Fluent material handling – with receiver or receiver coacting mea – Filling or refilling of dispensers – By operation of means causing or controlling dispensing
Reexamination Certificate
2002-02-25
2003-10-28
Douglas, Steven O. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Filling or refilling of dispensers
By operation of means causing or controlling dispensing
C141S059000, C141S002000, C141S018000, C604S411000, C604S416000
Reexamination Certificate
active
06637470
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
The invention relates to the transfer of a fluid which itself is already an injectable product or which forms an injectable product when brought together with a solid or fluid component. The invention further relates to a multi-lumen cannula such as is suitable for transferring a fluid in a particular way.
2. Description of the Related Art
Devices for transferring medicines, mostly using so-called disposable syringes, have been known to patients and medically trained personnel for a long time. Essentially, in the case of a disposable syringe, the cannula is pushed through a puncture membrane of a normal medicine container, then air is pressed through the cannula into the medicine container in order to finally suction medicine from the medicine container through the cannula into the disposable syringe. Normal medicine containers are containers air-tight sealed which have an opening sealed by a puncture membrane.
The same transferring process is also the basis for filling a disposable ampoule which is inserted into an infusion pump or an injection pen. Such infusion pumps are known for example from patent specification EP 0 143 895. Injection pens are known for example from patent specification WO 87/02895. Disposable ampoules differ from disposable syringes in that the cannula can be de-coupled from the rest of the ampoule casing and the stopper from the piston rod. The transferring process is elaborate.
A device for transferring a product fluid from one container into another container is known from CH 676 548 A5, wherein another solid or fluid product is situated in the other container. The other container is sealed at the front end by a puncture membrane and at the rear end by a movable stopper. When transferring the product fluid into the other container, the stopper is pushed further backwards. The product fluid thus comes into contact with an area of the other container which has been previously exposed to the environment. This results in problems of sterility.
More recent injection pens and infusion pumps are designed for the use of so-called pre-filled ampoules, i.e. ampoules which are filled by a medicine manufacturer and not by the patient. Such injection pens or infusion pumps are known from patent specifications WO 93/16740 and WO 98/47552. In order to prevent supply bottle-necks with such pre-filled ampoules, and for the same injection pen or the same infusion pump to be easily used with as many different medicines as possible, the supplier of injection pens and infusion pumps should also provide devices which enable a medicine to be transfused from a normal medicine container into a disposable syringe or disposable ampoule, and then into an ampoule which is preferably filled with a sterile gaseous substance, or otherwise into an ampoule which is identical to the pre-filled ampoule. These ampoules which are preferably filled with a sterile gaseous substance or are otherwise identical to the pre-filled ampoule are called empty ampoules in the following. Empty ampoules consist of an ampoule body which is sealed at its front end by a puncture membrane and at its rear end by a movable stopper. The stopper is arranged at the rear end of the empty ampoule for reasons of sterility. If the medicine is then to be transfused from the disposable ampoule or disposable syringe into the empty ampoule, the sterile gaseous substance has to be displaced, since the stopper arranged at the rear end of the empty ampoule would otherwise be forced out of the empty ampoule.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a transferring device for a product fluid which is easily operated by the patient and which enables the product fluid to be transferred into a container which is at least partially filled with gas, without changing the volume of the container.
The object is solved by the subjects of the independent claims.
A transferring device for transferring a product fluid comprises: a first container with a container opening through which the product fluid can be delivered into the first container or out of the first container; a delivering means for delivering the product fluid into the first container or out of the first container; and a cannula which is suitable for piercing a membrane and which comprises a front, first cannula opening. The cannula is or can be connected to the first container via a rear, first cannula opening, such that the product fluid can be delivered through the cannula and the cannula openings into the first container or out of the first container. In accordance with the invention, the cannula comprises a rear, second cannula opening which during transfer forms a fluid connection from a second container to a pressure equalization means or directly to the environment. In this way, a pressure burden or partial vacuum arising from the product fluid being delivered in or out of the second container is decreased without changing the volume of the second container. If the second container is sealed by a piston, no force is exerted on it once the pressure in the second container is equal to the ambient pressure. The piston is prevented from moving.
A fluid connection between the first container and the second container, and a fluid connection between the second container and the pressure equalization means or the environment, is created via the cannula. These fluid connections are established via at least one lumen in the cannula which is connected to the cannula openings. Particularly preferably, the cannula is fixedly connected to the first container. In order to establish a fluid connection, a membrane with which the second container is sealed is pierced through. If both containers are sealed with a membrane, one cannula can be used to establish the fluid connection between the two containers, by the cannula piercing both membranes.
Particularly preferably, the cannula comprises at least two lumens, wherein the fluid connection between the first and the second container is formed by one of the two lumens and the fluid connection between the second container and the pressure equalization means or the environment is formed by the other of the two lumens. One of the at least two through lumens extends from the front, first cannula opening to the rear, first cannula opening and the other of the at least two through lumens extends between a front, second cannula opening and the rear, second cannula opening. The at least two through lumens can be designed in one part, for example by channels or bores. Preferably, a double-lumen tube can be used, whose openings are accordingly connected to the containers. Each through lumen is preferably designed in its own part. Preferably, two conventional hollow injection needles are used, which jointly form the cannula.
The at least two through lumens are preferably arranged side by side. They are particularly preferably arranged parallel. If, for example, two conventional hollow injection needles are used, these can form the cannula spaced parallel. They are preferably fixedly connected to each other, particularly preferably along an outer surface line of the injection needles, respectively.
The puncture membrane of the second container is preferably pierced by the two hollow injection needles. Each injection needle comprises two ends. The front ends of the two injection needles are preferably cut at an angle, to facilitate piercing the membrane. The rear ends of the injection needles are connected to different spaces. The rear end of one injection needle is connected to the first container, for example to the hollow space of a disposable syringe or a disposable ampoule, and the rear end of the other injection needle terminates exposed in the environment. In principle, a connection to the environment can also be established by a differently designed opening on the other injection needle. If, for example, this injection needle is drawn up as far as the ampoule, then the connection to the environment or to another pressure equalization space can for example be for
Boos Bruno
Eberhart Andreas
Hirsiger Michel
Hommann Edgar
Latscha Peter
Disetronic Licensing AG
Dorsey & Whitney LLP
Douglas Steven O.
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