Surgery – Container for blood or body treating material – or means used...
Patent
1995-07-21
1997-03-18
Weiss, John G.
Surgery
Container for blood or body treating material, or means used...
604411, 604415, 604905, 604 86, 604167, 215247, A61M 500
Patent
active
056117922
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a valve device for enabling the aseptic injection and withdrawal of medical fluids into/from an infusion container. More particularly, the invention relates to a valve device which comprises a valve body having a centrally located, self-sealing passage portion, a portion surrounding the passage portion and a surrounding peripheral portion. An application surface of the valve device is at least in part adhesive to enable its application onto the infusion container, preferably after the container has been filled. The invention may also find utility in other fields of application where aseptic technique is employed, for example within the food and beverage industry.
During various types of medical infusions, additions of various sorts may be necessary as may certain withdrawals, for example, samples for analysis. These may be exemplified by mineral or vitamin solutions, insulin and the like which are to be supplied to the infusion fluid.
In the case of patients suffering from renal insufficiencies and dependent on dialysis treatment, withdrawals of dialysis fluid via a catheter are necessary, these withdrawals being effected by the actual patient taking a gravity drawn sample via an implanted conduit into a special sample pouch which is sent off, as a unit, for analysis. This is a bulky and impractical, as well as a delicate, routine. Dialysis patients themselves also make additions to the dialysis fluid, as treatment is largely attended to by the patient in the home environment nowadays.
The infusion container is most commonly fitted at the manufacture stage with a stub located alongside the usual outlet. Such containers are manufactured, for example, by Fresenius AG, Bad Homburg. These include a valve construction which is assembled from several parts. Additions and withdrawals are made through the membrane with a syringe.
International Patent Application No. WO 84/00025 describes the use of an injection port having a construction similar to the abovementioned stub, for injecting fluids into an infusion container with a syringe. The port comprises a pad-like membrane included in a complicated and very intricate construction, which results in high manufacturing costs.
During the use of membrane devices of this sort there is always the risk that, due to the pressure the fluid exerts on the membrane, some of the contents of the container are withdrawn with the needle when the needle is taken out through the membrane after the routine, and are then deposited on the surface of the membrane. This involves a clear risk of infection of the contents of the container in those cases where repeated injections and/or withdrawals are necessary. The membrane diameter of the above device is so small that the membrane can be difficult to locate, particularly for a patient whose sight is impaired, which is often the case in renal insufficiency. As sterility is crucial in such treatments, unnecessary probing for the right injection point in these cases involves a not insubstantial infection risk and accordingly jeopardises the patient's health.
Manufacture of infusion containers fitted with the currently employed stubs or injection ports as in WO 84/00025 represents completely unnecessary expense in certain cases as the stubs/ports are not always utilized. Additionally, the attachment of these studs or injection ports to the container is a leakage risk and furthermore constitutes a resource demanding step in an otherwise relatively simple manufacturing process.
International Patent Application WO 82/03776 describes the use of a self-adhesive valve device for the addition or withdrawal of fluid to or from a fluid-filled container. One embodiment with this construction involves a substantial risk of infection because, in this case as well, fluid from the container is easily drawn along through the valve device when the needle is withdrawn after addition/withdrawal. The contents of the container exert a pressure at the injection point which may cause partial loosening of the adhesive device and l
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Dicamed AB
Snow Bruce E.
Weiss John G.
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