# US 10,864,131 B2 · Extracorporeal life support system and methods of use thereof

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- Number: US 10,864,131 B2
- Document ID: US10864131B2
- Status: Granted
- Kind: B2
- Application number: 16/107,115
- Filed: 2018-08-21
- Published: 2019-01-10
- Granted: 2020-12-15
- Earliest claimed: 2013-03-15
- Applicants: The Children's Hospital of Philadelphia
- Inventors: Alan Flake; Emily Partridge; Marcus Davey
- Web page: https://patentgrep.com/patent/US10864131B2

## CPC

- A61G 11/00: Baby-incubators; Couveuses
- 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 1/3623: {Means for actively controlling temperature of blood}
- A61M 1/168: {Sterilisation or cleaning before or after use}
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/7518: bacterial
- A61M 2240/00: Specially adapted for neonatal use
- 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)
- 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)}

## Abstract

Extracorporeal membrane oxygenation systems and methods of use are disclosed. Several publications and patent documents are cited throughout the specification in order to describe the state of the art to which this invention pertains. Full citations of these references can be found throughout the specification. Each of these citations is incorporated herein by reference as though set forth in full.

## Claims

### Claim 1

A method for supporting a human premature fetus in an extrauterine life support system, the method comprising the steps of:
cannulating the premature fetus to a pumpless oxygenation circuit such that the pumpless oxygenation circuit defines a premature fetus blood path that includes a first portion that provides blood outflow from the premature fetus to an inflow port of an oxygenator, a second portion that passes through the oxygenator from the inflow port to an outflow port of the oxygenator, and a third portion that provides return blood flow from the outflow port to the premature fetus;
positioning the premature fetus inside an incubation chamber;
sealing the incubation chamber with the cannulated premature fetus inside the incubation chamber to form a water-tight internal environment for the premature fetus;
transferring a synthetic amniotic liquid from a supply tank defining a first volume into the incubation chamber defining an internal incubation chamber volume, the first volume being greater than the internal incubation chamber volume;
submerging the premature fetus in the synthetic amniotic liquid inside the incubation chamber;
priming the oxygenator with either fetal or maternal blood;
circulating fetal blood from the premature fetus to the oxygenator and back from the oxygenator to the premature fetus through the pumpless oxygenation circuit wherein the circulating fetal blood is pumped by the premature fetus; and
periodically draining at least a portion of the synthetic amniotic liquid from the incubation chamber and in response to the draining step transferring fresh synthetic amniotic liquid from the supply tank into the incubation chamber.

### Claim 2 (depends on 1)

The method of claim 1 further comprising flowing an oxygen-containing sweep gas into the oxygenator and flowing an oxygenator exhaust gas from the oxygenator.

### Claim 3 (depends on 2)

The method of claim 2 wherein the oxygen-containing sweep gas has an oxygen content and further comprising monitoring the oxygen content of the oxygen-containing sweep gas.

### Claim 4 (depends on 3)

The method of claim 3 wherein the oxygenator exhaust gas has an oxygen content and further comprising monitoring the oxygen content of the oxygenator exhaust gas.

### Claim 5 (depends on 4)

The method of claim 4 wherein the oxygen-containing sweep gas has a flow rate into the oxygenator and further comprising monitoring the flow rate of the oxygen-containing sweep gas into the oxygenator.

### Claim 6 (depends on 5)

The method of claim 5 further comprising calculating an oxygen consumption across the oxygenator.

### Claim 7 (depends on 6)

The method of claim 6 wherein the oxygenator exhaust gas has a carbon dioxide content and further comprising monitoring the carbon dioxide content of the oxygenator exhaust gas.

### Claim 8 (depends on 6)

The method of claim 6 wherein the oxygen-containing sweep gas is a blended gas mixture of gaseous oxygen supplied from an oxygen gas source and gaseous air supplied from an air gas source.

### Claim 9 (depends on 6)

The method of claim 6 further comprising the step of removing fetal waste products from the sealed incubation chamber via a suction device through a water-tight seal on the incubation chamber wherein the step of removing fetal waste products is accomplished without opening the sealed incubation chamber.

### Claim 10 (depends on 6)

The method of claim 6 wherein the incubation chamber is a medical grade plastic bag or sac.

### Claim 11 (depends on 6)

The method of claim 6 wherein the oxygenator is a polymethyl pentene hollow fiber membrane oxygenator.

### Claim 12 (depends on 6)

The method of claim 6 wherein the first portion of the pumpless oxygenation circuit includes a cannula and tubing wherein the tubing is about 12 inches or less and extends between the cannula and the oxygenator.

### Claim 13 (depends on 1)

The method of claim 1 further comprising the step of removing fetal waste products from the sealed incubation chamber via a suction device through a water-tight seal on the incubation chamber wherein the step of removing fetal waste products is accomplished without opening the sealed incubation chamber.

### Claim 14 (depends on 1)

The method of claim 1 wherein the incubation chamber is a medical grade plastic bag or sac.

### Claim 15 (depends on 1)

The method of claim 1 wherein the oxygenator is a polymethyl pentene hollow fiber membrane oxygenator.

### Claim 16 (depends on 1)

The method of claim 1 wherein the first portion of the pumpless oxygenation circuit includes a cannula and tubing wherein the tubing is about 12 inches or less and extends between the cannula and the oxygenator.
