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EP 3 424 483 A1 |
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EUROPEAN PATENT APPLICATION |
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Date of publication: |
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09.01.2019 Bulletin 2019/02 |
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Date of filing: 05.07.2017 |
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International Patent Classification (IPC):
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Designated Contracting States: |
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AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL
NO PL PT RO RS SE SI SK SM TR |
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Designated Extension States: |
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BA ME |
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Designated Validation States: |
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MA MD |
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Applicant: Giaccari, Alessandro |
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87100 Cosenza (IT) |
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Inventor: |
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- Giaccari, Alessandro
87100 Cosenza (IT)
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MULTI-CHAMBER FLUID BAG WITH NEEDLE |
(57) Flexible fluid bag (1) comprising a first chamber (2) for a liquid solvent, a second
chamber (3) for a dry concentrate, the first and the second chamber separated by a
first reversible partition (4) configured to be broken by manually pressing the bag
in order to mix the solvent and the concentrate. The bag (1) is connected to a needle
(6) through a hollow exit channel (5). A second reversible partition (4) is placed
in the hollow exit channel to prevent fluid from exiting the bag during the mixing
phase.
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[0001] The Fast Dilution Bag is a medical device applicable in the administration of parenteral
therapy.
[0002] Currently the techniques used for the parenteral administration and dilution of drugs
such as, for example, antibiotics, involves the procedures outlined below:
- 1) Phial containing sterile solution for dilution (solvent), in glass or plastic,
minimum capacity 5ml.
- 2) Disposable syringe, sterile, with needle, variable capacity from 10ml to 20ml.
- 3) Drug in powder to be diluted, contained in glass phial.
[0003] Each of the aforementioned items of medical equipment needs to be conserved in a
container made of paper or non recyclable material. The procedure currently adopted
by health workers for the dilution of the drug to be administered, involves the following
steps:
- A) Aspiration of the sterile solvent from the phial (n°1 in the list) by means of
a disposable syringe (n°2), taking care not to touch the plunger in order to avoid
contamination.
- B) Injection of sterile solvent in the glass phial containing the drug in powder (n°3)
to dilute the solution;
- C) Aspiration of the dissolved drug into the intravenous drip for administration
[0004] With the FAST DILUTION BAG, on the other hand, the procedure takes place in a much
simpler manner, with significant reductions both in terms of time taken for the dilution
itself, and in the materials utilised (notable savings also as regards cost) and a
consequent reduction of the amount of waste for disposal (material from the health
service is treated in a different way from other refuse because of its nature and
the cost of disposal is based on weight)
[0005] The invention is a bag of plastic or rubbery material (possibly polyisobutylene)
which is flexible, impermeable and small in size (see main figure) containing two
chambers within the bag itself separated by a reversible partition (see figure 4),
one designed to contain the sterile liquid (see figure 2) and the other containing
the powdered drug to be diluted (see figure 3)
[0006] At one end of this there is a sterile needle in a protective sheath, measuring 18G-
1.20x 40 (figure 6), and a small passage connecting the needle and the bag (figure
5), separated from the two main chambers by another reversible partition (figure 4).
[0007] The whole procedure for preparing the parenteral therapy to be administered with
the FAST DILUTION BAG follows these steps:
- 1) Press manually on the bag so as to break the first reversible partition separating
the two chambers thus enabling the sterile water to mix with the powdered drug.
- 2) Shake the bag to ensure the solution is fully dissolved.
- 3) Remove the sheath from the needle and insert it in the intravenous drip to transfer
the drug to be administered.
- 4) Press the bag again in order to break the second thin partition and allow the solution
contained therein to reach the needle and, then the drip. The latter procedure will
ensure that the contents of the bag have been entirely transferred to the drip, and
from there to the patient.
[0008] Important: unlike the preceding technique there is no risk of contamination of the
solution since everything takes place within an hermetically sealed environment, thereby
maintaining its aseptic properties.
[0009] The FAST DILUTION BAG could replace the obsolete dilution techniques that involve
waste of both time and materials (thereby reducing disposal costs).
[0010] Its adoption would thus represent an economic gain both for the producers of medical
goods by a reduction of materials required, and for the health sector itself through
a reduction in the amount of waste to be disposed of.
[0011] Yet the most important benefit would be the speeding up of parenteral therapy and
the consequent time saving in the work of hospitals.
1. Soft hollow bag (elastic) in polysobutylene (PIB), or similar plastic material, which
is robust, impermeable and flexible, contains two distinct chambers separated by a
reversible partition the purpose of which is to keep the two substances apart until
required. One chamber contains the medicine in powder and the other the sterile solution
to be used for injection;
2. First chamber contains the medicine in powder;
3. Second chamber contains sterile water for injection;
4. Reversible partition separates the two chambers until broken by pressing on the bag
manually;
5. Sterile needle 18G- 1.20x40mmpink, with plastic sheath connected to bag;
6. Hollow passage connecting bag to needle. This will be equipped with another reversible
partition in order to be kept separate from the main chambers until required.