MXPA01000203A - A medical delivery device and a cartridge assembly for use in the same - Google Patents

Abstract

The present invention relates to a medication delivery device comprising a cartridge assembly, a dosing assembly and optionally a needle assembly. The cartridge assembly comprises a cartridge having a stopper adapted to receive a plunger means. Furthermore, the cartridge assembly has one end sealed with a pierceable sealing, said end comprising coupling means for engaging a needle assembly, and another end comprising coupling means for engaging the dosing assembly. At least one of the coupling means of the cartridge assembly is unitarily moulded with the cartridge. The dosing assembly comprises a plunger means and has coupling means for engaging the cartridge assembly. The cartridge assembly and the dosing assembly are coupled together for delivering selected doses of medication. The cartridge is preferably moulded from a plastic material, such as a transparent material, and may be housed in a cartridge housing for protection of the cartridge. The coupling means may be selected from threaded locks, snap locks, hinged locks, or bayonet locks. The medication delivery device is especially suitable for delivering insulin, growth hormone or the like medicines.

Description

A MEDICAL RELEASE DEVICE AND A CARTRIDGE ASSEMBLY FOR USE IN THE SAME The invention relates to a medication delivery device having a cartridge assembly and dosage assembly coupled together to release the selected medication dosages, wherein at least one of the cartridge coupling means is unitarily molded with the cartridge .

Background ' Some medication, such as insulin, is self-administered. The patient with typical diabetes will require insulin injections several times during the day.

The required dosage of insulin will vary from patient to patient, and often for each patient it will also vary during the day. Each patient will often establish a regimen for the administration of insulin adjusted for their necessary insulin as well as lifestyle. Drug release deposits have been developed to facilitate the self-administration of medication, such as insulin. REF .: 126259 & -, previous includes a tank body assembly comprising a medication cartridge and a piston device. A needle assembly could be connected to the tank body assembly. The medication is released by moving or pressing a piston in the direction of the needle assembly, whereby the medication is released. When the medication in the cartridge runs out, the body assembly of the reservoir is discarded. Depending on the medication needed for each individual, the medication in the cartridge will last for several days. During this period the needle assembly will often have to be displaced by a new assembly or new needle due to the increase of needle de-needleing making the injections painful for the patient.

Due to environmental and economic reasons, medication release deposits were developed, for these deposits only part of the deposit was Discard after the medication has run out, such as only the cartridge.

An example of prior art deposits is described in EP 0 688 571 where a deposit of medication release has a body assembly of the reusable tank and an available cartridge assembly that are threadedly engaged with one another. The available cartridge assembly includes a piston and can freely receive a needle cannula assembly through a threaded coupling. An actuating means in the assembly of the reservoir body couples the piston after the coupling of the reservoir body assembly and the cartridge assembly, whereby the reservoir is ready for metering the medicine into the cartridge. The cartridge holder assembly can be removed from the reservoir body assembly after the medication in the reservoir body has been exhausted, discarded and replaced. However, a drawback of the aforementioned deposit is that the drive means of the tank body could be decoupled from the cartridge piston during normal use, resulting in imprecise dosing of the medicine.

For the device described in EP 0 688 571, the needle assembly will often have to be replaced regardless of cartridge replacement. tto ^ - ^? r ~ ^ "-? ** ^^,, - > -... ^^ Aa ^ ife ^^ When the water assembly of the cartridge assembly is released, the cartridge assembly could be inadvertently released or partially released from the tank body assembly. For this reason, the drive means of the tank body could be uncoupled from the cartridge piston. In particular, if the assembly of the tank body is only partially released from the cartridge assembly, the user will most likely not be aware of the uncoupling. but will receive only a portion or even nothing of the medicine.

Even tanks with slanted threaded couplings and / or threaded couplings have different diameters, whereby the force exerted to hold and / or release a coupling is greater than the force required for the other coupling that presents this problem. It is easy to imagine that a small obstruction (for example a sand) that goes towards the smoother coupling will need a greater force to hold / release such coupling, this force tends towards the force necessary for the other coupling.

Therefore it is an objective of this invention to provide a medication delivery device with which the inadvertent uncoupling of the actuation means and the piston means of the piston or plug in the cartridge is prevented.

Brief Description of the Invention According to a first aspect of the invention, a medication delivery device is provided comprising a cartridge assembly, having a sealed end with a pierceable seal, the end of the cartridge assembly comprising the coupling means for mounting 1 liberally a needle assembly and comprises a cartridge having a plug adapted to receive the piston means, a dosage assembly comprising the medium piston, and optionally a needle assembly, where the cartridge assembly and the assembly of dosing are coupled together, and the device it further comprises the means for securing such a piston means which rests on the plug during the use of the device.

In a preferred embodiment, the dosage assembly is reusable and the cartridge assembly is available, and therefore, a second aspect of the present invention is a medication delivery device wherein the dosage assembly is freely engages the cartridge assembly.

The term "use of the device" means normal use, including measuring and releasing the medication, removing a cap from the cartridge assembly and / or needle as well as joining and releasing the needle assembly. It is understood that the piston means must uncouple the plug when the cartridge assembly is freed freely from the dosing assembly, because the medication in the cartridge has run out and the assembly of cartridge is going to be discarded. In this situation, the piston means will retract to the dosing assembly before mounting the device with a new cartridge assembly.

Securing the support of the piston medium in the plug during the use of the medication release device, in particular when the needle assembly is coupled to and / or disconnected from the cartridge assembly, could be carried out by a variety of means. In a preferred embodiment the support is secured by preventing the cartridge assembly from being inadvertently released from the dosage assembly.

Furthermore, it is a preferred aspect of the invention to provide a medication delivery device, such device is arranged to ensure that such a piston means abuts the plug during the coupling and / or uncoupling of the needle assembly.

In one embodiment of the invention, the dosing assembly is coupled to the cartridge assembly at the end of the cartridge assembly opposite the means for mounting the needle assembly, and the piston means is a roller element adapted to exert an axial movement of the plug towards the sealed end of the cartridge.

Therefore, it is an object of the present invention to provide a medication delivery device, wherein the means for coupling the assembly The dosing and cartridge assembly together are such that the coupling and / or uncoupling of the needle assembly does not cause an axial movement of the cartridge assembly with respect to the dosing assembly. In this way, it is ensured that such roller element does not uncouple the plug in the cartridge when the user joins the needle assembly or removes it after use. Therefore, the user can be sure of the accuracy of the selected dosage.

The means for coupling the dosing assembly and the cartridge assembly together could be any appropriate coupling, preferably a released coupling. Examples of the coupling are spring locks, such as spring locks with one-line waveguide and side spring locks, spring locks released by means of threads, bayonet locks, luer locks (hermetic locks), hinged locks, threaded locks and any appropriate combination of the same.

In particular, when the cartridge assembly is released from the dosing assembly by means of a agaa ^ ,.; ".-, ... -------- Mt.i.a .- ^ aí. §f ^ 2j ^ y || g ¡^^ g ^^ & < J ^ i ^ ^ ß ^ 3JJ ^^^^^^^^^^^^ movement including an axial movement, such as by a threaded coupling is preferred that the means for acopar 1 iberadament and mounting The needle and the cartridge assembly together are such that the coupling and / or uncoupling of the needle assembly can not cause an axial movement of the cartridge assembly with respect to the dosage assembly. Thus, in such respective examples of the preferred couplings between the needle assembly and the cartridge assembly include released spring locks. Another preferred embodiment includes a secure coupling between the dosing assembly and the cartridge assembly, such as hinged in the coupling or a threaded coupling released only after exerting an axial pressure in the coupling.

According to the invention, preferred combinations of couplings between the mounting dosing and cartridge assembly and between the needle assembly and the cartridge assembly, respectively, are combined threaded engagement with a coupling spring, a lock of bayonet or a luer lock combined with a spring lock, or a spring lock combined with a spring lock, or any other combination for which the couplings are working independently.

Another aspect of the present invention is a cartridge assembly for use in the medication delivery device according to the invention. The cartridge assembly comprises a cartridge so that the medication is released. The cartridge assembly has a sealed end with a puncturable sealing end of such cartridge mounting comprises means for mounting liberally a needle assembly, and another end comprising coupling means adapted to engage a dosing assembly. In addition, the cartridge comprises a stopper.

The cartridge assembly could further comprise a housing for protecting at least a portion of the cartridge assembly.

In a preferred embodiment, at least one coupling means of the cartridge assembly is unitarily molded with the cartridge, and in a more preferred embodiment all of the coupling means is unitarily molded with the cartridge. In the latter case, the ^ ^^^ ^^ ^^^^^^^^^ to ^^^^^^ í é ± M ^^^ J ^ g ^ ^ ^ __ ^ cartridge assembly could be comprised of only one part, i.e. the cartridge including the coupling means.

In another embodiment, the invention relates to a medication delivery device for transferring medication from the cartridge into a syringe with a needle. In this embodiment, the coupling means for coupling the needle assembly could be replaced by the coupling means for coupling the syringe or the coupling means for both could be provided. The coupling means could be a syringe holder, for example a cylinder coupled to the cartridge comprising a central core for receiving the syringe. The syringe is attached to the cartridge that has the needle that pierces the seal. By activating the dosing medium, the measured amount of medication is actuated in the syringe. The syringe is then ready for injection after it is removed from the cartridge.

Drawings Fig. 1 is an enlarged perspective view of the medication delivery device.

Fig. 2 is a cross-sectional view showing part of the medication delivery device, 2a immediately after mounting before the first injection, and 2b after some time of use.

Fig. 3 is a cross-sectional view showing the cartridge before mounting the medication delivery device. 10 Detailed Description of the Invention In 15 overall, a medication delivery device according to the present invention is identified by numeral 20 in Fig. 1 and 2. The device 20 includes deliberation medication dosing assembly 6 and assembly of cartridge 1, a needle assembly 16 and a lid 14.

The metering assembly 6 is illustrated in Fig. 1 and 2. However, it is understood that the metering assembly 6 according to the invention could be any suitable metering unit including the piston means, and therefore, could such variations of the modality represented and are considered to be within the scope of this invention. In the embodiment shown, the dosing assembly 6 includes a cylindrical housing that surrounds the piston means 17 of the dosing unit and has opposite proximal and distal ends.

In one aspect of the invention, the piston means comprises a roller element 7 which is adapted to couple the plug 4 of the cartridge assembly 1. The roller element 7 advances axially in the cartridge 5 during the injections. The dosing assembly could have any suitable driving means for advancing the roller element 7. The metering unit 6 preferably also comprises the scale means 10 indicating the selected dosage amount, activating the dosing adjustment means 9 for define the selected dosages specified of the medication to be released. The selected dosage could be released by actuating the actuator button 18. The actuator button is part of the actuating means of the actuator. dosing assembly that exerts its force on the roller element 7 The dosing assembly further comprises the coupling means 8 adapted to be coupled with the cartridge assembly. The coupling means 8 could be internal or external couplings. In a preferred embodiment, the coupling 8 is an internal coupling.

The cartridge assembly 1 is illustrated in Fig. 1 and 2, and in greater detail in Fig. 3. In Fig. 1 the cartridge assembly 1 includes a molded cartridge 5 extending from the proximal end 21 to the distal end 22. At the distal end 22 of the cartridge assembly 1, the coupling means 2 is provided for freely mounting a needle assembly 11. At the proximal end 21 of the cartridge assembly 1, the means of coupling 3 for mounting a dosing assembly 6. The coupling means are as described above.

The cartridge 5 also comprises a plug 4 in adjusted sliding fluid coupling inside the cartridge 5. The plug 4 is adapted to receive the pill means, such as a roller element 7 of the metering assembly 6.

The cartridge assembly 1 could further comprise a housing for protecting some or all of the cartridge 5. When the cartridge assembly 1 includes a housing, one or both of the cartridge couplings 2, 3 could be integrally molded with the housing.

In a preferred embodiment, at least one of the couplings 2, 3 is molded unitarily with the cartridge 5, minimizing the total number of parts of the device and therefore, the production costs. Also, a very precise coupling is obtained, since no additional steps are taken to join the coupling means to the cartridge.

Instead, the protective housing of the cartridge 5 could have integrally molded rethreads of the cartridge wall.

The illustrated cartridge 5 is cylindrical having the couplings 2, 3 at the opposite ends. Without i, í As. ^^ .. ^^ a¿a¿. ha »¿... ^,,. . - ^^^ > ^^^^ -. ^^^ ..,., ^^^^^,: ^^^ however, the cartridge could contain any appropriate shape and the cross section could be circular or non-circular, such as substantially triangular or oval.

In Fig. 1 and Fig. 2 the couplings 2, 3 are opposite each other having the same axis. However, the axis of the coupling 2 could be arranged to be separate from the coupling 3, ie it is at any angle with respect to the axis of the coupling 3. In this way, the axis of the coupling 2 could be perpendicular to the axis of the coupling 3 or could be parallel, but not superimposed.

A preferred choice of material allows the cartridge to be at least partially transparent, whereby the user can see if any content, such as a liquid is left in the cartridge.

Referring to Fig. 3, the cartridge coupling means are shown in greater detail. The coupling means 3 is an external thread, while the coupling means 2 is a space for a spring lock of the assembly of ^ j ^^^^^^^^ t ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ Both coupling means are unitarily molded with the cartridge.

The device according to the invention could include a protective cap 14 removably mounted on the cartridge assembly 1 and / or the needle 11 and removed before injection of the medication into the cartridge 5. The cover further ensures that the content of the cartridge is protected against the light 10 of the sun.

The various parts of the medication delivery device are advantageously made of plastics, e.g. by injection molding. The medication delivery device 20 could further comprise any suitable needle assembly 11, such as a double-ended needle 13 having the opposite proximal and distal points and a lumen extending axially therebetween.

A mounting hub 12 engages the needle 13 and removably connects to the coupling means 2 at the needle end of the cartridge assembly. The relative location of the mounting hub 12 ensures ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^ that the proximal point of the needle 13 pierces the seal when the mounting hub 12 engages with the middle of coupling 2 in the cartridge assembly 1.

The needle assembly 11 could further comprise a removable cover or cover 15 to protect against accidental needle spikes.

The device according to the invention is suitable to release the preset dosages of insulin, however, it is understood that such a device is suitable for injection dosages is pre-tablecidas other liquids.

In use, the user will establish the dosage by means of the dosing adjustment means 9. Before activating the actuator button 18, the lid 14 must be removed from the cartridge assembly 1, whereby the device 20 is prepared for an injection. The injection is effected by actuating the actuator button 18, which again will cause the cap 4 to move towards the needle at the sealed end 22 of the cartridge 5, whereby the desired pre-set dosage is directly released. A dosage of subsequent medication will be established in exactly _ ^ ___ ___ 5aJl-É aí -_- ___ ^ fe = afe ÉÉÉÉÍii ts & &amp KTM;? M in the same way as described above. However, for such subsequent dosing, the roller member 7 and the plug 4 will be in a partially advanced position as the starting point. The adjustment of the dosage and the injections can be carried out until all the medication has been used.

It is noted that in relation to this best known 10 method by the applicant to implement the said invention is conventional for the manufacture of objects that it refers to.

Having described the invention as above, the content of the following is claimed as property. twenty - * * - í ^^^^ g ^^^^^^ - ^^^^^^^. ^^^^^^^ fo ^^^^^

Claims (16)

1. A medication delivery device, characterized in that it comprises a cartridge assembly having a distal end and a proximal end, the distal end of the cartridge assembly comprises the coupling means for releasably mounting a needle assembly, and the mounting 10 of cartridge comprises a cartridge having a sealed end with a pierceable seal and having a plug adapted to receive the piston means, a dosage assembly comprising the piston means 15, and optionally a needle assembly, wherein the cartridge assembly and the dosage assembly are releasably coupled together, and the device comprises a combination of couplings between the dosing assembly and the cartridge assembly and between the needle assembly and the cartridge assembly, the combination able to secure such piston means 25 is supported on the plug during the coupling and / or uncoupling of the needle assembly.

2. A medication delivery device according to any of the preceding claims, characterized in that the piston means comprises a roller element adapted to exert an axial movement of the cap toward the sealed end of the cartridge.

3. A medication delivery device according to any of the preceding claims, characterized in that the means for releasably coupling the dosing assembly and the cartridge assembly together are such that the coupling and / or decoupling of the needle assembly does not cause a movement of the cartridge assembly with respect to the dosing assembly.

4. A medication delivery device according to any of the preceding claims, characterized in that the dosing assembly is released from the cartridge assembly by means of a movement that includes an axial movement.

5. A medication delivery device according to claim 4, characterized in that the dosing assembly is released from the cartridge assembly through a threaded coupling.

6. A medication delivery device according to any of the preceding claims, characterized in that the dosage assembly comprises scale means.

7. A medication delivery device according to any of the preceding claims, characterized in that the dosage assembly comprises dosing adjustment means for defining the specified selected dosages of medication to be released.

8. A medication delivery device according to any of the preceding claims, characterized in that the cartridge assembly comprises a housing.

9. A medication delivery device according to any of the preceding claims, characterized in that the cartridge is unitarily molded with at least one coupling means.

10. A medication delivery device according to any of the preceding claims, characterized in that it further comprises a cover for protecting the needle assembly and / or the cartridge assembly.

11. A cartridge assembly for use in the medication deliberation device as claimed in any of claims 1-10, characterized in that it has a sealed end with a pierceable seal, the end of the cartridge assembly comprises the coupling means for coupling a needle assembly, and another end comprising the coupling means adapted to couple a dosing assembly, further comprising a cartridge, the cartridge comprises a slidable plug.

12. A cartridge assembly according to claim 11, characterized in that it also comprises a housing.

13. A cartridge assembly according to claim 11 or 12, characterized in that the cartridge is unitarily molded with at least one coupling means.

14. A cartridge assembly according to any of claims 11-13, characterized in that the coupling means adapted to couple the dosing unit is such that the coupling and / or uncoupling of the needle assembly does not cause an axial movement of the cartridge assembly with respect to the dosage assembly.

15. A cartridge assembly according to claim 11 or 14, characterized in that the dosage assembly is released from the cartridge assembly through a movement including axial movement.

16. A cartridge assembly according to claim 15, characterized in that the dosing assembly is released from the cartridge assembly through a threaded coupling. SUMMARY OF THE INVENTION The present invention relates to a medication delivery device comprising a cartridge assembly, a dosage assembly and optionally a needle assembly. The cartridge assembly comprises a cartridge having a plug adapted to receive a piston means. In addition, the cartridge assembly has a sealed end with a pierceable seal, the end comprises coupling means for coupling a needle assembly and another end comprising the coupling means and the dosage assembly. The dosing assembly comprises a piston means and has the coupling means for coupling the cartridge assembly. The cartridge assembly and dosing assembly are coupled together to release the selected dosages of medication. The device further comprises means for securing such a piston means that supports such a plug during use of the device, in particular when the dosing assembly is releasably coupled to the cartridge assembly. The securing means is preferably a means to prevent the cartridge assembly from being inadvertently released from the dosage assembly. The cartridge is preferably molded from a plastic material, such as a transparent material, and could be housed in a cartridge housing the protection of the cartridge. The medication delivery device is especially suitable for the release of insulin, growth hormone or as medicines.