U.S. patent application number 10/874320 was filed with the patent office on 2005-01-13 for disposable cassette.
Invention is credited to Frey, Stephan, Lapp, Uwe.
Application Number | 20050008505 10/874320 |
Document ID | / |
Family ID | 33441659 |
Filed Date | 2005-01-13 |
United States Patent
Application |
20050008505 |
Kind Code |
A1 |
Lapp, Uwe ; et al. |
January 13, 2005 |
Disposable cassette
Abstract
The invention relates to a disposable cassette as a replaceable
component of an analysis instrument comprising fluid paths
integrated in the cassette. In accordance with the invention, at
least one container with a liquid, for example a calibration fluid,
is integrated in a liquid-tight manner in the disposable cassette.
An integrated spike is provided in the disposable cassette, for
example as a pivotable rocker hook, via which the pouch can be
opened so that the liquid can be guided into the fluid paths of the
disposable cassette.
Inventors: |
Lapp, Uwe; (Butzbach,
DE) ; Frey, Stephan; (Frankfurt, DE) |
Correspondence
Address: |
JACOBSON HOLMAN PLLC
400 SEVENTH STREET N.W.
SUITE 600
WASHINGTON
DC
20004
US
|
Family ID: |
33441659 |
Appl. No.: |
10/874320 |
Filed: |
June 24, 2004 |
Current U.S.
Class: |
417/313 ;
417/572 |
Current CPC
Class: |
B01L 2400/049 20130101;
B29C 45/00 20130101; B01L 2400/0633 20130101; B01L 2200/10
20130101; B01L 2300/0867 20130101; B01L 3/505 20130101; B01L 3/502
20130101; G01N 35/00594 20130101; G01N 35/00693 20130101; B01L
2300/0672 20130101; B01L 2200/16 20130101; B01L 2200/148 20130101;
B01L 2300/0809 20130101 |
Class at
Publication: |
417/313 ;
417/572 |
International
Class: |
F04B 023/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 8, 2003 |
DE |
103 30 803.2 |
Claims
1: A disposable cassette comprising fluid paths integrated in the
cassette, characterised in that at least one container with a
liquid, for example a calibration fluid, is integrated in the
disposable cassette in a liquid-tight manner and in that an
integrated spike is provided at the disposable cassette and the
container can be opened via it such that the liquid can be guided
into the fluid paths of the disposable cassette.
2: A disposable cassette in accordance with claim 1, wherein the
region of the rocker hook in the disposable cassette is covered by
a film and in that the region of the spike is surrounded in
ring-shaped manner by a sealing web while leaving free a merging
fluid path.
3: A disposable cassette in accordance with claim 1, wherein the
container is a flexible pouch of an aluminium multilayer film.
4: A disposable cassette in accordance with claim 1, wherein the
integrated spike consists of a rocker hook hinged to the disposable
cassette.
5: A disposable cassette in accordance with claim 4, wherein the
rocker hook has a fluid passage in the form of a channel such that
a possible occlusion of the free flow is prevented.
6: A disposable cassette in accordance with claim 1, wherein the
container has a deep-drawn spherical arrangement in the film wall
in the region of the spike at the side facing away from the
spike.
7: A disposable cassette in accordance with claim 1, wherein the at
least one spike is made in one piece with the disposable
cassette.
8: A disposable cassette in accordance with claim 1, wherein the
disposable cassette is a replaceable component of an analysis
instrument.
9: A method of providing a sterile access for a container inserted
into a disposable cassette in accordance with claim 1,
characterised in that the container filled with liquid is connected
to the disposable cassette in a completely sealed manner and in
that a wall of the pouch is cut open by means of the associated
spike to open the container access without damaging the opposite
wall of the pouch formed as a deep-drawn spherical arrangement.
Description
[0001] The invention relates to a disposable cassette in accordance
with the preamble of claim 1.
[0002] Disposable plastic articles with fluid carrying passages are
frequently used in medical equipment. Corresponding cassette
systems have proven their worth here as alternatives to
conventional hose systems. The corresponding fluid paths are formed
in these cassette systems. The fluid flowing through the fluid
paths is introduced by means of corresponding actuators. For
instance, valves are, for example, used via which the fluid paths
are switched open or are closed. On the other hand, pumps for the
transport of the fluid are integrated in such cassette systems. In
the field of medical application, disposable cassette systems are
already known in which a rigid part is provided in which passages
are let into chambers. This rigid part is covered by a continuously
flexible film. In accordance with DE 102 39 597, this flexible film
is formed by flexibly formed regions in the rigid part, with the
rigid and flexible regions being able to be manufactured in one
piece using a two-component injection moulding technology.
[0003] The aforesaid cassette systems can also be used to advantage
in the field of analysis technology.
[0004] The liquids required for the analysis, for example
calibration fluid, have to be connected in accordance with the
prior art by means of expensive access adapters provided especially
for this purpose for sterile connection. Such access adapters
result, for example, from U.S. Pat. No. 6,016,683, U.S. Pat. No.
6,136,607 A or EP 1 243 336 A2.
[0005] It is the object of the invention to provide a disposable
cassette in which the sterile access to a liquid, for example to
the calibration fluid, is made possible in a simple manner without
special access adapters having to be provided for this purpose.
[0006] The object is solved in accordance with the invention by the
combination of the features of claim 1. Accordingly, at least one
container with a liquid, for example the calibration fluid, is
integrated in a liquid-tight manner into the disposable cassette.
At the same time, a spike which is preferably made as a pivotable
rocker hook, is provided at the disposable cassette and the pouch
can be opened via it such that the liquid can be guided into the
fluid paths of the disposable cassette.
[0007] Particular advantages of the invention result from the
dependent claims following the main claim.
[0008] Accordingly, the region of the spike in the disposable
cassette can be covered by a film and the region of the spike is
preferably surrounded in ring-like manner by a sealing web while
leaving a merging fluid path free. It is thus ensured after the
cutting of the one film wall by means of the spike that the
discharged liquid is guided into the merging fluid path without
leakage.
[0009] The container can preferably be made as a pouch from
aluminium multilayer film.
[0010] The pouch can have at least one deep-drawn spherical
arrangement in the film wall in the region of the rocker hook on
the side facing away from the rocker hook, said spherical
arrangement ensuring that the film in which this spherical
arrangement is provided is not damaged on the pivoting in of the
rocker hook. Any other design of a spike can serve to open the film
wall instead of the previously described rocker hook which can be
pivoted in.
[0011] The rocker hook is preferably made in one piece with the
disposable cassette. The disposable cassette is an injection
moulded plastic part and the rocker hook can be moulded pivotably
to this injection moulded plastic part such that it can be pivoted
by means of a machine pusher such that it cuts open a side of the
pouch correspondingly inserted in the disposable cassette. The
rocker hook can advantageously have a fluid passage in the form of
a channel such that a possible occlusion of the free flow is
prevented.
[0012] In accordance with a further aspect, the invention relates
to a method for the provision of a sterile access for a pouch
inserted into a disposable cassette in accordance with the present
invention. Accordingly, the pouch filled with liquid is connected
to the disposable cassette in a completely sealed manner. A wall of
the pouch is cut open by means of the associated rocker hook to
open the pouch access without damaging the opposite wall of the
pouch formed as a deep-drawn spherical arrangement.
[0013] The system has the advantage that the pouch is completely
sealed before the corresponding cutting open by the rocker hook and
has no openings in the film wall. The storage capability of a
sensitive liquid such as a calibration fluid is improved in this
manner.
[0014] Details and advantages of the invention result from an
embodiment shown in the drawing. There are shown:
[0015] FIG. 1: the plan view of a disposable cassette in accordance
with an embodiment of the invention;
[0016] FIG. 2: a section corresponding to the section line II-II
through FIG. 1;
[0017] FIG. 3: a section corresponding to the section line III-III
through FIG. 1;
[0018] FIG. 4: a pouch for insertion into a disposable cassette in
accordance with FIG. 1 in plan view; and
[0019] FIG. 5: a section corresponding to the section line V-V
through FIG. 4.
[0020] In the disposable cassette 10 shown in FIGS. 1 and 2, a
passage structure 14 is formed in a first part 12, which is made as
an injection moulded plastic part, for the purpose of the fluid
guidance and is covered in a known manner by means of flexible
elastomer material in accordance with DE 102 39 597 of the same
applicant. The injection moulded plastic part 12 has a shell-like
recessed region 16 in which there lie 3 pouches with calibration
fluid 18 and one waste pouch 20. The pouches 18 which are provided
with calibration fluid and which are closed in the unused state of
the disposable cassette 10 are connected to passages 14 via input
regions which are to be opened directly. The waste pouch 20 is
likewise connected to the passages at 28. A series of actuators is
present in the passage system 14 in the form of valves not shown in
more detail here or in the form of a pump 32. Respective flexible
plastic layers, which can be actuated via pushers on the machine
side not shown in more detail here, are provided in the valves or
in the pump 32. Reference can be made to DE 102 39 597 for the more
detailed function. Liquid can be directly transported in the
passage system 14 by a corresponding control of the valves 30 or of
the pump 32.
[0021] A sample port 34 is present for the inlet of a sample
liquid, for example whole blood, serum or urine.
[0022] The sample port 34 can be closed via a slider 40 which
cooperates with a plastic flap 38. The whole sample port can be
flushed by introducing a flushing liquid after introducing the
sample and closing the plastic flap 38.
[0023] An old blood sample or an old calibration solution can be
replaced by fresh calibration solution by this flushing. The
disposable cassette 10 represented in its design and in its
function is inserted into the analysis instrument not shown in any
more detail here and is pressed tight. Usually, the disposable
cassettes are designed for a period of use of 24 hours or of
approximately 30 measurements. The required calibration solution is
taken from the corresponding pouches 18. These pouches are
integrated into the disposable cassette in a liquid tight manner
prior to the measurement, i.e. they lie on top of one another in
the manner shown in FIG. 2 in the region 16 of the injection
moulded plastic part 12 recessed in the form of a shell. The
pouches 18 are firmly connected to the injection moulded plastic
part 12 in each case in the region 50, 52 or 54.
[0024] The design of a pouch 18 results from FIGS. 4 and 5. The
pouch 18 consists in each case of an upper and a lower layer of an
aluminium multilayer film 56 or 58 which are welded together along
a weld line 60 such that they leave an opening region 62 free. The
opening region is defined by two weld seams 64 which initially
extend parallel to one another and move away from one another
toward the outer end of the pouch 18 as conical weld lines 66 while
forming a conical opening region 68. One half of the film has a
deep-drawn spherical arrangement 68. In addition, a region of
deep-drawn passages 70 which extend parallel to one another and
which bring about a reinforcement of the pouch and thus protection
against kinking is realised in the opening region 62.
[0025] In FIG. 4, the pouch 18 is shown during filling. After
filling and after welding the opening closed, the pouch is firmly
connected, preferably adhesively bonded, to the first part 12 of
the disposable cassette 10 made as an injection moulded plastic
part. In FIG. 3, a sectional representation of the region is shown
in which it is shown that the pouch 18 consisting of the layers 56
and 58 is adhesively bonded to the injection moulded plastic part
12. In this process, the spherical arrangement 68 deep-drawn in the
film 56 is positioned at a location in which a pivotably moulded
rocker hook 72 is arranged in the region of the injection moulded
plastic part 12. As can in particular be seen in FIG. 3, a sealing
lip 74 is arranged around the rocker hook and is upwardly sealingly
covered by means of a flexible plastic layer 76. A fluid passage 14
opens at one side.
[0026] In order to open the pouch 18, the rocker hook 72 is pivoted
about an actuation pusher on the machine side, which is not shown
in any more detail here, such that the sharp tip 78 of the rocker
hook 72 severs or cuts open the film 58 of the pouch 18, as is
shown in FIG. 3. The film 56 of the pouch 18 is not damaged due to
the deep-drawn spherical arrangement 68. The calibration fluid
contained inside the pouch 18 now flows through the opening created
in this manner into the space surrounded in ring-shaped manner by
the sealing web 74 and can thus be guided into the passage 14. A
corresponding vacuum in the passage system 14 can be built up via
the pump 32.
[0027] In this manner, a sterile access to a film pouch can be
created in a very simple manner. The invention disclosed here with
reference to a disposable cassette system which is proposed as a
replaceable component of an analysis instrument can also be used
within the framework of another system in which it is a question of
the problem of a sterile access to a liquid filled in a film pouch
without leaving the framework of the invention,
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