EMBOLIC DEFLECTION DEVICE

• US 20100179585A1
• Filed: 01/11/2010
• Published: 07/15/2010
• Est. Priority Date: 09/11/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Robinson, Timothy W., Rezac, David A., Fortier, Richard C., Cerier, Jeffrey C., Carpenter, Jeffrey P., Carpenter, Judith T.
• Granted Patent: US 9,339,367 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0021 square
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

There is disclosed a porous emboli deflector for preventing cerebral emboli while maintaining cerebral blood flow during an endovascular or open surgical procedure. The device prevents the entrance of emboli of a size able to cause stroke (such as greater than 100 microns) from entering either the right or left common carotid arteries, and/or the right or left vertebral arteries by deflecting emboli downstream of these vessels. The device can be placed prior to any manipulation of the heart or aorta allowing maximal protection of the brain during the index procedure. The deflector has a low profile within the aorta which allows sheaths, catheters, or wires used in the index procedure to pass. Also disclosed are methods for insertion and removal of the deflector.

Claims

1. A temporary emboli diversion device, comprising:

an elongate, flexible shaft, having a proximal end and a distal end;

a deflector on the distal end;

the deflector comprising a length extending between a first end and a second end and a width extending between a first side and a second side;

wherein the deflector is convertible between a folded configuration in which both the first end and the second end point in the distal direction, and a deployed configuration in which the first and second ends point in lateral directions.

2. The device of claim 1, wherein the first end and the second end comprise radioopaque markers.

3. A temporary emboli diversion device, comprising:

an elongate flexible tubular body, having a proximal end, a distal end, and at least one lumen extending therethrough;

an elongate, flexible shaft, axially movably extending through the lumen; and

a deflector carried by the shaft, the deflector movable between a first configuration for positioning within the lumen and a second configuration for deployment;

wherein the deflector in the second configuration comprises a length measured transverse to the shaft which exceeds a width measured perpendicular to the length.

4. A temporary emboli diversion device, comprising:

an elongate flexible tubular body, having a proximal end, a distal end, and at least one lumen extending therethrough;

an elongate, flexible shaft, axially movably extending through the lumen; and

a deflector carried by the shaft, the deflector movable between a first configuration for positioning within the lumen and a second configuration for deployment;

the deflector comprising a flexible frame extending around the periphery of the deflector, a membrane attached to the periphery of the deflector, and a suture loop encircling the flexible frame in at least one location on the periphery of the deflector.

5. A temporary emboli diversion device, comprising:

an elongate flexible tubular body, having a proximal end, a distal end, and at least one lumen extending therethrough;

an elongate, flexible shaft, axially movably extending through the lumen; and

a deflector carried by the shaft, the deflector comprising first and second transversely biased lobes, each lobe having a medial end carried by the shaft and a lateral end.

6. A temporary emboli diversion device, comprising:

an elongate, flexible shaft, having a proximal end and a distal end;

a deflector carried by the shaft, the deflector having only a single plane of symmetry;

wherein the shaft lies within the plane of symmetry.

7. A temporary emboli diversion device, comprising:

an elongate, flexible shaft, having a proximal end, a distal end and a longitudinal axis;

a first porous lobe attached to the distal end of the shaft, the first porous lobe deflectable between an axial orientation and a lateral orientation; and

a second porous lobe attached to the distal end of the shaft, the second porous lobe deflectable between an axial orientation and a lateral orientation.

8. The temporary emboli diversion device of claim 7, wherein the first porous lobe and the second porous lobe comprise pores having an average diameter of no greater than about 100 micrometers.

9. A temporary emboli diversion device, comprising:

an elongate flexible tubular body, having a proximal end, a distal end, and at least one lumen extending therethrough;

an elongate, flexible shaft, axially movably extending through the lumen;

a deflector carried by the shaft, the deflector extending transversely with respect to the shaft between a first end and a second end; and

a first radiopaque marker carried by the first end and a second radiopaque marker carried by the second end.

10. A temporary emboli diversion device, comprising:

an elongate flexible tubular body, having a proximal end, a distal end, and at least one lumen extending therethrough;

an elongate, flexible shaft, axially movably extending through the lumen;

a deflector carried by the shaft, the deflector extending transversely with respect to the shaft and having a length which exceeds its width; and

a torque control carried by the shaft.