U.S. patent application number 10/782440 was filed with the patent office on 2004-09-23 for packaged bag system with identification tags.
This patent application is currently assigned to MacoPharma. Invention is credited to Demay, Sylvie, Goudaliez, Francis, Verpoort, Thierry.
Application Number | 20040182734 10/782440 |
Document ID | / |
Family ID | 32749695 |
Filed Date | 2004-09-23 |
United States Patent
Application |
20040182734 |
Kind Code |
A1 |
Demay, Sylvie ; et
al. |
September 23, 2004 |
Packaged bag system with identification tags
Abstract
The invention includes an assembly including a package and a bag
system for collecting a biological fluid, in particular blood. The
system may be confined in a sterile fashion in the package. The
system may include a fluid collecting bag and a device for sampling
the fluid to be collected which includes at least one sampling
receptacle associated dissociably with the system. The collecting
bag and the sampling receptacle are each provided with an
identification tag which includes information making it possible,
after dissociation of the receptacle from the bag system, to
unequivocally establish that the sampling receptacle and the
collecting bag come from the same bag system.
Inventors: |
Demay, Sylvie; (Halluin,
FR) ; Goudaliez, Francis; (Faches-Thumesnil, FR)
; Verpoort, Thierry; (Mouvaux, FR) |
Correspondence
Address: |
BAKER BOTTS, LLP
910 LOUISIANA
HOUSTON
TX
77002-4995
US
|
Assignee: |
MacoPharma
|
Family ID: |
32749695 |
Appl. No.: |
10/782440 |
Filed: |
February 19, 2004 |
Current U.S.
Class: |
206/459.1 |
Current CPC
Class: |
A61B 5/150389 20130101;
A61B 5/150786 20130101; A61B 5/15003 20130101; A61B 5/150305
20130101; A61B 5/150366 20130101; A61M 1/0236 20140204; A61B
5/150351 20130101; A61B 5/150503 20130101; A61B 5/154 20130101;
A61B 5/150717 20130101; A61M 1/0218 20140204; A61B 5/150572
20130101; A61B 5/150992 20130101; A61M 1/0209 20130101; A61B
5/150732 20130101; A61B 5/150824 20130101 |
Class at
Publication: |
206/459.1 |
International
Class: |
B65D 085/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 19, 2003 |
FR |
FR 0302033 |
Claims
1. An assembly comprising: a package; and a bag system for
collecting a biological fluid including: a collection device; a
collection bag in fluid communication with the collection device; a
sampling device having at least one sampling receptacle associated
dissociably with the system; and at least two identification tags,
one on the collection bag and one on the sampling receptacle
wherein the tags allows the establishment, after their
dissociation, that both the collection bag and receptacle
originated from the same bag system, and wherein the bag system is
confined in a sterile fashion in the package, which is arranged so
as to be able to be opened prior to the use of the system.
2. The assembly of claim 1, further comprising the collection bag
in fluid communication with the collection device through a first
tube to which the sampling device is in fluid communication through
a second tube.
3. The assembly of claim 2, wherein the sampling device further
comprises a sampling bag connected to a downstream end of the
second tube.
4. The assembly of claim 1, wherein the sampling device further
comprises a transferring device operable to transfer fluid from the
bag system to a sampling receptacle.
5. The assembly of claim 4, wherein the transfer device further
comprises: a hollow guide open at a front part to allow
introduction of the sampling receptacle; and a hollow needle in
fluid communication with the bag system, wherein the hollow needle
passes through a rear part of the guide so that a downstream part
of the needle extends inside the guide and an upstream part of the
needle extends outside the guide, and wherein the hollow needle is
operable to perforate the closure element of the receptacle,
placing the downstream part of the needle inside the
receptacle.
6. The assembly of claim 5, wherein the guide further comprises an
association device operable to allow a reversible association of
the receptacle inside the guide and sliding of the receptacle
inside the guide between a standby position at a distance from the
needle and a transfer position.
7. The assembly of claim 6, wherein the association device further
comprises a first and second set of projections distributed
longitudinally on an internal face of the guide, wherein the
projections are arranged so as to be deformable by sliding the
receptacle inside the guide, and wherein the projections are
arranged so as to permit a reversible association of the receptacle
inside the guide and the sliding of the receptacle inside the guide
between a standby position at a distance from the needle and the
transfer position.
8. The assembly of claim 7, further comprising a plurality of
transfer devices, each having a receptacle associated in a
dissociable fashion and each in fluid communication with the bag
system through the second tube or a third tube.
9. The assembly of claim 6, further comprising the association
device operable to support at least two receptacle in the standby
position and to allow their sequential guidance into the guide.
10. The assembly of claim 1, further comprising a tube connecting
the sampling device to the bag system, wherein the tube is weldable
and breakable, and wherein an inlet orifice of at least one
receptacle is connected to a downstream end of the tube.
11. The assembly according to claim 10, further comprising a
flexible sampling receptacle.
12. The assembly of claim 1, wherein the identification tag further
comprises a label provided with a bar code, the label placed on the
collecting bag and each sampling receptacle.
13. The assembly of claim 1, further comprising a flexible,
transparent package.
14. The assembly of claim 1, further comprising a fourth tube in
fluid communication with the collection bag and at least one
satellite bag, wherein the satellite bag is also provided with an
identification tag.
15. A method of manufacturing an assembly comprising: placing an
identification tag on at least a collection bag and at least one
sampling receptacle, wherein the collection bag and sampling
receptacle form part of one bag system, placing the bag system in
packaging, wherein wherein the tags allows the establishment, after
their dissociation, that both the collection bag and receptacle
originated from the same bag system.
16. The method of claim 15, further comprising: sterilizing the bag
system; and placing the bag system in the packaging.
17. The method of claim 15, further comprising pasteurizing the bag
system and the packaging after placement of the bag system in the
packaging.
18. The method of claim 15, further comprising sterilizing the bag
system and the packaging after placement of the bag system in the
packaging.
19. The method of claim 15, further comprising: sterilizing the bag
system absent the receptacle; and associating the receptacle with
the bag system.
20. The method of claim 19, further comprising: placing the bag
system with receptacle in the packaging; and pasteurizing the bag
system and packaging.
Description
PRIORITY CLAIM
[0001] The present invention claims priority under 35 U.S.C.
.sctn.119(d) to French Patent Application Serial No. 03/02033,
filed Feb. 19, 2003.
FIELD OF THE INVENTION
[0002] The invention concerns an assembly including a package and a
system of bags for collecting a biological fluid as well as a
method of manufacturing such an assembly. For reasons of asepsis,
the bag system is normally confined in a sterile fashion in the
package at the time of manufacture, the package being arranged so
as to be opened prior to the use of the system.
BACKGROUND
[0003] The invention may be used when a biological fluid, typically
whole blood, is collected from the donor in a collecting bag. To do
this, the bag system includes, in closed circuit, a device for
drawing the blood which is in fluid communication with at least one
blood collecting bag. In addition, the system includes a device for
sampling the blood which is intended to receive some of the blood
taken off, the device including at least one sampling receptacle
which is associated dissociably with the system.
[0004] The use of such a sampling device makes it possible to
obtain, in each receptacle, a sample of blood, the receptacles then
being able to be dissociated from the system in order to analyse
the samples, in particular in order to carry out serology, virology
and a cell count or hematocrit.
[0005] In particular, the bag system can be used by drawing the
first millilitres of blood in the sampling device, which has a
certain number of advantages. Firstly, this reduces the risk of
contamination stemming from the presence of bacteria or other
foreign substances on the skin of the donor because the first
millilitres of blood collected, to which this contamination
relates, are sent into the sampling device rather than into the
collecting bag. Secondly, this makes it possible to produce the
samples before the bag is completely filled and consequently not to
waste any time. Finally, at the time the blood is collected the
loss of the volume of blood for the donor is compensated for by the
addition of plasma, causing the haematocrit reading of the blood to
be analysed to be lower if the sampling device is filled after the
collecting bag. Consequently the count would be inaccurate.
[0006] One problem which is posed by such a system is that of the
traceability of the samples of blood contained in the receptacles.
Because the purpose of the tests carried out on the samples is to
know the characteristics of the blood collected, it is essential to
be able to know the source of the samples. Otherwise, incorrect
information may be associated with blood contained in a collecting
bag, which can have serious consequences when the blood is
transfused to a patient.
[0007] In current practice, the resolution of this problem falls
upon the user of the bag system, who must identify, for example by
means of labels, the sampling receptacles which are used to sample
the blood collected in each bag system. To this end, the user must
place a label on the collecting bag and on each receptacle, the
labels containing information making it possible to know the source
of the sample. In particular, these labels contain common
information which make it possible to link the sampling receptacles
to the collecting bag containing the sampled blood.
[0008] This practice is not satisfactory because it leaves room for
a handling error on the part of the user, an error which is all the
more probable when the user is handling a large number of bag
systems.
SUMMARY
[0009] The invention includes a bag system with which at least one
sampling receptacle is associated dissociably. An identification
tag is disposed, prior to the packaging of the bag system, on each
receptacle and on the collecting bag. The identification tag
includes information for unequivocally establishing that the
receptacle or receptacles and the sampling bag come from the same
bag system.
[0010] By integrating the identification tag at the time of
manufacture of the packaged bag system, the user merely has to open
the package in order to use the bag system, without worrying about
the traceability of the samples obtained.
[0011] To this end, and according to a first aspect, the invention
concerns an assembly including a package and a bag system for
collecting a biological fluid, in particular blood. The said system
may be confined in a sterile fashion in the package, which is
arranged so as to be able to be opened prior to the use of the
system. The system may include a fluid collection device which is
in fluid communication with at least one fluid collecting bag, and
a device for sampling the fluid to be collected which includes at
least one sampling receptacle associated dissociably with the
system. The collecting bag and the sampling receptacles are each
provided with an identification tag which includes information
making it possible, after dissociation of the receptacle from the
bag system, to unequivocally establish that the sampling receptacle
and the collecting bag come from the same bag system.
[0012] According to a second aspect, the invention concerns a
method of manufacturing such an assembly, the method including,
prior to the packaging of the bag system, providing the collecting
bag and each receptacle with an identification tag which includes
information making it possible, after dissociation of the
receptacle from the bag system, to unequivocally establish that the
sampling receptacle and the collecting bag come from the same bag
system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Other objects and advantages of the invention will emerge
during the following description, given with reference to the
accompanying drawings, in which:
[0014] FIG. 1A depicts schematically a bag system for collecting
blood which includes a sampling device according to a first
embodiment;
[0015] FIG. 1B depicts schematically a bag system for collecting
the blood and separating the blood components which includes a
sampling device according to a second embodiment;
[0016] FIG. 2 depicts schematically the transfer portion of the
sampling device depicted in FIG. 1A;
[0017] FIGS. 3A and 3B depict schematically the transfer device of
FIG. 2 in which a sampling receptacle is disposed respectively in a
position at a distance and in a transfer position; FIG. 3C is a
representation similar to FIG. 3B showing a variant embodiment of
the transfer device;
[0018] FIG. 4 depicts schematically a bag system for collecting the
blood which includes a sampling device provided with several
transfer portion according to FIG. 2;
[0019] FIGS. 5A to 5E depict schematically the transfer portion of
the sampling device of FIG. 2, respectively in front view, in
perspective, in profile, in plan view and in transverse section,
the sampling receptacles being in the standby position;
[0020] FIGS. 6A and 6B depict schematically the transfer device of
FIG. 5 according to a variant embodiment, respectively in front
view and profile, the receptacles being in the standby position;
FIG. 6C is a view similar to FIG. 6B in which a receptacle is in
the transfer position;
[0021] FIG. 7 depicts a bag system for collecting the blood which
includes a sampling device according to a third embodiment;
[0022] FIGS. 8A and 8B depict schematically an assembly including a
package in which a bag system respectively according to FIGS. 4 and
1B is confined in a sterile fashion.
DETAILED DESCRIPTION
[0023] FIGS. 1A, 1B and 7 depict bag system 1 including a device
for collecting the a biological fluid from a donor and at least one
collecting bag 2 intended to receive the fluid collected. In a
particular embodiment, the fluid may be blood.
[0024] The collection device may consist in particular of needle 3
allowing access to the vein of the donor and cap 4 protecting
needle 3. In addition, needle protector 5 may be placed slidably on
first tube 6. First tube 6 provides fluid communication between
collecting bag and the collection device.
[0025] Bag system 1 also includes a sampling device, which is in
fluid communication with collecting bag 2 by way of first tube 6
and second tube 7, which are connected at first connector 8 by a
three-way junction.
[0026] In the embodiments depicted, the sampling device includes
sampling bag 9 which is connected to the downstream end of second
tube 7. The terms downstream and upstream are defined with respect
to the direction of circulation of the blood, from the collection
device to the bags and the sampling device.
[0027] The sampling device also includes a transfer device 10 for
transferring the fluid which is in fluid communication with
collecting bag 2 by way of first tube 6 and second tube 7, and
possibly third tube 11 connected to second tube 7 at second
connector 12 in the form of a three-way junction.
[0028] As depicted in FIG. 2, transfer device 10 includes hollow
guide 13, open at front part 14 to allow the introduction of
sampling receptacle 15, and hollow needle 16 passing through rear
part 17 of guide 13, so that the downstream part of needle 16
extends inside guide 13 and an upstream part of needle 16 extends
outside guide 13. The downstream segment of hollow needle 16 is
enclosed in elastic sheath 18. The upstream segment of hollow
needle 16 enables the transfer device to be connected with bag
system 1. A fluid communication device or tube is then connected to
the upstream segment.
[0029] First clamp 19 and second clamp 20 can be situated
respectively on first tube 6, downstream of connector 8, and on
second tube 7. Clamps 19 and 20 make it possible to orient the flow
of fluid collected, either to sampling bag 9, where first clamp 19
is closed while second clamp 20 is open, or to collecting bag 2,
where second clamp 20 is closed while first clamp 19 is open.
[0030] Sampling receptacle 15 is filled with the collected blood
contained in sampling bag 9 when receptacle 15 is placed in the
transfer position, namely when the downstream end of needle 16 is
in fluid communication with the inside of receptacle 15, by
perforation of closure element 21 of receptacle 15.
[0031] Circuit openers can be provided within bag system 1. In
particular circuit opener 22 may be situated on second tube 7 close
to first connector 8.
[0032] As depicted in FIG. 1B, in order to perform steps of
filtration and separation as well as the removal of leukocytes with
regard to the various constituents of the blood, collecting bag 2
may be in fluid communication, by way of fourth tube 23, with
satellite bags 24a-c. Leukoreduction filter 25 is situated between
collecting bag 2 and satellite bag 24a. Satellite bag 24a may be in
fluid communication with one or more other satellite bags. For
example satellite bag 24a may be in fluid communication with two
other satellite bags 24b, c. Clamp 26 may be provided on fourth
tube 23 between collecting bag 2 and leukoreduction filter 25.
According to one embodiment, satellite bags 24a-c may be provided
with identification tag 35.
[0033] According to a first embodiment, transfer device 10 is
provided with a device for associating sampling receptacle 15, as
depicted in FIG. 2. The association device includes first 27 and
second 28 set of projections distributed longitudinally on the
internal surface of guide 13, respectively close to needle 16 of
the guide and close to front part 14 of guide 13. The projections
are arranged so as to be deformable when sliding receptacle 15
inside guide 13 so as to allow a reversible association of
receptacle 15 inside guide 13. The projections allow a sliding of
receptacle 15 inside guide 13 between a standby position (FIG. 3A)
at a distance from needle 16 and the transfer position (FIG.
3B).
[0034] As depicted in FIGS. 2, 3A and 3B, the projections are
flexible, in particular elastic, and are reversibly deformable from
a position inclined forwards towards a position inclined towards
the rear by contact of receptacle 15 when it slides inside guide 13
in the front to rear direction. When receptacle 15 is removed from
guide 13, the projections incline from rear to front so that the
receptacle is not dissociated from its closure element 21. In the
embodiment depicted, sampling receptacle 15 includes closure
element 21 whose diameter is greater than that of the body of
receptacle 15 and it is during the passage of closure element 21
that the projections incline in one direction or the other.
[0035] According to a variant depicted in FIG. 3C the projections
in first set 27 situated close to needle 16 are breakable under the
effect of the sliding of receptacle 15 placed in the transfer
position. The perforation of closure element 21 is thus visible and
the user can check that the perforation did not take place prior to
the taking of samples.
[0036] As depicted in FIG. 4, several transfer devices 10, in each
of which a sampling receptacle 15 is associated dissociably, may be
connected to bag system 1 by way of second tube 7 or third tube 11,
connected to second tube 7 by second connector 12. Dissociably
associating several receptacles 15 with several transfer devices 10
has advantages, firstly a saving in time for the person responsible
for the collecting because he or she does not have to put
receptacle 15 in place in transfer device 10 and secondly a
reduction in the risk of error in traceability of the donations,
because this makes it possible to fix labels prior to the taking of
samples, in particular at the time of manufacture.
[0037] According to a second embodiment, the association device is
arranged so as to be able to support several receptacles 15 at a
distance from guide 13 in a standby position and their sequential
guiding in guide 13, as depicted in FIGS. 1B and 5A to 5E.
[0038] The association device and the transfer device 10 may be
associated by clipping or welding or can be moulded in one and the
same piece.
[0039] The association device may include housing 29 associated
with guide 13. Housing 29 is provided with skirt 30 in which
closure element 21 of receptacles 15 is introduced to allow
longitudinal sliding of receptacles 15 in housing 29 towards guide
13. The internal wall of skirt 30 is provided with projection 31
intended, by interaction with closure elements 21, to prevent the
transverse withdrawal of receptacles 15 from housing 29.
[0040] Skirt 30 includes an open end disposed opposite a scallop
formed in the guide, and an opposite closed end. In the other axis,
a first open end is disposed opposite another end which is open so
that the body of receptacle or receptacles 15 extends beyond
housing 29.
[0041] At the time of manufacture, sampling receptacles 15 are
introduced into guide 13 through its open front part 14 so that
closure element 21 is situated level with groove 32 in housing 29
so that it can be slid therein.
[0042] Cap 33 is then placed on guide 13, making it possible to
hold receptacles 15 in housing 29 until samples are taken by the
user of system 1.
[0043] The housing can be of variable size so as to contain from
two to ten receptacles 15. The number of receptacles 15 used varies
according to the legislation, in France in particular five
receptacles 15 are used for carrying out normal analyses.
[0044] When samples are taken, the person responsible for the
sampling removes cap 33 from guide 13, makes receptacles 15 slide
as far as guide 13, and then introduces them so that, by
perforation of closure element 21 of receptacle 15, the downstream
end of needle 16 is in fluid communication with the inside of
receptacle 15. After receptacle 15 has been filled, the user
withdraws it from guide 13. In one example embodiment, cap 33 may
be provided with a tamper-evident element, such as a tongue which
is broken on first opening, so as to be able to identify the first
manipulation of cap 33.
[0045] According to a variant, depicted in FIGS. 6A to 6C, transfer
device 10 can slide on the association device, so that it can be
placed level with each receptacle 15. When transfer device 10 is
placed level with receptacle 15, the user may then move the
transfer device 10 transversely so that closure element 21 is
perforated by needle 16. So that transfer device 10 may slide on
the association device, two opposite scallops are then formed in
guide 13.
[0046] As depicted in FIG. 1B, transfer device 10 associating
several sampling receptacles 15 may be connected to bag system 1 by
way of second tube 7 and possibly third tube 11.
[0047] According to a third embodiment, depicted in FIG. 7, the
sampling receptacle or receptacles may be flexible, preformed and
connected to a tube of the bag system, in particular to second tube
7.
[0048] The sampling receptacle or receptacles 15 are filled,
simultaneously or successively, with the collected blood contained
in sampling bag 9.
[0049] Filling takes place by mechanical pressure on sampling
receptacle 15, the air contained in preformed receptacle 15 is
driven into sampling bag 9, while the blood contained in bag 9 is
driven into receptacle 15.
[0050] After samples are collected, sampling receptacle 15 is
hermetically welded and detached from bag system 1.
[0051] A septum 34 may be provided on the end of receptacle 15
opposite to the end where the welding is carried out. In this way,
after welding, one or more sampling receptacles 15 compatible with
automatic analysis controllers are obtained. In order to perform a
certain number of analyses, receptacle 15 may then be placed in a
receptacle of the automatic controller, and a needle of the
automatic controller pierces septum 34.
[0052] With known bag systems for collecting blood, the person
responsible for the collecting must, by way of some mark, identify
collecting bag 2 and sampling receptacle or receptacles 15
corresponding to one and the same donation.
[0053] According to the invention, the possibility of error in
traceability of these donations is considerably reduced because, as
depicted in FIGS. 8A and 8B, sampling receptacle or receptacles 15
and collecting bag 2 are dissociably associated at the time of
manufacture. In addition, at the time of manufacture, collecting
bag 2 and sampling receptacle or receptacles 15, as well as any
satellite bags 24a-c, are each provided with an identification tag
35, for example a self-adhesive bar code label, which includes
information making it possible, after dissociation of the
receptacles from bag system 1, to unequivocally establish that
sampling receptacle 15 and collecting bag 2, as well as any
satellite bags 24a-c, come from the same bag system 1. Bag system 1
according to the invention may be packaged in flexible transparent
package 36. Bag system 1 and package 36 thus form an assembly.
[0054] The method of manufacturing such an assembly makes
provision, prior to the packaging of bag system 1, for providing
collecting bag 2 and each receptacle 15 with an identification tag
which includes information making it possible, after dissociation
of the receptacle from bag system 1, to unequivocally establish
that sampling receptacle 15 and collecting bag 2 come from the same
bag system 1. In an example embodiment where label 35 is provided
with a bar code, the bar code may be printed on label 35 subsequent
to its placement.
[0055] According to a first embodiment, the method includes
disposing sterilised bag system 1 in package 36 and then may
include pasteurising the whole.
[0056] According to a second embodiment, the method includes
disposing bag system 1 in package 36 and then sterilising the
whole.
[0057] According to a third embodiment, the method includes
sterilising the bag system without receptacles 15, associating
receptacles 15 with the bag system, packaging the system and then
possibly pasteurising the whole. This embodiment is particularly
adapted to the case where sampling receptacles 15 contain reagents
sensitive to the sterilisation step. Moreover, closure elements 21
for sampling receptacles 15 may also be sensitive to the
sterilisation step.
* * * * *