CN119746195A - An extracorporeal life support system - Google Patents
An extracorporeal life support system Download PDFInfo
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- CN119746195A CN119746195A CN202510046633.4A CN202510046633A CN119746195A CN 119746195 A CN119746195 A CN 119746195A CN 202510046633 A CN202510046633 A CN 202510046633A CN 119746195 A CN119746195 A CN 119746195A
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Abstract
本发明提供了一种体外生命支持系统，其包括：体外血液循环系统，与早产儿脐带血管连接，用于实现早产儿体外血液循环和营养物质供给；人造羊水循环过滤系统，用于提供早产儿体外羊水环境；智能监测系统，包括第一监测模块、第二监测模块和预警控制模块，第一监测模块用于监测体外血液循环系统的运行参数，第二监测模块用于监测人造羊水循环过滤系统的运行参数，预警控制模块与第一监测模块和第二监测模块相连，用于在体外血液循环系统和/或人造羊水循环过滤系统的运行参数不满足预设条件时进行预警，从而在早产儿离体后，可以借助本系统直至发育成熟，由此极大地提高了早产儿生存率，降低了发育不良的概率。
The present invention provides an extracorporeal life support system, which comprises: an extracorporeal blood circulation system connected to the umbilical cord blood vessels of premature infants, and used to realize extracorporeal blood circulation and nutrient supply for premature infants; an artificial amniotic fluid circulation and filtration system, and used to provide an extracorporeal amniotic fluid environment for premature infants; an intelligent monitoring system, comprising a first monitoring module, a second monitoring module and an early warning control module, wherein the first monitoring module is used to monitor the operating parameters of the extracorporeal blood circulation system, the second monitoring module is used to monitor the operating parameters of the artificial amniotic fluid circulation and filtration system, and the early warning control module is connected to the first monitoring module and the second monitoring module, and is used to issue an early warning when the operating parameters of the extracorporeal blood circulation system and/or the artificial amniotic fluid circulation and filtration system do not meet preset conditions, so that after the premature infant leaves the body, the system can be used until the premature infant matures, thereby greatly improving the survival rate of the premature infant and reducing the probability of maldevelopment.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to an in-vitro life support system.
Background
The oxygenator is a core component in extracorporeal Circulation (CPB) and extracorporeal membrane pulmonary oxygenation (ECMO), and has the function of replacing human lung function to exchange blood and gas, so that oxygenation of blood and removal of carbon dioxide are realized, and the blood is converted into arterial blood from venous blood.
In the prior art, 1500 ten thousand premature infants are born annually according to WHO statistics, wherein nearly 100 ten thousand deaths are directly attributable to premature birth, and the survival rate of premature infants is about 94% after 28 weeks of gestation, 50% after 24 weeks of gestation and 6% after 22 weeks of gestation. Ultra-premature infants, due to very immature whole body organ development, particularly the lungs, have a incidence of respiratory distress exceeding 85% in premature infants from 24-27 weeks gestational age.
Currently, in vitro life support systems are medical devices for premature infant rescue and life support, and at the heart of in vitro life support are in vitro blood circulation techniques and artificial amniotic fluid circulation techniques to provide in vitro cardiopulmonary function and in vitro fluid survival for ex vivo premature infants. However, the in vitro life support system provided by the prior related technology cannot maintain the in vitro development and growth of premature infants for a long time due to imperfect functions, especially the premature infants with extremely low ages. This is because very low body weight and very low umbilical cord blood flow in very low-age premature infants, and existing in vitro life support systems are unable to provide in vitro life support for premature infants with very low body weight and umbilical cord blood.
Disclosure of Invention
The present invention proposes an in vitro life support system in order to solve the above-mentioned problems.
The invention provides an extracorporeal life support system which comprises an extracorporeal blood circulation system, an artificial amniotic fluid circulation filtering system and an intelligent monitoring system, wherein the extracorporeal blood circulation system is connected with umbilical cord blood vessels of a premature infant and is used for realizing extracorporeal blood circulation and nutrient supply of the premature infant, the artificial amniotic fluid circulation filtering system is used for providing an extracorporeal amniotic fluid environment of the premature infant, the intelligent monitoring system comprises a first monitoring module, a second monitoring module and an early warning control module, the first monitoring module is used for monitoring operation parameters of the extracorporeal blood circulation system, the second monitoring module is used for monitoring operation parameters of the artificial amniotic fluid circulation filtering system, and the early warning control module is connected with the first monitoring module and the second monitoring module and is used for carrying out early warning when the operation parameters of the extracorporeal blood circulation system and/or the artificial amniotic fluid circulation filtering system do not meet preset conditions.
Further, the extracorporeal blood circulation system comprises a hemodialysis machine connected with a venous blood vessel in an umbilical cord blood vessel of the premature infant for purifying blood in the venous blood vessel, and a membrane oxygenator connected with the hemodialysis machine and two arterial blood vessels in the umbilical cord blood vessel for performing oxygenation and carbon dioxide removal on blood flowing out of the hemodialysis machine and supplying the treated blood into the arterial blood vessel of the umbilical cord blood vessel.
Further, a first interface is arranged on a connecting pipeline between the hemodialysis device and the membrane oxygenator, and a second interface is arranged on a connecting pipeline between each arterial blood vessel and the membrane oxygenator. The first interface and the second interface are each for monitoring sampling and/or nutrient supply.
Further, the hemodialyzer includes a first housing assembly and a plurality of dialysis membrane filaments and a first potting compound. The first shell component comprises an upper cover, a cylinder body and a lower cover which are sequentially connected along the axial direction of the first shell component, wherein the upper cover, the cylinder body and the lower cover form a dialysis cavity together. The upper cover is provided with the dialysis inlet, the lower cover is provided with the dialysis liquid outlet, the dialysis liquid inlet is connected with the venous blood vessel in the umbilical cord blood vessel, the dialysis liquid outlet with the membrane oxygenator is connected, the barrel is provided with the dislysate entry and the dislysate export that supply dislysate to go in and out. The two ends of the dialysis membrane wires are encapsulated in the dialysis cavity through the first potting adhesive, and the inside of each dialysis membrane wire is hollow and communicated with the dialysis liquid inlet and the dialysis liquid outlet.
Further, the membrane oxygenator comprises a second shell component, an inner barrel, a plurality of oxygenation membrane wires, a liquid separation column and a second potting adhesive. The second shell assembly comprises a first end cover, an outer cylinder and a second end cover which are sequentially connected along the axial direction of the second shell assembly, the first end cover is provided with an oxygenation liquid inlet and an oxygenation air inlet, the outer cylinder is provided with two oxygenation liquid outlets, the second end cover is provided with oxygenation air outlets, the liquid outlet direction of each oxygenation liquid outlet is perpendicular to the liquid inlet direction of the oxygenation liquid inlet, and the air outlet direction of the oxygenation air outlets is consistent with the air inlet direction of the oxygenation air inlet. The inner cylinder is arranged in the outer cylinder and is arranged with the outer cylinder at intervals to form an oxygenation cavity, the two axial ends of the inner cylinder are respectively connected with the first end cover to form a liquid separation cavity together, and the liquid separation cavity is communicated with the oxygenation cavity. And two ends of the plurality of oxygenation membrane wires are encapsulated in the oxygenation cavity through the second potting adhesive, and the interior of each oxygenation membrane wire is hollow and communicated with the oxygenation air inlet and the oxygenation air outlet. The liquid separation column is arranged in the liquid separation cavity, one end of the liquid separation column is connected with the inner cylinder, and the other end of the liquid separation column extends out of the inner cylinder.
Further, one end of the liquid separation column extending out of the inner cylinder exceeds the second pouring sealant.
Further, the outer cylinder is provided with a circumferential liquid collecting tank, and the oxygenation liquid outlet is provided on a portion of the outer cylinder corresponding to the circumferential liquid collecting tank.
Further, the liquid separation column comprises a first liquid separation section and a second liquid separation section, the first liquid separation section is arranged on the axial direction of the second shell component and close to the oxygenation liquid inlet, and the section of the first liquid separation section is arranged on the axial direction of the second shell component and is sequentially enlarged from the oxygenation liquid inlet to the oxygenation liquid outlet. The part of the inner barrel corresponding to the second liquid separation section is provided with a plurality of rows of liquid separation holes along the axial direction of the second shell component at intervals, and each row of liquid separation holes comprises a plurality of liquid separation holes arranged along the circumferential direction of the inner barrel at intervals.
Further, the artificial amniotic fluid circulating and filtering system comprises an artificial amniotic fluid storage bag, a circulating pump, a filter, a heater and an ultraviolet sterilizer which are connected in sequence. The artificial amniotic fluid preservation bag is used for providing an external artificial amniotic fluid environment for a premature infant, the circulating pump is used for driving the artificial amniotic fluid to circulate, the filter is used for removing metabolic waste of the premature infant in the artificial amniotic fluid, the heater is used for maintaining the external artificial amniotic fluid temperature, and the ultraviolet sterilizer is used for sterilizing the external artificial amniotic fluid.
Further, the artificial amniotic fluid circulating and filtering system further comprises a standby branch, wherein two ends of the standby branch are respectively connected with the heater and the circulating pump, and the standby branch is connected with the filter in parallel.
Further, the first monitoring module comprises a first flow sensor, a first pressure sensor, a second pressure sensor, a third pressure sensor and an oxygen saturation sensor which are connected with the early warning control module. The first flow sensor is arranged on a connecting pipeline between the hemodialysis device and a venous blood vessel in the umbilical cord blood vessel of the premature infant and is used for monitoring the extracorporeal blood circulation flow. The first pressure sensor is arranged on a connecting pipeline between the hemodialysis device and the membrane oxygenator and is used for monitoring the blood inlet pressure before blood enters the membrane oxygenator. The second pressure sensor and the third pressure sensor are respectively arranged on connecting pipelines between the two arterial blood vessels and the membrane oxygenator and are used for monitoring the outlet pressure of blood after the blood flows out of the membrane oxygenator. The blood oxygen saturation sensor is arranged on a connecting pipeline between the membrane type oxygenator and any arterial blood vessel and is used for monitoring blood oxygen saturation of blood after the blood is oxygenated by the membrane type oxygenator. The early warning control module is used for early warning when any one of the blood circulation flow, the blood inlet pressure, the blood outlet pressure and the blood oxygen saturation degree does not meet preset conditions.
Further, the second monitoring module comprises a second flow sensor and a temperature sensor which are connected with the early warning control module. The second flow sensor is arranged on a connecting pipeline between the artificial amniotic fluid storage bag and the circulating pump and is used for monitoring the external artificial amniotic fluid circulating flow. The temperature sensor is arranged in the artificial amniotic fluid storage bag and is used for monitoring the temperature of the artificial amniotic fluid in the artificial amniotic fluid storage bag. The early warning control module is used for early warning when the artificial amniotic fluid circulation flow and/or the artificial amniotic fluid temperature do not meet preset conditions.
The beneficial effects of the invention are as follows:
In the application, the extracorporeal blood circulation system can provide extracorporeal blood circulation and nutrient supply for the premature infant, and the artificial amniotic fluid circulation filtering system can provide a sterile, healthy and proper extracorporeal amniotic fluid environment for the premature infant, so that the extracorporeal blood circulation system and the artificial amniotic fluid circulation filtering system can jointly create a living environment very similar to the maternal uterine environment, and after the premature infant is isolated, the premature infant can develop and mature by means of the system, thereby greatly improving the survival rate of the premature infant and reducing the probability of dysplasia. In addition, the extracorporeal life support system is further provided with the first monitoring module for monitoring the operation parameters of the extracorporeal blood circulation system and the second monitoring module for monitoring the operation parameters of the artificial amniotic fluid circulation filter system, and based on the cooperation between the first monitoring module and the second monitoring module and the early warning control module, early warning can be carried out when the operation parameters of the extracorporeal blood circulation system and/or the artificial amniotic fluid circulation filter system do not meet preset conditions, so that abnormal conditions of premature infants can be found in time, relevant guardianship personnel can be warned to carry out treatment and rescue, and survival rate of premature infants is further improved.
The summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the disclosure, nor is it intended to be used to limit the scope of the disclosure.
Drawings
The foregoing and other objects, features and advantages of the disclosure will be apparent from the following more particular descriptions of exemplary embodiments of the disclosure as illustrated in the accompanying drawings wherein like reference numbers generally represent like parts throughout the exemplary embodiments of the disclosure.
FIG. 1 shows a schematic diagram of the connection of the in vitro life support system of the present invention to umbilical vessels of a premature infant;
fig. 2 shows a schematic external structure of the hemodialyzer of the present invention;
FIG. 3 is a schematic view showing the internal structure of the hemodialyzer of the present invention;
FIG. 4 shows a perspective view of the membrane oxygenator of the present invention;
FIG. 5 is a schematic view showing the internal structure of the membrane oxygenator of the present invention;
FIG. 6 shows a schematic view of the connection of the liquid separation column to the inner barrel of the membrane oxygenator of the present invention;
fig. 7 shows a schematic structural view of the outer cylinder in the housing assembly of the present invention.
Wherein, the reference numerals are as follows:
10. an extracorporeal blood circulation system;
11. Hemodialysis device 111, first shell component 1111, upper cover 1112, barrel 1113, lower cover 112, dialysis membrane wire 113, first potting colloid A1, dialysis liquid inlet, dialysis liquid outlet A2, dialysis liquid inlet A3, dialysis liquid inlet A4, dialysis liquid outlet B, dialysis cavity;
12. Film oxygenator, 121, second shell component, 1211, first end cover, 1212, outer cylinder, 1213, second end cover, 122, inner cylinder, 123, oxygenation film wire, 124, liquid separating column, 1241, first liquid separating section, 1242, second liquid separating section, T1, liquid separating hole, E1, air inlet cavity, E2, air outlet cavity, 125, second potting colloid, B1, oxygenation liquid inlet, B2, oxygenation liquid outlet, B3, oxygenation air inlet, B4, oxygenation air outlet, C, oxygenation cavity, D, liquid separating cavity, F, zhou Xiangji liquid groove;
13. A first interface;
14. a second interface;
20. an artificial amniotic fluid circulating and filtering system; 21, an artificial amniotic fluid storage bag, 22, a circulating pump, 23, a filter, 24, a heater, 25, an ultraviolet sterilizer, 26, and a standby branch;
30. The intelligent monitoring system comprises an intelligent monitoring system, a first monitoring module, an L1 first flow sensor, a P1 first pressure sensor, a P2 second pressure sensor, a P3 third pressure sensor, an M blood oxygen saturation sensor, a 32 second monitoring module, an L2 second flow sensor, a T temperature sensor, a 33 early warning control module;
200. Umbilical cord blood vessel, 210, venous blood vessel, 220, arterial blood vessel.
Detailed Description
Embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While embodiments of the present disclosure are illustrated in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.
The term "comprising" and variations thereof as used herein means open ended, i.e., "including but not limited to. The term "or" means "and/or" unless specifically stated otherwise. The term "based on" means "based at least in part on". The terms "one example embodiment" and "one embodiment" mean "at least one example embodiment. The term "another embodiment" means "at least one additional embodiment". The terms "first," "second," and the like, may refer to different or the same object. Other explicit and implicit definitions are also possible below.
An in vitro life support system according to an embodiment of the present application is described below with reference to fig. 1-7.
An in vitro life support system is a medical device for premature infant rescue and life support that can support premature infants in vitro in an ex vivo setting to increase survival rate of premature infants and reduce dysplasia.
Referring to fig. 1, an extracorporeal life support system of an embodiment of the present application includes an extracorporeal blood circulation system 10, an artificial amniotic fluid circulation filter system 20, and an intelligent monitoring system 30.
The extracorporeal blood circulation system 10 mainly mimics the function of a maternal placenta for connection to the umbilical cord blood vessel 200 of a premature infant, and mainly functions to provide oxygen to the blood of the premature infant to remove carbon dioxide and metabolic waste in the blood, while the extracorporeal blood circulation system 10 may be used to introduce nutrients into the blood of the premature infant to provide necessary nutrition for the development of the premature infant, whereby extracorporeal blood circulation of the premature infant and nutrient supply may be achieved through the extracorporeal blood circulation system 10.
The artificial amniotic fluid circulation filter system 20 is designed to simulate primarily a maternal amniotic fluid environment for providing a sterile, healthy, suitable in vitro amniotic fluid environment for premature infants to avoid premature infants having their lungs exposed to air prematurely resulting in blocked lung development and associated chronic diseases.
The intelligent monitoring system 30 includes a first monitoring module 31, a second monitoring module 32, and an early warning control module 33. The first monitoring module 31 is configured to monitor an operation parameter of the extracorporeal blood circulation system 10, the second monitoring module 32 is configured to monitor an operation parameter of the artificial amniotic fluid circulation filter system 20, and the early warning control module 33 is connected to the first monitoring module 31 and the second monitoring module 32 and is configured to perform early warning when the operation parameter of the extracorporeal blood circulation system 10 and/or the artificial amniotic fluid circulation filter system 20 does not meet a preset condition.
In this embodiment, since the extracorporeal blood circulation system 10 can provide extracorporeal blood circulation and nutrient supply for the premature infant, and the artificial amniotic fluid circulation filter system 20 can provide a sterile, healthy and suitable extracorporeal amniotic fluid environment for the premature infant, the extracorporeal blood circulation system 10 and the artificial amniotic fluid circulation filter system 20 of the present application can jointly create a living environment very similar to that of the mother uterus, so that after the premature infant is isolated, the premature infant can still live as in the mother uterus until the premature infant is developed and mature, thereby greatly improving survival rate of the premature infant and reducing dysplasia probability. Moreover, since the extracorporeal life support system according to the embodiment of the present application is further provided with the first monitoring module 31 for monitoring the operation parameters of the extracorporeal blood circulation system 10 and the second monitoring module 32 for monitoring the operation parameters of the artificial amniotic fluid circulation filter system 20, and based on the cooperation between the first monitoring module 31 and the second monitoring module 32 and the early warning control module 33, early warning can be performed when the operation parameters of the extracorporeal blood circulation system 10 and/or the artificial amniotic fluid circulation filter system 20 do not meet the preset conditions, so that abnormal conditions of premature infants can be found in time and relevant guardianship personnel can be warned and prompted to perform treatment and rescue, thereby further improving survival rate of premature infants.
In some embodiments, referring to fig. 1, an extracorporeal blood circulation system 10 includes a hemodialysis machine 11 and a membrane oxygenator 12.
The hemodialyzer 11 is connected to a venous blood vessel 210 in the umbilical cord blood vessel 200 of the premature infant for purifying blood in the venous blood vessel 210 of the premature infant. The hemodialysis unit 11 is internally provided with a dialysate, and metabolic waste in blood flowing into the hemodialysis unit 11 from the venous blood vessel 210 is dissolved in the dialysate and carried away by the dialysate, thereby achieving the purpose of purifying the blood.
The membrane oxygenator 12 is connected to the hemodialyzer 11 and two arterial vessels 220 of the umbilical cord vessel 200, and the membrane oxygenator 12 can provide oxygen to the blood of the premature infant for oxygenation and carbon dioxide removal of the blood exiting the hemodialyzer 11 and for feeding the treated blood to the arterial vessels 220 of the umbilical cord vessel 200.
Specifically, based on the extracorporeal blood circulation system 10, the venous blood in the umbilical cord blood vessel 200 of the premature infant is led out from the venous blood vessel 210, is sequentially treated by the hemodialysis device 11 and the membrane oxygenator 12, and is divided into two paths, and the two paths are respectively returned to the premature infant body through the two arterial blood vessels 220 in the umbilical cord blood vessel 200, thereby realizing the extracorporeal blood circulation of the premature infant.
In this embodiment, the haemodialyzer 11 is used to remove metabolic waste in the blood of the premature infant to purify the blood, whereas the membrane oxygenator 12 allows the premature infant to perform extracorporeal blood circulation (of the membrane oxygenator 12) without pulmonary breathing after it has been removed from the maternal environment, to support the premature infant for extracorporeal life until it has developed, thereby greatly improving the survival rate of the premature infant (especially a premature infant of low age) and reducing the probability of dysplasia.
In some embodiments, referring to fig. 1, a first port 13 is provided on the connection line between the hemodialyzer 11 and the membrane oxygenator 12, and a second port 14 is provided on the connection line between each arterial vessel 220 and the membrane oxygenator 12. Wherein both the first interface 13 and the second interface 14 may be used for monitoring sampling and/or nutrient supply.
Specifically, luer connectors, multi-way standard adapter connectors (such as tee adapter connectors) and the like can be arranged on the first interface 13 and the second interface 14, and can be used as interfaces for monitoring sampling, nutrient injection and monitoring of a pressure sensor.
In some embodiments, referring to fig. 2 and 3, the hemodialyzer 11 includes a first housing assembly 111, a plurality of dialysis membrane filaments 112, and a first potting compound 113.
The entire hemodialysis device 11 may have a columnar structure. The first housing assembly 111 comprises an upper cover 1111, a cylinder 1112 and a lower cover 1113 connected in sequence along its axial direction, the upper cover 1111 together with the cylinder 1112 and the lower cover 1113 forming a dialysis chamber B.
The upper cover 1111 is provided with a dialysis liquid inlet A1, the lower cover 1113 is provided with a dialysis liquid outlet A2, the dialysis liquid inlet A1 is connected with a venous vessel 210 in the umbilical vessel 200, the dialysis liquid outlet A2 is connected with the membrane oxygenator 12, and the cylinder 1112 is provided with a dialysis liquid inlet A3 and a dialysis liquid outlet A4 for the ingress and egress of dialysis liquid.
The two ends of the plurality of dialysis membrane wires 112 are encapsulated in the dialysis cavity B through the first potting compound 113, and the inside of each dialysis membrane wire 112 is hollow (i.e., is a hollow tubular structure) and is communicated with the dialysis liquid inlet A1 and the dialysis liquid outlet A2.
The dialysis fluid inlet A1 and the dialysis fluid outlet A2 of the hemodialyzer 11 are used for the ingress and egress of blood in the venous blood vessel 210 into and out of the hemodialyzer 11, and the dialysate inlet A3 and the dialysate outlet A4 are used for the ingress and egress of dialysate into and out of the hemodialyzer 11.
After blood enters the hemodialysis device 11 through the dialysis liquid inlet A1, the blood flows through the inside of the dialysis membrane wire 112, and the dialysis liquid flows through the outside of the dialysis membrane wire 112 through the dialysis liquid inlet A3, the dialysis membrane wire 112 can allow metabolic waste in the blood to pass through, but not allow blood cells and other macromolecular substances in the blood to pass through, and due to the concentration difference of the metabolic waste in the blood and the dialysis liquid, the metabolic waste in the blood can pass through the dialysis membrane wire 112, dissolve in the dialysis liquid and be taken away by the dialysis liquid (namely, flow out of the hemodialysis device 11 through the dialysis liquid outlet A4), so that the metabolic waste in the blood can be removed, and the purpose of purifying the blood can be achieved.
In some embodiments, referring to fig. 4 and 5, the membrane oxygenator 12 includes a second housing assembly 121, an inner barrel 122, a plurality of oxygenation membrane filaments 123, a liquid separation column 124, and a second potting compound 125.
Specifically, the membrane oxygenator 12 as a whole may be of columnar structure. The second housing assembly 121 may include a first end cap 1211, an outer barrel 1212, and a second end cap 1213 connected in sequence along an axial direction thereof. The first end cap 1211 is provided with an oxygenation inlet B1 and an oxygenation inlet B3, the outer cylinder 1212 is provided with two oxygenation outlets B2, and the second end cap 1213 is provided with an oxygenation outlet B4. Wherein, the liquid outlet direction of each oxygenation liquid outlet B2 is perpendicular to the liquid inlet direction of the oxygenation liquid inlet B1, the air outlet direction of the oxygenation air outlet B4 is consistent with the air inlet direction of the oxygenation air inlet B3, the oxygenation liquid inlet B1 and the oxygenation liquid outlet B2 are used for blood after being purified by the blood supply dialyser 11 to enter and exit the membrane type oxygenator 12, and the oxygenation air inlet B3 and the oxygenation air outlet B4 are used for air to enter and exit the membrane type oxygenator 12.
The inner cylinder 122 is disposed in the outer cylinder 1212 and is spaced from the outer cylinder 1212 to form an oxygenation chamber C, and two axial ends of the inner cylinder 122 are respectively connected with the first end cover 1211 to form a liquid separation chamber D, where the liquid separation chamber D is communicated with the oxygenation chamber C, the oxygenation liquid inlet B1 and the oxygenation liquid outlet B2.
Two ends of the plurality of oxygenation membrane wires 123 are encapsulated in the oxygenation cavity C through a second potting compound 125, and the inside of each oxygenation membrane wire 123 is hollow (i.e., is a hollow tubular structure) and is communicated with the oxygenation air inlet B3 and the oxygenation air outlet B4.
The liquid separation column 124 is disposed in the liquid separation chamber D, and one end of the liquid separation column 124 is connected to the inner cylinder 122, and the other end extends out of the inner cylinder 122.
The second potting compound 125 is disposed at two ends of the plurality of oxygenation film wires 123, and each second potting compound 125 at the two ends encapsulates and fixes the plurality of oxygenation film wires 123 in the oxygenation chamber C between the inner cylinder 122 and the outer cylinder 1212. Wherein, an oxygenation air inlet cavity E1 is formed by one second potting compound 125 together with the first end cover 1211, an oxygenation air outlet cavity E2 is formed by the other second potting compound 125 together with the second end cover 1213, the oxygenation air inlet cavity E1 is communicated with the oxygenation air inlet B3, the oxygenation air outlet cavity E2 is communicated with the oxygenation air outlet B4, and the oxygenation air inlet cavity E1 is communicated with the oxygenation air outlet cavity E2 through the inside of the oxygenation film wire 123.
When the extracorporeal life support system of the present application is used for extracorporeal life support of premature infants, the liquid inlet A1 of the membrane oxygenator 12 can be connected with the dialysis liquid outlet A2 of the hemodialysis machine 11, and two arterial blood vessels 220 in the umbilical cord blood vessel 200 are respectively connected with a corresponding one of the oxygenation liquid outlets B2. External oxygen can enter and flow through the inside of the oxygenation membrane filaments 123 through the oxygenation air inlet B3, blood in the hemodialyzer 11 can enter the oxygenation chamber C through the oxygenation liquid inlet B1 and the liquid separation chamber D in sequence, liquid in the blood flows through the outside of the oxygenation membrane filaments 123 (i.e. gaps between adjacent oxygenation membrane filaments 123), and gas in the blood flows through the inside of the oxygenation membrane filaments 123 to exchange gas between the oxygen and the gas in the blood, so that the purposes of oxygenation of the blood flowing out of the hemodialyzer 11 and removal of carbon dioxide in the blood (i.e. venous blood can be converted into arterial blood through the membrane type oxygenator 12) are achieved. After oxygenation and removal of carbon dioxide from the blood in the venous blood, the venous blood is converted into arterial blood which in turn enters the two arterial blood vessels 220 in the umbilical cord blood vessel 200 via the corresponding oxygenation outlets B2, whereby extracorporeal circulation of the premature blood is achieved for extracorporeal life support of the premature.
In the application, through the design of the single oxygenation liquid inlet B1 and the two oxygenation liquid outlets B2, the umbilical cord blood vessel physiological characteristics of the premature infant can be matched, and the membrane type oxygenator 12 is convenient to connect and is suitable for providing in-vitro life support for the premature infant.
Wherein, since the liquid outlet direction of each oxygenation liquid outlet B2 is perpendicular to the liquid inlet direction of the oxygenation liquid inlet B1, after blood enters the liquid separation cavity D through the oxygenation liquid inlet B1, the blood sequentially flows through the plurality of oxygenation membrane filaments 123 along the direction perpendicular to the axial direction of the membrane oxygenator 12 (i.e. all radial directions of the membrane oxygenator 12), so that the flow path of the blood in the oxygenation cavity C is minimum (i.e. the flow distance is the difference between the inner diameters of the outer cylinder 1212 and the inner cylinder 122), thereby realizing extremely low transmembrane pressure difference, and the blood pressure generated by the premature heart can be directly utilized without depending on a blood pump, so that the extracorporeal circulation of the premature blood can be realized by utilizing the membrane oxygenator 12 of the application.
In addition, since the membrane oxygenator 12 of the present application can eliminate the effects of blood pumps on the hemodynamics of premature infants, the membrane oxygenator 12 of the present application can be adapted to provide in vitro life support for very low age premature infants ranging from 22 weeks to 28 weeks.
It should be noted that, when oxygen flows through the inside of the oxygenation membrane wire 123 and blood flows through the outside of the oxygenation membrane wire 123, the oxygen enters the blood from the inside of the oxygenation membrane wire 123 and the carbon dioxide enters the inside of the oxygenation membrane wire 123 due to the fact that the oxygen concentration inside the oxygenation membrane wire 123 is higher than the oxygen concentration in the blood outside the oxygenation membrane wire 123 and the carbon dioxide concentration is lower than the carbon dioxide concentration in the blood, when the oxygen flows through the inside of the oxygenation membrane wire 123 and the blood flows through the outside of the oxygenation membrane wire 123, so that the oxygenation of blood and the removal of carbon dioxide in the blood are achieved.
In some embodiments, referring to fig. 5, the end of the dispensing column 124 that extends beyond the inner barrel 122 is disposed beyond the second potting compound 125.
In this embodiment, when the end of the liquid separation column 124 extending out of the inner tube 122 is beyond the second potting compound 125, the distance between the liquid separation column 124 and the oxygenation inlet B1 is relatively short, and after the blood enters through the oxygenation inlet B1 and before the blood does not enter the inner tube 20, the blood will first impact on the liquid separation column 124 and be dispersed to each region of the liquid separation cavity D in the circumferential direction through the liquid separation column 124, so that the distribution uniformity of the blood in the circumferential direction of the liquid separation cavity D is significantly improved. Further, this arrangement reduces the volume of the distribution chamber D, thereby reducing the priming volume of the membrane oxygenator 12 of the present application.
In some embodiments, referring to fig. 5 and 6, the liquid separation column 124 includes a first liquid separation section 1241 and a second liquid separation section 1242, the first liquid separation section 1241 is disposed near the oxygenation inlet B1 in the axial direction of the second housing assembly 121, and the cross-section of the first liquid separation section 1241 is sequentially increased in the axial direction of the second housing assembly 121 from the oxygenation inlet B1 toward the oxygenation outlet B2.
In other words, the first liquid-dividing section 1241 has a structure with a thin top and a wide bottom, such that the cross section of the cavity between the first liquid-dividing section 1241 and the first end cap 1211 and the cross section of the liquid-dividing cavity D between the first liquid-dividing section 1241 and the inner tube 122 are gradually narrowed from top to bottom, which is beneficial for guiding the blood to the second liquid-dividing section 1242 along the axial direction of the membrane oxygenator 12, thereby further facilitating the uniform distribution of the blood in the axial direction of the membrane oxygenator 12.
The portion of the inner cylinder 122 corresponding to the second liquid separation section 1242 is provided with a plurality of rows of liquid separation holes T1 at intervals along the axial direction of the second housing assembly 121, and each row of liquid separation holes T1 includes a plurality of liquid separation holes T1 at intervals along the circumferential direction of the inner cylinder 122.
Based on the multiple rows of liquid separation holes T1 arranged at intervals along the axial direction of the membrane oxygenator 12 and the multiple liquid separation holes T1 arranged at intervals along the circumferential direction of the inner cylinder 122 in each row of liquid separation holes T1, blood can uniformly flow into different parts in the oxygenation cavity C in the axial direction of the membrane oxygenator 12 through the corresponding liquid separation holes T1, which is beneficial to improving the gas exchange efficiency between the blood in the umbilical cord blood vessel and the external gas and the extracorporeal blood circulation efficiency of premature infants.
In some embodiments, referring to fig. 5 and 7, the outer cylinder 1212 is provided with Zhou Xiangji fluid reservoirs F, with the oxygenated fluid ports B3 being provided on portions of the outer cylinder 1212 corresponding to the circumferential fluid reservoirs F.
Wherein the circumferential liquid collecting groove F is recessed inwards from the inner wall of the outer cylinder 1212, which makes the inner diameter of the inner wall of the outer cylinder 1212 corresponding to the Zhou Xiangji liquid groove F larger than the inner diameter of the inner wall of the other part of the outer cylinder 1212, namely the gap between the inner wall of the outer cylinder 1212 at the circumferential liquid collecting groove F and the nearest oxygenated film wire 123 is larger than the gap between the inner wall of the other part of the outer cylinder 1212 and the nearest oxygenated film wire 123.
Thus, in this embodiment, based on the provision of the circumferential sump F on the inner wall of the outer barrel 1212, blood can be pooled within the circumferential sump F on the inner wall of the outer barrel 1212, thereby facilitating the flow of blood out of the membrane oxygenator 12 via the Zhou Xiangji sump F and the oxygenation outlet B3.
In some embodiments, the volume of the membrane oxygenator 12 is 110cm 3-125cm3. Illustratively, the membrane oxygenator 12 may have a volume of 110cm3、111cm3、112cm3、113cm3、114cm3、115cm3、116cm3、117cm3、120cm3、121cm3、122cm3、123cm3、124cm3、125cm3 or the like.
In some embodiments, the membrane oxygenator 12 of the present application is suitable for premature infants with reduced body weight and cord blood content. Illustratively, the membrane oxygenator 12 of the present application may be suitable for premature infants having a body weight of less than 1kg and an umbilical cord blood flow of less than 200ml/min. Further, the membrane oxygenator 100 of the present application can be applied to very low-age premature infants ranging from 22 weeks to 28 weeks, which have a weight of less than 1kg and a umbilical cord blood flow of less than 200ml/min.
In some embodiments, the pre-charge of the membrane oxygenator 12 of the present application is 10ml-15ml. Illustratively, the pre-charge of the membrane oxygenator 10 may be 10ml, 11ml, 12ml, 13ml, 14ml, 15ml, etc.
In some embodiments, referring to fig. 1, an artificial amniotic fluid circulation filter system 20 of the present application includes an artificial amniotic fluid storage bag 21, a circulation pump 22, a filter 23, a heater 24, and an ultraviolet sterilizer 25 connected in sequence.
The artificial amniotic fluid retaining bag 21 can provide a closed sterile environment for premature infants, and premature infants in vitro can be placed in the artificial amniotic fluid retaining bag 21 for growth and development. I.e. artificial amniotic fluid retaining bag 21 is used to provide an in vitro artificial amniotic fluid environment for premature infants which is able to avoid premature exposure of premature infants with premature lung maturation to air.
The circulation pump 22 is disposed between the amniotic fluid inlet and the amniotic fluid outlet of the artificial amniotic fluid storage bag 21 for driving the artificial amniotic fluid to circulate, and the circulation pump 22 is connected with the filter 23, which can also cooperate with the filter 23 to remove the metabolic wastes such as the fetal manure of the premature infant.
A filter 23 may be fitted with the circulation pump 22 for removing metabolic waste from premature infants in the artificial amniotic fluid.
The heater 24 is used to maintain the artificial amniotic fluid temperature in vitro, i.e. when the artificial amniotic fluid temperature is low, the artificial amniotic fluid may be heated to maintain the amniotic fluid temperature within a temperature range suitable for survival of premature infants.
The ultraviolet sterilizer 25 is used for sterilizing the artificial amniotic fluid in vitro, that is, the ultraviolet sterilizer 25 can inactivate bacteria in the artificial amniotic fluid by utilizing ultraviolet rays so that the artificial amniotic fluid in the artificial amniotic fluid storage bag 21 is in a sterile state, and a sterile artificial amniotic fluid growth environment is provided for premature infants.
Therefore, in this embodiment, based on the cooperation among the artificial amniotic fluid retaining bag 21, the circulation pump 22, the filter 23, the heater 24 and the ultraviolet sterilizer 25, an in vitro artificial amniotic fluid growth environment which is sterile, free of metabolic waste, suitable in temperature and capable of circulating can be provided for the premature infant, so that the premature infant can still live in the mother uterus until the premature infant is mature, thereby greatly improving the survival rate of the premature infant and reducing the probability of dysplasia.
In some embodiments, referring to fig. 1, the artificial amniotic fluid circulation filter system 20 further includes a backup leg 26, both ends of the backup leg 26 are connected to the heater 24 and the circulation pump 22, respectively, and the backup leg 26 is connected in parallel with the filter 23.
In this embodiment, the backup branch 26 is blocked when the filter 23 is normally operated, and the backup branch 26 is opened when the filter 23 is abnormally cleaned or replaced, and the backup branch 26 is used to connect the heater 24 with the circulation pump 22 so that the artificial amniotic fluid can be normally circulated, thereby continuously providing an artificial amniotic fluid growth environment for premature infants.
In some embodiments, referring to fig. 1, the first monitoring module 31 includes a first flow sensor L1, a first pressure sensor P1, a second pressure sensor P2, a third pressure sensor P3, and an oxygen saturation sensor M connected to the early warning control module 33.
A first flow sensor L1 is provided on the connection line between the hemodialysis machine 11 and the venous blood vessel 210 in the umbilical cord blood vessel 200 of the premature infant for monitoring the extracorporeal blood circulation flow.
The first pressure sensor P1 is disposed on the connection line between the hemodialyzer 11 and the membrane oxygenator 12 for monitoring the blood inlet pressure of the blood before entering the membrane oxygenator 12.
The second pressure sensor P2 and the third pressure sensor P3 are respectively disposed on the connecting lines between the two arterial blood vessels 220 and the membrane oxygenator 12, and are used for monitoring the outlet pressure of blood after flowing out of the membrane oxygenator 12.
The blood oxygen saturation sensor M is disposed on a connecting line between the membrane oxygenator 12 and any one of the arterial blood vessels 220, and is used for monitoring blood oxygen saturation of blood oxygenated by the membrane oxygenator 12.
The early warning control module 33 is used for early warning when any one of the blood circulation flow rate, the blood inlet pressure, the blood outlet pressure, and the blood oxygen saturation does not satisfy a preset condition.
In this embodiment, the first monitoring module 31 can timely monitor the parameters such as the extracorporeal blood circulation flow, the blood inlet pressure before the blood enters the membrane oxygenator 12, each blood outlet pressure after the blood flows out of the membrane oxygenator 12, and the blood oxygen saturation, and when the related parameters exceed the set threshold, the early warning control module 33 can timely send out warning to prompt the related guardian to process and/or rescue, thereby further improving the survival rate of premature infants.
In some embodiments, referring to FIG. 1, the second monitoring module 32 includes a second flow sensor L2 and a temperature sensor T connected to the early warning control module 33.
The second flow sensor L2 is disposed on a connection line between the artificial amniotic fluid storage bag 21 and the circulation pump 22, and is used for monitoring the external artificial amniotic fluid circulation flow.
The temperature sensor T is provided in the artificial amniotic fluid storage bag 21 for monitoring the temperature of the artificial amniotic fluid in the artificial amniotic fluid storage bag 21.
The early warning control module 33 is used for early warning when the artificial amniotic fluid circulation flow and/or the artificial amniotic fluid temperature do not meet the preset conditions.
In this embodiment, the second monitoring module 32 is utilized to timely monitor the external artificial amniotic fluid circulation flow and the temperature of the artificial amniotic fluid, and the early warning control module 33 performs early warning when the artificial amniotic fluid circulation flow and/or the temperature of the artificial amniotic fluid do not meet the preset conditions, so that the relevant guardian can control the rotation speed of the circulation pump 22 according to the early warning information to maintain the flow stable and control the heater to realize the constant temperature, thereby providing an in vitro artificial amniotic fluid growth environment with a proper temperature and an external artificial amniotic fluid growth environment suitable for the amniotic fluid circulation flow rate of the premature infant, and further improving the survival rate of the premature infant.
The foregoing description of the embodiments of the present disclosure has been presented for purposes of illustration and description, and is not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the various embodiments described. The terminology used herein was chosen in order to best explain the principles of the embodiments, the practical application, or the technical improvements in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.
Claims (10)
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