Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-07-08
2003-06-24
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S187000
Reexamination Certificate
active
06582408
ABSTRACT:
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.
Due to the environmental and economical reasons medication delivery pens were developed, for which pens only a part of the pen was discarded after medication exhaustion, such as the cartridge only.
An example of prior art pens is disclosed in EP 0 688 571 wherein a medication delivery pen has a reusable pen body assembly and a disposable cartridge assembly that are threadedly engageable with one another. The disposable cartridge assembly includes a plunger and can releasable receive a needle cannula assembly through a threaded coupling. A driving means in the pen body assembly engages the plunger after engagement of the pen body assembly and the cartridge assembly, whereby the pen is ready for dosing the medicine within the cartridge. The cartridge holder assembly can be disassembled from the pen body assembly after the medication therein has been exhausted, discarded and replaced.
However, a drawback of the above-mentioned pen is that the driving means of the pen body may be disengaged from the plunger of the cartridge during normal use resulting in inaccurate dosing of the medicine.
For the device disclosed in EP 0 688 571, the needle assembly will often have to be replaced independently of replacement of the cartridge. When releasing the needle assembly from the cartridge assembly the cartridge assembly may inadvertently be released or partly released from the pen body assembly. Thereby the driving means of the pen body may be disengaged from the plunger of the cartridge. In particular if the pen body assembly is only partly released from the cartridge assembly the user will most probably not be aware of the disengagement but will receive only a portion or even nothing of the medicine.
Even pens with differently pitched threaded couplings and/or threaded couplings having different diameters whereby the force exerted to fasten and/or release one coupling is greater than the force necessary for the other coupling present this problem. It is easy to imagine that a small obstruction (a sandskorn, for example) to the smoothest going coupling will necessitate a greater force to fasten/release that coupling which force tends towards the force necessary for the other coupling.
Accordingly, it is an object of the present invention to provide a medication delivery device with which the inadvertent disengagement of the driving means and plunger means from the plunger or stopper in the cartridge is avoided.
SUMMARY OF THE INVENTION
According to a first aspect of the invention a medication delivery device is provided which comprises
a cartridge assembly, having one end sealed with a pierce able sealing, said end of the cartridge assembly comprising coupling means for releasable mounting a needle assembly, and comprising a cartridge having a stopper adapted to receive plunger means,
a dosing assembly comprising plunger means,
and optionally a needle assembly,
wherein the cartridge assembly and the dosing assembly are coupled together, and the device further comprises means for securing that the plunger means abuts on the stopper during use of the device.
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 releasable coupled to the cartridge assembly.
By the term “use of the device” is meant the normal use, including metering and delivering the medication, removing a cap from the cartridge assembly and/or needle as well 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 the 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.
Furthermore, it is a preferred aspect of the invention to provide a medication delivery device, which device is arranged for securing that the plunger means abuts on the stopper during coupling and/or decoupling 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 plunger means is a rod element adapted to exert an axial movement of the stopper towards the sealed end of the cartridge.
Accordingly, it is an aspect of the present invention to provide a medication delivery device, wherein the means for coupling the dosing assembly and the cartridge assembly together are such that the coupling and/or decoupling 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 assured that the rod element does not disengage the stopper in the cartridge when the user attaches the needle assembly or removes it after use. Thereby the user can be confident of the accuracy of the dosage selected.
The means for coupling the dosing assembly and the cartridge assembly together may be any suitable coupling, preferably a releasable coupling. Examples of the coupling are snap locks, such as snap locks with guidewire and sideways snap locks, snap locks released through threads, bajonet locks, luer locks, hinged locks, threaded locks and any suitable combinations thereof.
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 releasable 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.
According to the invention preferred combinations of couplings between the dosing assembly and the cartridge assembly and between the needle assembly and the cartridge assembly, respectively, are a thr
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
Sirmons Kevin C.
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