METHODS OF DEPLOYING AND RETRIEVING AN EMBOLIC DIVERSION DEVICE

• US 20100179583A1
• Filed: 01/11/2010
• Published: 07/15/2010
• Est. Priority Date: 09/11/2006
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Fortier, Richard C., Cerier, Jeffrey C., Carpenter, Jeffrey P., Robinson, Timothy W., Rezac, David A., Carpenter, Judith T.
• Application Number:
  US12/685,539
• Publication Number:
  US 20100179583A1
• 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 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 method of deploying an embolic deflector, comprising the steps of:

providing an elongate, flexible tubular body, having a proximal end, a distal end, and a central lumen;

the central lumen containing a deflector having a first end and a second end;

advancing the distal end of the tubular body through a side branch vessel and into a main vessel; and

advancing the deflector distally relative to the tubular body, such that the first end of the deflector extends from the tubular body within the main vessel in an upstream blood flow direction of the main vessel, and the second end of the deflector extends within the main vessel in a downstream blood flow direction of the main vessel from the tubular body.

2. The method of claim 1, wherein the side branch vessel is the brachiocephalic artery and the main vessel is the aorta.

3. The method of claim 1, wherein the tubular body is a sheath having a diameter of no larger than 6 French.

4. The method of claim 1, wherein at least one of the first and second ends of the deflector comprise radioopaque markers thereon, and advancing the distal end of the tubular body through a side branch vessel is accomplished using fluoroscopy.

5. The method of claim 1, wherein the distal end of the tubular body, and at least one of the first and second ends of the deflector have radioopaque markers thereon, and advancing the distal end of the tubular body through a side branch vessel is accomplished using fluoroscopy.

6. A method of removing an embolic deflection device having an elongate, flexible shaft extending through a side branch vessel and a deflector at the distal end of the shaft positioned within a main vessel, the deflector comprising a first portion extending in a first longitudinal direction within the main vessel and a second portion extending in a second longitudinal direction within the main vessel from a patient, comprising the steps of:

drawing the deflector proximally into the distal end of a tubular body such that the first portion advances towards the second portion; and

proximally retracting the deflection device through the side branch vessel and from the patient.

7. The method of claim 6, wherein the tubular body is a sheath surrounding the elongate flexible shaft.

8. The method of claim 6, wherein prior to step drawing the deflector proximally, the elongate flexible shaft and tubular body are advanced into the lumen of the main vessel.