• 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:
    Plasmatic therapeutic replacement device. Device for therapeutic plasma exchange comprising an extracorporeal circuit comprising a blood supply line, a separation unit, an infusion line of cellular components, a replacement liquid infusion line, a blood plasma line, a line of anticoagulant and at least one independent line of therapeutic medicine. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2629163A1
    申请号:ES201700336
    申请日:2017-03-30
    公开日:2017-08-07
    发明作者:Carlos ROURA FERNÁNDEZ；Carlos ROURA SALIETTI；Antonio Manuel PÁEZ REGADERA
    申请人:Grifols Worldwide Operations Ltd；
    IPC主号:
    专利说明:

      2DESCRIPTION Therapeutic plasma exchange device The present invention relates to the medical device sector, in particular it relates to a therapeutic plasma replacement device that allows the administration of a therapeutic drug simultaneously with the performance of the plasma exchange procedure and independently of the administration of a replacement liquid. The therapeutic plasma exchange, better known by its acronym in English TPE ("Therapeutic Plasma 10 Exchange") is part of a larger set of techniques called plasmapheresis. In plasmapheresis, blood is taken from the human body and processed so that the plasma is separated from the main blood cell components (erythrocytes, leukocytes, platelets, among others). At present, plasmapheresis is used for various reasons, including transfusion, plasma donation for subsequent fractionation and obtaining blood products, or the treatment of diseases, the treatment of which is carried out by plasma removal. blood of specific disease factors. TPE is a particular type of plasmapheresis indicated as a treatment in numerous diseases, in which the plasma, which is separated from the rest of the cellular components, is discarded with the aim of eliminating harmful substances from the patient's blood. The separated blood cell components are usually mixed with a liquid, known as replacement fluid, and returned to the patient. Among the most common replacement fluids are isotonic saline solutions, colloidal solutions of albumin or fresh plasma, among others. In order to avoid hypotension or peripheral edema, it is preferable to provide a replacement liquid based on a colloidal solution of albumin or fresh plasma capable of maintaining oncotic pressure. In most cases, 4-5% albumin in isotonic saline solution is the preferred option as replacement fluid, since unlike fresh plasma, it is not specific to a blood group and carries a lower risk of allergic reactions. One of the greatest risks arising from the use of the TPE technique is due to the decrease in the concentration of most plasma proteins, such as coagulation factors, transport proteins, complement system proteins, as well as antibodies, and in particular the immunoglobulins G. For this reason, the administration of therapeutic drugs is frequently necessary after the completion of the plasma exchange procedure, with the aim, among others, of rebalancing the normal levels of plasma proteins in the patient. Such administration is usually carried out intravenously, intramuscularly or subcutaneously, among others. 35 There is a need to have TPE devices that allow the administration of one or more therapeutic drugs simultaneously with the plasma exchange procedure, so as to allow, among others, the maintenance of plasma protein levels in the patient during the duration of the plasma exchange procedure, without having to wait until the end of it 40 to be rebalanced. TPE devices known in the state of the art only allow the administration of a therapeutic medication if it is dissolved in the replacement liquid. This leads to various problems and 3these consequent risks to the patient's health, including the risk of manipulation of the replacement fluid or the inability to control the flow of the therapeutic medication independently of the flow rate of the replacement fluid, among others. Plasmapheresis or plasma exchange devices are known in the state of the art. For example, US Patent US5679245A discloses an apparatus for extracorporeal blood treatment comprising a filtration unit, a primary circuit and a secondary circuit. Said patent also discloses an anticoagulant liquid line and a replacement liquid line that converge with the primary circuit. 10 Another drawback of the TPE devices known in the state of the art is due to their large size and difficult portability that force the patient to travel to the medical center to receive treatment. There is, therefore, the need to have TPE devices that overcome the disadvantages of the devices belonging to the prior art. The inventors of the present invention have developed a TPE device that overcomes the problems mentioned above and is surprising for several reasons. Among them we can mention: the possibility of administering a therapeutic medicine simultaneously to the plasma exchange procedure and independently to the administration of a replacement liquid, as well as an improved portability. 20 In this document, the term "extracorporeal circuit" refers to the combination of the different independent lines comprising the TPE device. Here, the term "independent line or line" refers to the combination of structural elements selected from: liquid conduction means, liquid delivery means, liquid flow control means, liquid storage means, between others, who jointly perform a certain function in the TPE device. The term line does not refer to a minimum combination of structural elements, for example, in some cases a line can be formed by conduction means and storage means, in other cases, a line can be formed by conduction means, means storage, drive media, among others. In addition, different lines can share one or several structural elements. Examples of lines are: - Blood supply line or supply line: refers to the combination of structural elements that allow the patient's blood conduction from the extraction area to the entrance of the separation unit. - Infusion line of cellular components or line of cellular components: refers to the combination of structural elements that allows the conduction of cellular components from the exit of the separation unit to the infusion zone. 40 - Replacement liquid infusion line or replacement liquid line: refers to the combination of structural elements that allows the replacement of liquid from the replacement liquid container to the infusion zone. 4- Blood plasma line or plasma line: refers to the combination of structural elements that allows the conduction of blood plasma from the plasma outlet of the separation unit to the blood plasma container. - Anticoagulant line: refers to the combination of structural elements that allows the conduction of anticoagulant liquid from the anticoagulant liquid container to the supply line. - Therapeutic medication infusion line or therapeutic medication line: refers to the combination of structural elements that allows the therapeutic medication to be conducted from the therapeutic medication container to the infusion zone. 10 In this document, the terms liquid conduction means or conduction means refer to elements such as tubes, conduits, pipes, among others, which allow the conduction of liquid between two points through its inner channel. 15 The terms liquid drive means or drive means refer to any element capable of transferring energy to a liquid to achieve its movement through the conduction means. In the present invention, said drive means are preferably pumps and more preferably peristaltic pumps. 20 The terms liquid flow control means or flow control means refer to any element capable of preventing / permitting or regulating the passage of liquid through the conduction means. In the present invention, said flow control means are preferably peristaltic valves and / or pumps. It is evident to a person skilled in the art that the same element can sometimes fulfill the functions of drive means and flow control means, for example, a peristaltic pump can fulfill both functions. It is also evident to the person skilled in the art that the flow control and flow means can be electronically controlled by a centralized control unit. The terms liquid storage medium, storage medium or container are used interchangeably in the present invention to refer to any element that allows to contain liquid inside and be connected to a conduction means. Said storage means are preferably: bottles, vials, plastic bags, among others, or combinations thereof. It is obvious to the person skilled in the art that the storage means may have an output and / or an input, depending on the function they fulfill in the extracorporeal circuit. It is also evident to the person skilled in the art that the entry and / or exit of said storage means can be controlled by means of flow control. The term "therapeutic medicine" refers to any therapeutic liquid known to a person skilled in the art. Preferably, said therapeutic medicament comprises human plasma proteins selected from the group comprising albumin (5-25%), α-1-antitrypsin, von Willebrand factor, coagulation factors such as factor VII, factor VIII and factor IX, immunoglobulins, plasminogen , plasmin, antithrombin III, fibrinogen, fibrin, thrombin or combinations thereof. 5 The term blood refers to whole blood, that is, it contains all the cellular components of the blood such as erythrocytes, leukocytes, platelets, etc. In addition to plasma. The term blood plasma or plasma refers to the acellular liquid part of the blood. 5 The term separation unit refers to any device capable of separating blood into its corresponding cell and acellular fractions. In this document, said fractions are also called cellular and plasma components, respectively. Therefore, the present invention discloses a TPE device comprising an extracorporeal circuit 10 comprising a blood supply line, a separation unit, an infusion line of cellular components, a replacement liquid infusion line , a blood plasma line, an anticoagulant line in addition to at least one independent therapeutic drug line. Said independent therapeutic drug line comprises at least one therapeutic medication container, conduction means, delivery means and flow control means of said therapeutic medicament. Preferably, said drive means of said independent therapeutic drug line are at least one peristaltic pump, more preferably said peristaltic pump is a reversible peristaltic pump. In another aspect of the present invention, the inventors have carried out a simplification of a TPE device comprising at least one therapeutic drug line, whereby it is possible to achieve a portable TPE device comprising at least one line of therapeutic medication Said device simplification has been carried out by sharing structural elements (conduction means, driving means, flow control means, among others) by several of the known lines in the state of the art (liquid line replacement, cell component line, supply line, among others) in addition to the at least one therapeutic medication line. In one embodiment, the therapeutic medication line of the device of the present invention shares structural elements with one or more of the other lines of the device. Preferably, said shared structural elements 30 are the conduction means, the drive means and the flow control means. In a preferred embodiment, said shared drive means are at least one reversible peristaltic pump. In another preferred embodiment said shared flow control means is a radial distributor. 35 The term radial distributor refers to a type of distributor such as that disclosed in Spanish Patent ES 2255772 B1 (Grifols Lucas, V.) Said distributor has several conduits that communicate with a common central point of the distributor and which can be put into communication with each other by operating the flow control means integrated in said radial distributor. Said operation can be controlled automatically by a centralized control unit. The device of the present invention has a blood collection zone from the patient and an infusion zone from the patient, said zones are also simply called the extraction zone and the infusion zone. In some embodiments of the present invention, the extraction zone and the infusion zone are non-zone 6 device matches, in other embodiments, the extraction zone and the infusion zone are coincident zones of the device. In one embodiment of the present invention, the separation unit is a filter. In a preferred embodiment said filter is a hollow fiber filter. In an embodiment of the present invention, the infusion line of cellular components, the infusion line of replacement fluid and the therapeutic medicament line comprise a bubble detector suitable for sending a signal capable of stopping the action of the media. drive when an air bubble is in the conduction means of any of said lines. In an embodiment of the present invention, the TPE device comprises means for measuring the pressure in the lines. In one embodiment of the present invention, the TPE device comprises conduction means that allow the replacement fluid line and the anticoagulant fluid line to be communicated. In one embodiment of the present invention the replacement liquid is an aqueous NaCl solution of concentration of 0.8 to 1% weight / volume. The present invention is described in detail below in relation to the following figures that do not limit the scope of the present invention, in which: Figure 1 is a diagram of a first embodiment of the TPE device of the present invention. Figure 2 is a diagram of a second embodiment of the TPE device of the present invention. Figure 3 is a front view of a third embodiment of the TPE device of the present invention. In a first embodiment, as seen in Figure 1, the TPE device contains a supply line formed by tube -1- and pump -2-. Said supply line extends from the extraction zone -3- to the input -4- of the separation unit -5- and transports whole blood from the area -3- to the input -4- of said separation unit. The anticoagulant line is formed by the tube -6-, the pump -7- and the anticoagulant bag -8-, said anticoagulant line extends from the bag -8- to the supply line and transports anticoagulant liquid from said bag -8- to the supply line, where 35 is mixed with whole blood before the blood enters the separation unit -5-, where the patient's blood is separated into blood plasma and cellular components. The plasma line is formed by the tube -9- and the bag -10-, said plasma line extends from the outlet -11- of the separation unit to the bag -10- of blood plasma and transports said plasma from the exit -11- to the bag -10-, where it is stored. The infusion line of cellular components is formed by tube -12-, bag -13- of 40 cellular components, tube -14- and pump -15-, said line of cellular components extends from outlet -16 - from the separation unit to the infusion zone -17- and transports the cellular components separated by the unit -5- from the outlet -16- to the bag -13-, where they are stored in an initial stage of the replacement process plasma, and subsequently transports the cellular components stored in the 7bag -13- from said bag -13- to zone -17-. The replacement liquid infusion line is formed by the tube -18-, the pump -19-, the replacement liquid bag -20-, the tube that extends from the junction point -21- to the area - 17- and the pump -15-, said replacement liquid line extends from the bag -20- to the area -17- and transports replacement liquid from said bag -20- to the area -17-. Finally, the therapeutic drug line is formed by the tube -22-, the pump -23-, the tubes -25-, -26- and -27- that converge at the junction point -24- with the tube - 22-, the valves -29-, -30- and -31- that regulate the passage of the therapeutic medications of the vials -32-, -33- and -34- and the tube that extends from the point of attachment - 28- to zone -17-, therefore, the therapeutic drug line extends from vials -32-, -33- and -34- to zone -17-. Said therapeutic medication line transports the therapeutic medications from said vials -32-, -33- and -34- to the infusion zone -17-. In a second embodiment, as seen in Figure 2, the TPE device contains an extraction zone coinciding with an infusion zone, said zone -3- is called the extraction / infusion zone. The TPE device also contains a supply line formed by the tube -1- and the pump -2-, said supply line extends from the area -3- to the input -4- of the separation unit -5- and it carries 15 whole blood from zone -3- to the separation unit -5-. The anticoagulant line is formed by the tube -6-, the pump -7- and the anticoagulant bag -8-, said anticoagulant line extends from the bag -8- to the junction point -36- and carries liquid anticoagulant from the bag -8- to the supply line, where it is mixed with whole blood before the entry of said blood into the separation unit, where the blood is separated into blood plasma and cellular components. The plasma line 20 is formed by the tube -9- and the plasma bag -10-, said plasma line extends from the outlet -11- of the separation unit to the bag -10- and transports the blood plasma separated by the separation unit from the exit -11- to the bag -10-, where it is stored. The infusion line of cellular components is formed by the tube -12-, the bag -13- of cellular components, the tube -14-, the tube that extends from the junction point -35- to the zone -3- and the pump -2-, therefore said line of cellular components 25 extends from the outlet -16- of the separation unit to the zone -3- and transports the cellular components separated by the separation unit from the outlet - 16- to zone -3-. The replacement liquid infusion line is formed by the tube -18-, the pump -19-, the replacement liquid bag -20-, the tube that extends from the junction point -21- to the area - 3- and the pump -2-, therefore said replacement liquid line extends from the bag -20- to zone -3- and transports replacement liquid from said bag -20- to zone -3- . Finally, the therapeutic drug line is formed by the tube -22-, the pump -23-, the tubes -25-, -26- and -27- that converge at the junction point -24- with the tube -22 -, the valves -29-, -30- and -31- that regulate the passage of the therapeutic medications of the vials -32-, -33- and -34-, the tube that extends from the junction point -28 - to zone -3- and pump -2-, therefore, the therapeutic medication line extends from vials -32-, -33- and -34- to zone -3-, 35 transporting medications therapeutic from said vials to the infusion zone -3-. In a third embodiment, as seen in Figure 3, the TPE device contains an extraction zone coinciding with an infusion zone and can be called the extraction / infusion zone -3- or venous access means. The device of the embodiment also contains a blood supply line that is formed by the means -3-, the connector -Y -36-, the tube -41-, the connector-Y -37-, the tube -42 -, the pump -2-, the radial distributor -47- and the tube -43-, therefore, said supply line extends from zone -3- to inlet -4- of the separation unit -5 - and transports whole blood from zone -3- to the separation unit -5-. The anticoagulant line is formed by a bag -8- of anticoagulant, a tube -45-, a 8 connector -Y -38-, a tube -46-, a pump -7- and a connector -Y -36-, therefore said line extends from the bag -8- to the connector -Y -36-, carrying anticoagulant liquid from said bag -8- to the supply line, where it is mixed with whole blood before the entry of said blood into the separation unit -5-, where the blood is separated into blood plasma and cellular components. The plasma line is formed by the tube -9- and the plasma bag -10-, said plasma line extends from the outlet -11- of the separation unit to the bag -10- and transports the blood plasma from exit -11- to bag -10-, where it is stored. The infusion line of cellular components is formed by tube -12-, bag -13- of cellular components, tube -14-, radial distributor -47-, pump -2-, tube -42-, the bubble detector -39-, the connector -Y -37-, the tube -41-, the connector -Y -36- and the means -3-, therefore, the line of cellular components extends from the outlet -16- from the separation unit to zone -3- and transports 10 the cellular components separated from exit -16- to zone -3-. The replacement liquid infusion line is formed by the replacement liquid bag -20-, the tube -18-, the distributor -47-, the tube -42-, the pump -2-, the detector -39- , the connector -Y -37-, the tube -41-, the connector -Y -36- and the means -3-, therefore the replacement liquid line extends from the bag -20- to the area - 3-, transporting replacement liquid from said bag -20- to zone -3-. The therapeutic medication line is formed by the vial -32- of therapeutic medication, the tube -22-, the distributor -47-, the tube -42-, the pump -2-, the detector -39-, the connector -Y -37-, the tube -41-, the connector -Y -36- and the means -3-, therefore, said therapeutic drug line extends from the vial -32- to the area -3-, transporting therapeutic medication from vial -32- to zone -3-. In addition, the TPE device of Figure 3 also contains means for measuring line pressures, said means are formed by tubes -40-, -41- and a unit for measuring 20 pressures that is not shown in the figure. Finally, the device of figure 3 contains the tube -44- which allows the anticoagulant line to be connected with the replacement liquid line. As mentioned above, the distributor -47- is part of the state of the art, said distributor comprises a plurality of valves that allow communicating a plurality of tubes (eg tubes -14-, -18-, - 22-, -42-, or -43-), so that by controlling said valves it is possible to allow the passage of a certain liquid and to prevent the passage of other liquids through said distributor. 
    权利要求:
    Claims (16)
    [1]
    9 CLAIMS 1. Device for therapeutic plasma exchange comprising an extracorporeal circuit comprising a blood supply line, a separation unit, an infusion line of cellular components, a replacement fluid infusion line, a blood plasma line and an anticoagulant line 5 characterized in that it further comprises at least one independent line of therapeutic drug.
    [2]
    Device, according to claim 1, characterized in that said independent line of therapeutic medicine comprises storage means, conduction means, impulsion means and means for controlling the flow of said therapeutic medicine. 10
    [3]
    3. Device, according to claim 2, characterized in that said means for driving said therapeutic drug line are at least one peristaltic pump.
    [4]
    Device, according to claim 3, characterized in that said peristaltic pump is a reversible peristaltic pump.
    [5]
    Device according to any of the preceding claims, characterized in that said therapeutic drug line shares structural elements with one or more of the other lines of the device. twenty
    [6]
    Device, according to claim 5, characterized in that said shared structural elements are the conduction means, the drive means and the flow control means.
    [7]
    Device according to claim 6, characterized in that the shared drive means are at least one reversible peristaltic pump. 25
    [8]
    Device, according to claim 6, characterized in that the shared flow control means are integrated in a radial distributor.
    [9]
    Device according to any of the preceding claims, characterized in that it has a zone for blood extraction and a zone for infusion to the patient that are coincident.
    [10]
    10. Device according to any of the preceding claims, characterized in that the therapeutic drug comprises human plasma proteins selected from the group comprising albumin (5-25%), α-1-antitrypsin, von Willebrand factor, coagulation factors such as factor VII, factor VIII, and factor IX, immunoglobulins, plasminogen, plasmin, antithrombin III, fibrinogen, fibrin, thrombin, or combinations thereof.
    [11]
    Device according to any of the preceding claims, characterized in that the separation unit is a filter. 40 12.
    [12]
    Device according to claim 11, characterized in that said filter is a hollow fiber filter. 1013.
    [13]
    Device according to any of the preceding claims, characterized in that the infusion line of cellular components, the infusion line of replacement liquid or the therapeutic drug line comprises a bubble detector.
    [14]
    Device, according to any of the preceding claims, characterized in that it comprises means 5 for measuring pressures in the lines of the device.
    [15]
    Device according to any of the preceding claims, characterized in that it comprises conduction means that allow the replacement liquid line to communicate with the anticoagulant line. 10
    [16]
    16. Device according to any of the preceding claims, characterized in that the replacement liquid is an aqueous solution of NaCl with a concentration of 0.8 to 1.0% weight / volume.
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    同族专利:
    公开号 | 公开日
    AR111529A1|2019-07-24|
    KR20180111532A|2018-10-11|
    CL2018000623A1|2018-05-25|
    TW201838676A|2018-11-01|
    RU2755866C2|2021-09-22|
    JP2018171434A|2018-11-08|
    AU2018201969A1|2018-10-18|
    MX2018003241A|2019-02-07|
    HK1259076A1|2019-11-22|
    BR102018005135A2|2018-10-30|
    ES2629163B1|2017-12-01|
    EP3381485A1|2018-10-03|
    RU2018109409A|2019-09-16|
    IL258015D0|2018-04-30|
    UY37633A|2018-07-31|
    CN108686277A|2018-10-23|
    US20180280603A1|2018-10-04|
    RU2018109409A3|2021-05-13|
    SG10201801962VA|2018-10-30|
    JP6717870B2|2020-07-08|
    CA2998586A1|2018-09-30|
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    法律状态:
    2017-12-01| FG2A| Definitive protection|Ref document number: 2629163 Country of ref document: ES Kind code of ref document: B1 Effective date: 20171201 |
    优先权:
    申请号 | 申请日 | 专利标题
    ES201700336A|ES2629163B1|2017-03-30|2017-03-30|Therapeutic plasma replacement device|ES201700336A| ES2629163B1|2017-03-30|2017-03-30|Therapeutic plasma replacement device|
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    CL2018000623A| CL2018000623A1|2017-03-30|2018-03-09|Therapeutic plasma replacement device.|
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    JP2018043808A| JP6717870B2|2017-03-30|2018-03-12|Device for plasmapheresis|
    TW107108641A| TW201838676A|2017-03-30|2018-03-14|Device for therapeutic plasma exchange|
    MX2018003241A| MX2018003241A|2017-03-30|2018-03-15|Device for therapeutic plasma exchange.|
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    ARP180100628A| AR111529A1|2017-03-30|2018-03-19|THERAPEUTIC PLASMATIC SPARE PARTS DEVICE|
    AU2018201969A| AU2018201969A1|2017-03-30|2018-03-20|Device for Therapeutic Plasma Exchange|
    US15/926,222| US20180280603A1|2017-03-30|2018-03-20|Device for therapeutic plasma exchange|
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