Fetal Intervention Using Magnetically-Guided Navigation

• US 20140276609A1
• Filed: 03/06/2014
• Published: 09/18/2014
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Fetal Care Consultants LLC
• Original Assignee: Fetal Care Consultants LLC
• Inventors: Magee, Kevin P., Nugent, Alan W.
• Granted Patent: US 9,333,043 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 34/73 Manipulators for magnetic surgery
• CPC Class Codes: A61M 2210/145 Embryo, fetus
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers

Abstract

Methods and systems for fetal intervention to address malformations or other conditions are presented. In one instance, a method is provided that includes introducing a guide catheter into the fetus'"'"' venous system and using controlled magnets to position the guide catheter at a desired location. The method also involves positioning the treatment catheter at a treatment location using the guide catheter and delivering a treatment using the treatment catheter at the treatment location. In one particular application, a hypoplastic left heart is treated by using a balloon catheter as the treatment catheter and inflating a balloon on the balloon catheter at the aortic valve. Other methods and systems are disclosed.

Claims

1. A method for addressing a fetal malformation in a fetus in utero through fetal intervention, the method comprising:

using a needle to access the fetus'"'"' circulation system;

providing a guide catheter having a magnetic object coupled proximate a distal end of the guide catheter;

positioning the guide catheter into the circulation system of the fetus through the needle;

providing a plurality of controlled magnets operable to guide the magnetic object on the guide catheter in three dimensions to within at least a centimeter;

using the plurality of controlled magnets to position the guide catheter at a desired location within the fetus;

introducing a treatment catheter over or in the guide catheter;

moving the treatment catheter along the guide catheter to position the treatment catheter at a treatment location;

treating the fetal malformation at the treatment location;

removing the treatment catheter;

removing the guide catheter; and

removing the needle.

2. The method of claim 1, wherein the step of using a needle to access the fetus'"'"' circulation system comprises placing the needle into the umbilical cord proximate the fetus'"'"' liver.

3. The method of claim 1, wherein the step of using a needle to access the fetus'"'"' circulation system comprises placing the needle into the umbilical cord at a free floating location.

4. The method of claim 1, wherein providing a plurality of controlled magnets comprises providing a Stereotaxis Robotic Navigation System from Stereotaxis, Inc. of St. Louis, Mo.

5. The method of claim 1, wherein:

the fetal malformation is a hypoplastic left heart;

the step of using the plurality of controlled magnets to position the guide catheter at a desired location within the fetus comprises positioning the guide catheter into the fetus'"'"' aorta;

the step of introducing a treatment catheter over or in the guide catheter comprises introducing a balloon catheter over the treatment catheter;

the step of moving the treatment catheter along the guide catheter comprises moving the balloon catheter until the balloon catheter is proximate the aortic valve; and

the step of treating the fetal malformation at the treatment location comprises inflating a balloon of the balloon catheter to expand the fetus'"'"' aortic valve.

6. The method of claim 1, wherein:

the fetal malformation is a stenotic pulmonary valve;

the step of using the plurality of controlled magnets to position the guide catheter at a desired location within the fetus comprises positioning the guide catheter into the pulmonary valve of the fetus;

the step of introducing a treatment catheter over or in the guide catheter comprises introducing a balloon catheter over the treatment catheter;

the step of moving the treatment catheter along the guide catheter comprises moving the balloon catheter until the balloon catheter is proximate the pulmonary valve; and

the step of treating the fetal malformation at the treatment location comprises inflating a balloon of the balloon catheter to expand the fetus'"'"' pulmonary valve.

7. The method of claim 1, wherein:

the fetal malformation is a congenital cystic adenomatoid malformation having a tumor;

the step of using the plurality of controlled magnets to position the guide catheter at a desired location within the fetus comprises positioning the guide catheter through the pulmonary artery of the fetus and into the tumor;

the step of introducing a treatment catheter over or in the guide catheter comprises introducing a delivery catheter over guide catheter;

the step of moving the treatment catheter along the guide catheter comprises moving the treatment until the treatment catheter is proximate the tumor; and

the step of treating the fetal malformation at the treatment location comprises delivering a coagulant through the treatment catheter to the tumor.

8. The method of claim 1, wherein:

the fetal malformation is a Bradycardia heart;

the step of using the plurality of controlled magnets to position the guide catheter at a desired location within the fetus comprises positioning the guide catheter into the ventricle of the fetus;

the step of introducing a treatment catheter over or in the guide catheter comprises introducing a catheter with a pacemaker releseably coupled proximate the distal end;

the step of moving the treatment catheter along the guide catheter comprises moving the treatment catheter so that the pacemaker is proximate the treatment location and releasing the pacemaker; and

the step of treating the fetal malformation at the treatment location comprises activating the pacemaker.

9. The method of claim 1, wherein providing a guide catheter comprises providing a solid guide line and the step of introducing a treatment catheter comprises introducing the treatment catheter over the guide catheter.

10. The method of claim 1, wherein providing a guide catheter comprises providing a tubular guide line and the step of introducing a treatment catheter comprises introducing the treatment catheter into the tubular guide line.

11. The method of claim 1, wherein:

the step of using a needle to access the fetus'"'"' circulation system of the fetus comprises placing the needle into the umbilical cord proximate the fetus'"'"' liver;

the step of providing a plurality of controlled magnets comprises providing a Stereotaxis Robotic Navigation System from Stereotaxis, Inc. of St. Louis, Mo.;

the fetal malformation is a hypoplastic left heart;

the step of using the plurality of controlled magnets to position the guide catheter at a desired location within the fetus comprises positioning the guide catheter into the aorta of the fetus;

the step of introducing a treatment catheter over or in the guide catheter comprises introducing a balloon catheter over the treatment catheter;

the step of moving the treatment catheter along the guide catheter comprises moving the balloon catheter until the balloon catheter is proximate the aortic valve; and

the step of treating the fetal malformation at the treatment location comprises inflating a balloon of the balloon catheter to expand the fetus'"'"' aortic valve.

12. A method of treating a heart malformation in a fetus in utero, the method comprising:

using a needle to access an umbilical vein of the fetus proximate the fetus'"'"' liver;

providing a guide catheter having a magnetic object proximate a distal end;

positioning the guide catheter into the umbilical vein of the fetus via the needle;

providing a magnetic guidance system;

using the magnetic guidance system to direct the guide catheter into the heart of the fetus at a desired location;

moving a treatment catheter to a treatment position in the fetus'"'"' heart; and

treating the fetal malformation at the treatment location.

13. The method of claim 12, wherein:

the heart malformation is a hypoplastic left heart syndrome;

the step of using the magnetic guidance system to direct the guide catheter into the heart of the fetus to a desired location comprises directing the guide catheter into the aorta of the fetus;

the step of moving the treatment catheter to a treatment position comprises moving the treatment catheter proximate the aortic valve;

the treatment catheter comprises a balloon catheter; and

the step of treating the fetal malformation comprises activating the balloon catheter to expand the aortic valve.

14. The method of claim 12 comprising;

providing an ultrasonic transducer for observing the fetus;

using the ultrasonic transducer to guide introduction of a needle into umbilical vein within the fetus;

using the plurality of controlled magnets to precisely lead the guide catheter into the right atrium, through the Foramen ovale, into the left atrium, through the left mitral valve into the left ventricle, and turning more than 120 degrees to or through the aortic valve;

introducing the treatment catheter in the form of a balloon catheter onto the guide catheter;

moving the treatment catheter along the guide catheter until a balloon portion of the treatment catheter is proximate the fetus'"'"' aortic valve;

inflating the balloon to dilate the aortic valve to treat the fetus'"'"' heart;

removing the treatment catheter; and

removing the guide catheter.

15. The method of claim 14, wherein the step of using a plurality of controlled magnets further includes leading the guide catheter to the aortic arch.

16. The method of claim 14, further comprising using radiography to verify the location of the balloon before inflating the balloon.

17. The method of claim 14, wherein providing a plurality of controlled magnets comprises providing a Stereotaxis Robotic Navigation System from Stereotaxis, Inc. of St. Louis, Mo.

18. A system for treating a fetal malformation, the system comprising:

a needle for accessing the fetus'"'"' venous system;

a guide catheter sized and configured to be introduced into the fetus'"'"' venous system through the needle, wherein the guide catheter comprises a magnetic object on a distal end of the guide catheter;

a controlled magnet subsystem for moving the magnetic object on the guide catheter within the fetus'"'"' venous system and into the cardiovascular system of the fetus to within three millimeters;

a treatment catheter sized and configured to coordinate with the guide catheter such that the treatment catheter may be guided along the guide catheter to a treatment location proximate the malformation; and

wherein the treatment catheter includes a treatment device for treating the heart malformation.