Note: Descriptions are shown in the official language in which they were submitted.
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A COLLECTION SYSTEM FOR STORAGE AND MANIPULATION OF A
SAMPLE
BACKGROUND OF THE INVENTION
(a) Field of the Invention
The invention relates to a tamper proof sample
collection system for potential automated manipulation
with reduced risk of contamination, degradation or
biological hazards.
(b) Description of Prior Art
It is known in the art to obtain a biological
sample from a person for further analysis, such as for
DNA testing, etc. These samples are typically placed
on a substrate for ease of transportation and
manipulation.
One known substrate is nitrocellulose paper,
which has to be dried in open air when a biological
substance (like blood, saliva, etc.) is applied on it.
This substrate is placed in or on a container forming a
device, which is typically not hermetic and does not
offer a full protection against humidity,
contamination, UV, degradation, etc. These devices
also cause problems because it is difficult to automate
the processes that use those kinds of devices. More
specifically, these devices are labour-intensive, and
require delicate manipulations prior to performing the
analysis on the sample contained therein.
Also, after applying a biological sample on the
paper, it is usually dried in open air for about 30
minutes before storing it. Such a sample might gets
contaminated while drying. They could be stored
immediately in a plastic bag containing a desiccant,
but this is not a convenient way to handle biological
sample and is not suitable for process automation.
Others substrates are used in petri dishes for
different biological processes. These substrates are
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also sensitive to contamination. Petri dishes are still
difficult to automate their manipulation.
An other issue with genetic material is the
security of genetic material samples in depository,
which are used in cases of forensic DNA analysis and
biopharmaceutical research for example. One major
concern is to prevent tampering with and the misuse of
this material.
Because genetic material contains personal
information about his owner and because the issue of
the genetic tests can be critical (DNA test in criminal
trials for example or medical diagnosis), the sample
storage must be extremely secure. Actually, no real
secure system protects the access to sample and no
records are kept on sample access. There is no
protection also on test results.
It is also known in the art to sample a part of
a biological sample manually to make a test. This
approach doesn't allow optimum usage of the biological
sample. Also, it is impossible for a technician to
recognize a sample based on the shape and the empty
spots left from previous sampling. Being able to
recognize a sample in that way can be a supplemental
security level in the sample manipulation. Using an
automated manipulation system can also reduce human
intervention and reduce the risks of human errors,
contamination and biological hazards. Some automated
sampling systems are actually existing, but they take a
sample always at the same position, which doesn't allow
multiple usage of the sample.
Accordingly, it is necessary to design an
automated biological sample collection system, which
allows automated manipulation of biological samples,
secure storage and automated sampling.
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It would be highly desirable to be provided with
a tamper proof biological sample collection system for
potential automated manipulation with reduced risk of
contamination, degradation or biological hazards.
SUMMARY OF THE INVENTION
One aim of the present invention is to provide a
tamper proof biological sample collection system for
potential automated manipulation with reduced risk of
contamination, degradation or biological hazards:
In accordance with the present invention there
is provided a cartridge for receiving a sample,
comprising:
- a housing;
- a lid capable of hermetically closing the
housing;
- a tampered-proof system, coupled to the
cartridge, to indicate to a user whether the
lid has been removed from the housing,
thereby allowing the user to determine if the
sample has been potentially contaminated, or
substituted or tampered with.
The cartridge in accordance with a preferred
embodiment of the present invention, wherein the
tampered-proof system comprises an indicator movable
into a first position indicating to a user that the
cartridge has not been used, into a second position
indicating to the user that the cartridge has been
hermetically closed, and into a third position
indicating to the user that the cartridge has been
opened.
The cartridge in accordance with a preferred
embodiment of the present invention, wherein the
tampered-proof system is coupled to the lid.
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The cartridge in accordance with a preferred
embodiment of the present invention, wherein the lid
comprises a sample substrate coupled thereto.
The cartridge in accordance with a preferred
embodiment of the present invention, wherein the sample
is a biological sample.
The cartridge in accordance with a preferred
embodiment of the present invention, wherein the
tampered-proof system comprises:
- an indicator comprising first and second
receiving positions for receiving a stopper
to maintain the indicator in a first open
position or a second hermetically closed
position;
- an element comprising first engaging means
for engaging with the first and second
receiving portions for moving the indicator
from a first open position to the second
hermetically closed position to a third open
position.
The cartridge in accordance with a preferred
embodiment of the present invention, wherein the
tampered-proof system further comprising a means for
locking said cartridge.
The cartridge in accordance with a preferred
embodiment of the present invention, wherein the
stopper is coupled to the element; and wherein the
element further comprises second engaging means for
engaging with corresponding receiving means provided on
the housing, thereby hermetically closing the housing.
The cartridge in accordance with a preferred
embodiment of the present invention, further comprising
a desiccant.
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In accordance with the present invention there
is provided an apparatus for storing samples, the
apparatus comprising:
- a housing;
- sample receiving means provided inside the
housing;
- a sample handling device for automatically
inserting and removing the samples from the
sample receiving means; and
- a user interface coupled to a control unit
for controlling the sample handling device.
The apparatus in accordance with a preferred
embodiment of the present invention, wherein the sample
is contained in a cartridge comprising:
- a housing;
- a lid capable of hermetically closing the
housing;
- a tampered-proof system, coupled to the
cartridge, to indicate to a user whether the
lid has been removed from the housing,
thereby allowing the user to determine if the
sample has been potentially contaminated.
The apparatus in accordance with a preferred
embodiment of the present invention, wherein the
control unit comprises a database for recording each
insertion and/or removal of a sample.
The apparatus in accordance with a preferred
embodiment of the present invention, wherein the sample
handling device comprises:
- a carrier movably mounted on the housing;
- an arm coupled to the carrier; and
- a grip coupled to the arm for gripping the
sample.
The apparatus in accordance with a preferred
embodiment of the present invention, wherein sample is
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contained in a cartridge comprising a bar code and/or a
RF tag, and wherein the grip comprises a bar code
and/or a RF scanner.
The apparatus in accordance with a preferred
embodiment of the present invention, wherein the sample
is a biological sample.
In accordance with the present invention there
is provided an apparatus for automatically sampling a
sample, the apparatus comprising:
- a CPU;
- a camera coupled to the CPU for scanning the
sample and identifying an optimal location
for sampling the sample; and
- a sampler for sampling the sample at the
optimal location.
The apparatus in accordance with a preferred
embodiment of the present invention, wherein the sample
is contained in a cartridge comprising a bar code
and/or a RF tag, and wherein the grip comprises a bar
code and/or a RF scanner.
The apparatus in accordance with a preferred
embodiment of the present invention, wherein the sample
is a biological sample.
The apparatus in accordance with a preferred
embodiment of the present invention, comprising means
to compare a visual signature of the sample with a
visual signature previously recorded in a database, the
database being located in a storage unit comprising:
- a housing;
- sample means provided inside the housing;
- a sample handling device for automatically
inserting and removing the samples from the
sample receiving means;
- a user interface coupled to a control unit
for controlling the sample handling device
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wherein the control unit comprises the
database.
For the purpose of the present invention the
following terms are defined below.
The term "biological sample" is intended to mean
a fluid sample such as blood, saliva, urine, and sperm,
a non-fluid sample such as hair, nail, tissue and skin.
The term "sample" is intended to mean all
biological samples as defined above and air sensitive
material, light sensitive material, vaccines,
pharmaceutical products, microbiological products and
blood or cellular products.
The term "sample substrate" is intended to mean
nitrocellulose absorbing membrane, agarose ge7_ used in
petri dishes, glass lamellas used in microscope.
The term "transaction" is intended to mean the
entry, the removal or the relocalization of a sample in
the storage unit, the sampling of a sample or the
modification of the visual signature.
The term "visual signature" is intended to mean
the numerization of the form of the sample comprising
the locations of previous samples taken. That visual
signature is unique for a sample.
BRIEF DESCRIPTION OF THE DRAWINGS
Having thus generally described the nature of
the invention, reference will now be made to the accom
panying drawings, showing by way of illustration, a
preferred embodiment thereof, and in which:
Fig. 1 illustrates a front elevation view of one
possible composition of a cartridge embodying the
present invention.
Fig. 2 illustrates a cross-sectional view of one
possible composition of the cartridge.
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Figs. 3A-C illustrate a front elevation view of
the tamper proof locking and indicator mechanism. Fig.
3A illustrates the tamper proof locking and indicator
mechanism in their initial position before the closing
of the cartridge. Fig. 3H illustrates the tamper proof
locking and indicator mechanism when the cartridge is
close. Fig. 3C illustrates the tamper proof lacking
and indicator mechanism after the opening of the
cartridge.
Fig. 4 illustrates the automated sample -storage
system.
Figs. 5A-B illustrate the horizontal mobile pick
and place device.
Fig. 6 illustrates the automatic sample pre-
processing system.
DETAILED DESCRIPTION OF THE INVENTION
zn accordance with the present invention, there
is provided a tampered-proof biological sample
collection cartridge. Fig. 1 shows a preferred
configuration of the cartridge device according to the
present invention, which contains an absorbing membrane
(1) where a biological sample (like blood but not
limited to) is to be applied, a desiccant (2), a
desiccant retainer (3), two seals (4), a fixed back
cover ( 5 ) and a s 1 iding front cover ( 6 ) . The not ch on
the side of the cartridge allows easy handling of the
cartridge in an automated manipulation process. These
notches enable gripping of the device by an automated
mechanism such as robotic arm. A flat surface enables
a bar code (7) to be applied to it for indexing a
further storage.
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Fig. 2 illustrates a cross-sectional view of one
preferred configuration of the cartridge device. It
incorporates a desiccant (1) to absorb humidity of the
sample, an absorbing membrane (2) where the biological
sample is applied, a puncture resistant, non-absorbing
support that will allow easy puncturing and retrieval
of a part of the absorbing membrane. The diagram shows
also the desiccant retainer (3 ) , two seals (4 ) , a back
cover (5) and a sliding front cover (6).
Depending on the use of the cartridge device,
the absorbing membrane can be replaced by another
sample substrate such as agarose gels and glass
lamellas. If the cartridge is used for non-fluid
biological samples, such hairs, the cartridge device
can has no sample substrate. If sample substrate is
nitrocellulose paper, or another type of sample
substrate needing drying, the device includes the
desiccant retainer and the silica gel desiccant.
The cartridge device preferably includes means
for closing it hermetically. Such hermetic closing
protect the sample from contamination with other
biological substances that can false tests results.
The device also has preferably a locking device, which
can be unlock only by a laboratory owning the unlocking
device.
The cartridge device preferably includes a
tampered-proof indicator. Figs. 3A-C are front
elevation views of the tampered-proof locking and
indicator mechanism. The first diagram shows the
tampered-proof mechanism when the cartridge is opened.
At that time, the wheel (1) is maintained in a first
opened position, such position indicating a blue color
in the indicator window contained in the back cover.
The blue color means that the cartridge was not used
yet. The tampered-proof indicator mechanism comprises
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an engaging means (2) and a stopper (3) for engaging
and maintaining the wheel in three distinct positions:
a first open position, a second closed position and a
third position indicating that the device has been
opened at least once, where that third position can not
be changed when it is reached.
The second diagram shows the tampered-proof
mechanism when the cartridge is closed for the first
time. At that time, the engaging means is engaging
with the first receiving portion (4) of the wheel for
moving the wheel from the first open position to a
second hermetically closed position and the stopper
maintain the wheel in that position. The indicator
shows a green color in the indicator window contained
in the back cover. The green color indicates that the
cartridge was never opened.
The third diagram shows the tampered-proof
mechanism when the cartridge is opened. At that time,
the engaging means is engaging with the second
receiving portion (5) of the wheel for moving the wheel
from the second hermetically closed position to a third
open position. The indicator shows a red color in the
indicator window contained in the back cover. The red
color indicates that the cartridge has been opened and
the sample may has been tampered with that opening.
The cartridge device has a flat surface at
extremity for bar code labeling. That bar code is
unique for each device and it is the item that allows
the sample identification and the information to be
tracked in the database of the automated sample storage
unit. The bar code label could be also coupled to a RF
tag embedded in the plastic body of the cartridge.
Typically, this cartridge device can be used for
sample analysis using PCR technique. One of these
analyses is DNA analysis in forensic investigations. A
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blood sample from a suspect can be kept in the
cartridge device for further DNA analysis, the
cartridge device protecting it from possible
contamination, W degradation or sample alteration.
Furthermore, the tampered-proof mechanism proves that
no sample alteration or substitution had happened and
guarantees that the DNA analysis is executed on the
suspect's blood sample.
Another possible use of the cartridge can be for
paternity testing. The user has to put a drop of blood
on an absorbing paper (substrate) in the cartridge,
close the cartridge and send it by messenger to the
laboratory for analysis. The tampered-proof mechanism
indicates to the laboratory if the cartridge had been
opened during transportation, which can mean that the
sample is altered. Because the samples are identified
with a bar code, the confidentiality of test results is
assured.
Automated sample storage system
This system, as illustrated in Fig. 4 consists
in a closed and temperature controlled unit comprising
mobile shelves for a secure and optimal sample storage.
The samples are stored in cases on the mobile shelves
and the correspondence between the sample and its
location in the unit is maintained in a database, using
bar codes and/or RF tag to identify sample and case
location.
Several levels of security exist in sample
access to avoid sample misuse. The unit is closed with
locked doors. To unlock these doors, the user should
enter an ID and a password at the user interface to
validate he is an authorized user of the system.
Information about storage unit access is kept in
database. There is also detectors on the door that
detects an unauthorized opening of the unit.
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Information about unauthorized opening of the unit is
kept in a separate "black box" that has is own power
supply.
The sample entry in the unit is executed using
an orifice on the system side. An optional support can
be used to enter more than one sample at a time.
When the sample is inserted in the unit, its bar
code and/or RF tag is read. If it is the first time
this sample is inserted, the user can enter additional
information about the sample via the user interface. A
horizontal mobile pick and place device, as seen in
Figs. 5A-B, brings the sample to an empty case on a
shelve of the unit. This horizontal mobile pick and
place device is constituted of a robotic arm using a
positioning linear two(2) axes system. The robotic arm
is terminated by a grip that can handle the sample and
rotate to pick or place a sample on a shelve. The grip
also comprises a bar code and/or RF scanner for sample
identification number before manipulation.
To remove a sample from the unit, the user shall
use the user interface and request a sample in entering
the sample number at the screen, or entering specific
information about the sample or scanning a bar code
identical to the one associated with the sample. At
that time, information about the sample request is
recorded in the storage unit database. The sample can
also be automatically removed from the unit depending
on the sample's analysis priority. Finally, after a
configurable maintenance delay, the sample is placed in
a disposal unit for its secure destruction. The
maintenance delay can be configured through the user
interface. The secure destruction prevents biological
hazards and also protects biological information
contained in the sample, preferably a biological
sample.
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All the transactions that are executed are saved
on the database using the user interface software that
also controls all the system's operations. This
database is back up regularly on an external secure
system to retrieve the information in case of system
failure.
Typically, the storage system can be used for
DNA-containing samples conservation. One of the
possible usages is genetic repository for bioforensic.
The secure storage unit database keep information about
sample request and the user needs to be an authorized
user to be allowed to remove a sample from the storage
unit. Also, the sample is identified by a bar code,
that confers confidentiality to the information related
to the sample and increase the security level of the
system.
Automated samt~lincr system
The system can also include an automated
sampling unit. This unit, as illustrated in Fig. 6 is
embodied in a casing containing a ring light (1), two
cameras (2-3), a linear drive (4), a puncturing device
(5), a manipulation device (6), a sterilization unit, a
visual inspection station, a bar code printer, an
opening device (7), a software control unit (8) and a
user interf ace ( 9 ) .
The system is used to automatically take a
sample from another sample that can be contained in a
plurality of different substrates. The sample is
preferably a DNA-containing sample.
The user can configure the system, using the
user interface, in order to adjust the system for a
plurality of containers. These containers can be, but
not limited to, microplates, Eppendorf tubes and test
tubes.
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When a user want to take a sample from another
sample, a container is first putted under the right
camera and a picture of the container is taken. The
system uses the picture to verify that the container is
empty. Then the material, which is preferably the
cartridge previously described, is inserted by the
manipulation device and placed under the left camera.
If the material is a cartridge, the opening device open
it. A picture of the material to be sample is taken
and analyzed.
Using the picture of the material, the
artificial vision technique identify where on the
material there is substance to be sample, where there
is no substance and where a sample was previously
taken. The artificial vision technique also optimizes
the sample localization. The optimization method uses
mathematical algorithms.
When the optimal sample localization is
determined, the puncturing device at that position
takes the sample. The sample is then putted in the
container and a picture, with the right camera, is
taken to validate the presence of the sample in the
container. If another sample is needed, the
optimization method is executed again. If not, the
puncturing device is sterilized in the sterilization
unit and the container with the sample is removed from
the sampling unit.
The sampling system is preferably coupled with
the sample storage unit previously described. When the
sampling unit takes a picture of the material to be
sampled, it compares the visual signature of the
material with the one previously saved in the storage
unit database. After the sample is taken, the new
visual signature is replaced in the storage unit
database. The storage unit and the sampling unit
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communicate together using TCP/IP protocol and SQL
queries.
While the invention has been described with
particular reference to the illustrated embodiment, it
will be understood that numerous modifications thereto
will appear to those skilled in the art. Accordingly,
the above description and accompanying drawings should
be taken as illustrative of the invention and not in a
limiting sense.
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