Device having an artificial gills system and use thereof for supporting a newborn

Abstract

A device and a method for supporting a human being, preferably a premature infant between the 21/0 and 28/0 week of pregnancy (SSW), The device comprises at least one through-flow system, comprising a number of fluid-permeable elements and connecting elements for the connection to an umbilical arterial catheter and an umbilical. venous catheter and a through-flow lumen for passing modified amniotic fluid enriched with oxygen or an oxygen-containing gas mixture through the fluid-permeable elements, and at least one connection for introducing the modified amniotic fluid into the through-flow system. The through-flow systema is configured in such a way that the modified amniotic fluid is guided through the fluid-permeable elements of the through-flow system while the fetal blood is passed along the outer side of the fluid-permeable elements, but directed past the through-flow lumen, whereby a gas exchange occurs.

Claims

1. A device for the life support of a newborn, in particular of an extremely premature infant between the 21/0 and 28/0 weeks of gestation (WG), comprising at least one flow-through system (21) comprising a number of fluid-permeable elements (22) and connecting elements (26, 28) configured for connection to the umbilical artery catheter (30) and umbilical vein catheter (32) of the newborn, and a flow-through lumen (20) for passing modified amniotic fluid enriched with oxygen or an oxygen-containing gas mixture through the fluid-permeable elements (22), and at least one connection (12) for introducing the oxygen- or oxygen-containing gas mixture-enriched modified amniotic fluid into the flow-through system (21), wherein the flow-through system (21) is configured to pass the oxygen- or oxygen-containing gas mixture-enriched modified amniotic fluid through the fluid-permeable elements (22) of the flow-through system (21) while passing the fetal blood past the outside of the fluid-permeable elements (22) via the flow-through lumen (20), whereby gas exchange takes place.

2. The device according to claim 1, characterized in that the flow-through system (21) is arranged in a container (10).

3. The device according to claim 1, characterized in that oscillation and pressure changes of the modified amniotic fluid in the flow-through system (21) are effected via a pressure valve (24) or via a supply device, preferably at a frequency of 0-100 Hz.

4. The device according to claim 1, characterized in that the fluid-permeable elements (22) of the flow-through system (21) are arranged or structured in a gill-like manner.

5. The device according to claim 4, characterized in that the fluid-permeable elements (22) have a lamellar, comb-shaped, leaf-shaped, tuft-shaped or tree-shaped structure.

6. The device according to claim 1, characterized in that the arrangement of the fluid-permeable elements (22) and the flow-through lumen (20) is such that the modified amniotic fluid enriched with oxygen or an oxygen-containing gas mixture flows through the fluid-permeable elements (22).

7. The device according to claim 1, characterized in that the fluid-permeable elements (22) are a plurality of membranes, tubes or microporous material arranged in series.

8. The device according to claim 1, characterized in that an additional absorber is provided for the disposal of cytokines, toxins, ammonia, bilirubin, myoglobin, creatinine, inflammatory substances or degradation products from the fetal blood.

9. The device according to claim 1, characterized in that devices are configured to facilitate monitoring of the vital functions of the newborn or regulation of the physiological fetal parameters via a network using artificial intelligence.

10. The device according to claim 1, characterized in that a housing (52) is equipped with a pump and a thermostat.

11. The device according to claim 1, characterized in that a pump for introducing the modified amniotic fluid is arranged at the flow-through system (21).

12. The device according to claim 1, characterized in that a storage container (42) is provided, via which medicaments, nutrients or medical products are additionally introduced into the flow-through system (21).

13. The device according to claim 1, characterized in that it comprises two or more flow-through systems (21).

14. The device according to claim 1, characterized in that it comprises a communication system configured to provide interaction between the fetus and the mother or the father via transmitting audio and/or video signals, in particular transmitting the parental voice, breathing, heartbeats or bowel sounds.

15. An ex-vivo method for life support of a human being, in particular extremely premature infant between the 21/0 and 28/0 weeks of gestation (WG), in which modified amniotic fluid or a plasma substitute solution is first enriched with oxygen or an oxygen-containing gas mixture and the enriched amniotic fluid or the plasma substitute solution is supplied to a flow-through system which consists of a number of fluid-permeable elements and connecting elements configured for connection to the arteries and veins of the human being and a flow-through lumen for passing the modified amniotic fluid through the fluid-permeable elements, and at least one connection for introducing the modified amniotic fluid enriched with oxygen or an oxygen-containing gas mixture into the flow-through system, wherein the oxygen-enriched modified amniotic fluid is passed through the fluid-permeable elements of the flow-through system while the blood is passed on the outside of the fluid-permeable elements via the flow-through lumen, and whereby gas exchange takes place.

16. The method according to claim 15, characterized in that there is a digital real-time connection between the fetus and the parents, in which the fetus is supplied with sounds of the mother and/or the father, preferably the voice, breathing, heartbeats and possibly bowel sounds.

17. The method according to claim 15, characterized in that electrolyte exchange, toxin and waste product disposal, in particular of bilirubin, ammonia, nitrogen, and osmoregulation are performed via the flow-through system.

18. The method according to claim 15, characterized in that, alternatively or additionally, moist gassing is carried out via modified amniotic fluid, plasma substitute solutions, electrolyte solutions.

19. The method according to claim 15, characterized in that the gas exchange in the flow-through system is controlled by the velocity of the amniotic fluid flowing through the flow-through system, the fluid volume, the direction/opposite direction, the frequency (oscillation 0-1000 Hz), the O.sub.2 supply and/or gas mixture supply and/or by a pressure change in the flow-through system.

20. The method according to claim 15, characterized in that the amniotic fluid is preheated to a temperature between 37 and 39° C. and simultaneously gassed with oxygen or the oxygen-containing gas mixture before being introduced into the at least one flow-through system,

21. The method according to claim 15, characterized in that a pressure between 5 mbar and 5 bar is maintained in the flow-through system.

22. The method according to claim 15, characterized in that medicaments, nutrients or medical products are additionally introduced into the flow-through system.

23. The method according to claim 15, characterized in that the flow-through system is arranged either inside or outside a container.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0064] The invention is explained in more detail in the following figures.

[0065] FIG. 1 shows a first embodiment of the device in which oxygenated modified amniotic fluid flows through membranes of the flow-through system (gill system),

[0066] FIG. 2 shows another embodiment n which the fetal blood flows through the flow-through system,

[0067] FIG. 3 shows an embodiment of an artificial womb system,

[0068] FIG. 4 shows another embodiment with two flow-through systems,

[0069] FIG. 5 shows an embodiment with a second amniotic fluid system for supplying the fetus with medicaments,

[0070] FIG. 6 shows the structure of an embodiment of the artificial gill system.

WAYS OF CARRYING OUT THE INVENTION

[0071] FIG. 1 shows the device according to the invention and its individual components. The device comprises a container 10 in which a flow-through system 21 is arranged. Via a pump system, modified amniotic fluid (preferably preheated) is introduced via a connection 12 into the flow-through system 21 through a line 14 via a connection piece 18. Oxygenation of the amniotic fluid may be provided via an oxygen line 16. Nevertheless, it is also provided that the artificial space inside the container can be gassed with medical breathing air via its own gas port. The flow-through system 21 itself comprises a number of more than 20 fluid-permeable elements which are permeable to O.sub.2 and CO.sub.2. Preferably, these are lamellar membranes or a number of tubes with integrated micropores for gas exchange. The catheter connection for the umbilical vein catheter 32 and the two umbilical artery catheters 30.1; 30.2 to the umbilical cord 36 of the fetus is made via connecting elements 26, 28 and at the other end via a port system 34. Via a pressure valve 24, the internal pressure of the gill system can be regulated at a frequency of 0-1000 Hz, preferably 10-80 Hz. Fetal blood is directed in accordance with the countercurrent principle via corresponding flow-through lumens 20 around the membrane of the flow-through system 21. This enables an efficient exchange of oxygen dissolved in the amniotic fluid and the fetal blood. By increasing the flow rate, the efficiency of the O.sub.2/CO.sub.2 exchange can be significantly enhanced. The pressure in the flow-through system is preferably maintained between 5 mbar and 5 bar. Inlets for oxygen or a gas mixture are provided. Furthermore, admission of a gas mixture of O.sub.2, CO.sub.2 and N.sub.2 can also be provided. Alternatively or additionally, the Carbogen gas mixture or O.sub.2 can also be admitted directly into the amniotic fluid.

[0072] The pressure valve 24 is used in addition to the amniotic fluid pump (not shown) to control the amount of amniotic fluid, the velocity and the pressure in the flow-through system 21. The control of the pressure valve 24 can be mechanical or digital. A sample for a measuring device can be taken via a measuring supply line (not shown), for example for determining the oxygen saturation in the blood before and after oxygenation.

[0073] FIG. 2 shows another embodiment in which the fetal blood directly flows through the fluid-permeable elements 22 of the flow-through system 21. In this embodiment, the modified amniotic fluid flows around the fluid-permeable elements 22, i.e. the capillaries or membranes.

[0074] FIG. 3 shows an embodiment of the device according to the invention as a vital system. The container 10 comprises a flow-through system 21. A connection 12 is used to supply modified amniotic fluid, which is preferably provided in a preheated storage container 42. For this purpose, the storage container 42 is preferably equipped with a thermostat and a pump. Preferably, a preheating temperature of 37° to 39° C is aimed for in the storage container 42 for the modified amniotic fluid in the gill system. Oxygenation of the amniotic fluid may be provided directly from an oxygen tank 40. Alternatively or additionally, direct gassing with oxygen of the artificial space of the container 10 and/or the flow-through system 21 may be performed. Via corresponding sensors 48, it is possible to monitor vital functions and to forward them via a network. Furthermore, it is possible to record and play sounds and noises via an audio device 43. Data are transmitted via a network 41 to corresponding servers 44 and ultimately analyzed via an analysis device 46. In the same way, the entire system can also be regulated.

[0075] In FIG. 4, an analogous system is shown, which is constructed similarly to the embodiment of FIG. 3. Herein, the gassing is carried out with a gas mixture of O.sub.2, CO.sub.2, N.sub.2, provided in tanks 40.1, 40.2, 40.3. The addition of CO.sub.2 can be useful, for example, for the decompression of vessels. According to the invention, two flow-through systems 21 are provided. However, as with the other embodiments, data exchange can also be performed via a smartphone 50, i.e. important vital signs, audio files or other information from and to the artificial womb system can be exchanged directly by the mother/father or other person monitoring the womb system.

[0076] In FIG. 5, a more advanced system is shown in which an additional container 60 with modified amniotic fluid is provided next to the storage container 42 filled with modified amniotic fluid. The fetus is supplied with the substances via the flow-through system 21, i.e. via artificial amniotic fluid enriched with the substances, which is provided by the storage container 42. This facilitates supplying the fetus with medicaments, including heparin, vitamins, proteins, growth factors and/or hormones. Via administering modified amniotic fluid to the fetus, which is supplied by the artificial gill system, for example neonatal care can be provided or prophylactic or therapeutic treatment can be carried out. For example, blood parameters of the fetus can be adjusted individually.

[0077] Preferably, water-soluble substances are used, which dissolve in the modified amniotic fluid. The system has the advantage that overhydration of the premature infant is avoided, because it prevents an increase in volume due to the absorption of too much fluid. Furthermore, decompensation occurring with other systems or treatment methods is prevented, because at least some of the active and nutritional substances can be absorbed via the gill system, thus avoiding unnecessary volume loading of the fetus. In this embodiment, it is therefore provided that the modified amniotic fluid of the storage container 42 for the gill system is separate from the amniotic fluid of the uterine system in the container 60. For example, the administration of heparin or other antithrombotic medicaments can be administered locally via the artificial gill system (flow-through system 21) to have an antithrombotic effect. Systemic exposure of the fetus to heparin is avoided.

[0078] In this embodiment, it is further provided that the flow-through system 21 is arranged in an external housing 52 as an external gill system. The umbilical cord 36 of the fetus is connected to the external artificial gill system via a port system 51. For optimal oxygenation, the temperature of the modified amniotic fluid in the storage container 42 can be cooled down to as low as 4° C. to increase the oxygenation of the amniotic fluid several times. Temperatures in the range of 4° C. to room temperature (about 21° C.) are preferred. However, temperatures as high as 39° C. are also possible. The admission of modified amniotic fluid from the storage container 42 to the flow-through system 21 is controlled by a valve 53.

[0079] In another embodiment (not shown), the storage container 42 for modified amniotic fluid equipped with a thermostat is omitted. In this embodiment, the function of the storage container 42 equipped with a thermostat and a pump is integrated into a housing 52. Accordingly, the housing 52 may include a pump and a thermostat.

[0080] FIG. 6 shows a ready-to-use device constructed according to the specifications of the invention.