WO2020227903A1 - 逆变流血液透析滤过方法与装置、血滤组件及其管路组件 - Google Patents

逆变流血液透析滤过方法与装置、血滤组件及其管路组件 Download PDF

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Publication number
WO2020227903A1
WO2020227903A1 PCT/CN2019/086707 CN2019086707W WO2020227903A1 WO 2020227903 A1 WO2020227903 A1 WO 2020227903A1 CN 2019086707 W CN2019086707 W CN 2019086707W WO 2020227903 A1 WO2020227903 A1 WO 2020227903A1
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Prior art keywords
tube
dialysate
blood
outlet
hollow fiber
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PCT/CN2019/086707
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English (en)
French (fr)
Inventor
谢华南
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谢华南
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Application filed by 谢华南 filed Critical 谢华南
Priority to PCT/CN2019/086707 priority Critical patent/WO2020227903A1/zh
Publication of WO2020227903A1 publication Critical patent/WO2020227903A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3413—Diafiltration
    • A61M1/3417—Diafiltration using distinct filters for dialysis and ultra-filtration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424—Substitution fluid path
    • A61M1/3427—Substitution fluid path back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424—Substitution fluid path
    • A61M1/3431—Substitution fluid path upstream of the filter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3455—Substitution fluids
    • A61M1/3465—Substitution fluids using dialysate as substitution fluid

Definitions

  • the invention relates to medical equipment, in particular to an inverted flow hemodiafiltration method and device, a hemofiltration assembly and a pipeline assembly thereof.
  • Blood purification includes hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF) and so on.
  • HD hemodialysis
  • HF hemofiltration
  • HDF hemodiafiltration
  • the replacement fluid is cultivated manually or online by a hemofiltration machine (commonly known as a double-pump machine).
  • the process is that the dialysis concentrate is mixed by the machine at a ratio of 1:32 and filtered through a double ultrafiltration device.
  • the main purpose is Removal of bacteria and endotoxins in the dialysate, after being injected into the patient's blood, it dilutes the patient's blood, so that the toxic metabolites in the patient's blood are more conducive to being removed by the hemofilter, and the replacement fluid pumped into the blood will also It is effectively filtered and removed in the balance system of the liquid in and out of the hemofiltration machine, that is to say, the amount of replacement fluid pumped in will be ultrafiltered and removed through the machine-controlled hemofilter, so as to maintain the balance of water and electrolytes in and out of the human body. Maintain the normal operation of various functions of the human body.
  • the above-mentioned hemodiafiltration method requires manual preparation or the online preparation of the hemofiltration machine to form the replacement fluid.
  • the online preparation of the replacement fluid is formed by ultrafiltration of the dialysate from the dialysis area of the hemofilter or bacterial filter into the blood area. Special equipment such as hemofiltration machine can be formed, and the treatment cost is high.
  • the hemodialysis machine (referred to as hemodialysis machine) in the prior art can only perform hemodialysis but cannot achieve hemofiltration; and when the blood flow at the arterial end of the patient is blocked or hypotension, the blood flow at the arterial end is insufficient, usually low At a blood flow of 100ml/min, the dialysis machine alarms to interrupt the hemodialysis, which brings inconvenience to the patient's blood purification.
  • the embodiment of the present invention provides an inverted flow hemodiafiltration method and device, hemofiltration assembly, and pipeline components, which can be used for hemodiafiltration using a common hemodialysis machine, and there is no need to interrupt treatment when the blood flow is low .
  • an embodiment of the present invention provides an inverter flow hemodiafiltration method, which includes the following steps:
  • the dialysate produced by the hemodialysis machine enters the dialysate area of the first hemofilter, and a negative pressure is generated in the hollow fiber membrane of the first hemofilter through the blood pump, so that a part of the dialysate is back ultrafiltered to the A replacement fluid is formed in the hollow fiber membrane of the first hemofilter to flow out of the first hemofilter, and another part of the dialysate flows out of the dialysate area of the first hemofilter and then flows through the dialysate area of the second hemofilter. Flow back to the hemodialysis machine after diafiltration;
  • the replacement fluid is mixed with the blood flowing out of the artery and then enters the hollow fiber membrane of the second hemofilter under the drive of the blood pump, and then flows into the vein after diafiltration.
  • the present invention provides a hemodiafiltration device, including a first blood filter, a second blood filter, a first arterial tube, a second arterial tube, a fluid supplement tube, and a venous tube;
  • the first hemofilter includes a first dialysis tube and a first hollow fiber membrane; the first hollow fiber membrane is located in the first dialysis tube; an end surface of the first dialysis tube is provided with a replacement fluid outlet, the The replacement fluid outlet is connected to the first hollow fiber membrane; a first dialysate inlet and a first dialysate outlet are provided on the tube wall of the first dialysis tube, the first dialysate inlet and the first dialysate The outlets are all connected to the space outside the first hollow fiber membrane;
  • the second hemofilter includes a second dialysis tube and a second hollow fiber membrane, the second hollow fiber membrane is located in the second dialysis tube, and one end of the second dialysis tube is provided with a blood inlet and the other end A blood outlet is provided, and the blood inlet and the blood outlet are both connected to the second hollow fiber membrane;
  • the second dialysis tube is provided with a second dialysate inlet and a second dialysate outlet, the first Both the second dialysate inlet and the second dialysate outlet are connected to the space outside the second hollow fiber membrane, and the second dialysate inlet is in communication with the first dialysate outlet;
  • One end of the second arterial tube communicates with one end of the first arterial tube, and the other end of the second arterial tube communicates with the blood inlet of the second blood filter; the other end of the first arterial tube is used for In connection with the artery;
  • One end of the fluid supplement tube is in communication with the replacement fluid outlet of the first hemofilter, and the other end of the venous tube is in communication with the junction of the first arterial tube and the second arterial tube;
  • the venous tube is connected to the blood outlet of the second blood filter, and the other end is used to communicate with the vein.
  • the present invention provides a hemofiltration assembly, including a first hemofilter and a second hemofilter,
  • the first blood filter includes a first dialysis tube and a first hollow fiber membrane; the first hollow fiber membrane is located in the first dialysis tube; one end of the first dialysis tube is closed, and the other end is provided with a replacement A fluid outlet, the replacement fluid outlet is connected to the first hollow fiber membrane; a first dialysate inlet and a first dialysate outlet are provided on the wall of the first dialysis tube, the first dialysate inlet The first dialysate outlet and the first dialysate outlet are both connected to the space outside the first hollow fiber membrane, the first dialysate inlet is located at the closed end of the first dialysis tube, and the first dialysate outlet is opposite to the first dialysate outlet. A dialysate inlet is close to the replacement fluid outlet;
  • the second hemofilter includes a second dialysis tube and a second hollow fiber membrane, the second hollow fiber membrane is located in the second dialysis tube, and one end of the second dialysis tube is provided with a blood inlet and the other end A blood outlet is provided, and the blood inlet and the blood outlet are both connected to the second hollow fiber membrane; the second dialysis tube is provided with a second dialysate inlet and a second dialysate outlet, the first The two dialysate inlets and the second dialysate outlet are both connected to the space outside the second hollow fiber membrane, and the second dialysate inlet is communicated with the first dialysate outlet.
  • the present invention provides a hemodiafiltration tube assembly, including a first arterial tube, a second arterial tube, and a fluid replacement tube; the ends of the first arterial tube, the second arterial tube, and the fluid replacement tube Departments are interconnected;
  • At least one of a replacement fluid pot, a stop clip, a replacement fluid flow regulator, and a one-way valve is provided on the fluid supplement tube;
  • a blood flow regulator is provided on the first arterial tube.
  • the blood flow can be driven by the blood pump, and at the same time, the driving force generated by the blood pump can generate negative pressure in the hollow fiber membrane of the first hemofilter, so that a part of the dialysate is back ultrafiltered into the hollow fiber membrane to form Replacement fluid.
  • the replacement fluid After the replacement fluid is injected into the blood flowing out of the artery and mixed, it can dilute the blood, making it easier for the various toxins in the blood to pass through the ultrafiltration of the second hemofilter, pass through the hollow fiber membrane and be quickly discharged from the body with the dialysate.
  • Diafiltration is achieved in the second hemofilter; at the same time, when the patient's blood flow is low, the replacement fluid can replenish the blood before dialysis and ultrafiltration, so as to prevent the hemodialysis machine from alarming and interrupting the dialysis treatment when the blood flow is low. Hemodiafiltration continues.
  • Figure 1 is a schematic diagram of a hemodiafiltration device provided by an embodiment of the present invention.
  • Fig. 2 is a schematic structural diagram of a blood filter assembly provided by an embodiment of the present invention.
  • the present invention provides an inverted flow hemodiafiltration method, including the following steps: the dialysate produced by the hemodialysis machine enters the dialysate area of the first hemofilter 11, and the blood pump 100 Negative pressure is generated in the hollow fiber membrane of the first hemofilter 11, so that a part of the dialysate is back ultrafiltered into the hollow fiber membrane of the first hemofilter 11 to form a replacement fluid and flow out of the first hemofilter 11, and the other part from the first hemofilter 11 After the dialysate area of 11 flows out, the dialysate area of the second hemofilter 12 is diafiltered and then flows back to the hemodialysis machine.
  • dialysate area refers to the space area outside the hollow fiber membrane in the blood filter, and the area inside the hollow fiber membrane is usually called the blood area.
  • the replacement fluid is mixed with the blood flowing out of the artery and then enters the hollow fiber membrane of the second hemofilter 12 under the drive of the blood pump 100, after diafiltration, flows into the vein.
  • the blood flow can be driven by the blood pump 100, and the driving force generated by the blood pump 100 can generate negative pressure in the hollow fiber membrane of the first blood filter 11, so that a part of the dialysate is back ultrafiltered into the hollow fiber membrane
  • the replacement fluid is formed. After the replacement fluid is injected into the blood flowing out of the artery and mixed, it can dilute the blood so that various toxins in the blood (including middle molecules, small molecule toxins, and excess electrolytes) can more easily pass through the second hemofilter 12 Ultrafiltration penetrates the hollow fiber membrane to enter the dialysate and quickly discharge from the body, thereby realizing diafiltration in the second hemofilter. At the same time, when the patient's blood flow is low, the replacement fluid can replenish the blood before dialysis and ultrafiltration, so as to avoid interruption of the hemodialysis machine treatment when the blood flow is low, and to ensure the continuous progress of hemodiafiltration.
  • the inverter flow hemodiafiltration method of the present invention can use ordinary hemodialysis machines to provide patients with diafiltration treatment HDF or continuous low-flow hemofiltration treatment CRRT, because the replacement fluid obtained is passed through the blood filter It is formed by reverse flow ultrafiltration, that is, the dialysate is reversely ultrafiltered from the dialysate area of the hemofilter to the blood area of the hemofilter, so it is called reverse flow hemofiltration diafiltration RHDF, so the present invention is simple and easy to implement, safe and reliable .
  • the blood pump 100 is the blood pump of the hemodialysis machine. Of course, other separate blood pumps can also be used to provide driving force.
  • the replacement fluid flows out of the first hemofilter 11 through the fluid replacement tube 21 to mix with the blood flowing out of the artery.
  • the fluid replacement tube 21 is provided with a replacement fluid pot 211, a stop clamp 212, and a replacement fluid flow rate. At least one of the regulator 213 and the one-way valve 214.
  • the replacement fluid flowing out of the first blood filter 11 is guided to the blood flowing out of the artery through the fluid replacement tube 21 to mix the two.
  • the valve 214 here in other embodiments, may be provided with only one or a combination of more than one of the replacement liquid pot 211, the stop clip 212, the replacement liquid flow rate adjustment and the one-way valve 214.
  • the replacement fluid pot 211 can be used to observe the dripping speed of the replacement fluid and bubble collection to prevent gas from entering the blood.
  • the replacement fluid pot 211 is close to the stop clamp 212, the replacement fluid flow regulator 213 and the one-way valve 214
  • the first blood filter 11 collects air bubbles in time.
  • An exhaust port is set on the replacement chamber pot to exhaust the collected gas.
  • the one-way valve 214 is used to make the fluid in the fluid replacement tube 21 only flow from the first blood filter 11 to the direction of arterial blood, thereby preventing the blood flowing out of the artery from flowing into the fluid replacement tube 21, causing blood loss of the patient.
  • the one-way valve 214 can effectively prevent blood from entering the fluid supplement tube 21.
  • the one-way valve 214 is far away from the first blood filter 11 relative to the replacement fluid pot 211, the stop clip 212, and the replacement fluid flow regulator 213, that is, the one-way valve 214 is closer to the output end of the fluid supplement tube 21.
  • the stop clip 212 is used to close the fluid supplement tube 21 to prevent the replacement fluid in the fluid supplement tube 21 from flowing.
  • the replacement fluid flow regulating valve is used to adjust the flow of the replacement fluid, which can be adjusted according to the blood flow of the patient’s arterial blood. For example, when the blood flow of the patient’s arterial stenosis is blocked or hypotension causes insufficient blood flow at the arterial end, Normally, if the blood flow is lower than 100ml/min, dialysis will alarm and interrupt the dialyzer. At this time, the replacement fluid flow regulator 213 can increase the amount of the replacement fluid entering the blood to ensure the stability of the dialysis blood flow, and perform low blood flow dialysis.
  • the blood flowing out of the artery is mixed with the replacement fluid through the first arterial tube 22 and then enters the hollow fiber membrane (ie, blood area) of the second hemofilter 12 through the second arterial tube 23.
  • the first arterial tube 22 and the second arterial tube 23 In communication with the fluid replacement tube 21, the blood pump 100 is arranged on the second arterial tube 23, and the first arterial tube 22 is provided with a blood flow regulator 221.
  • the first arterial tube 22 can guide the blood flowing out of the artery to mix with the replacement fluid, and then guide the mixture through the second arterial tube 23 into the hollow fiber membrane of the second hemofilter 12.
  • the blood pump 100 is arranged on the second arterial tube 23.
  • the blood pump 100 When the blood pump 100 is running, it can drive arterial blood and replacement fluid to flow, and at the same time generate negative pressure in the hollow fiber membrane of the first blood filter 11 to continuously generate replacement fluid.
  • the first arterial tube 22 is provided with a blood flow regulator 221, which can adjust the flow of arterial blood so that a proper ratio of arterial blood and replacement fluid are mixed.
  • An arterial kettle 231 and an arterial pressure gauge 232 are provided on the second arterial tube 23.
  • the blood passes through the blood pump 100 and flows into the arterial kettle 231.
  • the arterial kettle 231 can be used to detect blood flow and gas collection.
  • the arterial pressure gauge 232 can detect the blood pressure in the arterial tube in real time.
  • the arterial pressure gauge 232 is provided on the arterial kettle 231.
  • the arterial pressure gauge 232 may be directly provided on the arterial tube.
  • the blood flowing out of the second hemofilter 12 flows into the vein through the venous tube 24.
  • the venous tube 24 is provided with a venous kettle 241 and a venous pressure gauge 242.
  • the diafiltered blood flowing out of the second blood filter 12 is guided to the vein through the venous tube 24.
  • the venous kettle 241 can be used to detect blood flow and gas collection.
  • the venous pressure gauge 242 can detect the blood in the venous tube 24 in real time. pressure.
  • the venous pressure gauge 242 is arranged on the venous kettle 241.
  • the venous pressure gauge 242 may be directly arranged on the venous tube 24.
  • the present invention also provides a hemodiafiltration device, including a first hemofilter 11, a second hemofilter 12, a first arterial tube 22, a second arterial tube 23, a fluid supplement tube 21, And venous tube 24.
  • the first hemofilter 11 includes a first dialysis tube 111 and a first hollow fiber membrane 112; the first hollow fiber membrane 112 is located in the first dialysis tube 111; the end surface of the first dialysis tube 111 is provided with a replacement fluid outlet 113, the replacement fluid The outlet 113 is connected to the first hollow fiber membrane 112; the wall of the first dialysis tube 111 is provided with a first dialysate inlet 114 and a first dialysate outlet 115, a first dialysate inlet 114 and a first dialysate outlet 115 All are connected to the space outside the first hollow fiber membrane 112.
  • the second hemofilter 12 includes a second dialysis tube 121 and a second hollow fiber membrane 122.
  • the second hollow fiber membrane 122 is located in the second dialysis tube 121.
  • One end of the second dialysis tube 121 is provided with a blood inlet 123 and the other end.
  • a blood outlet 124 is provided at the end surface, and the blood inlet 123 and the blood outlet 124 are both connected to the second hollow fiber membrane 122;
  • the second dialysis tube 121 is provided with a second dialysate inlet 125 and a second dialysate outlet 126.
  • the dialysate inlet 125 and the second dialysate outlet 126 are both connected to the space outside the second hollow fiber membrane 122, and the second dialysate inlet 125 is in communication with the first dialysate outlet 115.
  • both the first hemofilter 11 and the second hemofilter 12 can use hemofilters (ie, blood filters) in the prior art.
  • the blood outlet 124 of the existing hemofilter is used as the replacement fluid outlet 113.
  • the blood inlet 123 of the hemofilter can be closed with rubber plugs, sealing caps and other devices, or the blood inlet 123 of the initial hemofilter can be blocked without opening the plug.
  • the second hemofilter 12 can be formed by connecting the dialysate inlet of the existing hemofilter with the dialysate outlet of the first hemofilter 11.
  • the first dialysate outlet 115 of the first hemofilter 11 and the second dialysate inlet 125 of the second hemofilter 12 may be connected by a hose.
  • the hose may be called a dialysate hose.
  • One end of the second arterial tube 23 communicates with one end of the first arterial tube 22, and the other end of the second arterial tube 23 communicates with the blood inlet 123 of the second blood filter 12.
  • the other end of the first arterial tube 22 is used to communicate with the artery, and is used to output the patient's blood.
  • One end of the fluid replacement tube 21 communicates with the replacement fluid outlet 113, and the other end of the fluid replacement tube 21 communicates with the junction of the first arterial tube 22 and the second arterial tube 23.
  • the fluid replacement tube 21, the first arterial tube 22 and the second arterial tube 23 may be connected by a three-way joint 20.
  • One end of the venous tube 24 is connected to the blood outlet 124, and the other end is used to communicate with the vein of the patient to return the diafiltered blood to the patient.
  • the first dialysate inlet 114 and the second dialysate outlet 126 are connected to the hemodialysis machine
  • the second arterial tube 23 is connected to the blood pump 100
  • the first arterial tube 22 is connected to The artery of the patient is connected
  • the venous tube 24 is connected to the vein of the patient.
  • first arterial tube 22, the second arterial tube 23, the fluid supplement tube 21, and the venous tube 24 can be the same as those described above, and will not be repeated here.
  • the first blood filter 11 and the second blood filter 12 are formed using existing blood filters.
  • the present invention also provides a hemofiltration assembly, which includes a first hemofilter 11 and a second hemofilter 12.
  • the first hemofilter 11 and the second hemofilter 12 are connected to form a hemofiltration assembly that can be independently processed and prepared, which can be used as a hemodiafiltration device after being connected to a pipeline.
  • the first hemofilter 11 includes a first dialysis tube 111 and a first hollow fiber membrane 112; the first hollow fiber membrane 112 is located in the first dialysis tube 111; one end of the first dialysis tube 111 is closed and the other end is provided at the end surface There is a replacement fluid outlet 113, which is connected to the first hollow fiber membrane 112; the wall of the first dialysis tube 111 is provided with a first dialysate inlet 116 and a first dialysate outlet 115, the first dialysate inlet 116 and the first dialysate outlet 115 are both connected to the space outside the first hollow fiber membrane 112, the first dialysate inlet 116 is located at the closed end of the first dialysate tube 111, and the first dialysate outlet 115 is opposite to the first dialysate inlet 116 is close to the replacement liquid outlet 113.
  • the second hemofilter 12 includes a second dialysis tube 121 and a second hollow fiber membrane 122.
  • the second hollow fiber membrane 122 is located in the second dialysis tube 121.
  • One end of the second dialysis tube 121 is provided with a blood inlet 123 and the other end.
  • a blood outlet 124 is provided at the end surface, and the blood inlet 123 and the blood outlet 124 are both connected to the second hollow fiber membrane 122;
  • the second dialysis tube 121 is provided with a second dialysate inlet 125 and a second dialysate outlet 126.
  • the dialysate inlet 125 and the second dialysate outlet 126 are both connected to the space outside the second hollow fiber membrane 122, and the second dialysate inlet 125 is in communication with the first dialysate outlet 115.
  • the second dialysate inlet 125 and the first dialysate outlet 115 may be connected by a hose, or they may be directly fixedly connected.
  • the second dialysate inlet 125 is fixedly connected to the first dialysate outlet 115, and the first dialysate inlet 116 and the second dialysate outlet 126 are arranged oppositely, so that the first dialysate tube 111 and the second dialysate tube
  • the relative arrangement of 121 can reduce the occupied space of the entire blood filter assembly.
  • first dialysate outlet 115 and the second dialysate inlet 125 may be threadedly connected, for example, the inner wall of the first dialysate outlet 115 is provided with internal threads, and the outer wall of the second dialysate inlet 125 is provided with external threads, or The outer wall of the first dialysate outlet 115 is provided with an external thread, and the inner wall of the second dialysate inlet 125 is provided with an inner thread, so that the two can be threadedly connected.
  • the first dialysate outlet 115 and the second dialysate inlet 125 are connected by a card slot.
  • a card slot can be formed in the tube of the first dialysate outlet 115, and the second dialysate inlet 125 can be inserted.
  • the second dialysate inlet 125 can be connected to the card slot, or the second dialysate inlet 125 can form a card slot, and the first dialysate outlet 115 can be inserted into the card slot, so that the two are fixedly connected.
  • first dialysis tube 111 and the second dialysis tube 121 are fixedly connected by the bracket 13 to improve the connection strength between the two.
  • the first dialysate inlet 116 and the second dialysate outlet 126 are respectively arranged at both ends of the first dialysis tube 111, and the first dialysate outlet 115 and the replacement fluid outlet 113 are located on the same side of the first dialysis tube 111. At the end, the contact time between the dialysate and the hollow fiber membrane can be fully increased, and the effect of testing the replacement fluid can be improved.
  • the second dialysate inlet 125 and the blood outlet 124 are located at the same end of the second dialysis tube 121, and the second dialysate outlet 126 and the blood inlet 123 are located at the same end of the second dialysis tube 121, through the direction of blood flow and dialysis The direction of the liquid is reversed, thereby increasing the contact time of the dialysate and blood to improve the diafiltration effect.
  • the second dialysate inlet 125 and the blood inlet 123 are located at the same end of the second dialysis tube 121, and the second dialysate outlet 126 and the blood The outlet 124 is located at the same end of the second dialysis tube 121, as shown in FIG. 1.
  • the present invention also provides a hemodiafiltration tube assembly, including a first arterial tube 22, a second arterial tube 23, and a fluid replacement tube 21; the first arterial tube 22, the second arterial tube 23, and the fluid replacement tube 21
  • the ends communicate with each other.
  • the ends of the first arterial tube 22, the second arterial tube 23, and the fluid replacement tube 21 may be connected by a three-way joint 20, or they may be integrally formed.
  • the first arterial tube 22, the second arterial tube 23, and the fluid supplement tube 21 are formed into a disposable product, which can be combined with the venous tube 24 in the prior art and the two hemofiltration tubes or the aforementioned hemofiltration components to form a set of blood
  • the diafiltration device is used.
  • first arterial tube 22, the second arterial tube 23, and the fluid supplement tube 21 may be the same as the foregoing embodiment, and will not be repeated here.
  • the end of the first arterial tube 22 away from the fluid replacement tube 21 is provided with an arterial connector, and the arterial connector may be a needle, an indwelling needle, or the like for connecting with the patient's artery.
  • the fluid replacement tube 21 is also provided with a fluid replacement label
  • the second arterial tube 23 is also provided with an arterial label, which can mark the fluid replacement tube 21 and the second arterial tube 23 to avoid connection errors during use.
  • the second arterial tube 23 is also provided with a blood pump 100 label.
  • the blood pump 100 label is close to the first arterial tube 22 relative to the arterial kettle 231 to indicate the installation position of the second arterial tube 23 and the blood pump 100 to avoid installation errors.
  • the dialysate produced by the hemodialysis machine enters the area outside the hollow fiber membrane of the first hemofilter 11 through the dialysate inlet of the first hemofilter 11 (ie, dialysis Fluid area), and then through the first dialysate outlet 115 of the first hemofilter 11 and the second dialysate inlet 125 of the second hemofilter 12 to enter the area outside the hollow fiber membrane of the second hemofilter 12 (ie the dialysate area ), and then return to the dialysis machine through the second dialysate outlet 126 of the second blood filter 12.
  • the dialysate inlet of the first hemofilter 11 ie, dialysis Fluid area
  • the blood at the arterial end passes through the first arterial tube 22 under the drive of the blood pump 100, enters the blood inlet 123 of the second blood filter 12 through the arterial blood flow regulator 221, and enters its internal hollow fiber membrane (by a semipermeable membrane with ultrafiltration It is composed of hollow fiber filaments), and then flows through the venous tube 24 through the blood outlet 124 of the second hemofilter 12 to return to the patient's vein, thereby forming an extracorporeal circulation circuit.
  • the dialysate When the negative pressure in the hollow fiber of the first hemofilter 11 is greater than the negative pressure in the dialysate area of the first hemofilter 11, the dialysate will enter the first hemofilter under the action of ultrafiltration In the hollow fiber of 11 (because the hollow fiber is a semi-permeable membrane, small molecules such as water and electrolytes can pass freely, while macromolecular substances such as bacteria and endotoxins cannot pass), so that a part of the dialysate enters the first
  • the replacement fluid is formed in the hollow fiber membrane of the hemofilter 11, which is similar to the plasma composition, passes through the fluid replacement tube 21, passes through the replacement fluid flow regulator 213, and the one-way valve 214 to mix with the blood at the arterial end of the patient.
  • various toxins in the blood including medium molecules, small molecule viruses, and excess electrolytes
  • the flow of dialysate into the second hemofilter 12 will be equal to the flow of dialysate out of the second hemofilter 12 (dialysis and dialysis is achieved through a balance chamber or a reciprocating pump). Therefore, the dialysate (replacement fluid) entering the arterial end will enter the dialysate through the ultrafiltration of the hollow fiber and be discharged from the body.
  • the amount of ultrafiltration entering the dialysate area through the hollow fibers of the second hemofilter 12 will be greater than the amount of replacement fluid entering the blood.
  • the dilution ratio of the blood can be achieved by adjusting the blood flow rate and the replacement fluid flow rate, which are negative feedbacks to each other.
  • the replacement fluid flow regulator 213 can increase the amount of replacement fluid entering the blood to ensure the stability of the dialysis blood flow, and perform low blood flow dialysis.
  • the one-way valve 214 can effectively prevent blood from entering the fluid supplement tube 21.
  • the purpose of the present invention is to use an ordinary dialysis machine to provide patients with dialysis filtration treatment HDF or continuous low-flow hemofiltration treatment CRRT, because the replacement fluid obtained is obtained by the reverse flow ultrafiltration of the hemofilter, namely dialysis
  • the fluid is reversely ultrafiltered from the dialysate area of the hemofilter to the blood area of the hemofilter, so it is called reverse flow hemofiltration diafiltration RHDF.
  • the replacement fluid of the traditional hemofiltration machine is that the dialysate is super-filtered from the dialysis area of the hemofilter.
  • the filter penetrates into the blood area, so the invention is simple, easy to implement, safe and reliable.

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Abstract

逆变流血液透析滤过方法，通过血泵（100）产生负压使透析液的一部分反超滤至第一血滤器（11）的第一中空纤维膜（112）内形成置换液流出第一血滤器（11）、透析液的另一部分从第一血滤器（11）的透析液区流出后进入第二血滤器（12）的透析液区进行透析滤过；置换液与血液混合后在血泵（100）驱动下进入第二血滤器（12）的第二中空纤维膜（122）内进行透析滤过。还公开了相应的设备、血滤组件及管道组件。血泵（100）驱动血液流动并在第一血滤器（11）的第一中空纤维膜（112）内产生负压形成置换液，置换液可稀释血液，使血液中的各种毒素更容易通过第二血滤器（12）的超滤作用迅速通过第二中空纤维膜（122）进入透析液中而排出体外。血流量较低时，置换液可对血液进行补充后再进行透析超滤，避免血液透析机治疗的中断，保证血液透析滤过的持续进行。

Description

逆变流血液透析滤过方法与装置、血滤组件及其管路组件 技术领域
本发明涉及医疗设备，尤其涉及一种逆变流血液透析滤过方法与装置、血滤组件及其管路组件。
背景技术
血液净化包括血液透析(HD)、血液滤过(HF)、血液透析滤过(HDF)等等。传统的血液滤过有两种实现方式，一种是将置换液通过一个泵将其泵入血液，进入血滤器的前端血路管的动脉壶内(也称前稀释法)；另一种是泵入血液流出血滤器后端的血路管的静脉壶内(也称后稀释法)。其中置换液是由人工培植或由血滤机(俗称双泵机)在线培植，其过程是由机器将透析浓缩液经过1:32混合后，经过双重超滤装置过滤而成，其目的主要是去除透析液里的细菌和内毒素，注入患者的血液后，稀释了患者的血液，使患者血液里的有毒的代谢产物更有利于被血滤器所清除，而泵入血液中的置换液也会在血滤机的液体进出的平衡系统中被有效的滤过清除，也就是说泵入置换液的量会通过机器控制的血滤器进行超滤清除，从而保持进出人体的水和电解质的平衡，维护人体各种机能正常运转。
上述血液透析滤过方法，由于需要人工配制，或者血滤机在线配制形成置换液，在线配制置换液是透析液由血滤器或细菌过滤器的透析区超滤渗透到血液区而形成，由于需要专门的设备如血滤机才能形成，治疗成本高。
现有技术中的血液透析机(简称血透机)由于只能进行血液透析，不能实现血液滤过；且当患者动脉端狭窄的血流受阻或低血压而造成动脉端血流不足，通常低于100ml/分血流，透析机会报警中断血液透析，给患者的血液净化带来不便。
发明内容
本发明实施例提供一种逆变流血液透析滤过方法与装置、血滤组件、及其管路组件，可使用普通的血透机进行血液透析滤过，且在低血流量时无需中断 治疗。
第一方面，本发明实施例提供了一种逆变流血液透析滤过方法，包括以下步骤：
使血透机产生的透析液进入到第一血滤器的透析液区，通过血泵在所述第一血滤器的中空纤维膜内产生负压使所述透析液的一部分反超滤至所述第一血滤器的中空纤维膜内形成置换液流出所述第一血滤器、所述透析液的另一部分从所述第一血滤器的透析液区流出后经第二血滤器的透析液区进行透析滤过后流回所述血透机；
所述置换液与自动脉流出的血液混合后在所述血泵驱动下进入所述第二血滤器的中空纤维膜内经透析滤过后流入静脉。
第二方面，本发明提供了一种血液透析滤过装置，包括第一血滤器、第二血滤器、第一动脉管、第二动脉管、补液管、及静脉管；
所述第一血滤器包括第一透析管和第一中空纤维膜；所述第一中空纤维膜位于所述第一透析管内；所述第一透析管的端面处设置有置换液出口，所述置换液出口连通至所述第一中空纤维膜内；所述第一透析管的管壁上设置有第一透析液入口和第一透析液出口，所述第一透析液入口和第一透析液出口均连通至所述第一中空纤维膜外的空间；
所述第二血滤器包括第二透析管和第二中空纤维膜，所述第二中空纤维膜位于第二透析管内，所述第二透析管的一端端面处设置有血液入口、另一端端面处设置有血液出口，所述血液入口及所述血液出口均连通至所述第二中空纤维膜内；所述第二透析管上设置有第二透析液入口和第二透析液出口，所述第二透析液入口和第二透析液出口均连通至所述第二中空纤维膜外的空间，所述第二透析液入口与所述第一透析液出口连通；
所述第二动脉管的一端与所述第一动脉管的一端连通、所述第二动脉管的另一端与所述第二血滤器的血液入口连通；所述第一动脉管的另一端用于与动脉连通；
所述补液管的一端与所述第一血滤器的置换液出口连通、所述静脉管的另一端与所述第一动脉管和所述第二动脉管的连接处连通；
所述静脉管与所述第二血滤器的血液出口连通，另一端用于与静脉连通。
第三方面，本发明提供了一种血滤组件，包括第一血滤器和第二血滤器，
所述第一血滤器包括第一透析管和第一中空纤维膜；所述第一中空纤维膜位于所述第一透析管内；所述第一透析管的一端闭合、另一端端面处设置有置换液出口，所述置换液出口连通至所述第一中空纤维膜内；所述第一透析管的管壁上设置有第一透析液入口和第一透析液出口，所述第一透析液入口和第一透析液出口均连通至所述第一中空纤维膜外的空间，所述第一透析液入口位于所述第一透析管的闭合端处，所述第一透析液出口相对所述第一透析液入口靠近所述置换液出口；
所述第二血滤器包括第二透析管和第二中空纤维膜，所述第二中空纤维膜位于第二透析管内，所述第二透析管的一端端面处设置有血液入口、另一端端面处设置有血液出口，所述血液入口及所述血液出口均连通至所述第二中空纤维膜内；所述第二透析管上设置有第二透析液入口和第二透析液出口，所述第二透析液入口和第二透析液出口均连通至所述第二中空纤维膜外的空间，所述第二透析液入口与所述第一透析液出口连通。
第四方面，本发明提供了一种血液透析滤过管路组件，包括第一动脉管、第二动脉管及补液管；所述第一动脉管、第二动脉管及补液管三者的端部相互连通；
所述补液管上设置有置换液壶、止流夹、置换液流量调节器及单向阀中的至少一个；
所述第一动脉管上设置有血液流量调节器。
本发明实施例中，通过血泵可以驱动血液流动，同时血泵产生的驱动力可以在第一血滤器的中空纤维膜内产生负压，使得透析液的一部分反超滤至中空纤维膜内形成置换液，置换液注入到动脉流出的血液混合后，可以稀释血液，使得血液中的各种毒素更容易通过第二血滤器的超滤作用通过中空纤维膜随透析液迅速排出体外，从而在第二血滤器中实现透析滤过；同时，在患者血流量较低时，置换液可以对血液进行补充后再进行透析超滤，从而避免血流量较低时血液透析机报警而中断透析治疗，保证血液透析滤过的持续进行。
附图说明
为了更清楚地说明本发明实施例技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本发明实施例提供的血液透析滤过装置的示意图；
图2是本发明实施例提供的血滤组件的结构示意图。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
结合图1所示，本发明提供了一种逆变流血液透析滤过方法，包括以下步骤：使血透机产生的透析液进入到第一血滤器11的透析液区，通过血泵100在第一血滤器11的中空纤维膜内产生负压使透析液的一部分反超滤至第一血滤器11的中空纤维膜内形成置换液并流出第一血滤器11、另一部分从第一血滤器11的透析液区流出后经第二血滤器12的透析液区进行透析滤过后流回血透机。此处，可以理解的，透析液区是指血滤器中位于中空纤维膜外侧的空间区域，中空纤维膜内的区域通常称之为血液区。置换液与自动脉流出的血液混合后在血泵100驱动下进入第二血滤器12的中空纤维膜内经透析滤过后流入静脉。
本发明中，通过血泵100可以驱动血液流动，同时血泵100产生的驱动力可以在第一血滤器11的中空纤维膜内产生负压，使得透析液的一部分反超滤至中空纤维膜内形成置换液，置换液注入到动脉流出的血液混合后，可以稀释血液，使得血液中的各种毒素(包括括中分子、小分子毒素和多余的电解质等)更容易通过第二血滤器12的超滤作用透过中空纤维膜进入透析液迅速排出体外，从而在第二血滤器中实现透析滤过。同时，在患者血流量较低时，置换液可以对血液进行补充后再进行透析超滤，从而避免血流量较低时血液透析机治疗的中断，保证血液透析滤过的持续进行。
本发明的逆变流血液透析滤过方法，可以使用普通的血液透析机，给患者提供透析滤过治疗HDF或进行持续低流血液滤过治疗CRRT，由于其获得的置换液是通过血滤器的逆变流超滤而成，即透析液由血滤器的透析液区反超滤至血滤器的血液区，故称为逆变流血液滤透析滤过RHDF，所以本发明简单易行，安全可靠。血泵100为血液透析机的血泵，当然也可以采用其他单独的血泵来提供驱动力。
为了便于对置换液进行流量观测及监控，置换液流出第一血滤器11经补液管21与自动脉流出的血液混合，补液管21上设置有置换液壶211、止流夹212、置换液流量调节器213及单向阀214中的至少一个。通过补液管21将第一血滤器11流出的置换液引导至自动脉流出的血液处并使二者混合。本实施例中，沿置换液的流向即自第一血滤器11至动脉血的方向，在补液管21上依次设有置换液壶211、止流夹212、置换液流量调节器213及单向阀214，此处在其他实施方式中，可以仅设有置换液壶211、止流夹212、置换液流量调节其及单向阀214中的其中一个或两个以上的组合。
置换液壶211可以用于观察置换液的滴落速度及气泡收集，避免气体进入到血液中，作为优选，置换液壶211相对止流夹212、置换液流量调节器213及单向阀214靠近第一血滤器11，以及时收集气泡。置换夜壶上设置排气口，可以将收集的气体排出。
单向阀214用于使补液管21的液体仅能自第一血滤器11至动脉血的方向，从而阻止自动脉流出的血液流动至补液管21内，造成患者血液损失。当血液透析滤过过程中患者的血压突然增高，单向阀214能够有效地防止血液进入补液管21内。作为优选，单向阀214相对置换液壶211、止流夹212、置换液流量调节器213均远离第一血滤器11，即单向阀214更加靠近补液管21的输出端处。
止流夹212用于关闭补液管21，以阻止补液管21内的置换液流动。置换液流量调节阀用于调节置换液的流量，可以根据患者的动脉血的血流量调节置换液的流量，例如，当患者动脉端狭窄的血流受阻或低血压而造成动脉端血流不足，通常低于100ml/分血流透析会报警中断透析器。这时可通过置换液流量调节器213加大置换液进入血液的置换液的量而保证了透析血流量的稳定， 而进行低血流量透析。
自动脉流出的血液经第一动脉管22与置换液混合后经第二动脉管23进入第二血滤器12的中空纤维膜内(即血液区)，第一动脉管22、第二动脉管23及补液管21连通，血泵100设置在第二动脉管23上，第一动脉管22上设置有血液流量调节器221。通过第一动脉管22可以引导自动脉流出的血液与置换液进行混合，混合后通过第二动脉管23引导至第二血滤器12的中空纤维膜内。血泵100设置在第二动脉管23上，当血泵100运行时，可以带动动脉血及置换液流动，同时在第一血滤器11的中空纤维膜内产生负压，以不断生成置换液。第一动脉管22上设置有血液流量调节器221，可以对动脉血的流量进行调节，使得合适比例的动脉血与置换液进行混合。
第二动脉管23上设置有动脉壶231及动脉压力表232。血液经过血泵100后流入动脉壶231，动脉壶231可以用于检测血液流动情况及气体收集，动脉压力表232可以实时检测动脉管内的血液压力。本实施例中，动脉压力表232设置在动脉壶231上，此处，在其他实施方式中，也可以在动脉管上直接设置动脉压力表232。
自第二血滤器12流出的血液经静脉管24流入静脉，静脉管24上设置有静脉壶241及静脉压力表242。通过静脉管24将子第二血滤器12流出的经过透析滤过的血液引导至静脉，静脉壶241可以用于检测血液流动情况及气体收集，静脉压力表242可以实时检测静脉管24内的血液压力。本实施例中，静脉压力表242设置在静脉壶241上，此处，在其他实施方式中，也可以在静脉管24上直接设置静脉压力表242。
基于前述血液透析滤过方法，本发明还提供了一种血液透析滤过装置，包括第一血滤器11、第二血滤器12、第一动脉管22、第二动脉管23、补液管21、及静脉管24。
第一血滤器11包括第一透析管111和第一中空纤维膜112；第一中空纤维膜112位于第一透析管111内；第一透析管111的端面处设置有置换液出口113，置换液出口113连通至第一中空纤维膜112内；第一透析管111的管壁上设置有第一透析液入口114和第一透析液出口115，第一透析液入口114和第一透析液出口115均连通至第一中空纤维膜112外的空间。
第二血滤器12包括第二透析管121和第二中空纤维膜122，第二中空纤维膜122位于第二透析管121内，第二透析管121的一端端面处设置有血液入口123、另一端端面处设置有血液出口124，血液入口123及血液出口124均连通至第二中空纤维膜122内；第二透析管121上设置有第二透析液入口125和第二透析液出口126，第二透析液入口125和第二透析液出口126均连通至第二中空纤维膜122外的空间，第二透析液入口125与第一透析液出口115连通。
本发明中，第一血滤器11及第二血滤器12均可以采用现有技术中的血滤器(即血液过滤器)。将现有的血滤器的血液出口124作为置换液出口113使用，血滤器的血液入口123可以采用胶塞、密封帽等装置封闭，或者不打开初始血滤器的血液入口123堵头即可形成第一血滤器11。将现有的血滤器的透析液入口与第一血滤器11的透析液出口连通即可形成第二血滤器12。第一血滤器11的第一透析液出口115与第二血滤器12的第二透析液入口125可以通过软管连接，为了便于描述，该胶管可以称之为透析液软管。
第二动脉管23的一端与第一动脉管22的一端连通、第二动脉管23的另一端与第二血滤器12的血液入口123连通。第一动脉管22的另一端用于与动脉连通，用于将患者的血液输出。补液管21的一端与置换液出口113连通、补液管21的另一端与第一动脉管22和第二动脉管23的连接处连通。此处，补液管21、第一动脉管22及第二动脉管23之间可以通过三通接头20连通。静脉管24的一端与血液出口124连通、另一端用于与患者的静脉连通，以将经过透析滤过的血液输回至患者体内。
本发明提供的血液透析滤过装置在使用时，将第一透析液入口114及第二透析液出口126与血液透析机连接，第二动脉管23与血泵100连接，第一动脉管22与患者的动脉连接，静脉管24与患者的静脉相连接。
第一动脉管22、第二动脉管23、补液管21、静脉管24的结构及设置可以与前述描述相同，此处不再赘述。
在前述实施方式中，采用现有的血滤器形成第一血滤器11和第二血滤器12。为了进一步方便使用，如图2所示，本发明还提供了一种血滤组件，包括第一血滤器11和第二血滤器12。通过将第一血滤器11和第二血滤器12连接 形成一个可以独立加工制备的血滤组件，与管路连接后可以作为血液透析滤过装置使用。
具体地，第一血滤器11包括第一透析管111和第一中空纤维膜112；第一中空纤维膜112位于第一透析管111内；第一透析管111的一端闭合、另一端端面处设置有置换液出口113，置换液出口113连通至第一中空纤维膜112内；第一透析管111的管壁上设置有第一透析液入口116和第一透析液出口115，第一透析液入口116和第一透析液出口115均连通至第一中空纤维膜112外的空间，第一透析液入口116位于第一透析管111的闭合端处，第一透析液出口115相对第一透析液入口116靠近置换液出口113。
第二血滤器12包括第二透析管121和第二中空纤维膜122，第二中空纤维膜122位于第二透析管121内，第二透析管121的一端端面处设置有血液入口123、另一端端面处设置有血液出口124，血液入口123及血液出口124均连通至第二中空纤维膜122内；第二透析管121上设置有第二透析液入口125和第二透析液出口126，第二透析液入口125和第二透析液出口126均连通至第二中空纤维膜122外的空间，第二透析液入口125与第一透析液出口115连通。
第二透析液入口125与第一透析液出口115可以通过胶管连接，也可以将二者直接固定连接。本实施例中，第二透析液入口125与第一透析液出口115固定连接，第一透析液入口116与第二透析液出口126二者相对设置，使得第一透析管111与第二透析管121相对设置，可以减小整个血滤组件的占用空间。具体地，第一透析液出口115与第二透析液入口125之间可以螺纹连接，例如，将第一透析液出口115的内壁设置内螺纹，第二透析液入口125的外壁设置外螺纹，或者将第一透析液出口115的外壁设置外螺纹，第二透析液入口125的内壁设置内螺纹，从而可以将二者螺纹连接。在另一种实现方式中，第一透析液出口115与第二透析液入口125之间通过卡槽连接，例如第一透析液出口115的管内可以形成卡槽，第二透析液入口125可以插接至卡槽中，或者第二透析液入口125的管内可以形成卡槽，第一透析液出口115可以插接至卡槽中，使得二者固定连接。
进一步，第一透析管111与第二透析管121之间通过支架13固定连接， 以提高二者的连接强度。
本实施例中，第一透析液入口116和第二透析液出口126分别设置在第一透析管111的两端处，第一透析液出口115与置换液出口113位于第一透析管111的同一端部处，可以充分增加透析液和中空纤维膜的接触时间，提高测试置换液的效果。
第二透析液入口125与血液出口124位于第二透析管121的同一端部处，第二透析液出口126与血液入口123位于第二透析管121的同一端部处，通过血流方向和透析液方向是反向走向的，从而增加透析液和血液的接触时间提高透析滤过效果。此处，在其他实施方式中，也可以是，第二血滤器12中，第二透析液入口125与血液入口123位于第二透析管121的同一端部处，第二透析液出口126与血液出口124位于第二透析管121的同一端部处，如图1所示。
本发明还提供了一种血液透析滤过管路组件，包括第一动脉管22、第二动脉管23及补液管21；第一动脉管22、第二动脉管23及补液管21三者的端部相互连通。第一动脉管22、第二动脉管23及补液管21三者的端部可以通过三通接头20连接，也可以三者一体加工成型。将第一动脉管22、第二动脉管23及补液管21三者形成一个一次性产品，可以结合现有技术中的静脉管24及两个血滤管或前述血滤组件连接形成一套血液透析滤过装置进行使用。
第一动脉管22、第二动脉管23及补液管21上的结构可以与前述实施例相同，此处不再赘述。
进一步地，第一动脉管22上远离补液管21的一端设置有动脉连接头，动脉连接头可以为针头、留置针等用于与患者的动脉连接。补液管21上还设置有补液标签，第二动脉管23上还设置有动脉标签，可以对补液管21及第二动脉管23进行标识，以避免在使用过程中连接错误。
第二动脉管23上还设置有血泵100标签，血泵100标签相对动脉壶231靠近第一动脉管22，用于表示第二动脉管23与血泵100的安装位置，避免安装错误。
在利用本发明提供的血液透析滤过装置及方法进行治疗时，血透机产生的透析液通过第一血滤器11的透析液入口进入第一血滤器11的中空纤维膜外侧的区域(即透析液区)，再通过第一血滤器11的第一透析液出口115及和第二 血滤器12的第二透析液入口125进入第二血滤器12的中空纤维膜外侧的区域(即透析液区)，再经第二血滤器12的第二透析液出口126返回透析机。
动脉端的血液在血泵100的驱动下通过第一动脉管22，经过动脉血液流量调节器221进入第二血滤器12的血液入口123进入其内部中空纤维膜(由具有超滤作用的半透膜的中空纤维丝所组成)，再经第二血滤器12的血液出口124流经静脉管24而返回患者的静脉内，从而形成体外循环回路。
在补液管21的止流夹212开放的情况下，由于血泵100的驱动，在第一血滤器11的中空纤维膜内形成一个负压(负压的大小和血泵100的转速以及置换液流调节器开放的大小有关)，当第一血滤器11中空纤维内的负压大于第一血滤器11透析液区的负压时，透析液就会在超滤的作用下进入第一血滤器11的中空纤维内(因为中空纤维是个半透膜，水和电解质等小分子的物质可以自由通过，而细菌、内毒素等大分子物质是不能通过的)，这样就有一部分透析液进入第一血滤器11的中空纤维膜内形成置换液，其与血浆成分相近似的，通过补液管21，经置换液流量调节器213，单向阀214而同患者动脉端的血液进行混合，由于患者的血液被置换液的稀释，所以血液中的各种毒素(包括中分子、小分子病毒和多余的电解质)更容易通过第二血滤器12的超滤作用迅速排出体外。
根据血液透析机的原理，在患者不脱水的状态下，进入第二血滤器12的透析液流量会和流出第二血滤器12的透析液流量相等(透析及通过平衡腔或往复泵来实现透析液的进出平衡)，所以进入动脉端的透析液(置换液)一定会通过中空纤维的超滤作用进入透析液而被排出体外。当然在患者脱水的情况下，通过第二血滤器12中空纤维进入透析液区的超滤量会大于进入血液的置换液量。
当血泵100的速度设置一定数量如200ml/分，血液的稀释比例可通过血液流量调节其和置换液流量调节其来实现，他们互为负反馈。
当患者动脉端狭窄的血流受阻或低血压而造成动脉端血流不足，通常低于100ml/分血流透析会报警中断透析。这时可通过置换液流量调节器213加大置换液进入血液的置换液的量而保证了透析血流量的稳定，而进行低血流量透析。
当透析过程中患者的血压突然增高，单向阀214能够有效地防止血液进入补液管21内。
本发明的目的就是使用普通的透析机，给患者提供透析过滤治疗HDF或进行持续低流血液滤过治疗CRRT，由于其获得的置换液是通过血滤器的逆变流超滤而成，即透析液由血滤器的透析液区反超滤至血滤器的血液区，故称为逆变流血液滤透析滤过RHDF，而传统的血滤机的置换液是透析液由血滤器的透析区超滤渗透到血液区，所以本发明简单易行，安全可靠。
以上，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到各种等效的修改或替换，这些修改或替换都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以权利要求的保护范围为准。

Claims (12)

  1. 一种血液透析滤过方法，其特征在于，包括以下步骤：
    使血透机产生的透析液进入到第一血滤器的透析液区，通过血泵在所述第一血滤器的中空纤维膜内产生负压使所述透析液的一部分反超滤至所述第一血滤器的中空纤维膜内形成置换液流出所述第一血滤器、所述透析液的另一部分从所述第一血滤器的透析液区流出后经第二血滤器的透析液区进行透析滤过后流回所述血透机；
    所述置换液与自动脉流出的血液混合后在所述血泵驱动下进入所述第二血滤器的中空纤维膜内经透析滤过后流入静脉。
  2. 根据权利要求1所述的血液透析滤过方法，其特征在于，所述置换液流出所述第一血滤器后经补液管与自动脉流出的血液混合，所述补液管上设置有置换液壶、止流夹、置换液流量调节器及单向阀中的至少一个。
  3. 根据权利要求2所述的血液透析滤过方法，其特征在于，自动脉流出的血液经第一动脉管与所述置换液混合后经第二动脉管进入第二血滤器的中空纤维膜内，所述第一动脉管、所述第二动脉管及所述补液管连通，所述血泵设置在第二动脉管上；所述第一动脉管上设置有血液流量调节器。
  4. 一种血液透析滤过装置，其特征在于，包括第一血滤器、第二血滤器、第一动脉管、第二动脉管、补液管、及静脉管；
    所述第一血滤器包括第一透析管和第一中空纤维膜；所述第一中空纤维膜位于所述第一透析管内；所述第一透析管的端面处设置有置换液出口，所述置换液出口连通至所述第一中空纤维膜内；所述第一透析管的管壁上设置有第一透析液入口和第一透析液出口，所述第一透析液入口和第一透析液出口均连通至所述第一中空纤维膜外的空间；
    所述第二血滤器包括第二透析管和第二中空纤维膜，所述第二中空纤维膜位于第二透析管内，所述第二透析管的一端端面处设置有血液入口、另一端端面处设置有血液出口，所述血液入口及所述血液出口均连通至所述第二中空纤维膜内；所述第二透析管上设置有第二透析液入口和第二透析液出口，所述第二透析液入口和第二透析液出口均连通至所述第二中空纤维膜外的空间，所述 第二透析液入口与所述第一透析液出口连通；
    所述第二动脉管的一端与所述第一动脉管的一端连通、所述第二动脉管的另一端与所述第二血滤器的血液入口连通；所述第一动脉管的另一端用于与动脉连通；
    所述补液管的一端与所述第一血滤器的置换液出口连通、所述补液管的另一端与所述第一动脉管和所述第二动脉管的连接处连通；
    所述静脉管的一端与所述第二血滤器的血液出口连通，另一端用于与静脉连通。
  5. 根据权利要求4所述的血液透析滤过装置，其特征在于，所述补液管上设置有置换液壶、止流夹、置换液流量调节器及单向阀中的至少一个。
  6. 根据权利要求4所述的血液透析滤过装置，其特征在于，所述第一动脉管上设置有血液流量调节器。
  7. 一种血滤组件，其特征在于，包括第一血滤器和第二血滤器，
    所述第一血滤器包括第一透析管和第一中空纤维膜；所述第一中空纤维膜位于所述第一透析管内；所述第一透析管的一端闭合、另一端端面处设置有置换液出口，所述置换液出口连通至所述第一中空纤维膜内；所述第一透析管的管壁上设置有第一透析液入口和第一透析液出口，所述第一透析液入口和第一透析液出口均连通至所述第一中空纤维膜外的空间，所述第一透析液入口位于所述第一透析管的闭合端处，所述第一透析液出口相对所述第一透析液入口靠近所述置换液出口；
    所述第二血滤器包括第二透析管和第二中空纤维膜，所述第二中空纤维膜位于第二透析管内，所述第二透析管的一端端面处设置有血液入口、另一端端面处设置有血液出口，所述血液入口及所述血液出口均连通至所述第二中空纤维膜内；所述第二透析管上设置有第二透析液入口和第二透析液出口，所述第二透析液入口和第二透析液出口均连通至所述第二中空纤维膜外的空间，所述第二透析液入口与所述第一透析液出口连通。
  8. 根据权利要求7所述的血滤组件，其特征在于，所述第二透析液入口与所述第一透析液出口螺纹连接；或者，
    所述第二透析液入口与所述第一透析液出口通过卡槽连接；或者，
    所述第二透析液入口与所述第一透析液出口通过软管连接。
  9. 根据权利要求7所述的血滤组件，其特征在于，所述第一透析管与所述第二透析管通过支架固定连接。
  10. 根据权利要求7所述的血滤组件，其特征在于，所述第一透析液出口与所述置换液出口位于所述第一透析管的同一端部处。
  11. 一种血液透析滤过管路组件，其特征在于，包括第一动脉管、第二动脉管及补液管；所述第一动脉管、第二动脉管及补液管三者的端部相互连通；
    所述补液管上设置有置换液壶、止流夹、置换液流量调节器及单向阀中的至少一个；
    所述第一动脉管上设置有血液流量调节器。
  12. 根据权利要求11所述的血液透析滤过管路组件，其特征在于，所述第一动脉管、第二动脉管及补液管三者的端部通过三通接头连通。
PCT/CN2019/086707 2019-05-13 2019-05-13 逆变流血液透析滤过方法与装置、血滤组件及其管路组件 WO2020227903A1 (zh)

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CN1809394A (zh) * 2003-06-19 2006-07-26 株式会社Jms 血液透析过滤装置
US20140190887A1 (en) * 2013-01-08 2014-07-10 Baxter Healthcare S.A. System and method to efficiently clean a blood filter
CN205460102U (zh) * 2016-01-07 2016-08-17 张静 血液灌流串联血液透析滤过系统
CN106938063A (zh) * 2017-02-24 2017-07-11 暨南大学 一种血液净化设备的溶质清除监测系统及其方法
CN108744103A (zh) * 2018-07-11 2018-11-06 何忠贵 一种具有血液滤过功能的血液透析滤过装置
CN208641389U (zh) * 2017-10-26 2019-03-26 连云港市第四人民医院 一种血液滤过体外循环管路

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US20140190887A1 (en) * 2013-01-08 2014-07-10 Baxter Healthcare S.A. System and method to efficiently clean a blood filter
CN205460102U (zh) * 2016-01-07 2016-08-17 张静 血液灌流串联血液透析滤过系统
CN106938063A (zh) * 2017-02-24 2017-07-11 暨南大学 一种血液净化设备的溶质清除监测系统及其方法
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