In-vitro life support system

Abstract

The invention provides an in-vitro life support system, which comprises an in-vitro blood circulation system connected with an umbilical cord blood vessel of a premature infant and used for realizing in-vitro blood circulation and nutrient supply of the premature infant; the artificial amniotic fluid circulating filtration system is used for providing an in-vitro amniotic fluid environment for 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 in-vitro blood circulation system, the second monitoring module is used for monitoring operation parameters of the artificial amniotic fluid circulation filtration system, and the early warning control module is connected with the first monitoring module and the second monitoring module. The early warning system is used for early warning when the operation parameters of the in-vitro blood circulation system and / or the artificial amniotic fluid circulation filtration system do not meet the preset conditions, so that after the premature infant is in vitro, the premature infant can develop mature by means of the system, the survival rate of the premature infant is greatly increased, and the probability of dysplasia is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an extracorporeal life support system. Background Art

[0002] The oxygenator is a core component in extracorporeal circulation (CPB) and extracorporeal membrane oxygenation (ECMO). Its function is to replace the human lung function to exchange blood and gas, thereby achieving blood oxygenation and carbon dioxide removal, and converting blood from venous blood to arterial blood.

[0003] In the prior art, according to WHO statistics, 15 million premature babies are born each year, of which nearly 1 million deaths are directly attributed to premature birth. According to statistics, the survival rate of premature babies at 28 weeks of gestation is about 94%, 50% at 24 weeks of gestation, and 6% at 22 weeks of gestation. Extremely premature babies have extremely immature organs, especially lungs, resulting in a respiratory distress syndrome incidence rate of more than 85% in premature babies with a gestational age of 24-27 weeks.

[0004] At present, the extracorporeal life support system is a medical device used for the rescue and life support of premature infants. The core of extracorporeal life support is the extracorporeal blood circulation technology and artificial amniotic fluid circulation technology, which provide extracorporeal cardiopulmonary function and extracorporeal liquid living environment for premature infants. However, the extracorporeal life support system provided by the existing related technology is unable to maintain the extracorporeal development and growth of premature infants for a long time due to its imperfect functions, especially for extremely young premature infants. This is because extremely young premature infants have extremely low body weight and extremely low umbilical cord blood flow. The existing extracorporeal life support system cannot provide extracorporeal life support for premature infants with extremely low body weight and umbilical cord blood. Summary of the invention

[0005] In order to solve the above problems, the present invention provides an extracorporeal life support system.

[0006] The present invention proposes an extracorporeal life support system, which includes: an extracorporeal blood circulation system, connected to the umbilical cord blood vessels of premature infants, for realizing extracorporeal blood circulation and nutrient supply for premature infants; an artificial amniotic fluid circulation and filtration system, for providing an extracorporeal amniotic fluid environment for premature infants; and an intelligent monitoring system, including a first monitoring module, a second monitoring module and an early warning control module, the first monitoring module being used to monitor the operating parameters of the extracorporeal blood circulation system, the second monitoring module being used to monitor the operating parameters of the artificial amniotic fluid circulation and filtration system, the early warning control module being connected to the first monitoring module and the second monitoring module, for issuing 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.

[0007] Furthermore, the extracorporeal blood circulation system includes: a hemodialyzer connected to the venous blood vessels in the umbilical cord blood vessels of premature infants, and used to purify the blood in the venous blood vessels; a membrane oxygenator connected to the hemodialyzer and two arterial blood vessels in the umbilical cord blood vessels, and used to oxygenate and remove carbon dioxide from the blood flowing out of the hemodialyzer and supply the treated blood to the arterial blood vessels of the umbilical cord blood vessels.

[0008] Furthermore, a first interface is provided on the connection pipeline between the hemodialyzer and the membrane oxygenator, and a second interface is provided on the connection pipeline between each arterial blood vessel and the membrane oxygenator. The first interface and the second interface are both used for monitoring sampling and / or nutrient supply.

[0009] Furthermore, the hemodialyzer includes a first shell assembly, a plurality of dialysis membrane filaments, and a first potting colloid. The first shell assembly includes an upper cover, a barrel, and a lower cover connected in sequence along its axial direction, and the upper cover, the barrel, and the lower cover together form a dialysis cavity. The upper cover is provided with a dialysis inlet, and the lower cover is provided with a dialysis outlet. The dialysis inlet is connected to the venous blood vessel in the umbilical cord blood vessel, and the dialysis outlet is connected to the membrane oxygenator. The barrel is provided with a dialysis fluid inlet and a dialysis fluid outlet for the dialysis fluid to enter and exit. The two ends of the plurality of dialysis membrane filaments are encapsulated in the dialysis cavity by the first potting colloid, and the interior of each dialysis membrane filament is hollow and connected to the dialysis inlet and the dialysis outlet.

[0010] Further, the membrane oxygenator includes a second shell assembly, an inner cylinder, a plurality of oxygenation membrane filaments, a liquid separation column and a second potting colloid. The second shell assembly includes a first end cap, an outer cylinder and a second end cap connected in sequence along its axial direction, the first end cap is provided with an oxygenation liquid inlet and an oxygenation gas inlet, the outer cylinder is provided with two oxygenation liquid outlets, the second end cap is provided with an oxygenation gas outlet, and the liquid outlet direction of each oxygenation liquid outlet is perpendicular to the liquid inlet direction of the oxygenation liquid inlet, and the gas outlet direction of the oxygenation gas outlet is consistent with the gas inlet direction of the oxygenation gas inlet. The inner cylinder is arranged in the outer cylinder and spaced from the outer cylinder to form an oxygenation cavity, and the axial ends of the inner cylinder are respectively connected to the first end cap and together form a liquid separation cavity, and the liquid separation cavity is connected to the oxygenation cavity. The two ends of the plurality of oxygenation membrane filaments are encapsulated in the oxygenation cavity by the second potting colloid, and the interior of each oxygenation membrane filament is hollow and connected to the oxygenation gas inlet and the oxygenation gas outlet. The liquid separation column is arranged in the liquid separation cavity, and one end of the liquid separation column is connected to the inner cylinder, and the other end extends out of the inner cylinder.

[0011] Furthermore, one end of the liquid separation column extending out of the inner cylinder is arranged beyond the second potting colloid.

[0012] Furthermore, the outer cylinder is provided with a circumferential liquid collecting groove, and the oxygenation liquid outlet is provided on a portion of the outer cylinder corresponding to the circumferential liquid collecting groove.

[0013] Further, the liquid separation column includes a first liquid separation section and a second liquid separation section, the first liquid separation section is arranged near the oxygenation liquid inlet in the axial direction of the second shell component, and the cross section of the first liquid separation section is arranged to increase in sequence from the oxygenation liquid inlet toward the oxygenation liquid outlet in the axial direction of the second shell component. The portion of the inner cylinder corresponding to the second liquid separation section is provided with multiple rows of liquid separation holes at intervals along the axial direction of the second shell component, and each row of the liquid separation holes includes a plurality of the liquid separation holes arranged at intervals along the circumference of the inner cylinder.

[0014] Furthermore, the artificial amniotic fluid circulation and filtration system comprises an artificial amniotic fluid storage bag, a circulation pump, a filter, a heater and an ultraviolet sterilizer which are connected in sequence. The artificial amniotic fluid storage bag is used to provide an artificial amniotic fluid environment in vitro for premature infants, the circulation pump is used to drive the circulation of artificial amniotic fluid, the filter is used to remove metabolic wastes of premature infants in the artificial amniotic fluid, the heater is used to maintain the temperature of the artificial amniotic fluid in vitro, and the ultraviolet sterilizer is used to sterilize the artificial amniotic fluid in vitro.

[0015] Furthermore, the artificial amniotic fluid circulation and filtration system also includes a backup branch, two ends of which are respectively connected to the heater and the circulation pump, and the backup branch is connected in parallel with the filter.

[0016] Further, the first monitoring module includes a first flow sensor, a first pressure sensor, a second pressure sensor, a third pressure sensor and a blood oxygen saturation sensor connected to the early warning control module. The first flow sensor is arranged on the connecting pipeline between the hemodialyzer and the venous blood vessel in the premature infant's umbilical cord blood vessel, and is used to monitor the extracorporeal blood circulation flow. The first pressure sensor is arranged on the connecting pipeline between the hemodialyzer and the membrane oxygenator, and is used to monitor the blood inlet pressure before the blood enters the membrane oxygenator. The second pressure sensor and the third pressure sensor are respectively arranged on the connecting pipelines between the two arterial blood vessels and the membrane oxygenator, and are used to monitor the blood outlet pressure after the blood flows out of the membrane oxygenator. The blood oxygen saturation sensor is arranged on the connecting pipeline between the membrane oxygenator and any one of the arterial blood vessels, and is used to monitor the blood oxygen saturation of the blood after the blood is oxygenated by the membrane oxygenator. The early warning control module is used to issue an early warning when any of the blood circulation flow, blood inlet pressure, blood outlet pressure and blood oxygen saturation does not meet the preset conditions.

[0017] Furthermore, the second monitoring module includes a second flow sensor and a temperature sensor connected to the early warning control module. The second flow sensor is arranged on the connecting pipeline between the artificial amniotic fluid storage bag and the circulating pump, and is used to monitor the circulation flow of the artificial amniotic fluid in vitro. The temperature sensor is arranged in the artificial amniotic fluid storage bag, and is used to monitor the temperature of the artificial amniotic fluid in the artificial amniotic fluid storage bag. The early warning control module is used to issue an early warning when the circulation flow of the artificial amniotic fluid and / or the temperature of the artificial amniotic fluid do not meet the preset conditions.

[0018] The beneficial effects of the present invention are as follows:

[0019] In the present invention, since the extracorporeal blood circulation system can provide extracorporeal blood circulation and nutrient supply for premature infants, and the artificial amniotic fluid circulation and filtration system can provide a sterile, healthy, and suitable extracorporeal amniotic fluid environment for premature infants, the extracorporeal blood circulation system and the artificial amniotic fluid circulation and filtration system of the present application can jointly create a living environment that is extremely similar to the maternal uterine environment, 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 premature infants and reducing the probability of maldevelopment. In addition, since the extracorporeal life support system of the embodiment of the present application is also provided with a first monitoring module for monitoring the operating parameters of the extracorporeal blood circulation system and a second monitoring module for monitoring the operating parameters of the artificial amniotic fluid circulation and filtration system, and based on the cooperation between the first monitoring module and the second monitoring module and the early warning control module, an early warning can be issued when the operating parameters of the extracorporeal blood circulation system and / or the artificial amniotic fluid circulation and filtration system do not meet the preset conditions, so that the abnormal situation of the premature infant can be discovered in time and the relevant guardians can be warned to handle and treat, thereby further improving the survival rate of the premature infant.

[0020] This 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 limit the scope of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above and other objects, features and advantages of the present disclosure will become more apparent through a more detailed description of exemplary embodiments of the present disclosure in conjunction with the accompanying drawings, wherein like reference numerals generally represent like components throughout the exemplary embodiments of the present disclosure.

[0022] Figure 1 A schematic diagram showing the connection between the extracorporeal life support system of the present invention and the umbilical cord blood vessels of a premature infant is shown;

[0023] Figure 2 The external structure schematic diagram of the hemodialyzer of the present invention is shown;

[0024] Figure 3 The internal structure schematic diagram of the hemodialyzer of the present invention is shown;

[0025] Figure 4 A perspective view of a membrane oxygenator of the present invention is shown;

[0026] Figure 5 A schematic diagram showing the internal structure of the membrane oxygenator of the present invention is shown;

[0027] Figure 6 A schematic diagram showing the connection between the liquid separation column and the inner cylinder of the membrane oxygenator of the present invention is shown;

[0028] Figure 7 A schematic structural diagram of an outer cylinder in a housing assembly of the present invention is shown.

[0029] The reference numerals are as follows:

[0030] 10. Extracorporeal blood circulation system;

[0031] 11. hemodialyzer; 111. first housing assembly; 1111. upper cover; 1112. barrel; 1113. lower cover; 112. dialysis membrane filament; 113. first potting colloid; A1. dialysis inlet; A2. dialysis outlet; A3. dialysis fluid inlet; A4. dialysis fluid outlet; B. dialysis cavity;

[0032] 12. membrane oxygenator; 121. second housing assembly; 1211. first end cap; 1212. outer cylinder; 1213. second end cap; 122. inner cylinder; 123. oxygenation membrane filament; 124. liquid separation column; 1241. first liquid separation section; 1242. second liquid separation section; T1. liquid separation 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 separation cavity; F. circumferential liquid collecting tank;

[0033] 13. First interface;

[0034] 14. Second interface;

[0035] 20. Artificial amniotic fluid circulation and filtration system; 21. Artificial amniotic fluid storage bag; 22. Circulation pump; 23. Filter; 24. Heater; 25. Ultraviolet sterilizer; 26. Backup branch;

[0036] 30. Intelligent monitoring system; 31. First monitoring module; L1. First flow sensor; P1. First pressure sensor; P2. Second pressure sensor; P3. Third pressure sensor; M. Blood oxygen saturation sensor; 32. Second monitoring module; L2. Second flow sensor; T. Temperature sensor; 33. Early warning control module;

[0037] 200. Umbilical cord blood vessels; 210. Venous blood vessels; 220. Arterial blood vessels. DETAILED DESCRIPTION

[0038] Embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to make the present disclosure more thorough and complete, and to fully convey the scope of the present disclosure to those skilled in the art.

[0039] As used herein, the term "including" and its variations mean open inclusion, i.e., "including but not limited to". Unless otherwise stated, the term "or" means "and / or". The term "based on" means "based at least in part on". The terms "an example embodiment" and "an embodiment" mean "at least one example embodiment". The term "another embodiment" means "at least one additional embodiment". The terms "first", "second", etc. may refer to different or the same objects. Other explicit and implicit definitions may also be included below.

[0040] Refer to the following Figure 1-7 The extracorporeal life support system according to an embodiment of the present application is described.

[0041] The extracorporeal life support system is a medical device used for the rescue and life support of premature infants. It can provide extracorporeal life support for premature infants outside the body to improve the survival rate of premature infants and reduce developmental disorders.

[0042] Reference Figure 1 The extracorporeal life support system of the embodiment of the present application includes an extracorporeal blood circulation system 10 , an artificial amniotic fluid circulation and filtration system 20 , and an intelligent monitoring system 30 .

[0043] The extracorporeal blood circulation system 10 mainly simulates the function of the maternal placenta. It is used to connect with the umbilical cord blood vessels 200 of premature infants. Its main function is to provide oxygen to the blood of premature infants to remove carbon dioxide and metabolic waste in the blood. At the same time, the extracorporeal blood circulation system 10 can also be used to input nutrients into the blood of premature infants to provide necessary nutrition for the development of premature infants. Therefore, the extracorporeal blood circulation and nutrient supply of premature infants can be achieved through the extracorporeal blood circulation system 10.

[0044] The artificial amniotic fluid circulation and filtration system 20 mainly simulates the maternal amniotic fluid environment, and is used to provide a sterile, healthy, and suitable extracorporeal amniotic fluid environment for premature infants, so as to prevent the premature lungs of premature infants from being exposed to air too early, leading to obstructed lung development and related chronic diseases.

[0045] 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 used to monitor the operating parameters of the extracorporeal blood circulation system 10, the second monitoring module 32 is used to monitor the operating parameters of the artificial amniotic fluid circulation and filtration 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 used to issue an early warning when the operating parameters of the extracorporeal blood circulation system 10 and / or the artificial amniotic fluid circulation and filtration system 20 do not meet the preset conditions.

[0046] In this embodiment, since the extracorporeal blood circulation system 10 can provide extracorporeal blood circulation and nutrient supply for premature infants, and the artificial amniotic fluid circulation and filtration system 20 can provide a sterile, healthy and suitable extracorporeal amniotic fluid environment for premature infants, the extracorporeal blood circulation system 10 and the artificial amniotic fluid circulation and filtration system 20 of the present application can jointly create a living environment that is extremely similar to the mother's uterine environment, so that after the premature infant leaves the body, the premature infant can still live like in the mother's uterus until it matures, thereby greatly improving the survival rate of premature infants and reducing the probability of maldevelopment. In addition, since the extracorporeal life support system of the embodiment of the present application is also provided with a first monitoring module 31 for monitoring the operating parameters of the extracorporeal blood circulation system 10 and a second monitoring module 32 for monitoring the operating parameters of the artificial amniotic fluid circulation and filtration 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, an early warning can be issued when the operating parameters of the extracorporeal blood circulation system 10 and / or the artificial amniotic fluid circulation and filtration system 20 do not meet the preset conditions, so that abnormal conditions of premature infants can be discovered in time and relevant guardians can be warned to handle and treat them, thereby further improving the survival rate of premature infants.

[0047] In some embodiments, reference Figure 1 The extracorporeal blood circulation system 10 includes a hemodialyzer 11 and a membrane oxygenator 12 .

[0048] The hemodialyzer 11 is connected to the venous blood vessel 210 in the premature infant's umbilical cord blood vessel 200, and is used to purify the blood in the premature infant's venous blood vessel 210. Dialysate is provided inside the hemodialyzer 11, and metabolic waste in the blood flowing into the hemodialyzer 11 from the venous blood vessel 210 will be dissolved in the dialysate and carried away by the dialysate, thereby achieving the purpose of purifying the blood.

[0049] The membrane oxygenator 12 is connected to the hemodialyzer 11 and two arterial blood vessels 220 in the umbilical cord blood vessel 200 . The membrane oxygenator 12 can provide oxygen to the blood of the premature infant, and is used to oxygenate and remove carbon dioxide from the blood flowing out of the hemodialyzer 11 and supply the processed blood to the arterial blood vessels 220 of the umbilical cord blood vessel 200 .

[0050] Specifically, based on the extracorporeal blood circulation system 10, the venous blood in the umbilical cord blood vessels 200 of the premature infant is drawn out from the venous blood vessels 210, and then processed by the hemodialyzer 11 and the membrane oxygenator 12 in sequence and divided into two paths. The two paths are then respectively transported back to the premature infant through the two arterial blood vessels 220 in the umbilical cord blood vessels 200, thereby realizing extracorporeal blood circulation for the premature infant.

[0051] In this embodiment, the hemodialyzer 11 is used to remove metabolic wastes from the blood of premature infants to purify the blood, and the membrane oxygenator 12 enables the premature infants to perform extracorporeal blood circulation instead of using lungs to breathe after leaving the maternal environment, so as to provide extracorporeal life support for the premature infants until the premature infants mature, thereby greatly improving the survival rate of premature infants (especially young premature infants) and reducing the probability of maldevelopment.

[0052] In some embodiments, reference Figure 1 A first interface 13 is provided on the connection pipeline between the hemodialyzer 11 and the membrane oxygenator 12, and a second interface 14 is provided on the connection pipeline between each arterial blood vessel 220 and the membrane oxygenator 12. The first interface 13 and the second interface 14 can be used for monitoring sampling and / or nutrient supply.

[0053] Specifically, the first interface 13 and the second interface 14 may be provided with a Luer connector, a multi-way standard conversion connector (such as a three-way conversion connector), etc., which may be used as interfaces for monitoring sampling, nutrient injection, and pressure sensor monitoring.

[0054] In some embodiments, reference Figure 2 and Figure 3 The hemodialyzer 11 includes a first housing component 111 , a plurality of dialysis membrane filaments 112 and a first potting colloid 113 .

[0055] The first housing assembly 111 includes an upper cover 1111, a barrel 1112 and a lower cover 1113 which are sequentially connected along the axial direction thereof, and the upper cover 1111, the barrel 1112 and the lower cover 1113 together form a dialysis chamber B.

[0056] The upper cover 1111 is provided with a dialysis inlet A1, and the lower cover 1113 is provided with a dialysis outlet A2. The dialysis inlet A1 is connected to the venous blood vessel 210 in the umbilical cord blood vessel 200, and the dialysis outlet A2 is connected to the membrane oxygenator 12. The cylinder 1112 is provided with a dialysis fluid inlet A3 and a dialysis fluid outlet A4 for the dialysis fluid to enter and exit.

[0057] Both ends of the plurality of dialysis membrane filaments 112 are encapsulated in the dialysis cavity B by the first potting colloid 113 . The interior of each dialysis membrane filament 112 is hollow (ie, a hollow tubular structure) and is connected to the dialysis liquid inlet A1 and the dialysis liquid outlet A2 .

[0058] The dialysate inlet A1 and the dialysate outlet A2 of the hemodialyzer 11 are used for blood in the venous blood vessel 210 to enter and exit the hemodialyzer 11 , and the dialysate inlet A3 and the dialysate outlet A4 are used for dialysate to enter and exit the hemodialyzer 11 .

[0059] After the blood enters the hemodialyzer 11 through the dialysis inlet A1, it will flow through the inside of the dialysis membrane filaments 112, while the dialysate will flow through the outside of the dialysis membrane filaments 112 through the dialysate inlet A3. The dialysis membrane filaments 112 allow metabolic waste in the blood to pass through, but do not allow blood cells and other macromolecules in the blood to pass through. Due to the concentration difference between metabolic waste in the blood and the dialysate, the metabolic waste in the blood will pass through the dialysis membrane filaments 112, dissolve in the dialysate and be carried away by the dialysate (i.e., flow out of the hemodialyzer 11 through the dialysate outlet A4), thereby removing the metabolic waste in the blood to achieve the purpose of purifying the blood.

[0060] In some embodiments, reference Figure 4 and Figure 5 The membrane oxygenator 12 includes a second housing assembly 121 , an inner cylinder 122 , a plurality of oxygenation membrane filaments 123 , a liquid separation column 124 and a second potting colloid 125 .

[0061] Specifically, the membrane oxygenator 12 may be a columnar structure as a whole. The second housing assembly 121 may include a first end cap 1211, an outer cylinder 1212, and a second end cap 1213 connected in sequence along the axial direction thereof. The first end cap 1211 is provided with an oxygenation liquid inlet B1 and an oxygenation gas inlet B3, the outer cylinder 1212 is provided with two oxygenation liquid outlets B2, and the second end cap 1213 is provided with an oxygenation gas outlet B4. Among them, the liquid outlet direction of each oxygenation liquid outlet B2 is perpendicular to the liquid inlet direction of the oxygenation liquid inlet B1, the gas outlet direction of the oxygenation gas outlet B4 is consistent with the gas inlet direction of the oxygenation gas inlet B3, the oxygenation liquid inlet B1 and the oxygenation liquid outlet B2 are used for the blood purified by the hemodialyzer 11 to enter and exit the membrane oxygenator 12, and the oxygenation gas inlet B3 and the oxygenation gas outlet B4 are used for gas to enter and exit the membrane oxygenator 12.

[0062] The inner cylinder 122 is arranged in the outer cylinder 1212 and is spaced apart from the outer cylinder 1212 to form an oxygenation chamber C, and the axial ends of the inner cylinder 122 are respectively connected to the first end cover 1211 to form a liquid separation chamber D, which is connected to the oxygenation chamber C, the oxygenation liquid inlet B1 and the oxygenation liquid outlet B2.

[0063] Both ends of the plurality of oxygenation membrane filaments 123 are encapsulated in the oxygenation cavity C by the second encapsulating colloid 125 . The interior of each oxygenation membrane filament 123 is hollow (ie, a hollow tubular structure) and is connected to the oxygenation air inlet B3 and the oxygenation air outlet B4 .

[0064] The liquid separation column 124 is disposed in the liquid separation cavity D, and one end of the liquid separation column 124 is connected to the inner cylinder 122 , and the other end thereof extends out of the inner cylinder 122 .

[0065] The second potting colloid 125 is disposed at both ends of the plurality of oxygenation membrane filaments 123, and each second potting colloid 125 at both ends encapsulates and fixes the plurality of oxygenation membrane filaments 123 in the oxygenation chamber C between the inner cylinder 122 and the outer cylinder 1212. Among them, one second potting colloid 125 forms an oxygenation air inlet chamber E1 together with the first end cap 1211, and another second potting colloid 125 forms an oxygenation air outlet chamber E2 together with the second end cap 1213. The oxygenation air inlet chamber E1 is connected to the oxygenation air inlet port B3, and the oxygenation air outlet chamber E2 is connected to the oxygenation air outlet port B4. The oxygenation air inlet chamber E1 is connected to the oxygenation air outlet chamber E2 through the interior of the oxygenation membrane filament 123.

[0066] When the extracorporeal life support system of the present application is used to provide extracorporeal life support for premature infants, the liquid inlet A1 of the membrane oxygenator 12 can be connected to the dialyzed liquid outlet A2 of the hemodialyzer 11, and the two arterial blood vessels 220 in the umbilical cord blood vessel 200 are respectively connected to a corresponding oxygenation liquid outlet B2. External oxygen can enter and flow through the interior of the oxygenation membrane filament 123 through the oxygenation gas inlet B3, and the blood in the hemodialyzer 11 can enter the oxygenation cavity C through the oxygenation liquid inlet B1 and the liquid separation cavity D in sequence, and the liquid in the blood flows through the outside of the oxygenation membrane filament 123 (i.e., the gap between adjacent oxygenation membrane filaments 123), and the gas in the blood flows through the inside of the oxygenation membrane filament 123 to perform gas exchange between oxygen and the gas in the blood, thereby achieving the purpose of oxygenating the blood flowing out of the hemodialyzer 11 and removing carbon dioxide in the blood (i.e., the membrane oxygenator 12 can convert venous blood into arterial blood). After the blood in the venous blood is oxygenated and carbon dioxide is removed, the venous blood is converted into arterial blood, and the arterial blood then enters the two arterial blood vessels 220 in the umbilical cord blood vessel 200 through the corresponding oxygenation outlet B2, thereby realizing extracorporeal circulation of the premature infant's blood to provide extracorporeal life support for the premature infant.

[0067] In the present application, the design of a single oxygenation inlet B1 and two oxygenation outlets B2 can meet the physiological characteristics of the umbilical cord blood vessels of premature infants, making it easy to connect the membrane oxygenator 12 to provide extracorporeal life support for premature infants.

[0068] Among them, 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 the blood enters the liquid separation chamber D through the oxygenation liquid inlet B1, the blood will flow through the multiple oxygenation membrane filaments 123 in sequence along the direction perpendicular to the axial direction of the membrane oxygenator 12 (that is, all radial directions of the membrane oxygenator 12), so that the flow path of the blood in the oxygenation chamber C is minimized (that is, the flow distance is the difference between the inner diameters of the outer cylinder 1212 and the inner cylinder 122), thereby achieving an extremely low transmembrane pressure difference, and the blood pressure generated by the heart of the premature infant can be directly used without relying on a blood pump, and the membrane oxygenator 12 of the present application can be used to achieve extracorporeal blood circulation of the premature infant.

[0069] In addition, since the membrane oxygenator 12 of the present application can eliminate the influence of the blood pump on the hemodynamics of premature infants, the membrane oxygenator 12 of the present application can be applied to provide extracorporeal life support for extremely young premature infants of 22 to 28 weeks.

[0070] It should be noted that the oxygenation membrane filament 123 in the oxygenation chamber C is a semipermeable membrane. When oxygen flows through the inside of the oxygenation membrane filament 123 and blood flows through the outside of the oxygenation membrane filament 123, since the oxygen concentration inside the oxygenation membrane filament 123 is higher than the oxygen concentration in the blood outside the oxygenation membrane filament 123 and the carbon dioxide concentration is lower than the carbon dioxide concentration in the blood, oxygen will enter the blood from the inside of the oxygenation membrane filament 123 and the carbon dioxide in the blood will enter the inside of the oxygenation membrane filament 123, thereby achieving blood oxygenation and removal of carbon dioxide in the blood.

[0071] In some embodiments, reference Figure 5 One end of the liquid separation column 124 extending out of the inner cylinder 122 is disposed beyond the second potting colloid 125 .

[0072] In this embodiment, the end of the liquid separator column 124 extending out of the inner cylinder 122 is arranged beyond the second potting colloid 125, so that the distance between the liquid separator column 124 and the oxygenation liquid inlet B1 is relatively close. After the blood enters through the oxygenation liquid inlet B1 and before entering the inner cylinder 20, the blood will first impact the liquid separator column 124 and be dispersed to various areas of the liquid separator cavity D in the circumferential direction through the liquid separator column 124, thereby significantly improving the uniformity of blood distribution in the circumferential direction of the liquid separator cavity D. Moreover, such a setting is equivalent to reducing the volume of the liquid separator cavity D, thereby reducing the pre-filled volume of the membrane oxygenator 12 of the present application.

[0073] In some embodiments, reference Figure 5 and Figure 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 arranged near the oxygenation liquid inlet B1 in the axial direction of the second shell component 121, and the cross-section of the first liquid separation section 1241 is arranged to increase in sequence from the oxygenation liquid inlet B1 toward the oxygenation liquid outlet B2 in the axial direction of the second shell component 121.

[0074] In other words, the first liquid separation section 1241 is a thin structure at the top and wide at the bottom, so that the cross section of the cavity between the first liquid separation section 1241 and the first end cover 1211 and the cross section of the liquid separation cavity D between the first liquid separation section 1241 and the inner cylinder 122 are gradually narrowed from top to bottom, which is conducive to guiding the blood along the axial direction of the membrane oxygenator 12 to the second liquid separation section 1242, thereby being more conducive to the uniform distribution of blood in the axial direction of the membrane oxygenator 12.

[0075] 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 shell assembly 121 , and each row of liquid separation holes T1 includes a plurality of liquid separation holes T1 arranged at intervals along the circumferential direction of the inner cylinder 122 .

[0076] Based on the multiple rows of liquid separation holes T1 arranged at intervals along the axial direction of the membrane oxygenator 12 and each row of liquid separation holes T1 including multiple liquid separation holes T1 arranged at intervals along the circumferential direction of the inner tube 122, blood can be evenly flowed into different parts of the oxygenation chamber C through the corresponding liquid separation holes T1 in the axial direction of the membrane oxygenator 12, which is beneficial to improving the gas exchange efficiency between the blood in the umbilical cord blood vessels and the external gas and the extracorporeal circulation efficiency of premature infants.

[0077] In some embodiments, reference Figure 5 and Figure 7 The outer tube 1212 is provided with a circumferential liquid collecting groove F, and the oxygenation liquid outlet B3 is provided on the portion of the outer tube 1212 corresponding to the circumferential liquid collecting groove F.

[0078] Among them, the circumferential liquid collecting groove F is recessed inward from the inner wall of the outer cylinder 1212, so that the inner diameter of the inner wall of the outer cylinder 1212 corresponding to the circumferential liquid collecting groove F is larger than the inner diameter of the inner wall of other parts of the outer cylinder 1212, that is, the gap between the inner wall of the outer cylinder 1212 at the circumferential liquid collecting groove F and the oxygenated membrane filament 123 closest to it is larger than the gap between the inner wall of other parts of the outer cylinder 1212 and the oxygenated membrane filament 123 closest to it.

[0079] Therefore, in this embodiment, based on the circumferential liquid collecting groove F provided on the inner wall of the outer tube 1212, blood can be collected in the circumferential liquid collecting groove F on the inner wall of the outer tube 1212, thereby facilitating the blood to flow out of the membrane oxygenator 12 through the circumferential liquid collecting groove F and the oxygenation outlet B3.

[0080] In some embodiments, the volume of membrane oxygenator 12 is 110 cm 3 -125cm 3 For example, the volume of the membrane oxygenator 12 may be 110 cm 3 、111cm 3 、112cm 3、113cm 3 、114cm 3 、115cm 3 、116cm 3 、117cm 3 、120cm 3 、121cm 3 、122cm 3 、123cm 3 、124cm 3 、125cm 3 wait.

[0081] In some embodiments, the membrane oxygenator 12 of the present application is suitable for premature infants with small weight and umbilical cord blood content. For example, the membrane oxygenator 12 of the present application can be suitable for premature infants with a weight of less than 1 kg and an umbilical cord blood flow of less than 200 ml / min. Further, the membrane oxygenator 100 of the present application can also be suitable for extremely young premature infants of 22 to 28 weeks, whose weight is less than 1 kg and whose umbilical cord blood flow is less than 200 ml / min.

[0082] In some embodiments, the priming volume of the membrane oxygenator 12 of the present application is 10 ml-15 ml. Exemplarily, the priming volume of the membrane oxygenator 10 can be 10 ml, 11 ml, 12 ml, 13 ml, 14 ml, 15 ml, etc.

[0083] In some embodiments, reference Figure 1 The artificial amniotic fluid circulation and filtration 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 which are connected in sequence.

[0084] The artificial amniotic fluid storage bag 21 can provide a closed sterile environment for premature infants, and the premature infants can be placed in the artificial amniotic fluid storage bag 21 for growth and development. That is, the artificial amniotic fluid storage bag 21 is used to provide an artificial amniotic fluid environment in vitro for premature infants, which can prevent premature infants with immature lungs from being exposed to air too early.

[0085] The circulation pump 22 is arranged between the amniotic fluid inlet and outlet of the artificial amniotic fluid storage bag 21 to drive the circulation of the artificial amniotic fluid. The circulation pump 22 is connected to the filter 23 and can also cooperate with the filter 23 to remove metabolic waste such as meconium of premature infants.

[0086] The filter 23 can cooperate with the circulation pump 22 to remove metabolic wastes of premature infants in the artificial amniotic fluid.

[0087] The heater 24 is used to maintain the temperature of the artificial amniotic fluid outside the body, that is, when the temperature of the artificial amniotic fluid is low, the artificial amniotic fluid can be heated to maintain the temperature of the amniotic fluid within a temperature range suitable for the survival of premature infants.

[0088] The ultraviolet sterilizer 25 is used to sterilize the artificial amniotic fluid in vitro, that is, the ultraviolet sterilizer 25 can use ultraviolet rays to inactivate bacteria in the artificial amniotic fluid, so that the artificial amniotic fluid in the artificial amniotic fluid storage bag 21 is in a sterile state, thereby providing a sterile artificial amniotic fluid growth environment for premature infants.

[0089] Therefore, in this embodiment, based on the cooperation between the artificial amniotic fluid preservation bag 21, the circulating pump 22, the filter 23, the heater 24 and the ultraviolet sterilizer 25, an in vitro artificial amniotic fluid growth environment that is sterile, free of metabolic waste, at a suitable temperature and can circulate can be provided for the ex vivo premature infants, so that the ex vivo premature infants can still live like in the mother's womb until they mature, thereby greatly improving the survival rate of premature infants and reducing the probability of maldevelopment.

[0090] In some embodiments, reference Figure 1 The artificial amniotic fluid circulation and filtration system 20 also includes a backup branch 26 , both ends of which are connected to the heater 24 and the circulation pump 22 , respectively, and the backup branch 26 is connected in parallel with the filter 23 .

[0091] In this embodiment, based on the setting of the backup branch 26, the backup branch 26 can be blocked when the filter 23 is working normally; when the filter 23 is abnormal and needs to be cleaned or replaced, the backup branch 26 can be opened, and the heater 24 is connected to the circulation pump 22 by using the backup branch 26, so that the artificial amniotic fluid can circulate normally, thereby continuously providing an artificial amniotic fluid growth environment for premature infants.

[0092] In some embodiments, reference Figure 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 a blood oxygen saturation sensor M connected to the early warning control module 33.

[0093] The first flow sensor L1 is disposed on the connecting pipeline between the hemodialyzer 11 and the venous blood vessel 210 in the premature infant's umbilical cord blood vessel 200, and is used to monitor the extracorporeal blood circulation flow.

[0094] The first pressure sensor P1 is disposed on the connecting pipeline between the hemodialyzer 11 and the membrane oxygenator 12 , and is used to monitor the blood inlet pressure before the blood enters the membrane oxygenator 12 .

[0095] The second pressure sensor P2 and the third pressure sensor P3 are respectively disposed on the connecting pipelines between the two arterial blood vessels 220 and the membrane oxygenator 12 , and are used to monitor the blood outlet pressure after the blood flows out of the membrane oxygenator 12 .

[0096] The blood oxygen saturation sensor M is disposed on the connection pipeline between the membrane oxygenator 12 and any arterial blood vessel 220 , and is used to monitor the blood oxygen saturation after the blood is oxygenated by the membrane oxygenator 12 .

[0097] The early warning control module 33 is used to issue an early warning when any one of the blood circulation flow, blood inlet pressure, blood outlet pressure and blood oxygen saturation does not meet the preset conditions.

[0098] In this embodiment, the first monitoring module 31 can timely monitor parameters such as the extracorporeal blood circulation flow rate, 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. When the above-mentioned related parameters exceed the set threshold value, the early warning control module 33 can timely issue a warning to prompt the relevant guardians to handle and / or treat, thereby further improving the survival rate of premature infants.

[0099] In some embodiments, reference Figure 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 .

[0100] The second flow sensor L2 is disposed on the connecting pipeline between the artificial amniotic fluid storage bag 21 and the circulation pump 22, and is used to monitor the circulation flow of the extracorporeal artificial amniotic fluid.

[0101] The temperature sensor T is disposed in the artificial amniotic fluid storage bag 21 to monitor the temperature of the artificial amniotic fluid in the artificial amniotic fluid storage bag 21 .

[0102] The early warning control module 33 is used to issue an early warning when the circulation flow rate of the artificial amniotic fluid and / or the temperature of the artificial amniotic fluid do not meet the preset conditions.

[0103] In this embodiment, the second monitoring module 32 can be used to timely monitor the in vitro artificial amniotic fluid circulation flow and the temperature of the artificial amniotic fluid, and the early warning control module 33 will issue an 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 a stable flow and control the heater to achieve a constant temperature, thereby providing an in vitro artificial amniotic fluid growth environment with a suitable temperature and adapted to the amniotic fluid circulation flow rate of premature infants, thereby further improving the survival rate of premature infants.

[0104] The embodiments of the present disclosure have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical applications, or technical improvements in the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. An extracorporeal life support system, characterized in that: include: An extracorporeal blood circulation system (10) connected to the premature infant's umbilical cord blood vessels (200) for achieving extracorporeal blood circulation and nutrient supply for the premature infant; An artificial amniotic fluid circulation and filtration system (20) for providing an extracorporeal amniotic fluid environment for premature infants; and The intelligent monitoring system (30) comprises a first monitoring module (31), a second monitoring module (32) and an early warning control module (33), wherein the first monitoring module (31) is used to monitor the operating parameters of the extracorporeal blood circulation system (10), the second monitoring module (32) is used to monitor the operating parameters of the artificial amniotic fluid circulation and filtration 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 used to issue an early warning when the operating parameters of the extracorporeal blood circulation system (10) and / or the artificial amniotic fluid circulation and filtration system (20) do not meet preset conditions.

2. The extracorporeal life support system according to claim 1, characterized in that: The extracorporeal blood circulation system (10) comprises: A hemodialyzer (11) connected to a venous blood vessel (210) in the umbilical cord blood vessel (200) of a premature infant, and used for purifying blood in the venous blood vessel (210); The membrane oxygenator (12) is connected to the hemodialyzer (11) and two arterial blood vessels (220) in the umbilical cord blood vessel (200), and is used to oxygenate and remove carbon dioxide from the blood flowing out of the hemodialyzer (11) and supply the treated blood to the arterial blood vessel (220) of the umbilical cord blood vessel (200).

3. The extracorporeal life support system according to claim 2, characterized in that: A first interface (13) is provided on the connecting pipeline between the hemodialyzer (11) and the membrane oxygenator (12); A second interface (14) is provided on the connecting pipeline between each arterial blood vessel (220) and the membrane oxygenator (12); The first interface (13) and the second interface (14) are both used for monitoring sampling and / or nutrient supply.

4. The extracorporeal life support system according to claim 2, characterized in that: The hemodialyzer (11) comprises a first housing component (111), a plurality of dialysis membrane filaments (112) and a first potting colloid (113); The first housing component (111) comprises an upper cover (1111), a barrel (1112) and a lower cover (1113) which are sequentially connected along the axial direction thereof, and the upper cover (1111), the barrel (1112) and the lower cover (1113) together form a dialysis chamber (B); The upper cover (1111) is provided with a dialysate inlet (A1), and the lower cover (1113) is provided with a dialysate outlet (A2); the dialysate inlet (A1) is connected to the venous blood vessel (210) in the umbilical cord blood vessel (200), and the dialysate outlet (A2) is connected to the membrane oxygenator (12); the cylinder (1112) is provided with a dialysate inlet (A3) and a dialysate outlet (A4) for the dialysate to enter and exit; Both ends of the plurality of dialysis membrane filaments (112) are encapsulated in the dialysis cavity (B) by the first potting colloid (113), and the interior of each dialysis membrane filament (112) is hollow and connected to the dialysis fluid inlet (A1) and the dialysis fluid outlet (A2).

5. The extracorporeal life support system according to claim 2, characterized in that: The membrane oxygenator (12) comprises a second housing component (121), an inner cylinder (122), a plurality of oxygenation membrane filaments (123), a liquid separation column (124) and a second potting colloid (125); The second shell component (121) comprises a first end cover (1211), an outer cylinder (1212) and a second end cover (1213) which are sequentially connected along the axial direction thereof, the first end cover (1211) being provided with an oxygenation liquid inlet (B1) and an oxygenation gas inlet (B3), the outer cylinder (1212) being provided with two oxygenation liquid outlets (B2), the second end cover (1213) being provided with an oxygenation gas outlet (B4), and the liquid outlet direction of each of the oxygenation liquid outlets (B2) being perpendicular to the liquid inlet direction of the oxygenation liquid inlet (B1), and the gas outlet direction of the oxygenation gas outlet (B4) being consistent with the gas inlet direction of the oxygenation gas inlet (B3); The inner cylinder (122) is arranged inside the outer cylinder (1212) and is spaced apart from the outer cylinder (1212) to form an oxygenation chamber (C), and the axial ends of the inner cylinder (122) are respectively connected to the first end cover (1211) and together form a liquid separation chamber (D), and the liquid separation chamber (D) is connected to the oxygenation chamber (C); Two ends of the plurality of oxygenation membrane filaments (123) are encapsulated in the oxygenation cavity (C) through the second potting colloid (125), and the interior of each oxygenation membrane filament (123) is hollow and 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).

6. The extracorporeal life support system according to claim 5, characterized in that: One end of the liquid separation column (124) extending out of the inner cylinder (122) is disposed beyond the second potting colloid (125); and / or The outer cylinder (1212) is provided with a circumferential liquid collecting groove (F), and the oxygenation liquid outlet (B2) is provided on a portion of the outer cylinder (1212) corresponding to the circumferential liquid collecting groove (F); and / or The liquid separation column (124) comprises a first liquid separation section (1241) and a second liquid separation section (1242); the first liquid separation section (1241) is arranged close to the oxygenation liquid inlet (B1) in the axial direction of the second shell component (121); and the cross section of the first liquid separation section (1241) is arranged to increase in sequence from the oxygenation liquid inlet (B1) toward the oxygenation liquid outlet (B2) in the axial direction of the second shell component (121); A 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) spaced apart along the axial direction of the second shell assembly (121), and each row of the liquid separation holes (T1) includes a plurality of the liquid separation holes (T1) spaced apart along the circumferential direction of the inner cylinder (122).

7. The extracorporeal life support system according to claim 1, characterized in that: The artificial amniotic fluid circulation and filtration system (20) comprises an artificial amniotic fluid storage bag (21), a circulation pump (22), a filter (23), a heater (24) and an ultraviolet sterilizer (25) which are connected in sequence; The artificial amniotic fluid storage bag (21) is used to provide an extracorporeal artificial amniotic fluid environment for premature infants, the circulating pump (22) is used to drive the circulation of artificial amniotic fluid, the filter (23) is used to remove metabolic waste of premature infants in the artificial amniotic fluid, the heater (24) is used to maintain the temperature of the extracorporeal artificial amniotic fluid, and the ultraviolet sterilizer (25) is used to sterilize the extracorporeal artificial amniotic fluid.

8. The extracorporeal life support system according to claim 7, characterized in that: The artificial amniotic fluid circulation and filtration system (20) further comprises a backup branch (26), the two ends of which are respectively connected to the heater (24) and the circulation pump (22), and the backup branch (26) is connected in parallel to the filter (23).

9. The extracorporeal life support system according to any one of claims 2 to 6, characterized in that: The first monitoring module (31) comprises a first flow sensor (L1), a first pressure sensor (P1), a second pressure sensor (P2), a third pressure sensor (P3) and a blood oxygen saturation sensor (M) connected to the early warning control module (33); The first flow sensor (L1) is arranged on a connecting pipeline between the hemodialyzer (11) and the venous blood vessel (210) in the umbilical cord blood vessel (200) of a premature infant, and is used to monitor the extracorporeal blood circulation flow; The first pressure sensor (P1) is arranged on the connecting pipeline between the hemodialyzer (11) and the membrane oxygenator (12), and is used to monitor the blood inlet pressure before the blood enters the membrane oxygenator (12); The second pressure sensor (P2) and the third pressure sensor (P3) are respectively arranged on the connecting pipelines between the two arterial blood vessels (220) and the membrane oxygenator (12), and are used to monitor the blood outlet pressure after the blood flows out of the membrane oxygenator (12); The blood oxygen saturation sensor (M) is arranged on the connecting pipeline between the membrane oxygenator (12) and any one of the arterial blood vessels (220), and is used to monitor the blood oxygen saturation after the blood is oxygenated by the membrane oxygenator (12); The early warning control module (33) is used to issue an early warning when any one of the blood circulation flow, blood inlet pressure, blood outlet pressure and blood oxygen saturation does not meet a preset condition.

10. The extracorporeal life support system according to any one of claims 7 to 8, characterized in that: The second monitoring module (32) comprises a second flow sensor (L2) and a temperature sensor (T) connected to the early warning control module (33); The second flow sensor (L2) is arranged on the connecting pipeline between the artificial amniotic fluid storage bag (21) and the circulation pump (22) and is used to monitor the circulation flow of the extracorporeal artificial amniotic fluid; The temperature sensor (T) is arranged in the artificial amniotic fluid storage bag (21) and is used to monitor the temperature of the artificial amniotic fluid in the artificial amniotic fluid storage bag (21); The early warning control module (33) is used to issue an early warning when the circulation flow rate of the artificial amniotic fluid and / or the temperature of the artificial amniotic fluid do not meet preset conditions.

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