Working fluid treatment device for mass transfer between working fluid and two fluid exchange media

Abstract

To provide a working fluid treatment device for excellent material movement between working fluid and two fluid exchange media.SOLUTION: An extracorporeal blood treatment device comprises a single housing defining an internal blood flow cavity. The housing accommodates an oxygenator, a heat exchanger and an additional mass transfer assembly, each having an array of fluid conduits. The arrays are co-located within an internal blood flow cavity such that blood flowing through the internal blood flow cavity flows substantially homogeneously around all the conduits. The arrays are arranged relative to one another within the internal blood flow cavity so that they together define a continuous blood flow path through the internal blood flow cavity along which blood can flow. The continuous blood flow path has a blood entry surface at one end and a blood exit surface at the opposite end. The overall blood flow direction from the blood entry surface along the blood flow path to the blood exit surface follows substantially a straight line.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present disclosure generally relates to a working fluid treatment apparatus. Such an apparatus is used to modify the properties of a working fluid, for example, by adding a substance to or removing a substance from the working fluid, or by heating or cooling the working fluid.

[0002] More specifically, the present disclosure relates to an extracorporeal blood treatment apparatus configured to exchange substances and / or energy between blood flowing through the extracorporeal blood treatment apparatus and a fluid transport medium. In particular, the present disclosure relates to an extracorporeal blood treatment apparatus including an oxygenator and a heat exchanger.

Background Art

[0003] Devices for treating working fluids such as beverages, industrial gases, liquid fossil fuels, body fluids, particularly blood, come in various forms. A typical example is the so-called blood oxygenator.

[0004] An oxygenator (artificial lung) is an extracorporeal gas exchange device that increases the oxygen in the blood. They may be used during surgeries where the blood supply from the heart to the body organs is interrupted. Non-limiting examples of procedures where an oxygenator can be used include cardiopulmonary bypass procedures, extracorporeal membrane oxygenation (ECMO) procedures, and pump-assisted lung protection (PALP) procedures.

[0005] Generally, oxygenators can be divided into two main groups: the so-called "bubble-type oxygenators" and "membrane-type oxygenators". The use of bubble-type oxygenators has been decreasing significantly over time because they are likely to damage blood cells and plasma proteins.

[0006] Membrane-type oxygenators direct the blood flow to contact the surface of a semipermeable membrane through which CO2 and O2 can diffuse or move. They are generally applied to mimic the function of the lungs during short-term cardiopulmonary bypass (CPB) and / or to oxygenate the blood in a long-term life support device called extracorporeal membrane oxygenation (ECMO).

[0007] Most currently available CPB and ECMO systems involve various external components and accessories, such as heat exchangers, blood concentrators, bubble detectors, infusion and sampling units, pumps, etc. These are connected to the tubing circuit of the oxygenator according to the operating settings and the patient's needs.

[0008] These CPB and ECMO systems have the drawback of including a large number of heterogeneous components and involving many tubes.

[0009] This drawback is not so prominent in commercially available membrane oxygenators that include an integrated heat exchange device. An example of such a device is disclosed in WO90 / 04419. This document shows an integrated blood heating and oxygenation device for use in cardiac surgery. It includes a central heat-conductive core disposed within an external housing. The heat exchange core has an outer surface formed by a plurality of adjacent blood receiving channels. This device further includes a gas-permeable membrane in the form of a porous hollow fiber membrane attached around the heat exchange core to cover the blood receiving channels. This membrane enables the exchange of CO2 and O2.

[0010] Document US2016 / 0000989A1, which is incorporated herein by reference in its entirety for all that it discloses, describes a carbon dioxide removal system. This system is configured similarly to an oxygenator but is not intended to actively oxygenate the patient's blood. This system has two chambers, each containing a hollow fiber gas exchange mat.

[0011] Document US8,133,195B2 shows another extracorporeal blood treatment device that includes an oxygenator, a heat exchanger, and a blood filter. Document US8,133,195B2 is incorporated herein by reference in its entirety for all that it discloses.

[0012] Another type of extracorporeal blood treatment device is disclosed in DE3733542A1. FIG. 10 of this document shows a device for heat and mass exchange of a modular structure. In this device, a heat exchanger module is coupled with an oxygen supply module to form a single entity. The device can be complemented by one or more further modules, such as a blood concentrator, for example.

[0013] The disadvantage of this device is that the blood treatment units (heat exchanger, oxygen supply, blood concentrator) within the separate modules are arranged in series, and these are connected to each other by intermediate connection rings. As a result, the blood path is constricted and then widened. This is accompanied by corresponding pressure changes, high shear stress, and blood cell damage in the longitudinal direction of the device. When moving from one module to another, the blood exits the hollow fibers of the first module, enters the transfer chamber, and then flows into the hollow fibers of the second module. The associated widening of the flow cross-sectional area from the first fiber to the transfer chamber and the subsequent narrowing of the flow cross-sectional area from the transfer chamber to the second fiber cause undesirable stress on the components of the blood and may damage these blood components.

[0014] Document WO2019 / 166823A1 relates to an oxygen supply having a supply gas dispersion configuration.

[0015] Document JP2001-079083A2 describes an artificial lung device having an oxygen addition region and a nitric oxide addition region.

[0016] Document WO2019 / 035869A1 relates to a dual-chamber gas exchanger. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0017] In light of the foregoing, it is an object of the present disclosure to provide a highly integrated working fluid treatment device.

[0018] A further object of the present disclosure is to provide a particularly compact working fluid treatment device.

[0019] A further object of the present disclosure is to provide a multi-purpose working fluid treatment device capable of performing a plurality of different processes on a working fluid according to a desired application.

[0020] A further object of the present disclosure is to provide a working fluid treatment device that enables mass transfer between a working fluid and a plurality of different fluid exchange media.

[0021] A further object of the present disclosure is to provide a compact extracorporeal blood treatment device that includes a membrane oxygenator integrated with at least one additional blood treatment assembly capable of not only heat exchange but also mass transfer, so that blood circulation is less stimulating, pressure drop is small, and blood cell damage is significantly reduced.

[0022] According to one aspect of the present disclosure, there is provided a working fluid treatment device for mass transfer between a working fluid and a first fluid exchange medium, and for mass transfer between the same working fluid and a second fluid exchange medium different from the first fluid exchange medium. The working fluid treatment device has a collective first fluid exchange medium inlet for introducing the first fluid exchange medium into the working fluid treatment device, a collective second fluid exchange medium inlet that is fluidly separated from the first fluid exchange medium inlet and for introducing the second fluid exchange medium into the working fluid treatment device, and an integrated working fluid treatment chamber. The chamber has a working fluid inlet, a working fluid outlet, and a first group of conduits of a first mass transfer conduit disposed between the working fluid inlet and the working fluid outlet. The first group of conduits has an inlet end for receiving the first fluid exchange medium into the first group of conduits, and an outlet end for discharging the used first fluid exchange medium from the first group of conduits. The first conduit group performs mass transfer of a first substance using a working fluid when the first fluid exchange medium flows through the first conduit group. The second conduit group of a second mass transfer conduit disposed between the working fluid inlet and the working fluid outlet has an inlet end for receiving a second fluid exchange medium into the second conduit group, and an outlet end for discharging the used second fluid exchange medium from the second conduit group. When the second fluid exchange medium flows through the second conduit group, it performs mass transfer of a second substance using a working fluid. The first fluid exchange medium inlet is connected to the inlet end of the first conduit group to collectively convey the first fluid exchange medium to all of the first mass transfer conduits of the first conduit group. The second fluid exchange medium inlet is connected to the inlet end of the second conduit group to collectively convey the second fluid exchange medium to all of the second mass transfer conduits of the second conduit group. The first conduit group and the second conduit group are disposed between the working fluid inlet and the working fluid outlet in the chamber. When the working fluid moves from the working fluid inlet into the chamber, then passes through the chamber, and then exits the chamber through the working fluid outlet, it flows around the first conduit group of the first mass transfer conduits and the second conduit group of the second mass transfer conduits. There is an essentially uniform conduit distribution throughout the total volume of the chamber such that the cross-sectional area of the flow of the working fluid is kept substantially constant through the chamber. It is a working fluid treatment device.

[0023] Since the flow cross-section of the entire working fluid treatment chamber is constant, the working fluid circulates through the device in a very smooth state. Furthermore, since all the conduit groups are located in the same place within the same single working fluid treatment chamber, the device of the present disclosure is very compact.

[0024] In one embodiment, the first mass transfer conduit and the second mass transfer conduit can be hollow semipermeable membrane fibers.

[0025] In one embodiment, the semipermeable membrane constituting the semipermeable membrane fiber is liquid-impermeable. It may be any of a permeable microporous membrane with micropores opened to increase mass transfer across the membrane, or a diffusion membrane having a non-porous layer to prevent long-term membrane wetting of the membrane.

[0026] In one embodiment, the semipermeable membrane constituting the first mass transfer conduit may be a permeable microporous membrane, and the semipermeable membrane constituting the second mass transfer conduit may be a diffusion membrane.

[0027] In one embodiment, the working fluid treatment device may further include a single shared fluid exchange medium outlet connected to the outlet ends of the first and second conduit groups for receiving the used first and second fluid exchange media.

[0028] In one embodiment, the working fluid treatment device may further include a first fluid exchange medium outlet connected to the outlet end of the first conduit group for receiving the used first fluid exchange medium, and a second fluid exchange medium outlet connected to the outlet end of the second conduit group for receiving the used second fluid exchange medium, and the second fluid exchange medium outlet may be fluidly separated from the first fluid exchange medium outlet.

[0029] In one embodiment, when the working fluid moves through the device, it can flow sequentially through the first conduit group and the second conduit group.

[0030] In one embodiment, during operation, a first portion of the working fluid can flow through the first conduit group, and in parallel, a second portion of the working fluid, different from the first portion, can flow through the second conduit group.

[0031] In one embodiment, the first conduit group and the second conduit group may be configured in cooperation with interleaved first and second mass transfer conduits that form the flow rate of the working fluid.

[0032] In one embodiment, the first conduit group and the second conduit group can be stacked on top of each other.

[0033] In one embodiment, each of the first conduit group and the second conduit group can constitute a bundle of hollow semipermeable membrane fibers.

[0034] In one embodiment, each fiber bundle can be an assembly of one or more layered fiber mats.

[0035] In one embodiment, the first conduit group and the second conduit group can form one or more stacked rectangular fiber mats.

[0036] In one embodiment, the first conduit group can define the flow direction of the first fluid exchange medium, the second conduit group can define the flow direction of the second fluid exchange medium, and the first flow direction and the second flow direction may be set at an angle of 90° to each other.

[0037] In one embodiment, the device can be a cylindrical wound fiber mat device.

[0038] In one embodiment, each fiber bundle can have a cross-section in the shape of a ring or a part of a ring, and the fiber bundles may be nested around a common central longitudinal axis.

[0039] In one embodiment, the fibers of each fiber bundle can have an open-loop shape.

[0040] In one embodiment, the fibers of all the fiber bundles may be looped around a common central longitudinal axis of the working fluid treatment device.

[0041] In one embodiment, the integrated working fluid treatment chamber may further include a third conduit group of heat exchange conduits for heat exchange between the working fluid and the heat exchange fluid.

[0042] In one embodiment, the device can be adapted to treat blood as the working fluid, the first conduit group can be adapted to oxygenate the blood, and the second conduit group can be adapted to deliver nitric oxide to the blood.

[0043] In one embodiment, the device can be adapted to treat blood as a working fluid, the first conduit group can be adapted to oxygenate the blood, and the second conduit group can be adapted to deliver an anesthetic to the blood.

[0044] According to a further aspect of the present disclosure, a method of treating a patient during a cardiopulmonary bypass surgery using a working fluid treatment device as described above is provided.

[0045] According to a further aspect of the present disclosure, an extracorporeal blood treatment device for the transfer of substances and energy between a patient's blood and a fluid exchange medium is provided. The extracorporeal blood treatment device comprises a housing defining an internal blood flow cavity having a substantially constant cross-section, the blood flow cavity being configured such that blood flow therethrough substantially traverses the entire volume of the internal blood flow cavity, The housing is a first mass transfer assembly configured to oxygenate the patient's blood via a first gas exchange medium, the first mass transfer assembly comprising an array of gas transfer conduits for transferring oxygen to the patient's blood and forming a first gas circuit for the first gas exchange medium, a heat exchange assembly configured to heat or cool the blood using a heat energy transfer medium and comprising an array of heat transfer conduits carrying the heat energy transfer medium, one or more additional mass transfer assemblies configured to provide mass transfer between the fluid exchange medium and the patient's blood, each of the one or more additional mass transfer assemblies comprising an array of mass transfer conduits for transferring one or more substances from or to the patient's blood, and each of the additional mass transfer assemblies forms a separate fluid circuit for a specific fluid exchange medium that is different from the first gas circuit, The blood flowing through the internal blood flow cavity flows substantially uniformly around all of the conduits of the first mass transfer assembly, the heat exchange assembly, and the one or more additional mass transfer assemblies, and the array of the one or more additional mass transfer assemblies is located in the same location within the internal blood flow cavity. An array of a first mass transfer assembly, a heat exchange assembly, and one or more additional mass transfer assemblies are arranged relative to one another within an internal blood flow cavity such that a continuous blood flow path is defined through the internal blood flow cavity along which blood flows and is processed by all of the assemblies. The continuous blood flow path has a blood inlet surface at one end and a blood outlet surface at an opposite end in the overall blood flow direction. The overall blood flow direction from the blood inlet surface along the blood flow path to the blood outlet surface follows a substantially straight line.

[0046] In one embodiment, each assembly may include respective inlets and respective outlets connected to a housing for introduction and removal of respective fluid exchange media to and from the individual assemblies.

[0047] In one embodiment, at least one of the additional mass transfer assemblies may be selected from the group consisting of fluid transfer assemblies configured to transfer a specific gas to the patient's blood, and the specific gas may be selected from the group consisting of volatile anesthetics (such as isoflurane or sevoflurane), nitric oxide (NO), and nitric oxide in a mixture with an inert gas.

[0048] In one embodiment, at least one of the additional mass transfer assemblies may be selected from the group consisting of fluid transfer assemblies configured to transfer a specific liquid to the patient's blood, and the specific liquid may be selected from the group consisting of drugs, buffers, and pH control agents in the form of acids or bases.

[0049] In one embodiment, at least one of the additional mass transfer assemblies may be configured to remove blood compounds or components circulating in the blood, such as blood electrolytes, plasma, antibodies, or endotoxins, and / or at least one of the other mass transfer assemblies may be configured for blood filtration and hemodialysis.

[0050] In one embodiment, at least one of the additional mass transfer assemblies can be configured to measure the partial pressure of a gas in a patient's blood.

[0051] In one embodiment, the mass transfer conduit and the gas transfer conduit can be hollow fibers, and the mass transfer conduit and the gas transfer conduit can have a microporous structure.

[0052] In one embodiment, each assembly inlet can have a distribution header for distributing each fluid exchange medium to the conduits of the assembly.

[0053] In one embodiment, the hollow fibers can have open ends that are spaced apart from each other and can be fixed to each other by a layer of potting material.

[0054] In one embodiment, the layer of potting material can form the inlet plate and the outlet plate of the assembly.

[0055] In one embodiment, each assembly inlet can have a distribution header for distributing each fluid exchange medium to the conduits of the assembly, and the inlet plate can be disposed at the bottom of the distribution header.

[0056] In one embodiment, the hollow fibers can be provided in the form of a fiber mat

[0057] In one embodiment, the conduits of two different assemblies can be set at an angle of 90° to each other and stacked.

[0058] In one embodiment, two assemblies can be paired within one chamber of the device, and the conduits of one assembly can alternate with the conduits of the other assembly in the direction of blood flow.

[0059] In one embodiment, the assembly can be arranged as a concentric ring.

[0060] In one embodiment, the assembly can be arranged in a loop and stacked on top of each other.

[0061] In one embodiment, the device can further include a single blood inlet and a single blood outlet attached to the housing, such that the inlet can introduce the patient's blood into the internal blood flow cavity of the device, such that the blood can pass through each array in a direction substantially perpendicular to the flow direction of the fluid exchange medium.

[0062] In one embodiment, internal partitions or constrictions can be eliminated from the internal blood flow cavity, disregarding the arrays of the assembly.

[0063] In one embodiment, the first mass transfer assembly i) a gas inlet disposed within the housing for introducing an oxygen-rich gas exchange medium into the first mass transfer assembly, and ii) a gas outlet disposed within the housing for discharging an oxygen-poor gas exchange medium from the first mass transfer assembly, and can further include Each of the additional mass transfer assemblies i) a dedicated separate fluid inlet different from the gas inlet, the dedicated separate fluid inlet being disposed within the housing for introducing a fluid exchange medium into the mass transfer assembly, and ii) a dedicated separate fluid outlet different from the gas outlet, the dedicated separate fluid outlet being disposed within the housing for discharging a fluid exchange medium from the mass transfer assembly, and can further include.

[0064] The definitions of the terms used in this disclosure are provided as follows. - Semipermeable membrane: A membrane that allows certain particles to pass through but not others. - Permeable Pore Membrane: A semi-permeable membrane with micropores that open to increase mass transfer across the membrane. The walls of the permeable pore membrane have numerous pores that extend across the entire thickness of the wall. The pores are open on both sides of the membrane wall. The permeable pore membrane is liquid-tight. Since it tends to become wet over time, the permeable pore membrane is typically used only for short-term applications such as CPB. Generally, it is not suitable for long-term use such as ECMO therapy. Commercial examples of permeable pore membranes are OXYPHAN (TM) (a polypropylene capillary membrane manufactured by Thermally Induced Phase Separation (TIPS) technology) sold by 3M (TM), and the Membrana (TM) oxygenation membrane series (a capillary membrane manufactured by polypropylene extrusion, where pores are generated by a continuous annealing and stretching process). Polypropylene is one of the materials suitable for manufacturing permeable pore membranes. - Diffusion Membrane: A semi-permeable membrane that includes a non-porous layer to prevent long-term membrane wetting. The non-porous layer can take the form of an outer skin. Gas can pass through the non-porous layer by first dissolving in the layer material on one side of the layer and then leaking out from the layer material on the opposite side of the layer. The diffusion membrane is liquid-tight. It is designed specifically for long-term use such as ECMO therapy. A commercial example of a diffusion membrane is OXYPLUS (TM) (an integral asymmetric hollow fiber oxygenation membrane made from polymethylpentene processed using TIPS technology) sold by 3M (TM). Polymethylpentene is one of the materials suitable for manufacturing diffusion membranes. - Heat Exchange Fiber: A liquid-tight fiber for controlling the temperature of a working fluid such as blood. Unlike gas exchange fibers made of semi-permeable membranes, heat exchange fibers are made of a liquid-tight material with excellent thermal conductivity. A commercial example of a heat exchange fiber is HEXPET (TM) (a transparent heat exchange capillary made from polyethylene terephthalate, which is a polyester) sold by 3M (TM). Polyethylene terephthalate (PET) is one of the materials suitable for manufacturing heat exchange fibers. - Uniform Flow: The laminar flow of a fluid with a constant pressure and flow rate throughout the flow. -Actuating fluid: A gas or liquid used to perform a specific type of function or operation. Blood is a type of actuating fluid because it is a liquid used for substance transport within the human body. -Straight line: The actuating fluid has a flow direction that follows a straight line as a whole when the outer boundary line of the flow remains straight throughout the relevant part of the flow. -Mass transfer: Mass transfer refers to the transfer to or from the actuating fluid of substances that have mass, such as gases (e.g., oxygen, carbon dioxide (CO2), nitrous oxide (N2O), volatile anesthetics (e.g., isoflurane or sevoflurane), nitric oxide (NO), and nitrous oxide in mixtures with inert gases, etc.) and / or liquids (e.g., plasma, drugs, electrolytes, buffers, or pH regulators in the form of acids or bases, etc.).

[0065] A further aspect of the present disclosure relates to a cardiopulmonary bypass system such as a heart-lung machine, which includes the blood treatment device of the present disclosure as well as other components such as pumps, bubble traps, arterial filters, bubble sensors, or other sensors.

[0066] Here, some embodiments of the present disclosure will be described merely as non-limiting examples with reference to the accompanying drawings. The present invention provides, for example, the following. (Item 1) An actuating fluid treatment device for mass transfer between an actuating fluid and a first fluid exchange medium and for mass transfer between the same actuating fluid and a second fluid exchange medium different from the first fluid exchange medium, wherein the actuating fluid treatment device has a collective first fluid exchange medium inlet for introducing the first fluid exchange medium into the actuating fluid treatment device, a collective second fluid exchange medium inlet that is fluidly separated from the first fluid exchange medium inlet for introducing the second fluid exchange medium into the actuating fluid treatment device, and an integrated actuating fluid treatment chamber, wherein the chamber has an actuating fluid inlet, an actuating fluid outlet, A first conduit group of a first mass transfer conduit disposed between the working fluid inlet and the working fluid outlet, wherein the first conduit group has an inlet end for receiving the first fluid exchange medium into the first conduit group, and an outlet end for discharging the used first fluid exchange medium from the first conduit group, wherein the first conduit group is a first conduit group that performs mass transfer of a first substance using the working fluid when the first fluid exchange medium flows through the first conduit group, and includes a second conduit group of a second mass transfer conduit disposed between the working fluid inlet and the working fluid outlet, wherein the second conduit group has an inlet end for receiving the second fluid exchange medium into the second conduit group, and an outlet end for discharging the used second fluid exchange medium from the second conduit group, wherein the second conduit group performs mass transfer of a second substance using the working fluid when the second fluid exchange medium flows through the second conduit group, wherein the first fluid exchange medium inlet is connected to the inlet end of the first conduit group to collectively transport the first fluid exchange medium to all of the first mass transfer conduits of the first conduit group, wherein the second fluid exchange medium inlet is connected to the inlet end of the second conduit group to collectively transport the second fluid exchange medium to all of the second mass transfer conduits of the second conduit group, wherein the first conduit group and the second conduit group are disposed between the working fluid inlet and the working fluid outlet in the chamber, and when the working fluid moves from the working fluid inlet into the chamber, then passes through the chamber, and then exits the chamber through the working fluid outlet, it flows around the first conduit group of the first mass transfer conduit and the second conduit group of the second mass transfer conduit, wherein there is an essentially uniform conduit distribution over the entire volume of the chamber such that the cross-section of the flow of the working fluid is kept substantially constant through the chamber, A working fluid processing device. (Item 2) The operation fluid processing apparatus according to item 1, wherein the first mass transfer conduit and the second mass transfer conduit are hollow semipermeable membrane fibers. (Item 3) The semipermeable membrane constituting the semipermeable membrane fiber is liquid-impermeable, and is either an osmotic pore membrane having micropores opened to increase mass transfer across the membrane, or a diffusion membrane including a non-porous layer that prevents long-term membrane wetting of the membrane. The operation fluid processing apparatus according to item 2. (Item 4) The semipermeable membrane constituting the first mass transfer conduit is an osmotic pore membrane, and the semipermeable membrane constituting the second mass transfer conduit is a diffusion membrane. The operation fluid processing apparatus according to item 3. (Item 5) The operation fluid processing apparatus according to any one of items 1 to 4, further comprising a single shared fluid exchange medium outlet connected to the outlet ends of the first and second conduit groups for receiving the used first and second fluid exchange media. (Item 6) A first fluid exchange medium outlet connected to the outlet end of the first conduit group for receiving the used first fluid exchange medium, and a second fluid exchange medium outlet connected to the outlet end of the second conduit group for receiving the used second fluid exchange medium, wherein the second fluid exchange medium outlet is fluidly separated from the first fluid exchange medium outlet. The operation fluid processing apparatus according to any one of items 1 to 4. (Item 7) The operation fluid processing apparatus according to any one of items 1 to 6, wherein when the operation fluid moves through the apparatus, it sequentially flows through the first conduit group and the second conduit group. (Item 8) During operation, a first portion of the operation fluid flows through the first conduit group, and in parallel, a second portion of the operation fluid, which is different from the first portion, flows through the second conduit group. The operation fluid processing apparatus according to any one of items 1 to 6. (Item 9) The first conduit group and the second conduit group are configured by cooperating with interleaved first and second mass transfer conduits that form a flow rate of the working fluid, the working fluid treatment apparatus according to any one of items 1 to 6. (Item 10) The first conduit group and the second conduit group are stacked one on top of the other, the working fluid treatment apparatus according to any one of items 1 to 9. (Item 11) Each of the first conduit group and the second conduit group constitutes a bundle of hollow semipermeable membrane fibers, the working fluid treatment apparatus according to any one of items 1 to 10. (Item 12) Each fiber bundle is an aggregate of one or more layered fiber mats, the working fluid treatment apparatus according to item 11. (Item 13) The first conduit group and the second conduit group form a stack of one or more rectangular fiber mats, the working fluid treatment apparatus according to item 12. (Item 14) The first conduit group defines the flow direction of the first fluid exchange medium, and the second conduit group defines the flow direction of the second fluid exchange medium, The first flow direction and the second flow direction are set at an angle of 90° with respect to each other, the working fluid treatment apparatus according to item 13. (Item 15) The apparatus is a cylindrical wound fiber mat apparatus, the working fluid treatment apparatus according to item 12. (Item 16) Each fiber bundle has a cross section in the shape of a ring or a part of a ring, and the fiber bundles are nested around a common central longitudinal axis, the working fluid treatment apparatus according to item 15. (Item 17) The fibers in each fiber bundle have an open loop shape, the working fluid treatment apparatus according to item 11. (Item 18) The fibers of all the fiber bundles are looped around a common central longitudinal axis of the working fluid treatment apparatus, the working fluid treatment apparatus according to item 17. (Item 19) The operating fluid treatment apparatus according to any one of items 1 to 18, wherein the integrated operating fluid treatment chamber further includes a third group of conduits of heat exchange conduits for heat exchange between the operating fluid and the heat exchange fluid. (Item 20) The apparatus is adapted to treat blood as the operating fluid, The operating fluid treatment apparatus according to any one of items 1 to 19, wherein the first group of conduits is adapted to oxygenate the blood, and the second group of conduits is adapted to deliver nitric oxide to the blood. (Item 21) The apparatus is adapted to treat blood as the operating fluid, The operating fluid treatment apparatus according to any one of items 1 to 19, wherein the first group of conduits is adapted to oxygenate the blood, and the second group of conduits is adapted to deliver an anesthetic to the blood. (Item 22) A method of treating a patient during a cardiopulmonary bypass surgery using the operating fluid treatment apparatus according to item 20 or 21. (Item 23) An extracorporeal blood treatment apparatus for substance and energy transfer between a patient's blood and a fluid exchange medium, the extracorporeal blood treatment apparatus comprising a housing defining an internal blood flow cavity having a substantially constant cross-section, the blood flow cavity being configured such that blood flow therethrough substantially traverses the entire volume of the internal blood flow cavity, The housing, A first mass transfer assembly configured to oxygenate the patient's blood through a first gas exchange medium, the first mass transfer assembly comprising an array of gas transfer conduits for transferring oxygen to the patient's blood, and forming a first gas circuit for the first gas exchange medium, A heat exchange assembly configured to heat or cool the blood using the heat energy transfer medium, the heat exchange assembly comprising an array of heat transfer conduits carrying the heat energy transfer medium, One or more additional mass transfer assemblies configured to provide mass transfer between a fluid exchange medium and the patient's blood, each comprising an array of mass transfer conduits for transferring one or more substances from or to the patient's blood, and the one or more additional mass transfer assemblies, Each of the additional mass transfer assemblies forms a separate fluid circuit for a specific fluid exchange medium that is different from the first gas circuit. The blood flowing through the internal blood flow cavity flows substantially uniformly around all of the conduits of the first mass transfer assembly, the heat exchange assembly, and the one or more additional mass transfer assemblies, and the array of the one or more additional mass transfer assemblies is located at the same location within the internal blood flow cavity. The array of the first mass transfer assembly, the heat exchange assembly, and the one or more additional mass transfer assemblies are arranged relative to each other within the internal blood flow cavity such that a continuous blood flow path is defined through the internal blood flow cavity along which blood flows and is processed by all of the assemblies. The continuous blood flow path has a blood inlet surface at one end and a blood outlet surface at the opposite end in the overall blood flow direction. The device in which the overall blood flow direction from the blood inlet surface along the blood flow path to the blood outlet surface substantially follows a straight line. (Item 24) The device according to item 23, wherein each assembly includes respective inlets and respective outlets connected to the housing for introduction and removal of respective fluid exchange media to and from the individual assemblies. (Item 25) At least one of the additional mass transfer assemblies is selected from the group consisting of the fluid transfer assemblies configured to transfer a specific gas to the patient's blood. The device according to item 23 or 24, wherein the specific gas is selected from the group consisting of volatile anesthetics (e.g., isoflurane or sevoflurane), nitric oxide (NO), and nitric oxide in a mixture with an inert gas. (Item 26) At least one of the additional mass transfer assemblies is selected from the group consisting of fluid transfer assemblies configured to transfer a specific liquid to the patient's blood, The device according to any one of items 23 to 25, wherein the specific liquid is selected from the group consisting of a drug, a buffer, and a pH control agent in the form of an acid or a base. (Item 27) At least one of the additional mass transfer assemblies is configured to remove a blood compound or component circulating in the blood, such as a blood electrolyte, plasma, antibody, or endotoxin, from the blood, and / or at least one of the other mass transfer assemblies is configured for blood filtration and hemodialysis, The device according to any one of items 23 to 26. (Item 28) The device according to any one of items 23 to 27, wherein at least one of the additional mass transfer assemblies is configured to measure the partial pressure of a gas in the patient's blood. (Item 29) The mass transfer conduit and the gas transfer conduit are hollow fibers, The device according to any one of items 23 to 28, wherein the mass transfer conduit and the gas transfer conduit have a microporous structure. (Item 30) The inlet of each assembly has a distribution header for distributing the respective fluid exchange medium to the conduit of the assembly, The device according to any one of items 24 to 29. (Item 31) The device according to item 29, wherein the hollow fibers are arranged at intervals from each other and have open ends fixed to each other by a layer of potting material. (Item 32) The device according to item 31, wherein the layer of potting material constitutes an inlet plate and an outlet plate of the assembly. (Item 33) Each assembly inlet has a distribution header for distributing the respective fluid exchange medium to the conduit of the assembly, The inlet plate is the device according to item 32, which is arranged at the bottom of the distribution header. (Item 34) The device according to item 29, wherein the hollow fibers are provided in the form of a fiber mat. (Item 35) The device according to any one of items 23 to 34, wherein the conduits of two different assemblies are set at an angle of 90° to each other and stacked. (Item 36) The device according to any one of items 23 to 35, wherein two assemblies are paired within one chamber of the device, and the conduits of one assembly alternate with the conduits of the other assembly in the direction of the blood flow. (Item 37) The device according to item 34, wherein the assembly is arranged as a concentric ring. (Item 38) The device according to item 34, wherein the assembly is arranged in a loop shape and stacked on each other. (Item 39) The device according to any one of items 23 to 38, further comprising a single blood inlet and a single blood outlet attached to the housing, wherein the inlet introduces the patient's blood into the internal blood flow cavity of the device, and the blood can pass through each array in a direction substantially perpendicular to the flow direction of the fluid exchange medium. (Item 40) The device according to any one of items 23 to 39, wherein there is no internal partition or constriction in the internal blood flow cavity if the array of the assembly is ignored. (Item 41) The first mass transfer assembly is i) a gas inlet arranged in the housing for introducing an oxygen-rich gas exchange medium into the first mass transfer assembly, and ii) a gas outlet arranged in the housing for discharging an oxygen-poor gas exchange medium from the first mass transfer assembly, and further comprises Each of the additional mass transfer assemblies i) A dedicated and separate fluid inlet different from the gas inlet, the dedicated and separate fluid inlet being disposed within the housing for introducing a fluid exchange medium into the mass transfer assembly; and ii) A dedicated and separate fluid outlet different from the gas outlet, the dedicated and separate fluid outlet being disposed within the housing for discharging the fluid exchange medium from the mass transfer assembly. The apparatus according to any one of items 23 to 40, further comprising the dedicated and separate fluid outlet.

Brief Description of the Drawings

[0067]

Figure 1

Figure 2

Figure 3

Figure 4a

Figure 4b

Figure 4c

Figure 4d

Figure 4e

Figure 5

Figure 6a

Figure 6b

Figure 7

Figure 8

DETAILED DESCRIPTION OF THE INVENTION

[0068] The present disclosure relates to an integrated device dedicated to mass transfer between an operating fluid and at least two different fluid exchange media. This device can be used to remove or add substances to a wide range of operating fluids in all kinds of chemical engineering applications. Preferred applications of embodiments of the present disclosure are in the medical treatment of human blood. However, the applications of embodiments of the present disclosure extend to fluids other than human blood.

[0069] In particular, the present disclosure relates to an innovative extracorporeal blood treatment device that can, in addition to adding oxygen to and temperature controlling a patient's blood flow, simultaneously add or remove additional substances to or from the blood in an efficient, effective, and safe manner with a minimally invasive method. In non-limiting exemplary embodiments, the device is adapted to directly access the patient's vascular system. According to certain non-limiting embodiments, the extracorporeal blood treatment device is specifically designed to remove or add various substances to the flow of a patient's blood in a single pass. This device can be used in a variety of medical and surgical applications, including, to name just a few, cardiopulmonary bypass surgery, delivery of anesthetics such as isoflurane and sevoflurane, addition of nitric oxide to a patient's blood, or pH control of the blood.

[0070] FIG. 1 shows an exemplary usage of a blood treatment device identified by reference numeral 10. The blood treatment device 10 is connected to the blood circuit of patient 1 via tube 12. As a result, the patient's blood bypasses her lungs 2 and instead circulates through the blood treatment device 10. The blood treatment device 10 effectively functions as an artificial lung and oxygenates the patient's blood, for example, during surgical interventions such as cardiopulmonary bypass procedures, ECMO procedures, or PALP procedures.

[0071] The blood treatment device 10 has a blood inlet 14 and a blood outlet 16. Both the inlet 14 and the outlet 16 are part of the housing 18 of the blood treatment device 10.

[0072] The blood treatment device 10 has an internal blood flow cavity. The internal blood flow cavity is located at the center of the blood treatment device 10. The transfer of substances and heat to and from the blood occurs within the internal blood flow cavity.

[0073] Figure 2 shows the internal blood flow cavity 20 of the blood treatment device 10. The internal blood flow cavity 20 is delimited by a box-shaped frame 22. The frame 22 is subdivided into two blood circulation chambers 24 and 26. Blood enters the blood flow cavity 20 from above 28, passes through the two chambers 24 and 26, and exits the blood flow cavity 20 at its lower part 30. In other words, the upper part 28 corresponds to the blood inlet of the cavity, and the lower part 30 corresponds to the blood outlet of the cavity. Here, the blood outlet 30 is located on the opposite side of the blood inlet 28. Based on the direction of blood flow, chamber 24 is the upper chamber, and chamber 26 is the lower chamber. Thus, the blood flow cavity 20 is configured such that the blood flow through it substantially covers its entire volume. In this context, substantially means within 10% of the total volume. Note that the cross-section of the internal blood flow cavity 20 is substantially constant. In this context, substantially means a constant cross-section with a variation of less than 10%.

[0074] In addition to the internal blood flow cavity 20, the blood treatment device 10 includes a first mass transfer assembly 32 configured to oxygenate the patient's blood via a first gas exchange medium. Also included is a heat exchange assembly 34 configured to control the temperature of the patient's blood circulating through the blood treatment device 10.

[0075] The blood treatment device 10 also has two additional mass transfer assemblies 36 and 38. In the current non-limiting example, the mass transfer assembly 36 is configured to deliver nitric oxide to the patient's blood. Thus, it may be referred to as the nitriding device 36. The second additional mass transfer assembly 38 can be configured to deliver, for example, volatile anesthetic agents to the patient's blood. Thus, it may be referred to as the anesthetic delivery assembly 38.

[0076] As schematically shown in FIG. 3, each of the assemblies 32, 34, 36, and 38 includes an array 40a - 40d of conduits 42a - 42d that carry a fluid exchange medium. The oxygenator array 40a is located within the upper chamber 24 of the internal blood flow cavity 20. The heat transfer array 40b is also located within the upper chamber 24. The nitriding device array 40c is disposed within the bottom chamber 26 of the cavity. The anesthetic delivery array 40d is also disposed within the bottom chamber 26.

[0077] All of the assemblies 40a - 40d may be made of a stack of mat layers. In the non-limiting example shown in FIG. 2, each stack is composed of three layers or mats. Each individual layer or mat includes a number of individual conduits 42a - 42d. As shown in FIGS. 2 and 3, the conduits 42 within one mat are spaced apart from each other and run parallel to each other.

[0078] In the embodiment shown in FIGS. 2 and 3, the three mats of the oxygenator array 40a intermesh with the three mats of the heat exchanger array 40b. Similarly, the three mats of the nitriding device array 40c intermesh with the three mats of the anesthetic delivery array 40d.

[0079] The conduits 42a - 42d of each array have specific material properties such that they are suitable for their dedicated purposes. For example, all conduits 42a - 42d could be hollow fibers. However, the oxygen supply conduit 42a, the nitriding device conduit 42c, and the transfer conduit 42d of the anesthetic delivery assembly may have a microporous structure to enable appropriate mass transfer, while the hollow fiber 42b forming the conduit of the heat exchange assembly must be liquid - tight. Since the heat exchange assembly 34 exchanges energy rather than substances, its fiber 42b does not have a microporous structure. In one embodiment, the oxygen exchange conduit 42a of the oxygen supply and the nitric oxide exchange conduit 42c of the nitriding device may be made of a diffusion membrane to prevent long - term membrane wetting. In one embodiment, the anesthetic delivery conduit 42d may be made of a permeable pore membrane that is appropriately permeable to volatile anesthetics.

[0080] In the embodiment shown in FIG. 2, the conduit 42a of the oxygen supply assembly 32 and the conduit 42b of the heat exchanger assembly 34 are set at an angle of 90° to each other.

[0081] Similarly, the conduit 42c of the nitriding device 36 and the conduit 42d of the anesthetic delivery assembly 38 are set at an angle of 90° to each other.

[0082] The conduits of one assembly can also be set at an angle different from 90° with respect to the conduits of another assembly.

[0083] The arrays 40a - 40d of all assemblies are located in the same place within the internal blood flow cavity 20. Thus, the blood flowing through the internal blood flow cavity 20 flows substantially uniformly around all of the conduits 42a - 42d of the assemblies as a result of the left - right symmetry and spatial efficiency of the structures of the various assemblies 32, 34, 36, and 38 relative to each other.

[0084] Arrays 40a - 40d cooperate to define a continuous blood flow path through which blood can flow through the internal blood flow cavity 20, and as a result are arranged relative to each other within the internal blood flow cavity 20 such that all of assemblies 32, 34, 36, and 38 process it during a single pass.

[0085] As shown in FIG. 3, the continuous blood flow path has a blood inlet surface E at one end and a blood outlet surface F at the opposite end. The overall blood flow direction D from the blood inlet surface E along the blood flow path to the blood outlet surface F follows a substantially straight line.

[0086] As shown in FIG. 2, each of assemblies 32, 34, 36, and 38 has a dedicated separate fluid inlet 44a - 44d. Each of these assemblies 32, 34, 36, and 38 also includes a dedicated separate fluid outlet on the opposite side of the fluid, one example 45 of which is shown in FIG. 4. In the exemplary example shown, the inlets and outlets each have a distribution header for distributing the respective fluid exchange medium to the conduits of the assembly. Each of assemblies 32, 34, 36, and 38 forms a separate fluid circuit for its fluid exchange medium that is independent and different from the fluid circuits of the other assemblies. In other words, since each fluid circuit is separated from all other fluid circuits, the fluid exchange media do not mix between circuits.

[0087] The hollow fibers 42a - 42d of each of assemblies 32, 34, 36, 38 can be fixed to each other by a layer of potting material. In this case, the potting material layer can constitute the inlet plate and the outlet plate of the assembly. In one variant, the blood flow cavity 20 can be encapsulated by a single integrally formed hollow rectangular parallelepiped potting.

[0088] In the non-limiting example shown in FIG. 2, it should be noted that, ignoring the array of assemblies, the internal blood flow cavity 20 has no internal partitions or constrictions. In other words, there are no internal partitions or constrictions within the blood flow cavity 20 except for the arrays 40a - 40d that are oriented perpendicular to the blood flow direction D. In particular, there are no internal partitions or constriction members oriented in the direction D of the blood flow.

[0089] Next, the operation of the blood treatment device 10 shown in FIGS. 1 - 3 will be briefly described. Blood coming from the patient 1 via the tube 12 enters the blood treatment device 10 at the blood inlet 14. The blood is then uniformly distributed across the entire inlet surface E and passes through the internal blood flow cavity 20 in accordance with the general blood flow direction D. By doing so, the oxygen in the blood is increased via the oxygen supply conduit 42a. The blood is also temperature-controlled via the heat energy transfer medium flowing through the heat exchanger conduit 42b. After being oxygenated and temperature-controlled, the blood exits the first chamber 24 and reaches the second chamber 26. In the second chamber 26, nitric oxide in the blood is increased via the nitriding device conduit 40c. Additionally, anesthetic gas is diffused into the blood via the anesthetic delivery conduit 40d. Next, the blood that is oxygenated, temperature-controlled, nitrided, and contains anesthetic exits the internal blood flow cavity 20 via the lower outlet surface F.

[0090] In other embodiments, the nitriding device is disposed within the first chamber 24 near the inlet surface E such that nitric oxide is delivered to the blood at the blood inlet of the oxygen supply.

[0091] Therefore, the blood treatment device 10 shown in FIGS. 1 - 3 can essentially simultaneously perform four functions, namely, providing the patient 1 with the oxygen necessary for metabolism, maintaining the blood temperature at a physiological level, suppressing platelet activity (adhesion or aggregation) by nitric oxide, and anesthetizing the patient 1 for surgery.

[0092] In this context, since these four functions are carried out in a single pass of the blood flow, they are essentially interpreted as being simultaneous. Of course, according to the present disclosure, one or more of assemblies 32, 34, 36, and 38 can be selectively disabled by matching the flow of the fluid exchange medium to its inlet and from its outlet. For example, during operation of the blood treatment device 10, a valve can be used to block the flow of the nitric oxide-rich fluid exchange medium to the nitriding device 36, and as a result, this assembly does not deliver nitric oxide to the blood flowing through the blood flow cavity 20. On the other hand, the other three assemblies 32, 34, and 38 are operating. In this case, the blood is oxygenated, temperature controlled, and volatile anesthetic is supplied. In another example, during operation of the blood treatment device 10, a separate valve can be used to block the flow of the volatile anesthetic-rich fluid exchange medium to the anesthetic delivery assembly 38, and as a result, this assembly does not deliver volatile anesthetic to the blood flowing through the blood flow cavity 20. On the other hand, the other three assemblies 32, 34, and 36 are operating. In this case, the blood is oxygenated, temperature controlled, and nitrided. Of course, it is possible to operate the blood treatment device 10 so that only assemblies 32 and 34 are operating, and as a result, the blood flowing through the blood flow cavity 20 is oxygenated and temperature controlled. In this case, two valves are used to simultaneously block the flow of the nitric oxide-rich fluid exchange medium to the nitriding device 36 and the flow of the volatile anesthetic-rich fluid exchange medium to the anesthetic delivery assembly 38.

[0093] Turning now to FIGS. 4a-4e, a second non-limiting embodiment of the blood treatment device of the present disclosure is described. This blood treatment device 50 is similar in many respects to the blood treatment device 10 of FIGS. 1-3. Only their differences will be described below. FIG. 4a is a perspective view of the blood treatment device 50, with some elements omitted to provide a view of the fiber mat inside the device. FIGS. 4b-4e are a front view, a rear view, a top view, and a bottom view, respectively, of the blood treatment device 50.

[0094] The blood treatment device 50 includes a single blood inlet 52 having a distribution header. The inlet 52 is attached to the housing such that the patient's blood is introduced into the internal blood flow cavity 20, such that the blood can pass through each array in a direction substantially perpendicular to the flow direction of the fluid exchange medium. The blood treatment device 50 also includes a single blood outlet 53.

[0095] In contrast to the first embodiment of FIGS. 1-3, in this blood treatment device 50, the internal blood flow cavity 20 has three chambers instead of two. Two additional mass transfer assemblies are disposed within the third chamber 54. These additional mass transfer assemblies enable further blood treatment. For example, one of these additional mass transfer assemblies in the third chamber 54 can provide a drug to the patient, while the other of these additional mass transfer assemblies in the third chamber 54 can provide a buffer or other pH control agent.

[0096] The principles of the present disclosure are applicable not only to stacked fibrous mat-type blood treatment devices such as those shown in FIGS. 1-4. These principles may also be applied to a wound-type fibrous mat blood treatment device 60. Such a blood treatment device 60 is shown in FIG. 5. In this variant, there is a heat exchanger assembly 62 on the outside, followed by an oxygen supply assembly 64 in the middle, and then a nitriding device assembly 66 on the inside. The respective fluid exchange media of the assemblies 62, 64, and 66 are introduced via separate headers 68a, 68b, and 68c, respectively. The three assemblies are ring-shaped and arranged concentrically in a cylindrical shape. The internal blood flow cavity 20 extends from the outer assembly 62 to the inner assembly 66. Thus, the internal blood flow cavity has a cylindrical ring shape. Blood enters the internal blood flow cavity 20 through an inlet face E located at the outer edge of the outer heat exchanger assembly 62, flows radially through the three assemblies 62, 64, and 66, and exits the internal blood flow cavity 20 through an outlet face F located at the inner edge of the inner nitriding device assembly 66. The general direction of blood flow also follows the straight line D here. Alternatively, the blood flow may be in the reverse direction, which means that the blood enters the device via the center and then flows radially outward towards its outer edge.

[0097] The principles of the present disclosure can also be applied to a third type of extracorporeal blood treatment device, namely, a spiral gold / cylindrical fiber loop-type blood treatment device. A typical example of such a device is shown in U.S. Patent No. 5,236,665, the content of which is incorporated herein by reference in its entirety.

[0098] A cylindrical fiber loop blood treatment device 70 according to one exemplary embodiment is shown in FIGS. 6a and 6b. FIG. 6a is a diagram of a stacked spiral fiber configuration, and FIG. 6b is a diagram of a hollow cylindrical casing that houses the stacked spiral fiber configuration.

[0099] The blood treatment device 70 has three blood treatment assemblies 72, 74, and 76. The three assemblies are stacked on top of each other. Each assembly includes a plurality of loops 77a - 77c that carry a fluid exchange medium. The fluid exchange medium enters each assembly 72, 74, and 76 through inlets 78a - 78c. Next, the used fluid exchange medium leaves the assembly via a header 80 common to all three assemblies. For example, assembly 72 can function as an oxygen supplier by exchanging oxygen, assembly 74 can function as a nitriding device by exchanging nitric oxide, and assembly 76 can function as an anesthetic delivery assembly by exchanging anesthetics. Of course, instead, one of these assemblies can be used to control temperature and function as a heat exchanger. The internal blood flow cavity 20 corresponds to the volume occupied by the loops of the three assemblies. Blood can flow through the sleeve-shaped internal blood flow cavity 20 from the top to the bottom of the stack or vice versa. The blood flow cavity 20 is bounded by the casing shown in FIG. 6b. In this case too, the general blood flow direction D follows a straight line.

[0100] FIG. 7 is a schematic diagram of the internal components of yet another blood treatment device 100 according to a rectangular stacked fiber mat design. This device 100 is a combination of an upper nitriding compartment 82, an intermediate heat exchanger compartment 84, and a lower oxygenation compartment 86. Blood flowing through this device first enters the nitriding section 82 where nitric oxide is added to the blood. Subsequently, the blood passes through the heat exchanger 84 where its thermal temperature is adjusted to a predetermined target value. Finally, the blood passes through the oxygen supplier 86 where the oxygen in the blood is increased.

[0101] FIG. 8 is a schematic diagram of internal components of yet another blood treatment device 200 according to the rectangular parallelepiped stacked fiber mat design. This device 200 is a combination of an upper nitriding compartment 82, an intermediate anesthesia compartment 88, and a lower compartment 90 where heat exchange and oxygenation are integrated. Blood flowing through this device first enters the nitriding section 82 where nitric oxide is added to the blood. Subsequently, the blood passes through the anesthetic agent 88 where an anesthetic substance, such as sevoflurane, is added to the blood. Finally, the blood passes through the lower compartment 90 where the oxygen in the blood is increased and at the same time the temperature is adjusted.

[0102] The blood treatment device of the present disclosure can also be provided for one or more of the following uses.

[0103] A) Monitoring of mass transfer performance

[0104] A specific test substance / (not necessarily required for medical use) test mass is added at a specific concentration to a first mass transfer medium flowing through a first mass transfer assembly. The test substance moves into the bloodstream and then rediffuses from the blood into a second mass transfer medium flowing through another second mass transfer assembly (which can be the last mass transfer assembly downstream and before the blood outlet). Then the concentration of the test substance in the second mass transfer medium can be measured. The higher the concentration of the test substance in the second mass transfer medium, the higher the mass transfer performance of the mass transfer assembly. This performance test can be performed at the start of an extracorporeal blood treatment procedure and can be performed again later. By comparing the measurement results, changes in performance during treatment can be detected.

[0105] In this way, the mass transfer performance can be monitored without interrupting or disturbing the extracorporeal blood treatment procedure. Therefore, a decrease in performance (e.g., due to clogging or fouling of the mass transfer assembly) can be detected early. This allows corrective measures (such as changing the blood treatment device) to be taken to prevent potential health risks to the patient.

[0106] B) Removal of antibodies

[0107] This can be achieved by attaching a specific antigen or biologic to the surface of the mass exchange fiber. For example, the outer surface of the fiber may be coated with an antigen. As a result, the immobilized antigen captures antibodies present in the blood flowing through the blood treatment device, leading to the removal of antibodies. In this way, the patient's tissues can be protected from harmful autoimmune reactions.

[0108] C) Measurement of gas pressure in blood

[0109] Under steady state conditions, there is an equilibrium between the partial and total gas pressures in the blood on one side of the mass transfer membrane and the partial and total gas pressures in the gas exchange medium on the opposite side of the mass transfer membrane. Utilizing this fact, the gas pressure in the blood can be measured by the following process: (a) Apply a vacuum to the gas exchange fiber until it is completely evacuated. (b) Wait until the gas in the blood diffuses through the membrane into the lumen of the fiber and a pressure equilibrium occurs across the membrane. (c) Measure the gas pressure inside the fiber and thus the gas pressure in the blood.

[0110] D) Hemofiltration, plasma separation, and hemodialysis

[0111] The blood treatment device may also include dedicated fibers made of a hemodialysis membrane. These membranes can be used to remove unwanted elements such as toxic substances from the blood by hemodialysis or to separate the blood into various components by filtration (hemofiltration / blood concentration, plasma separation). In this application, mass transfer through the filtration membrane is driven by a pressure difference (transmembrane pressure or TMP) across the fiber membrane, without reducing the hydrostatic pressure of the fluid outside the fiber.

[0112] Furthermore, the above-described embodiments of the blood treatment device provide one or more advantages over previous blood treatment devices. One advantage is that different membranes can be used in dedicated parts for various purposes within one device. For example, in the case of gases, one type of microporous membrane can be used for the delivery of volatile anesthetics, while a diffusion membrane (not permeable to volatile anesthetics) can be used for long-term oxygenation or CO2 removal purposes. Another advantage is that as a result of using different membranes, gases and fluids are exchanged using different mass exchange media in different parts within one device. This enables specific practical functions such as built-in blood concentrators and hemodialyzers. Another advantage is the possibility of absorbing components in the blood (antibodies and toxins (endotoxins)) within a dedicated part. Another advantage is the possibility of administering drugs through the membrane within a dedicated part. Another advantage is the possibility of monitoring the mass exchange performance within a device equipped with a dedicated part. Another advantage is the possibility of measuring the total gas pressure and partial gas pressure of the blood within a dedicated part.

[0113] The present disclosure has been described with reference to a plurality of exemplary embodiments, but it will be understood by those skilled in the art that various changes may be made without departing from the scope of the present disclosure, and equivalents may replace its elements. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present disclosure without departing from the essential scope of the present disclosure. Therefore, the present invention is not limited to the specific embodiments disclosed herein as defined in the appended claims, and the present invention is intended to include all embodiments falling within the scope of the claims. Also, in the drawings and description, exemplary embodiments are disclosed, and even if specific terms are used, unless otherwise specified, they are used in a general and explanatory sense only, not for purposes of limitation. Furthermore, the use of terms such as first, second, etc. does not indicate order or importance, and the terms first, second, etc. are used to distinguish one element from another. Furthermore, the use of terms such as a, an, etc. does not indicate a limitation of quantity, but indicates that at least one of the items being referred to exists unless otherwise specified.

Claims

[Claim 1] An apparatus as shown in the drawings, etc.

Images