Patent Application
20140249483
The invention relates to a medical drug delivery apparatus such as an injection pen in which a piston rod moves a piston or plunger forward inside a cartridge and more specifically the invention relates to a piston rod foot or washer for such injection pen.
People suffering from diabetes often have to inject themselves with insulin at a daily basis. For this purpose a great number of different pen systems have been developed over the last 30 years. Common for pen injectors is that they contain a container or cartridge containing the liquid drug to be injected. The cartridge is provided with a piston which is moved forward in order to transfer the liquid drug from the injection pen and into the body of the user.
An example of such commercial successful injection pen, the Flexpen® by Novo Nordisk A/S, is given in U.S. Pat. No. 6,235,004. The cartridge (89) as e.g. depictured in FIG. 15-17 contains the liquid drug to be expelled. At the proximal end the cartridge (89) is closed by a rubber piston which is moved forward inside the cartridge (89) by a piston rod (7). In order to transfer and distribute the force from the piston rod (7) to the rubber piston, a piston rod foot (9) is provided between the piston rod (7) and the rubber piston. The piston rod foot is significantly smaller in diameter than the cartridge interior and the piston sliding inside the cartridge.
For prefilled injection pens which is characterized by the fact that they are discarded when the user has used the prefilled amount of drug there is no possibility for the user to return the piston rod to its initial position. The dosing mechanism is usually constructed such that the piston rod can only move in the distal direction since the injection pen is designed only to be used until the prefilled amount of drug has been used. Further, such injection pens are sealed such that the user can not physically obtain contact with the piston rod. In such injection pens the piston rod foot is normally laying loosely between the rubber piston and the piston rod without being attached to any of the two components since this is the easiest way to assemble the injection pen.
Many pharmaceutical companies prescribe that the liquid drug is stored in a refrigerator or another cold storage facility. However, at the same time many of the liquid drugs available are sensible to frost. The liquid drug should therefore be stored above 0 degrees Celsius at all time. Liquid drugs are often contained in a glass cartridge. If such glass cartridge is exposed to frost not only will the liquid drug be damaged but the liquid will also expand its volume. The increased pressure arising from the expansion can cause the glass of the glass cartridge to fracture if no other possibility for expansion is provided.
WO 2007068061 (especially the FIGS. 6 and 7) discloses a container for a liquid drug in which the cap can move axially if the drug is exposed to frost.
In a prefilled injection pen, the piston can not move freely in the proximal direction due to the presence of the piston rod which again is used to expel the liquid drug. However, if the piston rod and the piston foot, which are located between the piston rod and the piston, do not obtain the entire area of the surface of the piston, the peripheral portion of the piston can move proximally thereby surrounding the piston rod foot.
Due to friction between the cartridge wall and the piston during expelling the maximum precision of the size of the injectable dose is obtained if the pressure from piston rod is applied to the piston equally distributed and especially distributed as close to the cartridge wall as possible. However, a large diameter on the piston rod foot, which is preferred in order to distribute the pressure applied at the periphery of the piston, prevents the piston from at least partly move in the proximal direction when exposed to frost thereby increasing the risk for breakage of the glass.
It is an object of the present invention to provide an injection device having a piston rod foot which can transfer the pressure at the periphery of the piston without preventing the piston from moving, at least partly, in the proximal direction should the liquid drug be exposed to frost and expand. It is further an object to provide a build-in freeze-and-thaw indicator indicating to the user whether the drug contained in the injection device has been exposed to frost or not.
The invention is defined in claim 1.
In a first embodiment the piston rod foot comprises a centre part and an outer part releasable connected to the centre part. If the liquid contained in the cartridge is frozen, the liquid will expand. This expansion moves the piston in the proximal direction, as the piston which is usually made from a rubber composition is the weakest link. However, the centre part of the piston rod foot abuts the piston rod which is prevented form movement in the proximal direction due to its coupling with the injection mechanism. As a consequence only the part of the piston lying outside the periphery of the centre part of the piston rod foot can move in the proximal direction. This movement moves the outer part of the piston rod foot proximally out of engagement with the centre part of the piston rod foot.
When the injection device is thawed after having been frozen, the piston will move into its non-frozen position and the outer part of the piston rod foot will remain in the position into which it was moved during freezing. This will provide a slightly lesser precision of the injection device, but the injection device will remain workable. A user inspecting the injection device will be able to visible see if the outer part has been dislocated relatively to the centre part.
The releasable coupling between the centre part and the outer part can be formed in any releasable form making it possible for the two parts to disengage when a certain threshold force is surpassed. The centre part and the outer part can be coupled together by breakable elements such as protrusions which break when a the predetermined threshold force is surpassed.
The piston moves the outer part of piston rod foot axially in the proximal direction when the liquid in the cartridge is exposed to frost. In one example of the invention, the centre part and the outer part have different colours such that a user can easily inspect if the outer part has moved relatively to the centre part.
In a further embodiment, the centre part and the outer can have different coefficients of thermal expansion. If the centre part is made from a first material which retracts more during freezing than a second material from which the outer part can be made, then the two parts can decouple fully or partly in the radial direction during freezing.
The piston rod foot is not necessarily provided as a loose part but can be rotatable or non-rotatable hinged to the piston rod. The inner part of the piston rod foot can also be formed integrally with the piston rod if the injection device e.g. is the type in which the piston rod foot do not rotate relatively to the piston rod during dose ejection.
The present invention also involves the piston rod foot comprising a centre part and an outer part releasable coupled together.
The ability of the two parts to release from each other can be provided in multiple of different ways. Either of the parts can be provided with protrusions engaging similar depressions in the opposite part which protrusion breaks when a certain, predetermined threshold force is surpassed in the axial direction. In a different embodiment, the two parts can be provided with a rim and track coupling which are releasable when a certain threshold force is surpassed. This decoupling can be enhanced by the physical shape of the engagement. If the two parts are made from materials having different thermal expansion a decoupling in the radial direction can be facilitated.
An “injection pen” is typically any kind of injection apparatus having an oblong or elongated shape somewhat like a pen for writing. Although such pens usually have a tubular cross-section, they could easily have a different cross-section such as triangular, rectangular or square or any variation around these geometries. Instead of the term “injection apparatus”, the term “drug delivery apparatus” or simply “injection device” is also sometimes used with the same meaning. The broad meaning of the term being any kind of device which is able to transfer a liquid to and/or from a person in a subcutaneous way.
As used herein, the term “drug” is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension. Representative drugs includes pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
Correspondingly, the term “subcutaneous” injection is meant to encompass any method of transcutaneous delivery to a subject.
“Cartridge” is the term used to describe the container containing the drug. Cartridges are usually made from glass but could also be moulded from any suitable polymer. A cartridge or ampoule is preferably sealed at one end by a pierceable membrane which can be pierced e.g. by an injection needle. The opposite end is closed by a plunger or piston made from rubber or a suitable polymer. The plunger or piston can be slidable moved inside the cartridge. The space between the pierceable membrane and the movable plunger holds the drug which is pressed out as the plunger decreased the volume of the space holding the drug. A “piston rod foot” is an element which distributes the force from the piston rod to the movable plunger or piston and is usually located between the piston rod and the movable piston or plunger.
All references, including publications, patent applications, and patents, cited herein are incorporated by reference in their entirety and to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
All headings and sub-headings are used herein for convenience only and should not be construed as limiting the invention in any way.
The use of any and all examples, or exemplary language (e.g. such as) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
The citation and incorporation of patent documents herein is done for convenience only and does not reflect any view of the validity, patentability, and/or enforceability of such patent documents.
This invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law.
The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:
The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.
When in the following terms as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical”, “clockwise” and “counter clockwise” or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.
In that context it may be convenient to define that the term “distal end” in the appended figures is meant to refer to the end pointing towards the needle cannula penetrating the patient whereas the term “proximal end” is meant to refer to the opposite end.
The piston rod 20 is connected to a not shown injection mechanism which moves the piston rod 20 forward during injection. During injection, the distal end 21 of the piston rod 20 abuts the circular depression 4 provided in the proximal surface 6 of the piston rod foot 1. The distal surface 7 of the piston rod foot 1 is in contact with the piston 15 at its back wall 17 such that a force applied to the piston rod 20 is transmitted to the piston 15 via the contact surface between the piston rod foot 1 and the piston 15.
In
If the liquid drug contained inside the cartridge 10 is exposed to frost as disclosed in
When the liquid drug is thawed, the piston 15 will transform to its original shape as disclosed in
Since the cartridge 10 is usually embedded in the housing of the drug delivery device this housing can be provided with a window in the position into which the outer part 3 if moved during freezing such that the user just by inspecting the window can obtain information regarding whether the drug delivery device has been exposed to frost or not. The housing could further be equipped with means for securing the outer part 2 in this proximal position. The outer part 3 is preferably coloured in a distinct colour thereby enhancing the visibility of the outer part 3 in the window.
Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 11180228.6 | Sep 2011 | EP | regional |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP2012/066696 | 8/28/2012 | WO | 00 | 4/21/2014 |
| Number | Date | Country | |
|---|---|---|---|
| 61532813 | Sep 2011 | US |
