Abstrict The invention is directed to a blood bag system for blood products
comprising a bag (3) and at least one tubing (11) connected thereto,
the system being made of at least partly transparent plastics material,
wherein photoactive substances (31) may be enclosed in a closed-off
section (A) of the tubing (11) of the ready-for-use system, which
may be handled individually as an independent unit. Every blood
bag system of this kind is adapted to be combined with another blood
bag system, which may comprise one or several bags (3 5 7 9)
and may likewise be handled as an independent unit, by interconnecting
both systems.
Claims We claim:
1. A ready-to-use blood bag system for donor blood or blood products
comprising a bag (3) and at least one tube (11) connected thereto,
the system being made of at least partially transparent plastic
material and photoactive substances (31) enclosed in a closed-off
section of the tube of the ready-to-use system with a frangible
valve in the tube between the bag (3) and the closed off section.
2. A ready-to-use blood bag system for donor blood or blood products
comprising a bag (3) and at least one tube (11) connected thereto,
the system being made of at least partly transparent plastics material,
wherein photoactive substances (31) are enclosed in a closed-off
section (A) of the tube (11) of the ready-to-use system and a frangible
valve (25) is in the tube between the bag and the photoactive substances
(11), which can be handled individually as an independent unit.
3. The blood bag system as claimed in claim 2 wherein the tubings
(11) of the one blood bag system are adapted to be welded to tubes
(11 13 15 17 21) of the other blood bag system.
4. The blood bag system as claimed in claim 2 wherein in the photoactive
substances (31) are provided in the liquid or dissolved state, respectively.
5. The blood bag system as claimed in claim 2 wherein phenothiazine
dyes are provided as said photoactive substances (31).
6. The blood bag system as claimed in claim 5 wherein methylene
blue or toluidine blue are provided as said dyes.
7. A ready-to-use blood bag system for donor blood or blood products
comprising bags (3 5 7 9) and tubes (11 13 15 17) made of
at least partly transparent plastics material, said tubes (11 13
15 17) interconnecting the bags (3 5 7 9) or being connected
to other tubes (19 21) wherein photoactive substances (31) are
enclosed in closed-off sections (A) of the tubes (11 13 15) of
the ready-to-use system and a frangible valve (25) is in the tubes
having photoactive substances therein, the valve being between the
photoactive substances and the other bags or tubes (11), which can
be handled individually as an independent unit.
8. The blood bag system as claimed in claim 7 wherein in the case
of the multi-bag system, collection bags (7) and further bags (3
5 9) are interconnected via tubes (11 13 15 17) which have substances
(31) enclosed therein.
9. A ready-to-use blood bag system for donor blood or blood products
comprising at least one bag and at least one tube connected thereto
through which the bags may be connected further, said material,
wherein a blood bag system which is to be handled independently
and individually and is composed of a bag (3) and tube (11) having
photoactive substances (31) enclosed in closed-off sections (A),
combined with another blood bag system which is to be handled independently
and individually and which is composed of a bag (3) and a tube (11)
or a plurality of bags (3 5 7 9) and tubes (11 13 15 17) interconnecting
said bags and a frangible valve (25) is in the tubes having photoactive
substances therein, the valve being between the photoactive substances
and the other bags or tubes (11), by interconnecting said blood
bag systems.
Description The invention is directed to a blood bag system for donor blood
and/or blood products comprising a bag and at least one tubing connected
thereto, the system being composed of at least partly transparent
plastics material.
Prior blood bag systems by means of which donor blood is collected
and processed comprise a collection bag and/or one or several further
bags connected thereto and interconnected by tubings. The bags are
made of a flexible plastic sheet material; the tubings are likewise
made of flexible plastics. The plastics materials of bags and tubings
are at least partly transparent. The bags are used, on the one hand,
for collecting blood or blood fractions into which the donor blood
is separated by centrifuging, for instance plasma, thrombocytes
and erythrocytes, and on the other hand for accommodating special
washing or additive solutions.
Working with blood bags poses the particular problem that the preparation
introduced into the sterile blood bag may contain viruses which
need to be inactivated.
It is the objective of the invention to provide a blood bag system
in which the blood or blood components from individual donors may
be rendered virus-safe or may be stored in virus-safe fashion, wherein
the means for rendering the blood or the blood components virus-safe
are stored up to the time of use in sections of the system which
are necessary for blood processing.
With a blood bag system for donor blood and/or blood products comprising
a bag and at least one tubing connected thereto, the system being
made of at least partly transparent plastics material, the above-specified
objective is achieved in accordance with the invention in that photoactive
substances (31) can be enclosed in a closed-off section of the tubing
of the ready-to-use system, which can be handled individually as
an independent unit.
Likewise, with a blood bag system for donor blood and/or blood
products comprising bags and tubings made of at least partly transparent
plastics material, in which the tubings interconnect the bags and/or
are connected to other tubings, the above-specified objective is
achieved in accordance with the invention in that photoactive substances
can be enclosed in closed-off sections of the tubings of the ready-to-use
system, which can be handled individually as an independent unit.
When photoactive substances are placed in the tubings of the blood
bag systems during manufacture thereof, and when these substances
are co-sterilized in the blood bag system, it is possible upon use
to perform in said blood bag systems by means of said additives
a treatment, especially virus inactivation of the donor blood or
blood plasma, by exposing the blood bag systems to light after the
donor blood has been combined with said photoactive substances.
The photoactive substances exhibit the property of being stimulated
by light and of emitting energy, which results in the inactivation
of viruses possibly present in the preparation.
Furthermore, with a blood bag system for donor blood and/or blood
products comprising at least one bag and at least one tubing connected
thereto by means of which the bags may be connected otherwise, wherein
the system is at least partly made of transparent plastics material,
the specified objective is achieved by the feature that a blood
bag system which is independent and may be handled individually
and comprises a bag and a tubing which encloses photoactive substances
in closed-off sections thereof, may be combined with another blood
bag system which is likewise independent and to be handled individually
and consists of a bag and a tubing or several bags with tubings
interconnecting said bags, by interconnecting said blood bag systems.
Thus, one of the two blood bag systems may be free from photoactive
substances. While virus inactivation is fully effective, it is possible
to provide one of the combined systems at less expense.
The combination may be effected by coupling a tubing of one blood
bag system to a tubing of the other blood bag system with the aid
of a welding device under sterile conditions.
In accordance with a further development of the second embodiment
of the invention the bags are constituted by a collection bag and
further bags connected thereto. In this way processing of the donor
blood may be performed in an initially closed system.
In accordance with a further development of the second embodiment
the invention provides that in case of a multi-bag system, collection
bag and further bags are interconnected via tubings which enclose
substances. Thus, processing of the donor blood may be performed
from the outset within a self-contained system.
The substances may be enclosed in the tubings by means of frangible
valves. Due to enclosure within the tubings it is ensured that the
substances are ready everywhere to come into contact with the blood
or blood fractions. The opening of the tubing connections by breaking
the frangible valves allows the enclosed substances to be brought
into contact with the blood or blood fractions in controlled fashion.
According to a preferred embodiment of the invention the photoactive
substances are provided in liquid or dissolved state, respectively.
The liquid state of aggregation permits particularly fast combining
of the photoactive substances with the blood or blood fractions.
A further development of the invention provides that the photoactive
substances used are phenothiazine dyes, preferentially methylene
blue or toluidine blue.
The invention will be explained in detail with reference to the
drawing, in which:
FIG. 1 shows a multi-bag blood bag system for donor blood in which
the individual bags are interconnected through frangible valves
and tubings and photoactive substances are enclosed in tubing sections,
FIG. 1a shows an enlarged detail A of a tubing section filled with
a photoactive substance,
FIG. 2 shows a single blood bag system comprising a single bag
and a tubing with photoactive substances enclosed within the tubing.
This blood bag system can be handled individually as an independent
unit and may be welded to a multi-bag blood bag system of FIG. 1
which can likewise be handled individually as an independent unit.
FIG. 1 shows a multi-bag blood bag system comprising two satellite
bags 3 5 a collection bag 7 and a bag 9 for an additive solution.
The satellite bag 3 and the collection bag 7 as well as the satellite
bag 5 and the collection bag 7 are interconnected via tubings 11
13. A tubing end 19 closed at the free end 27 thereof and called
a pigtail is provided on the satellite bag 5. A collection tubing
21 is fitted to the collection bag 7. The tubings 11 and 13 leading
from the satellite bags 3 and 5 are joined by a one-way valve 23.
In this way they are communicated via a common tubing 15 with the
collection bag 7.
Within the tubing 11 there is a central section 11a which in the
ready-to-use state of the blood bag system is closed by frangible
valves 25. Likewise, the tubing 13 includes a central section 13a
which in the ready-to-use state is closed on either side by means
of frangible valves 25. The tubing end 19 which is closed at the
free end 27 thereof is coupled to the satellite bag 5 by means of
another frangible valve 25.
The frangible valves,,which are only schematically illustrated,
are of known design. They are injection-moulded plastic articles
including a through-channel the passage through which is initially
blocked upon manufacture by means of a co-injected membrane or the
like. The frangible valves are so-called disposable valves and are
configured so that the blockage of the through-passage is cancelled
upon bending. The membrane is removed upon bending. The passage
is then open and an exchange of media may take place via the through-channel.
A tubing 17 provides direct communication between the collection
bag 7 and the additive bag 9. The connections between the tubing
17 and the bags 7 and 9 are provided by frangible valves 25. A collection
tubing 21 is coupled to the collection bag via a further frangible
valve 25.
In FIG. 1 sections of the tubings 11 13 19 and 17 are emphasized
by circles referenced A. These sections A are shown extremely enlarged
in FIG. 1a. This is a sectional view of the tubing sections. The
cut-out area shows that the tubing sections 11a, 13a, 17 19 contain
a photoactive substance 31 between the tubing walls 29. In the ready-to-use
state the photoactive substances 31 are enclosed between the frangible
valves 25 within the tubing sections 11a, 13a, 17 19. By breaking
of the valves 25 the photoactive substances are allowed to flow
into the respective bags 3 5 7 9.
FIG. 2 shows a single-bag blood bag system comprising a bag 3 provided
with a tubing 11. The tubing 11 opens into the bag 3 via a frangible
valve 25. Also, a further frangible valve 25 is provided in the
tubing 11 at a distance from the frangible valve 25 on the bag 3
whereby a closed-off tubing section 11a is formed. A photoactive
substance 31 is enclosed within the closed-off tubing section 11a.
This is indicated by the detail A which corresponds to the configuration
of FIG. 1a. Initially, the free end 11b of the delivery tubing 11
is not connected.
The free end 11b of the delivery tubing 11 may, for example, be
coupled with a tubing of the blood bag system of FIG. 1.
For this, a welding device may be used for welding, and thus connecting
the free end 11b for instance to the tubing 15 of FIG. 1.
For the purposes of the invention, the photoactive substances are
used as liquids 31. Of course, it would also be possible to use
them in solid state (for instance as powders).
When it is desired that the blood plasma or a cellular blood fraction
should be combined with the photoactive substance the frangible
valves 25 are opened by breaking. In this way the bag system remains
self-contained so that there is no risk at all of a bacterial infection.
Analogously, it would of course be possible also to equip other
systems comprising a greater or lesser number of bags with photoactive
substances in the same way.
Examples of useful photoactive substances are phenothiazine dyes.
Among those, the most suitable ones are methylene blue and toluidine
blue. |