Surgery – Container for blood or body treating material – or means used... – Container with piercable closure
Reexamination Certificate
2001-09-20
2004-06-29
Mendez, Manuel (Department: 3763)
Surgery
Container for blood or body treating material, or means used...
Container with piercable closure
Reexamination Certificate
active
06755810
ABSTRACT:
The present invention relates to a transfer device for transferring medicaments to a syringe with needle as well as a method for filling syringes.
PRIOR ART
Some patients may parentally administer medicaments on a regular basis. Medicaments, such as insulin or growth hormone, are very important to dose accurately. Often the dose is aspirated from a vial to a calibrated syringe, and due to the potency of the medicament it is important that the amount of the medicament aspirated into the syringe for each dose is precise. The accuracy depends on a variety of factors, such as the calibration of the syringe, the patient's vision as well as general motoric abilities to precisely dose the medicament.
To encrease the accuracy several dosage measuring devices have been presented wherein the calibration is carried out by an apparatus whereby the medicament is expelled into the syringe from a vial. In some systems a syringe is coupled to a vial or container and the needle cannula on the syringe is piercing a piston of the vial or container, whereby a force driving the syringe into the container presses the medicament in the container into the syringe via the needle.
For example, WO 93/02723 discloses a syringe-filling mechanism wherein a syringe held within a syringe holder is filled from a container including a piston mounted within a container. The syringe holder is threadably mounted to the vial with the needle cannula piercing the piston to permit the syringe holder to be driven against the piston in a controllable way to meter the pharmaceutical introduced into the syringe. By this mechanism the piston must allow several piercings without leakage. In practice it has proved a problem to design a material for a piston which is of sufficient strength to act as the piston while also being enough flexible to be pierced several times without leaking.
Other systems comprise a container comprising a piston and opposite the piston a sealing. The needle cannula then pierces the sealing and the medicament is forced into the syringe via the needle by driving the piston towards the sealing.
An example hereof is the system of WO 93/02921 disclosing a device wherein the piston is provided at the end of the container opposite the syringe holder. Thereby the piston material may not necessarily be pierceable. However, this kind of system exhibits another problem, namely that the piston may be drawn from the piston driver, if the person using the system, draw the syringe plunger rod before releasing the syringe from the syringe holder. This will lead to an uncorrect larger dosage in the syringe. Next time the person is dosing a smaller dosage is metered because the first part of the dosing movement will lead the container piston rod to abut the piston again and only thereafter the dosing movement will move the piston to fill the syringe.
SUMMARY OF THE INVENTION
The present invention is related to a device, wherein the above problems have been solved and which permits even an untrained person to easily and accurately fill a syringe with the correct dose of a liquid medicament.
Accordingly in one aspect, the present invention relates to a transfer device for transferring medicament from a medicament container to a syringe with a needle, comprising a medicament container having one end sealed with a pierceable sealing, and a piston slidably arranged within the container, means for mounting the syringe to the device with the needle piercing the sealing, the device further comprising dosing means including a piston driver, said dosing means being adapted for forwards calibrated movement for transferring medicament from the container to the syringe via the needle, and wherein the piston driver is adapted to be non-releasably engaged with the piston during transfer of the medicament.
The container forms an enclosed chamber filled with the medicament liquid and has the open end closed by a piston. The piston is slidable longitudinally relative to the container, and the piston is in fluid-tight connection with the container wall in any position of the piston sliding movement.
The device according to the invention is thus constructed to secure that the piston will not move forwards if the patient by mistake draws the syringe plunger rod before the needle is removed from the sealing. Accordingly, the piston can only move forwards when driven by the piston driver during activation of the dosing means. The term “during transfer” refer to the situation where the syringe is coupled to the device with the needle piercing the sealing, i.e. the situation wherein the route for transferring medicament to the syringe is intact. Thereby, a very safe, reliable and precise transfer device is provided.
The piston is driven forwards by a piston driver into the container by a movement corresponding to the dose to be transferred into the syringe.
In one embodiment the piston may be coupled to the piston driver by engagement means. The engagement means may be any suitable means, such as a snap lock, a threaded coupling, a bajonet lock, a luer lock or a suitable combination thereof or any other coupling that secure that the piston is engaged to the piston driver during transfer.
The snap lock may be a rotatable snap lock, whereby rotation of the piston driver is not transmitted as rotation of the piston during dosing. In another embodiment the snap lock may be a unidirectional, rotatable snap lock.
In a further embodiment the piston is integrated with the piston driver. The integration process may be carried out by any suitable process known to the skilled person. The piston may be moulded onto the piston driver by a two-component moulding process, or the piston may be moulded of the same material as the piston driver in one process. In the latter case, the fluid-tight engagement of the piston to the container wall may be secured by an O-ring on the piston.
Integration can also be carried out be applying glue or adhesive on the part of the piston driver abutting the piston, whereby when inserting the piston driver into the container, the piston and the piston driver are connected and remain so for the lifetime of the container.
Furthermore, the piston and the piston driver may be welded together for permanent engagement.
The piston is moved or forced forwards by the piston driver, which is activiated by the dosing means. The dosing means may be connected to the piston driver by means of a welding process, a gluing process, or a moulding process. In a preferred embodiment the dosing means is moulded unitarily with the piston driver. This reduces the amounts of parts to be produced for the device, and furthermore, the transmission chain from the dosing means to the piston is shortened which diminishes the variations in the dosing quantities.
The dosing means is coupled to the container in any suitable manner allowing the dosing means to activate the piston driver moving the piston forwards. Preferably, the dosing means is coupled through a threaded coupling to the container so that rotating the dosing means in a rotary direction relative to the container drives the piston in the container towards the sealing end of the container.
In the present context, the movement towards the sealing is denoted forwards movement. The movement is calibrated, which in a preferred embodiment is made by providing the device with means for precisely indicating the volume of medicament which has been transferred from the vial to the syringe. The amount of medicament delivered into the syringe may be indicated in several ways. The amount can be easily and precisely controlled by controlling the number of full and partial revolutions of the dosing means relative to the vial. The control is eased by providing an audible sound for each partial revolution, e.g. a click per unit of medicament.
The indication may be carried out in any suitable way as is apparent to the skilled person. In a preferred embodiment the indication is provided by including at least one detent lock protruding from the container and at least one ridge axially extending along the
Buch-Rasmussen Thomas
Ljunggreen Henrik
Poulsen Jens-Ulrik
Began, Esq. Marc A.
Bosk, Esq. Richard W.
Green, Esq. Reza
Mendez Manuel
Novo Nordisk A S
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