Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-09-27
2001-09-11
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S408000
Reexamination Certificate
active
06287284
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a bag assembly for use in pharmaceutical manufacturing and for holding health care related solutions and, more particularly, to an improved bag assembly manufactured of silicone.
At the present time, virtually all bags used by the pharmaceutical industry and for holding health care related solutions (such as intravenous bags) are manufactured of polyvinyl chloride (PVC). PVC is a commonly used inexpensive plastic material which is naturally hard. To soften such material so that it can be used as a flexible bag and as flexible tubing, plasticizers such as phthalate esters are added to the PVC to soften it. Recently there has been concern that phthalates may leach from the PVC to which they have been added, thereby contaminating aqueous fluids held in PVC bags and traveling through PVC tubing. Since PVC bags are used to store intravenous solutions and blood for transfusions, phthalates which leach from the PVC are infused directly into a patient's bloodstream. It would therefore be desirable to have a phthalate-free bag and tubing for such purposes.
SUMMARY OF THE INVENTION
It is known that silicone is a relatively inert chemical in aqueous solutions, i.e., it does not react with contacting liquids or leach chemicals into contacting liquids. Accordingly, the present invention provides the combination of at least one silicone tube having an open central passageway and a flexible silicone membrane formed into a tubular shape with opposed ends. The membrane tubular shape is larger in diameter than the tube. Each tube extends into a respective end of the membrane so that the respective open central passageway of the tube is in communication with the interior of the tubular shaped membrane. Each of the membrane ends is flattened and sealed to itself and to a respective tube, thereby forming a bag assembly.
In accordance with an aspect of this invention, the flexible silicone membrane is formed as a seamless tube.
In accordance with another aspect of this invention, the flexible silicone membrane is a silicone sheet having opposed edges overlapped and joined together so that the membrane attains a tubular configuration.
REFERENCES:
patent: 4573992 (1986-03-01), Marx
patent: 6019751 (2000-02-01), Gabbard et al.
Davis David L.
Nguyen Anhtuan T.
NPT, Inc.
Thompson Michael M.
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