JP5847171B2 - Drive mechanism for a drug delivery device - Google Patents

Description

  The present invention relates to a drive mechanism for a drug delivery device.

  In a drug delivery device, the piston within the cartridge containing the drug can be displaced distally relative to the cartridge by a piston rod that moves distally relative to the cartridge.

  A fixed dose pen-type syringe is a device that can be used to inject many set dose sizes from a prefilled cartridge that may be made of glass. This is ideally suited for chronic daily treatments where repeated doses of the same size are regularly required. The device may be disposable or reusable.

  An object of the present invention is to provide a drive mechanism that can be reset.

To achieve this objective, a drive mechanism for a drug delivery device is provided that can be switched between a normal operation mode and a reset mode.
The drive mechanism is:
A housing comprising a proximal end and a distal end;
-Adapted to displace distally relative to the housing to deliver a dose in the normal operating mode of the drive mechanism and displaced proximally relative to the housing in the reset mode of the drive mechanism Piston rod adapted to do;
A drive member whose rotation is movable relative to the housing in a rotational direction;
Where in the normal operation mode the rotational movement of the drive member in the rotational direction relative to the housing is converted into the distal movement of the piston rod relative to the housing and in the reset mode the piston rod is driven The drive member is connected to the piston rod so as to release the connection from the member.

  After delivering all the doses and replacing the cartridge with a new one that contains the drug, this drive mechanism that can replace the cartridge can be reset. During this change, the drive mechanism must be reset. The device can be easily reconfigured by the user. Moreover, the device is reusable and therefore protects the environment.

  In normal operation, the rotational motion of the drive member in the rotational direction relative to the housing can be converted to the rotational motion of the piston rod in the same direction, and in the reset mode, the piston rod can rotate relative to the drive member. is there. In other words, in the reset mode, the piston rod disengages from the drive member so that the piston can rotate proximally relative to the initial starting position.

  In one embodiment, the drive member is splined to the piston rod in the normal operating mode. The drive member does not spline engage the piston rod in the reset mode. The spline connection, meaning that the spline engages the piston rod in the normal operating mode, is retractable, and the spline disengages from the piston rod in the reset mode.

  Further embodiments of the drive mechanism operate in different ways. In the normal operation mode, the rotational movement of the drive member relative to the piston rod is converted into the distal movement of the piston rod relative to the housing, and in the reset mode, the piston rod is simply axially relative to the drive member. Just move. The drive member is threadedly connected to the piston rod in the normal operation mode. In the reset mode, the drive member, which can be implemented by separating the protrusion forming the outer thread of the screw connection from the track of the piston rod forming the inner thread of the screw connection, is no longer screw connected. This makes it possible to move the piston rod axially to its initial starting position.

  One embodiment of the drive mechanism is suitable for releasably coupling with the cartridge holder, wherein the drive mechanism switches to a reset mode when the cartridge holder is removed from the drive mechanism. In other words, removing and attaching the cartridge holder serves as a trigger for switching between operating modes.

  One embodiment of the drive mechanism having an inner side facing the piston rod and an outer side of the piston rod includes engagement means. In the normal operating mode, the engaging means protrudes inward and engages the track at the piston rod. In the reset mode, the engagement means protrudes outward. The engagement means may be integrally formed with a drive member, for example a tongue-shaped part that can be pushed inward, thereby spline engaging the drive member with the piston rod. Alternatively, the engagement means may be formed as a separate part that couples to a drive member, for example, a radially movable rivet-shaped engagement means.

  In one embodiment, the engagement means includes a spring and the engagement means is biased outward. Preferably, the drive member releases the connection from the piston rod at this position.

  The drive mechanism may further include push means for moving the engagement means to a position that pushes the engagement means inward when the drive mechanism switches to the normal operation mode. In the reset mode, the pushing means moves away from the engaging means so that it moves outward. Alternatively, the drive mechanism includes push means, where the drive member moves relative to the push means so that when the drive mechanism switches to a normal operation mode, the push means pushes the engagement means inward. In other words, the pushing means can be pushed towards the engaging means, or the engaging means can be pushed towards the pushing means.

  One embodiment of the engagement means is formed as a spring having a projecting element that engages the drive member and the piston rod in the normal operating mode, thereby spline engaging the drive member with the piston rod. The protruding element is biased so that the drive member is rotatable relative to the piston rod. The spring is deformable so that the protruding element can lock the rotation of the drive member and the piston rod.

  In one embodiment, the drive member has a track and the piston rod has a track. The protruding element engages the track in the normal operation mode. The track of the drive member can be formed as a groove in which the protruding element can extend into the track of the piston rod.

  In one embodiment, a push member is provided that is movable to a position that pushes the protruding element in the track of the drive member and piston rod. The push member may push the protruding element, thereby coupling the drive member with the piston rod.

As used herein, the term “drug” preferably means a pharmaceutical formulation comprising at least one pharmaceutically active compound,
Here, in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da and / or a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody, hormone or oligonucleotide Or a mixture of the above pharmaceutically active compounds,
Here, in a further embodiment, the pharmaceutically active compound is diabetic or diabetic complications such as diabetic retinopathy, thromboembolism such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS) ), Useful for the treatment and / or prevention of angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis,
Here, in a further embodiment, the pharmaceutically active compound comprises at least one peptide for the treatment and / or prevention of diabetes or complications associated with diabetes such as diabetic retinopathy,
Here, in a further embodiment, the pharmaceutically active compound comprises at least one human insulin or human insulin analog or guide, glucagon-like peptide (GLP-1), or an analog or guide or exendin- 3 or exendin-4 or exendin-3 or an analog or guide of exendin-4.

  Insulin analogues include, for example, Gly (A21), Arg (B31), Arg (B32) human insulin; Lys (B3), Glu (B29) human insulin; Lys (B28), Pro (B29) human insulin; B28) Human insulin; human insulin, wherein proline at position B28 is replaced with Asp, Lys, Leu, Val or Ala, and at position B29, Lys may be replaced with Pro; Ala (B26) human insulin; Des (B28-B30) human insulin; Des (B27) human insulin, and Des (B30) human insulin.

  Insulin guides are, for example, B29-N-myristoyl-des (B30) human insulin; B29-N-palmitoyl-des (B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28 -N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N- (N-palmitoyl-γ ) -Des (B30) human insulin; B29-N- (N-ritocryl-γ-glutamyl) -des (B30) human insulin; B29-N- (ω-ca Ruboxyheptadecanoyl) -des (B30) human insulin and B29-N- (ω-carboxyheptadecanoyl) human insulin.

Exendin-4 is, for example, exendin-4 (1-39), 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-NH ₂ sequence Means peptide.

Exendin-4 guides are, for example, the following compound list:
H- (Lys) 4-desPro36, desPro37 exendin -4 (1-39) -NH _2;
H- (Lys) 5-desPro36, desPro37 exendin-4 (1-39) -NH ₂ ;
desPro36 [Asp28] exendin-4 (1-39);
desPro36 [IsoAsp28] exendin-4 (1-39);
desPro36 [Met (O) 14, Asp28] exendin-4 (1-39);
desPro36 [Met (O) 14, IsoAsp28] exendin-4 (1-39);
desPro36 [Trp (O2) 25, Asp28] exendin-4 (1-39);
desPro36 [Trp (O2) 25, IsoAsp28] exendin-4 (1-39);
desPro36 [Met (O) 14Trp (O2) 25, Asp28] exendin-4 (1-39);
desPro36 [Met (O) 14Trp (O2) 25, IsoAsp28] Exendin-4 (1-39); or desPro36 [Asp28] Exendin-4 (1-39);
desPro36 [IsoAsp28] exendin-4 (1-39);
desPro36 [Met (O) 14, Asp28] exendin-4 (1-39);
desPro36 [Met (O) 14, IsoAsp28] Exendin- (1-39);
desPro36 [Trp (O2) 25, Asp28] exendin-4 (1-39);
desPro36 [Trp (O2) 25, IsoAsp28] exendin-4 (1-39);
desPro36 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (1-39);
desPro36 [Met (O) 14, Trp (O2) 25, IsoAsp28] Exendin-4 (1-39);
Here, group -Lys6-NH ₂ may be combined with C- terminus of exendin guide member;

Or an exendin-4 guide of the following sequence:
H- (Lys) 6-desPro36 [Asp28] Exendin-4 (1-39) -Lys6-NH ₂ ;
desAsp28, Pro36, Pro37, Pro38 Exendin-4 (1-39) -NH ₂ ;
H- (Lys) 6-desPro36, Pro38 [Asp28] exendin-4 (1-39) -NH ₂ ;
H-Asn- (Glu) 5desPro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) -NH ₂ ;
desPro36, Pro37, Pro38 [Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2;
H- (Lys) 6-desPro36, Pro37, Pro38 [Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2;
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39)-(Lys) 6-NH ₂ ;
H- (Lys) 6-desPro36 [ Trp (O2) 25, Asp28] Exendin _{-4 (1-39) -Lys6-NH 2} ;
H-desAsp28 Pro36, Pro37, Pro38 [Trp (O2) 25] Exendin -4 (1-39) -NH _2;
H- (Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin -4 (1-39) -NH _2;
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin -4 (1-39) -NH _2;
desPro36, Pro37, Pro38 [Trp ( O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2;
H- (Lys) 6-des Pro36 , Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2;
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2;
H- (Lys) 6-desPro36 [Met (O) 14, Asp28] exendin-4 (1-39) -Lys6-NH ₂ ;
desMet (O) 14, Asp28, Pro36, Pro37, Pro38 Exendin-4 (1-39) -NH ₂ ;
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39) -NH ₂ ;
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39) -NH ₂ ;
desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-(Lys) 6-NH ₂ ;
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-(Lys) 6-NH ₂ ;
H-Asn- (Glu) 5, desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2;
H-Lys6-desPro36 [Met ( O) 14, Trp (O2) 25, Asp28] Exendin _{-4 (1-39) -Lys6-NH 2} ;
H-desAsp28, Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25] Exendin -4 (1-39) -NH _2;
H- (Lys) 6-des Pro36 , Pro37, Pro38 [Met (O) 14, Asp28] Exendin -4 (1-39) -NH _2;
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin -4 (1-39) -NH _2;
desPro36, Pro37, Pro38 [Met ( O) 14, Trp (O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2;
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin -4 (S1-39) - (Lys) 6-NH 2;
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2;
Or a pharmaceutically acceptable salt or solvate of any one of the foregoing exendin-4 guides;
Selected from.

  The hormones include, for example, gonadotropin (folytropin, lutropin, corion gonadotropin, menotropin), somatropine (somatropin), desmopressin, telllippressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin, etc. Pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists displayed in the chapter.

  Polysaccharides include, for example, glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin, or ultra low molecular weight heparin, or guides thereof, or sulfated, for example, polysulfated forms of the above polysaccharides and / or Or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium salt.

Pharmaceutically acceptable salts include, for example, acid addition salts and base salts. Examples of acid addition salts include HCl or HBr salts. The base salt is, for example, a cation selected from an alkali or alkaline earth metal, such as Na ⁺ , K ⁺ , or Ca ²⁺ , or an ammonium ion N ⁺ (R1) (R2) (R3) ( Wherein R1 to R4 are, independently of one another, hydrogen; optionally substituted C1-C6 alkyl group; optionally substituted C2-C6 alkenyl group; optionally substituted C6- A C10 aryl group, or an optionally substituted C6-C10 heteroaryl group. Other examples of pharmaceutically acceptable salts are described in “Remington's Pharmaceutical Sciences”, 17th edition, Alfonso R. Gennaro (edited), Mark Publishing, Easton, Pa., USA, 1985 and Encyclopedia of Pharmaceutical Technology. Yes.

  Examples of pharmaceutically acceptable solvates include hydrates.

  Further features, improvements and utilities will become apparent from the following description of exemplary embodiments in connection with the drawings.

FIG. 2 schematically illustrates a partial side cross-sectional view of an exemplary embodiment of a drug delivery device. Fig. 3 schematically shows a partial perspective cross-sectional view of a drive mechanism according to a first embodiment with a schematically illustrated movement of the elements of the drive mechanism during dose setting. Figure 3 shows a more detailed side view of the part of Figure 2; FIG. 6 shows a side view of a drug delivery device during cartridge change. FIG. 6 shows a side view of a drug delivery device during cartridge change. FIG. 6 shows a side view of a drug delivery device during cartridge change. FIG. 6 shows a partial cross-sectional view of one embodiment of a drive mechanism in a reset mode. FIG. 8 shows a cross-sectional view of the portion of the embodiment of FIG. 7 in normal mode. FIG. 6 shows a partial side view of another embodiment of a drive mechanism. FIG. 10 shows a partial cross-sectional view of the embodiment of FIG. FIG. 4 shows a partially exploded view of a further embodiment of the drive mechanism. 12A-12C show cross-sectional views of the embodiment of FIG. 11 in a normal operation mode. 13A-13C show cross-sectional views of the embodiment of FIG. 11 in the reset mode. 14A-14C show different views of one embodiment of the drive member. 15A and 15B show a cross-sectional view of the embodiment of FIG. 14 and the piston rod in a normal operating mode. 16A and 16B show a cross-sectional view of the embodiment of FIG. 14 and the piston rod in a reset mode.

  FIG. 1 shows a drug delivery device 1 comprising a cartridge unit 2 and a drive unit 3. The cartridge unit 2 includes a cartridge 4. The drug 5 is held in the cartridge 4. The drug 5 is preferably a liquid drug. The cartridge 4 preferably contains multiple doses of drug 5. Drug 5 may include insulin, heparin or growth hormone. The cartridge 4 has an outlet 6 at its distal end. Drug 5 can be dispensed from the cartridge through outlet 6. The device 1 may be a pen-type device, in particular a pen-type syringe. Device 1 may be a disposable or reusable device. Device 1 may be a device configured to administer a fixed or changeable dose of drug, preferably a user configurable dose. Device 1 may be a needle-based or needleless device. Device 1 may be an injection device.

  The term “distal end” of the drug delivery device 1 or a component thereof may refer to the end of the device or component closest to the administration end of the device 1. The term “proximal end” of drug delivery device 1 or a component thereof may refer to that end of the device or component furthest away from the dispensing end of the device. In FIG. 1, the distal end of device 1 identifies reference number 7 and the proximal end of the device identifies reference number 8.

  The outlet 6 may be covered with a membrane 9 that protects the drug 5 against external influences during storage in the cartridge. For drug delivery, the membrane 9 can be opened, for example perforated. For example, the membrane 9 can be perforated with a needle unit (not explicitly shown). The needle unit can be releasably attached to the distal end of the cartridge unit 2. A needle unit may be provided for fluid communication from the inside of the cartridge 4 through the outlet 6 to the outside of the cartridge.

  The piston 10 is held in the cartridge 4. The piston 10 is movable with respect to the cartridge. The piston 10 can seal the drug 5 within the cartridge. The piston 10 conveniently seals the inside of the cartridge proximally. Movement of the piston 10 relative to the cartridge 4 in the distal direction causes the drug 5 to be dispensed from the cartridge via the outlet 6 during operation of the device.

  The cartridge unit 2 further includes a cartridge holding member 11. The cartridge 4 is held in the cartridge holding member 11. The cartridge holding member 11 can mechanically stabilize the cartridge 4. In addition, or alternatively, the cartridge holding member 11 may include a fixing member (not explicitly shown) for attaching the cartridge unit 2 to the drive unit 3.

  The cartridge unit 2 and the drive unit 3 are fixed to each other, and preferably fixed to be releasable. The cartridge unit 2 releasably secured to the drive unit, for example, can provide a new cartridge 4 if all doses of the drug that were in the cartridge previously attached to the drive unit 3 have already been administered In order to achieve this, the drive unit 3 may be removed. The cartridge holding member 11 can be releasably fixed to the drive unit 3 via, for example, a screw thread.

  Alternatively, the cartridge holding member 11 may be omitted. In this case, it is particularly advantageous to apply a strong cartridge 4 and to attach the cartridge directly to the drive unit 3.

  The drive unit 3 transmits a force, preferably a force applied by the user, particularly preferably a manually applied force, to the piston 10 so as to displace the piston 10 relative to the cartridge 4 in the distal direction. To be configured. The dose of drug may be administered from the cartridge in this manner. The size of the delivery dose can be determined by the distance that the piston 10 is displaced relative to the cartridge 4 in the distal direction.

  The drive unit 3 includes a drive mechanism. The drive mechanism includes a piston rod 12. The piston rod 12 is configured to transmit force to the piston 10, thereby displacing the piston distally relative to the cartridge 4. The distal end surface of the piston rod 12 may be disposed adjacent to the proximal end surface of the piston 10. A bearing member (not explicitly shown) may be arranged to advance the piston 10 and preferably adjacent to the proximal end face of the piston 10. The bearing member may be disposed between the piston 10 and the piston rod 12. The bearing member may be fixed to the piston rod 12 or to the separating member. It is particularly advantageous to provide a bearing member when the piston rod 12 is configured to rotate during operation of the device, eg during delivery of a dose. The bearing member can be displaced together with the piston rod 12 (rotating) relative to the housing. The piston rod may be rotatable with respect to the bearing member. In this way, the rotating piston rod punctures the piston, thereby reducing the risk of damaging the piston. Thus, while the piston rod rotates and is displaced relative to the housing, the bearing member preferably only undergoes displacement, i.e. does not rotate. The piston rod 12 can be adjacent by a bearing member.

  The drive unit 3 includes a housing 13 that can be part of a drive mechanism. The piston rod 12 can be held in the housing. The proximal end side 14 of the cartridge unit 2 can be fixed to the drive unit 3 on the distal end side 15 of the housing 13, for example through a screw connection. The housing 13, the cartridge 4 and / or the cartridge holding member 11 may have a tubular shape.

  The term “housing” preferably refers to any external housing (“main housing”, “body”, “shell”) that may have a unidirectional axial connection to prevent proximal movement of a particular component. Or an internal housing (“insert”, “internal body”). The housing can be designed to allow safe, accurate and comfortable handling of the drug delivery device or any of its mechanisms. In general, any internal components of the drug delivery device (eg, drive mechanism, cartridge, piston, piston rod) are preferably housed to limit exposure to contaminants such as liquids, dust, and debris. Designed to secure, protect, guide and / or engage. In general, the housing may be a one-piece or multi-piece component having a tubular or non-tubular shape.

  The term “piston rod” shall mean a component adapted to operate through / in a housing, which is through / inside a drug delivery device, preferably from a drive member to a piston, eg, injectable. It can be designed to transmit axial movement for the purpose of expelling / administering medicinal products. The piston rod may or may not be flexible. It may be a single rod, lead screw, rack and pinion system, worm gear system and the like. “Piston rod” shall further mean a component having a circular or non-circular cross-sectional area. It can be made from any suitable material known to those skilled in the art and may be a unitary or multi-part structure.

  The drive unit 3 includes a dose part 16. The dose part 16 is movable relative to the housing 13. The dose portion 16 may be movable proximally with respect to the housing to set the dose of drug 5 to be delivered and distally with respect to the housing for delivery of the set dose. The dose portion 16 is preferably connected to the housing 13. The dose portion 16 can fix rotational movement relative to the housing. The dose portion 16 can move (displace) between the proximal and distal end positions relative to the housing 13 (not explicitly shown). The distance that the dose member is displaced relative to the housing during dose setting can determine the size of the dose. The proximal end position and the distal end position may be determined with a respective stop mechanism that may limit proximal or distal travel of the dose member relative to the housing. Device 1 may be a variable dose device, ie a device configured to deliver different doses of different medicaments, preferably user-configurable sizes. Alternatively, the device may be a fixed dose device.

  The device 1 may be a manual, in particular non-electrically driven device. A force (applied by the user) that moves the dose portion 16 distally relative to the housing 13 may be transmitted to the piston rod 12 by a drive mechanism. For this purpose, other elements of the drive mechanism not explicitly shown in FIG. 1 may be provided. The drive mechanism is preferably configured such that the piston rod 12 cannot be moved relative to the housing 13 when the dose portion moves proximally relative to the housing for dose setting.

  Embodiments of suitable drive mechanisms provided in the drug delivery device 1 described above are described in detail below.

  An embodiment of a drive mechanism suitable for implementation in the drug delivery device 1 described above will be described in connection with the following drawings.

  The drive mechanism includes a housing portion 17. Housing portion 17 has a proximal end 18 and a distal end 19. The housing part 17 may be the (external) housing 13 of FIG. 1, its part, or an insert within the housing 13, which is preferably for rotational and axial movement with respect to the housing 13. Can be fixed. The housing part 17 may be, for example, an insert sleeve. For example, the insert sleeve may be snap-fitted or glued to the housing 13. The housing part 17 may have a tubular shape. The housing part 17 may include an external fixing element, for example a snap-fit element, to fix the housing part 17 to the housing 13.

  The piston rod 12 is held in the housing 13, preferably in the housing part 17. The piston rod 12 drives distally relative to the housing portion 17 during dose delivery.

  The drive mechanism further includes a drive member 20. The drive member 20 is held in the housing part 17. The drive member 20 transmits force and is preferably configured to transmit torque to the piston rod 12. The transmitted force can cause the piston rod 12 to displace distally with respect to the housing portion 17 for dose delivery.

  The drive member 20 is rotatable with respect to the housing part 17. The drive member 20 can engage the piston rod 12. A rotational movement of the drive member, for example a rotational movement in the second direction, can be converted into a distal movement of the piston rod 12 with respect to the housing part 17. This is described in more detail below.

  The drive mechanism further includes a rotating member 21. The rotating member 21 is rotatable with respect to the housing part 17 in a first direction, in particular for setting a dose of medicament and in a second direction, in particular for delivering a set dose. . The second direction is opposite to the first direction. The first direction can be, for example, counterclockwise when viewed from the proximal end of the device, and the second direction can be clockwise.

  The drive member, the rotation member and / or the piston rod are preferably configured to be rotatable about a (common) rotation axis. The axis of rotation may extend through the drive member, the rotation member and / or the piston rod. The axis of rotation can be the main longitudinal axis of the piston rod. The axis of rotation can run between the proximal and distal ends of the housing portion 17.

  The rotating member 21 is connected to the driving member 20 by a one-way clutch mechanism, in particular, a friction clutch mechanism. This clutch mechanism allows the rotary member 21 to rotate relative to the drive member 20 when the rotary member rotates in the first direction relative to the housing portion 17. The clutch mechanism prevents rotational movement of the rotating member 21 relative to the drive member 20 when the rotating member rotates in the second position relative to the housing portion 17. The drive member 20 can consequently follow the rotational movement of the rotary member 21 in the second direction relative to the housing part 17.

  The drive member 20 is arranged adjacent to and / or engaged with the rotating member and in particular engages with the rotating member 21. The drive member 20 includes a tooth portion 22. The teeth 22 can be provided at one end of the drive member, for example at its proximal end. The rotating member includes a tooth portion 23. The tooth portions 22 and 23 face each other. The teeth 23 can be provided at one end of the rotating member whose end faces the drive member 20, for example at the distal end of the rotating member. The tooth part 22 includes a plurality of teeth 24. The tooth part 23 includes a plurality of teeth 25. Teeth 24 and / or 25 may extend and preferably may be oriented along the axis of rotation. The teeth 22 and 23 can be configured to fit together. The rotating member and the driving member can be engaged with each other by the teeth 22 and 23 in the engaged state.

  As can be seen from the axis of rotation, each tooth of the tooth 24 and / or the tooth 25 may in particular be of a ramp shape along the azimuth (angle) direction. Each tooth ramp extends less than the steep end face of the tooth, i.e., extends parallel to the axis of rotation, or protrudes on this axis, and smaller than the axis of rotation when protruding on this axis. Limited by the tooth surface containing the angle (in the angular direction). The sharp end face continues with the ramp of the next tooth.

  The teeth 24 can be arranged circumferentially on the drive member 20, in particular at the end of the drive member 20 facing the rotating member 21. The teeth 25 can be arranged circumferentially on the rotating member 21, in particular at the end of the rotating member 21 facing the drive member 20.

  When the sharp end surfaces of the two teeth are adjacent and the rotating member further rotates in the second direction, the abrupt side surfaces become adjacent and the drive member 20 follows the rotation of the rotating member 21. When the rotating member rotates in the first direction, tooth ramps, particularly ramps extending obliquely with respect to the rotation axis, slide along each other, and as a result, the rotating member 21 moves relative to the drive member 20. Can rotate.

  The drive mechanism further includes a stop member 26. The drive member may be disposed between the stop member 26 and the rotation member 21. The stop member 26 is configured to prevent rotational movement of the drive member 20 in the first direction relative to the housing portion 17 during dose setting, i.e., when the rotary member rotates in the first direction. Therefore, the rotating member 21 can rotate in the first direction with respect to the housing part 17, while the drive member 20 and the stop member 26 do not rotate.

  The stop member 26 is connected to the drive member 20 by another one-way clutch mechanism, in particular, a friction clutch mechanism. This clutch mechanism prevents the drive member 20 from rotating relative to the stop member 26 when the rotary member 21 rotates in the first direction relative to the housing portion 17. The clutch mechanism allows the drive member 20 to rotate relative to the stop member 26 when the rotary member 21 rotates in the second direction relative to the housing portion 17.

  Therefore, the rotating member 21 may rotate with respect to the drive member 20 and the stop member 26 in the first direction during dose setting, and the rotation of the drive member 20 is prevented by its interaction with the stop member 26. As such, the rotating member 21 as well as the drive member 20 can rotate relative to the stop member 26 in a second direction during dose delivery.

  Stop member 26 may be positioned adjacent to and / or engaged with drive member 20 during dose setting and preferably during dose delivery. The stop member 26 has a tooth portion 27. The teeth 27 are provided at one end of a drive member, for example a stop member facing the proximal end thereof. The teeth may be ramp-shaped with steep sides and gentle ramps. The teeth can be arranged azimuthally along the stop member, in particular around the stop member.

  The drive member 20 has a tooth portion 28. The teeth 28 may be provided at one end of a stop member, eg, a drive member facing the distal end of the drive member. The teeth of the teeth 28 may extend and are preferably oriented along the axis of rotation. The teeth 22 and 28 of the drive member 20 are arranged on the opposite side. The tooth portion 28 may be configured to be based on the tooth portion 21 of the rotating member. The teeth 22 can be configured to be based on the teeth 27 of the stop member. The teeth 27 and 28 may face each other. The tooth portions 27 and 28 may be fitted to each other. The teeth 27 and 28, in particular the steep sides of the teeth, cooperate to prevent rotation of the drive member 20 with respect to the housing part 17 in the first direction and in particular with respect to the stop member 26; For example, they are adjacent.

  The stop member 26 preferably fixes the rotational movement with respect to the housing part 17 and particularly preferably fixes the rotational movement permanently. The stop member 26 may be fixed relative to the housing or may be integrated within the housing. The stop member 26 can be fixed in displacement relative to the housing part 17 or can be displaceable relative to the housing 17.

  As illustrated in this embodiment, the stop member 26 is displaceable relative to the housing, but not rotatable relative to the housing portion 17. For that purpose, one or more, preferably oppositely arranged guide functions, for example guide lugs 29, are provided on the stop member 26. Each guide feature 29 engages a corresponding guide slot 30 that may be provided in the housing, for example, in the housing portion 17. This can be seen in FIGS. The guide function 29 cooperates with the guide slot 30 to prevent rotational movement of the stop member relative to the housing part 17 and allows axial movement of the stop member 26 relative to the housing. The axial movement of the stop member 26 may compensate for play between the components of the drive mechanism during operation.

  One or more members, preferably two or three members, from the group comprising the drive member 20, the stop member 26 and the rotation member 21 are for the housing part 17, preferably for the piston rod 12. And can be displaced in the axial direction. In it, the drive member and another one of the cited members can be axially displaceable relative to the housing. The remaining members may ensure axial displacement or be axially displaceable during operation of the drive mechanism for drug delivery. As a result, if the drive member and stop member are axially displaceable, the rotating member may be axially displaceable or axially displaceable, and so forth. The clearance between the components caused by the relative (axial) movement of the components of the clutch mechanism relative to the housing can be compensated by this method. The distance that each component can be displaced axially relative to the housing can correspond to the (maximum) depth of the tooth of each tooth 22 or 28 of the drive member. Alternatively, the distance may be greater than the (maximum) depth of the teeth of each tooth.

  Furthermore, the drive mechanism includes a resilient member 31, preferably a spring member. The resilient member 31 may be biased during a drug delivery operation of the drive mechanism. The resilient member may provide a force that tends to maintain the drive member 20 in engagement with the stop member 26 and / or the rotating member 21. The force can be applied along the axis of rotation. In the situation shown in FIGS. 2 and 3, this force can be applied in the proximal direction. The resilient member 31 may be a helical (coiled) spring. The resilient member 31 may be a compression spring.

  The resilient member 31 may maintain the drive member 20 and the stop member 26 under (permanently) mechanical contact with each other during, for example, drug dose setting and delivery, eg, adjacent. Alternatively or additionally, the resilient member 31 may maintain the drive member 20 and rotating member 26 under (permanently) mechanical contact with each other, preferably adjacent, during drug dose setting and delivery.

  The resilient member 31 may be integrated within the stop member 26 or may be a separate component. The resilient member 31 may be disposed on the distal end side of the stop member 26.

  The drive mechanism further includes a support member 32. The support member 32 conveniently fixes axial and rotational movement relative to the housing part 17 or is incorporated into the housing part 17. The support member 32 is disposed on the side surface of the drive member 20 away from the stop member 26. The support member 32 may be a protrusion, for example, a ring-shaped protrusion. The rotating member 21 may extend through the opening of the support member 32. The support member 32 may provide a reaction force that opposes the force applied by the elastic member 31. During drug set-up and delivery, permanent adjacency with the drive member of the rotating member and with the stop member of the drive member is facilitated in this manner.

  The rotating member 21 has a member 33 protruding outward (in the radial direction), for example, a flange portion. A protruding member 33 is conveniently provided for adjacent the adjacent support member 32, particularly the distal end side of the support member 32.

  The drive mechanism further includes a dose member 34. The dose member 34 may be the dose portion 16 or may be a portion of the dose portion 16 of FIG. The dose member 34 is movable relative to the housing in a proximal direction for dose setting and for dose delivery. For example, the dose member 34 can move proximally relative to the housing portion 17 during dose setting and distally relative to the housing portion 17 during dose delivery. The dose member 34 may engage the housing portion 17 or alternatively another portion of the housing 13 (not explicitly shown). The dose member 34 preferably ensures rotational movement with respect to the housing part 17. The dose member 34 may include a guide feature 35, eg, a guide lug or guide slot that engages another guide feature provided in the housing portion 17 or the housing 13, eg, a guide slot or guide lug, respectively. The dose member 34 can be displaced in the rotational direction relative to the housing part 17, preferably only along the axial direction and / or around the axis of rotation.

  The dose member 34 may move proximally and distally relative to the rotating member 21. The dose member 34 is arranged in a connectable manner and preferably moves in a proximal direction relative to the housing part 17 for movement of the dose member, e.g. for dose setting of the medicament. Due to the movement of the dose member, for example for the delivery of the dose, the movement of the dose member in the distal direction relative to the housing part 17 is converted into a rotational movement in a second direction opposite to the first direction. It is (permanently) connected to the rotating member 21 so as to be converted into a rotating motion of the rotating member 21 in FIG.

  The rotating member 21 may comprise an (external) thread 36. The thread 36 may engage one or more engaging members 42 of the dose member 34. Each engagement member may be disposed inside the dose member. Each engagement member may be, for example, a thread or a threaded portion. Therefore, the dose member 34 and the rotation member 21 are threaded and in particular can be threadedly engaged. The rotating member 21 can be arranged inside the dose member 21.

  The rotating member 21, drive member 20, stop member 26 and / or dose member 34 may each be a sleeve or may include a sleeve. The piston rod 12 is arranged to drive, in particular it can be arranged to drive through one, more or all of these sleeves. The piston rod 12 can extend through one, more or all of these sleeves.

  The drive member 20 and the piston rod 12 are configured such that the rotational movement of the drive member 20 with respect to the housing is converted into the rotational movement of the piston rod with respect to the housing. The drive member 20 can engage the piston rod 12. The piston rod 12 can be displaced with respect to the drive member 20 along the displacement axis. Now, the displacement axis extends along the rotation axis. The drive member 20 may be spline engaged with the piston rod 12, for example.

  The piston rod 12 is threadedly connected to the housing 13 and may include an engagement member 37, preferably an engagement track disposed on the outside in two opposite directions. The (respective) engagement track 37 may block the thread. The (respective) engagement tracks 37 in which the piston rod is displaceable relative to the housing, in particular relative to the drive member, preferably extend along an axis.

  Rotational motion with respect to the housing of the drive member 20 may consequently be converted to rotational motion with respect to the housing of the piston rod 12 with respect to the housing, and the rotational motion of the piston rod 12 with respect to the piston rod and the housing. Due to the (partial) screw engagement, it is translated into piston rod movement relative to the housing in the distal direction.

  The dose portion 16 may include a dose knob that may be configured to be grasped by the user. A dose knob 41 may be disposed and coupled to the dose member 34 at the proximal end. The dose knob and the dose member may be integral.

  The operation of the drive mechanism of the present invention for delivering drug from the cartridge 4 of FIG. 1 is described as follows.

  To set the dose, the user can move the dose member 34 in a proximal direction (arrow 43) relative to the housing portion 17. To do so, the user may grasp the dose knob and pull it proximally. The dose member 34 also moves proximally with respect to the rotating member 21. Proximal movement of the rotating member is prevented by the support member 32 adjacent to the protruding member 33 of the rotating member 21. As a result, the proximal movement of the dose member 34 relative to the housing part 17 is in a first direction (arrow 44) relative to the housing part 17, in particular due to the screw engagement of the dose member 34 and the rotary member 21. , Converted into the rotational motion of the rotating member 21. Therefore, the rotating member 21 rotates in a first direction relative to the housing, which is counterclockwise as can be seen from the proximal end of the rotating member. The rotating member 21 also rotates with respect to the driving member 20 and the stopping member 26. The drive member 20 is prevented from rotating in the first direction by interaction with the stop member 26, for example, by interlocking of the tooth portions 27 and 28. Since the piston rod 12 is coupled to the drive member 20 and rotation in the first direction of the drive member will cause the piston rod to travel in the proximal direction, the piston rod 12 is connected to the stop member 26 and the drive member. Twenty interactions prevent drive in the proximal direction. By preventing the movement of the piston rod 12 during dose setting, the accuracy of the dose can be improved.

  When the rotating member 21 rotates in the first direction, the tooth ramp of the tooth portion 23 of the rotating member 21 slides along the tooth ramp of the tooth portion 22. Thus, the teeth of the rotating member may be indexed around the axis of rotation until the tooth engages one of the next teeth of the tooth portion 22 of the drive member 20. The teeth of the rotating member 21 slide along the ramp of the teeth of the driving member 20. During this movement, the drive member 20 and in particular the stop member 26 are preferably moved relative to the piston rod 12 and the housing before the teeth of the tooth 23 disengage (completely) the teeth of the tooth 22. Furthermore, it is displaced along the rotation axis by a distance determined to be equal to the tooth depth of the tooth portion 22. Thereafter, the teeth of the rotating member 21 engage with the next tooth of the tooth portion 22 and the force provided by the elastic member 31 causes the drive member 20 and in particular the stop member 26 to move into the starting position of the shaft into the rotating shaft. Retreat along. Consistent movement of the stop member and drive member in the distal direction and conversely in the proximal direction is indicated by double arrows 45 in FIGS.

  The tooth of the rotating member that engages the next tooth of the drive member may provide audible and / or tactile feedback to the user.

  The drive mechanism is suitable for a fixed dose device or a user settable dose device. The size at which the fixed dose size of the drug to be delivered or the user settable dose can be varied by the user is preferably determined by the tooth distribution of the respective teeth on the drive member, rotating member and stop member. The The rotating member may rotate more than one tooth (dose increment) of the drive member for the user configurable dose device, and may rotate with one tooth (only) for a fixed dose device. During dose setting, the number of teeth of the drive member 20 around which the rotating member 21 rotates determines the size of the dose that is actually delivered.

  After the dose is set, the dose portion 16 and with it, the dose member 34 is moved (pushed) distally relative to the housing portion 17 by the user. Therefore, the dose member 34 moves distally relative to the housing part 17. As a result, the rotating member 21 rotates in a second direction that is opposite to the first direction with respect to the housing. The drive member 20 follows the rotational movement of the rotating member in the second direction. The rotational movement of the drive member 20 in the second direction is converted into the rotational movement of the piston rod 12 in the second direction, and the movement is sequentially converted into the movement of the piston rod 12 in the distal direction. As a result, the piston 10 of FIG. 1 can be displaced distally with respect to the cartridge 4 and the dose of drug 5 dispenses that amount from the cartridge corresponding to the preset dose.

  During dose delivery, the teeth 22 and 23 interlock and the tooth ramp of the tooth 28 of the drive member 20 slides along the tooth ramp of the tooth 27 of the stop member 26. As described above, this movement is similar to the relative rotational movement of the rotating member and the driving member having the opposite rotation direction. The stop member 26 is thereby displaced in the distal direction relative to the drive member 20 by a distance corresponding to the tooth depth of the tooth 27 on the stop member 26. When the next tooth 28 of the tooth portion 28 is engaged by the respective tooth of the tooth portion 27, the elastic member 31 applies a force to the stop member 26 in the reverse direction to the starting position in the axial direction.

  A drive member tooth that engages the next tooth of the stop member may provide audible and / or tactile feedback to the user.

  In a normal operation state, the drive member 20 is locked by being rotated by the piston rod 12 using a spline that allows only axial movement between the drive member 20 and the piston rod 12.

  In order to reset the drive mechanism, the piston rod 12 must be retracted into the housing in the proximal direction. This is not possible when the drive mechanism is engaged. The piston rod 12 needs to rotate through threaded engagement with the housing. The drive member 20 will spline engage the piston rod 12 and will also rotate. The stop member 26 stops the rotation of the drive member 20. During resetting, the drive member 20 releases the connection from the piston rod 12 so that the piston rod 12 can rotate back to the initial starting position.

  FIG. 4 shows the device and in particular the position of the piston 12 after delivery of the final dose. FIG. 5 shows this device after the cartridge holder 11 has been removed. When the cartridge holder 11 is removed, the piston rod 12 is released from the drive member (not shown in FIGS. 4-6). FIG. 6 shows the device after returning the piston rod 12 to its initial starting position and installing a new cartridge. In this mode, the drive member is again splined to the piston rod.

  FIG. 7 shows a cross-sectional view along line AA ′ in FIG. 6 of one embodiment of the portion of the drive mechanism in the reset mode. Only the drive member 20, the piston rod 12, and the spring 70 suitable for spline engagement of the drive member 20 with the piston rod 12 are shown. In the reset mode, the drive member 20 and the piston rod 12 are disconnected.

  The piston rod 12 includes a first track 71 extending in the axial direction. The track may be the engagement track 37 shown in FIG. The drive member 20 includes a second track 72 formed as a hole. The spring 70 extends in a partial circumferential shape around the drive member 20. The spring 70 has a protruding portion 73 suitable for being pushed through the second track 72 of the drive member 20 in the first track 71 of the piston rod 12 so that the drive member 20 and the piston rod 12 cannot rotate relative to each other. Have. In other words, the protruding element 73 can function as a spline. However, axial movement is still possible. The protruding portion 73 can slide along the first track 71. In the reset mode, the spring 70 relaxes so that the protruding element 73 is withdrawn from at least the first track 71, so that the piston rod 12 is relative to the drive member 20 that can reset the device. It can be rotated. The protruding element 73 can be formed integrally with a spring, for example as part of a V-shaped or U-shaped spring 70. Alternatively, the protruding element 73 may be a pin-shaped element attached to the spring 70.

  The spring 70 relaxes so that the protruding element 73 moves radially outward when the cartridge holder (not shown in FIG. 7) is removed. Disengagement causes the piston rod 12 to rotate and move proximally, while the drive member 20 does not rotate relative to the housing 17.

  FIG. 8 shows a cross-sectional view of the embodiment shown in FIG. 7 in a normal operating mode, where the protruding element 73 extends through the second track 72 of the drive member 20 into the first track 71 of the piston rod 12. , Thereby connecting the drive member 20 and the piston rod 12 so that they cannot rotate relative to each other.

  The spring 70 can be deformed so that the protruding element 73 is pushed radially inward when the cartridge holder is attached. The cartridge holder may be configured to connect the drive member 20 and the piston rod 12 when the spring 70 is deformed and the cartridge holder is attached. In one embodiment, the cartridge holder includes a radially inwardly extending protrusion 74 that functions as a push member that pushes the protruding element radially inward when the cartridge holder is attached. In another embodiment, the cartridge holder pushes the element of the device so that the spring 70 is deformed. Alternatively, the drive member 20 slides away from the push member, which may be part of the housing 17, when the cartridge holder is removed. This movement can be caused by a relaxation spring element.

  FIGS. 9 and 10 show a further embodiment, in which the spring 70 extends partially circumferentially around the drive 20, and the spring 70 includes a protruding element 73. In this embodiment, the protruding element 73 is formed as an end that extends inside the spring 70. The piston rod 12 includes a first track 71 extending in the axial direction and disposed on the opposite side of the piston rod 12. The drive member 20, including the second track formed as a hole on the opposite side of the drive member 20, the first and second tracks are centered. A pushing member 75 suitable for deforming the spring 70 is provided so that the protruding element 73 engages the track at the drive member 20 and the piston rod 12. The push member 75 may be the part of the cartridge holder that slides along the spring 70 so that it deforms during installation as shown on the right side of FIG. During removal of the cartridge holder, the push member 75 moves away from the spring 70 so that it relaxes and the protruding element disengages as shown on the left hand side of FIG. During attachment, the distal portion of the push element 75 that avoids blocking and allows the push element 75 to slide over the spring 75 during attachment may be inclined. The left-hand side of FIG. 10 shows a protruding element 73 that disengages from the first track 71 in the piston rod 12. The right hand side of FIG. 10 shows a protruding element 73 that engages the first track 71.

  FIG. 11 shows an exploded view of a further embodiment including the housing 17, the piston rod 12, the stop member 26 and the drive member 20. 12A and 13A show cross-sectional embodiments in normal operation mode and reset mode.

  The drive member 20 includes a portion formed as a sleeve 96 and is positioned inside the housing 17 suitable for guiding the drive member 20, the sleeve 96 having a circumferential groove 99.

  The piston rod 12 includes at least one, preferably more than one, axially extending track 71. A splice 91 is provided for the drive member 20 and piston rod 12 that are releasably connected using a spline connection. The peg 91 includes a connecting portion 92 suitable for engaging a shaft 97 having a track 71 and a head 93, where the diameter of the shaft 97 is smaller than one of the heads 93. The shaft 93 is placed through the hole 94 in the drive member 20. The hole 94 has a size and shape corresponding to the cross section of the shaft 97, but movement of the head 93 and the connecting portion 92 through the wall of the drive member 20 is avoided. The movement of the nail 91 in the radial direction with respect to the driving member 20 is limited by the head 93 positioned outside the driving member 20 and the connecting portion 92 positioned inside the driving member 20. The leaf spring 95 is located outside the drive member 20, and the leaf spring 95 has a hole 98. The leaf spring 95 is located in the cavity 89 of the drive member 20. The leaf spring 95 bends in the relaxed state. The contour of the cavity 89 corresponds to the flat shape of the leaf spring 95 under compression. The hole 94 of the drive member 20 and the hole 98 of the leaf spring 95 are aligned. The shaft 97 of the nail 91 extends through the holes 94, 98 so that the connecting portion 92 is located inside the drive member 20 while the head 93 is located outside. When the leaf spring 95 is relaxed, the nail 91 is biased outward so that the head 93 and the connecting portion 92 are pushed radially outward. When the head 93 is pushed inward, the leaf spring 98 is deformed by the underside of the head 93 pushing onto the leaf spring 95, thereby causing the connecting portion 92 to be radially inward to engage the track 71. move. The position of the joint 91 is aligned with the position of the track 71.

  FIG. 12A shows the embodiment of FIG. 10 in cross-sectional view. FIG. 12B is a detailed view of the mark portion of FIG. 12A. FIG. 12C shows the arrangement of the nail 91 in detail. 12A, 12B, and 12C show the drive mechanism in the normal operation mode, which means that the drive member 20 and the piston rod 12 are connected.

  In the normal mode of operation, there is a gap 85 between the housing 17 and the stop member 26 that is held away from the housing 17 by a spring member (not shown). The spring member pushes the stop member 26 proximally when the cartridge holder is attached. The stop member 26 forces the drive member 20 to a position where the head 93 of the nail 91 does not align with the groove 99. In other words, the sleeve 96 functioning as a pushing means pushes the nail 91 inward in the radial direction so that the connecting portion 92 engages with the track 71 in the piston rod 12. The head 93 is located in the cavity 89 and does not protrude or slightly protrudes outside the drive member 20.

  FIG. 13A shows the embodiment of FIG. 11 in cross-sectional view. FIG. 13B is a detailed view of the mark portion of FIG. 13A. FIG. 13C shows details of the arrangement of the nail 91. 13A, 13B and 13C show the drive mechanism in a reset mode which means that the cartridge holder is removed. After removal, stop member 26 and drive member 20 move distally relative to housing 17. When the head 93 of the joint 91 reaches the groove 99, the leaf spring 95 relaxes because the head 93 protrudes from the drive member 20 into the groove 99, thereby moving the connecting portion 92 toward the inside of the drive member 20. Move. When the peg 91 moves radially outward, the coupling portion 92 engages from the track 71 at the piston rod 12 so that the drive member 20 and the piston rod 12 can be reset with respect to each other. Is released.

  14A, 14B, 14C show another embodiment of the drive member 20 having a nail 91. FIG. FIG. 14A shows a three-dimensional view. FIG. 14B shows a cross-sectional view. FIG. 14C shows an exploded cross-sectional view.

  The peg 91 is U-shaped. Each nail 91 has two shafts 97 with a connecting portion 92 and a head 93 protruding at the end of the connecting portion 92. A further embodiment of the peg (not shown) includes more than two axes 97. The shaft 97 extends through the hole 94 in the drive member 20. The elastic member urges the nail 91 to the outside. The spring coil 88 extends around each shaft 97 between the outside of the drive member 20 and the head 93. The hole 94 is located in the cavity 89 so that the head 93 does not protrude from the outside of the drive member 20 when the head 93 is pushed inward in the radial direction.

  FIG. 15A and more detailed 15B show cross-sectional views of the drive member of FIGS. 14A, 14B, and 14C in the normal mode of operation. When the cartridge holder is attached, the sleeve 96 functioning as the pushing means 75 pushes on the head 93 of the nail 91 so that the connecting portion 92 engages the track 71 at the piston rod 12.

  FIG. 16A and more detailed 16B show a cross-sectional view of the drive member 20 of FIGS. 14A, 14B, and 14C in a reset mode. After removing the cartridge holder, the drive member 20 moves axially relative to the sleeve 96 so that the head 93 reaches the groove 99 in the sleeve 96. Thereafter, the spring coil 88 relaxes, thereby pushing the head 93 radially outward into the groove 99. This movement causes disengagement from the track 71 of the connecting portion 92 in the piston rod 12 that allows rotational movement of the piston rod 12 relative to the drive member 20 for the purpose of resetting the piston rod 12.

  Of course, the features of the embodiments can be combined.

reference number:
1: drug delivery device;
2: Cartridge unit;
3: Drive unit;
4: Cartridge;
5: drug;
6: Exit;
7: distal end of the device;
8: proximal end of the device;
9: membrane;
10: piston;
11: Cartridge holding member;
12: piston rod;
13: Housing;
14: proximal end side of the cartridge unit;
15: the distal end side of the cartridge unit;
16: dose part;
17: housing part;
18: proximal end of the housing part;
19: distal end of the housing part;
20: driving member;
21: Rotating member;
22: tooth part;
23: tooth part;
24: Teeth;
25: Teeth;
26: stop member;
27: tooth part;
28: tooth part;
29: Guidance function;
30: Guide slot;
31: elastic member;
32: support member;
33: projecting member;
34: dose member;
35: Guidance function;
36: Thread;
37: engagement track;
41: dose knob;
42: engagement member;
43, 44, 45: arrows;
70: Spring;
71: first track;
72: second track;
73: protrusion part;
74: extension protrusion;
75: pushing means;
85: gap;
88: Spring coil;
89: cavity;
91: fit nail;
92: connecting part;
93: Head;
94: hole;
95: leaf spring;
96: sleeve;
97: axis;
98: hole;
99: groove;
AA ′: line;

Claims (11)

A drive mechanism for a drug delivery device capable of switching between a normal operation mode and a reset mode, comprising:
A housing (17, 13) having a proximal end (8) and a distal end (7);
In a normal operating mode of the drive mechanism, adapted to displace distally with respect to the housing (17, 13) to deliver a dose, and in a reset mode of the drive mechanism, the housing (17, 13) A piston rod (12) adapted to be displaced in a proximal direction with respect to the housing; and, relative to the housing (17, 13), the drive member (20) whose rotation is movable in the rotational direction is in a normal operating mode The piston rod (10) so that the rotational movement of the drive member (20) in the rotational direction relative to the housing (17, 13) is converted into the movement of the piston rod (12) in the distal direction relative to the housing (17, 13). 12) and in a reset mode, the piston rod (12) is disengaged from the drive member (20). ;
Only including,
here,
The piston rod (12) has a thread and a track (71);
In the normal operation mode, the rotational movement of the drive member (20) relative to the housing (17, 13) is converted into the rotational movement of the piston rod (12) in the same direction; The piston rod (12) is rotatable relative to the drive member (20);
-In the normal operation mode, the drive member (20) is splined to the piston rod (12), and in the reset mode, the drive member (20) is released from the spline engagement with the piston rod (12). ,
The drive member (20) having an inner surface facing the piston rod (12) and an outer surface facing away from the piston rod (12) includes engagement means (73, 91) and engages in the normal operating mode; The means (73, 91) project inward, whereby the drive member (20) is splined to the piston rod (12) and engaged with the track (71) of the piston rod (12), in the reset mode. , The engaging means (73, 91) protrude outward,
The engaging means (73, 91) comprise springs (70, 98, 88), the engaging means (73, 91) being biased outward;
The drive mechanism.   In the normal operation mode, the rotational movement of the drive member relative to the piston rod is converted into the distal movement of the piston rod relative to the housing, and in the reset mode, the piston rod simply moves axially relative to the drive member. The drive mechanism according to claim 1. 3. The drive mechanism according to claim 1, wherein the drive mechanism is suitable for releasably connecting with the cartridge holder (11) when the cartridge holder (11) is removed from the drive mechanism. The above drive mechanism that switches to a mode. The drive mechanism according to claim 3 , further comprising push means (74, 75, 96) that move to a position that pushes the engagement means (91) inward when the drive mechanism is switched to the normal operation mode. When the drive mechanism is switched to the normal operation mode, the drive member (20) moves relative to the push means (75, 96) so that the push means (75, 96) pushes the engagement means (91) inward. The drive mechanism according to claim 3 , further comprising a push member (75, 96). A projecting element, wherein the engagement means (70) engages the drive member (20) and the piston rod (12) in a normal operation mode, thereby spline engaging the drive member (20) with the piston rod (12). The drive mechanism according to any one of claims 1 to 3 , wherein the drive mechanism is formed as a spring having (73). The projecting element is such that the drive member (20) is rotatable relative to the piston rod (12) in the reset mode and the spring (70) is biased out of engagement in the reset mode. The drive mechanism according to claim 6 , wherein (73) is biased outward. The drive member (20) has a track (72) and the piston rod (12) has a track (71), and in a normal operation mode, the protruding element (73) engages the track (71, 72). The drive mechanism according to claim 6 or 7 . 9. Drive mechanism according to claim 8 , further comprising pushing means (74) that move to a position that pushes the protruding element (73) in the track (71, 72) of the drive member (20) and piston rod (12). The drive mechanism according to any one of the preceding claims, further comprising a rotating member (21) adjacent to the drive member (20) and rotatable relative to the housing (17, 13). The drive mechanism according to claim 10, further comprising a stop member (26) adjacent to the drive member (20) on the opposite side of the rotation member (21) and allowing the drive member (20) to rotate in only one direction.

Images