TWI391154B - Medicament delivery device - Google Patents

Description

Drug delivery device

The present invention relates to a drug delivery device; in particular, a drug delivery device having a small number of parts.

The use of drug delivery devices in the form of injections is becoming more common, and in many instances, the injection sequence is automatically performed by the user upon activation. In most drug delivery devices, the injection is accomplished by a stopper applied to the drug delivery device by a plunger rod that is advanced by a force applying device (typically a spring, such as a compression spring).

Although injection springs are very useful in many cases, they also have some drawbacks. One is that they tend to be slightly longer because it must cover the length of the plunger rod and at least a portion of the injection spring, even though a portion of the spring may be placed inside the plunger rod. Another disadvantage is how to handle the force of the injection spring. Some devices are pulled from the factory to pull the springs. Due to the risk of the device being stored for long periods of time prior to use, the design must take into account the internal forces that cause material creep, whereby specific parts must be designed with high safety and/or other materials, such as metal instead of plastic, to make the device More expensive. Other devices that are not pre-tensioned springs, and devices that are designed to be retracted by the user before injection, have the disadvantage that these devices require additional parts for the user to perform the spring's retraction.

Some devices without injection springs have been completed. Document WO00035520 discloses a syringe having a reservoir containing compressed gas. When a user presses a start button, a seal ruptures in the reservoir where compressed gas is directed to act on the floating plunger rod. The plunger rod advances against the engaged piston, thus ejecting the drug. This disadvantage is that a gas reservoir component is required, at least as expensive as a spring, and requires a lot of space within the device, which needs to be replaced if the syringe is used multiple times. Furthermore, long-term storage may adversely affect the reservoir in many ways, so that the device may no longer operate.

Another aspect of the invention is that the use of multi-compartment drug containers within drug delivery devices, such as syringes, is becoming more common. The reason for this is that the powdered drug can be stored for a longer period of time than the drug dissolved in the liquid without deterioration.

Thus, the drug and liquid are placed in different compartments within the drug container and mixed by moving the dividing wall or stopper before use so that the compartments can communicate.

However, the multi-chamber drug container takes on more steps before injecting a dose of the drug, because in order to mix the drugs, the plunger rod of the syringe must move the stopper of the drug container.

Many solutions of mixing have been proposed, from manual operations (such as integrating the two parts of the syringe) to an automated operation. A manual operation is described in EP 0 288 443, a front cover of the syringe is rotated, whereby a powdered drug chamber is displaced toward the plunger rod, breaking the aluminum film so that the liquid mixes with the powder. This design is simple and requires fewer parts, and is rugged and functional.

The primary object of the present invention is to provide a multi-compartment drug delivery device that is easy to use and safe, making up for the shortcomings of today's devices.

This object can be accomplished by the features of the independent item of the patent scope of the present invention. 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 conventional elongated housing includes a proximal portion and a distal portion; a drug container including a proximal opening closed by a septum; an axially movable end stopper; and a first a wall in which the liquid and gas-like fluid is sealed; a drug delivery member attached to the proximal side and having a non-transporting end; a drug container support, wherein the drug container is placed coaxially, the drug container is supported The member is moveable coaxially within the proximal portion and includes a support device capable of supporting the drug container support in an inactive position, wherein the drug container support is releasably engaged with the proximal portion and a predetermined distance Displayed between the diaphragm and the non-transporting end; a manual pressure mechanism can be moved from the non-pressure position to the pressure position where the pressure is generated within the container; an activation mechanism interacts with the support device (only when the manual pressure mechanism is present) In the pressure position), the container support is disengaged from the non-activated position to the actuating position, wherein the container support is axially displaced by the predetermined distance, thereby separating the container support Non-punctured delivery end, and the internal pressure generated by the liquid ejected.

The present invention has a number of advantages, with manual handling providing a simple and reliable mixing and/or pressure generation within the drug container with a few parts. This pressure is used to perform drug delivery without the use of a force/drive device.

Another advantage relates to the safety of premature delivery because the support device is locked by the safety lock device until after mixing and/or pressure generation is performed.

Another sturdy and practical feature is that the drive mechanism consists of a button that directly activates the device first (only after mixing and/or pressure generation), and then directly connects the drug container to the drug delivery member by internal pressure, followed by pressure Causes the delivery of a dose of medication.

In order to facilitate the operation of the device, the window is visible on the device, providing information to inform the user that the activation mechanism is in a non-pressure position, mixing has occurred, and/or the activation mechanism is in a pressure position. In addition to visual information, the device also provides audio and/or tactile information.

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. Correspondingly, the proximal side means the drug delivery device or the member closest to the user at the time of injection.

The drug delivery device includes a generally elongated outer casing including a proximal portion and a distal end of the two outer casing portions, a proximal portion 10 and a distal end portion 12; a drug container 18 including a proximal opening closed by a septum 30, An axially movable end stopper 26, and a first wall 20, wherein the liquid and gas-like fluid is sealed; a drug delivery member 36 is attached to the proximal portion 10 and has a non-transporting end 34; a drug a container support 16, where the drug container is placed coaxially, the drug container support is movable coaxially within the proximal portion 10, and includes support means 38, 40 capable of supporting the drug container support 16 for non-activation Position, where the drug container support is releasably engaged with the proximal portion 10, and a predetermined distance is displayed between the septum 30 and the non-transport end 34; a manual pressure mechanism includes a housing portion 10, 12 and a static plunger rod 44 are placed at the end of the end stopper 26 and the end portion 12 Between these, a manual pressure mechanism moves from a non-pressure position (the outer casing portion can be coaxially and movably interconnected and the plunger rod abuts the end stopper) to a pressure position (the outer casing portion moves inwardly from each other) The plunger rod 44 is moved into the drug container 18 to create pressure within the wall).

The two outer casing portions 10, 12 are joined to each other via threads 14, but may be joined by any other engagement means, the function of which is described below. The drug container is a multi-chambered drug container 18, but a single-chamber container can also be used in a drug delivery device where the liquid gaseous fluid drug is sealed. The multi-chambered drug container 18 includes a first wall 20 having a liquid and a gaseous fluid, where the fluid may be a diluent; a second wall 22 having a freeze-dried/liquid medicament, at least one conduit between the first and second walls And an axially moving proximal stopper 24 divides the first and second walls. The end stopper 26 is at the end of the container and has a proximal neck 28 on the proximal side of the container, here having a septum 30 which is formed of a resiliently pierceable material such as rubber. The proximal neck 28 is located within a neck 32 at the proximal end of the proximal outer casing portion 10. The neck portion 32 of the proximal outer casing portion is coupled to the attachment means for attachment to a drug delivery member 36, such as a needle (as shown). However, it will be appreciated that the drug delivery member may be used by the present invention, such as a nozzle, an injection port, and the like.

The support device includes at least one resilient arm 38 that is disposed within the distal end portion of the drug container support 16. Each arm is provided with an outwardly projecting ledge 40 that releasably engages a mounting surface 41 on the proximal side of the housing. The ledge also has an end inclined surface 42, the function of which is described below. The static plunger rod 44 includes a proximal side central member 60 that is proximally in contact with the end stopper and that is fixedly coupled to the distal end of the distal housing portion 12.

The activation mechanism includes a button 48 having a proximally facing arm 62 acting on the resilient arm 38 (only when the manual pressure mechanism is in the pressure position such that the ledge 40 is removed from the fixation surface 41).

The drug delivery device further includes a safety lock device 50 that is circumferentially movable and axially movable with the plunger rod and is in contact with the arm 38 to be separable from the arm when the manual pressure mechanism is in the pressure position. The safety drive 50 in the figures is an annular member that is slidable along the plunger rod 44. When the drug container support 16 is in the inactive position, the annular members are located within the recess 52 in the inner face of the arm 38 to prevent them from radially contracting inwardly. At least one opening or window 54 is provided on the inner surface of the proximal portion of the distal outer casing portion 12. The proximal outer casing portion 10 is further provided with at least one indicator device 56 that provides visual and/or audible and/or tactile information sufficient to the user regarding the state of the device, such as: non-use, mixed medication, use, and the like. One example of the indicia is that at least one resilient tongue includes a colored outwardly extending projection inserted into at least one window 54 to provide audible, visual, and tactile information when the manual pressure mechanism is moved from a non-pressure position to a pressure position. The designation may be a number that can be seen from the window 54 of the end housing portion 12, as described below. The indication 56 can be seen from the window 54, perhaps other symbols such as symbols, words, letters, etc., providing sufficient information to the user.

This drug delivery device operates as follows. When the drug container is a single-chamber container and the patient has to take a dose of medication, the window 54 of the end housing shows a number "1" indicating that the activation mechanism is in a non-pressure position. The user then attaches a drug delivery member (such as injection needle 36) to the neck 32 of the proximal outer casing portion 10, but the non-delivery end 34 of the drug delivery member does not pierce the septum 30 of the drug container 18. As shown, the user then screws the proximal outer casing portion 10 into the end housing. Part 12, even if the device becomes shorter. This causes the container support 16 to move toward the end into the end outer casing portion. The corresponding movement of the container support 16 and movement of the drug container 18 relative to the plunger rod 44 causes the end stopper 26 to move axially internally to create pressure in the gas within the drug reservoir 18. Rotation of the proximal outer casing portion 10 relative to the distal outer casing portion may be aided by at least two clamps 11 on its outer side. When the outer casing portions are displaced inwardly from each other, window 54 displays an indication of the number "2" indicating that the activation mechanism is at the pressure position. And this position can be indicated by a click and/or tactile indication.

Furthermore, when the drug container is a multi-chamber container and the patient is to administer a dose of medication, the window 54 of the end housing portion displays the number "1" indicating that the activation mechanism is in a non-pressure position (as shown) and then uses The proximal outer casing portion 10 is screwed into the outer end portion 12, even if the device is shortened. This causes the container support 16 to move toward the end into the end outer casing portion. The corresponding movement of the container support 16 and the movement of the drug container 18 relative to the plunger rod 44 causes the end stopper 26 to move axially inside so that the contents of the first wall enter the second wall from at least one conduit, the contents being Mixing in the second wall (Figures 2 and 5). At the same time as the mixing occurs, the gas in the drug container 18 produces a synthetic pressure. When the mixing is completed, the number "2" is displayed in the window 54 as an indication. And this position can be indicated by a click and/or tactile indication. The user then attaches the drug delivery member (injector needle 36 in the figure) to the neck 32 of the proximal outer casing portion 10, but the non-delivery end 34 of the drug delivery member 36 does not pierce the septum 30 of the drug container 18. In order to place the activation mechanism in the pressure position, the user further rotates the two outer casing portions 10, 12, and the number "3" is displayed in the window 54 as an indication.

When the activation mechanism is in the pressure position, the end of the inclined surface 42 of the ledge 40 of the arm 38 abuts the proximal side of the proximally facing arm 62 of the safety lock device 50, pushed away by the proximal central member 60, whereby the arms 38 are free to bend.

The user now places the delivery device member containing the injection needle at the injection site and initiates drug delivery by pressing button 48. The distal end of the proximally facing arm 62 of the button 48 slides over the inclined surface 42 of the ledge 40 of the arm 38, whereby the arm is radially inwardly contracted and the ledge 40 is removed from the distal end face 41 of the proximal outer casing portion 10. . Due to the pressure within the drug container 18, the drug container support 16 is moved forward, whereby the non-delivery end 34 of the drug delivery member 36 pierces the septum 30 of the drug container 18. Due to the pressure within the drug container 18, the liquid drug is pushed out to the user via the drug delivery member 36. After the drug is delivered, the device can be withdrawn from the injection site and discarded. The two outer casing portions 10, 12 can also be selectively removed from the other side, and the empty drug container 18 is replaced by a new one. Only the drug delivery member 36 is discarded.

With the development of drug delivery devices, the device may also include a non-vertical locking mechanism (not shown). If the device is placed vertically with the conveying member facing down, at least one pendulum or the like is connected to the starting mechanism to prevent the starting mechanism. Interact with the support device.

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 side

11‧‧‧clip

12‧‧‧End

14‧‧‧ thread

16‧‧‧Drug container support

18‧‧‧ drug container

20‧‧‧First wall

22‧‧‧Second wall

24‧‧‧ Near stopper

26‧‧‧End stopper

28‧‧‧ proximal neck

30‧‧‧Separator

32‧‧‧ neck

34‧‧‧Non-transport end

36‧‧‧Drug delivery components

38‧‧‧Flexible arm

40‧‧‧ ledge

41‧‧‧Fixed surface

42‧‧‧Sloping surface

44‧‧‧Plunger rod

48‧‧‧ button

50‧‧‧Safety lock (drive) device

52‧‧‧ Groove

54‧‧‧ openings (window)

56‧‧‧Marking device

60‧‧‧ proximal central components

62‧‧‧arm

The present invention is described in the following detailed description, and the drawings are as follows:

Figure 1 is a side view of a drug delivery device according to the present invention, The starting state.

Figure 2 is a side view according to Figure 1, when the drug has been mixed.

Figure 3 is an exploded view according to Figure 1.

Figure 4 is a side cross-sectional view according to Figure 1, the initial state.

Figure 5 is a side cross-sectional view according to Figure 1, when mixing has occurred.

Figure 6 is a side cross-sectional view according to Figure 1, when activated before injection.

Figure 7 is a side cross-sectional view according to Figure 1, after injection.

10‧‧‧ proximal side

11‧‧‧clip

12‧‧‧End

14‧‧‧ thread

48‧‧‧ button

54‧‧‧ window

56‧‧‧Marking device

Claims (9)

A drug delivery device comprising: a substantially elongated outer casing comprising two outer casing portions having a distal end and a proximal end, namely a proximal portion (10) and a distal end portion (12); a drug container (18) including a proximal side The opening is closed by a diaphragm (30), an axially movable end stopper (26), and a first wall (20), wherein the liquid and gas-like fluid are sealed; a drug delivery member (36) Attached to the proximal portion (10) and having a non-transporting end (34); a drug container support (16), wherein the drug container is coaxially disposed, the drug container support being coaxially movable Within the proximal portion (10), and including support means (38, 40) capable of holding the drug container support (16) in a non-activated position in which the drug container support and the proximal portion (10) Releasably engaging, and in the non-actuated position, a predetermined distance is displayed between the diaphragm (30) and the non-transporting end (34); characterized in that the drug delivery device additionally comprises: a manual pressure mechanism comprising a housing portion Parts (10, 12) and a static plunger rod 44 are placed at the end of the end stopper (26) and the end portion (12) Wherein the manual pressure mechanism moves from a non-pressure position (the housing portions are coaxially and movably interconnected and the plunger rod abuts the end stopper) to a pressure position (the housing portions move inwardly relative to each other) The plunger rod (44) is moved into the drug container (18) to generate a synthetic pressure within the wall); and an activation mechanism interacts with the support device (only when the manual pressure is applied) When the mechanism is in the pressure position, the container support is disengaged from the non-activated position to the activated position, wherein the container support is axially displaced by the predetermined distance, whereby the diaphragm is non-delivered (34) Puncture, and the liquid is discharged due to the generation of internal pressure. The drug delivery device of claim 1, wherein the drug container further comprises a second wall (22) having a freeze-dried/liquid medicament, at least one conduit between the first and second walls, and an axially movable The proximal stopper (24) divides the first and second walls. The drug delivery device of claim 2, wherein the contents of the first and second walls are mixed when the manual pressure mechanism is moved from the non-pressure position to the pressure position. The drug delivery device of claim 1, wherein the support device comprises at least one resilient arm (38) disposed in a distal end portion of the drug container support (16), and wherein the at least one resilient arm is provided with a ledge ( 40), the ledge and the fixing surface (41) on the proximal side of the housing are releasably engaged. The drug delivery device of claim 4, wherein the activation mechanism comprises a button (48) acting on the resilient arm (38) such that the ledge (40) is removed from the fixation surface (41) so as not to contact. The drug delivery device of claim 5, wherein the button (48) is capable of acting on the resilient arm (38) only when the manual pressure mechanism is in the pressure position. The drug delivery device of claim 4, wherein the drug delivery device further comprises a safety lock device (50) surrounding and axially movable The plunger rod is moved and brought into contact with the arm (38) so that when the manual pressure mechanism is in the pressure position, it can be moved away from the arm (38) into contact. The drug delivery device of claim 1, wherein the distal end portion is provided with a window (54), and the proximal portion is provided with a marking device (56) such that when the manual pressure mechanism is at a predetermined position, the predetermined position is The information is displayed by the pointing device and is viewable from the window. The drug delivery device of claim 8 wherein the information further includes audiological and/or tactile information.