Method and apparatus for extracorporeal support of premature fetus

Patent metadata

Field	Value
Publication number	US-10945903-B2
Application number	US-202016848085-A
Country	US
Kind code	B2
Filing date	Apr 14, 2020
Priority date	Jun 19, 2015
Publication date	Mar 16, 2021
Grant date	Mar 16, 2021

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 method comprising the steps of:
positioning the human premature fetus in a fetal chamber including a first portion having a rigid first frame having a first perimeter lip defining a first opening for the first portion, a second portion having a rigid second frame having a second perimeter lip defining a second opening for the second portion, wherein before said positioning step first moving the first and second portions of the fetal chamber relative to each other to separate the first and second perimeter lips to accommodate the positioning of the human premature fetus into the fetal chamber;
connecting the premature human fetus to an oxygenation circuit including connecting a drain line configured to transport blood from the human premature fetus to an oxygenator and connecting an infusion line configured to transport blood from the oxygenator to the human premature fetus;
oxygenating blood from the premature human fetus via the oxygenation circuit by flowing the blood through the drain line into the oxygenator and from the oxygenator into the premature human fetus through the infusion line whereby the oxygenator provides oxygen to and removes carbon dioxide from the blood and wherein the blood flow from the premature human fetus through the drain line, into the oxygenator, and through the infusion line back into the premature human fetus is propelled by the premature human fetus thus forming a pumpless circuit;
closing the fetal chamber after the premature human fetus is positioned within the fetal chamber by moving the first and second perimeter lips together and latching a plurality of latches located proximate to the first and second perimeter lips to create a liquid-tight seal between the first and second perimeter lips in a closed position for the fetal chamber;
injecting synthetic amniotic liquid through an inlet line into the closed fetal chamber to fill the fetal chamber with the synthetic amniotic liquid and immersing the premature human fetus in the synthetic amniotic liquid within the fetal chamber whereby the synthetic amniotic liquid in the fetal chamber is prevented from passing between the first and second perimeter lips;
periodically discharging a used synthetic amniotic liquid from the fetal chamber and injecting fresh synthetic amniotic liquid into the fetal chamber;

wherein the fetal chamber is positioned upon a cart wherein the cart has a hood; and
positioning the hood such that the hood in conjunction with the cart encloses the fetal chamber.

2. 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 premature human fetus.

3. The method of claim 2 wherein the fetal chamber has a length greater than a width.

4. The method of claim 2 wherein the extracorporeal system further includes a central controller comprising a computer having a display.

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

6. The method of claim 4 wherein the extracorporeal system further includes an outlet line from the fetal chamber to carry the used synthetic amniotic fluid from the fetal chamber and a discharge pump on the outlet line and further comprising using the central controller to control the discharge pump to control the flow of the used synthetic amniotic fluid from the fetal chamber.

7. The method of claim 6 further comprising the step of using the discharge pump to withdraw an amount of the used synthetic amniotic fluid from the fetal chamber to maintain a fluid pressure in the fetal chamber within a desired range.

8. The method of claim 6 further comprising the step of activating the discharge pump to remove the used synthetic amniotic fluid from the fetal chamber in response to sensed turbidity in the fetal chamber.

9. The method of claim 2 further comprising the step of priming the drain line and the infusion line with maternal or fetal blood prior to connecting the premature human fetus to the oxygenation circuit.

10. The method of claim 9 further comprising the step of lining the drain line and the infusion line with anti-clotting compounds.

11. The method of claim 2 wherein the extracorporeal system further includes a fluid pressure sensor on the drain line and a fluid pressure sensor on the infusion line and wherein the method further comprises monitoring a fluid pressure drop over the oxygenator.

12. The method of claim 11 wherein the extracorporeal system further includes a fluid flow meter on the infusion line and wherein the method further comprises monitoring the fluid flow rate of blood returning to the premature human fetus.

13. The method of claim 2 further comprising the step of rotating the fetal chamber with the premature human fetus in the fetal chamber.

14. The method of claim 2 further comprising the step of tilting the fetal chamber with the premature human fetus in the fetal chamber.

15. The method of claim 2 wherein the cart further includes a support arm attached to the hood and the method further comprises the step of translating the hood upward away from the fetal chamber to expose the fetal chamber by moving the hood along the support arm.

16. The method of claim 4 wherein the method further includes the step of using the controller to control a flow rate of oxygen and air into the oxygenator.

17. The method of claim 4 wherein the cart includes a mount for supporting the central controller and further comprising the step of transporting the cart with the fetal chamber containing the premature human fetus from an operating room to a neonatal care center.

18. The method of claim 17 wherein the cart includes a portable amniotic tank of the fresh synthetic amniotic fluid in fluid communication with the inlet line and the method further comprises injecting the fresh synthetic amniotic fluid from the portable amniotic tank into the fetal chamber.

19. The method of claim 2 wherein the fetal chamber includes a one-way flow valve impeding liquid flow from the fetal chamber, and the method further comprises the step of inserting a suction device through the one-way flow valve into the fetal chamber.

Assignees

• Childrens Hospital Philadelphia

Inventors

• Flake Alan
• Davey Marcus

Classifications

• A01N1/143

  for organ perfusion · CPC title

• A61G11/00 Primary

  Baby-incubators; Couveuses · CPC title

• A61G11/006 Primary

  by pivoting · CPC title

• A61G11/008

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

• A61G2210/30

  for intensive care · CPC title