TWI415643B - Medicament delivery device - Google Patents

Abstract

The present invention relates to a medicament delivery device comprising a distal housing part (12); a proximal housing part (10) into which a multi-chamber medicament container (14) is arranged and wherein said proximal housing part is arranged to be movable in relation to said distal housing part for mixing at least two substances arranged inside said container; a plunger rod (32) arranged to act on a distal stopper (34) in said medicament container, wherein a relative movement of said housing parts (10, 12) towards each other forces said distal stopper against the plunger rod in a proximal direction for mixing at least two substances arranged inside said container; a drive force unit (58, 74, 76, 78) capable of forcing said plunger rod (32) in the proximal direction for subsequent delivery of medicament from said medicament container; an activation member (80) slidably arranged through said distal housing part and releasibly connected to the drive force unit; wherein said device further comprises a guide shell (24) one-way rotatable arranged in said distal housing part, wherein said guide shell is provided with threads (22) arranged to cooperate with corresponding threads (20) on said proximal housing, and wherein said guide shell and said plunger rod are arranged with guide members such that they are rotationally locked but slidable in relation to each other.

Description

Drug delivery device

The present invention relates to a drug delivery device, particularly a reusable device capable of handling a multi-compartment drug container.

There are many drug delivery devices on the market, and the location of the drug in the container is also protected by patents, such as syringes, cartridges, etc., and the drug is exposed to pressure while it is being delivered. A common design is a thin tubular compartment having a stopper at one end of the compartment and a delivery member attached to the other end of the compartment, such as an injection needle, a nozzle, etc., capable of delivering medication to the patient.

In order to deliver a large amount of drug, the stopper is exposed to pressure, such as by pushing the plunger into the compartment, either manually by finger (this is a simple hand-held syringe) or by a pressure device such as: Springs are often used in automatic or semi-automatic syringes.

The plunger rods of many drug delivery devices are threaded and cooperate with the nut whereby the plunger rod or nut rotates as the plunger rod advances. This is very suitable for disposable drug delivery devices because when the plunger rod is moved to the foremost position, the drug container becomes empty and the drug delivery device can be discarded. However, when the reusable drug delivery device uses a threaded plunger rod, it may cause problems due to the need to return to the original position.

Most users do not like this type of operation, and are not sure how much distance the plunger rod will move back and operate incorrectly. Furthermore, there are many delivery mechanisms for drug delivery member devices and mechanisms associated with delivery that do not allow the plunger rod to return.

Furthermore, multi-compartment drug containers are becoming more and more popular, whereby the drug can be mixed with dry and liquid drugs prior to delivery. This requires further action and may be implemented in different ways. Document WO 2007/115424 discloses a multi-chamber container drug delivery device comprising two outer casing portions that are helically engaged. When the two outer casing portions are rotated together, the plunger rod in the outer casing portion acts on the stopper of the drug container end, whereby the dry drug is mixed with the liquid drug. This device is also disclosed to prevent misuse and to set and deliver doses after the device is locked. The device can then be discarded. However, the device of WO2007/115424 is not intended for use in multiple doses or in multiple containers.

The primary object of the present invention is to provide a multi-use drug delivery member that is capable of handling a multi-compartment drug container in a simple and reliable manner.

This goal can be accomplished by the characteristics of a separate item of patent scope. A more preferred embodiment of the invention is the subject matter of the scope of this patent.

According to a primary aspect of the present invention, a drug delivery device includes an end housing portion; a proximal housing portion, a multi-chamber drug container therein, and wherein the proximal housing portion is relative to the end housing Moving to mix at least two substances in the container; a plunger rod acts on the end stopper in the drug container, whereby relative movement of the outer portions toward each other forces the end stopper to lean toward the plunger rod Moving at the end to mix at least two substances in the container; a driving force assembly capable of forcing the plunger rod to move proximally to subsequently deliver the drug from the drug container; an activation member slidably passing through the end housing portion And releasably coupled to the driving force assembly; The device further includes a flow guiding barrel rotatably unidirectional to the end housing portion, wherein the flow guiding barrel is threaded to cooperate with a corresponding thread on the proximal housing, and the guiding barrel and the plunger are here The rod is provided with a guiding member for rotationally locking, but is slidable relative to each other.

According to another aspect of the present invention, the guide bucket is provided with a longitudinally extending ratchet on its outer circumferential surface, where the ratchet cooperates with the ledge of the resilient tongue on the end outer casing portion, and the ratchet and the ledge are connected thereto. The guide tube can only be unidirectionally rotated relative to the end housing portion.

According to another aspect of the present invention, the device includes a proximal outer casing portion locking member coupled to the distal outer casing portion, wherein the locking device locking device and the proximal outer casing portion when the outer casing portion reaches a particular relative position after material mixing The corresponding lock member is engaged, and when the drug container is replaced, the lock member of the proximal outer casing portion is activated to release the engagement between the lock devices such that the outer casing portion also moves relative to each other while the outer casing portion is moved relative to each other The guide bucket rotates, whereby the plunger rod moves to the initial position in the distal direction, and the proximal outer casing portion is unscrewed from the distal outer casing portion.

According to another aspect of the present invention, the driving force assembly includes a driving nut that is screw-engaged with the plunger rod and releasably coupled to the activation member; a manually operated spring-retracting device includes a resilient locking tongue that is loose The grounding is coupled to the ratchet of the drive nut such that the spring tensioning device can only rotate unidirectionally relative to the drive nut; and a drive spring has one end coupled to the spring tensioning device and coupled to a second end At the end outer casing portion, such that when the spring retracting device is operated, the driving spring is locked in a contracted state, and when the actuating member is operated, the driving nut is loosened and thus the driving spring is retracted The state is released, whereby the plunger rod is moved proximally to deliver the drug.

Preferably, the drive spring member is a torsion spring.

The invention has many advantages. When a used drug container is replaced with a new container, the plunger rod is moved back to the initial position when the proximal end is turned out of the end housing portion due to the use of the diversion barrel and interaction with the proximal housing portion. Thereby, the device is ready to receive a new drug container without the need to additionally move the plunger rod, facilitating the operation of the device.

In addition to this, according to the device of the invention, a plurality of doses can be delivered, and the dose setting button can also be used as a tensioner for driving the spring. This means that the device does not need to be in a pre-tensioned state before use.

These and other advantages of the invention will be apparent from the description and appended claims.

In the current application, the terminus means the drug delivery device or the member that is furthest from the user at the time of injection. Similarly, proximal refers to the end of the drug delivery device or member that is closest to the user at the time of injection.

As shown in FIG. 1, the drug delivery device of the present invention includes a proximal outer casing portion 10 and an outer end outer casing portion 12. Quite rationally, the outer casing can be designed in many other styles. The proximal outer casing portion is used as a drug container support, and the drug container support can accommodate the multi-chamber drug container 14. The proximal outer casing portion is moveable relative to the distal outer casing portion to mix at least two of the contents of the container. The proximal outer casing portion has a neck portion 16 at its proximal end for attaching a drug delivery member (e.g., an injection needle, a mouthpiece, a nozzle, etc.) thereto. Furthermore, the proximal outer casing has two operational structures Item 18, its function is described below. Also, there is a thread 20 on the outside of the proximal outer casing portion.

The device in turn includes a set of members, referred to herein as the baffle 24, which rotates in a single direction within the end outer casing portion. The thread 20 of the proximal outer casing cooperates with the corresponding thread 22 (Fig. 5b) on the inner face of the sleeve member. The end of the guide bucket 24 is provided with an end wall 26 having a central passage 28 (Fig. 2). This central passage 28 is provided with a flow guiding member 30 which projects radially inwardly. The plunger rod 32 is slidable within the central passage and is provided with a respective flow guiding member 33, such as a longitudinal groove 33, for engaging the projection 30 to provide a rotational lock between the plunger rod 32 and the diversion tub 24. The proximal end of the plunger rod is in contact with the end stopper 34 in the drug container (Fig. 5a). A proximal stopper 35 is located within the medicament container, thereby forming two chambers 36, 38 in the container 14, one chamber 36 containing the first substance (e.g., the drug in dry form) and the other chamber 38 containing the second substance (e.g., Liquid dilution) (Figure 5a). The outer casing portions 10, 12 are relatively moved such that the end stopper moves proximally against the plunger rod to mix at least two of the contents of the container.

The guide bucket 24 is provided with a longitudinally extending ratchet 40 on the outer periphery of the end circumference (Fig. 2), where the ratchet 40 cooperates with the ledge 44 of the resilient tongue 42 on the end outer casing portion 12, and the ratchet and ledge 44 therein The guide bucket can only be rotated in the same direction relative to the end casing portion (Fig. 5a). Further, a lock member 46 (Fig. 3) is designed as an annular member 48 provided with two button-like members 50 located at both ends of the diameter of the annular member 48. The two button-like members 50 protrude through the two diameter passages 52 on the end outer casing portion 12 (Fig. 2). Furthermore, the annular member 48 is provided with a lock member 54 (such as a groove at both ends of the diameter) and a corresponding lock member. 56 (such as the two ribs on the outer side of the outer casing) engage (Figure 3). When the outer casing portion reaches a specific relative position after mixing, and when the medicine container is replaced, the proximal outer casing portion lock member is activated to release the engagement between the lock members 54, 56, so that when the outer casing portion 10, 12 is moved relative to each other and rotates the guide bucket, whereby the plunger rod is moved back to the initial position and the proximal outer casing portion is unscrewed from the end outer casing portion.

Further, a driving force assembly is located within the end housing portion and is interactively coupled to the plunger rod, wherein the driving force assembly is configured to force the plunger rod to move proximally to thereby deliver medication from the drug container. Further, an actuating member 80 is slidably passed through a slit on the circumferential surface of the end outer casing portion and detachably coupled to the driving force assembly, as will be described below.

The driving force assembly includes a drive nut 58 that is interwoven with the plunger rod 32 and releasably coupled to the activation member, as will be described below; a manually operated spring-splitting device includes a resilient locking tongue 72 Removably coupled to the ratchet 70 of the nut such that the spring-striking device can only rotate unidirectionally relative to the nut, as will be described below; and a drive spring 78 has one end coupled to the spring-striking device and a second end is coupled to the end outer casing portion; the drive spring is locked in a retracted state when the spring retracting device is operated, and the drive nut is released when the actuating member is operated The drive spring is thus released from the contracted state whereby the plunger rod is moved in the proximal direction to deliver the drug.

The plunger rod 32 is located within the drive nut 58 and the inner surface of the drive nut 58 is provided with threads 60 (Fig. 2) that cooperate with threads 62 on the outside of the plunger rod 32. The drive nut 58 is further provided with an annular proximal wall frame 64 having a plurality of teeth 66 rings. Around the ledge, its function will be described as follows. The end of the drive nut 58 is provided with an annular portion 68, and the inner circumferential surface of the ring is provided with a longitudinal stop ledge 70.

The manually operated spring retraction device includes a common tubular drive member 74 and a dose setting button 76. The stop wall mount 70 of the drive nut cooperates with the resilient arms 72 at the proximal end of the conventional tubular drive member 74 (Fig. 2). The end of the drive member 74 protrudes through the end of the end housing portion, which is the attachment of the dose setting button 76 to rotate the drive member 74.

However, the cooperation of the stop ledge 70 and the resilient arms 72 causes the drive member 74 to rotate only in a single direction relative to the drive nut 58, where the resilient arms 72 slide over the stop ledge 70. In the other direction, the end of the resilient arm 72 abuts the stop ledge 70, thus locking the rotation. A drive spring (which is a torsion drive spring) is coaxially located on the drive member 74 and includes a fixed portion (e.g., end housing portion 12) attached to the drive member 74 at one end and attached to the device at a second end.

A predetermined dose is set by using a spring-stretching device, and the required predetermined dose is achieved by the same incremental scale. A preset increment is equivalent to rotating the dose setting button 76 in a clockwise direction to a preset scale, which corresponds to a preset degree of rotation. Therefore, each increment requires an additional clockwise rotation of the dose setting knob to the preset degree of rotation. Therefore, in order to set a preset dose equivalent to two incremental scales, it is necessary to rotate the dose setting knob two scales clockwise. When the dose setting button is rotated, the drive member 74 will rotate accordingly, and thus one end of the drive spring is also attached to the drive member 74. The drive spring thus winds up and accumulates the same amount of energy as the spring tensioning device. And the resilient arm 72 slides over the stop ledge 70.

The activation member includes an annular member 82 having a distal end surface that is provided with teeth 84 that cooperate with the teeth 66 that drive the nut 58 (Fig. 2). A return spring 86 is located between the proximal end surface of the annular member 82 of the actuating member 80 and a distal end surface of a central annular wall 88 (Fig. 5b), the inner surface of the end outer casing portion 12, forcing the member by the teeth The objects 66, 84 are intermeshing.

The device operates as follows. A drug container 14 is located within the proximal housing portion 10. The proximal end is manually screwed into the flow tube 24. Engagement of the resilient tongue 42 and the ratchet 40 prevents the guide bucket 24 from rotating. When the proximal outer casing portion 10 is threaded into the distal outer casing portion 12, the proximal end of the plunger rod 32 contacts the end stopper 34, whereby the distal stopper 34 is moved proximally into the medicament container. Further movement of the proximal outer casing portion also causes the proximal stopper 35 to move, thereby creating a passage between the two chambers 36, 38 for communication, thereby causing drug mixing and dilution. When the spine 56 on the proximal outer casing portion engages the groove 54 of the lock member 46, the proximal outer casing portion is locked from moving.

When a dose is to be delivered, the dose setting button 76 is rotated, whereby the drive member 74 is also rotated. This rotation causes the torsion drive spring 78 to be pulled. During rotation, the resilient arms 72 are removed from the stop ledge 70 of the annular portion 68 of the drive nut 58 until it contacts the stop ledge 70. The resilient arm 72 is in contact with the stop ledge 70 to prevent the drive member 74 from rotating.

Again, the teeth 66 of the drive nut contact the teeth 84 of the actuating member to prevent the drive nut 58 from rotating. The dose setting button 76 is rotated until the desired dose is set.

The user now places the drug delivery device at the injection site and manually activates the drug delivery device (sliding the activation member against the force of the return spring 86) 80). This causes the teeth 84 of the actuating member 80 to move out of the teeth 66 of the drive nut 58. Due to the accumulated force of the drive spring, the drive member 74 can now be rotated by the force of the torsion drive spring 78. The drive nut 58 is also rotatable due to the connection between the resilient arm 72 and the stop ledge 70.

Due to the rotation of the driving nut 58, the thread 62 of the plunger rod 32 is interlaced, and since the plunger rod 32 and the guiding barrel 24 are rotationally locked together, the plunger rod 32 is slidably advanced, causing the plunger rod to move the bottle. And launched a dose of drugs.

The delivery member can now be removed from the injection site. Subsequently, in order to deliver the drug, a new delivery member is attached and the dose setting button 76 is rotated to set the dose and the torsion drive spring 78 is pulled. After the container that can accommodate multiple doses is empty and replaced, the proximal outer casing portion can be manually rotated counterclockwise. In order to be able to do so, the lock 46 must be activated. This is done by pressing the button 50. Thereby the annular member 48 will flex radially so that the groove 54 can exit from the ridge 56 of the proximal outer casing portion 10. The proximal outer casing portion 10 is now free to rotate. However, due to the connection with the guide bucket 24, the guide bucket 24 will also rotate (by the resilient tongue 42 sliding in the clockwise direction through the ratchet 40). Since the rotary lock is located between the guide barrel and the plunger rod, the guide barrel 24 rotates so that the plunger rod also rotates. Since the teeth of the drive nut 58 are locked with the teeth 84 of the actuating member to prevent the drive nut 58 from rotating, the plunger rod 32 moves toward the end of the device until the circumferential ledge 90 on the plunger rod 32 and the diversion barrel The proximal end surface of the 24 end wall 26 is in contact. The proximal outer casing portion 10 continues to rotate relative to the flow tube 24, whereby the proximal outer casing portion 10 is unscrewed from the flow tube 24 and the drug container can be removed and replaced with a new drug container 14.

The embodiments and the drawings described above are only to be considered as limiting examples of the invention, and the invention may be modified in many ways within the scope of the patent.

10‧‧‧ proximal shell

12‧‧‧End shell

14‧‧‧ drug container

16‧‧‧ neck

18‧‧‧Operating components

20‧‧‧Near end housing thread

22‧‧‧drain barrel thread

24‧‧‧drain bucket

30‧‧‧Guide members

32‧‧‧Plunger rod

33‧‧‧Guide members

34‧‧‧End stopper

40‧‧‧Longitudinal extension ratchet

42‧‧‧Flexible tongue

44‧‧‧ ledge

46‧‧‧Locks

58‧‧‧Drive nuts

64‧‧‧Ring to the proximal ledge

70‧‧‧ ratchet

72‧‧‧Flexible lock tongue

74‧‧‧ drive components

76‧‧‧Dose setting button

78‧‧‧Torque drive spring

80‧‧‧Starting components

82‧‧‧ ring members

86‧‧‧Return spring

In the following detailed description of the invention, the reference figures are as follows:

Figures 1 - 2 are diagrams of physical explosions in accordance with the present invention.

Figure 3 is a detailed view of the proximal end portion of the body in accordance with the present invention with the end outer casing portion removed.

Figure 4 is a detailed view of the components in accordance with the present invention.

Figures 5-6 are cross-sectional views of different functional descriptions in accordance with the present invention.

10‧‧‧ proximal shell

12‧‧‧End shell

14‧‧‧ drug container

16‧‧‧ neck

18‧‧‧Operating components

24‧‧‧drain bucket

32‧‧‧Plunger rod

46‧‧‧Locks

58‧‧‧Drive nuts

64‧‧‧Ring to the proximal ledge

74‧‧‧ drive components

76‧‧‧Dose setting button

78‧‧‧Torque drive spring

80‧‧‧Starting components

82‧‧‧ ring members

86‧‧‧Return spring

Claims (5)

A drug delivery device comprising: an end outer casing portion (12); a proximal outer casing portion (10) in which a multi-chamber drug container (14) is located, wherein the proximal outer casing portion is movable relative to the distal outer casing portion To mix at least two substances in the container; a plunger rod (32) acts on the end stopper (34) in the drug container, whereby relative movement of the outer casing portions (10, 12) toward each other forces the end The stopper moves proximally against the plunger rod to mix at least two substances in the container; a driving force assembly (58, 74, 76, 78) can force the plunger rod to move proximally to follow The drug container delivers a drug; an activation member (80) slidably passes through the end housing portion and is releasably coupled to the driving force assembly; wherein the device further comprises: a diversion barrel (24), Rotatable in the end housing portion, wherein the diversion tub is provided with threads (22) for cooperating with corresponding threads (20) on the proximal housing, and wherein the diversion tub and the plunger rod are provided with guidance The members (30, 33) are rotationally locked but are relatively slidable. A drug delivery device according to claim 1, wherein the guide tube is provided with a longitudinally extending ratchet (40) on an outer circumferential surface thereof, wherein the ratchet and the ledge of the elastic tongue (42) on the end outer casing portion ( 44) cooperation, and wherein the ratchet and the ledge (44) are connected, so that the guiding bucket can only be opposite to the end The shell portion rotates in one direction. The drug delivery device of claim 2, wherein the device comprises a proximal outer casing lock (46) coupled to the distal outer casing portion, wherein the lock of the lock member when the outer casing portion reaches a particular relative position after mixing The device (54) engages with a corresponding locking device (56) on the proximal housing portion, and wherein when the drug container is replaced, the locking member of the proximal housing portion is activated to release the locking device (54, 56) Engaging so that the shroud is also rotated when the outer casing portions (10, 12) are moved relative to each other, whereby the plunger rod is moved to the initial position in the distal direction, and the proximal outer casing portion is from the outer end portion Being screwed out. The drug delivery device according to any one of claims 1 to 3, wherein the driving force component (58, 74, 76, 78) comprises: a driving nut (58) and the plunger rod (32) Tightly engaged and releasably coupled to the activation member; a manually operated spring retraction device (74, 76) including a resilient locking tongue (72) releasably coupled to the ratchet (70) of the drive nut So that the spring tensioning device can only rotate unidirectionally with respect to the driving nut; and a driving spring (78) has one end connected to the spring drawing device, and a second end connected to the end housing portion, so that when When the spring retracting device is operated, the driving spring is locked in a contracted state, and when the starting member is operated, the driving nut is loosened and thus the driving spring is released from the contracted state, thereby The plunger rod moves proximally to deliver medication. The drug delivery device of claim 4, wherein the drive spring is a torsion drive spring (78).