Subintimal re-entry device

Abstract

A subintimal recanalization catheter, including an elongate shaft including a first tubular member and a penetration member slidably disposed in a lumen of the first tubular member. The penetration member includes a distal tip positioned proximal of a distal nose of the first tubular member. The distal nose of the first tubular member includes a ramp and a guide wire lumen extending through the distal nose of the first tubular member. Longitudinal movement of the penetration member relative to the first tubular member causes the penetration member to contact the ramp to direct the distal tip of the penetration member away from the first tubular member.

What is claimed is: 
     
         1 . A subintimal recanalization catheter, comprising:
 an elongate shaft including a first tubular member and a penetration member slidably disposed in a lumen of the first tubular member, wherein the penetration member is configured to puncture an intima layer of a blood vessel;   the first tubular member including a side-facing opening disposed proximal of a distal nose and a guide wire lumen extending through the distal nose of the first tubular member;   the penetration member including a distal tip positioned within the opening proximal of the distal nose of the first tubular member; and   an actuatable sleeve surrounding the opening and the distal tip of penetration member, the actuatable sleeve being actuatable between a first position in which the sleeve covers the distal tip of the penetration member and a second position in which the distal tip of the penetration member is exposed from the sleeve;   wherein the distal tip of the penetration member is permitted to deflect away from the first tubular member when the sleeve is in the second position.   
     
     
         2 . The subintimal recanalization catheter of  claim 1 , wherein the guide wire lumen extending through the distal nose extends from the side-facing opening to a distal tip of the distal nose. 
     
     
         3 . The subintimal recanalization catheter of  claim 1 , wherein the penetration member includes a first guide wire exit port at the distal tip of the penetration member and a second guide wire exit port located proximal of the distal tip of the penetration member. 
     
     
         4 . The subintimal recanalization catheter of  claim 3 , further comprising a guide wire extending through a lumen of the penetration member and through the guide wire lumen of the distal nose of the first tubular member. 
     
     
         5 . The subintimal recanalization catheter of  claim 4 , wherein the guide wire is permitted to selectively extend from one of the first guide wire exit port and the second guide wire exit port. 
     
     
         6 . The subintimal recanalization catheter of  claim 5 , wherein the distal tip of the penetration member is prevented from deflecting away from the first tubular member when the actuatable sleeve is in the first position and the guide wire extends through the guide wire lumen of the distal nose. 
     
     
         7 . The subintimal recanalization catheter of  claim 6 , wherein the guide wire extends through the first guide wire exit port and the guide wire lumen of the distal nose. 
     
     
         8 . The subintimal recanalization catheter of  claim 7 , wherein the distal tip of the penetration member is permitted to deflect away from the first tubular member when the actuatable sleeve is in the second position and the guide wire has been withdrawn from the guide wire lumen of the distal nose. 
     
     
         9 . The subintimal recanalization catheter of  claim 5 , wherein the distal tip of the penetration member is permitted to deflect away from the first tubular member when the actuatable sleeve is in the second position and the guide wire extends through the guide wire lumen of the distal nose. 
     
     
         10 . The subintimal recanalization catheter of  claim 9 , wherein the guide wire extends through the second guide wire exit port and the guide wire lumen of the distal nose. 
     
     
         11 . The subintimal recanalization catheter of  claim 3 , wherein the first guide wire exit port of the penetration member is co-axial with the guide wire lumen through the distal nose of the first tubular member. 
     
     
         12 . The subintimal recanalization catheter of  claim 1 , wherein when the distal tip of the penetration member is unconstrained by the sleeve, the distal tip of the penetration member is permitted to be deflected into a curved configuration. 
     
     
         13 . The subintimal recanalization catheter of  claim 12 , wherein the distal tip of the penetration member is biased to assume the curved configuration when unconstrained. 
     
     
         14 . The subintimal recanalization catheter of  claim 13 , wherein the distal tip of the penetration member is pre-configured to assume the curved configuration when unconstrained. 
     
     
         15 . A method of recanalizing a blood vessel having an occlusion therein, the method comprising:
 i) advancing a guide wire through a lumen of a blood vessel to a location proximal of a proximal end of an occlusion;   ii) directing a distal end of the guide wire out of the lumen of the blood vessel and between a first tissue layer and a second tissue layer of a wall of the vessel to a location distal of a distal end of the occlusion;   iii) advancing a recanalization catheter along the guide wire with the guide wire passing through a guide wire lumen of the recanalization catheter, the recanalization catheter including a first tubular member and a penetration member slidably disposed in a lumen of the first tubular member, the penetration member including a distal tip positioned proximal of a distal nose of the first tubular member, the distal nose of the first tubular member including a guide wire lumen extending through the distal nose of the first tubular member;   iv) positioning the distal nose of the first tubular member of the recanalization catheter between the first tissue layer and the second tissue layer at a location distal of the distal end of the occlusion;   v) retracting a sleeve covering the distal tip of the penetration member to expose the distal tip of the penetration member, wherein longitudinal movement of the sleeve relative to the first tubular member permits the distal tip of the penetration member to deflect away from the first tubular member; and   vi) re-entering the lumen of the blood vessel distal of the distal end of the occlusion with the distal tip of the penetration member.   
     
     
         16 . The method of  claim 15 , wherein the guide wire extends through a lumen of the penetration member while the recanalization catheter is advanced along the guide wire. 
     
     
         17 . The method of  claim 16 , further comprising:
 prior to step v), retracting the guide wire proximally of the distal tip of the penetration member.   
     
     
         18 . The method of  claim 16 , wherein the lumen of the penetration member is co-axial with the guide wire lumen through the distal nose of the first tubular member. 
     
     
         19 . The method of  claim 16 , wherein the penetration member includes a first guide wire exit port at the distal tip of the penetration member and a second guide wire exit port located proximal of the distal tip of the penetration member; and
 wherein the method further includes the steps of:   vii) withdrawing a distal end of the guide wire into the lumen of the penetration member through the second guide wire exit port; and   viii) then advancing the distal end of the guide wire out of the penetration member through the first guide wire exit port.