Subintimal re-entry catheter with shape controlled balloon

A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space, comprising:

• an elongate shaft extending distally from a hub assembly;
• an inflatable balloon mounted on a distal region of the elongate shaft, the inflatable balloon configured to be inflated in the subintimal space to a first inflation state at inflation pressures below a threshold inflation pressure and inflated to a second inflation state at inflation pressures above the threshold inflation pressure;
• and
• means for retaining the inflatable balloon in the first inflatable state until the inflatable balloon is inflated to an inflation pressure above the threshold inflation pressure.

A method of recanalizing a blood vessel having an occlusion therein, the method comprising:

• advancing a distal region of a catheter shaft including an inflatable balloon mounted thereon into a subintimal space between a first tissue layer and a second tissue layer of a wall of a blood vessel;
• inflating the inflatable balloon to a first inflation state in the subintimal space by inflating the inflatable balloon to a first inflation pressure below a threshold inflation pressure to orient a lateral port in the distal region of the catheter shaft toward a lumen of the blood vessel distal of the occlusion;
• advancing a penetration member from the lateral port of the catheter shaft to penetrate through the first tissue layer into the lumen of the blood vessel;
• and
• thereafter, inflating the inflatable balloon to a second inflation state different from the first inflation state by inflating the inflatable balloon to a second inflation pressure above the threshold inflation pressure to expand the subintimal space.