Low-profile ventriculoamniotic shunt for fetal aqueductal stenosis

Patent metadata

Field	Value
Publication number	US-10744308-B2
Application number	US-201615765723-A
Country	US
Kind code	B2
Filing date	Oct 13, 2016
Priority date	Oct 14, 2015
Publication date	Aug 18, 2020
Grant date	Aug 18, 2020

Abstract

The invention relates to an in-utero ventriculoamniotic shunting device that includes a shunt tube (26) composed of polymer composite and having metallic wire embedded therein, one or more anchors (30) composed of superelastic wire, e.g., thermal shape-set nitinol structures, that are mechanically attached to an exterior surface of the shunt tube (26), and a one-way passive valve (32) composed of a thin polymer membrane. The anchors (30) are effective to prevent migration and dislodgement of the shunting device following its deployment, and the valve (32) is effective to prevent the backflow of amniotic fluid (23).

First claim

We claim:

1. An in-utero ventriculoamniotic shunting device, comprising:
a shunt tube ( 26 ), comprising:
an exterior surface;
a first end;
an opposite second end;
a length;
an inner diameter;
an outer diameter;
a composite that forms the inner diameter and the outer diameter, the composite comprising:
one or more polymer layers; and
metallic wire embedded in the one or more polymer layers;

one or more anchors ( 28 ) mechanically attached to the exterior surface of the shunt tube ( 26 ), the one or more anchors ( 28 ) comprising:
nitinol wire configured in a shape that extends outwardly from the exterior surface of the shunt tube ( 26 ) to prevent migration of the shunting device; and
a mechanism ( 30 ) to connect the nitinol wire to the exterior surface of the shunt tube ( 26 ); and

a one-way passive valve ( 32 ), comprising:
a membrane cover mechanically connected to a portion of a perimeter of the opposite second end of the shunt tube ( 26 ) in a hinge-like configuration.

2. The device of claim 1 , wherein the length of the shunt tube ( 26 ) is from about 2 to about 10 cm.

3. The device of claim 1 , wherein the inner diameter of the shunt tube ( 26 ) is from about 0.5 to about 1.5 mm.

4. The device of claim 1 , wherein the outer diameter of the shunt tube ( 26 ) is from about 1.0 to about 3.0 mm.

5. The device of claim 1 , wherein the nitinol wire is configured in the shape of a coil ( 5 ) having a plurality of spirals formed on the exterior surface and wrapped around the outer diameter of the shunt tube ( 26 ).

6. The device of claim 1 , wherein the nitinol wire is configured in the shape of two curves ( 10 ) extending outwardly from the exterior surface of the shunt tube ( 26 ).

7. The device of claim 1 , wherein the one or more anchors ( 30 ) is mechanically attached to the outside surface of the shunt tube at a position approximately mid-point on the length of the tube.

8. The device of claim 1 , wherein the one or more anchors ( 30 ) has a length of about 1 to about 4 cm.

9. The device of claim 1 , wherein the valve ( 32 ) comprises a thin polymeric membrane.

10. The device of claim 9 , wherein the valve ( 32 ) comprises poly(ester urethane) urea.

11. The device of claim 10 , wherein the poly(ester urethane) urea is fabricated by electrospinning.

12. A method of ventriculoamniotic shunting for fetal isolated aqueductal stenosis, comprising:
prenatally detecting and diagnosing aqueductal stenosis in a fetus;
forming a shunting device, comprising:
obtaining a shunt tube ( 26 ), comprising:
an exterior surface;
a first end having an opening;
an opposite second end having an opening;
a length;
an inner diameter;
an outer diameter;
a composite that forms the inner diameter and the outer diameter, the composite comprising:
one or more polymer layers; and
metallic wire embedded in the one or more polymer layers;

mechanically attaching one or more anchors ( 28 ) to the exterior surface of the shunt tube ( 26 ), comprising:
fabricating nitinol wire;
thermally configuring the nitinol wire in a shape that extends outwardly from the exterior surface of the shunt tube ( 26 ) for preventing migration of the shunting device; and
employing a mechanism ( 30 ) for connecting the nitinol wire to the exterior surface of the shunt tube ( 26 ); and

mechanically attaching a membrane cover ( 32 ) to a portion of a perimeter of the opposite second end of the shunt tube ( 26 ) in a hinge-like configuration;

introducing the shunting device in-utero through a skull ( 22 ) and into a brain ( 24 ) of the fetus, such that the first end of the shunt tube ( 26 ) is positioned in the skull ( 22 ) and the opposite second end of the shunt tube ( 26 ) is positioned in an amniotic sac ( 23 ) outside of the skull ( 22 );
allowing cerebrospinal fluid in the brain ( 24 ) to flow into the first end and through the shunt tube ( 26 );
pushing outward the membrane cover ( 32 ) by the flow of cerebrospinal fluid through the shunt tube ( 26 ); and
discharging the cerebrospinal fluid through the opposite second end of the tube ( 26 ) into the amniotic sac ( 23 ).

Assignees

• Univ Of Pittsburgh-Of The Commonwealth System Of Higher Education
• Univ Of Pittsburgh—Of The Commonwealth System Of Higher Education

Inventors

• Chen Yanfei
• Chun Young Jae
• Emery Stephen
• Gu Xinzhu
• Wagner William
• Greene Stephanie

Classifications

• A61M27/00

  Drainage appliance for wounds or the like {, i.e. wound drains, implanted drains} ({negative pressure wound therapy devices A61M1/90;} implements for holding wound open A61B17/02 {; middle ear drainage A61F11/202}) · CPC title

• A61L31/128

  containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127 · CPC title

• A61B5/4362

  Assessing foetal parameters · CPC title

• A61M39/24

  Check- or non-return valves · CPC title

• A61M27/006 Primary

  Cerebrospinal drainage; Accessories therefor, e.g. valves · CPC title