WO2018126333A1 - 集成血液净化器 - Google Patents

集成血液净化器 Download PDF

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WO2018126333A1
WO2018126333A1 PCT/CN2017/000015 CN2017000015W WO2018126333A1 WO 2018126333 A1 WO2018126333 A1 WO 2018126333A1 CN 2017000015 W CN2017000015 W CN 2017000015W WO 2018126333 A1 WO2018126333 A1 WO 2018126333A1
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fiber
resin
blood
hollow
dialyzer
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PCT/CN2017/000015
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French (fr)
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于杰
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于杰
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Priority to PCT/CN2017/000015 priority Critical patent/WO2018126333A1/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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/38—Removing constituents from donor blood and storing or returning remainder to body, e.g. for transfusion

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  • Uremic patients require dialysis treatment almost daily or every other day in order to expel more water in the body, ie urine.
  • the dialyzer cannot remove the large molecular waste in the blood.
  • the accumulation of medium and large molecular metabolic waste in the body will affect health and should be removed in time when it is produced.
  • the blood perfusion device can remove medium and large molecular waste, but the shortcoming in use is that it cannot be dehydrated, including small molecule waste. Therefore, when applied to uremic patients, it must be used in series with the dialyzer.
  • the perfusate is adsorbed and the dialyzer is separated by membrane separation, so the two have different structures, and the influence on the blood flow rate is different in use, and the operation is inconvenient.
  • the function of the perfusion device is to adsorb and remove the large and medium molecular metabolic waste accumulated in the patient, and it is not required to be used frequently every day or every other day.
  • the concept and product of a "high-throughput" dialyzer is proposed in order to replace or partially replace the perfusion device to remove macromolecular waste.
  • "high-throughput" dialysis with high-protein molecules removed from macromolecular waste requires compensation for the patient's input protein at any time.
  • the object of the present invention is to provide a patient who is suitable for uremia and can clear blood at any time.
  • Medium-sized molecular waste which simultaneously discharges urine and small-molecule waste; and medical device technology solutions that do not lose high-quality protein molecules, solve the problems in the prior art.
  • the basic technical solution of the present invention is an integrated blood purifier characterized in that the perfusate housing is replaced with a permeable membrane; the purifier is disposed in the blood permeate collection container.
  • the permeable membrane is a hollow fiber membrane, the permeate collection container is a dialyzer; each medium fiber membrane is a blood purifier unit, and the integrated blood purifier is a bundle of hollow fiber membranes disposed in a dialyzer;
  • the two ends are fixed on the inner walls of both ends of the dialyzer by a sealing material, which blocks the open space of the open fiber space and the interstitial space of the fiber to prevent the blood from being contaminated by the dialysate; in the dialyzer casing, the fiber bundles cover the fiber at both ends
  • the hollow mouth is provided with a mesh which allows blood to pass through but blocks the passage of resin particles; the adsorption resin is filled in the hollow fiber between the two ends of the mesh.
  • An end cap is disposed at both ends of the dialyzer, and the end cap is sealingly connected with the dialyzer housing, and a blood collecting space is left between the end cap and the net, and the end cap is provided with a nozzle communicating with the external blood channel.
  • the filling method of the adsorbing resin particles in the hollow fiber is: a part of the fiber hollow filling resin, another part of the fiber hollow filling resin, or all the fiber hollow filling resin; the resin filling volume is the total hollow volume of the fiber Or a part of the hollow volume of the fiber.
  • the micro-nano-sized medical adsorption resin powder is dissolved in the fiber slurry and then enters the fiber molding process, and the resin is contained in the fiber membrane wall.
  • 1, 2, and 3 are schematic views of the present invention for use in a dialyzer.
  • FIG. 1 is a schematic view of the structure of a hollow fiber dialyzer. Among them, each fiber The membrane is an integrated blood purifier unit of the present invention. In the dialyzer, a bundle of a plurality of fibrous membranes constitutes an integrated blood purifier of the present invention.
  • the identification numbers indicate: 1A indicates blood inflow, 1B indicates blood outflow, 2A indicates dialysate inflow, and 2B indicates dialysate outflow.
  • FIG. 3A and 3B in Fig. 2 respectively denote a mesh covering the inflow and outflow of blood into the blood vessel 4 port.
  • FIGS. 1 and 2 are a partial enlarged views of FIGS. 1 and 2, in which the fibrous hollow tube is a divided blood vessel 4, the gap is a dialysate chamber 5, and the small balls in the divided blood vessel 4 represent a resin ball 6.
  • 3A, 3B, 3C and 3D are electron microscopic enlarged views of the resin particles in the hollow fiber, and the bright colored balls are fluorescently labeled resins.
  • Fig. 3 some of the respective blood vessels 4 are filled with the resin balls 6, and some are not filled; the filled resin is filled with the partial blood vessels 4, and some of the partial blood vessels are filled with hollow.
  • the role of the resin ball 6 is to adsorb and remove large molecular waste in the blood. The choice of each filling method is based on the amount of macromolecular waste produced or accumulated in the patient.
  • the integrated blood purifier of the present invention integrates the dialyzer and the perfusion device, there is no problem of a difference in blood flow rate during operation. Tests have shown that whether in the same fiber bundle, there are some hollow fiber filling resins, some are not filled with resin, some are filled with resin until they are filled with hollow, or there is little or no resin filling, because the diameter of the hollow fiber is small, each Even if the resin ball is filled in the hollow fiber, it is only a few particles; the gap of the resin ball is also a blood flow channel, and the integrated purifier as a whole has a uniform blood flow rate through each fiber hollow.
  • the particle size of the resin in the integrated blood purifier of the present invention depends on the size of the pores on the mesh 3.
  • the particle size of the resin is larger than the pores on the mesh 3 that allow blood to pass through, and the resin is prevented from falling out of the purifier into the blood vessel.
  • the blood purification technology of resin adsorption and membrane dialysis is integrated into one device.
  • the resin adsorbs and removes the large molecular waste in the blood and the hollow fiber membrane dialysis to remove small molecular waste and urine at the same time.
  • the dialysis pore size on the dialysis membrane is generally 1.3-2.5 nm, the high-flux average is 2.9 nm, the maximum diameter is about 3.5 nm, and is not more than 5 nm; the resin particle size is much larger than this, it will not pass through, and will not block the fiber. Dialysis well on the membrane.
  • the hollow diameter of the fiber is to allow the resin particles to move freely to the lower limit.
  • the dialysis rate of the fiber membrane is determined by the area thereof, and the inner diameter and length of the desired fiber can be calculated from the dialysis amount to obtain the fiber membrane area, which belongs to the prior art.
  • the position of the resin in the hollow space of the fiber in Figure 3 is a schematic representation of the static placement.
  • the blood inlet is placed below, and when the blood enters the hollow fiber, that is, the blood vessel 4, the resin ball 6 gathers in the upper position under the blood flow pressure.
  • the resin of the invention distributes along the blood flow direction in the hollow fiber, and utilizes the difference of the solute concentration gradient more effectively than the blood perfusion in the perfusion device to increase the resin adsorption rate.
  • 4A is a photograph of the hollow fiber
  • 4B is a magnified photograph at 4A, and it can be seen that the fiber wall has a layered section, and there are dialysis holes in the layer, and the membrane
  • the material contains micro-nano-sized resin particles
  • 4C is a partial re-amplification of the 4B, and it can be seen that the fiber wall contains the granular resin
  • 4D is a re-enlarged image of the inner wall surface of the fiber at 4C, which can be seen.
  • the inner surface has a concave-convex surface due to the inclusion of resin particles in the fiber wall; 4E is a magnified view at 4D, and it can be more clearly seen that the convex portion is a resin particle contained by the fibrous material; 4F is a resin film containing the resin. An enlarged view of the outer wall surface. Experiments have shown that the resin still has a significant adsorption effect in the form in which the resin particles are contained in the fiber wall.
  • Figure 5 is a photograph of a test article of an embodiment of the present invention.
  • the brightly colored spots in the photo are resin particles in the fiber membrane wall or fluorescent signs in the fiber hollow.
  • Fig. 6, Fig. 7, Fig. 8 and Fig. 9 are adsorption mass spectra of experiments for adsorbing and scavenging representative substances of hollow fiber membranes in two types of resin-incorporated forms of the integrated blood purifier of the present invention. It is proved that in the present invention, the macromolecular representative substance endotoxin and VB12 have excellent adsorption effects, and at the same time, urine and small molecule waste can be discharged through the fiber membrane dialysis.
  • the resin acts to adsorb and remove macromolecular waste, there is no loss of high-quality protein in the medium and large molecules, and there is no need to compensate for the protein.
  • the integrated blood purifier of the present invention has the function of dialysis to remove urine and small molecule waste while providing targeted adsorption to remove macromolecular waste in the body. Simultaneous operation of one instrument to remove large, medium and small molecular waste and urine from the blood. The damage caused by the accumulation of medium-sized macromolecular waste on patients' health not only simplifies the treatment procedures, improves clinical safety, but also reduces treatment costs.
  • the above is a description of the technical solution of the present invention by using a dialyzer as an embodiment.
  • the basic idea of the present invention is to replace the perfusion vessel body with a permeable membrane, or to use it in a medical device such as plasma separation for blood purification.
  • the permeation pore size of the permeable membrane is controlled, and the solute and plasma of different molecular weights in the blood are separated by the permeable membrane, and can be separately purified on both sides of the permeable membrane, and then recirculated back to the body.
  • the technical scheme of the invention integrates two blood purification instruments belonging to different action mechanisms: a resin-adsorbed blood perfusion device and a hemodialyzer separated by a membrane dialysis, or a plasma separator separated from a membrane dialysis, etc., and solves the problem so far.
  • a long-standing problem that cannot be solved in the field of blood purification in the same instrument, under the same blood flow rate, the different substances in the blood and the large, medium and small molecular weight solute are separated, and one or several solute is dialyzed through the membrane. After separation, it is removed; or after separation, resin adsorption purification treatment is performed separately, and then the flow or the flow compensation is returned to the blood circulation blood path.

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Abstract

一种集成血液净化器，以渗透膜置换灌流器壳体，灌流器设置在血液渗透液收集容器中。

Description

集成血液净化器
所属技术领域：血液净化医疗器械
现有技术背景
尿毒症患者几乎每天或者隔天就需要透析治疗以便及时排出体内多于的水，即尿液。但是透析器不能清除血液中的中大分子废物，中大分子代谢废物在体内蓄积会影响健康，应当在其产生时及时清除。血液灌流器可以清除中大分子废物，但是使用中存在的缺点是不能脱水，包括小分子废物。因此在应用于尿毒症患者时，必须与透析器串联使用。由于灌流器和透析器清除废物的机理不同，灌流器是吸附清除，透析器是膜分离清除，因而二者具有不同的构造，使用中对血流速的影响不同，在操作上存在不便。灌流器的作用是吸附清除患者体内蓄积的中大分子代谢废物，不需要每天或隔天频繁地使用。为此提出“高通量”透析器的概念和产品，目的是取代或者部分取代灌流器清除中大分子废物。但是“高通量”透析伴随中大分子废物清除出来的还有优质蛋白质分子，就需要随时对患者补偿输入蛋白质。不仅增加治疗内容，也增加患者负担。能有一种血液净化器械可以克服上述各种器械存在的缺点，在清除水和小分子废物的同时，把中大分子废物也清除；或者在清除中大分子废物的同时，能够脱水和清除小分子废物，是血液净化医疗器械领域长期以来的期盼。
发明的内容：
本发明的目的是提出一种适用于尿毒症患者随时可以清除血液 中的中大分子废物，同时排出尿液和小分子废物；且不损失优质蛋白分子的医疗器械技术方案，解决现有技术中存在的问题。
本发明的基础技术方案是：集成血液净化器，其特征在于：以渗透膜置换灌流器壳体；所述净化器设置在血液渗透液收集容器中。
所述渗透膜是中空纤维膜，所述渗透液收集容器是透析器；每条中纤维膜是一个血液净化器单元，集成血液净化器是中空纤维膜集束，其设置在透析器中；集束纤维两端部由密封材料固定于透析器两端内壁上，隔断纤维开放的空心空间与纤维间隙空间的联通，防止血液被透析液污染；在所述透析器壳体中，纤维束两端面覆盖纤维空心口、设置允许血液透过、却阻断树脂颗粒通过的隔网；吸附树脂充填于两端隔网之间的纤维空心中。透析器两端设置端盖，端盖与透析器壳体密封连接，在端盖与隔网之间留有血液汇集空间，端盖上设置与外接血路联通的管口。
所述集成净化器中，纤维空心中吸附树脂颗粒的充填方式是：部分纤维空心充填树脂、另一部分纤维空心不充填树脂，或者是全部纤维空心都充填树脂；树脂充填体积是纤维空心容积的全部或者是纤维空心容积的部分。再一种方式是制作中空纤维时，把微纳米级粒径的医用吸附树脂粉料溶于纤维浆料中再进入纤维成型工序，树脂包容在纤维膜壁中。
本发明的实施例如附图所示：
图1、图2、图3是本发明用于透析器中的示意图。
图1全图是一张中空纤维透析器的结构示意图。其中，每条纤维 膜即是一个本发明所述的集成血液净化器单元。在透析器中则是多个纤维膜的集束，构成本发明的集成血液净化器。
标识数字分别表示：1A表示血液流入，1B表示血液流出，2A表示透析液流入，2B表示透析液流出。
图2中的3A和3B分别表示覆盖血液流入和流出分血管4管口的隔网。
图3是图1、图2的局部放大图，其中纤维空心管是分血管4，其间隙是透析液腔5；分血管4中的小球表示树脂球6。图3A、图3B图3C和图3D是在纤维空心中树脂颗粒的电子显微放大图，亮色的球是着上荧光标记的树脂。
图3中，在各个分血管4中有的填充了树脂球6，有的没填充；填充的树脂体积有的充满了分血管4，有的填充了部分分血管空心。这是表示在如何填充树脂和填充多少树脂时，存在多种选择。树脂球6的作用是吸附清除血液中的中大分子废物。每种填充方式选择的依据是与患者体内产生或者蓄积的中大分子废物的量相关。
由于本发明的集成血液净化器是把透析器与灌流器集成为一体，在操作时不存在血流速差异的问题。试验表明，无论是在同一纤维集束中有的纤维空心充填树脂、有的没充填树脂，有的充填树脂多直到充满空心，还是充填树脂少甚至没有树脂，由于纤维空心的直径很小，每个纤维空心中即使填充了树脂球也仅仅是几粒而已；树脂球的间隙也是血流通道，集成净化器作为一个整体，通过每个纤维空心的血流速是一致的。
本发明集成血液净化器中树脂的粒径大小取决于隔网3上的孔隙大小。树脂粒径大于隔网3上允许血液通过的孔隙即可，避免树脂从净化器中脱落进入血管。
把树脂吸附与膜透析两种不同机理的血液净化技术集成在一件器械中，树脂吸附清除血液中的中大分子废物与中空纤维膜透析清除小分子废物和尿液同时工作。
透析膜上的透析孔径一般是1.3-2.5nm,高通量平均2.9nm,最大直径是在3.5nm左右，不会大于5nm；树脂粒径远大于此，不会透过，也不会堵塞纤维膜上的透析孔。纤维的空心直径以容许树脂颗粒自由移动为下限。纤维膜的透析率由其面积决定，根据透析量可以计算所需纤维的内径及长度得出纤维膜面积，属于现有技术。
实施例附图3中树脂在纤维空心腔中的位置是静态放置时的示意表示。血液入口设置在下方，在血液进入纤维空心即分血管4时，树脂球6在血流压力下会聚集在上部位置。
本发明树脂在纤维空心中沿血流向分布，比在灌流器中做血液灌流更有效利用溶质浓度梯度差，提高树脂吸附率。
本发明还有另外一种实施方式，区别之处是吸附树脂的放置方式不同；即，将微纳米级粒径的树脂包容在中空纤维壁内。本实施方式如附图4A，4B，4C，4D，4E和4F所示。几张附图都是中空纤维实物在电子显微镜下的照片。其中4A是纤维空心的照片；4B是在4A处的放大照片，看得出纤维壁断面有分层，分层中有透析孔，膜 材料包容了微纳米级粒径树脂颗粒；4C是4B处局部再放大的照片，可看得出纤维壁内部包容了颗粒状的树脂；4D是4C处纤维内壁表面的再放大图，可以看得出内表面因纤维壁内包容了树脂颗粒而有凹凸面；4E是4D处再放大图，可以更清楚地看到凸起之处是被纤维材料包容的树脂颗粒；4F是包容树脂的纤维膜外壁表面放大图。实验证明在这种树脂颗粒被包容在纤维壁内的形式下，树脂仍然具有显著的吸附作用。
附图5是本发明实施例的试验品实物照片。照片中泛亮色斑处是纤维膜壁中，或者纤维空心中带有荧光标志的树脂颗粒。
本发明的两种树脂放置方式在实验中都表现了优良的吸附清除中大分子废物的功能。附图6、附图7、附图8和附图9是本发明集成血液净化器两种树脂加入形式的空心纤维膜吸附清除代表物质实验的吸附质谱图。证明在本发明对中大分子代表物质内毒素和VB12均具有优异的吸附效果，同时可以通过纤维膜透析排出尿液和小分子废物。
由于树脂起到了吸附清除中大分子废物的作用，并不会发生中大分子优质蛋白丢失的情况，也不需要补偿蛋白质。
此前，发明人已经根据吸附质的不同属性针对性地发明了具有选择性吸附功能的吸附树脂，其中部分已经申请和获得发明专利或者已经公开发表。使本发明集成血液净化器在对不同患者提供具有针对性吸附清除体内中大分子废物的同时，具有透析清除尿液和小分子废物的功能。一件器械同时操作清除血液中的大中小分子废物和尿液，避 免中大分子废物蓄积对患者健康造成的损害，既简化了治疗操作程序，提高临床安全性，也降低治疗费用。
以上是以透析器作为实施例对本发明技术方案的说明。本发明的基础构思是以渗透膜置换灌流器罐体，也可以用在血液净化的血浆分离等医疗器械中。控制渗透膜的渗透孔径，通过渗透膜实现血液中不同分子量大小的溶质和血浆分离，可以在渗透膜两侧分别给予净化处理，然后再汇流返回体内。
本发明技术方案把属于不同作用机理的两种血液净化器械：树脂吸附的血液灌流器和膜透析分离的血液透析器，或者和膜透析分离的血浆分离器等集成为一体，解决了至今为止在血液净化领域长期存在而未能解决的问题：实现在同一器械中，同一血流速条件下，把血液中不同质和大中小分子量的溶质分离开，把其中一种或几种溶质通过膜透析分离后清除；或者分离后同时分别做树脂吸附净化处理，而后汇流或者汇流补偿一同回流至血液循环血路中。这是与现有技术相比具有突出实质性特点之处。本发明在具体实施上简便易行，并且可以节约医疗资源，造福患者，这是与现有技术相比具有的显著进步之处。

Claims (4)

  1. 集成血液净化器，其特征在于：以渗透膜置换灌流器壳体；所述灌流器设置在血液渗透液收集容器中。
  2. 如权利要求1所述的集成血液净化器，其特征在于：所述渗透膜是中空纤维膜，渗透液收集容器是透析器；集束中空纤维设置在透析器中，纤维集束两端部由密封材料固定于透析器两端内壁上；在所述透析器壳体中，纤维束两端面覆盖纤维空心口、设置允许血液透过却阻断树脂颗粒通过的隔网；吸附树脂充填于两端隔网之间的纤维空心中；透析器两端设置端盖，端盖与透析器壳体密封连接，在端盖与隔网之间留有血液汇集空间，端盖上设置与外接血路联通的管口。
  3. 如权利要求2所述的集成血液净化器，其特征在于：所述血液净化器中，纤维空心中吸附树脂颗粒的充填方式是：部分纤维空心充填树脂、另一部分纤维空心不充填树脂，或者是全部纤维空心都充填树脂；树脂充填体积是纤维空心容积的全部或者是纤维空心容积的部分。
  4. 如权利要求2所述的集成血液净化器，其特征在于：所述血液净化器中，微纳米粒径树脂包容在纤维壁中。
PCT/CN2017/000015 2017-01-03 2017-01-03 集成血液净化器 WO2018126333A1 (zh)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030148017A1 (en) * 2001-12-07 2003-08-07 Olli Tuominen Copolymer coating for a hydrophobic membrane
CN102462866A (zh) * 2010-11-17 2012-05-23 于杰 一种复合半透膜血液透析罐
CN203507204U (zh) * 2013-09-18 2014-04-02 天津市肾友达医疗设备技术开发有限公司 一体式血液透析吸附器
CN204275132U (zh) * 2014-11-17 2015-04-22 珠海健帆生物科技股份有限公司 一种可同步实现透析与灌流治疗的血液净化装置
CN105343954A (zh) * 2015-09-25 2016-02-24 珠海健帆生物科技股份有限公司 复合血液净化装置及其制作方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030148017A1 (en) * 2001-12-07 2003-08-07 Olli Tuominen Copolymer coating for a hydrophobic membrane
CN102462866A (zh) * 2010-11-17 2012-05-23 于杰 一种复合半透膜血液透析罐
CN203507204U (zh) * 2013-09-18 2014-04-02 天津市肾友达医疗设备技术开发有限公司 一体式血液透析吸附器
CN204275132U (zh) * 2014-11-17 2015-04-22 珠海健帆生物科技股份有限公司 一种可同步实现透析与灌流治疗的血液净化装置
CN105343954A (zh) * 2015-09-25 2016-02-24 珠海健帆生物科技股份有限公司 复合血液净化装置及其制作方法

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