Occlusion bypassing apparatus with a re-entry needle and a distal stabilization balloon

An apparatus for bypassing an occlusion in a blood vessel comprising:

• an outer shaft component having a distal port at a distal end thereof and a side port proximal to the distal end thereof, the outer shaft component including a needle lumen there-through that includes a curved distal portion that bends from a longitudinal axis of the apparatus and terminates at the side port of the outer shaft component, an inflation lumen there-through configured to receive inflation fluid, and a guidewire lumen that extends along at least a portion of the outer shaft component and terminates at the distal port of the outer shaft component, the guidewire lumen of the outer shaft component being configured to slidingly receive a guidewire there-through;
• a needle housing disposed within the needle lumen of the outer shaft component, the needle housing including a curved distal portion that defines the curved distal portion of the needle lumen and a transition proximal portion that has a variable flexibility along its length that decreases in a distal direction;
• a needle component configured to be slidably disposed within the needle lumen of the outer shaft component and removable therefrom;
• an inflatable balloon disposed at the distal end of the outer shaft component and in fluid communication with the inflation lumen of the outer shaft component, the balloon including a body portion that is disposed distal to the distal end of the outer shaft component, the body portion of the balloon having a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space;
• and
• a reinforced tubular component disposed adjacent to the distal end of the outer shaft component, the reinforced tubular component distally extending beyond the distal end of the outer shaft component through the balloon, wherein the reinforced tubular component defines a lumen in fluid communication with the guidewire lumen of the outer shaft component.