Vascular Re-Entry Device

Abstract

An ultrasonic device having a tri-axial configuration including an ultrasound transmission member, a dilator, and a sheath is disclosed. The ultrasound device may be used in a procedure to treat an occluded blood vessel. The ultrasound transmission member can transmit ultrasonic energy from an ultrasonic transmission member into the subintimal space of a blood vessel. The sheath may articulate to aid in the process of re-entering the central lumen of the blood vessel.

1 - 20 . (canceled) 
     
     
         21 . A method of repositioning a guidewire that has deflected into a subintimal space of a vessel from a central lumen of the vessel, comprising:
 advancing an articulating distal end of a sheath having a sheath lumen over a guidewire and past a guidewire distal end of the guidewire and into the subintimal space of the vessel;   determining the precise position and orientation of the sheath; and   actuating the articulating distal end of the sheath, whereby the actuating causes the articulating distal end of the sheath to deflect in a direction toward the central lumen of the vessel.   
     
     
         22 . The method of  claim 21 , further comprising removing the guidewire from the sheath after the step of actuating the articulating distal end of the sheath. 
     
     
         23 . The method of  claim 22 , further comprising advancing an ultrasound transmission member through the sheath, the ultrasound transmission member having a proximal end configured to be coupled to a sonic connector and a UTM distal end configured to penetrate a vessel wall. 
     
     
         24 . The method of  claim 23 , further comprising:
 providing a dilator having a dilator distal tip and a tapered portion that narrows in a direction toward the dilator distal tip, wherein the ultrasound transmission member, dilator, and sheath are in a tri-axial arrangement with the dilator arranged over the ultrasound mission member and the dilator arranged within the sheath lumen; and   advancing the dilator over the ultrasound transmission member.   
     
     
         25 . The method of  claim 23 , further comprising:
 advancing the UTM distal tip out of the articulating distal end of the sheath; and   transmitting ultrasonic vibrations through the ultrasound transmission member and the UTM distal tip to the vessel wall of the vessel, whereby the step of transmitting ultrasonic vibrations facilitates penetration of the UTM distal end into the vessel wall from the subintimal space and into the central lumen of the vessel.   
     
     
         26 . The method of  claim 25 , further comprising:
 providing a dilator having a dilator distal tip and a tapered portion that narrows in a direction toward the dilator distal tip, wherein the ultrasound transmission member, dilator, and sheath are in a tri-axial arrangement with the dilator arranged over the ultrasound mission member and the dilator arranged within the sheath lumen;   advancing the dilator over the ultrasound transmission member; and   leaving 1-5 mm of the UTM distal tip exposed beyond the dilator distal tip.   
     
     
         27 . The method of  claim 26 , further comprising:
 removing the ultrasound transmission member from the ultrasonic reentry device and a host of the vessel; and   advancing a second guidewire into the sheath.   
     
     
         28 . The method of  claim 27 , further comprising: removing the sheath and the dilator from the ultrasonic reentry device and the host of the vessel. 
     
     
         29 . The method of  claim 28 , further comprising:
 advancing a balloon catheter with a stent over the second guidewire; and   positioning the stent within the vessel past the occlusion.   
     
     
         30 . The method of  claim 21 , wherein the step of actuating the articulating distal end of the sheath is controlled by pulling a puller wire. 
     
     
         31 . The method of  claim 21 , wherein a degree of actuation of the articulating distal end of the sheath is selected by the user. 
     
     
         32 . A method for operating an ultrasonic reentry device, comprising:
 providing a dilator having a dilator distal tip, a dilator lumen, and a tapered portion that narrows in a direction toward the dilator distal tip;   providing a sheath disposed over the dilator;   advancing an articulating distal end of the sheath having a sheath lumen over the dilator and past a guidewire distal end of the guidewire and into the subintimal space of the vessel;   determining the precise position and orientation of the sheath; and   actuating the articulating distal end of the sheath, whereby the actuating causes the articulating distal end of the sheath to deflect in a direction toward the central lumen of the vessel.   
     
     
         33 . The method of  claim 32 , further comprising providing a guidewire disposed within the lumen of the dilator lumen, the guidewire having a guidewire distal end. 
     
     
         34 . The method of  claim 33 , further comprising removing the guidewire from the dilator lumen after the step of actuating the articulating distal end of the sheath. 
     
     
         35 . The method of  claim 34 , further comprising advancing an ultrasound transmission member through the dilator lumen, the ultrasound transmission member having a proximal end configured to be coupled to a sonic connector and a UTM distal end configured to penetrate a vessel wall, wherein the ultrasound transmission member, dilator, and sheath are in a tri-axial arrangement. 
     
     
         36 . The method of  claim 35 , further comprising:
 advancing the UTM distal tip out of the articulating distal end of the sheath; and   transmitting ultrasonic vibrations through the ultrasound transmission member and the UTM distal tip to the vessel wall of the vessel, whereby the step of transmitting ultrasonic vibrations facilitates penetration of the UTM distal end into the vessel wall from the subintimal space and into the central lumen of the vessel.   
     
     
         37 . The method of  claim 36 , further comprising:
 removing the ultrasound transmission member from the ultrasonic reentry device and a host of the vessel; and   advancing a second guidewire into the sheath.   
     
     
         38 . The method of  claim 37 , further comprising: removing the sheath and the dilator from the ultrasonic reentry device and the host of the vessel. 
     
     
         39 . The method of  claim 38 , further comprising:
 advancing a balloon catheter with a stent over the second guidewire; and   positioning the stent within the vessel past the occlusion.