WO2018053779A1 - 佩戴式滤过型人工肾装置 - Google Patents

佩戴式滤过型人工肾装置 Download PDF

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WO2018053779A1
WO2018053779A1 PCT/CN2016/099811 CN2016099811W WO2018053779A1 WO 2018053779 A1 WO2018053779 A1 WO 2018053779A1 CN 2016099811 W CN2016099811 W CN 2016099811W WO 2018053779 A1 WO2018053779 A1 WO 2018053779A1
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blood
artificial kidney
detector
pressure detector
wearable
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PCT/CN2016/099811
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English (en)
French (fr)
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赵长生
苏白海
赵伟锋
孙树东
王臣
施振强
刘强
张小华
付平
周建辉
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四川大学
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Priority to CN201690001743.3U priority Critical patent/CN209900240U/zh
Priority to US15/521,621 priority patent/US10500325B2/en
Priority to PCT/CN2016/099811 priority patent/WO2018053779A1/zh
Publication of WO2018053779A1 publication Critical patent/WO2018053779A1/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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1621—Constructional aspects thereof
    • 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
    • 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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • 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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/30—Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3672—Means preventing coagulation
    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3679—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by absorption
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3355—Controlling downstream pump pressure
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body

Definitions

  • the invention relates to a biomedical device, in particular to a wearable filtered artificial kidney device.
  • Artificial kidney is a device that replaces kidney function and is mainly used to treat kidney failure and uremia. It extracts blood from the body by using dialysis, filtration, adsorption, membrane separation and other principles to eliminate excess nitrogen compounds, metabolic products or overdose drugs, regulate electrolyte balance and then lead the purified blood back to the body.
  • the current artificial kidney device is mainly a hemodialysis type or a blood perfusion type.
  • F.P. Huowen et al. provide artificial kidneys for progressive and at least semi-continuous blood treatment (CN201210350296), in which artificial anticoagulation is first achieved, followed by preliminary blood cells and large and medium molecular weight molecules ( For example, proteins) are separated from plasma and reinfused back into the bloodstream, regulating water and salt by shunting excess plasma water and removing accumulated material and toxic substances from blood, plasma or plasma water by removing specific electrolytes and waste. The balance, in which purified or partially purified plasma and plasma water are returned to the blood vessels of the body. Peng Luomin et al.
  • a multifunctional portable artificial kidney (CN200610070809), which reduces the dialysate supply system, enables accurate capacity monitoring, is free of acetic acid dialysis, and is flexible depending on the water source.
  • Zhao Zuoning et al. invented a mobile artificial kidney (CN03214805), which involves an artificial kidney host.
  • the water supply system connected to the artificial kidney host is composed of a dialysate storage tank, a constant pressure water pump and a water supply. Pipeline composition.
  • A. D. Belz et al. invented a portable artificial kidney (CN93104127) that does not require ancillary equipment and is sized and shaped to be lightweight and relatively small. It can be worn or attached to the patient without affecting normal human activity.
  • the artificial kidney has a plasma separation unit that receives impure whole blood from the human body, separates a predetermined amount of plasma, and returns the blood after separation of the partial plasma to the human body.
  • the separated plasma is passed through a chemical processing unit in which toxic plasma is removed from uric acid, creatinine, phosphate and ammonium ions.
  • the detoxified plasma is sent to a dehydration unit, and the detoxified plasma is then returned to the human circulatory system.
  • the artificial kidney is also a miniaturized hemodialysis device that can be placed at the waist of the patient and weighs only 10 pounds (about 4.5 kg). The complete therapeutic function of a hemodialysis machine will enter the clinical trial phase before the end of 2015. .
  • Dong Fan et al. provided a combined artificial kidney (CN201380037335), which is a combined artificial kidney without a perfusion filler in use.
  • the idea of the invention is to use a blood filter to remove the toxin and excess water in the blood by ultrafiltration without using the dialysate and the dialysate circulation system, thereby realizing the miniaturization and wearability of the artificial kidney device (or wearing ) sexual and convenient for patients with renal failure.
  • the object of the present invention is to provide a solution to the above problems.
  • a new artificial kidney device is proposed: imitating the glomerulus
  • the filtration function is performed by using a blood filter to prepare a wearable artificial kidney, and a miniaturized wear-through type artificial kidney device for the artificial kidney device is realized.
  • a wearable filtered artificial kidney device includes a blood conduit, and the blood conduit is sequentially provided with a blood inlet switch, an infusion port, a blood pump, and a blood pump.
  • the blood filter comprises an inlet, an outlet and a waste liquid port, wherein the inlet and the outlet are connected to the blood pipe, and the waste liquid port is connected to a waste liquid pipe, and the waste liquid pipe is provided with an ultrafiltration control pump and a waste liquid switch.
  • the arterial pressure tester and the venous pressure tester respectively detect a hemofilter inlet pressure and an outlet end pressure, and the bubble detector detects the amount of bubbles in the returned blood.
  • a resin perfusion device and an activated carbon perfusion device are disposed between the arterial pressure detector and the hemofilter.
  • the activated carbon perfusate is provided with a coated activated carbon adsorbent and/or an endotoxin adsorbent.
  • the resin infusion is equipped with an adsorbent resin microballoons urease and ⁇ 2 - microglobulin adsorbent.
  • the arterial pressure detector, the venous pressure detector and the bubble detector are provided with an alarm unit, and when the monitored data exceeds a preset threshold, an alarm is issued, and each detector is connected to a display.
  • both ends of the blood pipe are used for connecting the blood vessel of the patient, and a closed circuit is formed with the blood vessel, the blood inlet switch is disposed at the blood outlet of the human body, and the blood outlet switch is disposed at the blood inlet of the human body.
  • the infusion port is actually an inlet for the external blood supply for the blood pipeline. We can input heparin, diluent and other medical liquids from the infusion port as needed to assist the treatment.
  • the blood pump is used to control the flow of blood in the blood line.
  • the blood filter itself has an anticoagulant function for mimicking the function of the glomerulus and achieving blood purification;
  • the ultrafiltration control pump is connected to the hemofilter to control the amount of dehydration.
  • the arterial pressure tester and the venous pressure tester are used to detect the pressure at the inlet and outlet ends of the hemofilter, and the pressure exceeds the threshold range to feed back the data to the controller.
  • Bubble detector detects bubbles from the blood filter that need to be returned to the blood of the patient, but the amount of bubbles exceeds the threshold range and the data is fed back to the controller.
  • the perfusion device is mainly used for acute and chronic drug poisoning, molecular toxin adsorption in uremia, absorption of pathogenic factors in liver diseases and immunology, and the resin perfusion device used in the present invention can adsorb ⁇ 2-microglobulin.
  • the urea is decomposed, and the activated carbon permeator adsorbs creatinine; it also has an acid-base balance function.
  • the blood flow rate is 60-150 mL/min
  • the membrane area of the blood filter is 0.6-1.0 square meters
  • the screening coefficient of the blood filtration membrane to vitamin B12 is 0.9
  • the retention rate of albumin is not less than 0.95
  • the ultrafiltration coefficient is not less than 200 mL/kPa.h.
  • the resin perfusion device has a adsorption capacity of ⁇ 2-microglobulin of not less than 50 mg, and a decomposition rate of urea of not less than 100 mg per hour.
  • the adsorption capacity of creatinine is not less than 250mg; at the same time has acid-base balance function.
  • the device does not use dialysate and complex dialysate circulation device, which greatly reduces the size and weight of the device and can be easily worn or worn.
  • the invention innovatively proposes a mode of hemofiltration + blood perfusion, and a part of the therapeutic dose is completed by perfusion to form a blood.
  • Filtered + blood perfusion "hybrid" blood purification mode use blood filter to mimic the filtration of glomerulus, remove excess water and some toxins in the blood, use perfusion to clear 2-2-microglobulin and urea nitrogen make up for the insufficiency of simple hemofiltration treatment.
  • the device provided by the invention has the advantages of simple structure, easy operation, low cost and easy realization of large-scale industrialization.
  • Figure 1 is a block diagram of the principle of the present invention.
  • blood inlet switch 1, inlet switch; 2, infusion port; 3, blood pump; 4, arterial pressure detector; 5, resin perfusion device; 6, activated carbon perfusion device; 7, blood filter; 8, venous pressure detection Instrument; 9, bubble detector; 10, ultrafiltration control pump; 11, waste switch; 12, blood outlet switch.
  • a wearable filtered artificial kidney device includes a blood conduit, and the blood conduit is sequentially provided with a blood inlet switch 1, an infusion port 2, a blood pump 3, and an arterial pressure detector along a blood flow direction. 4, blood filter 7, venous pressure detector 8, bubble detector 9, blood outlet switch 12;
  • the blood filter 7 includes an inlet, an outlet and a waste liquid port, wherein the inlet and the outlet are connected to a blood pipe, and the waste liquid port is connected to a waste liquid pipe, and the waste liquid pipe is provided with an ultrafiltration control pump 10 and a waste liquid switch. 11,
  • the arterial pressure detector 4 and the venous pressure detector 8 detect the inlet pressure and the outlet end pressure of the hemofilter 7, respectively, and the bubble detector 9 detects the amount of bubbles in the returned blood.
  • a resin perfusion device 5 and an activated carbon perfusion device 6 are disposed between the arterial pressure detector 4 and the blood filter device 7; the activated carbon perfusion device 6 is provided with a coated activated carbon adsorbent and/or endotoxin.
  • the arterial pressure detector 4, the venous pressure detector 8 and the bubble detector 9 are each provided with an alarm unit, and when the detected data exceeds a preset threshold, an alarm is issued, and each detector is connected to a display.
  • the components are miniaturized and miniaturized for easy wearing.
  • the blood inlet switch 1 and the blood outlet switch 12 are connected to the patient's blood vessel through the blood conduit during the treatment, and the diluent can be input into the infusion port 2, and the patient's blood and the diluent input into the infusion port 2 are delivered to the arterial pressure by the blood pump 3.
  • the instrument 4 detects the pressure, and then delivers it to the resin perfusion device 5 and the activated carbon suction perfusion device to purify the blood, and then delivers it to the blood filter 7 to further purify the blood, and then delivers the blood to the venous pressure detector 8 and bubble detection.
  • the instrument 9 performs venous pressure detection and bubble detection, respectively, and detects the safety and returns to the patient's blood.
  • the blood inlet switch 1 Before the treatment, the blood inlet switch 1 is closed, and heparinized saline is input from the infusion port 2 to realize heparinization of the blood conduit, and the air bubbles in the blood pipe, the resin perfusion device 5, the activated carbon perfusion device 6, and the blood filter 7 are removed, and the blood is started.
  • the filter 7 and the ultrafiltration control pump 10 are filtered out with physiological saline at the waste switch 11, and after the bubbles are completely eliminated, the washing of the heparin physiological saline is stopped.
  • the blood pipe is connected to the patient's blood at both ends, and the blood inlet switch 1 and the blood outlet switch 12 are opened, so that the blood pipe and the human body constitute a closed blood circuit, and the blood blood flows through the blood pipe through the blood pump 3 and the arterial pressure detector 4,
  • the resin perfusion device 5, the activated carbon perfusion device 6, the blood filter 7, the venous pressure detector 8, the bubble detector 9, the purification of the resin perfusion device 5, the activated carbon perfusion device 6, and the hemofilter 7, the waste liquid is waste
  • the liquid switch 11 is removed, and the purified blood is returned to the patient.
  • the blood inlet switch 1 is closed, the physiological saline is input from the infusion port 2, the physiological saline is continuously washed and input into the patient, the waste liquid is not removed, the blood outlet switch 12 is closed, the blood filter 7 is closed, and the ultrafiltration is turned off.
  • the pump 10 is controlled.
  • the blood flow rate is 60-150 mL/min
  • the membrane area of the blood filter 7 is 0.6-1.0 square meters
  • the screening coefficient of the blood filtration membrane to vitamin B12 is 0.9
  • the retention rate of albumin is not less than 0.95
  • the ultrafiltration coefficient is not less than 200 mL/kPa.h.
  • the resin perfusion device 5 has an adsorption capacity of ⁇ 2-microglobulin of not less than 50 mg and a decomposition rate of urea of not less than 100 mg per hour.
  • the activated carbon perfusion device 6 has an adsorption capacity for creatinine of not less than 250 mg; and has an acid-base balance function.
  • the amount of dehydration was 1-3L
  • the total amount of ⁇ 2-microglobulin decreased by 30%
  • the total amount of urea nitrogen decreased by 30-35%.

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Abstract

一种佩戴式滤过型人工肾装置，包括输液口（2）、血泵（3）、动脉压检测仪（4）、血液滤过器（7）、静脉压检测仪（8）、气泡检测仪（9），该输液口（2）、血泵（3）、动脉压检测仪（4）、树脂灌流器（5）、活性炭灌流器（6）、血液滤过器（7）、静脉压检测仪（8）、气泡检测仪（9）依次连接，血液滤过器（7）的废液口连接有超滤控制泵（10）。该装置模仿肾小球的滤过作用，利用血液滤过器（7）的超滤来实现清除血液中毒素和多余水分的目的，不使用透析液和复杂的透析液循环装置，大大减少了装置的体积和重量，可方便佩戴或穿戴，结构简单，易操作，成本低，容易实现大规模产业化。

Description

佩戴式滤过型人工肾装置 技术领域
本发明涉及一种生物医疗设备，尤其涉及一种佩戴式滤过型人工肾装置。
背景技术
人工肾是一种替代肾脏功能的装置，主要用于治疗肾功能衰竭和尿毒症。它将血液引出体外利用透析、过滤、吸附、膜分离等原理排除体内过剩的含氮化合物，新陈代谢产物或逾量药物等，调节电解质平衡然后再将净化的血液引回体内。
目前的人工肾装置主要是血液透析型，或血液灌流型。F·P·霍温等人提供了用于渐次的和至少半连续的血液处理的人工肾(CN201210350296)，在人工肾中，首先实现抗凝作用，然后初步将血细胞以及大和中等分子量的分子(例如蛋白质)从血浆分离并重新输回到血流中，通过分流过量的血浆水和通过除去特定的电解质和废物进一步从血流、血浆或血浆水中除去蓄积的物质和有毒物质来调节水和盐的平衡，其中纯化或部分纯化的血浆和血浆水送回到身体的血管中。彭罗民等人发明了一种多功能便移式人工肾(CN200610070809)，该装置减化了透析液供给系统，能进行精确的容量监控，无醋酸透析，不依赖水源，能灵活应用。赵作宁等人发明了一种可移动人工肾(CN03214805)，涉及人工肾主机，与人工肾主机相连的供水系统由透析液储存罐、定压水泵和供水 管路组成。A·D·贝尔兹等人发明了一种不需辅助设备的可携带人工肾(CN93104127)，其大小和形状使其重量轻且相当小。它可佩带或附在病人身上而不会影响正常的人体活动。人工肾有一血浆分离单元，从人体中接收不纯的全血，将预定量的血浆分离，再将分离部分血浆后的血液送回人体。分离出来的血浆通过一化学处理单元，在该单元中有毒血浆被除去尿酸、肌酸酐、磷酸盐和铵离子。清毒后的血浆被送至一脱水单元，然后清毒后的血浆被重新送回人体循环系统。
2009年，由洛杉矶西奈医疗中心的Victor Gura和加州大学洛杉矶分校医学院的David Geffen共同领导的研究团队曾展示过一款可穿戴人工肾(WAK)的概念产品。该人工肾同样是小型化血液透析装置，可背在患者的腰间，重量仅10磅(约4.5公斤)，并且有一台血液透析机完整的治疗功能，将在2015年年底之前进入临床试验阶段。另外，董凡等人提供了一种组合型人工肾(CN201380037335)，是一种在使用中免拆灌流器的组合型人工肾。
本发明的思路是利用血液滤过器，在不使用透析液和透析液循环系统的情况下，依靠超滤作用清除血液中毒素和多余水分，实现人工肾装置的小型化和可佩戴(或穿戴)性，方便肾衰竭病人的活动。
发明内容
本发明的目的就在于提供一种解决上述问题，针对目前人工肾装置结构复杂，体积和重量大，不便于佩戴(或穿戴)的等问题，提出一种新的人工肾装置：模仿肾小球的滤过作用，利用血液滤过器，制备佩戴式人工肾，实现人工肾装置的小型化佩戴式滤过型人工肾装置。
为了实现上述目的，本发明采用的技术方案是这样的：一种佩戴式滤过型人工肾装置，包括血液管道，所述血液管道沿血液流向依次设有血液入口开关、输液口、血泵、动脉压检测仪、血液滤过器、静脉压检测仪、气泡检测仪、血液出口开关；
所述血液滤过器包括入口、出口和废液口，其中入口和出口连接血液管道，废液口连接一废液管，所述废液管上设有超滤控制泵和废液开关，
所述动脉压检测仪和静脉压检测仪分别检测血液滤过器入口压力和出口端压力，所述气泡检测仪检测回输血液中的气泡量。
作为优选：所述动脉压检测仪和血液滤过器间设有树脂灌流器和活性炭灌流器。
作为优选：所述活性炭灌流器内设有包膜活性炭吸附剂和/或内毒素吸附剂。
作为优选：所述树脂灌流器内设有脲酶树脂微球吸附剂和β2-微球蛋白吸附剂。
作为优选：所述动脉压检测仪、静脉压检测仪和气泡检测仪均设有报警单元，且当监测到数据超过预设阈值时报警，且各检测仪均连接一显示器。
本发明中：血液管道两端用于连接患者血管，并与血管形成闭合的回路，血液入口开关设置在人体血液出口处，血液出口开关设置在人体血液入口处。
输液口其实是为血液管道预留一个外接液体的入口，我们可根据需要从输液口输入肝素、稀释液等医用药液，来进行辅助治疗。
血泵用于控制血液管道内血液的流量。
血液滤过器自身具有抗凝血功能，用于模仿肾小球的功能，实现血液净化； 超滤控制泵连接血液滤过器，控制脱水量。
动脉压检测仪、静脉压检测仪用于检测血液滤过器入口端和出口端的压力，且压力超过阈值范围则反馈数据给控制器。
气泡检测仪：检测从血液滤过器出来需要回输到患者体内血液的中的气泡，但气泡量超过阈值范围则反馈数据给控制器。
灌流器，目前主要应用于急慢性药物中毒、尿毒症中分子毒素吸附，肝病及免疫领域致病因子的吸附，而本发明所采用的树脂灌流器，能对β2-微球蛋白进行吸附，对尿素进行分解，而活性炭灌流器对肌酐进行吸附；同时具有酸碱平衡功能。
本发明中：血液流速60-150mL/min，血液滤过器的膜面积为0.6-1.0平方米；血液滤过膜对维生素B12的筛分系数为0.9；对白蛋白的截留率不低于0.95；超滤系数不低于200mL/kPa.h。
树脂灌流器，对β2-微球蛋白的吸附容量不低于50mg，对尿素的分解速率不低于100mg每小时。
活性炭灌流器，对肌酐的吸附容量不低于250mg；同时具有酸碱平衡功能。
与现有技术相比，本发明的优点在于：
1、该装置不使用透析液和复杂的透析液循环装置，大大减少了装置的体积和重量，可方便佩戴或穿戴。
2、克服了现有技术中，大量滤过液的无法排放和置换液无法补充的问题，本发明创新性地提出血液滤过+血液灌流的模式，通过灌流完成一部分治疗剂量，形成一种血液滤过+血液灌流的“杂合”式的血液净化模式；利用血液滤过器模仿肾小球的滤过作用，清除血液中多余水分和部分毒素，利用灌流清除 β2-微球蛋白和尿素氮，弥补了单纯血滤治疗效果的不充分。
3、本发明提供的装置结构简单，易操作，成本低，容易实现大规模产业化。
附图说明
图1为本发明原理框图。
图中：1、血液入口开关；2、输液口；3、血泵；4、动脉压检测仪；5、树脂灌流器；6、活性炭灌流器；7、血液滤过器；8、静脉压检测仪；9、气泡检测仪；10、超滤控制泵；11、废液开关；12、血液出口开关。
具体实施方式
下面将结合附图对本发明作进一步说明。
实施例1：参见图1，一种佩戴式滤过型人工肾装置，包括血液管道，所述血液管道沿血液流向依次设有血液入口开关1、输液口2、血泵3、动脉压检测仪4、血液滤过器7、静脉压检测仪8、气泡检测仪9、血液出口开关12；
所述血液滤过器7包括入口、出口和废液口，其中入口和出口连接血液管道，废液口连接一废液管，所述废液管上设有超滤控制泵10和废液开关11，
所述动脉压检测仪4和静脉压检测仪8分别检测血液滤过器7入口压力和出口端压力，所述气泡检测仪9检测回输血液中的气泡量。
本实施例中：所述动脉压检测仪4和血液滤过器7间设有树脂灌流器5和活性炭灌流器6；所述活性炭灌流器6内设有包膜活性炭吸附剂和/或内毒素吸附剂；所述树脂灌流器5内设有脲酶树脂微球吸附剂和β2-微球蛋白吸附剂； 所述动脉压检测仪4、静脉压检测仪8和气泡检测仪9均设有报警单元，且当监测到数据超过预设阈值时报警，且各检测仪均连接一显示器。
本发明中，针对佩戴式滤过型人工肾装置，将各部件小型化和微缩化，方便佩戴。
血液入口开关1和血液出口开关12在治疗过程中通过血液管道连接患者血管，输液口2中可以输入稀释液，患者的血液和输液口2中输入的稀释液通过血泵3输送至动脉压检测仪4检测压力，然后依次输送至树脂灌流器5和活性炭吸灌流器对血液进行净化，然后输送至血液滤过器7进一步对血液进行净化，然后将血液输送至静脉压检测仪8和气泡检测仪9分别进行静脉压检测和气泡检测，检测安全后回流至患者血液。
治疗前，血液入口开关1关闭，从输液口2处输入肝素生理盐水实现血液管道的肝素化，排除血液管道、树脂灌流器5、活性炭灌流器6和血液滤过器7中的气泡，启动血液滤过器7和超滤控制泵10，废液开关11处有生理盐水滤出，待完全排除气泡后，停止肝素生理盐水的冲洗。
治疗过程中，血液管道两端连接患者血液，打开血液入口开关1、血液出口开关12，使血液管道与人体构成闭合血液回路，血血液经血液管道依次流经血泵3、动脉压检测仪4、树脂灌流器5、活性炭灌流器6、血液滤过器7、静脉压检测仪8、气泡检测仪9，通过树脂灌流器5、活性炭灌流器6和血液滤过器7的净化，废液从废液开关11处排除，净化后的血液回流至患者体内。
治疗结束后，关闭血液入口开关1，从输液口2中输入生理盐水，生理盐水连续冲洗并输入病人体内，待废液不再排除，关闭血液出口开关12，关闭血液滤过器7和超滤控制泵10。
本发明中：血液流速60-150mL/min，血液滤过器7的膜面积为0.6-1.0平方米；血液滤过膜对维生素B12的筛分系数为0.9；对白蛋白的截留率不低于0.95；超滤系数不低于200mL/kPa.h。
树脂灌流器5，对β2-微球蛋白的吸附容量不低于50mg，对尿素的分解速率不低于100mg每小时。
活性炭灌流器6，对肌酐的吸附容量不低于250mg；同时具有酸碱平衡功能。
预临床实验结果，脱水量为1-3L，β2-微球蛋白总量下降30％，尿素氮总量下降30-35％。
以上所述，仅是本发明的较佳实施例而已，并非对本发明的技术范围作任何限制，故凡是依据本发明的技术实质对以上实施例所作的任何细微修改、等同变化与修饰，均仍属于本发明技术方案的范围内。

Claims (5)

  1. 一种佩戴式滤过型人工肾装置，其特征在于：包括血液管道，所述血液管道沿血液流向依次设有血液入口开关(1)、输液口(2)、血泵(3)、动脉压检测仪(4)、血液滤过器(7)、静脉压检测仪(8)、气泡检测仪(9)、血液出口开关(12)；
    所述血液滤过器(7)包括入口、出口和废液口，其中入口和出口连接血液管道，废液口连接一废液管，所述废液管上设有超滤控制泵(10)和废液开关(11)，
    所述动脉压检测仪(4)和静脉压检测仪(8)分别检测血液滤过器(7)入口压力和出口端压力，所述气泡检测仪(9)检测回输血液中的气泡量。
  2. 根据权利要求1所述的佩戴式滤过型人工肾装置，其特征在于：所述动脉压检测仪(4)和血液滤过器(7)间设有树脂灌流器(5)和活性炭灌流器(6)。
  3. 根据权利要求2所述的佩戴式滤过型人工肾装置，其特征在于：所述活性炭灌流器(6)内设有包膜活性炭吸附剂和/或内毒素吸附剂。
  4. 根据权利要求2所述的佩戴式滤过型人工肾装置，其特征在于：所述树脂灌流器(5)内设有脲酶树脂微球吸附剂和β2-微球蛋白吸附剂。
  5. 根据权利要求1所述的佩戴式滤过型人工肾装置，其特征在于：所述动脉压检测仪(4)、静脉压检测仪(8)和气泡检测仪(9)均设有报警单元，且当监测到数据超过预设阈值时报警，且各检测仪均连接一显示器。
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