JP4031932B2 - Donor identification method and biological substance identification means - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
  The present inventionThe present invention relates to a donor identification method and biological material identification means using a specific cell group or biological material such as blood.
[0002]
[Prior art]
Management of biological materials such as blood, tissues and cells taken out of an individual from an individual can be done indirectly by attaching a label containing information or data on the biological material donor to a container etc. It is the usual way to do it.
[0003]
In recent years, cells that have been removed from the body have been cultured outside the body due to factors such as the fact that a large amount of factors that proliferate various types of cells have been produced by genetic engineering, and cell culture technology has advanced. Cell therapy has been attempted to treat the disease by giving it back to the body after giving it the proper properties.
[0004]
There are roughly two types, one that uses the donor's own cells and the other that uses other people's cells, but those that use self cells are more harmful than those that use other people's cells, without the risk of introducing viral infections. Since there is no immune response and it is much safer, it is highly expected as a new treatment.
[0005]
Types of cell therapy include immune cell therapy (activated self lymphocyte therapy) that is used for treatment by culturing and processing donor's own lymphocytes, as well as those that are used for the treatment of burns by culturing skin cells, There is also a field called regenerative medicine, such as culturing cartilage cells and using them to treat joint diseases. Furthermore, attempts have been made to cultivate embryonic stem cells and differentiate them into various cells such as liver cells and nerve cells.
[0006]
[Problems to be solved by the invention]
It is not allowed to mistake a donor in cell medicine in which the donor's own cells are taken out, cultured and processed outside the body, and administered only to the person himself. Therefore, it is extremely important to prevent the donor from being mistaken. is important.
[0007]
Conventional methods for preventing donors' confusion include identifying cells using the outer surface of the container, for example, attaching an identification label to the outer surface of the container used for cell culture, and the donor's name and ID number on the outer surface of the container. I had to take a method of directly writing etc.
[0008]
However, even in this method of identifying cells using the outer surface of the container, the name and ID number of the donor written on the label or container during the cell culturing / processing process, especially when the container is transferred, etc. As a result of mistakes in the cell, the description on the outer surface of the cell and the container may not match and may result in the same result as if the donor was mistaken, or if the label was used, the label was removed. There was still a possibility that the cells would be lost.
[0009]
The same applies to other treatments and tests using biological materials, such as blood sampling and testing, as long as the method for identifying cells using the outer surface of the container as described above is used. There was still a possibility that the biological material, the container, the donor and / or the recipient would not match.
[0010]
In order to eliminate the problems as described above, the present invention uses biological material identification means to identify biological materials such as cells and blood used for medical care, and to eliminate the mistake of donors and / or recipients. Is.
[0011]
[Means for Solving the Problems]
  That is, the present inventionIn a container containing a specific cell group or biological material such as bloodBiological material identification means different from the biological material is mixed so as to coexist with the biological material, and the biological material identification information as information for identifying the biological material transmitted from the biological material identification means is read by the reading device, Using the biological material identification information read by the reading device, it is possible to identify a donor and / or a recipient corresponding to the biological material.
[0012]
In such a case, since the biological material identification means is mixed in the container containing the biological material so as to coexist with the biological material, the correspondence between the biological material and the biological material identification means is maintained. The substance can be transferred to another container, and unlike a method using a label, the mistake of overlooking the label and transferring the biological substance to a container having a label that does not correspond to the biological substance can be eliminated. Further, since the biological material identification information is transmitted to the biological material identification means itself, the biological material identification information when reading the biological material identification information and administering the biological material to a donor and / or a recipient is used. A matching of the corresponding donor and / or recipient with the actual donor and / or recipient can be ensured. In the following description, simply “mixing the biological material identification means with the biological material” means mixing the biological material identification means in a container containing the biological material so as to coexist with the biological material.
[0013]
If it is necessary to identify a donor and / or recipient individual, the donor and / or recipient's name and date of birth or the serial number assigned to each donor and / or recipient in the biological material identification information, etc. What is necessary is just to include specific information, such as a donor which is information which specifies a recipient. On the other hand, when it is sufficient to know the attributes of the donor and / or the recipient, such as blood type, information indicating the necessary attributes may be included in the biological material identification information.
[0014]
Furthermore, when it is desired to confirm donors and / or recipients corresponding to the biological material as needed, a reader that reads the biological material identification information in a non-contact manner may be used. If it does in this way, the said reading apparatus can be provided for every location which performs each process, the said biological material identification information can be read using the said reading apparatus, and a corresponding donor and / or recipient can be confirmed.
[0015]
As an example of a specific method for identifying and collating a donor and / or a recipient, the reader and the information processing device are connected by wire or wirelessly, and the biological material identification information received by the reader is processed by the information processor. Can be mentioned. Note that “outputting biological material identification information to the information processing apparatus” includes converting the biological material identification information into another format and outputting it.
[0016]
As another example of a specific method for identifying and collating donors and / or recipients, the reader and the information processing device are connected by wire or wirelessly, and the biological substance identification information received by the reader, There can be mentioned a method for collating information such as donor collation information stored in the collation means on the donor and / or recipient side by the information processing apparatus. If this is the case, the biological material identification information stored in the biological material identification means and the matching information stored in the matching means on the donor and / or recipient side are collated through the information processing device. The verification can be performed reliably. Note that “connecting the reading device and the information processing device in a wired or wireless manner” includes integrally configuring them. Furthermore, the collation means, the reading device, and the information processing device may all be integrated.
[0017]
As a method for collating the biological material identification information and the donor etc. collation information, the biological material identification information and the donor etc. collation information are stored in association in the information processing apparatus, and the biological material received in the information processing apparatus is stored. A method is also conceivable in which the matching information such as the donor corresponding to the identification information is compared with the received matching information such as the donor. With such a method, even if the information identifying unit and the collated unit are configured so as not to be writable, these correspondences are stored in advance in the information processing apparatus, and when this is received, Correspondence and verification can be performed.
[0018]
As another example of the method for collating the biological material identification information and the donor collation information, the biological material identification information stored in the information identification unit and the donor collation information stored in the collated unit are the same. The thing which has a content can be mentioned. If it is such, it can collate only by comparing biomaterial identification information with collation information, such as a donor.
[0020]
    As biological substance identification means used for such a donor identification method,Includes biological substances such as specific cell groups and bloodA biological material identification information storage unit for storing biological material identification information, which is information for identifying the biological material, and a transmitter for transmitting the biological material identification information are mixed in the container so as to coexist with the biological material. The thing to comprise can be mentioned. According to such a biological material identification unit, the biological material identification information stored in the biological material identification information storage unit is transmitted from the transmission unit, thereby confirming information in a state where the identification unit and the biological material are mixed. It can be performed.
[0021]
In order to make it possible to coexist with a medium containing moisture, it may be made water-resistant by applying a waterproof coating or using a water-resistant material.
[0022]
In order to be able to eliminate mistakes such as accidentally placing biological material identification means in the body, it can be separated from the cells used for the medical practice by filtering with a filter.
[0023]
In order to allow the biological material identification means to be extracted together with the biological material when the biological material is extracted by centrifugation using a pipette or a syringe, the biological material may be sucked by the pipette.
[0024]
To prevent the biological material adhered to the surface when the container is transferred, for example, the cell is caught and cannot pass through the pipette, and the biological material identification means is not mixed with the biological material. A treatment for preventing the adhesion of the biological material may be performed on the surface, such as coating with a material that prevents the adhesion of the biological material, or configuring the biological material identification means itself with a material that is difficult to adhere to the biological material.
[0025]
In order to be able to take out the biological material identification means in a state of being mixed with the target biological material more effectively, the specific gravity should be made substantially the same as that of the target biological material. This is because the biological material identification means is located in the same layer as the target biological material when the target biological material is extracted by centrifugation.
[0026]
In order to further reduce the size of the biological material identification means and to prevent contamination of cells etc. due to elution of the substance in the battery of the biological material identification means, an electromagnetic wave is received. Then, a receiving unit that converts the power into electric power may be provided, and this electric power may be a power source of the transmitting unit. This is because the receiving unit receives electromagnetic waves and converts them into electric power, so that it is not necessary to provide a battery in the biological material identification means.
[0027]
In order to be able to set the biological material identification information in an arbitrary format, the biological material identification information may be configured to be writable.
[0028]
    As a specific configuration of the information processing apparatus used to collate the biological substance identification information received by the reader and the collation information such as the donor stored in the collation means on the donor and / or recipient side,ReaderAnd a first receiving unit that is connected to the biological material identification unit from a reading device by wire or wireless connection,Means to be verifiedAnd the second receiving unit that receives the collation information stored in the donor and the like and the collation unit that collates them.
[0029]
In order to be able to perform collation even if the biomaterial identification information and the collation information such as the donor show different contents, the identification that stores the biomaterial identification information and the collation information such as the donor in association with each other What is necessary is just to further comprise a collation information storage part.
[0030]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, a first embodiment of the present invention will be described with reference to the drawings.
[0031]
The donor identification method according to the present embodiment is used in “activated self lymphocyte therapy”. This is because the donor and / or recipient are the same, and lymphocytes derived from their own peripheral blood are removed, cultured and processed outside the body, and given various properties. It is to be returned to the body.
[0032]
First, the apparatus used for this embodiment is demonstrated. As shown in FIG. 1, in the present embodiment, the biological material identifying means 1 for mixing the biological material lymphocyte L and storing the biological material identification information J1, the donor and / or the recipient. Provided on the side (in this embodiment, the donor and the recipient are the same), a verification means 2 for storing verification information J2 such as donor, and the apparatus for reading the biological substance identification information J1 and the verification information J2 such as donor And the information processing device 4 that receives the biological substance identification information J1 and the matching information J2 such as donors from the reading device 3 and performs matching. The reading of the biological material identification information J1 from the biological material identification means 1 by the reading device 3 and the reading of the donor collation information J2 from the means 2 to be verified are performed in a non-contact manner by communication using electromagnetic waves in this embodiment. The reading device 3 is connected to the information processing device 4 by wire.
[0033]
The configuration and operation function of each device will be described below. FIG. 2 is a functional block diagram showing the operation functions of the device.
[0034]
The biological material identification means 1 is configured using a non-contact type IC chip coated with resin or the like.
[0035]
    As shown in FIG. 3, the non-contact IC chip includes a receiving unit 11 that receives electromagnetic waves and converts it into electric power as a power source, a biological material identification information storage unit 12 that stores biological material identification information, and the biological material. A biological material identification information transmission unit 13 that transmits identification information as electromagnetic waves is provided. The receiving unit 11 is configured using a circuit that receives an electromagnetic wave of a constant frequency, in the present embodiment, 2.45 GHz and converts it into electric power. The biological material identification information storage unit 12 is configured using a memory that stores the biological material identification information J1. This biological substance identification information J1 is a specific cell group, blood, etc.Biological materialInformation necessary for identification or a combination thereof, and in this embodiment, as shown in FIG. 4, the donor and / or recipient identification information includes donor number J11 assigned to each donor and / or recipient, Furthermore, the date of collection and the information on the number of times of collection are combined. The biological material identification information transmitting unit 13 converts the biological material identification information J1 stored in the biological material identification information storage unit 12 into a signal, and reads it as an electromagnetic wave having a constant frequency, in this embodiment, 2.45 GHz.3To call.
[0036]
In this embodiment, the biological material identification means 1 is a non-contact IC chip having a size of 0.4 mm square and a thickness of 60 microns, so that the lymphocytes having a diameter of 7 to 16 microns. Greater than.
[0037]
The coating is waterproof with a resin, and has been treated to prevent albumin adhesion by fixing albumin on the surface. The total specific gravity including the coating of the biological material identification means 1 is T-type lymphocytes (specific gravity 1.077 g / cm) as the target biological material.^Three).
[0038]
The collation means 2 is configured by embedding a non-contact type IC chip having the same structure as that used for the biological material identification means 1 in a card or the like in this embodiment.
[0039]
As shown in FIG. 5, the IC chip constituting the collation means 2 includes a receiving unit 21 that receives electromagnetic waves and converts it into power as a power source, a donor collation information storage unit 22 that stores collation information such as a donor, and the like. It functions as a donor verification information transmitter 23 that transmits the donor verification information as an electromagnetic wave.
[0040]
The donor matching information storage unit 22 is configured using a memory for storing donor matching information J2. This donor collation information J2 is information necessary for identifying the donor himself or an attribute necessary for treatment or examination, or a combination thereof. In the present embodiment, the donor collation information J2 has the same format as the biological material identification information J1, and the information stored in advance as the biological material identification information J1 is transferred to the donor and / or the recipient. I am doing so.
[0041]
In addition, the receiving unit 21 and the matching information transmitting unit 23 such as a donor have the same functions as the receiving unit and the transmitting unit of the biological material identification unit, respectively.
[0042]
As shown in FIG. 6, the reading device 3 transmits a transmitter 301 that transmits an electromagnetic wave converted into power of the biological material identification unit 1 and the verification target unit 2, and transmits from the biological material identification unit and the verification unit. An antenna 302 that receives the received electromagnetic wave, an output terminal 303 that outputs the received signal, and a control chip 304 that controls them are provided. Then, as shown in FIG. 2, the CPU 31 in the control chip executes a program built in the memory in the control chip to transmit electromagnetic waves, and the biological material identification information transmitted by the biological material identification means as electromagnetic waves. Functions as a reading unit 32 that receives the information and the biological material identification information received by the receiving unit.
[0043]
As shown in FIG. 7, the information processing apparatus 4 receives signals from a CPU 401, a main memory 402, an input device 403 such as a keyboard, an external storage device 404 such as an HDD, an output device 405 such as a display and a printer, and a reading device. An input / output interface 406 and the like are provided. Then, the CPU 401 operates according to the program stored in the main memory 402, the external storage device 404, etc., and functions as a receiving unit 41, a collating unit 42, and a result output unit 43 as shown in FIG.
[0044]
The receiving unit 41 is configured using the input / output interface 406 and the like, and receives the biological substance identification information J1 and the donor collation information J2 output from the reading device 3.
[0045]
The collation unit 42 compares the biological material identification information J1 received by the reception unit 41 with the collation information J2 such as a donor, and when these have the same value, “1”, and when they have different values, “0”. The determination result identifier R taking the binary value of “is generated.
[0046]
The result output unit 43 is configured using the output device 405 or the like. If the value of the determination result identifier R generated by the collation unit 42 is “1”, it is “OK”, and “0”. Message “NG” is output.
[0047]
Next, the flow of this cell therapy will be described below. FIG. 8 shows an outline of this flow.
[0048]
First, the biological material identification unit 1 is sterilized in advance using ethanol, gas, ozone, γ rays, or the like. Next, as shown in FIG. 9, the biological material identification means 1 is placed in the vacuum blood collection tube T (ST1), and as shown in FIG. 10, the vacuum blood collection tube T containing the biological material identification means 1 is contained. To collect blood from the donor and / or recipient (ST2). From the collected blood BL, lymphocytes L are separated and processed by the following method, and the lymphocytes are further cultured.
[0049]
First, the collected blood BL is centrifuged so that the lymphocyte layer LL including the lymphocyte L can be taken out (ST3). The state after the centrifugation is shown in FIG. At this time, since the biological material identification unit 1 has substantially the same specific gravity as the target biological material lymphocyte L, the biological material identification unit 1 coexists in the lymphocyte L layer.
[0050]
The layer in which the lymphocyte L and the biological material identification means 1 coexist is taken out with a pipette PP as shown in FIG. 12, and transferred to the flask FL shown in FIG. 13 (ST4). The diameter of the tip of the pipette PP is large enough to allow the biological material identification means 1 to pass through. Then, a stimulating antibody is added to the flask FL to give the lymphocyte L an immune function. Thereafter, in the present embodiment, the lymphocyte L is cultured for about one week until it reaches a certain amount (ST5).
[0051]
When the lymphocyte L in the flask FL reaches a certain amount, as shown in FIG. 14, the lymphocyte suspension L1 containing the lymphocyte L is transferred together with the biological substance identification means 1 to a container called a bag BG ( In ST6), the culture is continued for about one week in this embodiment until it reaches a certain amount (ST7).
[0052]
When the lymphocyte L substantially fills the bag BG, as shown in FIG. 15, the lymphocyte suspension L1 containing the lymphocyte L as the contents of the bag BG and the biological substance identification means 1 is put into the centrifuge bottle BT1. Transfer (ST8) and perform centrifugation to separate and purify lymphocyte L from the culture medium or the like (ST9). Similarly, the biological substance identification means 1 coexists in the lymphocyte L layer. The layer of the administration lymphocyte suspension L2 containing the purified lymphocytes L is transferred to the infusion bottle BT2 shown in FIG. 16 (ST10).
[0053]
Then, before administering the administration lymphocyte suspension L2 containing the lymphocyte L, which is a biological material used for treatment, to the donor and / or the recipient, as shown in FIG. 3 is read and the biological material identification information J1 is read. Then, the reader 3 is similarly brought close to the collation means 2 given to the donor and / or the recipient side, and the donor collation information J2 is read (ST11).
[0054]
The flow of processing performed by the information processing apparatus 4 is shown in FIG. First, the receiving unit 41 receives biological material identification information J1 (ST101). Next, similarly, the receiving unit 41 receives the donor matching information J2 (ST102). The collation unit 42 receives the biological substance identification information J1 and the donor collation information J2 from the reception unit 41 (ST103), compares them (ST104), and if it is the same content, “1” (ST105), otherwise Generates a determination result identifier R that takes a binary value of “0” (ST106) and passes it to the result output unit 43 (ST107). The result output unit 43 determines whether or not the value of the determination identifier R is “1” (ST108). If so, “OK” (ST109), and the value of the determination identifier R is not “1” but “1”. If “0”, “NG” is output (ST110).
[0055]
Then, as shown in FIG. 8, with reference to the collation result output by the doctor who performs administration (ST12), the biological substance identification means 1 passes through the infusion bottle BT2 only when “OK” is output. A filter FI configured to be impossible is attached, an infusion tube and an injection needle are attached, and infusion is performed on the donor and / or the recipient as shown in FIG. 18 (ST13).
[0056]
When “NG” is output, an infusion bottle BT2 containing a lymphocyte suspension L2 mixed with another biological material identification means 1 is prepared (ST14), and the operation for performing the collation is similarly performed with “OK”. "Is repeated until" "is output. If the correct infusion bottle is not available, notify the cell culture institution, and if found, inform the donor and / or recipient and cell culture institution to administer the dose on the designated date. If “NG” is output, the collating operation with the reader 3 close to the same infusion bottle BT2 is repeated a predetermined number of times, and after confirming that “OK” is never output, another operation is performed. An infusion bottle BT2 may be prepared. In this case, as long as “OK” is output twice in a row, it is of course possible not to proceed to the drip operation.
[0057]
As described above, since the biological substance identification means 1 is mixed with the lymphocyte L, the container of the label indicating the donor and / or the recipient who has overlooked the label during the processing step or mistakenly identified the lymphocyte L as a different donor. It is possible to eliminate mistakes that are mistakenly transferred to. Further, since the biological material identification information J1 is stored in the biological material identification means 1 itself, and the biological material identification information J1 is transmitted to the reading device 3, the label is removed unlike the case where a label is used. In other words, the contents of the label cannot be read due to a problem or chemicals, and the verification can be performed reliably.
[0058]
Further, the matching means 2 storing donor matching information J2 is passed to the donor and / or recipient side, while the reading device 3 and the information processing device 4 are connected by wire to connect the biological material identification information J1 and the biological information. Since the information such as the donor verification information J2 is verified by the information processing device 4, the donor and / or the recipient can be reliably identified.
[0059]
Furthermore, since the biological substance identification information J1 and the donor collation information J2 have the same contents, collation can be performed simply by comparing them.
[0060]
On the other hand, the biological material identification means 1 is provided with a waterproof coating to provide water resistance, so that the biological material identification means 1 can coexist with a medium containing moisture.
[0061]
In addition, since the biological material identifying means 1 is treated to prevent cell adhesion, it is not possible for the adhered cells to be caught in the pipette inlet and sucked into the pipette while the biological material identifying means coexists with lymphocytes. Preventing it from becoming possible.
[0062]
In addition, since the biological material identification unit 1 includes the receiving unit 11 that receives electromagnetic waves and converts them into electric power, it is not necessary to provide a battery, and further miniaturization and prevention of contamination due to elution of substances in the battery can be prevented. Can be planned.
[0063]
And since the said biological substance identification means 1 is larger than the lymphocyte L, it can remove by filtering with a filter in the case of administration, and it does not enter into a donor and / or a recipient's body accidentally.
[0064]
Further, since the biological material identification unit 1 can be sucked by the pipette PP while being mixed with the lymphocyte L, the biological material identification unit 1 mixed with the lymphocyte L during the step of taking out the lymphocyte L after centrifugation. It can be removed as it is and saves you the trouble of checking the label.
[0065]
As a modification of the first embodiment, an embodiment in which the biological material identification unit 1 and the collation target unit 2 are configured to be writable and the biological material identification information J1 and the collation information J2 such as a donor are written each time can be considered. With this configuration, the donor and / or the recipient can be present when writing to each, so that the biological material identifying means 1 that does not correspond to the checked means 2 is mixed with the blood BL in the first stage. Can be easily eliminated. In this case, sterilization may be performed after writing, or writing may be performed while maintaining sterilization.
[0066]
Moreover, as another modification, the information processing apparatus 4 of the first embodiment includes the biological material identification information J1, the name of the donor and / or the recipient, the date of birth, the date of collection, and the chart number, respectively. The name and date of birth of the donor and / or recipient corresponding to the biological material identification information J1 when the biological material identification means 1 and the verified means 2 are collated are stored. You may make it search a month and day, a medical chart number, and output a search result.
[0067]
If it is such, the doctor etc. which administer can collate an output result with the name of a real donor and / or recipient, a birth date, the date of collection, and a medical record number.
[0068]
As yet another modification, collation by the information processing apparatus 4 is not performed, and the biological substance identification information J1 and the collation information J2 such as a donor may be output side by side and collated by a doctor who performs administration. Further, the verification means 2 itself is omitted, and the biological material identification information J1 itself, or the name, date of birth, date of collection, and chart number of the donor and / or recipient corresponding to the biological material identification information J1 Or the like, and the doctor or the like who performs administration may collate with the actual name of the donor and / or recipient, the date of birth, the date of collection, the medical record number, and the like. Even in these cases, the verification is dependent on the human eye, but since the biological material identification means 1 is mixed with the lymphocyte L or the like, the lymphocyte L and the living body from collection to administration are unchanged. It is possible to keep correspondence with the substance identification means 1 and to identify the donor and / or recipient of the lymphocyte L itself.
[0069]
Next, a second embodiment of the present invention will be described with reference to the drawings. Here, the same name and code | symbol are attached | subjected regarding the apparatus and functional block corresponding to the said 1st Embodiment.
[0070]
The donor identification method according to this embodiment is similar to the first embodiment, in which lymphocytes L, which are biological materials, are extracted from the human body of the donor and / or recipient individual (same in this embodiment), cultured and processed outside the body. It is used for cell therapy to return various things with various properties to the body as cell medicines.
[0071]
First, the apparatus used for this embodiment is demonstrated. As shown in FIG. 19, in this embodiment, the lymphocyte L is mixed, and the biological material identification means 1 for storing the biological material identification information J1 is provided on the donor and / or recipient side. The collation means 2 for storing donor collation information J2, the reader 3 for reading the biological substance identification information J1, and the second reader 5 for reading the donor collation information J2. And the information processing apparatus 4 that receives the biological substance identification information J1 from the reading device 3 and the matching information J2 such as donor from the second reading device 5 and performs matching. In this embodiment, the reading of the biological material identification information J1 from the biological material identification unit 1 by the reading device 3 is performed in a non-contact manner by communication using electromagnetic waves. In the present embodiment, the second reader 5 reads the donor collation information J2 from the collation means 2 using a bar code reader. The reading device 3 and the second reading device 5 are connected to the information processing device 4 by wire.
[0072]
Next, the configuration and function of each device will be described. FIG. 20 is a functional block diagram showing the operation functions of the device.
[0073]
Since the configurations of the biological material identification unit 1 and the reading device 3 are the same as those in the first embodiment, a detailed description thereof will be omitted.
[0074]
In this embodiment, the collation means 2 is configured by using a bar code printed on a predetermined sheet. The content of this bar code is donor matching information J2, which corresponds to the donor's and / or recipient's name, date of birth, date of collection, and chart number. The donor collation information J2 is stored in the information processing apparatus 4 in association with the biological material identification information J1, as will be described later.
[0075]
In the present embodiment, the second reading device 5 is configured using a known barcode reader, a reading unit 51 that reads donor collation information J2 printed as a barcode, and a reading unit 51. The function as the transmission part 52 which transmits the collation information J2 etc., such as donors read to the information processing apparatus 4, is exhibited.
[0076]
The information processing apparatus 4 is the same as that used in the first embodiment. As shown in FIG. 2, the CPU 401, the main memory 402, an input device 403 such as a keyboard, an external storage device 404 such as an HDD, a display, a printer, and the like Output device 405, an input / output interface 406 such as a terminal for inputting signals from the reading device and the second reading device, and the like. Then, the CPU 401 operates according to programs stored in the main memory 402, the external storage device 404, etc., and functions as the receiving unit 41, the second receiving unit 44, the identification collation information storage unit 45, the collation unit 42, and the result output unit 43. .
[0077]
The receiving unit 41 is configured using the input / output interface 406 and the like, and receives the biological material identification information J1 output from the reading device 3.
[0078]
The second receiving unit 44 is configured using the input / output interface 406 or the like, and receives the donor collation information J2 transmitted from the second reading device 5.
[0079]
The identification / collation information storage unit 45 is formed in a predetermined area such as the main memory 402, the external storage device 404, etc., and the biological substance identification information J1 and the collation information J2 such as donor are associated with each other as shown in FIG. To be stored. Then, donor collation information J2 corresponding to the biological material identification information J1 received by the reception unit 41 is passed to the collation unit 42.
[0080]
The matching unit 42 compares the donor matching information J2 passed from the identification matching information storage unit 45 with the donor matching information J2 received by the second receiving unit 44. If it has a different value, a determination result identifier R having a binary value of “0” is generated.
[0081]
The result output unit 43 is configured using the output device 405 or the like. If the value of the determination result identifier R generated by the collation unit 42 is “1”, it is “OK”, and “0”. Message “NG” is output.
[0082]
Next, the flow of this cell therapy will be described below. FIG. 22 shows an outline of this flow.
[0083]
First, the biological material identification unit 1 is sterilized in advance using ethanol, gas, ozone, γ rays, or the like. Next, as shown in FIG. 9, the biological material identification means 1 is placed in the vacuum blood collection tube T (ST21), and as shown in FIG. 10, the vacuum blood collection tube T in which this biological material identification means 1 is contained. To collect blood from the donor and / or recipient (ST22).
[0084]
At the stage where blood collection is finished, the biological material identification information J1 is read (ST23). Next, a barcode including donor matching information J2 is created (ST24). Then, the biomaterial identification information J1 and the donor collation information J2 are stored in association with the identification collation information section 45 of the information processing apparatus 4 (ST25).
[0085]
From the collected blood BL, lymphocytes L are separated and processed by the following method, and the lymphocytes are further cultured.
[0086]
First, a lymphocyte layer LL containing lymphocytes L can be extracted from the collected blood BL by centrifugation (ST26). The state after the centrifugation is shown in FIG. At this time, since the biological material identification means 1 has substantially the same specific gravity as the lymphocyte L, the biological material identification means 1 coexists in the lymphocyte L layer.
[0087]
The layer in which the lymphocyte L and the biological material identification unit 1 coexist is taken out with the pipette PP as shown in FIG. 12, and transferred to the flask FL shown in FIG. 13 (ST27). The diameter of the tip of the pipette PP is large enough to allow the biological material identification means 1 to pass through. Then, a stimulating antibody is added to the flask FL to add an immune function, and the lymphocyte L is cultured for about one week in this embodiment until it reaches a certain amount (ST28).
[0088]
When the lymphocyte L in the flask FL reaches a certain amount, as shown in FIG. 14, the lymphocyte suspension L1 containing the lymphocyte L is transferred together with the biological substance identification means 1 to a container called a bag BG ( ST29) In this embodiment, the culture is continued for about one week until it reaches a certain amount (ST30).
[0089]
When the lymphocyte L substantially fills the bag BG, as shown in FIG. 15, the lymphocyte suspension L1 containing the lymphocyte L as the contents of the bag BG and the biological material identification means 1 are placed in the centrifuge bottle BT1. Transfer (ST31) and perform centrifugation to separate and purify lymphocytes L from the culture medium or the like (ST32). Similarly, the biological substance identification means 1 coexists in the lymphocyte L layer. The layer of the administration lymphocyte suspension L2 containing the purified lymphocytes L is transferred to the infusion bottle BT2 shown in FIG. 16 (ST33).
[0090]
Before the administration lymphocyte suspension L2 containing the lymphocyte L, which is a biological material used for treatment, is administered to the donor and / or the recipient, the reader 3 is brought close to the infusion bottle BT2 to identify the biological material. The information J1 is read (ST34). Then, the second reading device 5 is brought close to the collation means 2 given to the donor and / or the recipient, and the collation information J2 such as donor is read (ST35).
[0091]
The flow of processing performed by the information processing apparatus is shown in FIG. First, the receiving unit 41 receives the biological material identification information J1 (ST201), and the identification verification information unit 45 searches for and obtains the donor verification information J2 corresponding to the biological material identification information J1 (ST202). Next, the second receiver 44 receives the donor verification information J2 (ST203). The collation unit 42 compares the donor collation information J2 obtained by searching the identification collation information unit 45 with the donor collation information J2 received by the second receiving unit 44 (ST204). 1 ”(ST205), otherwise, a determination result identifier R having a binary value of“ 0 ”is generated (ST206) and passed to the result output unit 43 (ST207). The result output unit 43 outputs “OK” (ST208) if the determination identifier is “1”, and “NG” if it is “0” (ST209).
[0092]
Then, as shown in FIG. 22, the collation result output by the doctor performing the administration is referred to (ST36), and only when “OK” is output, the biological material identification means 1 does not pass through the infusion bottle BT2. A filter FI configured as possible is attached, and an infusion tube and an injection needle are attached, and infusion is performed on the donor and / or the recipient as shown in FIG. 18 (ST37).
[0093]
When “NG” is output, an infusion bottle containing the lymphocyte suspension L2 mixed with another biological material identification means 1 is prepared (ST38), and the operation for performing the collation is similarly performed with “OK”. Repeat until is output. If the correct infusion bottle is not available, notify the cell culture institution, and if found, inform the donor and / or recipient and cell culture institution to administer the dose on the designated date. If “NG” is output, the collating operation is repeated a predetermined number of times by bringing the reading device 3 close to the same infusion bottle BT2, and after confirming that “OK” is never output, another operation is performed. An infusion bottle BT2 may be prepared. In this case, as long as “OK” is output twice in a row, it is of course possible not to proceed to the drip operation.
[0094]
As described above, since the biological material identification information J1 and the donor matching information J2 are stored in the identification matching information unit 45 of the information processing apparatus 4 in association with each other, the biological material identification information J1 and the donor matching information J2 are made the same. Even if it does not exist, collation is cerebral by comparing with the donor collation information J2 corresponding to the biological substance identification information J1 received by the said identification collation information storage part, and the received donor collation information J2.
[0095]
Moreover, since the biological material identification means 1 is mixed with the lymphocyte L as in the first embodiment, and this biological material identification means 1 has the same configuration as that of the first embodiment, the main material according to the first embodiment is used. This effect can also be obtained in the second embodiment.
[0096]
As a modification of the second embodiment, the collation means 2 is composed of a writable medium instead of a bar code, such as a card with a magnetic stripe or a writable IC chip. The equal collation information J2 may be written, and the donor collation information J2 written in the collation means 2 and the biological material identification information J1 in the biological material identification means 1 may be associated with each other and stored in the information processing apparatus 4.
[0097]
Further, as another modification of the second embodiment, the collation means 2 is composed of donor and / or recipient himself / herself, donor etc. collation information J2 is composed of biological information unique to the donor and / or recipient himself / herself, such as a fingerprint, The donor verification information J2 which is biological information unique to the donor and / or the recipient may be stored in the information processing apparatus 4 in association with the biological material identification information J1 in the biological material identification means 1. In this case, the biological material identification unit 1 is writable, and the donor collation information J2 is written in the biological material identification unit 1 as the biological material identification information J1 as it is or after being compressed using a predetermined algorithm. It may be.
[0098]
As still another modification of the second embodiment, an identification / collation information storage unit is provided not in the information processing apparatus 4 but in the reading apparatus 3, and biological material identification information J1 corresponding to the read donor etc. collation information J2. An embodiment is also conceivable in which information is retrieved and output to the information processing apparatus 4 and the information processing apparatus 4 performs collation by the same procedure as in the first embodiment.
[0099]
Also in the modification described above, all the main effects in the second embodiment can be obtained.
[0100]
The present invention is not limited to the embodiment described above.
[0101]
For example, instead of providing the biological material identification means with a waterproof coating, the biological material identification means itself may have a water-resistant structure so that it can coexist with a medium containing water. It does not have to have.
[0102]
In addition, the size of the biological material identification means may be lymphatic if it can be prevented from being accidentally injected into the donor and / or recipient body, for example, by including a magnetic substance and adsorbing it to a magnet at the time of administration. It may be smaller than particles of biological material administered to donors and / or recipients such as spheres, erythrocytes and the like. Alternatively, even when the biological material identification means can be injected into the body of the donor and / or the recipient, the size of the biological material identification means need not be larger than that of the biological material particles.
[0103]
On the other hand, in order to take out biological substances such as lymphocytes after centrifugation, a pipette is used in the two embodiments described above, but a syringe may be used. In this case, the biological material identification means may pass through the injection needle, and the biological material identification means may be sucked by the syringe while being mixed with the biological material. That is, the size of the biological material identification means may be within a range that can pass through all of the instruments such as the injection needle, pipette, and tube used when transferring the biological material between the containers.
[0104]
Furthermore, if cells that do not easily adhere to the surface of the biological material identification means are administered, there is no need to perform a special treatment for preventing cell adhesion. In addition, cell adhesion can be prevented by fixing other cell non-adhesive biocolloids instead of albumin, such as nonionic hydrophilic synthetic polymer, or graft polymerization of acrylamide. Good.
[0105]
In addition, the electromagnetic wave used for the power of the biological material identification means may have any frequency other than 2.45 GHz described in the above embodiment unless the energy is high energy that destroys the biological material. Good. Moreover, you may use things other than electromagnetic waves, such as a sound wave, as a motive power source. Furthermore, for example, one or a plurality of granular biological material identification means that emit light when irradiated with electromagnetic waves of a predetermined wavelength are mixed with biological material, and the color or combination of colors of the biological material identification means is associated with biological material identification information in advance. Biological substance identification means, such as a method of identifying a biological substance from the color of light or a combination of colors by irradiating an electromagnetic wave of the predetermined wavelength immediately before administration, and collating it with a donor and / or a recipient You may use methods other than transmitting electromagnetic waves from.
[0106]
In addition to cell therapy as described in the above embodiment, other medical treatments such as a test performed by extracting serum as a biological material from blood of a donor and / or a recipient, blood transfusion for injecting blood as a biological material, etc. It can also be applied to actions.
[0107]
For example, in the case of a test performed by taking out serum, the biomaterial identification information is read immediately before or after the test of each department, so that misdiagnosis caused by mislabeling or the like can be prevented. . In this case, since serum forms a supernatant when blood is centrifuged, it is not necessary to set the specific gravity of the biological material identification means to be substantially the same as that of serum as long as it is lighter than serum.
[0108]
If it is sufficient that the attributes of the donor and / or the recipient can be distinguished, not the donor and / or the recipient individual, the biological material identification information need not include the donor and / or recipient identification information. For example, when the present invention is applied to blood transfusion, the biological material identification information may be a blood type alone.
[0109]
【The invention's effect】
In the present invention, as described in detail above, since the biological material identification means is mixed with the biological material, the biological material is transferred to another container while the correspondence between the biological material and the biological material identification means is maintained. Unlike the method using a label, it is possible to eliminate the mistake of overlooking the label and transferring the biological material to a container having a label that does not correspond to the biological material. Further, by storing and transmitting the biological material identification information in the biological material identification unit itself, the information can be reliably verified.
[Brief description of the drawings]
FIG. 1 is an overall configuration diagram of a donor identification method according to a first embodiment of the present invention.
FIG. 2 is a functional block diagram of each device used in the donor identification method in the embodiment.
FIG. 3 is an internal configuration diagram of a biological material identification unit in the embodiment.
FIG. 4 is a schematic diagram of biological material identification information in the embodiment.
FIG. 5 is an internal configuration diagram of a collation means in the embodiment.
FIG. 6 is an internal configuration diagram of the reading device according to the embodiment.
FIG. 7 is an internal configuration diagram of the information processing apparatus in the embodiment.
FIG. 8 is a processing flowchart of cell therapy in the embodiment.
FIG. 9 is a schematic view showing a state of a blood collection tube immediately before starting blood collection in the same embodiment.
FIG. 10 is a schematic diagram showing blood collection from a donor and / or a recipient in the same embodiment.
FIG. 11 is a schematic view showing a state in which blood collected from a donor and / or a recipient is centrifuged in the same embodiment.
FIG. 12 is a schematic view showing an operation of taking out lymphocytes and biological material identification means from blood collected from a donor and / or a recipient in the embodiment.
FIG. 13 is a front view showing a flask used for cell therapy in the same embodiment.
FIG. 14 is a schematic view showing an operation of transferring lymphocytes and biological material identification means from the flask to the bag in the same embodiment.
FIG. 15 is a schematic diagram showing an operation of transferring lymphocytes and biological material identification means from the bag to the centrifuge bottle in the same embodiment.
FIG. 16 is a front view showing an infusion bottle in the embodiment.
FIG. 17 is a flowchart showing processing performed by the information processing apparatus used for collation of biological material identification information in the embodiment.
FIG. 18 is a schematic diagram showing an infusion operation in the embodiment.
FIG. 19 is an overall configuration diagram of a donor identification method in a second embodiment of the present invention.
FIG. 20 is a functional block diagram of each device used in the donor identification method in the embodiment.
FIG. 21 is a schematic diagram showing biological substance identification information and donor and other collation information stored in the identification and collation information storage unit in the same embodiment;
FIG. 22 is a processing flowchart of cell therapy in the embodiment.
FIG. 23 is an exemplary flowchart illustrating processing performed by the information processing apparatus used for collating biological material identification information according to the embodiment;
[Explanation of symbols]
1. Biological substance identification means
11: Biological substance identification means
12 ... Biological substance identification information storage unit
13 ... Biological substance identification information transmitter
2 ... Checked means
3 Reading device
4 ... Information processing device
41. Reception unit
42 ... collation part
44 ... second receiving unit
45. Identification verification information storage unit
J1 ... Biological substance identification information
J11 ... Donor number (donor and / or recipient identification information)
J2 ... Donor collation information
L ... Lymphocytes (biological substances)
L1 ... lymphocyte suspension
L2 ... Lymphocyte suspension for administration (biological material)
FI ... Filter
PP ... Pipette

Claims (16)

The biological material transmitted from the biological material identification means by mixing a biological material identification means different from the biological material in a container containing the biological material such as a specific cell group or blood so as to coexist with the biological material. Biological substance identification information, which is information for identifying the biological substance, is read by a reader, and the donor and / or recipient corresponding to the biological substance can be identified using the biological substance identification information read by the reader. A donor identification method.   The donor identification method according to claim 1, wherein the biological material identification information includes identification information such as a donor that is information for identifying a donor and / or a recipient.   3. The donor identification method according to claim 1, wherein the biological material identification information transmitted from the biological material identification means is read using a reader.   4. The donor identification method according to claim 3, wherein the reading device and the information processing device are connected by wire or wireless, and the biological material identification information received by the reading device is output from the information processing device.   The reader and the information processing device are connected by wire or wirelessly, and the biological substance identification information received by the reader, and the matching information stored in the matching means on the donor and / or recipient side, 4. The donor identification method according to claim 3, wherein a donor and / or a recipient corresponding to the biological material is identified by collating with the information processing apparatus.   6. The donor identification method according to claim 5, wherein the donor verification information is information indicating characteristics of a donor and / or a recipient individual.   The information processing apparatus stores biological substance identification information and donor verification information in association with each other, and compares the donor verification information corresponding to the biological substance identification information received by the information processing apparatus with the received donor verification information. The donor identification method according to claim 5 or 6, wherein a donor and / or a recipient corresponding to the biological material are identified by collation.   The donor identification method according to claim 5 or 6, wherein the biological substance identification information stored in the biological substance identification unit and the matching information stored in the compared unit have the same contents. A biological material identification information storage unit for storing biological material identification information, which is information for identifying a biological material, to be mixed with a biological material in a container containing a biological material such as a specific cell group or blood ; And a biological material identifying means comprising a transmitter for transmitting the biological material identification information. The biological material identification means according to claim 9 , which has water resistance. The biological material identification means according to claim 9 or 10 , wherein the biological material identification means has a size that can be separated from the biological material by filtration using a filter. 9., 10, or 11 wherein the biological material identification means, characterized in that it comprises a pipette or syringe by the left blotting possible size was mixed with the biological material. 9., 10, 11, or 12 biological material identification means, wherein the process for preventing adhesion of biological material on the surface are subjected. 9. specific gravity is equal to or is substantially the same as the biological material of interest, 10, 11, 12, or 13, wherein the biological material identification means. Comprising a receiving unit for converting the electric power by receiving electromagnetic waves, according to claim 9, characterized in that this power is the power source of the transmitting section, 10, 11, 12, 13, or 14 biological material identification according means. Claim 9, characterized in that configured to be able to write the biological substance identification information, 10, 11, 12, 13, 14, or 15 biological material identification means according.

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