Vascular introducer system incorporating inflatable occlusion balloon

A vascular introducer apparatus having an occlusion balloon, said apparatus comprising:

• an elongate pliable introducer body insertable into a blood vessel, said introducer body having a proximal end, a distal end, an outer surface and a working lumen extending longitudinally therethrough;
• an inflatable occlusion balloon mounted on the outer surface of the introducer body;
• a balloon inflation lumen extending through at least a portion of the introducer body to permit infusion of inflation fluid into said balloon;
• a hemostasis valving apparatus associated with the working lumen of said introducer apparatus, said valving apparatus comprising a self sealing passageway which will become fully closed and prevent fluid from backflowing out of the proximal end of said working lumen when no elongate object is inserted therethrough, and which will permit insertion of an elongate object through said valving apparatus and through the working lumen of the introducer;
• said valving apparatus including a sealing apparatus to seal against a elongate object inserted through said valving apparatus to thereby prevent fluid from backflowing out of the proximal end of said working lumen when an elongate object is inserted therethrough;
• and
• wherein said valving apparatus is incorporated into a valving assembly mounted on the proximal end of said introducer body, said valving assembly comprising:
• i. an end cap mounted over said valving apparatus, said end cap having a proximal opening formed therein, the proximal opening of said end cap being in alignment with the self-sealing passageway of said valving apparatus such that an elongate object may be inserted through said proximal opening of the end cap, through the self-sealing passageway of said valving apparatus, and through the main lumen of said introducer body;
• and
• ii. a gripping apparatus operative to frictionally engage and hold an elongate object inserted through said introducer apparatus, said gripping apparatus comprising a compressible gripping ring mounted in alignment with the proximal opening of said end cap such that, when said end cap is tightened, said gripping ring will be compressed, and first and second rigid washers positioned on opposite sides of said gripping ring such that when said end cap is tightened, said gripping ring will be compressed between said washers.

A vascular introducer apparatus having an occlusion balloon, said apparatus comprising:

• an elongate pliable introducer body insertable into a blood vessel, said introducer body having a proximal end, a distal end, an outer surface and a working lumen extending longitudinally therethrough;
• an inflatable occlusion balloon mounted on the outer surface of the introducer body;
• a balloon inflation lumen extending through at least a portion of the introducer body to permit infusion of inflation fluid into said balloon;
• a hemostasis valving apparatus associated with the working lumen of said introducer apparatus, said valving apparatus comprising a self sealing passageway which will become fully closed and prevent fluid from backflowing out of the proximal end of said working lumen when no elongate object is inserted therethrough, and which will permit insertion of an elongate object through said valving apparatus and through the working lumen of the introducer;
• said valving apparatus including a sealing apparatus to seal against a elongate object inserted through said valving apparatus to thereby prevent fluid from backflowing out of the proximal end of said working lumen when an elongate object is inserted therethrough;
• and
• a dilator member insertable through the working lumen of the introducer apparatus, said dilator member having a tapered distal portion which extends beyond the distal end of the introducer apparatus, said dilator member comprising:
• i. an elongate member having a proximal end, a distal end, and an outer surface, said tapered distal region being immediately adjacent said distal end thereof;
• ii. said dilator member being insertable through said valving apparatus and through the working lumen of the introducer apparatus such that the tapered distal portion of the dilator protrudes beyond the distal end of the introducer apparatus and the valving member forms a seal against the outer surface of the dilator member;
• and
• a guidewire lumen extending longitudinally through said dilator member.