The present application claims priority to Luxembourg Patent Application No. LU 102921 filed on Mar. 25, 2022. The aforementioned application is hereby incorporated by reference in its entirety.
The disclosure relates to a consumable which is a device intended for single use comprising a cavity for receiving a liquid.
Automated analyser systems for use in clinical diagnostics and life sciences are produced by a number of companies. For example, STRATEC SE, Birkenfeld, Germany, produces a number of devices for specimen handling and detection for use in automated analyser systems and other laboratory instrumentation.
For performing a so-called polymerase chain reaction (PCR) process, whether real-time PCR or quantitative PCR, always a consumable, which is device intended for single use comprising a cavity for receiving a liquid like a liquid sample from a patient is required for handling of such a liquid. This consumable comprises besides a cavity a kind of a sealing element, like a cap or a foil. Consumable and sealing must be stored and finally combined in a further process so that the cavity of the consumable is sealed.
A defined number of steps needs to be performed in order to prepare a liquid sample comprised in a consumable prior to performing a PCR process. In order to avoid a liquid loss during the repeated cycles of heating and cooling of the sample the cavity must be sealed air tight. In the context of the present disclosure, the complete preparation process comprises at least the following steps:
There are certain different systems for PCR sample preparation known from the prior art. One example relates to a PCR consumable comprising individual PCR caps and PCR tubes which are provided together in a plastic storage box or in a blister packaging. The consumable tubes and caps are for example arranged next to each other in a storage box. It is possible to process the liquids in the tubes of the storage box. A vial gripper can take a cap and snap it onto a tube for closing or sealing it.
Another solution from the state of the art for preparing samples prior to performing a PCR relates to a PCR plate comprising 384 wells which are firmly integrated in a frame. Such plates are usually used in batch processing applications. Said system may use different vial or well geometries with a round and flat bottom shape. The wells will be sealed with a heat sealer after liquid handling for closing and sealing all wells arranged in a frame. There are also other sealing technologies available like a pressure sensitive glue or a sealing using an ultrasonic welding process.
A disadvantage of nearly all existing solutions for preparing samples for PCR by sealing wells or cavities refers to using several single parts which must be handled and stored in additional steps separately.
Known solutions using only a single part have the disadvantage that the cavities of the consumables will have to be sealed manually. A fully automatic closing would increase the complexity and reliability of such systems.
There are also consumables available which refer to the use of a microfluidic device or a microfluidic chip. Such a microfluidic chip has a complex structure and therefore manufacturing of microfluidic devices is by far more complex and expensive in comparison to other designs.
Published European patent application EP 3 964 292 A1 relates to an enclosed unit for biological sample processing comprising a support with a housing for receiving a reaction tube containing a biological sample to process and guide means movable with respect to the support, so that said displacement pulls out a protruding plug of the reaction tube placed in the housing of the support and allows a reagent to fall into the reaction tube. It is disadvantageous that a device according to EP 3 964 292 A1 requires a separate reaction tube with a protruding plug. The device of EP 3 964 292 A1 is intended for handling reaction tubes and does not provide a reaction tube itself which can be sealed and opened in a simple way.
Published U.S. Pat. No. 9,841,360 B1 discloses a sample analysis cup assembly, system and method for purging including a cell body, including a top end; a bottom end; a cell body wall extending axially from the top end to the bottom end; a transverse wall adjacent the top end, including a plurality of apertures extending therethrough; and a raised portion on the transverse wall including a central aperture extending therethrough; a rotatable cap, including a top surface; a bottom surface; and a series of apertures extending from the top surface through the bottom surface, the rotatable cap being structured to engage with the top end of the cell body; and a ring member structured to couple with the bottom end of the cell body are provided.
There is a need for a device and a method for preparing samples for an analytical assay like a PCR which is fast and easy to handle with respect to sealing a cavity comprising a liquid sample.
The present disclosure provides a consumable for use in an automated analyser system for performing biochemical assays, comprising a rim surrounding at least one cavity for receiving a fluid, wherein the at least one cavity is connected via a flexible bridge to the rim; and a cover foil that is arranged on top of the consumable and above the openings of the at least one cavity, wherein the cover foil comprises holes which are configured to be arranged in an open position above the openings of all cavities, wherein the cover foil is connected rotatable at and around a centrally arranged hole.
The at least one cavity can be made of a white or translucent material in another embodiment of the disclosure.
A further aspect of the disclosure relates to the cover foil which can be made of a translucent material.
It is further intended that the at least one cavity can be made of a thermally conductive material.
The consumable may in another embodiment comprise a centrally arranged hole which is configured to accommodate a gripper for taking up the consumable with an alignment cone.
It is further envisaged that the bridges are configured to allow a horizontal and/or vertical movement of the cavities.
Another embodiment relates to a cover foil which may have additional holes configured to accommodate spikes of a rotation gripper for rotating the cover foil from an open position to a closed position where the cover foil closes the opening of the at least one cavity.
A further aspect of the disclosure relates to the consumable, wherein the upper end of the cavities' openings comprise a raised border made of a heat meltable material.
The foil of a consumable according to the present disclosure can made of a heat meltable material, is coated with an adhesive or glue on the surface directed towards the cavities' openings.
Another aspect of a consumable relates to the rim which may comprise a snap-in feature comprising a retaining element at the bottom side of the rim and a hook arranged above the retaining element and thus above the rim.
Another object of the present disclosure is a system for performing biochemical assays, comprising
In another aspect of the instant disclosure's system, the glass fibres are arranged above each cavity for introducing light into the respective cavity.
It is further intended for a system according to the present disclosure that it comprises a rotation gripper with spikes which are configured to accommodate into additional holes of the cover foil for rotating the cover foil from an open position to a closed position and vice versa.
The system may comprise in another embodiment a member for sealing the cover foil onto the consumable, which can be a heating element.
It is also envisaged that the system can comprise a gripper for moving a consumable, wherein the gripper comprises an interface pin which is arranged centrally in a strip-off-shell.
The interface pin of a system according to the present disclosure may further comprise a rotation lock, which can be flattened longitudinal surfaces on the interface pin.
Still other aspects, features, and advantages of the present disclosure are readily apparent from the following detailed description, simply by illustrating preferable embodiments and implementations. The present disclosure is also capable of other and different embodiments and its several details can be modified in various obvious respects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. Additional objects and advantages of the disclosure will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the disclosure.
The disclosure will be described based on figures. It will be understood that the embodiments and aspects of the disclosure described in the figures are only examples and do not limit the protective scope of the claims in any way. The disclosure is defined by the claims and their equivalents. It will be understood that features of one aspect or embodiment of the disclosure can be combined with a feature of a different aspect or aspects of other embodiments of the disclosure, in which:
The technical problem is solved by the independent claims. The dependent claims cover further specific embodiments of the disclosure.
The term consumable refers within the present disclosure to a device which provides cavities, receptacles or recesses for receiving a fluid which can be a liquid patient sample for instance. The term fluid refers to a liquid which can be a patient sample that comprises solids. A patient sample may be liquids like whole blood, urine, lymph or saliva.
The present disclosure comprises a disposable consumable with multiple reaction cavities. Such a consumable is intended for single use only for performing an analytical assay like a PCR. It is obvious for a person having ordinary skill in the art that the consumable according to the present disclosure may also be used for other assays and is thus not limited to its use in PCR.
The consumable according to the present disclosure comprises an integrated sealing element, which can be heat sealed or welded to obtain air-tight sealed reaction cavities. The consumable is furthermore stackable for minimizing the required space. The sealing element can be closed and subsequently sealed with a heat-sealing device for obtaining the air-tight sealed cavities. It is an advantage of a consumable according to the present disclosure that no other elements than the consumables with its already connected parts must be handled.
A relevant feature of the present disclosure relates to the integrated heat-sealing element that allows stacking of the consumable as well as sealing of multiple cavities. This sealing element safeguards further processing and avoids evaporation of the liquids in the cavity as well as contamination of said liquids.
The present disclosure provides a new consumable design and sample preparation process prior to performing an assay like a PCR. The consumables according to the instant disclosure is stackable and relate to a multi-cavity consumable with preferably four cavities. It is obvious that consumable with a different number of cavities for receiving a liquid also within the scope of the present disclosure.
As already mentioned, the consumables provide an integrated sealing element which is a foil thin sheet of a material that is suitable heat-sealing or welding to cover the cavity inside the instrument while offering the possibility to open the cavities before heat sealing or welding for adding a liquid to a cavity. The cavities will be air-tight sealed when the respective liquid or multiple liquids have been filled into a cavity.
The consumables according to the present disclosure further comprises structural elements enabling handling of the consumable with a simple gripper. The structural element is a circular hole for accommodating a gripper.
It is further intended that the cover or seal of the cavities is made of a translucent material for enabling fluorescence measurement at least through a window made of a translucent material in the cover or seal. It is also within the scope of the present disclosure to use a translucent and thin sealing element allowing to measure fluorescence. The walls of the cavity may also be made of a translucent material or alternatively of a white material for enhancing emitted fluorescence, respectively for reflecting optical signals resulting from emitted fluorescence.
The consumables 2 for assay preparation according to the present disclosure comprises an integrated and rotatable cover which is a cover foil 5 or can be a plate (comp.
The consumable 2 further provides a centrally arranged hole 11 for taking up the tip of a gripper so that the consumable can be moved (comp.
Each of the separate cavities 7 is fixed through a bridge 8 to the rim 15 (comp.
The tolerance compensation is in particular required for use of the consumable with cavities in a thermocycler because it is necessary that the consumable fits exactly in the thermo unit, respectively the cavities providing the surfaces for transferring thermal changes to the cavities of the consumable. Appropriate heat transfer can only be guaranteed if the side walls of the cavities are in tight contact with the surfaces of the heating and cooling element.
Light can be introduced into the cavities through a first light guiding fiber 80 arranged above each cavity and emitted fluorescent light can be absorbed by a second light guiding fiber 80. Due to the thin foil and the consumable design, it is possible to bring the glass fibers as close as possible to the fluid surface to get the best readout (comp.
The cover foil 5 can be rotated and thus allows for closing all cavities simultaneously.
The consumables can be handled via a gripper 25 comprising an interface pin 27 for engaging into hole 11 and a strip-off-shell 29 for setting down or placing down the consumable 2 with cover foil 5 (comp.
The interface pin 27 provides a rotation lock to avoid an unintentional twisting, turning, or rotating of the consumable during handling. The anti-rotation function of the interface pin 27 is realized by three or more flattened longitudinal surfaces 28 which are arranged at the outer circumference of the interface pin 27 (comp.
Different steps are necessary for the whole sample preparation process like a PCR.
The advantages of the disclosure can be summarized as follows:
Alternative designs of a multi cavity consumable 2 and a cover 6 for sealing are shown in
Another design of a multi-well consumable is shown in
There are also other designs conceivable for obtaining a tolerance compensation between the cavities of a consumable and a rim or supporting frame.
There are also other methods conceivable for sealing a consumable with a cover foil without thermo sealing, comprising:
The processing of a consumables 2 with a rotatable cover foil 5 is similar to the processing of a consumables of the present disclosure as shown in
A difference resulting from the consumable design shown in
The foregoing description of the preferred embodiment of the disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the disclosure. The embodiment was chosen and described in order to explain the principles of the disclosure and its practical application to enable one skilled in the art to utilize the disclosure in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the disclosure be defined by the claims appended hereto, and their equivalents. The entirety of each of the aforementioned documents is incorporated by reference herein.
Number | Date | Country | Kind |
---|---|---|---|
102921 | Mar 2022 | LU | national |