阅读说明：本技术 一种用于血液氧合的高透气致密中空纤维膜 (High-permeability compact hollow fiber membrane for blood oxygenation ) 是由 张吉松 周才金 谢冰琪 于 2019-09-26 设计创作，主要内容包括：本发明提供一种用于血液氧合的高透气致密中空纤维膜。膜材料是氧合器的关键部分,决定了氧合器的氧合效率、使用寿命和安全性。本发明提出的中空纤维膜,具有高透气性的特点,当富含二氧化碳的血液流过氧合器时,血液中的二氧化碳和氧气会迅速的交换,使血液得到快速更新,可以减少氧合器体积和血液预充量。另外,本发明的膜表面疏水且致密,血液不会和气体直接接触,也不会渗透进入气体管路中,避免了蛋白质泄漏和透气性下降等问题,由本发明的中空纤维膜配制的氧合器可以长周期反复使用。同时,由于膜材料生物相容性好,当血液流过膜表面时,血液的理化性质可以保持不变,具有长周期的抗凝血功能。(The invention provides a high-permeability compact hollow fiber membrane for blood oxygenation. The membrane material is a key part of the oxygenator and determines the oxygenation efficiency, service life and safety of the oxygenator. The hollow fiber membrane provided by the invention has the characteristic of high air permeability, when blood rich in carbon dioxide flows through the oxygenator, the carbon dioxide and oxygen in the blood can be rapidly exchanged, so that the blood is rapidly renewed, and the volume of the oxygenator and the blood priming volume can be reduced. In addition, the membrane surface of the invention is hydrophobic and compact, blood can not directly contact with gas, and can not permeate into a gas pipeline, thereby avoiding the problems of protein leakage, air permeability reduction and the like. Meanwhile, as the membrane material has good biocompatibility, the physicochemical property of the blood can be kept unchanged when the blood flows through the surface of the membrane, and the membrane has long-period anticoagulation function.)

1. The high-permeability compact hollow fiber membrane for blood oxygenation is characterized by being prepared from Teflon AF 2400 and Teflon AF1600 materials and having the characteristics of high permeability, high hydrophobicity and good biocompatibility.

2. The hollow fiber membrane of claim 1, wherein the hollow fiber membrane is a dense membrane having a pore size of 0.01 to 0.1 nm.

3. The hollow fiber membrane according to claim 1, wherein the thickness of the hollow fiber membrane is 5 to 100 μm.

4. The hollow fiber membrane according to claim 1, wherein the hollow fiber of the hollow fiber membrane has an inner diameter of 20 to 500 μm.

5. The hollow fiber membrane of claim 1, wherein the hollow fiber membrane has a length of 0.01m to 1 m.

6. The hollow fiber membrane of claim 1, wherein the hollow fiber membrane is formed by melt extrusion molding or solvent casting.

7. The hollow fiber membrane of claim 1, wherein the hollow fiber membrane is used in an in vivo oxygenation procedure, or in an in vitro blood oxygenation procedure.

Technical Field

The invention belongs to the technical field of biomedical engineering, and particularly relates to a novel high-permeability compact hollow fiber membrane for blood oxygenation.

Background

Extracorporeal membrane oxygenation, as one effective cardiopulmonary support treatment technology, is widely used in the treatment of severe heart failure, acute lung failure, large operation, cardiac vascular diseases, etc. Wherein, the membrane lung oxygenator replaces the functions of the heart and the lung, thereby gaining precious time for treating patients. Membrane lung oxygenators therefore represent a state and hospital emergency level.

The main structure of the membrane lung oxygenator is composed of a blood pump, an artificial lung and an air source. Among them, the artificial lung is the most important component. CO in blood as it is transported through the artificial lung by the blood pump₂The gas is rapidly replaced by oxygen, so that the blood is refreshed. The membrane material is a key part in the gas replacement process, the gas permeability of the membrane material determines the exchange rate of gas, and the surface of the membrane material influences the physicochemical properties of blood. In the initial application stage of the membrane oxygenator, commonly used membrane materials comprise silicon and polypropylene, and have the advantages of high gas exchange rate and the like. However, in practical application, the biocompatibility of the material is poor, and a large number of micropores exist on the surface of the membrane. In the oxygenation process, gas permeates the micropores to be directly contacted with blood, so that hemocyte is easy to generate hemolysis and the like, the problems of thrombus and the like are caused, and the danger of the oxygenation process of the blood is increased. In addition, the membrane surface is easy to adsorb blood protein and platelets, so that the platelets are deposited, the oxygenation efficiency is reduced, and the effective use time of the oxygenator is greatly shortened. With the development of hollow fiber membrane technology, the most common membrane material of the oxygenator at present is polymethylpentene (PMP), which has the advantages of higher air permeability, easy surface coating and the like, and can improve the oxygenation time to dozens of days. However, since the microporous structure still exists, there are new problems that the oxygenation efficiency is lowered and thrombus occurs as the oxygenation time increases. In addition, at present, there is also a class of membrane-based oxygenators in vivo, which are used for assisting the respiratory system and infant respiratory support, and the problems of low oxygenation efficiency, short service time, poor safety and the like caused by the membrane material problem also exist. Therefore, the development of the membrane oxygenator based on a novel membrane material with high gas mass transfer rate and good biocompatibility can realize a high-efficiency, safe and long-period blood oxygenation process, and has important significance.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide a novel high-permeability compact hollow fiber membrane for blood oxygenation, and the membrane material has the characteristics of good hydrophobicity and biocompatibility. In the oxygenation process, the compact hollow fiber membrane realizes that gas quickly passes through the membrane material by the gas dissolution diffusion principle, avoids the direct contact of the gas and blood on the premise of having the similar air permeability with the conventional porous membrane material, and avoids the oxygenation efficiency reduction caused by the leakage of protein and blood platelets; meanwhile, the surface of the membrane material has high hydrophobicity and biocompatibility, and can avoid blood coagulation on the premise of not coating anticoagulant substances, thereby ensuring the stability and oxygenation efficiency of the membrane material after long-time operation.

The above purpose of the invention is realized by the following technical scheme:

A high-permeability compact hollow fiber membrane for extracorporeal blood oxygenation is a membrane formed by two methods of hot-melt extrusion forming and solution casting, and has the characteristics of high permeability, hydrophobicity and good biocompatibility. The high air permeability of the membrane material can achieve the efficiency of blood-gas exchange; meanwhile, different from the prior art, in the oxygenation process, the membrane material only allows gas to pass through but does not allow blood to permeate, so that the gas exchange process is completed without directly contacting oxygen and blood, the problems of blood rejection, protein leakage, platelet adhesion and the like are reduced, and the efficient and safe oxygenation process of the blood is favorably realized.

Further, the optimum membrane length, membrane thickness and hollow fiber inner diameter of the hollow fiber membrane were verified using a set of apparatus mainly composed of the blood pump 1, gas mass flow meter 2, oxygenator 3, and thermostatic water bath 4, and the stability and oxygenation efficiency of the hollow fiber membrane after long-term operation were characterized.

Furthermore, the membranes of the hollow fiber membranes are preferably made of Teflon AF 2400 and Teflon AF1600 materials, the hollow fiber membranes are compact membranes, and the pore diameter of membrane pores is 0.01-0.1 nm. The hollow fiber membrane has an inner diameter of 20-500 μm, a membrane thickness of 5-100 μm, and a membrane length of 0.01m-1m, and the hollow fiber membrane molding method is preferably a melt extrusion molding and solvent casting film forming method.

further, the hollow fiber membrane is applied to an in vivo oxygenation process, or to an in vitro blood oxygenation process.

Compared with the prior art, the invention has the following beneficial effects:

1. The micro-pores on the surface of the membrane material adopted by the prior art are easy to damage blood cells to cause coagulation, thrombus and other problems after long-term use, and the hollow fiber membrane has a high-density surface and does not have a micro-pore structure, thereby avoiding the direct contact between blood and oxygen and reducing the problems of protein leakage, thrombus and the like.

2. After the currently used membrane material is used for long-time oxygenation, because platelets and proteins are adsorbed on the surface of the membrane and can permeate into membrane pores to block the membrane pores, the stability and oxygenation efficiency of the membrane material can be reduced, but the hollow fiber membrane liquid of the invention cannot permeate, the surface of the material has high hydrophobicity, the problem that the platelets and proteins are attached to the surface of the membrane is avoided, and the stability and efficiency of the membrane material after long-time oxygenation are ensured.

3. The hollow fiber membrane has high air permeability, and the oxygenator developed based on the membrane has the characteristics of high gas-liquid mass transfer efficiency, small volume of the oxygenator, small blood priming volume required before the oxygenation process and the like.

Drawings

FIG. 1 is a schematic diagram of a device for characterizing oxygenation rates of membrane materials in example 1 of the present invention.

FIG. 2 is a microscopic view of an individual hollow fiber of the hollow fiber membrane of example 1 of the present invention.

Detailed Description

the materials and microdevices for extracorporeal blood oxygenation provided by the present invention are described and illustrated in detail below with reference to specific examples in order to enable the skilled person to better understand the present invention, but they are not to be construed as limiting the scope of the invention.