Emboli Protection devices and related methods of use

A method for treating a diseased blood vessel, comprising:

• positioning a guide catheter proximate to the diseased blood vessel;
• positioning an evacuation sheath assembly within the diseased blood vessel;
• prior to advancing a device across a diseased area of the blood vessel, stopping normal antegrade blood flow in the blood vessel proximate to the diseased area;
• advancing a guidewire through the guide catheter and the evacuation sheath assembly across the diseased area of the blood vessel while the blood flow is stopped;
• causing retrograde flow of blood within the diseased blood vessel to remove embolic debris dislodged by advancement of the guidewire;
• advancing an interventional catheter into the blood vessel to treat the diseased area of the blood vessel;
• and
• causing retrograde flow of blood within the vessel to remove embolic debris dislodged by advancement of the interventional catheter.

A method of performing a procedure on a blood vessel, comprising;

• positioning a guide catheter proximate to the blood vessel;
• positioning an evacuation sheath assembly within the guide catheter;
• measuring pressure in the blood vessel to obtain a first pressure measurement;
• creating a seal between the evacuation sheath assembly and the blood vessel;
• measuring pressure in the blood vessel to obtain a second pressure measurement;
• and
• comparing the first and second pressure measurements.

A method of isolating fluid communication between a catheter and a blood vessel to facilitate visualization of the blood vessel, comprising:

• advancing a catheter proximate to the blood vessel;
• advancing an evacuation sheath assembly including a sealing surface through the catheter and partially into the blood vessel;
• expanding the sealing surface to create a seal between the blood vessel and the evacuation sheath assembly thereby stopping normal blood flow in the vessel;
• and
• injecting contrast dye into the blood vessel while the normal blood flow is stopped.

An evacuation sheath assembly comprising:

• an elongated tube defining an evacuation lumen having proximal and distal ends;
• a proximal sealing surface at a proximal end of the tube configured to form a seal with a catheter;
• and
• a distal sealing surface configured to form a seal with a blood vessel.

An evacuation sheath assembly comprising:

• an elongated sheath defining an evacuation lumen having open proximal and distal ends, wherein the sheath is expandable from a delivery configuration to an operational configuration;
• a proximal hollow shaft connected to a proximal end of the sheath;
• and
• an actuation wire connected to a distal end of the sheath, the actuation wire being movable within said shaft from a distal position to a proximal position to expand said sheath.

A method of treatment of a blood vessel, comprising:

• advancing a guide catheter proximate to the blood vessel;
• advancing an evacuation sheath assembly through the guide catheter and into the blood vessel while retaining a proximal portion of the evacuation sheath assembly within the guide catheter;
• creating a first seal between the proximal portion of the evacuation sheath assembly and the guide catheter;
• creating a second seal between a distal portion of the evacuation sheath assembly and the blood vessel;
• stopping normal antegrade blood flow within the blood vessel;
• treating a stenosis within the blood vessel;
• causing retrograde flow within the blood vessel to thereby remove embolic material dislodged during the treating and carried by the retrograde flow into the evacuation sheath assembly;
• and
• re-establishing normal antegrade blood flow within the blood vessel.

An evacuation sheath assembly, comprising:

• an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end;
• at least one inflatable sealing surface in fluid communication with the inflation lumen;
• and
• a soft steerable tip on a distal end of the elongated tube.

An evacuation sheath assembly, comprising:

• an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end;
• and
• at least one inflatable sealing surface in fluid communication with the inflation lumen;
• wherein the open distal end of the evacuation lumen is angled.

An evacuation sheath assembly, comprising:

• an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end;
• and
• first and second sealing surfaces on the tube;
• wherein the open proximal end of the evacuation lumen is angled.

An evacuation sheath assembly, comprising:

• an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end;
• and
• at least one inflatable sealing surface in fluid communication with the inflation lumen;
• wherein the evacuation lumen is shorter than the inflation lumen.

An evacuation sheath assembly, comprising:

• an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end;
• and
• at least one inflatable sealing surface in fluid communication with the inflation lumen;
• wherein a proximal portion of the evacuation lumen has a first diameter and a distal portion of the evacuation lumen has a second diameter larger than the first diameter.

A method for treating a diseased blood vessel, comprising:

• positioning a guide catheter within the ostium of a target vessel;
• advancing an evacuation sheath assembly through the guide catheter and beyond a major side branch of the target vessel;
• forming a first seal between the target vessel and a distal portion of the evacuation sheath assembly;
• forming a second seal between the catheter and a proximal portion of the evacuation sheath assembly;
• and
• advancing an interventional device through a lumen of the evacuation sheath assembly to treat the target vessel.