Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-07-07
2003-05-13
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06562011
ABSTRACT:
The present invention relates to a medication delivery device having a cartridge and a dosing assembly coupled together for delivering selected doses of medication, wherein at least one of the coupling means of the cartridge is unitarily moulded with the cartridge.
BACKGROUND
Some medication, such as insulin is self-administered. The typical diabetes patient will require injections of insulin several times during the day. The required insulin dose will vary from patient to patient, and will for each patient often also vary during the day. Each patient will often establish a regimen for the insulin administration adjusted to his or her insulin need as well as lifestyle. Medication delivery pens have been developed to facilitate the self-administration of medication, such as insulin.
One prior art medication delivery pen includes a pen body assembly comprising a medication cartridge and a plunger device. A needle assembly may be connected to the pen body assembly. The medication is delivered by moving or pressing a plunger in the direction of the needle assembly thereby delivering the medication. When the medication in the cartridge is exhausted the pen body assembly is discarded. Depending on the medication needs for each individual the medication in the cartridge will last for several days. During this period the needle assembly will often have to be replaced by a new assembly or new needle due to increasing bluntness of the needle making injections painful for the patient.
More recent developments have revealed medication delivery pens, wherein the cartridge holder assembly can be disassembled from the pen body assembly after the medication therein has been exhausted, discarded and replaced by a new medicine-containing cartridge assembly.
An example of this is shown in EP 0 688 571 disclosing a medication delivery pen having a reusable pen body assembly and a disposable cartridge assembly that are threadedly engageable with one another. The cartridge assembly comprises a cartridge, a cartridge housing, a cap between the distal end of the cartridge and the housing, securing the cartridge in the housing and being adapted for engagement with a needle assembly. Furthermore, the cartridge comprises a plunger within the cartridge. The reusable pen body assembly is coupled through a threaded coupling to the cartridge housing. Thus, the total number of parts comprising the prior art cartridge assembly is high.
It is an object of the present invention to provide a medication delivery device wherein the amount of parts of the cartridge is minimized.
SUMMARY OF THE INVENTION
Accordingly, the present invention relates to a medication delivery device comprising a cartridge assembly, a dosing assembly and optionally a needle assembly,
said cartridge assembly having one end sealed with a pierceable sealing, said end of the cartridge assembly comprising coupling means for engaging a needle assembly, and another end comprising coupling means for engaging the dosing assembly, said cartridge assembly further comprising a cartridge wherein at least one of the coupling means of said cartridge assembly is unitarily moulded with the cartridge, the cartridge further comprising a stopper adapted to receive plunger means, and
said dosing assembly comprising plunger means has coupling means for engaging the cartridge assembly, and said plunger means is adapted to engage the stopper of the cartridge when the dosing assembly is coupled to the cartridge.
The unitarily moulded coupling or coupling ensure that the coupling is not accidentally released from the cartridge during use and storage. Also, the above-described medication delivery device has fewer parts that the prior art devices because at least one coupling means is moulded unitarily with the cartridge. Thereby the costs involved in the production and assembling of the device are reduced, and the device is more economical, which is an important feature for a disposable device.
The medical delivering device may either be manufactured as a disposable device which is sold pre-filled with the insulin or it may appear as a durable medical delivering device so designed that it can receive disposable cartridges with insulin.
In a preferred embodiment the dosing assembly is reusable and the cartridge assembly is disposable, and accordingly, a second aspect of the present invention is a medication delivery device wherein the dosing assembly is releasably coupled to the cartridge assembly.
The medication delivery device is preferably constructed so as to ensure that the plunger means abuts on the stopper during use of the device, such as attaching and releasing the needle assembly. It is understood that the plunger means must disengage the stopper when the cartridge assembly is deliberately released from a reusable dosing assembly because the medication in the cartridge has been exhausted and the cartridge assembly is to be discarded. In this situation the plunger means is to be retracted to the dosing assembly before assembling the device with a new cartridge assembly.
Securing the abutment of the plunger means on the stopper during use of the medication delivery device, in particular when the needle assembly is coupled to and/or decoupled from the cartridge assembly, may be carried out by a variety of means. In a preferred embodiment the abutment is secured by preventing the cartridge assembly from being inadvertently released from the dosing assembly.
In particular, when the cartridge assembly is released from the dosing assembly through a movement including an axial movement, such as through a threaded coupling, it is preferred that the means for releasably coupling the needle assembly and the cartridge assembly together are such that the coupling and/or decoupling of the needle assembly cannot cause an axial movement of the cartridge assembly with respect to the dosing assembly. Thus, in that respect examples of the preferred couplings between the needle assembly and the cartridge assembly include releasable snap locks. Another preferred embodiment includes a safety on the coupling between the dosing assembly and the cartridge assembly, such as hinge on the coupling or a threaded coupling releasable only after exerting an axial pressure on the coupling.
A second aspect of the present invention is a cartridge assembly for use in a medication delivery device, said cartridge assembly having one end sealed with a pierceable sealing, said end of the cartridge assembly comprising coupling means for engaging a needle assembly, and another end comprising coupling means for engaging the dosing assembly, said cartridge assembly further comprising a cartridge wherein at least one of the coupling means of said cartridge assembly is unitarily moulded with the cartridge, said cartridge further comprising a stopper.
The cartridge assembly may further comprise a cartridge housing for protecting the cartridge in use. Furthermore, when the cartridge is moulded unitarily with one coupling means the cartridge housing may comprise the other coupling means. Accordingly, in one embodiment of the invention the housing of the cartridge assembly comprises coupling means for coupling the cartridge assembly to the dosing assembly, preferably the coupling means is moulded unitarily with the housing. The cartridge is arranged within the cartridge housing. The cartridge housing may be non-releasably attached to the cartridge, once the cartridge is arranged in the housing, whereby the housing is disposed with the cartridge. In another embodiment the housing is reusable and the cartridge is arranged releasably in the housing.
In a preferred embodiment all the coupling means of the cartridge assembly are unitarily moulded with the cartridge. Thereby, it is possible to construct the cartridge assembly without the housing providing a cartridge assembly with even fewer parts.
The coupling means of the cartridge assembly may be for any suitable coupling, preferably a releasable coupling. Examples of the coupling are snap locks, such as snap locks with guidewire and sideways snap locks, sn
Buch-Rasmussen Thomas
Jensen Jens Møller
Jensen Peter Møller
Ljungreen Henrik
Munk Benny
Began, Esq. Marc A.
Bork, Esq. Richard W.
Casler Brian L.
Green, Esq. Reza
Novo Nordisk A S
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