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Patent 2132813 Summary

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Claims and Abstract availability

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(12) Patent Application: (11) CA 2132813
(54) English Title: REAGENT KIT AND ANALYZER SUITABLE FOR USING IT
(54) French Title: BOITIER POUR REACTIFS ET ANALYSEUR UTILISANT CE BOITIER
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • G01N 35/00 (2006.01)
  • B01L 9/00 (2006.01)
  • B65D 47/38 (2006.01)
  • G01N 35/10 (2006.01)
  • G01N 35/04 (2006.01)
(72) Inventors :
  • HENZEN, IGNATZ WOLFGANG (Switzerland)
(73) Owners :
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
(71) Applicants :
(74) Agent: GOWLING LAFLEUR HENDERSON LLP
(74) Associate agent:
(45) Issued:
(22) Filed Date: 1994-09-23
(41) Open to Public Inspection: 1995-04-29
Examination requested: 1994-09-23
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data:
Application No. Country/Territory Date
3254/93 Switzerland 1993-10-28

Abstracts

English Abstract



Abstract

Reagent kit which contains at least one container which
contains a reagent, and an analyzer in which a reagent kit of this
type can be used.

In order to make it possible to keep the reagents at a
suitable temperature, the reagent kit is, essentially composed of
a housing (12) which has a base (13) and side walls (14-18), and
of the at least one container (31, 32) which is contained in the
housing, where the housing consists of a material whose thermal
conductivity is greater than that of air and has at least one
interior wall (43-46) which is in interlocking contact at least
with one part of the outer wall of the at least one reagent
container (31, 32). In the analyzer, the reagent kits are located on
a carrier plate which is cooled by means of a Peltier element.

Fig. 1


Claims

Note: Claims are shown in the official language in which they were submitted.


.
11
Claims
1. A reagent kit which contains at least one container
which contains a reagent, said kit being essentially composed of
a housing which has a base and side walls and
of the at least one container which is contained in the
housing, where the housing consists of a material whose thermal
conductivity is greater than that of air and has at least one
interior wall which is in interlocking contact at least
with one part of the outer wall of the at least one reagent
container

2. A reagent kit according to claim 1, wherein the
housing has a removable lid which has openings through
which the contents of the reagent containers are accessible for
pipetting steps carried out automaticaliy.

3. A reagent kit according to claim 1, wherein each
reagent container is closed with a closure which can be
pierced by the pipetting needle of the pipetting device of
the analyzer but which closes again after removal of the
pipetting needle.

4. An automatic analyzer which is able to receive a
plurality of reagent kits according to claim 1, said
analyzer containing the following components: a carrier plate
on which it is possible to dispose reagent kits
according to the invention received in the analyzer, a Peltier
element for cooling the carrier plate and thus the
reagent kits and the reagent containers
contained therein, and an automatic pipetting device
with which the pipettings necessary in the analyzer are carried
out, with, inter alia; particular reagent volumes being removed
from the reagent containers and transferred to particular
reaction vessels which each contain a sample to be investigated.

Description

Note: Descriptions are shown in the official language in which they were submitted.


~; 2i32~13

RAN 4090/247


The invention rela~es to a reagent kit which contains at
least one container which contains a reagent.

The invention also rela~es to an automatic analyzer which
is able to receive a plurality of reagent kits. :~
Automatic treatment of reagent kits is desirecl in automatic
analyzers, that is to say no manual operations should be neces-
sary to use the reagent kits used in an analyzer. The achievement
of this object is impeded by the fact that the reagent cont~ainers
shouid, before their initial use in the analyzer and between
pipetting steps, be closed with a closure in order to avoid losses
of reagen~ or the reagent usabllity period being too short.

It is also desirable in autornatic analyzers in which a
20 plurality of reagent containers with different reagents and a
plurali~y of reaction vessels with different samples are present
hat the pipetting device has a freely selected access (~Irandom
access") to a particular reagent container or to a par~icular
~: reaction vessel.
2s
In automatic analyzers in which a plurality o~ reagent
con~ainers with different reagen~s are held it is addi~ionally ~-
desirable that the reagents be kept cool to a particular
temper~ture.
The invention as claimed is intended to satisfy ~he two~
part aim of proYiding a reagent kit and an analyzer with which all
~he above mentioned objectives can be achieved.

According to the invention the firs~ part of ~his aim is
achieved by a reagent kit which is essentially composed of a
housing which has a base and side walls, and of at least one
container contained in the housing, where the housing consists of
- -.:
Ve/So 17.8.94

~ 2132~1~

a thermally conducting material and has at least one interior wall `
which is in interlocking contact at least with one part of the
outer wall of the at least one reagent container.
The essential advantage of the rea~ent kit according to the
invention is that it is suitable in particular for keeping the ~ `
reagents cooled to the desired temperature.

According to the invention the second part of the
10 aforementioned aim is achieved by an analyzer which contains the
~ollowing components: a carrier plate on which it is possible to
dispose reagent ki~s according to the invention received in the
analyzer, a Peltier element for cooling the carrier plate and thus
the reagent kits and the reagent containers contained therein, and
an automatic pipetting device with which the pipettings
necessary in ~he analyzer are carried out, with, inter alia,
particular reagen~ volumes being removed from the reagent
containers and transferred to particular reaction vessels which
each contain a sample to be investigated.
The essential advantages of the analyzer according to the
invention are as follows: the analyzer according to the invention
makes comple~ely automatic treatment of the reagent kits
possible. On the one hand, ~this reduces the work needed to operate
z5 the analyzer and, on the other hand, there is an increase in the
reliability when carrying out a large number of differen~
investigations which require a correspondingiy large number of
different reagents or reagent combinations for carrying them out.

An exemplaly ernbodiment of the invention is desoribed
hereinaf~er by means of the appended drawings.
.
Fig. 1 shows a perspective view of a first embodiment of a ` ~ ~
reagent kit 11 aoeording to the invention, ~ ~ -
3 5 ~
Fig. 2 shows a reagen~ ki~ 11 as shown in Fig. 1 and a spike 39 ~ - -
~or tes~ing and for opening ~he pre-punched point 29 on
~he lid 19 of the reagent kit 11,

--``` 2132~13
: ~ 3

Fig. 3 shows a view from above of the reagent kit 11 shown in
Fig. 1,

5 Fig. 4 shows a view frorn below of the reagent kit 11 shown in
Fig. 19

Fig. 5 shows a diagrammatic cross-section of the reagent kit
11 shown in Fig. 1,
Fig. 6 shows a perspective view of a second embodiment of a
reagent kit according to the invention,

Fig. 7 shows a view from above of the reagent kilt shown in Fig.
6,

Fig. 8 shows a perspective view of a third embodiment of a
reagent kit according to the invention,

~o Fig. 9 shows a view from above of the reagent kit shown in Fig.
8,
Fig. 1û shows a perspective view of a earrier (rack) for
receiving reagent kits according to ~he invention,
Fig. 11 shows a perspec~ive view of ~he carrier (rack) shown in
Fig. 10 with a number of reagent kits according to the
invention disposed thereon,

30 Fig. 12 shows a view from above of an arrangement of a
plurali~y of carriers with reagent kits on a carrier plate
provided ~herefor in an analyzer,

Fig. 13 shows a cross-sectional view of a carrier plate for
carriers of reagent kits according to the inven~ion and of
Peltier elements for cooling ~he carrier pla~e,

~, 2~32~1~

Fig. 14 shows a view, partly in cross-sectlon, of one of the
closures 35-36 in Fig. 1,
Fig. 15 shows a view, partly in cross-sec~ion, of the lid 81 in
Fig. 14,

Fig. 16 shows a cross-sec~ion of ~he stopper 91 in Fig. 1~, .

Fig. 17 shows a view, partly in cross-section, of the closure 35
0 shown in Fig. 14 and of a spike 90 inserted therein, and

Fig. 18 shows a view, partly in cross-section, of the closure 3S
shown in Fig. 14 and of a pipetting needle 101 in~rodllced
through it.
Fir~ er~bQ~im~n~ ~f ~ n~kit according to thç invention

A first embodiment of a reagent kit according to the
invention is described hereinafter by means of Figures ï-5.
As depicted in Fig. 1, a reagent kit 11 according to ~he
invention is essentially composed of a cuboidai housing 12 and of
containers 31, 32 which can be disposed in the housing 12 as in ~:
Fi~ures ~-4. The reagent eontainers 31, 32 can be giass or made
25 o~ a suitable piastic, for example of low ~ensity polyethylene
~LDPE) or high density polye~hylene (HDPE). In ~he first embodi-
ment shown in Figures 1-5, ~he body of ~he reagent container 31
has a cuboidal st-apie; the body of ~he reagen~ container 32 is
cylindrical.
The housing 12 is produced of a material whose thermal ~.;
conductivi~y is greater than 1:ha~ of air, for example from a
thermally conduc~ing plas~ic such as7 for example, polys~yrene.

The housing 12 has a base 13, side walls 14, 1 5, 16, 17, 18
and a removable lid 19. I~ is important for the functioning
according to the inven~ion of ~he container 1 Z ~hat it has interior
walls which are in in~erlocking contac~ a~ ieas~: wi~h a par~ of

- 2132~13



the outer wall of each of the reagent containers con~ained in the
housing. As is evident from Fig. 2-5 in particular, ~he housing 12
has interior walls 43, 44, 46 which are intended to come into
interlocking contact with in each case one part of the outer wall
s of the reagent containers 31, 32.

As is evident from Figures l and 2, the lid l 9 has a pre-
punched point 29 which can be opened with a spike 39.
0The lid 19 of the housing 12 has openings 21, 22 ~hrough
which the contents of the reagent containers 31, 32 are
accessible for pipetting steps carried out automa~ically.

The housing 12 carries a machine-readable label 2~ which
t5 is attached to adjacent side walls of the housing 12. This label
carries information about the reagents contained in the housing.

The housing 12 shown in Figures 1-5 can, for example for a
test with two components, be equipped with one container with
20 12.5 ml of a reagent Rl and one container with 6.5 ml of a
startins reagent.
::Each of the reagen~ containers is closed with a closure 3S,
36 which can be pier~ed by a pipetting needle 101, depicted in
2s Fig. 12, of the pipetting deYice of an analyzer but which closes
again after removal of the pipeKing needle. The closures 35, 36 -:
are prefer~biy closures as described in European Patent
Application wi~h publication number EP-A-0 504697 A1. These
closures are described hereinaf~:er by means of Figures 14-lg.
Second embodimen~ of a rea~ent kit acçording tQ the invention

A second embodimen~ 41 of a reayen~ kit according to the ~ :
invention is described hereinafter by means of Figures 6 and 7.
This second ernbodiment differs ~rom the first embodiment
shown in Figures 1-5 merely by a different shape of ~he reagen~
containers and a correspondingly different shape of the interior

--~ 2132~3

walls. In ~his second embodiment, both reagent con~ainers 32, 33
are cylindrical and both have the same dimensions.

The housing 12 shown in Figures 6 and 7 has the same
s external shape and the same external dimensions as the housing
12 shown in Figures 1-5.

The housing 12 shown in Figures 6 and 7 has interior walls
53, 54, 5~, 56, 57, 58 which are in~ended to come into
0 interlocking contact in each case with one part of the outer wall
of the reagent containers 32, 33.

The housing 12 shown in Figures 6 and 7 can, for example
for a test with one component, be equipped with two containers
with 12.5 ml of a re~gent.

Third em~Q~iment of a reagent kit ~cc~rding to the Inv~n~on

A ~hird embodiment of a reagent kit according to the
20 invention is described hereinafter by means of Figures 8 and 9.

This third embodimen~ differs from the second embodiment
shown in FigLIres 6-7 essentially by ~he number of reagen~
con~ainers in the housing 12 and by a correspondingly altered
25 shape of the interior walis. In this ~hird embodimen~, the housing
12 contains three containers 32, 33, 34. ~hese are cylindrical and
have the same dimensions. :.

The housing 12 shown in Figures 8 and 9 has the same
30 external shape and the same ex~ernal dimensions as ~he housir7g
12 shown in Figures 1-5.

The housing 12 shown in Figures 8 and 9 has interior walls
62, 63, 64 which are intended to come in~o in~eriocking cvntact
35 with in each case one part of the ou~er wall of ~he reagent
containers 32, 33, 34.

1 3




The housing 12 shown in Figures B and 9 can, for exan'lple
for a test with ~hree components, be equipped with one eontainer
with 6.5 ml of a reagent R1, ~ne container with 6.5 ml of a
reagen~ R2, and one container with 6.5 ml of a startiny reagent.




Carrie~ f~2r reag~n:t kits ~ccording to th~invention

Figures 10 and 11 depict a carrier 66 for reagent kits 11,
41 and 51 according to ~he invention. It is provide~ for the
0 purpose of the invention that the carrier ~6 is also produced from
a ~hermally conducting material, for example from a metal such
as, for exarnple, aluminium. It is furthermore provided for the
purpose of the invention ~ha~ cooling of the reagents contained in
~he reagent container be achieved by bringing the reagent
5 containers into contact with a cooling device via the interior
walls of the housing 12 and via ~he carrier 66.

ampl~ of ~n~h~zer a~Qrdin~to the inventiQn
As described hereinafter by means of Figures 12 and 13, a
automatic analyzer according to thc invention is suitable ~or
receiving a plurality of the reagen~ kits 11, ~1, 51 described
above. As depicted in Fig. 12, an analyzer of this type eon~ains the
following componen~s:
- a carrier plate 71 which is loca~ed in an opening of a
working surface 68 of the analy7er on an insulating wa31 77
and on which carriers 66 with reagent kits 11, ~1, 51 are
located on guide rails 67, where the carriers 66 wi~h ~he
reagent kits are ~hermally insulated to the outside by
further insulating walls 76, 78, 79.

- a cooling deviee (see Figures 12 and 13) which containsPeltier elements 7Z, 73 which are located in openings in the
insulating wall 77 and are in contact with the carrier pla~e
71, where each Pel~ier element is connected to a cooling
body 74 and 75 respeetively,




,; ~ .
. . .

`~ 8 2132~t3
- an automa~ic pipetting device with which the pipettings
necessary in the analyzer are carried out.

A central co~trol unit, which is not shown in Fig. 1~,
5 controls all the functions in the analyzer.

The carrier plate 71 is cooled with the abovementioned
cooling device. A uniform cooling of the reagents contained in the
reagen~ kits is achieved in this way.
The abovementioned automatic pipetting device con~ains a
transport unit for a pipetting needle 101. This transport unit
con~ains a transport carriage 103 and a rod 102 on which the
carriage 103 travels. This transport unit serves mainly to bring
the pipe~ting needle along three mutually perpendicular ~ -
directions to a plurality of pipetting positions where pipettings
are carried out.

In the pipettings which have just been mentioned, inter alia
20 particular reagent volumes are removed from the reagent
containers and transferred to particular reaction vessels which ~ ~'
each contain a sample to be investigated.
-~L
Throughout the time each of the reagent containers is in tlse
25 in the analyzer it is closed with a closure 34, 35 or 36 which can
be pierced by the pipetting needle 101 of ~he pipet~ing device.

A preferred embodiment of the analyzer according to the
invention contains a unit with which the integrity of the reagent
30 kits t 1 received in the analyzer can be tested. This ~esting unit
essentially consis~$ of the spike 39 which is depic~ed in Fig. 2
and which is carried by the transport carriage 103 of the
pi,oetting needle 101 and which cooperates with a sensor unit
which is not shown. To test the integrity of a reagent kit 11, the
35 spike 39 is advanced by a sui~able drive towards the pre-punched
point 29 in the lid 19 of the reagent kit 11. If the spike 39 finds
this point closed, this is taken ~o be confirmation of the integrity
of the reagent ki~ 11. Thereafter this point is opened by a

9 2132~13
suitable pressure exerted by the spike in order to cancel the
reagent kit. On the other hand, if the spike finds the pre-punched
point open, this is taken to be an indicator o~ a reagent kit which
has already been cancelled and therefore should no~ be used. If the
5 latter is the case, the reagent kit is brought by the ltransport
device to the ejection point.

During operation of the analyzer, reagent volumes are taken
as required from one of the reagent kits 11 present on a carrier
0 66 and passed to a reaction vessel, which is not shown, in a
processing station, which is likewise not shown, for
sample/reagent mixtures.

Description of the clos~res of the rçagen~ontainer$
1 5
The closures 35-37 have the same design. The design of the
closure 35 is described hereinafter by means of Figures 14-18.
As shown in Fig. 14, the closure 35 is essentially composed of a
lid 81 as shown in Fig. 15 and a stopper 91 as shown in Fig. 16,
20 which can be inserted as seal between the lid 81 and the
container and which is produced, for examplc, from bromobutyl
rubber.

The lid 81 shown in Fig. 15 is a par~ moulded in one piece
25 from a plastic, for example, from polyethylene, preferably 50%
low density polye~hylene (LDPE) and 50% high density
polyethylene (HDPE). It has a cylindrical side wall 83 and an
annular upper wall 84 which adjoins the side wall and which
merges into a conical wall 85 which extends inwards from the
30 inner circle of ~he upper wail and terminates in a tip 86 which is
located on the axis of symmetry of the cylindrical wall and which
can be pierced, for example, by the pipetting needle of an
automatic pipetting device. A first par~, which adjoins the upper
wall 84, of the conical wall 85 forms an angle of 10 with the
35 axis of symmetry of the cylindrical side wall 83. The conical wall
85 has a second part which forms the tip 86 of the conical wall
and which forms an angle of 30~ with the axis of symmetry of the
cylindrical side wall 83.

~` 2~32~3

The lid 81 is a screw closure which has in its side wall 83
an internal thread 89 which corresponds to an external thread on
the neck of the reagen~ container ~not shown) which is closed
5 with the closure 35.

The access to the conical wall 85 is preferably sealed with
a metaliic sealing foil 98.

0 The stopper 91 shown in Fig. 16 has in the eentre a passage
92 whose shape matches the outer surface of the conical wall 85
of the lid in such a way that, when the container is closed with
the stopper 91 and the lid 81, the outer surface of the conical
wali 85 is sealingly in contact with the inner wall of the passage
92 in the stopper 91.

The use of the closure 35 shown in Fig. 14 is described
hereinafter by means of Figures 17 and 18.

As shown in Fig. 17, the tip 86 of the conical wall ~ is
pierced by ~he tip of a spike 90, which has cuttir-g wings 87, 88.
In ~his ease the lower sharp edges of the cutting wings 87, 88 cut
in~o ~he lower parlt of the conical wall 85. ~fter removal of the
spike 90, the conical wall 85 has slits 94, 95 for ventilation.
2s
As shown in Fig. 18, it is now possible to introduce a
pipet~ing needle 101 through ~he central opening lef~ by the spike
90 a~ the ~ip 86 of the conical wall 85 into the reagen~ container,
for example in order ~o remove a particular volume of a liquid
30 reagent con~ained therein.

Representative Drawing

Sorry, the representative drawing for patent document number 2132813 was not found.

Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(22) Filed 1994-09-23
Examination Requested 1994-09-23
(41) Open to Public Inspection 1995-04-29
Dead Application 1998-09-23

Abandonment History

Abandonment Date Reason Reinstatement Date
1997-09-23 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $0.00 1994-09-23
Registration of a document - section 124 $0.00 1995-03-24
Maintenance Fee - Application - New Act 2 1996-09-23 $100.00 1996-08-20
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
F. HOFFMANN-LA ROCHE AG
Past Owners on Record
HENZEN, IGNATZ WOLFGANG
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Examiner Requisition 1997-07-25 2 71
Prosecution Correspondence 1994-09-23 1 33
Cover Page 1995-04-29 1 68
Abstract 1995-04-29 1 51
Claims 1995-04-29 1 55
Drawings 1995-04-29 13 648
Description 1995-04-29 10 809
Fees 1996-08-20 1 62