Surgery – Container for blood or body treating material – or means used... – Bag type
Reexamination Certificate
2000-02-28
2001-06-05
Ruhl, Dennis (Department: 3761)
Surgery
Container for blood or body treating material, or means used...
Bag type
C604S403000, C215S247000, C206S828000
Reexamination Certificate
active
06241717
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a single use universal access means/container combination for the maintenance and delivery of a medical fluid from the container to a site of administration. Preferred embodiments of the invention relate to a single use universal access means/prefilled collapsible bags and bottles for the maintenance and delivery of a medical fluid therefrom to a site of administration.
2. Reported Developments
Parenteral fluids, such as therapeutic drugs, diagnostic contrast media and nutrients are conventionally administered to a patient from a container, such as a collapsible bag or bottle having a fluid exit port. The fluid exit port may include means, such as a tube, spike or cannula, the distal end of which is in communication with the fluid content of the container and the proximal end of which is connected to the desired site on the patient. Conventionally, the proximal end of said means includes a needle that can puncture the skin of a patient. The fluid exit port is sealed by a membrane which is punctured by inserting a spike into the exit port when fluid delivery is desired. The membrane can also be a resealable membrane which after puncture reseals itself, due to its highly elastomeric properties, to prevent further fluid flow through the fluid exit port.
One approach used by the prior art to penetrate the membrane covering the fluid exit port comprises the use of syringes or spikes which carry the danger of accidental injuries caused by the sharp points of the needles and spikes. Such injuries accidentally inflicted on the health practitioner carry the further risk of getting infected with diseases such as AIDS. In order to reduce the danger of accidental injuries, spikes having relatively blunt tips were used. However, such pikes puncture a large area of the membrane and once the spikes are removed the membrane no longer seals the fluid exit port.
Another approach used by the prior art is the provision of a tubular member which is more blunt than a spike so that it is unlikely to penetrate the skin yet capable of penetrating the latex diaphragm type seals.
Still another approach used by the prior art is a valve positioned in the fluid exit port, the valve being operable by engagement with a spikeless or needleless IV component and contains a resilient valve disc positioned in the fluid passageway and blocks fluid flow when the disc is in the closed position, and allows fluid flow when the disc is in the open position.
Still another needleless connector of the prior art uses a resilient conical valve head in a housing. The conical valve head is positioned against the valve seat to form a seal. When the male fitting of a syringe, or some other device, is inserted into the inlet of the housing, it pushes the tip portion of the resilient valve head inwardly so that the valve head is deformed away from the valve seat thereby allowing fluid communication. In still other embodiments of the prior art, a needleless connector includes an elastomeric conical valve head biased against a conical valve seat by a helical spring to form a seal.
The above generally described devices have greatly reduced the risk of needle-stick associated injuries by the use of syringes to withdraw medical fluids from collapsible bags and bottles.
However, there still exists the need to provide a universal connector which may be used with a wide variety of connection sites. A seal or diaphragm is a main component of the herein-described invention which does not require penetration by any sharp or even blunt object in order to establish fluid communication between the content of the container and the site of delivery.
SUMMARY OF THE INVENTION
In accordance with the present invention there is provided a universal connector which can be used to access the fluid content of a container or to transfer a fluid into the container. The universal connector can be used in collapsible and non-collapsible bags, bottles and vials made of glass or polymeric material which contain a fluid exit port into which the universal connector is inserted sealing the fluid exit port. The fluid contained in the container may be a therapeutic liquid, diagnostic media or a nutritional formula which can be sterilized in bulk and then aseptically transferred into the container or it can be sterilized in the container stoppered with the universal connector. The universal connector is made of rigid or semi-rigid polymeric materials such as polyvinyl chloride, polyethylene and polypropylene.
The fluid in a container stoppered by the universal connector can be accessed by means well-known in the art, such as syringes having sharp or blunt needle cannulas. Preferably, the access means comprises a luer connector in order to prevent accidental injuries to health care workers and patients caused by the use of syringes.
The universal connector comprises:
(1) a connector body of tube-like configuration the distal end of which is designed to be slideably insertable into the fluid exit port, and the proximal end of which is designed to seal the content of the container by an elastomeric membrane and also to receive a removable cap; and
(2) a removable cap threaded onto the proximal end of the connector which, prior to use, is removed so that the content of the container could be accessed by the use of a luer connector having a configuration that is similar to the configuration of the cap or by other access means, such as sharp or blunt needle cannulas.
The elastomeric membrane sealing the proximal end of the universal connector is of an inert, gas-impermeable polymeric material capable of flexing under internal or external pressures such as exerted thereon during steam sterilization. It preferably has a thickness of from about 0.001 mm to about 1.00 mm and a durometer of from about 25 to about 80 Shore A. It is capable of being ruptured by the twisting motion of a blunt luer connector or syringes having sharp or blunt needle cannula. The configuration of the elastomeric membrane is of cylindrical, however, preferred embodiments of the present invention include dome-shape, cone-shape, conic-section elastomeric membranes which can be ruptured or pierced even more readily by blunt access means than the cylindrical configuration embodiment.
The tube-like body of the universal connector further comprises: first cap-locking ring on the proximal end of the body which serves as a male thread to receive the removable cap; and second cap-locking ring spaced from the first cap-locking ring towards the distal end of the tube-like body, which serves as stopping means for the cap when the cap is threaded onto the tube-like body of the universal connector.
Preferred medical containers used in combination with the single use universal access means are those disclosed in copending applications
(1) Ser. No. 09/027,325,
(2) Ser. No. 08/900,739 and
(3) Ser. No. 09/196,084,
each of which is incorporated by reference herein in its entirety constituting first, second and third embodiments of the present invention.
First Embodiment
In the first embodiment, a flexible collapsible medical container equipped with the single use universal access means is packaged in an overwrap in order to prevent degradation of a light-sensitive medical fluid contained in the medical container.
The medical container in combination with the single use universal access means comprising:
first and second transparent polymeric sheets having a square, round, oval, hexagonal, octagonal or rectangular configuration superimposed and sealed together at their periphery defining an interior reservoir, said container having a top portion and a bottom portion;
an access port located at the bottom center portion sealed between said first and second polymeric sheets removably covered with a cap, said access port is designed for allowing filling of the medical container with a medical fluid and access thereto by an access means for delivery of the medical fluid to a patient, said access means comprising the single use universal connect
Balogh Imre
Bracco Diagnostics, Inc
Ruhl Dennis
LandOfFree
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