Prefilled telescoping multiple chamber ampoule device

Details Prefilled telescoping multiple chamber ampoule device Prefilled telescoping multiple chamber ampoule device

2001-11-08

2004-04-13

Casler, Brian L. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S082000, C222S145500

Reexamination Certificate

active

06719729

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates to prefilled telescoping multiple chamber ampoule devices separately storing at least two different flowable components. More particularly, the invention relates to prefilled telescoping multiple chamber ampoule devices for dispensing at least two different flowable components which are separately stored in the device. The dispensed components are allowed to intermix with one another after being released and prior to application, or they are kept separately after being released for successive application. The range of application comprises the fields of medicine, chemistry, bio genetics, cosmetics and other fields where it is necessary to store the different components of a multi-component product separately from one another and just mix them with one another immediately prior to application or apply them successively. Furthermore, in these fields of application it is frequently necessary or at least desirable to store the individual components in an air-tight or fluid-tight manner.
International PCT application having the publication number WO 99/17833, published on Apr. 15, 1999, discloses a fibrin sealant cartridge assembly for applying a solution of fibrinogen and a solution of thrombin. The cartridge assembly comprises a container unit having a first and a second container arranged parallel to one another, a piston unit comprising a first and a second piston matingly cooperating with the first and the second container, respectively. Each container stores one of the two solutions. Each piston has a passageway axially extending within the piston through the entire piston. Hence, each passageway has an axial inlet opening which is always in fluid communication with the associated container. Furthermore, each passageway has an axial outlet opening which is in fluid communication with a nozzle attached to the piston. Telescopic movement of the container unit towards the piston unit decreases the volumetric capacity of the containers forcing the solutions therein to flow into the passageways and be dispensed from the nozzles onto an application site. A trip applicator may be attached to the two nozzles for dispensing the two solutions in close proximity to one another. The trip applicator allows a user to spread and/or mix the protein solutions on the application site after they have been dispensed through the outlet openings of the trip applicator. By arranging the outlet openings of the trip applicator very close to each other the solutions intermix before being tripped onto the application site.
In the fibrin sealant cartridge assembly described above, there is a possibility of contaminating the solutions stored in the container as the passageways axially extending through the entire pistons are in continuous fluid communication with the containers. Furthermore, the piston unit consists of several parts including a sealing ring being attached to the outer wall of each piston.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a prefilled telescoping multiple chamber ampoule device which prevents contamination of individual components contained in the device during transportation and storage, and which has a simple construction, can be assembled in an easy manner and manufactured at low expense for allowing the device to be disposed of after use.
Another object of the invention is to provide a prefilled telescoping multiple chamber ampoule device which avoids an unintentional release or dispense of the components stored in the device.
Another object of the invention is to provide a prefilled telescoping multiple chamber ampoule device which offers the possibility of adapting it to various application purposes without changing the basic design.
Another object of the invention is to provide a novel piston unit for use in a prefilled telescoping multiple chamber ampoule device.
These and other objects are accomplished by providing a novel prefilled telescoping multiple chamber ampoule device separately storing at least two different flowable components. The ampoule device comprises a container having at least two axially extending chambers which are arranged in parallel to one another. Each chamber has a closed rearward end and an open forward end. An integrally formed circumferential sealing means projects inwardly from the inner wall of each chamber. In addition, the ampoule device comprises a piston unit having at least two pistons. A transversely extending mount integrally adjoins the forward ends of the pistons. Each piston has a passage which axially extends within the interior of the piston. The passage has an axial outlet opening at a forward end of the piston and a transverse inlet opening near a rearward end of the piston. Each piston is aligned with one of said chambers and, with its rearward end ahead, is inserted into the open forward end of the chamber and matingly arranged therein for coaxial telescoping movement of the container and the piston unit towards one another from a closed storage position into an open release position. In the closed storage position the rearward end of each piston is spaced a distance from the rearward end of the respective chamber so as to define therein a reservoir containing one of the flowable components. Furthermore, in the closed storage position the circumferential sealing means is sealingly pressed into circumferential contact with the outer wall of the piston at a location so as to prevent fluid communication between the reservoir and the transverse inlet opening of the passage of the piston. Thereby, release of the component from the reservoir into the transverse inlet opening of the passage is prevented in the closed storage position. After initial and during telescoping movement into the open release position, the rearward ends of the pistons are moved towards the rearward ends of the chambers whereby the sealing means expose the transverse inlet openings of passages of the pistons to the reservoirs. Thereby, the components stored in the reservoirs are released through the outlet openings of the passages of the pistons as the volumes of the reservoirs are reduced. Furthermore, after initial telescoping movement the sealing means come into sealing contact with the outer walls of the pistons at a location between the transverse inlet openings and the forward ends of the pistons. Thereby, escape of the components from the reservoirs to the open forward ends of the chambers is prevented.
Preferably, the circumferential sealing means is a sealing lip which, in the closed storage position, is in sealing contact with the outer wall of the piston at a location between the rearward end and the transverse inlet opening of the piston. Optionally, an additional sealing lip is provided which is axially spaced from the first mentioned sealing lip in forward direction. The additional sealing lip assists frictional holding in the closed storage position and guidance during telescoping movement.
In order to provide a multi component dispensing system featuring mixing of the released components, in a preferred embodiment of the invention, the piston unit has a collection and mixing compartment integrally formed on top of the forward ends of the pistons. The collection and mixing compartment is in fluid communication with each one of the outlet openings of the passages of the pistons for simultaneously receiving each one of the released components during telescoping movement.
In order to provide a multi component dispensing system featuring separate and successive application of the released components, in a preferred embodiment of the invention, the piston unit has at least two separate compartments integrally formed on top of the forward ends of the pistons. The compartments extend in axial direction and are arranged in parallel to one another. Each compartment is in fluid communication with only one of the outlet openings of the longitudinal passages of the pistons for separately receiving only one of the released components during telescoping movement. The compart

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