Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-10-21
2001-11-06
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S211000
Reexamination Certificate
active
06312413
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to cylinder ampoules having a first end sealed by a closure through which an injection unit can communicate with a medicament in the ampoule and a second end closed by a piston which can be forced into the ampoule to press out a dose of a medicament stored in the ampoule between the closure and the piston through said injection unit.
It shall be noticed that a cylinder is defined as a surface described when a line, the generatrix, with a defined orientation in space is moved along a guiding curve. What colloquially is called a cylinder is a so-called right circular cylinder, i.e. a cylinder whose guiding curve is a circle and whose generatrix is a line perpendicular to the plane of said circle. When talking about cylinder ampoules the word cylinder should be interpreted in the widest sense of the word although cylinder ampoules known so far are of the kind corresponding to the colloquial interpretation of the word cylinder.
Cylinder ampoules may be designed for use in syringes which are e.g. used by diabetics for the injection of insulin. Some insulin types are suspended in a liquid and the ampoule has to be shaken, rotated and turned upside down for some time to re-establish the suspension of the insulin crystals which will form a sediment when the ampoule is not in use. In a common cylinder ampoule having a circular cross-section perpendicular to its axis rotating of the ampoule will only result in a rotation of the ampoule and its content as a whole when the rotation of the ampoule is stopped, the liquid body will continue its rotation and the outer part of the rotating liquid body will break away some of the crystals which have segregated on the inner wall of the ampoule and suspend them in the said outer part of the rotating liquid body, but a homogeneous suspension where the concentration of crystals are equally suspended in the outer part and the part near the axis is difficult to obtain. Alternatively the ampoule may rotate without immediately drawing the liquid body with it. Also in this case a suspension of the segregated crystals in the outer part of the liquid body may be obtained when the ampoule wall moves relative to the liquid body but also in this case a homogeneous suspension is difficult to obtain.
From EP 235 691 it is known to place in the ampoule one or more mixing bodies in the shape of balls made from a material having a density which is different from the liquid. When the ampoule is rotated the balls will run along the wall and loosen crystals sediments. However, the balls may have a grinding effect on the crystals which may then be deactivated.
BACKGROUND OF THE INVENTION
It is an object of the invention to provide an ampoule in which sediments can be re-suspended without the use of mixing bodies.
This is obtained by an ampoule of the kind described in the opening of this application which ampoule according to the invention has a non-circular inner cross section and the piston has a non-circular cross section corresponding to the inner cross section of the ampoule.
In known syringes, the piston is pressed into the ampoule by a piston rod which acts on the piston directly or through a pressure foot, the piston rod being non-rotatable but axially displaceable in the syringe. Many dose setting devices are based on engaging threads on the piston rod and a dose setting member, respectively, and a dose is set by rotating the dose setting member relative to the piston rod.
By way of example EP 327 910 discloses a device by which doses may be set by increasing the total length of a piston rod, which abuts a piston of an ampoule in the device, and a piston rod extension which is through a threaded connection coupled to the piston rod. The increase is obtained by rotating the piston rod extension relative to the piston rod by rotating a dose setting member which can be rotated relative to the housing and consequently relative to the piston rod. A connection between the dose setting member and the piston rod extension makes the piston rod extension follow the rotation of the dose setting member. By the resulting increase of the total length of the piston rod and its extension, the outer end of the piston rod extension which was previously flush with the end of the housing is passed out through the end of the housing. The projecting end of the piston rod extension is used as an injection button which can be pressed until it again is flush with the housing. Thereby the piston is pressed into the ampoule a distance corresponding to the set increase of the total length of the piston rod and the piston rod extension.
By such dose setting devices the piston rod must be secured against rotation relative to the housing of the syringe so that the rotation of the dose setting member relative to the piston rod may be performed by holding the house of the syringe and rotate the dose setting member relative to this housing and consequently relative to the piston rod.
This securing of the piston rod against rotation relative to the housing is commonly obtained by using a piston rod which has a non-circular cross section and which passes through a conforming guiding opening through a guiding element secured to the housing.
In a cylinder ampoule according to the invention, the piston has a cross-section corresponding to the inner cross-section of the ampoule and as this cross-section is not circular it is ensured that the piston cannot be rotated relative to said housing.
According to the invention this requirement may be complied with by providing the piston rod with a pressure foot which has a cross section corresponding to the inner cross section of the ampoule and is non-rotatably connected to the piston rod.
In another embodiment the piston rod may be secured non-rotatably to the piston.
A cylinder ampoule according to the invention may form a syringe housing and the piston rod may be threaded to form a part of a dose setting mechanism.
REFERENCES:
patent: 2736315 (1956-02-01), Feeny
patent: 3563240 (1971-02-01), Silver
patent: 4275729 (1981-06-01), Silver et al.
patent: 4563174 (1986-01-01), Dupont et al.
patent: 5108378 (1992-04-01), Firth et al.
patent: 5445618 (1995-08-01), Adobatti
patent: 2108381 (1972-08-01), None
Buch-Rasmussen Thomas
Jensen Jens Møller
Poulsen Jens Ulrik
Kennedy Sharon
Novo Nordisk A S
Serke Catherine
Skadden, Arps, Slate, Meager & Flom LLP
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