WO2022217659A1 - 超高分子人工肺制作方法 - Google Patents

超高分子人工肺制作方法 Download PDF

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Publication number
WO2022217659A1
WO2022217659A1 PCT/CN2021/091037 CN2021091037W WO2022217659A1 WO 2022217659 A1 WO2022217659 A1 WO 2022217659A1 CN 2021091037 W CN2021091037 W CN 2021091037W WO 2022217659 A1 WO2022217659 A1 WO 2022217659A1
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artificial lung
blood
oxygen
frame
wall frame
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PCT/CN2021/091037
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English (en)
French (fr)
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张勇
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上海超高环保科技股份有限公司
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Publication of WO2022217659A1 publication Critical patent/WO2022217659A1/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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • A61M1/3667—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines with assisted venous return
    • 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
    • A61M1/1698—Blood oxygenators with or without heat-exchangers
    • 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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • 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
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • 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
    • 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 an artificial lung of life support technology, in particular to a method for making artificial lung products using ultra-high polymer materials.
  • Artificial lung is a life support technology that can be used when the human body's own lung function fails to maintain sufficient oxygen supply to human organs, or in the long run, it can be permanently implanted into the human body to partially or completely replace the human lung function. .
  • the artificial lungs currently in use in the market can be developed from the initial vertical screen, rotating disc, and bubbling artificial lung products to the widely used microporous hollow fiber membrane artificial lung products according to their structural forms.
  • these structures Forms of artificial lung products have the following disadvantages:
  • the bubbling artificial lung is to directly pass oxygen into the blood for gas exchange, which will cause a certain degree of damage to the blood, and it is easy to make the blood directly contact to cause air embolism and other diseases.
  • the microporous hollow fiber membrane artificial lung is made of hollow fiber bundles to form a membrane, and the components are divided into inner and outer cavities.
  • the two cavities can exchange substances through the hollow membrane wall, which can simulate some of the microvessels.
  • the surface of the hollow fiber is coated with a coating layer, so that the relative molecular mass of the interception is also different, and the quality of its oxygenation is limited.
  • the above-mentioned artificial lung products are limited by the structural form and selection of materials, and the first two types of oxygenators obviously cannot meet the needs of clinical use; while the microporous hollow fiber membrane artificial lung is made of hollow fiber bundles.
  • the area of the fiber membrane is affected, which limits the oxygen exchange capacity of the artificial lung oxygenator, and is prone to the phenomenon of plasma blockage of membrane pores and easy deposition of blood components.
  • the clinical use of microporous hollow fiber membrane artificial lung oxygenator Short lifespan leads to high cost of use; in addition, the membrane materials currently used in clinical use are all made of foreign brand materials. Once the supply of foreign brand membrane materials is cut off, domestic assembly and clinical application will not be possible, and the resulting defects will endanger the patient's life. .
  • the task of the present invention is to provide a method for manufacturing an ultra-high polymer artificial lung, which adopts the ultra-high polymer material sintered into a fully-penetrating structure and encapsulates the dual-core membrane layer in a transparent frame, which facilitates the transport of oxygen from the outer layer to the inner core, so as to facilitate the transportation of oxygen from the outer layer to the inner core.
  • Oxygen from the outside is transported to the form of blood flowing inside, allowing the oxygen to penetrate through the inner core in a molecular state to combine with the hemoglobin in the blood and exchange oxygen with carbon dioxide, which promotes the artificial lung to achieve the best in terms of gas exchange capacity and blood compatibility. Therefore, the service life of the artificial lung can be prolonged, the trouble of replacing the artificial lung during the operation is reduced, and the treatment cost of using the artificial lung can be reduced, thereby solving the problems existing in the above-mentioned existing artificial lung products.
  • a method for manufacturing an ultra-high polymer artificial lung which comprises an artificial lung outer frame, and an artificial lung outer wall frame is made by sintering an ultra-high polymer material with a fully through structure, and the artificial lung outer wall frame is placed inside the artificial lung outer frame;
  • the artificial lung outer wall frame encapsulates the artificial lung inner core component, the artificial lung outer wall frame is provided with an oxygen inlet and outlet channel of the outer wall frame, a blood inlet and outlet channel of the outer wall frame, and an oxygenation space in the outer frame box, and the outer wall frame oxygen inlet and outlet channels are connected and arranged in the outer frame.
  • the artificial lung inner core assembly is provided with two columns of circular disc-shaped membrane boxes, the interior of the membrane boxes is covered with fan filter layers, and the two columns of membrane boxes constitute a dual-nuclear membrane layer.
  • the bottom ends of the bellows are connected to each other through a connecting tube, and the tops of the two columns of bellows are respectively connected to the blood inlet pipe and the blood outlet pipe;
  • the dual-nuclear membrane layer that encapsulates the artificial lung inner core component is conducive to the delivery of oxygen from the outer layer of the artificial lung outer wall frame to the inner core. Because the artificial lung outer wall frame is sintered into a fully through structure from ultra-high polymer materials, the outer wall only allows air to pass through and carbon dioxide to exchange and precipitate without exchanging. Allowing the blood to seep out, the artificial lung can transport oxygen from the outside to the blood flowing inside, so that the oxygen permeates through the inner core in a molecular state to combine with the hemoglobin in the blood and exchange oxygen and carbon dioxide, which promotes the artificial lung to increase the gas exchange capacity and blood. Compatibility is at its best.
  • the outer frame of the artificial lung is a transparent engineering plastic frame.
  • the artificial lung inner membrane sheet U-shaped fluid control device is installed between the connecting tubes at the bottom ends of the two columns of bellows.
  • the method for making the ultra-high polymer artificial lung of the present invention is based on the existing research on the gas separation micro-channel, adopts the ultra-high polymer material sintered into a full-through structure, and encapsulates the dual-nuclear membrane layer in a transparent engineering plastic frame, It is beneficial for oxygen to be transported from the outer layer to the inner core, and the external oxygen is transported to the blood flowing inside, so that oxygen permeates through the inner core in a molecular state and combines with hemoglobin in the blood and exchanges oxygen and carbon dioxide, which promotes the artificial lung in gas exchange. Optimum status in terms of volume and blood compatibility.
  • the ultra-high polymer artificial lung prepared according to the method of the present invention is a membrane box type artificial lung, which changes the oxygenation mode of blood, and uses the multi-layer membrane box with hydrophobicity and full of micropores as the interface between blood and gas.
  • Blood gas exchange, blood and gas are not in direct contact, so blood damage is small, air embolism is not easy to occur, it is safer to use, and has the advantages of low impedance and high gas exchange capacity.
  • oxygen permeates through the inner core in a molecular state, combines with hemoglobin in the blood and exchanges oxygen and carbon dioxide, and promotes the artificial lung to reach the best state in terms of gas exchange capacity and blood compatibility, thereby prolonging the artificial lung.
  • the service life of the lung can reduce the trouble of replacing the artificial lung during the operation, and reduce the treatment cost of using the artificial lung.
  • Fig. 1 is the front view structure schematic diagram of an ultra-high polymer artificial lung made by the method of the present invention.
  • FIG. 2 is a schematic top view of the ultra-polymer artificial lung shown in FIG. 1 .
  • FIG. 3 is a schematic side view of the structure of the ultra-polymer artificial lung shown in FIG. 1 .
  • Figure 4 is a schematic diagram of the outer wall structure of an ultra-polymer artificial lung.
  • Figure 5 is a schematic diagram of the inner core structure of an ultra-polymer artificial lung.
  • FIG. 6 is an enlarged schematic view of part A in FIG. 5 .
  • 1 is an artificial lung outer frame
  • 12 is a blood inlet pipe
  • 13 is a blood outlet pipe
  • 14 is an outer frame mounting bracket
  • 15 is an oxygen inlet pipe
  • 16 is a carbon dioxide outlet pipe
  • 17 is an oxygenation index sensor interface
  • 2 is the outer wall frame of the artificial lung, 22 is the oxygen inlet and outlet channels of the outer wall frame, 23 is the blood inlet and outlet channels of the outer wall frame, and 24 is the oxygenation space in the outer frame box;
  • 3 is the artificial lung inner core assembly
  • 32 is the artificial lung inner core membrane sheet
  • 33 is the branch pipe channel of the artificial lung inner core membrane sheet
  • 34 is the artificial lung inner core membrane sheet fastening device
  • 35 is the artificial lung inner core membrane sheet U-shaped fluid control device.
  • the present invention provides a method for manufacturing an ultra-high polymer artificial lung.
  • an artificial lung outer frame 1 is set.
  • the artificial lung outer frame 1 is a transparent engineering plastic frame, which can be a cuboid structure.
  • Outer frame mounting brackets 14 are provided on both sides of the artificial lung outer frame 1 .
  • An oxygen inlet pipe 15 and a carbon dioxide outlet pipe 16 are installed on the other two sides of the artificial lung outer frame 1 .
  • an ultra-high polymer material sintered into a fully through structure is used, and it is made into an artificial lung outer wall frame 2 .
  • the artificial lung outer wall frame 2 is placed inside the artificial lung outer frame 1 .
  • the artificial lung inner core assembly 3 is encapsulated in the artificial lung outer wall frame 2 .
  • the outer wall frame 2 of the artificial lung is provided with an oxygen inlet and outlet channel 22 in the outer wall frame, a blood inlet and outlet channel 23 in the outer wall frame, and an oxygenation space 24 in the outer frame box.
  • the oxygen inlet and outlet channels 22 of the outer wall frame communicate with the oxygen inlet pipe 15 and the carbon dioxide outlet pipe 16 installed on the outer frame 1 of the artificial lung.
  • the artificial lung inner core assembly 3 is provided with two columns of circular disc-shaped membrane boxes, the inside of the membrane boxes is covered with fan filter layers, and the two columns of membrane boxes constitute a binuclear membrane layer.
  • Each column of membrane boxes is set to several stacked membranes, and the number of stacked membranes can be set as required.
  • the bottom ends of the two columns of bellows are connected to each other by connecting pipes.
  • the tops of the two columns of bellows are respectively connected to the blood inlet pipe 12 and the blood outlet pipe 13 .
  • the top and bottom ends of the two columns of capsules are respectively installed with artificial lung inner membrane sheet fastening devices 34 .
  • a U-shaped flow control device 35 for the inner membrane of the artificial lung is installed between the connecting tubes at the bottom ends of the two columns of bellows to adjust and control the blood flowing through the tube.
  • FIG. 6 the figure shows an enlarged artificial lung inner membrane sheet 32 in the capsule.
  • the artificial lung inner membrane sheet 32 is provided with a branch channel 33 of the artificial lung inner membrane sheet radially from the center of the membrane to the edge of the disc.
  • the branch tube channel is the channel used for fixing and pumping blood.
  • an oxygenation index sensor interface 17 is installed on the outer frame 1 of the artificial lung, which is convenient to observe and grasp the oxygenation performance of the artificial lung.
  • an ultra-polymer artificial lung manufacturing method of the present invention by encapsulating the dual-nuclear membrane layer of the artificial lung inner core component 3 in a transparent engineering plastic frame, it is convenient for oxygen to be transported from the outer layer of the outer wall frame 2 of the artificial lung to the inner core.
  • the outer wall frame 2 of the lung is sintered into a full-through structure from ultra-high polymer materials.
  • the outer wall only allows air to pass through and carbon dioxide to exchange and precipitate, but does not allow blood to leak out.
  • the artificial lung can transport the external oxygen to the flowing blood inside, so that the oxygen is in a molecular state. Osmosis through the inner core binds with hemoglobin in the blood and exchanges oxygen and carbon dioxide, which promotes the artificial lung to achieve the best state in terms of gas exchange capacity and blood compatibility.
  • the membrane box-type artificial lung of the present invention changes the oxygenation mode of blood, that is, the multi-layer membrane box with hydrophobicity and full of micropores is used as the interface between blood and gas to exchange blood and gas, and blood and gas are not in direct contact, so blood Small damage, not easy to produce air embolism, safer to use, and has the advantages of low impedance and high gas exchange capacity.
  • the external oxygen is transported to the blood flowing in the inner membrane box through the outer cuboid structure, so that the oxygen permeates in a molecular state.
  • the artificial lung can reach the best state in terms of gas exchange capacity and blood compatibility, thereby prolonging the service life of the artificial lung and reducing the trouble of replacing the artificial lung during surgery. , reduce the treatment cost of using artificial lungs, and can choose suitable artificial lungs for cardiopulmonary emergency treatment and cardiopulmonary surgery.

Abstract

一种超高分子人工肺制作方法，设置一人工肺外框（1），采用烧结成具有全贯通结构的超高分子材料并制成人工肺外壁框（2），同时置于人工肺外框（1）内部，再封装人工肺内核组件（3）。设置外壁框（2）氧气进出口通道（22）、血液进出口通道（23）以及外框盒内氧合空间（24）。人工肺内核组件（3）设有两列圆形盘状膜盒，其内部满布扇面过滤层，构成双核膜层，两列膜盒底端相互连接，顶端连接血液入口管（12）和出口管（13）。封装人工肺内核组件（3）的双核膜层，可将外部的氧气输送到内部流动的血液，使氧气以分子状态渗透通过内核与血液中的血红蛋白结合并进行氧气与二氧化碳的交换，促使人工肺在气体交换量和血液相容性方面达到最佳状态，延长人工肺使用期限，降低使用费用。

Description

超高分子人工肺制作方法 技术领域
本发明涉及一项生命支持技术的人工肺，特别涉及一种采用超高分子材料制作人工肺产品的制作方法。
背景技术
为加快推进医疗装备高质量发展，不断提升应对突发公共卫生事件医疗装备的供给保障能力，更好满足人民日益增长的医疗卫生健康需求，推动制造强国和健康中国建设，并随着高新材料的开发、基础研究的深入和临床经验的积累，人工肺必将开创治疗重症呼吸系统疾患的新局面。
当前，通过改进膜材料、优化设计以及对各种性能的实验评估和临床评价，人工肺的研究着力于提高气体交换能力和生物相容性，为抢救患者的生命提供更可靠的手段。人工肺是一项生命支持技术，可以在人体自身肺功能出现衰竭不能维持人体器官充分的氧供时使用，或者从长远发展来看，可永久性地植入人体，部分或完全替代人体肺功能。
目前市场上在用的人工肺按结构形式可从最初的垂屏式、转碟式、鼓泡式人工肺产品，发展到如今广为采用的微孔中空纤维膜式人工肺产品，但是这些结构形式的人工肺产品存在有以下缺点：
1、垂屏式、转碟式人工肺，这两种人工肺因其氧合性能有限，先要预充氧气，而且预充量大，操作工艺复杂，安全性能低，已被淘汰使用。
2、鼓泡式人工肺，是将氧气直接通入血液中进行气体交换，这样对血液造成一定程度的损伤，还容易使气血直接接触引发气栓等病情。
3、微孔中空纤维膜式人工肺，是由中空纤维集束制成膜，将组件分为内、外两腔，两腔体之间可通过中空膜壁进行物质交换，可以模拟微血管的某些功能，但由于膜材料与微孔大小不同，中空纤维表面敷有涂覆层，使截留相对分子质量也不同，其氧合的质量受到限制。
上述人工肺产品由于受到结构形式和选用材料的限制，前两类的氧合器显然 已经不能满足临床使用的需要；而微孔中空纤维膜式人工肺是由中空纤维集束制成的膜使得中空纤维膜面积受到影响，使人工肺氧合器对氧气的交换能力受限，容易出现血浆堵塞膜孔和血液成分易沉积等现象，另外，微孔中空纤维膜式人工肺氧合器的临床使用寿命短，导致使用成本高；加之目前临床使用的膜材料都选用国外品牌的材料，一旦国外品牌膜材料断供，国内将无法进行组装和在临床应用，由此造成的缺陷将会危及病人生命。
有鉴于此，研发一种能广泛应用于呼吸衰竭的抢救治疗，具有体外生命支持的新型材料人工肺氧合器成为该领域科研人员寻求的新目标。
发明内容
本发明的任务是提供一种超高分子人工肺制作方法，采用烧结成具有全贯通结构的超高分子材料，通过将双核膜层封装于透明框架内，利于氧气从外层输送到内核，以外部的氧气输送到内部流动的血液的形式，使氧气以分子状态渗透通过内核与血液中的血红蛋白结合并进行氧气与二氧化碳的交换，促使人工肺在气体交换量和血液相容性方面达到最佳状态，从而延长人工肺的使用期限，减少手术中更换人工肺的麻烦，降低使用人工肺的治疗费用，由此解决了上述现有人工肺产品所存在的问题。
本发明的技术解决方案如下：
一种超高分子人工肺制作方法，设置一人工肺外框，采用烧结成具有全贯通结构的超高分子材料并制成人工肺外壁框，该人工肺外壁框放置于人工肺外框内部；
所述人工肺外壁框内封装人工肺内核组件，人工肺外壁框设有外壁框氧气进出口通道、外壁框血液进出口通道以及外框盒内氧合空间，外壁框氧气进出口通道连通设置在人工肺外框上的氧气进口管和二氧化碳出口管；
所述人工肺内核组件设有两列圆形盘状膜盒，膜盒内部满布扇面过滤层，两列膜盒构成双核膜层，每列膜盒的膜片与膜片叠装，两列膜盒底端通过接管相互连接，两列膜盒顶端分别连接血液入口管和血液出口管；
封装人工肺内核组件的双核膜层，利于氧气从人工肺外壁框外层输送到内核，因人工肺外壁框是由超高分子材料烧结成全贯通结构，外壁只允许空气通过和二氧 化碳交换析出而不允许血液渗出，人工肺可将外部的氧气输送到内部流动的血液，使氧气以分子状态渗透通过内核与血液中的血红蛋白结合并进行氧气与二氧化碳的交换，促使人工肺在气体交换量和血液相容性方面达到最佳状态。
所述人工肺外框是一透明的工程塑料框架。
所述两列膜盒底端的接管之间装有人工肺内核膜片U型流控装置。
本发明的超高分子人工肺制作方法是在已有气体分离微通道研究的基础上，采用烧结成具有全贯通结构的超高分子材料，通过将双核膜层封装于透明的工程塑料框架内，利于氧气从外层输送到内核，以外部的氧气输送到内部流动的血液的形式，使氧气以分子状态渗透通过内核与血液中的血红蛋白结合并进行氧气与二氧化碳的交换，促使人工肺在气体交换量和血液相容性方面达到最佳状态。
按本发明方法制作的超高分子人工肺是一种膜盒式人工肺，它改变了血液的氧合方式，利用疏水性与满布微孔的多层膜盒作为血液和气体的分界面进行血气交换，血液和气体不直接接触，因此血液损伤小，不易产生气栓，使用更安全，具有低阻抗及高气体交换能力等优点，这样外部的氧气透过外层长方体结构输送到内部膜盒内流动的血液的形式，使氧气以分子状态渗透通过内核与血液中的血红蛋白结合并进行氧气与二氧化碳的交换，促使人工肺在气体交换量和血液相容性方面达到最佳状态，从而延长人工肺的使用期限，减少手术中更换人工肺的麻烦，降低使用人工肺的治疗费用，可为心肺紧急救治、心肺手术时选用人工肺产品提供一种新的选项。
附图的简要说明
图1是按本发明方法制作的一种超高分子人工肺的主视结构示意图。
图2是按图1所示超高分子人工肺的俯视结构示意图。
图3是按图1所示超高分子人工肺的侧视结构示意图。
图4是一种超高分子人工肺外壁结构示意图。
图5是一种超高分子人工肺内核结构示意图。
图6是图5中A部分的放大示意图。
附图标记：
1为人工肺外框，12为血液入口管，13为血液出口管，14为外框安装支架， 15为氧气进口管，16为二氧化碳出口管，17为氧合指数传感器接口；
2为人工肺外壁框，22为外壁框氧气进出口通道，23为外壁框血液进出口通道，24为外框盒内氧合空间；
3为人工肺内核组件，32为人工肺内核膜片，33为人工肺内核膜片支管通道，34为人工肺内核膜片紧固装置，35为人工肺内核膜片U型流控装置。
本发明的最佳实施方式
下面结合附图和实施例对本发明作详细说明。
参看图1至图3，本发明提供一种超高分子人工肺制作方法，首先设置一个人工肺外框1，该人工肺外框1是一透明的工程塑料框架，可以是长方体结构。在人工肺外框1的两侧设置外框安装支架14。在人工肺外框1的另外两侧安装氧气进口管15和二氧化碳出口管16。
参看图4和图5，采用烧结成具有全贯通结构的超高分子材料，并将其制作成人工肺外壁框2。将人工肺外壁框2放置于人工肺外框1内部。在人工肺外壁框2内封装人工肺内核组件3。
人工肺外壁框2设置有外壁框氧气进出口通道22、外壁框血液进出口通道23以及外框盒内氧合空间24。外壁框氧气进出口通道22连通安装在人工肺外框1上的氧气进口管15和二氧化碳出口管16。
如图5中所示，人工肺内核组件3设置两列圆形盘状膜盒，膜盒内部满布扇面过滤层，两列膜盒构成双核膜层。每列膜盒设置成数个叠装在一起的膜片，叠装的膜片数量可按需设置。两列膜盒底端通过接管相互连接。两列膜盒顶端分别连接血液入口管12和血液出口管13。两列膜盒的顶端和底端分别安装人工肺内核膜片紧固装置34。两列膜盒底端的接管之间安装人工肺内核膜片U型流控装置35，用以调节控制管内流经的血液。
参看图6，图中放大显示了膜盒中的人工肺内核膜片32，人工肺内核膜片32设有从膜片中心向圆片边缘呈放射状的人工肺内核膜片支管通道33，该膜片支管通道是用作固定和抽送血液的通道。
如图3中所示，人工肺外框1上安装有氧合指数传感器接口17，便于观测和掌握人工肺的氧合性能。
工业实用性
按本发明的一种超高分子人工肺制作方法，通过将人工肺内核组件3的双核膜层封装于透明的工程塑料框架内，利于氧气从人工肺外壁框2外层输送到内核，因人工肺外壁框2是由超高分子材料烧结成全贯通结构，外壁只允许空气通过和二氧化碳交换析出而不允许血液渗出，人工肺可将外部的氧气输送到内部流动的血液，使氧气以分子状态渗透通过内核与血液中的血红蛋白结合并进行氧气与二氧化碳的交换，促使人工肺在气体交换量和血液相容性方面达到最佳状态。
本发明的膜盒式人工肺改变了血液的氧合方式，即利用疏水性与满布微孔的多层膜盒作为血液和气体的分界面进行血气交换，血液和气体不直接接触，因此血液损伤小，不易产生气栓，使用更安全，具有低阻抗及高气体交换能力等优点，这样，外部的氧气透过外层长方体结构输送到内部膜盒内流动的血液，使氧气以分子状态渗透通过内核与血液中的血红蛋白结合并进行氧气与二氧化碳的交换，促使人工肺在气体交换量和血液相容性方面达到最佳状态，从而延长人工肺的使用期限，减少手术中更换人工肺的麻烦，降低使用人工肺的治疗费用，可为心肺紧急救治、心肺手术时选用合适的人工肺。
当然，本技术领域内的一般技术人员应当认识到，上述实施例仅是用来说明本发明，而并非用作对本发明的限定，只要在本发明的实质精神范围内，对上述实施例的变化、变型等都将落在本发明权利要求的范围内。

Claims (3)

  1. 一种超高分子人工肺制作方法，其特征在于：设置一人工肺外框(1)，采用烧结成具有全贯通结构的超高分子材料并制成人工肺外壁框(2)，该人工肺外壁框(2)放置于人工肺外框(1)内部；
    所述人工肺外壁框(2)内封装人工肺内核组件(3)，人工肺外壁框(2)设有外壁框氧气进出口通道(22)、外壁框血液进出口通道(23)以及外框盒内氧合空间(24)，外壁框氧气进出口通道(22)连通设置在人工肺外框(1)上的氧气进口管(15)和二氧化碳出口管(16)；
    所述人工肺内核组件(3)设有两列圆形盘状膜盒，膜盒内部满布扇面过滤层，两列膜盒构成双核膜层，每列膜盒的膜片与膜片叠装，两列膜盒底端通过接管相互连接，两列膜盒顶端分别连接血液入口管(12)和血液出口管(13)；
    封装人工肺内核组件(3)的双核膜层，利于氧气从人工肺外壁框(2)外层输送到内核，因人工肺外壁框(2)是由超高分子材料烧结成全贯通结构，外壁只允许空气通过和二氧化碳交换析出而不允许血液渗出，人工肺可将外部的氧气输送到内部流动的血液，使氧气以分子状态渗透通过内核与血液中的血红蛋白结合并进行氧气与二氧化碳的交换，促使人工肺在气体交换量和血液相容性方面达到最佳状态。
  2. 按权利要求1所述的超高分子人工肺制作方法，其特征在于：所述人工肺外框(1)是一透明的工程塑料框架。
  3. 按权利要求1所述的超高分子人工肺制作方法，其特征在于：所述两列膜盒底端的接管之间装有人工肺内核膜片U型流控装置(35)。
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