U.S. patent application number 10/782077 was filed with the patent office on 2004-11-18 for bag system with device for associating sampling receptacles.
This patent application is currently assigned to Maco Pharma. Invention is credited to Demay, Sylvie, Goudaliez, Francis, Verpoort, Thierry.
Application Number | 20040230153 10/782077 |
Document ID | / |
Family ID | 32732027 |
Filed Date | 2004-11-18 |
United States Patent
Application |
20040230153 |
Kind Code |
A1 |
Demay, Sylvie ; et
al. |
November 18, 2004 |
Bag system with device for associating sampling receptacles
Abstract
The invention includes a bag system for collecting a biological
fluid, in particular blood. The system includes a device for
collecting the fluid which is in fluid communication with at least
one fluid collection bag, and a device for sampling the fluid to be
collected which includes at least one sampling receptacle. The
sampling device includes a device for transferring the fluid from
the bag system into the sampling receptacle or receptacles, in
which the transfer device is provided with a device for associating
the receptacle or receptacles. The transfer device may be arranged
to allow the support of the receptacle or receptacles in a standby
position, the guidance of the receptacle or receptacles to a
transfer position and, after transfer, the dissociation of the
receptacle or receptacles from the 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: |
Maco Pharma
|
Family ID: |
32732027 |
Appl. No.: |
10/782077 |
Filed: |
February 19, 2004 |
Current U.S.
Class: |
604/6.15 |
Current CPC
Class: |
A61B 5/150305 20130101;
A61B 5/150732 20130101; A61B 5/150572 20130101; Y10T 137/4707
20150401; A61B 5/150824 20130101; Y10T 137/2733 20150401; A61B
5/150366 20130101; A61B 5/150992 20130101; A61B 5/15003 20130101;
A61B 5/150503 20130101; A61B 5/150389 20130101; A61J 2205/10
20130101; A61B 5/150786 20130101; A61M 1/0218 20140204; A61B
5/150351 20130101; A61B 5/154 20130101; A61M 1/0236 20140204; A61J
1/12 20130101; Y10T 137/469 20150401; A61B 5/150717 20130101; A61M
1/0209 20130101; A61J 2205/30 20130101 |
Class at
Publication: |
604/006.15 |
International
Class: |
A61M 037/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 19, 2003 |
FR |
FR 03/02034 |
Claims
1. A bag system for collecting a biological fluid comprising: a
collection device; a fluid collection bag in fluid communication
with the collection device; and a sampling device in fluid
communication with the collection device, the sampling device
including: at least one sampling receptacle; and a transfer device
having an associating device operable to support the receptacle in
a standby position, guide the receptacle to a transfer position,
and allow dissociation of the receptacle from the bag system.
2. The system of claim 1, wherein the biological fluid comprises
blood.
3. The system of claim 1, further comprising: a first tube to
establish fluid communication between the collection device and the
fluid collection bag; and a second tube to establish fluid
communication between the collection device and the sampling
device.
4. The system of claim 3, wherein the sampling device further
comprises a sampling bag connected to the downstream end of the
second tube.
5. The system of claim 1, wherein the receptacle has a body having
a first diameter and further comprises a closure element having a
second diameter greater than the first diameter
6. The system of claim 5, 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.
7. The system 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 system of claim 7, further comprising at least one flexible
projection reversibly deformable from a position included towards
the rear of the guide by contact of the receptacle while sliding
inside the guide in a rear to front direction, to a position
inclined towards the front of guide while sliding in a front to
rear direction.
9. The system of claim 7, further comprising the a first set of
projections breakable under the deformation and located near the
needle.
10. The system 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.
11. The system 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.
12. The system of claim 11, wherein the association device further
comprises: a housing associated with the guide; and a skirt
provided on the housing into which the closed end of the receptacle
is introduced in order to allow the longitudinal sliding of the
receptacle in the housing towards the guide, wherein an internal
wall of the skirt is provided with a projection intended, by
interaction with the closure element, to prevent transverse
withdrawal of the receptacle from the housing.
13. The system of claim 12, wherein the skirt further comprises: an
open end disposed opposite a scallop formed in the guide; and a
closed end.
14. The stem of claim 6, wherein the guide further comprises a cap
having a tamper-evident element.
15. The system of claim 1, further comprising the transfer device
having several receptacles associated therewith and the transfer
device in fluid communication with the bag system through the
second tube or a third tube.
16. The system of claim 1, further comprising at least two
identification tags, one disposed on the collection bag and the
other disposed on the receptacle, wherein the tags allows the
establishment, after their dissociation, that both the collection
bag and receptacle originated from the same bag system.
17. The system of claim 16, 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.
18. A method of collecting a biological fluid comprising: placing a
collection device in a donor; collecting the fluid in a sampling
device having at least one receptacle and a transfer device having
an association device; placing a first receptacle in a standby
position in the association device of the transfer device; moving
the first receptacle to a transfer position in the transfer device
to allow flow of the biological fluid into the first receptacle;
dissociating the first receptacle from the association device.
19. The method of claim 1, further comprising: moving a second
receptacle in the association device from the standby position to
the transfer position; and dissociating the second receptacle from
the association device.
Description
PRIORITY CLAIM
[0001] The present invention claims priority under 35 U.S.C.
.sctn.119(d) to French Patent Application Serial No. 03/02034,
filed Feb. 19, 2003.
FIELD OF THE INVENTION
[0002] The invention concerns a bag system for collecting a
biological fluid in which sampling receptacles are associated.
BACKGROUND
[0003] Biological fluids such as whole blood must be collected from
a donor in a collection bag. To accomplish this, one normally uses
a the bag system including in closed circuit, a device for
collecting the blood which is in fluid communication with at least
one blood collection bag. In addition, the system includes a device
for sampling the blood which is intended to receive some of the
blood taken. The device normally includes at least one sampling
receptacle.
[0004] The use of such a sampling device makes it possible to
obtain, in each receptacle, a sample of blood intended to be
analysed, in particular for carrying out serology, virology and a
blood count.
[0005] In particular, the bag system may be used by collecting the
first millilitres of blood in the sampling device, which has a
certain number of advantages. Firstly, this reduces the risk of
contamination resulting from the presence of bacteria or other
foreign substances on the skin of the donor because the first
millilitres of blood collected, which are more likely to be
affected by this contamination, are sent into the sampling device
rather than into the collection bag. Secondly, this makes it
possible to take samples before the collection bag is completely
filled and consequently does not waste time. Finally, during the
collection, the loss of blood volume for the donor may be
compensated for the addition of plasma, resulting in a lower
haematocrit reading than if the sampling device were filled after
the collection bag, and consequently the count would be
incorrect.
[0006] One problem which is posed is that of the difficulty in
handling known bag systems. This is because the user must position
several receptacles in order to obtain the samples, which gives
rise to a loss of time.
[0007] One aim of the invention is in particular to resolve this
problem by proposing a bag system in which each sampling receptacle
is stored at the device for transferring fluid from the bag system
into it, the receptacle then being able to be guided by the
operator into the transfer device for collecting a sample.
SUMMARY
[0008] The invention includes a bag system for collecting a
biological fluid, in particular blood. The system includes a device
for collecting the fluid which is in fluid communication with at
least one fluid collection bag, and a device for sampling the fluid
to be collected which includes at least one sampling receptacle.
The sampling device includes a device for transferring the fluid
from the bag system into the sampling receptacle or receptacles, in
which the transfer device is provided with a device for associating
the receptacle or receptacles. The association device is arranged
to allow the support of the receptacle or receptacles in a standby
position, the guidance of the receptacle or receptacles to a
transfer position and, after transfer, the dissociation of the
receptacle or receptacles from the bag system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Other objects and advantages of the invention will emerge
during the following description given with reference to the
accompanying drawings, in which:
[0010] FIG. 1A depicts schematically a bag system for collecting
blood which includes a sampling device according to a first
embodiment;
[0011] FIG. 1B depicts schematically a bag system for collecting
blood and separating the blood components which includes a sampling
device according to a second embodiment;
[0012] FIG. 2 depicts schematically the transfer device of the
sampling device depicted in FIG. 1A;
[0013] 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;
[0014] FIG. 4 depicts schematically a bag system for collecting
blood which includes a sampling device provided with several
transfer devices according to FIG. 2;
[0015] FIGS. 5A to 5E depict schematically the transfer device of
the sampling device of FIG. 2, respectively front on, in
perspective, in profile, in plan view and in transverse section,
the sampling receptacles being in the standby position;
[0016] FIGS. 6A and 6B depict schematically the transfer device of
FIG. 5 according to a variant embodiment, respectively front on and
in 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.
DETAILED DESCRIPTION
[0017] FIGS. 1A and 1B depict bag system 1 including a collection
device for collecting fluid from a donor and at least one
collection bag 2 intended to receive the fluid collected, in
particular blood.
[0018] 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 places collection bag 2 in fluid
communication with the collection device.
[0019] Bag system 1 also includes a sampling device, which is in
fluid communication with collection bag 2 by way of first 6 and
second 7 tubes connected at first connector 8 in the form of a
three-way junction.
[0020] 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 flow of the blood, from the collection device
to the bags and sampling device.
[0021] The sampling device also includes fluid transfer device 10
which is in fluid communication with collection bag 2 by way of
first 6 and second 7 tubes, and possibly third tube 11 connected to
second tube 7 at second connector 12 in the form of a three-way
junction.
[0022] As depicted in FIG. 2, transfer device 10 includes hollow
guide 13, open at front part 14 to allow the insertion of sampling
receptacle 15, and hollow needle 16 passing through rear part 17 of
the guide, so that a 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 allows
the connection of the transfer device with bag system 1. A fluid
communication device or tube is then connected to the upstream
segment.
[0023] First 19 and second 20 clamps may 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, when first clamp 19 is closed
while second clamp 20 is open, or to collection bag 2, when second
clamp 20 is closed while first clamp 19 is open.
[0024] 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.
[0025] Circuit openers may be provided within bag system 1. In
particular circuit opener 22 may be situated on second tube 7 close
to first connector 8.
[0026] As depicted in FIG. 1B, in order to perform filtration and
separation steps as well as the removal of the leukocytes from the
various constituents of the blood, collection bag 2 may be in fluid
communication, by way of fourth tube 23, with satellite bags 24a-c.
Leukoreduction filter 25 may be situated between collection 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 collection bag 2 and leukoreduction filter 25. According to
one embodiment, satellite bags 24a-c may be provided with
identification tag 35.
[0027] 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 sets 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 by sliding of receptacle 15
within guide 13 so as to allow a reversible association of
receptacle 15 inside guide 13, and 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).
[0028] As depicted in FIGS. 2, 3A and 3B, the projections are
flexible, in particular elastic, and are reversibly deformable from
a forward inclined position to a rearward inclined position by
contact of receptacle 15 when it slides inside guide 13 in the
front to rear direction. When receptacle 15 is withdrawn 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, it is during the passage of closure element 21 that
the projections incline in one direction or the other.
[0029] According to a variant, depicted in FIG. 3C, the projections
of 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 may check that the perforation has not taken place
prior to the collecting of samples.
[0030] As depicted in FIG. 4, several transfer devices 10, in each
of which one sampling receptacle 15 is associated in a dissociable
fashion, 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. Associating several receptacles 15 in a dissociable fashion
with several transfer devices 10 has advantages, firstly a saving
in time for the person responsible for collecting the fluid because
he or she does not need to place receptacle 15 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
traceability labels prior to the collecting of samples, in
particular at the time of manufacture.
[0031] According to a second embodiment, the association device is
arranged to enable the supporting of several receptacles 15 at a
distance from guide 13 in a standby position and their sequential
guidance in guide 13, as depicted in FIGS. 1B and 5A to 5E.
[0032] The association device and the transfer device 10 may be
associated by clipping on or welding, or may be moulded in one and
the same piece.
[0033] The association device includes 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 the
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.
[0034] 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 the other end which is open
so that the body of receptacle or receptacles 15 extends beyond
housing 29.
[0035] 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 may be slid therein.
[0036] Cap 33 is then placed on guide 13 making it possible to hold
receptacles 15 in housing 29 until the samples are collected by the
user of system 1.
[0037] The housing may 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 foe example five
receptacles 15 are used for carrying out normal analyses.
[0038] When samples are collected, the person responsible for
collection 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
handling of cap 33.
[0039] According to a variant, depicted in FIGS. 6A to 6C, transfer
device 10 may slide on the association device, so that it may be
placed level with each receptacle 15. When transfer device 10 is
placed level with receptacle 15, the user may then move 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.
[0040] 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.
[0041] With known bag systems for collecting blood, the person
responsible for collection must identify, by way of a mark,
collection bag 2 and sample receptacle or receptacles 15
corresponding to one and the same donation.
[0042] According to the invention, the possibility of error in
traceability of these donations is considerably reduced because
sampling receptacle or receptacles 15 and collection bag 2 are
associated at the time of manufacture in a dissociable fashion. In
addition, upon manufacture, collection bag 2 and sampling
receptacle or receptacles 15, as well as satellite bags 24a-c, are
each provided with identification tag 35, for example by way of a
self-adhesive label with bar codes, which includes information
making it possible, after dissociation of the receptacle from bag
system 1, to unequivocally establish that sampling receptacle 15
and collection bag 2, as well as any satellite bags 24a-c, come
from the same bag system 1.
* * * * *