FETAL SHUNT

• US 20130006162A1
• Filed: 11/18/2010
• Published: 01/03/2013
• Est. Priority Date: 11/18/2009
• Status: Active Grant

• Current Assignee: Ruben A. Quintero
• Original Assignee: Ruben A. Quintero
• Inventors: Quintero, Ruben A.
• Granted Patent: US 8,734,379 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 2027/004 with at least a part of the circuit outside the body
• CPC Class Codes: A61M 2202/0496 Urine
• CPC Class Codes: A61M 2210/145 Embryo, fetus
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

A medical device, system, and method are described for treating in utero a fetus with a lower urinary tract obstruction. An implantable medical device may have a flexible catheter and an anchor. The catheter may define a proximal port, a distal port, a longitudinal axis, and a lumen providing fluid communication between the ports. The anchor may be affixed to the catheter at a position between the ports, and may have a resilient proximal member and a resilient distal member spaced a longitudinal distance apart, the proximal member and distal member each extending radially outward with respect to the longitudinal axis. An elongate delivery member may be releasably affixed to the medical device, and the medical device may be delivered through a tubular sheath defining a sheath lumen.

Claims

1. An implantable medical device, comprising:

a flexible catheter defining a proximal port, a distal port, a longitudinal axis, and a lumen providing fluid communication between the ports; and

an anchor affixed to the catheter at a position between the ports, the anchor having a resilient proximal member and a resilient distal member spaced a longitudinal distance apart, the proximal member and distal member each extending radially outward with respect to the longitudinal axis.

2. The medical device of claim 1, wherein the catheter further comprising a plurality of proximal ports and a plurality of distal ports.

3. The medical device of claim 1, wherein a proximal portion and a distal portion of the catheter each have a curved pig-tail shape.

4. The medical device of claim 1, wherein the proximal member and distal member each extend radially outward and circumferentially around the longitudinal axis.

5. The medical device of claim 1, wherein the proximal member and distal member both have a disk shape.

6. The medical device of claim 1, wherein the anchor further comprises an inner trunk member extending longitudinally between the proximal member and the distal member.

7. The medical device of claim 6, wherein the trunk member defines a longitudinal passage, and the catheter extends through the passage.

8. The medical device of claim 1, further comprising an elongate delivery member releasably affixed to one of the catheter and the anchor.

9. The medical device of claim 6, wherein the elongate delivery member is releasably affixed to a proximal portion of the anchor.

10. The medical device of claim 1, further comprising a proximal fastener and a distal fastener, each fastening a portion of the catheter and anchor together.

11. A medical shunt system, comprising:

an implantable medical device having;

an elongate flexible catheter defining a plurality of proximal ports, a plurality of distal ports, a longitudinal axis, and a catheter lumen providing fluid communication between the proximal ports and the distal ports, a proximal portion and a distal portion of the catheter each having a curved pig-tail shape;

an anchor affixed to the catheter at a position between the proximal ports and the distal ports, the anchor having an inner trunk member, a resilient proximal member and a resilient distal member, the proximal member and distal member being spaced a longitudinal distance apart and each extending radially outward and circumferentially around the longitudinal axis;

an elongate delivery member releasably affixed to the medical device; and

a tubular sheath defining a sheath lumen, the medical device and delivery member being in the sheath lumen in a delivery configuration, and the delivery member pushing the medical device distal of the tubular sheath in a deployment configuration.

12. A method of medical treatment of a fetus, comprising:

providing a sheath and a medical device, the medical device having a flexible catheter and an anchor affixed to the catheter;

moving a distal end of the sheath into proximity with the fetus;

advancing a distal portion of the catheter and a distal member of the anchor from a first position inside a lumen defined by the tubular sheath to a second position inside the fetal bladder;

allowing the distal member of the anchor to resiliently expand into a disk shape;

maintaining a proximal portion of the catheter and the proximal member of the anchor in a position outside the fetus;

withdrawing the sheath in a proximal direction;

allowing the proximal member of the anchor to resiliently expand into a disk shape;

allowing fluids in the fetal bladder to enter the distal port, pass through the catheter lumen, and exit the proximal port.

13. The method of claim 12, further comprising providing a delivery member releasably coupled to the medical device, wherein advancing a distal portion of the catheter and a distal member of the anchor is performed by pushing on a proximal portion of the delivery member.

14. The method of claim 13, after advancing a distal portion of the catheter and a distal member of the anchor, further comprising uncoupling the delivery member from the medical device.

15. The method of claim 12, after advancing a distal portion of the catheter and a distal member of the anchor, the proximal member entering the fetal bladder, further comprising withdrawing the medical device back into the sheath lumen by pulling proximally on the delivery member.

16. The method of claim 12, before withdrawing the sheath, further comprising confirming desired placement of the medical device.

17. The method of claim 16, wherein confirming desired placement of the medical device is performed using ultrasound.

18. The method of claim 16, wherein confirming desired placement of the medical device is performed using an endoscope.

19. The method of claim 12, before uncoupling the delivery member from the medical device, further comprising confirming desired placement of the medical device.

20. The method of claim 12, wherein confirming desired placement of the medical device further comprises evaluating the position of the proximal member, distal member, and a fastener fastening the catheter and anchor together.