CONTAINER FOR COLLECTING, TRANSPORTING AND STORING A BIOLOGICAL TISSUE SAMPLE
20240019345 ยท 2024-01-18
Inventors
- Francesco Visinoni (Mozzo (BG), IT)
- Matteo Minuti (Brignano Gera d'Adda, IT)
- Michele Martinelli (Brembate (BG), IT)
- Roberto Lorenzi (Ranica (BG), IT)
Cpc classification
G01N1/30
PHYSICS
B01L3/50
PERFORMING OPERATIONS; TRANSPORTING
International classification
G01N1/30
PHYSICS
Abstract
The invention refers to a container (100, 300, 400) for collecting, transporting and storing a biological tissue sample of a human or animal, wherein the container (100, 300, 400) comprises a tag (10) with a receiver (12.1) for receiving data relating to the biological tissue sample, a non-volatile memory (11) for storing the data received by the receiver (12.1), and a transmitter (12.2) for transmitting the data stored by the memory (11).
Claims
1. A container (100, 300, 400) for collecting, transporting and storing a biological tissue sample of a human or animal, wherein the container (100, 300, 400) comprises a tag (10) with a receiver (12.1) for receiving data relating to the biological tissue sample, a non-volatile memory (11) for storing the data received by the receiver (12.1), and a transmitter (12.2) for transmitting the data stored by the memory (11).
2. The container (100, 300, 400) according to claim 1, wherein the container (100, 300, 400) is filled with a component (3) being a fixative, wherein the container (100, 300, 400) is preferably filled with a further component (4) being a fluid such as a liquid, wherein the further component has a lower specific gravity than the fixative (3) and is immiscible with the fixative (3) such that the component (4) is stratified on top of the fixative (3).
3. The container (100, 300, 400) according to claim 1, wherein the data relating to the biological tissue sample includes a time stamp, wherein the time stamp is configured to relate to a fixation of the biological tissue sample contained in the container (100, 300, 400), in particular configured to indicate the beginning of fixation of the biological tissue sample contained in the container (100, 300, 400), wherein, preferably, the time stamp comprises a date, wherein the time stamp optionally comprises a fraction of the date, such as an hour and preferably a minute and more preferably a second, and/or wherein the time stamp optionally comprises a time zone and/or a format of time.
4. The container (100, 300, 400) according to claim 1, wherein the memory (11) is configured to store data including: an identifier of the object from which the biological tissue sample is taken, such as a patient identifier and/or an organ identifier, a dimension, a weight, and/or a parts count of the biological tissue sample, and/or information regarding the fixative used in the container.
5. The container (100, 300, 400) according to claim 1, wherein the memory (11) comprises a first memory section for storing first data and a second memory section for storing second data, wherein each of the memory sections is configured to lock the respective data independently from the data of the respective other memory section, and/or wherein the memory is configured to encrypt the data and/or to protect the data by a password or passcode.
6. The container (100, 300, 400) according to claim 1, wherein the tag comprises, or is, an RFID tag and/or an NFC tag.
7. The container (100, 300, 400) according to claim 1, further comprising a visual, machine-readable tag (20) such as a barcode, in particular a one- or two-dimensional barcode.
8. A system (500, 600, 700, 800, 900, 1000, 1100), comprising: a container (100, 300, 400) according to claim 1, a transmitting unit (30) for sending data to be received by the receiver (12.1) of the container (100, 300, 400) and then stored in the memory (11) of the container (100, 300, 400), and a reading unit (40) for reading data transmitted by the transmitter (12.2) of the container (100, 300, 400).
9. The system (500, 600, 700, 800, 900, 1000, 1100) according to claim 8, comprising a control unit (50) functionally connected to the transmitting unit (30) and the reading unit (40).
10. The system (500, 600, 700, 800, 900, 1000, 1100) according to claim 9, wherein the control unit (50) is configured to receive a signal indicating the presence of the container (100, 300, 400) and, upon receiving the signal, to activate the transmitting unit (30) in order to send, by the transmitting unit (30), data to the container (100, 300, 400), and/or to activate the reading unit (40) in order to read, by the reading unit (40), data transmitted by the container (100, 300, 400), wherein the reading unit (40) is preferably configured to generate the signal.
11. The system (500, 600, 700, 800, 900, 1000, 1100) according to claim 10, further comprising a user interface configured to generate the signal, wherein the user interface is preferably manually operable.
12. The system (500, 600, 700, 800, 900, 1000, 1100) according to claim 8, wherein the data sent by the transmitting unit (30) and received by the receiver (12.1) of the container (100, 300, 400) includes a time stamp, in particular a time stamp configured to relate to a fixation of the biological tissue sample contained in the container (100, 300, 400), wherein the time stamp preferably comprises a date, wherein the time stamp more preferably comprises a fraction of the date, such as an hour and preferably a minute and more preferably a second, and/or wherein the time stamp optionally comprises a time zone and/or a format of time.
13. The system (600, 700, 800, 900, 1000, 1100) according to claim 8, further comprising a visual reading unit (70) for reading a visual tag (20) comprised by the container (100, 300, 400), such as a barcode, in particular a one- or two-dimensional barcode, wherein the visual reading unit (70) is optionally configured to generate a signal upon reading the visual tag (20) and to transmit this signal to the control unit (50), for example as the signal indicating the presence of the container (100, 300, 400).
14. The system (600, 700, 800, 900, 1000, 1100) according to claim 8, further comprising a base (60) on which the container (100, 300, 400) can be placed, wherein the base (60) comprises at least part of the transmitting unit (30) and/or at least part of the reading unit (40) and/or, if present, at least part of the control unit (50), wherein, preferably, a wall (80) extends from the base (60) so as to extend on a lateral side of the container (100, 300, 400) when the container (100, 300, 400) is placed on the base, wherein the wall (80) comprises at least part of the reading unit (30) and/or at least part of the transmitting unit (40) and/or, if present, at least part of the visual reading unit (70), wherein the wall (80) optionally comprises an opening (81), wherein the visual reading unit (70) is arranged to read a visual tag (20) via the opening (81).
15. A method, comprising the steps of: a) providing a container (100, 300, 400) according to claim 1, b) transmitting, by a transmitting unit (30), data relating to a biological tissue sample, c) receiving, by the receiver (12.1) of the container (100, 300, 400), the data, and d) storing, by the non-volatile memory (11) of the container (100, 300, 400), the data received by the receiver (12.1).
16. The method according to claim 15, further comprising, preferably before step a), the step of placing the biological tissue sample in the container (100, 300, 400).
Description
DESCRIPTION OF PREFERRED EMBODIMENTS
[0072] Further advantages and specific features will now be described with respect to the accompanied figures, according to which:
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[0087] As can be seen in
[0088] According to the embodiment shown in
[0089] The second component 4 is usually filled into the container 100 after the container 1 has been (pre-)filled with the first component 3. The second component 4 is a fluid (e.g. a liquid or liquid solution). The second component 4 has a lower specific gravity (or density or specific weight) compared to the first component 3. Moreover, the second component 4 is immiscible with the first component 3. It is thus possible to stratify the second component 4 on top of the first component 3 so that the second component 4 covers the whole top surface of the first component 3. These two layered components 3, 4 are thus provided in the container 100 such that the first component 3 is at a bottom of the container 1 (preferably opposite the top opening 6) and the second component 4 is placed (preferably in direct and plane contact with the first component 3) on top of the first component 3. Thereby, the second component 4 can form a protective film on top of the first component 3 within the container 100 to prevent fumes of the first component 3 to escape from the container 100. It is thus possible to eliminate or at least severely reduce the fume exposure of the operators involved in the specimens collection and examination.
[0090] Just as an example, the first component 3 can be associated to water, e.g. being the NBF basically comprising 4% formaldehyde and 96% water. In this exemplary case, the specific gravity is around 1. In this case, a second component is used having a specific gravity of about between 0.79 to 0.93. However, the present invention is not limited to this example.
[0091] The volume of the second component 4 is preferably from 0.1% to 50% of the total volume of both components (i.e. first component 3+second component 4) and is more preferable between 3% to 5%. It is thus possible to provide a sufficiently thick and thus secure protective film on top of the first component 3.
[0092] The second component 4 can be a solution, preferably a single solution or a blended solution of organic or inorganic components. The second component 4 is preferably less toxic than the fixative and more preferable has no or low toxicity for human beings by inhalation. According to a preferred embodiment, the second component 4 can be made by mineral oils or a mixture of mineral oils, hydrocarbons or a mixture of hydrocarbons, or by isoparaffin C9-C12. As an example, the occupational Exposure Limit Values (TLV-TWA) of Isoparaffin hydrocarbons C9-C12 is an average of 300 ppm, while formalin is an average of 0.75 ppm for an eight hour work day. When considering a short-term exposure limit (TLV-STEL), which is the maximum exposure allowed during a 15 minute period, for formalin it is 2 ppm, while for Isoparaffin C9-C12 it is not even reported in the reagent Material Safety Data Sheets (MSDS) as it is irrelevant. The second component 4 can be, for instance, provided in a liquid, jelly or foamy state. According to a preferred embodiment, the second component 4 can contain a dye to better distinguish the second component 4 from the first component 3 when being filled in the container 1 and layered one above the other.
[0093] Accordingly, by means of the second component 4, a protective film can be created on top of the first component 3 to prevent its fumes to escape when the container 100 is open; e.g. in case the lid member 2 is opened for placing the sample into or removing the sample out of the container 100. Thereby, toxic fixatives such as formaldehyde can be securely used due to the severe reduction or even elimination of the fume exposure of operators involved in the specimen's collection and examination.
[0094] The container 100 may comprise a sidewall 103. The sidewall 103 delimits a space in which the biological tissue sample and, if present, the one or more components 3, 4 can be placed (contained, etc.). The sidewall 103 is not limited to a specific form. For example, the sidewall 103 is curved or has a circular or oval cross-section. The one or more components 3, 4, if present, are in contact with the sidewall 103. The scale 5 may be arranged on the sidewall 103. The sidewall 103 may extend from a bottom 104. When the container 100 is filled with the components 3, 4, only the first component 3 may be in contact with the bottom 104. In other words, the second component 4 may be distanced from the bottom 104.
[0095] The container 100 comprises a (electronic) tag (or label) 10 with a non-volatile memory 11, a receiver 12.1 and a transmitter 12.2. In other words, the tag 10 is configured to communicate in order to receive data and in order to transmit (or send) data. The receiver 12.1 and the transmitter 12.2 may be provided separately or together in a single unit, such as in a unit forming a transceiver. By the tag 10, it is thus possible to electronically attach information to the container 100. The tag may comprise an antenna and/or a coil 12 that comprises the receiver 12.1 and the transmitter 12.2. The memory 11 is configured to store (digital) data relating to the biological tissue sample, which is received by the receiver 12.1 or antenna (and/or coil) 12. The memory 11 is a readable and writeable memory, in particular a memory that is writeable more than once. In other words, the memory 11 is a read-write memory. The transmitter 12.2, or the antenna (and/or the coil) 12, is further connected to the memory 11 in such a way that the data stored by the memory 11 can be transmitted, for example to a reading unit.
[0096] The memory 11 may comprise one or more electric circuitries. For example, the memory 11 comprises a transponder and/or one or more (micro) chips. The memory 11 may comprise flash memory, such as NOR flash and/or NAND flash. The memory 11 is not limited to a specific memory space. The memory space may be in a range from 8 bit to 1 gigabit. In an embodiment, the memory space is in a range from 4 byte to 8 Kbyte. The memory 11 may be partitioned in different memory sections or blocks; accordingly, each memory section may contain a portion of the entire memory size. For example, the memory 11 may comprise a first memory section for storing first data and a second memory section for storing second data, wherein each of the memory sections is configured to lock the respective data independently from the data of the respective other memory. Thereby, the respectively locked data is protected against deletion or modification after the lock is activated. The memory 11 may be configured to encrypt the data and/or to protect the data by a password or passcode.
[0097] The tag 10 may be provided with or without an own energy source, such as an energy source integrated with the components of the tag 10. In an embodiment, the tag 10 is provided without an own energy source and thus forms a passive tag. This means that the power used for receiving and transmitting data by the tag 10 is drawne.g. wirelesslyfrom an (outside) energy source not comprised by the container or tag 10, such as from a reading and/or transmitting (or writing) unit configured to receive data transmitted by the tag 10 and/or to transmit data to be received by the tag 10. For example, the energy source is configured to transmit radio energy that is used by the tag 10 to be powered in order to receive and transmit data by the receiver 12.1 and by the transmitter 12.2, respectively, such as by the antenna and/or the coil. In an embodiment, the tag 10 may comprise a power input that can be contacted by the energy source so that the energy source supplies the tag 10 with power in order to receive and transmit data. The power input may comprise an electrical contact. In an embodiment, the tag 10 may be provided with, or connected to, an own energy source and thus may form an active tag. The own energy source may be fixed relative to the tag 10, such as integrated in the tag 10 or positioned on a section of the container 100, such as on the sidewall 103 or bottom 104.
[0098] In an embodiment, the tag 10 comprises, or is, an RFID tag and/or an NFC tag.
[0099] The tag 10 is not limited to a specific position. As shown in
[0100] The container 100 may comprise one or more tags 10. In an embodiment, the container 100 may comprise only one tag 10. In another embodiment, the container 100 may comprise a plurality of the tag 10, which may be evenly distributed over the sidewall 103. The tag 10 may extend over more than 50% of the height of the container 100, which height may extend from the bottom 104 to the top of the lid member 102 or any other top of the container 100. Thereby, the tag 10 may be advantageously enlarged in order to provide, for example, more memory space.
[0101] The data of the biological tissue sample, which can be received by the receiver 12.1, subsequently stored by the memory 11 and then transmitted by the transmitter 12.2 (e.g. in order to inform a user), can include various information about, or at least related to, the sample. In particular, the data may include a time stamp that is configured to indicate the beginning of fixation of the biological tissue sample contained in the container, i.e. the time when the biological tissue sample is placed into the fixative. For example, in a first step, the biological tissue sample is placed into the fixative filled into the container, wherein in a second step, e.g. (immediately) directly after the first step, the data including the time stamp is sent, e.g. semi-automatically or automatically, to the tag 10 in order to be received by the receiver 12.1 and then stored by the memory 11. In a third step after the second step, the time stamp may be transmitted by the transmitter 12.2, e.g. for being retrieved by a user, such as a user at a location different from the location where the biological tissue sample was fixed. Thereby, the user and/or a computing unit can check how long the biological sample is fixed and if a predefined fixation time has been exceeded. Accordingly, the fixation of the biological sample can be easily controlled and/or verified.
[0102] Additionally, or alternatively, data of the biological tissue sample may include: an identifier of the object from which the biological tissue sample is taken, such as a patient identifier and/or an organ identifier; a dimension, a weight, and/or a parts count of the biological tissue sample; and/or information regarding the fixative used in the container.
[0103] The container 100 may further comprise a visual tag 20 that is machine-readable, such as by a visual or optical reading unit. The visual tag 20 comprises a code that may be printed. For example, the printed code comprises variously patterned bars. The visual tag 20 may be a barcode, such as a one- or two-dimensional barcode. The code may contain an information regarding the container 100, such as a unique identifier. The code may be configured such that, when read by a visual reading unit, a process is triggered to transmit data to the tag 10 and/or to receive data from the tag 10 and/or to energize the tag 10 so that the tag 10 can receive and/or transmit data. The visual tag 20 may comprise a label with the code printed thereon. The visual tag 20 is not limited to a specific position. For example, the visual tag 20 may be provided on the sidewall 103. The visual tag 20 and the tag 10 may be provided on the same wall of the container 100.
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[0108] The system 500 may comprise a control unit 50 that is functionally connected to the transmitting unit 30 and the reading unit 40. Accordingly, the control unit 50 is configured to control the units 30, 40. In particular, the control unit 50 may be configured to receive a signal indicating the presence of the container 100 and, upon receiving the signal, to activate the transmitting unit 30 in order to send, by the transmitting unit 30, data to the container 100 in order to be received by the tag 10 where it is then stored by the memory 11. For example, after insertion of the biological tissue sample in the container 100 (e.g. in order to start a fixation of the biological tissue sample), the signal may be automatically generated, whereby the control unit 50 activates the transmitting unit 30 to send a time stamp (e.g. based on a time set in the control unit 50) to be received by the tag 10 of the container 100. Thereby, the start time of fixation of the biological tissue sample is stored in the memory 11 of the tag 10. If desired, a user can then draw, by the reading unit 40, the time stamp from the memory 11 in order to check or analyze the fixation of the respective biological sample.
[0109] The signal indicating the presence of the container 100 may be generated in many different ways. In particular, the reading unit 40 may be configured to generate the signal. For example, the reading unit 40 may be configured to supply energy (such as in the form of electromagnetic waves and/or by electromagnetic induction) to the tag 10 and configured to detect that the tag 10 draws energy or not, e.g. because the tag 10 is out of distance to be supplied by the energy provided by the reading unit 40. Based on this detection, the reading unit 40 can generate the signal and forward the so generated signal to the control unit 100. Additionally or alternatively, the system may comprise a presence sensor configured to detect the presence of the container 100 in a defined area and, upon detecting the presence of the container in the defined area, to generate the signal. Accordingly, the presence sensor may be functionally connected to the control unit 50. The presence sensor may comprise a weight sensor and/or a distance sensor.
[0110] Additionally or alternatively, the system may comprise a user interface (not shown) configured to generate the signal. The user interface may be manually operable, such as by a user's hand. Upon activation of the user interface (such as by a user touching and/or pushing the user interface), the signal indicating the presence may be generated, e.g. by simply closing an electric circuit. For example, the user interface may be a (single) pushbutton. The user interface may be part of a base of the system, such as of the base 60 described herein below.
[0111] As shown in
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[0113] The visual reading unit 70 may be a barcode scanner. As shown in
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[0119] As shown in
[0120] Additionally or alternatively, the control unit 50 may be configured to be connectable to a network or computer network, such as a local area network (LAN), a wide area network (WAN) and/or the internet. Accordingly, data drawn from the tag 10 of the container 100 can be sent and/or distributed over a wide range. In particular, the control unit 50 may be configured to be connectable to a system such as a Laboratory Information System (LIS, LIMS, or LMS).
[0121] In the following, a preferred method for using the container is described.
[0122] In a first step, a biological tissue sample may be placed in a container 100 comprising a tag and being filled with a fixative. This step may be executed at the excision site.
[0123] In a second step, which is optional, a visual tag 20 is applied on the container 100. The visual tag 20 may indicate the patient's name or patient's code or other patient related information written as visual code, such as a barcode, a datamatrix, a QR-code or the like. This step is preferably between the before-mentioned first step and the following third step of placing the container 100 in such a way that the tag 10 is read or data is stored by the tag 10.
[0124] In a third step, the container 100 is placed close to transmitting and reading units 30, 40, such as on a base 60 comprising at least part of these units. The visual tag 20, if present, may be read manually or automatically by a visual reading unit 70.
[0125] In a fourth step, data including a time stamp indicating the beginning or starting of the fixation of the biological tissue sample (e.g., the current date and time) is written on the memory 11 of the tag 10 automatically, e.g. by a control unit 50. If present, even the information of the visual tag 20, read by the visual reading unit 70, may be written on the memory 11. Moreover, if other information is entered using the control unit 50 or any other device connected to the control unit 50, such information is written on the memory 11 as well. Such an automatic writing may be triggered by the presence detection of the tag 10 and/or visual tag 20, e.g. by using the units 30, and/or the unit 70. To operate in this way, the units 30, 40 may continuously monitor for the presence of an electronic tag (such as the tag 10) and/or the unit 70 may continuously monitor for the presence of a visual tag (such as the visual tag 20).
[0126] In a fifth step, the container 100 is transported with the biological tissue sample (specimen) to a laboratory.
[0127] In a sixth step, the container 100 is placed close to (further) transmitting and reading units 40, such as on a (further) base 60 comprising at least part of these units, of a station such as the laboratory upon reception. Data stored by the tag 10, i.e. memory 11 of the tag 10, is read by the reading unit 40. In particular, the time stamp (such as the date and time) of the beginning of the fixation of the biological tissue sample is read and received. Thus, knowing when the fixation started (such as only the date or specified to the hour or even minute or second), the laboratory is able to calculate the remaining fixation time according to the preferred guidelines. The data read may be stored on the control unit and may be made available to be acquired by an object, such as a network, in particular a Laboratory Information System.
[0128] In a seventh step, which is optional, further data relating to the biological tissue sample, such as a (further) unique identifier assigned by the laboratory, can be sent, by the transmitting unit 30, to the tag 10 and stored by its memory 11.
[0129] In an eighth step, the container 100 is transferred to a further station such as a grossing station.
[0130] In a ninth step, during the grossing, the right container with the right biological tissue sample is identified by reading the data stored in the tag 10 by a further reading unit 40. Subsequently, the biological tissue sample is transferred to a histological cassette, in which the sample may be placed in a fixative.
[0131] In a tenth step, the time stamp indicating the beginning of fixation of the biological tissue sample is compared with the current time. Based on this comparison, the already elapsed fixation time is calculated and compared with the required (proper) fixation time. If the required fixation time has not been reached yet, the biological tissue sample remains in the fixative (i.e. waits) until the proper fixation time of the biological tissue sample is completed. Then, the biological tissue sample proceeds with the tissue processing. During tissue processing, at least a portion and/or a completion of the fixation may occur or may be carried out, e.g., during the first phase of tissue processing.
[0132] Moreover, the method may comprise further reading/transmitting (writing) steps using further transmitting and reading units (such as reading/writing stations) placed on the path from the excision site to the laboratory, e.g., checkpoints to track the transport.
[0133] Furthermore, the method may comprise further reading/transmitting (writing) steps using further transmitting and reading units placed inside the laboratory to track the container during the transfer or to read or add information or identifications, displaced in several checkpoints along the path between the accessioning and grossing.
[0134] In addition, the method may also comprise the step of encryption of data, and/or protection of data by a password or passcode, and/or locking data against deletion or modification. This step may be part of at least one or each of the steps described above, in particular of the steps using a transmitting unit 30.
[0135] The present invention is not limited to the embodiment as described herein above. All the features in the embodiments can be interchangeably combined as long as being covered by the appended claims. In particular, the invention is not limited to the shape, design, dimensions and composite materials of the container as long as they are suitable for the corresponding field of histology and thus also for storing the corresponding components 3, 4 and biological tissue samples even for a long time.