridge containing medication (101), and the plunger rod (50) interacts with a plug (105), being disposed in the cartridge containing medication (101), to dispense the medication (103).
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    同族专利:
    公开号 | 公开日
    AU2010330032B2|2014-07-24|
    IL220168D0|2012-07-31|
    CN102686257A|2012-09-19|
    BR112012013769A2|2020-08-25|
    BR112012013769B8|2021-06-22|
    DE202010018521U1|2017-05-11|
    CA2779284A1|2011-06-16|
    DK2509662T3|2019-08-05|
    JP2013512743A|2013-04-18|
    US9289560B2|2016-03-22|
    EP2509662A2|2012-10-17|
    US20130110054A1|2013-05-02|
    AU2010330032A1|2012-06-21|
    WO2011069935A2|2011-06-16|
    JP5830027B2|2015-12-09|
    EP2509662B1|2019-05-22|
    EP3192548B1|2021-01-27|
    WO2011069935A3|2011-08-11|
    DK3192548T3|2021-04-19|
    EP3192548A1|2017-07-19|
    IL220168A|2014-12-31|
    CN102686257B|2014-09-03|
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    法律状态:
    2020-09-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-12-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-03-02| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 02/03/2021, OBSERVADAS AS CONDICOES LEGAIS. |
    2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/12/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |
    优先权:
    申请号 | 申请日 | 专利标题
    EP09178213|2009-12-07|
    EP09178213.6|2009-12-07|
    PCT/EP2010/068915|WO2011069935A2|2009-12-07|2010-12-06|Drive assembly for a drug delivery device and drug delivery device|
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