Surgery – Container for blood or body treating material – or means used...
Reexamination Certificate
2001-04-27
2003-08-05
Huson, Gregory L. (Department: 3751)
Surgery
Container for blood or body treating material, or means used...
C604S408000, C604S080000, C604S089000, C604S090000
Reexamination Certificate
active
06602239
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an infusion bag in accordance with the preamble of claim
1
, and an infusion system in accordance with the preamble of claim
10
. Particularly, the invention relates to an infusion bag and an infusion system exhibiting a high degree of imperviousness against leakage when supplying medically effective substances to the infusion bag
BACKGROUND OF THE INVENTION
Infusion bags are utilized for intravenous delivery of fluids and medically effective substances to human beings or animals. For this reason, the infusion bag is provided with at least one outlet channel through which fluid can flow to a connecting device such as, for example, a cannula. When preparing the fluids which are to be administrated to the body from the infusion bag, it is common that medically effective substances are supplied to a pre-sealed infusion bag which is filled with a transport fluid, usually in the form of sodium chloride solution or a glucose solution. In certain cases, medically effective substances are harmful to other persons than the patient who has been prescribed predetermined doses as a result of an indication of a specific disease. This is particularly the case when long-term exposure is concerned, which can happen to medical staff when handling and preparing drugs for an extended period of time. For example, this is the case when preparing infusion bags containing cytotoxins, antibiotics and antiviral drugs. For this reason, there are special directions requiring preparation in safety cabinets and use of personal protective equipment, which implies that handling cannot take place without using these protective measures and devices. As a rule, the preparation is performed by means of injecting the medically effective substance through a membrane arranged in connection with an inlet channel arranged through the wall of the infusion bag. When performing this type of injection, leakage often occurs when the penetrating needle is withdrawn after having penetrated the membrane. Since the penetrating needle is often coarse, a major leakage may occur. A droplet of medically effective substance will be transported from the tip of the cannula 5 to the area surrounding the perforation in the membrane, at which leakage occurs.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to reduce the risk of exposure to medically effective substances when preparing infusion bags. A second object is to provide infusion bags which enable the preparation to take place in any optional location without any leakage occurring, something which reduces staff resources needed for the preparation, reduces the preparation time; and also can provide treatment advantages and reduce the need of personal protective equipment and special peripheral equipment in the form of safety cabinets. The above-mentioned objects are achieved by means of an infusion bag according to the characterising portion of claim
1
and an infusion system according to the characterising portion of claim
8
, by means of the infusion bag being provided with an inlet channel, arranged in connection with an integrated communicating member having an opening where a first flexible membrane is arranged in said opening to be accessible to a second flexible membrane arranged on a connecting member, and wherein said communicating member exhibits means for holding said second flexible membrane with a pressure against said first membrane, so that droplet formation on the surface of the first membrane is prevented, wherein occurrence of leakage after injection is prevented.
REFERENCES:
patent: 4441538 (1984-04-01), Larkin et al.
patent: 4460365 (1984-07-01), Ganshirt et al.
patent: 4463862 (1984-08-01), Hansen
patent: 4479989 (1984-10-01), Mahal
patent: 4516977 (1985-05-01), Herbert
patent: 5971181 (1999-10-01), Niedospial et al.
patent: 6179821 (2001-01-01), Caspary et al.
patent: 6398771 (2002-06-01), Gustafsson et al.
patent: 2001/0012930 (2001-08-01), Ebner et al.
Carmel Pharma AB
Flynn Amanda
Huson Gregory L.
Norris & McLaughlin & Marcus
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