Method and apparatus for extracorporeal support of premature fetus

Patent metadata

Field	Value
Publication number	US-12083048-B2
Application number	US-202117172239-A
Country	US
Kind code	B2
Filing date	Feb 10, 2021
Priority date	Jun 19, 2015
Publication date	Sep 10, 2024
Grant date	Sep 10, 2024

Abstract

A system configured to support growth and development of a premature fetus is disclosed. Specifically, a method and apparatus configured to provide extracorporeal support for premature fetuses is disclosed.

First claim

The invention claimed is:

1. A method of using an extracorporeal system to support a human premature fetus in an extrauterine environment and maintain the human premature fetus during maturation, the extracorporeal system including a fetal chamber and a turbidity sensor and the method comprising the steps of:
positioning the human premature fetus in the fetal chamber designed to hold the premature fetus in a heated bath of synthetic amniotic liquid;
filling the fetal chamber with a quantity of synthetic amniotic liquid and heating the synthetic amniotic liquid to a temperature corresponding to a temperature of amniotic fluid in utero;
using the turbidity sensor to monitor the synthetic amniotic liquid within the fetal chamber for a presence of stool from the human premature fetus wherein the presence of stool in the synthetic amniotic liquid thereby creates a contaminated synthetic amniotic liquid within the fetal chamber;
sensing the presence of stool from the human premature fetus in the contaminated synthetic amniotic liquid within the fetal chamber by way of the turbidity sensor and in response thereto removing the contaminated synthetic amniotic liquid from the fetal chamber and introducing fresh synthetic amniotic liquid into the fetal chamber to maintain a liquid level within the fetal chamber.

2. The method of claim 1 wherein the turbidity sensor is electronically connected to a central controller comprising a computer and a display and further comprising the step of the central controller receiving one or more signals from the turbidity sensor.

3. The method of claim 2 wherein the extracorporeal system includes a synthetic amniotic liquid inlet to the fetal chamber and a contaminated synthetic amniotic liquid outlet from the fetal chamber and further comprising the step of the central controller, in response to receiving the one or more signals from the turbidity sensor, causing the contaminated synthetic amniotic liquid to exit the fetal chamber through the synthetic amniotic liquid outlet and the fresh synthetic amniotic liquid to be introduced into the fetal chamber.

4. The method of claim 3 wherein the extracorporeal system includes a pump located on a contaminated synthetic amniotic liquid drain line connected to the contaminated synthetic amniotic liquid outlet and the central controller causes the pump to withdraw the contaminated synthetic amniotic liquid from the fetal chamber in response to receiving the one or more signals from the turbidity sensor.

5. The method of claim 1 wherein the fetal chamber has an expandable inner volume and the method includes the step of expanding the inner volume of the fetal chamber without opening the fetal chamber in response to growth of the human premature fetus.

6. The method of claim 4 wherein the extracorporeal system further includes a fresh synthetic amniotic liquid inlet line connected to the synthetic amniotic liquid inlet and a control valve and a fluid flow meter on the inlet line and further comprising the step of using the central controller to regulate flow of fresh synthetic amniotic liquid into the fetal chamber by controlling the control valve in response to input from the fluid flow meter.

7. An extracorporeal system to support a human premature fetus in a synthetic amniotic liquid and maintain the fetus during maturation, the extracorporeal system comprising:
a fetal chamber for positioning and holding the premature fetus, wherein the fetal chamber has a lower perimeter forming a wall structure capable of holding a volume of synthetic amniotic liquid surrounding the premature fetus, wherein the fetal chamber can be enclosed to provide an enclosed environment, and wherein the wall structure is a flexible wall such that an interior volume defined by the fetal chamber is adjustable;
a synthetic amniotic liquid circuit configured to provide fresh synthetic amniotic liquid to the fetal chamber such that the fresh synthetic amniotic liquid surrounds the premature fetus and to remove contaminated amniotic liquid from the fetal chamber, the synthetic amniotic liquid circuit having an inlet line connected to a liquid inlet port of the fetal chamber for transporting fresh synthetic amniotic liquid into the fetal chamber and an outlet line connected to a liquid outlet port of the fetal chamber for removing a quantity of synthetic amniotic liquid from the fetal chamber;
means for heating the synthetic amniotic liquid within the fetal chamber to a temperature corresponding to a temperature of amniotic fluid in utero;
a turbidity sensor associated with the fetal chamber to monitor the synthetic amniotic liquid surrounding the premature fetus within the fetal chamber for a presence of stool from the human premature fetus wherein the presence of stool in the synthetic amniotic liquid thereby creates a contaminated synthetic amniotic liquid within the fetal chamber; and
a central controller comprising a computer and a display, wherein the central controller is configured to receive signals from the turbidity sensor reflecting that there is contaminated synthetic amniotic liquid within the fetal chamber.

8. The extracorporeal system of claim 7 , further comprising a discharge pump positioned on the outlet line to pump contaminated synthetic amniotic liquid from the fetal chamber.

9. The extracorporeal system of claim 8 , wherein the central controller regulates the discharge pump.

10. The extracorporeal system of claim 9 , wherein the system is configured such that a signal from the turbidity sensor to the central controller reflecting that there is contaminated synthetic amniotic liquid within the fetal chamber causes the central controller to regulate the discharge pump to pump contaminated synthetic amniotic liquid from the fetal chamber.

11. The extracorporeal system of claim 10 , wherein the system further includes a pressure sensor to monitor a liquid pressure within the fetal chamber.

12. The extracorporeal system of claim 11 , wherein the system is further configured such that the central controller also controls a flow of fresh synthetic amniotic liquid through the inlet line into the fetal chamber to maintain a set liquid pressure within the fetal chamber.

13. The extracorporeal system of claim 7 , further comprising a heater located on the inlet line configured to heat the fresh synthetic amniotic liquid being transported into the fetal chamber.

14. The extracorporeal system of claim 7 , further comprising a fluid line coupleable to an umbilical cord of a fetus, the fluid line extending from an interior side to an exterior side of the fetal chamber.

15. The extracorporeal system of claim 7 , wherein the fetal chamber includes a first end and a second end opposite the first end in a longitudinal direction, and
wherein the liquid inlet port and the liquid outlet port are spaced from each other in the longitudinal direction.

Assignees

• Childrens Hospital Philadelphia

Inventors

• Flake Alan
• Davey Marcus

Classifications

• A01N1/143

  for organ perfusion · CPC title

• A61G2210/30

  for intensive care · CPC title

• A61G2203/34

  for pressure · CPC title

• A61G11/009

  with hand insertion windows, e.g. in the walls · CPC title

• A61G11/008

  tiltable about a horizontal axis, e.g. oscillating · CPC title