Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-03-21
2004-09-28
Mancene, Gene (Department: 3764)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S247000, C604S411000, C604S905000, C285S332000
Reexamination Certificate
active
06796971
ABSTRACT:
FIELD OF INVENTION
The present invention relates to a device for storing and administering a medical fluid, comprising a sealed flexible generally bottle formed container provided with an insert in its opening to which an injection means can be attached.
BACKGROUND OF THE INVENTION
It is a well established technique in pharmaceutical industry to manufacture prefilled bottle formed containers for sterile fluids from blow molding a polymer material, filling and sealing the so formed container in a continuous operation. Such a blow-fill-seal method is disclosed for example in U.S. Pat. No. 4,342,184. In the European patent specification EP 0 670 709, it is disclosed a container made from such a method comprising essentially only a polyolefin based material so a highly environmental friendly container is obtained with a high compatibility to the stored fluids which also satisfies the requirement that the finally sealed container shall be sterilized with high pressure steam (i.e. autoclavation at about 120° C. for more than about 15 minutes). This bottled formed container is suitable for repeated collection of fluid with a syringe needle piercing its elastomer containing resilient sealing insert. This type of containers has many advantages from their cheap and efficient production method and they will successfully replace glass bottles or ampoules in numerous applications. A drawback with these containers is that it requires a certain skill and accuracy to correctly pierce the insert to establish fluid communication between the bottle and syringe so as to collect a desired amount of stored fluid for adminstration to a patient or for transfer to another container.
EP 0 088 056 and EP 0 326 391 disclose plastic bottle formed ampoules having twist off heads and neck parts formed as a female luer so as to fit with the male luer heads of a connected syringe when transferring fluids from the bottle to the syringe. In many applications, it would be of advantage to be able to directly use the bottle formed container filled for administering its sterile fluid to a patient. The transferring step using an attachable syringe results in an extra routine and thereby a risk for contamination and faulty handling.
FR 27 18 017 discloses a bottle for liquid pharmaceuticals made of a polymeric material which is sealed with a detachable cap. The bottle has top part formed as a male luer like connection to a cannula (or a similar device) with corresponding form. After tearing off the cap
6
a lock ring
11
is engaged over the flange
10
bottle opening. The lock ring will serve as safe and tight connecting piece between the bottle opening and the cannula. The European patent application 0 788 804 describes a flexible bottle of a polymeric material. The bottle may contain a rinse fluid (sodium chloride solution) which for example can be used for flushing a catheter connected to a vein of a patient, just before the infusion of a drug or a parenteral nutrient. It generally comprises a bottle with a cap which the user removes to free its opening. A separate connecting piece with attachment means for a cannula is inserted into the opening. The assembled device is thereby ready to be used for administering the contents of the bottle to a patient, or for transferring of the fluid into another container. The device of EP 0 788 804 suffers from a number of obvious drawbacks. At first, the inserting procedure of the connector is inconvenient and results in additional handling for the hospital personal and will always include a risk for inadvertent contamination of the fluid. Secondly, the device, if used for vein flushing, may deliver air bubbles with the fluid when the fluid is administered by squeezing the flexible bottle. The introduction of air bubbles into the blood system can not be tolerated due to the risk of embolism
Also U.S. Pat. No. 4,259,095, EP 0 310 227 and FR 954 795 disclose plastic bottles filled medical liquids which have removable cap parts exposing a male luer neck part for connection to a corresponding female part of a cannula. These containers aim to provide containers which directly can be transformed to an adminstration tool for injection of the stored liquid to a patient. However, as injection devices these containers in many aspects are inferior when compared to ordinary syringes operating by actuating a piston rod connected to a piston during the administration of the fluid. One drawback with conventional blow-fill-seal formed containers of this type is that the joints from the molding process when connecting the container pieces remain and cause impairments of the fitting of luer connection between the container top and a cannula. It is of further importance that they do not admit any safe routines when it comes to removing air bubbles from the injection fluids, as being performed by a routine de-aeration step with conventional syringes in order to avoid injection of air. U.S. Pat. No. 5,538,306 reveals a construction of such a bottle formed squeezable containers attachable to a cannula which aims to overcome the problems, but is complicated in construction and requires a prescribed handling including several steps. WO/95/07720 discloses a needless valve for use in intravenous infusion which is normally closed to prevent fluid communication. A needless connector can be engaged with a male element of the valve to open the valve. The administration can not be performed by simply squeezing the container. WO98/3 1408 describes a slotted-disc check valve adapted to receive flow-fittings, such as a tubing and Luer fittings. Depending on the flow direction, the check-valve opens and closes, respectively. Using an external member, the check-valve allows fluid to flow in both directions.
There is obviously a demand for bottle formed plastic containers for storing medical fluids that readily can be converted into a safe and convenient injection device with a minimum of complicated operations and thereby having the highest possible safety in terms of contamination of the fluid during the handling. This is attained by the present invention as will be explained in the following.
DESCRIPTION OF THE INVENTION
The present invention relates to a device for storing and administering a medical fluid, comprising a sealed flexible container which is generally bottle formed or of a similar shape. In its front end, the container is provided with an opening part, in which an insert is sealingly positioned. In order to protect the insert during handling and storing prior to the use of the device, the container is formed during its manufacturing so it directly extends into sealing cap over said insert. The cap is removable by being provided with weak line or a similarly rupturable zone so the user by a simple twisting motion may remove the entire cap or a substantial part thereof to expose the insert when the fluid in the container shall be used and fluid communication shall be established between the container and an attachable injection means, preferably with a conventionally shaped cannula comprising a front needle part connected to generally conical hollow rear part. This is accomplished by that the rear part of the cannula is attached to a generally tubular part of the insert with a generally conical shape in cross-section fitting with the hollow part of the cannula. Preferably, the tubular part of the insert and the hollow part of the cannula are cooperating luer fittings, so said tubular part corresponds to male luer fitting and said hollow part corresponds to a female luer fitting. Furthermore, to ensure that the injection means is safely attached, the insert is provided with a engagement means which comprises a radially extended annular recess in the insert which extends axially into the insert a sufficient distance to secure the attachment of a conventional cannula having a rear end shaped as a female luer fitting. To improve on the engagement, the outer periphery of the annular recess preferably is provided with screw threaded grooves, so as to form a luer lock attachment between the cannula and
Andersson Gunnar
Petterson Bert
Fresenius Kabi AB
Hahl Robert W.
Katten Muchin Zavis & Rosenman
Mancene Gene
Nicolas Frederick C.
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