• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Transfusion safety device, to carry out an ABO blood group check of a packed red blood cell (CH) contained in a bag (3) and ABO blood group of the blood of a recipient and determine its compatibility to carry out said transfusion, which it comprises a blood transfusion unit (1), a first blood group verification device (2), for establishing the blood group of the CH contained in the bag (3), a second device for verifying the blood group (4), destined to establish the blood group of the individual recipient of the transfusion, and a control unit (5), intended to perform a reading of the results obtained in the verification devices (2, 4), to establish the compatibility or incompatibility of both Blood groups based on the reading of the results, and to operate a flow regulator (9) to allow or prevent the flow of CH. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2660513A1
    申请号:ES201630992
    申请日:2016-07-21
    公开日:2018-03-22
    发明作者:José Luis BUENO CABRERA
    申请人:Hurtado Mondejar Maria Del Carmen；Parrado Gonzalez Carmelo；Proposit Bio S L；Proposit Bio SL；
    IPC主号:
    专利说明:

    OBJECT OF THE INVENTION
    The present invention falls within the technical field of devices for taking blood samples, specifically those for blood measurements in vivo, as well as in the means for controlling the flow of agents. towards the body or to dose the agents to be introduced into the body, and in that of chemical analysis of biological material and immunological research or analysis in which blood groups or types are involved, and refers in particular to a device for testing blood group of the blood contained in a transfusion unit and the blood of a transfusion recipient and determine its compatibility before performing a transfusion. BACKGROUND OF THE INVENTION
    Blood transfusion is a very common medical procedure; It is estimated that about 2 million blood components are transfused in Spain every year. Most of these transfused components are red blood cell concentrates, which are the amount of red blood cells obtained from a blood donation after the rest of the blood components are separated, and are generally used to increase the mass of red cells in the blood. transfusion recipient.
    The main risks associated with transfusion are those derived from pulmonary complications that may arise, as well as those due to errors in the administration of an inappropriate blood component, which occurs when a red blood cell concentrate is transfused, also referred to as an ABO group, incompatible with that of the recipient, and may even cause death. In fact, it is considered that currently in Spain the error in the administration of incompatible red blood cell concentrates is the most important cause of transfusion-related deaths.
    These types of incidents are caused by a series of possible errors, which can be classified into three main groups. First of all, there are the errors produced when the sample of the receiving individual is extracted to carry out a pre-transfusion study, as happens for example when the healthcare professional who extracts the sample erroneously labels the tube where the blood is extracted, with the data of another individual. Secondly, there are errors in the labeling of red blood cell concentrates, due to failures of blood bank personnel when labeling the bags with an individual name different from the real one. Finally, there are the errors derived from the incorrect administration of the component at the time of the transfusion, in which the nursing staff does not correctly identify the individual to whom the transfusion is going to be applied, introducing an incompatible red blood cell concentrate in their organism, That was intended for another individual.
    Finally, there is a risk that the red blood cell concentrate contains red blood cells from a different ABO group than the one on its label; or even, that the control tubular that is usually used to identify the ABO group of the bag is different from the ABO group of the red blood cells contained in said bag, as a result of improper handling during the production of the component, or even by malicious manipulation .
    Various devices and their corresponding associated methods are known in the state of the art, aimed at preventing these errors. Such prevention methods are usually based on the placement of identifying devices, such as wristbands, which contain the basic data of the individual to whom the red blood cell concentrate is to be transfused. These methods require strict protocols, for which all personnel involved in the transfusion process must be properly trained and ensure that they are strictly followed. It is also usually necessary to operate a computer system, composed of both the software and the computer devices themselves, in order to properly monitor and control the entire process. In any case, the effectiveness of these systems or procedures is subject to strict monitoring of the protocol established by the personnel involved in the transfusion process.
    These methods involve, first of all, a considerable increase in the transfusion process, which is currently quantified at around 5-7 euros for each transfusion performed, in addition to not being infallible due to factors such as lack of staff training or the needs produced in emergency situations, not strictly following the established protocol, and as a consequence, erroneous transfusions are carried out despite the existence of a pre-established transfusion security method. At present, no solution is known in the market that avoids the possibility of boycotting or accidental error, since the order to make the connection between the red blood cell bag to be transfused and the recipient's route is always in the hands of the medical staff.
    On the other hand, the available systems are not able to prevent an incident by ABO incompatibility due to an error in the labeling of the red blood cell concentrate, or when there is a discrepancy between the blood inside the bag and a used control tubular for the determination of the ABO group of the stock market.
    From the above, the need to have a transfusion security system that avoids at least the incompatibility errors in the blood group, referred to as ABO group, that is not subject to the follow-up of a procedure or protocol, is deduced. and that it is physically capable of preventing a transfusion when there is an incompatibility between the ABO group of the individual and the ABO group of the stock exchange. DESCRIPTION OF THE INVENTION
    The object of the invention is a device to ensure the control of the transfusion practice of units of a red blood cell concentrate, hereinafter referred to by its acronym as CH, by using a chemical-immunological detection system of the ABO group in the CH and in the individual's blood, and an automatic control device capable of identifying the ABO result of the chemical-immunological test and that additionally integrates the compatibility check between the blood component and the blood of the individual, causing automatic release of a flow regulating device that allows the transfusion or infusion of the CH to the individual to be initiated, only in case of compatibility in the ABO group between the CH and the individual's blood. In this way, adverse reactions in the individual linked to a possible incompatibility between ABO groups are avoided.
    For this, the transfusion safety device incorporates at least one ABO blood group verification device into a traditional CH infusion system, at least one control unit, which is preferably a portable PDA type computer unit, capable of reading and interpreting the results shown by the verification devices, and a CH flow regulating device, preferably a solenoid valve, interposed in the infusion system conduit to control the passage of said CH therethrough depending on the orders received from the control unit; which performs a computer compatibility test between the ABO result detected in each of the verification devices.
    Blood group verification devices, based on an antigen-antibody type reaction, are filled by gravity or capillarity and require only a few drops of sample to enter through a small capillary. The incorporation into the transfusion safety device of at least a first device, intended to carry out the verification of the ABO blood group corresponding to the CH to be transfused, and a second device, for checking the ABO blood group of the recipient receiving said transfusion is performed.
    The antigen-antibody reaction system generates a result that is displayed on the verification device itself, whose visualization and interpretation is likely to be performed by the user himself visually, as well as by the computer reading unit.
    The housing in which both verification devices are housed is designed to be physically coupled at the time of reading, so as to avoid the possibility of errors derived from double reading by the control unit, that is, that said control unit reads the same camera twice by mistake. In turn, the infusion line that allows the passage of CH to the individual remains blocked by the regulating device, which can only be released when the control unit that performs the reading of both verification chambers determines that there is a result of compatibility between the ABO group detected in the CH verification device and in the individual's blood verification device.
    The control unit is preferably provided with an application that firstly is responsible for reading the results obtained by the ABO blood group verification devices, and secondly for interpreting said results based on an algorithm that includes the possible combinations of compatibility and incompatibility between ABO blood groups. As a result of this interpretation, the control unit sends a signal based on the test result to the flow regulating device to allow or prevent the passage of CH towards the individual.
    Unlike other equipment and procedures known in the state of the art, the device is not based on a direct agglutination that faces blood samples (cross test between individual and CH product), but on the use of a rapid test for determining the ABO blood group independently applicable to individual and product to be used in the instant prior to the transfusion. The final determination about the compatibility between both results is made with an external control unit.
    The main advantages provided by the device are that it physically prevents the transfusion of a CH to an individual when there is an incompatibility in the ABO group; being effective even when the personnel involved in the transfusion has not been trained for it. Another important advantage lies in the speed of the verification process, since it can be done in less than 1 minute using a small volume of the CH and the individual's blood, of no more than 1 ml. In addition, the device is able to detect an ABO incompatibility even when there is an error in the labeling of the CH bag, or when the content of a control tubular used for the determination of the ABO group of the bag is different from the ABO group of blood contained in the CH bag.
    Additionally, the device is advantageous because for successive transfusions it is not necessary to retest the ABO group of the individual, since the result obtained the first time, is visible in the latter's verification device, with additional time savings. Finally, the device is disposable and allows an economic implementation of a global transfusion safety protocol at the hospital level, since it is estimated that only each transfusion procedure costs about € 3-5.
    In turn, in an alternative embodiment, the device for verification of the product to be transfused may come pre-connected and verified from the CH preparation laboratory, which is usually a transfusion center, being sufficient to perform its reading at the previous time to the transfusion.
    The device can be an alternative to other transfusion security systems, or it can complement them. It even allows double verification with the current wristband identification systems of individuals, if a QR code, preferably dynamic type, is added to the product verification device whose configuration contains the individual's identification number, which usually appears on a wristband Identification and whose reading prior to the transfusion confirms that the assignment of the product is unequivocal for the individual to be transfused.
    However, and in the specific case of extremely urgent transfusions, catastrophes or other extraordinary circumstances, it is envisaged that the device will incorporate an alternative that allows the transfusion safety protocol to be violated under the responsibility of the healthcare professional in charge of supervising the process. .
    In addition and since each unit of transfused CH is unambiguously linked to an ABO group verification test performed on the verification device, this test can be done either at the head of the individual, or at a previous time; even at the transfusion center itself at the time the CHs occur.
    Thus each CH produced comprises a verification device where the ABO group of the CH is determined, which is used at the time of the transfusion to perform the verification against the ABO group of the individual. This provision makes it possible to accelerate the process of verification of compatibility between a verification device of the CH that has already been performed previously, compared to an ABO verification device of the individual; which in turn has been done only once, and that is valid for successive CH transfusions.
    DESCRIPTION OF THE DRAWINGS
    To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical implementation thereof, a set of drawings is attached as an integral part of said description. where, for illustrative and non-limiting purposes, the following has been represented:
    Figure 1.- Shows a schematic view of the transfusion safety device, in which its main constituent elements are appreciated.
    Figure 2.- Shows a detailed view of one of the blood group verification devices, in which it is observed how it is coupled with the other device in the moment prior to reading the results.
    Figure 3.- Shows a schematic view of the response algorithm introduced in the control unit, in which column A corresponds to the possible situations in which transfusion is allowed, and column B to those in which it is not allowed . PREFERRED EMBODIMENT OF THE INVENTION
    Next, a detailed explanation of a preferred embodiment of the object of the present invention is provided with the aid of the aforementioned figures.
    The described transfusion safety device, shown schematically in Figure 1, is made up of a blood transfusion unit (1), to which a first blood group verification device (2) is connected by means of connections. to identify the blood group of a red blood cell concentrate, also referred to by its acronym CH, contained in a bag (3), and a second blood group verification device (4), intended to specify an individual's own blood group at which is going to be transfused. This second device can be used additionally for any other type of intravenous infusion, also referred to as venoclysis, other than blood transfusion.
    A control unit (5) makes a reading of the results obtained in the first (2) and second (4) blood group verification device to establish the compatibility or incompatibility of both groups, based on a previously introduced algorithm, and allow or prevent the passage of a flow of CH from the bag (3) to the individual. In the preferred embodiment described herein, said control unit (5) is a mobile electronic device type PDA provided with an application for reading results.
    It is expected that the first (2) and second (4) verification devices have a complementary geometry to each other, which allows them to be unequivocally coupled at the time of reading results, avoiding errors derived from double readings or similar failures.
    The blood transfusion unit (1) in turn comprises a bag line (6) and a line of the recipient individual (7), which are linked to each other at the time of transfusion via a connection (8). The bag line (6) additionally incorporates, in a position prior to connection (8), a flow regulator (9) operable by the control unit (5).
    In the preferred embodiment described herein, the connection (8) is of the male-female luer type, each of the respective portions of the connection disposed at the free end of each of the lines (6.7) while the regulator Flow (9) comprises a magnetic valve that functions as a two-position relay or solenoid, normally open or normally closed, to regulate the passage of blood therethrough depending on the orders received from the control unit (5).
    The bag line (6) further comprises, at the opposite end to that by which the individual's line (7) is linked, a punch (10) intended to be introduced into the bag (3) to extract and channel the CH content inside. The incorporation of a macro-aggregate filter (11), in a post-punch position (10), is also provided to retain clots, cell debris and other residues present in the CH contained in the bag (3), and prevent its introduction into The receiving individual. A roller clamp (12) regulates the speed of passage of the CH through the bag line (6).
    On the other hand, the line of the individual (7) has, at the opposite end to that by which it is linked to the bag line (6), a lighter type connection point (13), intended to be inserted in a path ( 14) practiced in a vein of the individual receiving the transfusion.
    To avoid errors, it is expected that the line of the individual (7) incorporates the own needle of the path (14) to be practiced in the individual. The flow regulator (9) that links the stock exchange line
    (6)  with the line of the individual (7) then controls the passage of a flow of CH from the bag
    (3) to the track (14).
    A first branch (15) takes a sample of the CH that circulates along the bag line
    (6) and leads it to the first blood group verification device (2) to identify the blood group corresponding to said CH. The interposition of a first non-return valve (16) in the first branch (15) is provided to prevent a return flow of said CH sample towards the bag line (6).
    A second shunt (17) takes a sample of the individual's blood from the pathway (14) and conducts it to the second blood group verification device
    (4)  to establish the blood group corresponding to the patient. The interposition of a second non-return valve (18) is envisaged in the second bypass (17) to avoid a return flow of said blood sample to the path (14).
    The blood group determination performed in both the first (2) and the second blood group verification device (4) is based on an agglutination reaction of the antigen-antibody type. Each of said devices (2, 4), shown schematically in Figure 2, comprises a first reaction chamber
    (19) containing an anti-A reagent, linked to a first reading chamber (20), and a second reaction chamber (21) containing an anti-B reagent, linked to a second reading chamber (22). A third reaction chamber (23) without antibody, linked to a third reading chamber (24) has a control function, to ensure that the sample inlet has not been blocked for causes other than the agglutination reaction.
    Since both the first (15) and the second (17) leads have a very small diameter, capillary type, it is envisaged the incorporation of a device for creating vacuum (25) piston type at the entrance to both verification devices of the group blood (2,4) to facilitate filling with the respective samples.
    Also, and for the specific case of this preferred embodiment, each reading chamber (20,22,24) incorporates a visual information element (26), which in this case is a two-dimensional code or previously printed QR code, which collects information concerning the ABO blood group and the control of both the bag and the recipient individual. This visual information element (26) will or may not be readable by the control unit (5) depending on the agglutination reaction produced in the reading chambers (20,22), except in the case of the visual information element (26) corresponding to the third reading chamber (24), which always remains legible; since it acts as a test-control.
    The incorporation into the first blood group verification device (2) of a dynamic QR code (27) that collects information relative to the individual destined to receive the CH contained in the bag (3) is also contemplated. This information is usually collected on an identification wristband attached to the individual, and its reading by the control unit (5) at a stage prior to the transfusion confirms that the assignment of the product is unequivocal for the individual to be transfused, also allowing to establish a traceability in the CH transfusion procedure.
    The control unit (5), which as indicated above is a PDA in this preferred embodiment, is provided with algorithms for determining compatibility.
    or incompatibility between blood groups. Said control unit (5) performs a reading by scanning the previous visual information element (26) in order to perform said determination.
    The sample, of CH or blood according to the device (2,4) in question, enters by capillarity in the first (19) and in the second (21) reaction chambers, and reacts with one, both or none of the reagents contained in said chambers. The reaction produces an agglutination that prevents the sample from flowing into the first (20) or second reading chamber (22). In case such agglutination occurs, the visual information element (26) is readable.
    If compatibility is established between both blood groups, the control unit (5) issues an order to the flow regulator (9) to allow passage through the flow of CH from the bag (3) to the connection point (13) with the path (14) of the individual, while if it is determined that the groups are incompatible, it does not send any signal, the flow regulator (9) remaining in its closed position.
    In an alternative embodiment of the invention, the CH container bags (3) are made with the incorporated bag line (6), which makes the punch (10) unnecessary. Therefore, the transfusion centers send the bags (3) with their bag line (6), which prevents a user from changing a bag (3) with the punch (10) to an incompatible one, after opening the regulator flow (9).
    The transfusion procedure that makes use of the device thus described comprises the following sequence of actions:
    - reading by the control unit (5) of the dynamic QR code (27) set in the first blood group verification device (2),
    -  connection of the bag line (6) to the CH container bag (3) through the punch (11),
    -  connection of the individual's line (7) to the track (14), through the connection point (13),
    -  union of the bag line (6) with the line of the individual (7) through the connection (8),
    -  entry of a sample of CH from the bag (3) to the first blood group verification device (2) through the first shunt (15),
    -  entry of a blood sample from the pathway (14) to the second blood group verification device (4) through the second shunt (17),
    -  linking each other of the first (2) and second blood group verification device (4),
    -  Simultaneous reading by the control unit (5) of the results shown in the respective reading chambers (20,22,24) of the verification devices (2,4) by scanning the visual information elements ( 26), which in this case are QR codes, visible after the agglutination reactions produced in the respective reaction chambers (19,21,23),
    -  determination by the control unit (5) of the compatibility or incompatibility between CH and blood, and
    -  in case of compatibility: sending an order from the control unit (5) to the flow regulator (9) for opening, thus allowing the passage of a flow of CH from the bag (3) to the track (14), or
    -  In case of incompatibility: no order is sent to the flow regulator (9), which remains in the closed position preventing the flow of CH from passing.
    By way of example of operation, in the first reading chamber (20), linked to the first reaction chamber (19), its corresponding visual information element
    (26) It will only be legible if there has been prior agglutination between the red blood cells in the sample and the anti-A reagent contained in said first reaction chamber (19). If not, if no agglutination occurs, blood flows to the first reading chamber (20) and prevents reading.
    If there is no reading of any of the visual information elements (26) corresponding to the first (20) and second (22) reading chambers, the algorithm introduced in the control unit (5) interprets it as group O. In case of agglutination in both first (19) and second (21) reaction chambers, both visual information elements (26) are read, which is interpreted by the algorithm as group AB. In the event that blood did not reach the third reading chamber (24), whose printed code corresponds to control, it should be considered that an error has occurred in the device, since the absence of antibody does not justify agglutination and it could be due to an incorrect filling of the reaction chambers (19,21,23), which requires a new group verification.
    权利要求:
    Claims (11)
    [1]
    1. Transfusion safety device, intended to perform a pre-transfusion check of the blood group of a red blood cell concentrate (CH), contained in a bag (3) and of the blood group of an individual receiving a transfusion and determine its compatibility to allow or prevent such transfusion, characterized in that it comprises:
    -  a blood transfusion unit (1) which in turn comprises:
    -  a bag line (6), intended to be linked to the bag (3) containing the CH,
    -  a line of the individual (7), intended to be linked to an individual receiving the transfusion,
    -  a connection (8) to link the bag line (6) with the receiver line (7), and
    - a flow regulator (9) disposed in the bag line (6), which controls the passage of the circulating CH flow between the bag line (6) and the individual line (7),
    -  a first blood group verification device (2), intended to establish the blood group of the CH contained in the bag (3), located at the end of a first shunt (15) that starts from the bag line (6),
    -  a second blood group verification device (4), intended to establish the blood group of the individual receiving the transfusion, located at the end of a second shunt (17) that starts from the line of the individual (7), and
    -  a control unit (5), intended to perform a simultaneous reading of the results obtained in the first (2) and second (4) blood group verification devices, to establish the compatibility or incompatibility of both blood groups based on the reading the results obtained in the first (2) and second
    (4)  blood group verification devices, and to operate the flow regulator
    (9)  to allow or prevent the passage through the flow of CH.
    [2]
    2. Transfusion safety device according to claim 1 characterized in that the bag line (6) additionally comprises:
    -  a punch (10) intended to be introduced into the bag (3) to extract the CH contained therein, and
    - a filter (11) of macroaggregates to retain residues present in the CH contained in the bag (3).
    [3]
    3. Transfusion safety device according to claim 1 characterized in that the line of the individual (7) additionally comprises a connection point (13) intended to be inserted in a path (14) made in a vein of the recipient individual.
    [4]
    Four. Transfusion safety device according to claim 1 characterized in that each of the first (2) and second (4) blood group verification devices comprises:
    - a first reaction chamber (19), in which an anti-A reagent is housed, linked to a first reading chamber (20),
    - a second reaction chamber (21), in which an anti-B reagent is housed, linked to a second reading chamber (22), and
    -  a third reaction chamber (23), linked to a third reading chamber
    (24) for control.
    [5]
    5. Transfusion safety device according to claim 4 characterized in that each of the first (2) and second (4) blood group verification devices additionally comprises a plurality of visual information elements (26) linked to each of the chambers of reading (20,22,24).
    [6]
    6. Transfusion safety device according to claim 5 characterized in that the plurality of visual information elements (26) is a plurality of QR codes
    [7]
    7. Transfusion safety device according to claim 1 characterized in that the first (2) and second (4) blood group verification devices have a complementary geometry to each other to facilitate their linking prior to the reading of their results by the unit of control (5).
    [8]
    8. Transfusion safety device according to claim 1 characterized in that the first bypass (15) incorporates a first non-return valve (16) to prevent a return flow of said CH sample.
    [9]
    9. Transfusion safety device according to claim 1 characterized in that the second bypass (17) incorporates a second non-return valve (18) to prevent a return flow of said blood sample.
    5. Transfusion safety device according to claim 1 characterized in that the control unit (5) is a mobile device provided with an application for reading and interpreting results.
    [11]
    11. Transfusion safety device according to claim 1
    10 characterized in that the flow regulator (9) is a controllable opening magnetic valve, actuated by the control unit (5).
    [12]
    12. Transfusion safety device according to claim 1 characterized in that the first blood group verification device (2)
    15 incorporates a dynamic QR code (27) that collects information related to the individual destined to receive the CH transfusion to guarantee the traceability of the procedure.
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    同族专利:
    公开号 | 公开日
    EP3272373B1|2019-08-14|
    EP3272373A1|2018-01-24|
    ES2756473T3|2020-04-27|
    ES2660513B1|2018-12-28|
    PT3272373T|2019-11-15|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    WO2001073426A2|2000-03-27|2001-10-04|Hagit Shapira|Blood transfusion method and device|
    WO2005049130A1|2003-11-18|2005-06-02|Pier Luigi Delvigo|Safety apparatus for transfusions of blood or blood derivatives and method for the use thereof|
    WO2006046242A2|2004-10-26|2006-05-04|Pro-Iv Ltd.|Apparatus, system and method for administration of a substance|
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    WO2013083619A1|2011-12-06|2013-06-13|Universite Libre De Bruxelles|Method and device for assaying an antigen present on erythrocytes or an antibody binding to an antigen present on erythrocytes|
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    FR2951951A1|2009-11-05|2011-05-06|Centre Nat Rech Scient|SECURE INFUSION SYSTEM AND METHOD FOR IMPLEMENTING SAID METHOD|
    法律状态:
    2016-12-02| PC2A| Transfer of patent|Owner name: MARIA DEL CARMEN HURTADO MONDEJAR Effective date: 20161128 |
    2021-12-03| FD2A| Announcement of lapse in spain|Effective date: 20211203 |
    优先权:
    申请号 | 申请日 | 专利标题
    ES201630992A|ES2660513B1|2016-07-21|2016-07-21|TRANSFUSIONAL SECURITY DEVICE|ES201630992A| ES2660513B1|2016-07-21|2016-07-21|TRANSFUSIONAL SECURITY DEVICE|
    EP16382674.6A| EP3272373B1|2016-07-21|2016-12-30|Transfusion safety device|
    ES16382674T| ES2756473T3|2016-07-21|2016-12-30|Transfusion safety device|
    PT163826746T| PT3272373T|2016-07-21|2016-12-30|Transfusion safety device|
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