# US 10,441,490 B2 · Systems, methods, and devices for artificial placentas and amniotic bed incubators > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,490 B2 - Document ID: US10441490B2 - Status: Granted - Kind: B2 - Application number: 16/242,732 - Filed: 2019-01-08 - Published: 2019-07-11 - Granted: 2019-10-15 - Earliest claimed: 2018-01-09 - Assignees: Amnion Life, LLC - Applicants: Amnion Life, LLC - Inventors: Amir Fassihi; Milos Ljubisa Radovanovic - Web page: https://patentgrep.com/patent/US10441490B2 ## CPC - A61G 11/00: Baby-incubators; Couveuses - A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells - A61K 35/51: Umbilical cord; Umbilical cord blood; Umbilical stem cells - A61M 1/02: Blood transfusion apparatus (blood infusion by syringes A61M5/14) - A61M 1/1698: {Blood oxygenators with or without heat-exchangers (intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00)} - A61M 1/3667: {with assisted venous return} - A01N 1/122: Preservation or perfusion media - A61K 2035/124: {the cells being hematopoietic, bone marrow derived or blood cells} - A61M 1/1629: {with integral heat exchanger} - A61M 1/3623: {Means for actively controlling temperature of blood} - A61M 5/44: having means for cooling or heating the devices or media - A61M 2202/0462: Placental blood, umbilical cord blood - A61M 2205/3334: Measuring or controlling the flow rate - A61M 2205/3368: Temperature - A61M 2205/502: User interfaces, e.g. screens or keyboards - A61M 2210/1458: Placenta - A61M 2210/1466: Umbilical cord - C12N 2502/025: extra-embryonic cells, e.g. amniotic epithelium, placental cells, Wharton's jelly - A61G: TRANSPORT, PERSONAL CONVEYANCES OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS (appliances for aiding patients or disabled persons to walk A61H3/00); OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES (embalming corpses A01N1/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract Described herein are systems, devices, and methods for an extracorporeal, artificial, placenta. In some embodiments, an artificial placenta and amniotic bed system may comprise a control unit, a gas delivery unit, a gas exchange unit or membrane oxygenator, a fluids delivery unit, an amniotic fluid bed, and a human machine interface. In some embodiments, the artificial placenta and amniotic bed systems, devices, and methods described herein may improve survival rates and minimize long-term disabilities in preterm, gestational-age, newborns. In some embodiments, the extracorporeal systems, devices, and methods comprise an artificial network through which oxygen and nutrient-rich blood may flow into a fetus (residing in an amniotic fluid bed), while carbon dioxide and wastes may be removed, thus re-establishing a form of intrauterine placental circulation. ## Claims ### Claim 1 An extracorporeal artificial placenta and amniotic bed system for the administration of oxygenated blood through an umbilical cord of an infant, the extracorporeal artificial placenta and amniotic bed system comprising: a simulated amniotic fluid bed comprising a thermo-regulated fluid environment configured to accommodate a body of the infant therein while maintaining a head of the infant above the thermo-regulated fluid environment; a fluid injection system connected to an amniotic fluid source, the fluid injection system configured to fill lungs of the infant with simulated amniotic fluid while the head of the infant is maintained above the thermo-regulated fluid environment; and an extra-uterine membrane oxygenation system configured to oxygenate blood of the infant, the extra-uterine membrane oxygenation system comprising: one or more arterial lines adapted to connect to the umbilical cord of the infant and configured to receive low-oxygen blood from the infant; a gas exchange unit comprising: an inflow capillary tree comprising a first branching structure, wherein the inflow capillary tree is configured to deliver the low-oxygen blood to a hollow fiber unit comprising one or more semipermeable hollow fibers capable of oxygenating the low-oxygen blood passing through the hollow fiber unit; and an outflow capillary tree comprising a second branching structure, wherein the second branching structure mirrors the first branching structure, and wherein the outflow capillary tree is configured to deliver oxygenated blood from the hollow fiber unit; and one or more venous lines adapted to connect to the umbilical cord of the infant and configured to receive the oxygenated blood from the outflow capillary tree and deliver the oxygenated blood to the infant; wherein the one or more hollow fibers are positioned in a geometric array, wherein each of the one or more hollow fibers is located substantially equidistantly from each adjacent hollow fiber of the hollow fiber unit, and wherein each of the one or more hollow fibers is oriented substantially parallel each other hollow fiber. ### Claim 2 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, wherein the extra-uterine membrane oxygenation system further comprises a catheter adapted to connect the one or more arterial lines and the one or more venous lines to the umbilical cord of the infant. ### Claim 3 (depends on 2) The extracorporeal artificial placenta and amniotic bed system of claim 2, wherein the extra-uterine membrane oxygenation system further comprises an anchor for maintaining the catheter above the thermo-regulated fluid environment. ### Claim 4 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, wherein the first branching structure of the inflow capillary tree and the second branching structure of the outflow capillary tree comprise one or more branching angles or branch diameters that naturally occur in a human body, such that the inflow capillary tree and outflow capillary tree mimic a branching of a natural capillary tree. ### Claim 5 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, wherein the simulated amniotic fluid bed further comprises: an incubating tank comprising simulated amniotic fluid; one or more heating elements; one or more temperature sensors; and one or more thermostats comprising a temperature regulation mechanism. ### Claim 6 (depends on 5) The extracorporeal artificial placenta and amniotic bed system of claim 5, wherein the simulated amniotic fluid comprises one or more of the following: electrolytes, minerals, proteins, peptides, lipids, lactate, pyruvate, enzymes, hormones, or amniotic stem cells. ### Claim 7 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, further comprising a gas delivery unit configured to supply a gas mixture to the gas exchange unit at a predetermined pressure and/or temperature, the gas delivery unit comprising: a gas supply; one or more inlet gas connectors configured to deliver one or more gases from the gas supply to an interior of the gas delivery unit; one or more gas control valves configured to control the flow of the one or more gases; a blender configured to blend the one or more gases into the gas mixture at a predetermined mixing ratio; a gas filter comprising a porous filter membrane configured to prevent impurities from entering the gas mixture; and one or more outlet gas connectors configured to deliver the gas mixture from the interior of the gas delivery unit to the gas exchange unit. ### Claim 8 (depends on 7) The extracorporeal artificial placenta and amniotic bed system of claim 7, wherein the gas mixture comprises oxygen and ambient air. ### Claim 9 (depends on 7) The extracorporeal artificial placenta and amniotic bed system of claim 7, wherein the gas supply comprises a central gas delivery system of a hospital. ### Claim 10 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, further comprising a graphical user interface configured to allow a user to monitor and control the simulated amniotic fluid bed extra-uterine membrane oxygenation system. ### Claim 11 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, further comprising a fluids delivery unit configured to deliver one or more fluids to the blood of the infant, the fluids delivery unit comprising: one or more fluid tanks, each fluid tank storing a fluid of the one or more fluids; one or more fluid pumps configured to meter the fluids at a predetermined flow rate into the one or more arterial lines and/or the one or more venous lines. ### Claim 12 (depends on 11) The extracorporeal artificial placenta and amniotic bed system of claim 11, wherein at least one of the one or more fluid tanks comprises a disposable fluid cartridge. ### Claim 13 (depends on 11) The extracorporeal artificial placenta and amniotic bed system of claim 11, wherein the one or more fluids comprise simulated amniotic fluid, nutrients, or Heparin. ### Claim 14 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, wherein the one or more venous lines comprise a bubble trap configured to remove bubbles from the one or more venous lines. ### Claim 15 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, wherein the one or more venous lines comprise a Luer port configured to allow direct pharmaceuticals administration to the oxygenated blood. ### Claim 16 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, further comprising a control unit configured to monitor and control the simulated amniotic fluid bed and/or the extra-uterine membrane oxygenation system, the control unit comprising: a plurality of system sensors configured to transmit system state data; a plurality of system control valves; one or more computer readable storage devices configured to store a plurality of computer executable instructions; and one or more hardware computer processors in communication with the one or more computer readable storage devices and configured to execute the plurality of computer executable instructions in order to cause the control unit to: continuously monitor the artificial placenta and amniotic bed system by receiving and analyzing the system state data from the plurality of system sensors; control one or more physical or chemical properties of blood, gas, and/or fluid within the extracorporeal artificial placenta and amniotic bed system by sending a generated command to the one or more of the plurality of system control valves. ### Claim 17 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, wherein the gas exchange unit further comprises a jacket, wherein the jacket encases the hollow fiber unit and seals an interior of the gas exchange unit. ### Claim 18 (depends on 1) The extracorporeal artificial placenta and amniotic bed system of claim 1, wherein the fluid injection system comprises one or more tubes, and wherein the one or more tubes are adapted to attach to one or both nostrils and/or a mouth of the infant. ### Claim 19 A clinical method for maintaining fetal blood circulation, providing a normal partial pressure of oxygen in lungs of an infant patient, and avoiding potentially harmful mechanical ventilation to the lungs, the clinical method comprising: placing a body of the infant patient in a simulated amniotic fluid bed comprising a thermo-regulated fluid environment configured to accommodate the infant therein while maintaining a head of the infant patient above the thermo-regulated fluid environment; connecting a fluid injection system to the infant patient, the fluid injection system connected to an amniotic fluid source, the fluid injection system configured to fill lungs of the infant patient with simulated amniotic fluid while the head of the infant patient is maintained above the thermo-regulated fluid environment; connecting, to the infant patient, an extra-uterine membrane oxygenation system configured to oxygenate the blood of the infant patient, the extra-uterine membrane oxygenation system comprising: one or more arterial lines connected to the umbilical cord of the infant patient and configured to receive low-oxygen blood from the infant patient; a gas exchange unit comprising: an inflow capillary tree comprising a first branching structure, wherein the inflow capillary tree is configured to deliver the low-oxygen blood to a hollow fiber unit comprising one or more semipermeable hollow fibers capable of oxygenating the low-oxygen blood passing through the hollow fiber unit; and an outflow capillary tree comprising a second branching structure, wherein the second branching structure mirrors the first branching structure, and wherein the outflow capillary tree is configured to deliver oxygenated blood from the hollow fiber unit, wherein the one or more semipermeable hollow fibers are positioned in a geometric array, wherein each of the one or more semipermeable hollow fibers is located substantially equidistantly from each adjacent semipermeable hollow fiber of the hollow fiber unit, and wherein each of the one or more semipermeable hollow fibers is oriented substantially parallel each other semipermeable hollow fiber; and one or more venous lines connected to the umbilical cord of the infant patient and configured-to receive the oxygenated blood from the outflow capillary tree and deliver the oxygenated blood to the infant patient; receive low-oxygen blood from the infant patient through the one or more arterial lines; oxygenate the low-oxygen blood within the extra-uterine membrane oxygenation system; and deliver the oxygenated blood to the infant patient. ### Claim 20 (depends on 19) The clinical method of claim 19, wherein the first branching structure of the inflow capillary tree and the second branching structure of the outflow capillary tree comprise one or more branching angles or branch diameters that naturally occur in a human body, such that the inflow capillary tree and outflow capillary tree mimic a branching of a natural capillary tree.