Devices, systems, and methods for controlled hydrodissection of vessel walls

Abstract

A device and method for intravascular dissection of a body lumen, and particularly a blood vessel wall, is disclosed herein. One aspect of the present technology, for example, is directed toward a tubular elongated member having a lumen therethrough, wherein the elongated member includes a distal region configured to be positioned within a blood vessel wall. The distal region can include an angled distal face having a distal-most edge configured to puncture the vessel wall and a proximal-most edge. The member can include an exit port fluidly coupled to the lumen, and positioned along the distal face between the distal-most edge and the proximal-most edge. A central longitudinal axis of the exit port can be offset from a central longitudinal axis of the elongated member such that the exit port is closer to the distal-most edge than the proximal-most edge.

1 - 30 . (canceled) 
     
     
         31 . A system for dissecting a blood vessel wall, the device comprising:
 an elongated tubular member having a sidewall that defines a lumen extending through the elongated tubular member, wherein the elongated tubular member includes—a proximal region configured to be positioned external to a human patient; and
 a distal region configured to be intravascularly delivered to and positioned within the blood vessel wall, the distal region including a slanted distal face having a proximal-most edge, a distal-most edge opposite the proximal-most edge and shaped to puncture the blood vessel wall, and an exit port positioned along the slanted distal face between the proximal-most edge and the distal-most edge, wherein a central longitudinal axis of the exit port is closer to the distal-most edge than a central longitudinal axis of the elongated tubular, and 
 wherein the elongated tubular member is configured to eject pressurized fluid through the exit port to separate the blood vessel into two portions via hydrodissection to create a dissection pocket between the two portions of the vessel wall; and 
   a tubular sheath slideably movable over the distal region of the elongated tubular member, wherein the sheath has a blunt distal face configured to cover the distal-most edge of the slanted distal face and engage tissue along a periphery of the dissection pocket during hydrodissection.   
     
     
         32 . The system of  claim 31  wherein the exit port has a first diameter and a longitudinal portion of the lumen proximal to the exit port has a second diameter greater than the first diameter. 
     
     
         33 . The system of  claim 31 , further comprising a catheter including a dissection assembly lumen configured to slidably receive the elongated tubular member and the tubular sheath and a visualization lumen configured to slidably receive a visualization catheter, the dissection assembly lumen being spaced radially apart from the visualization lumen. 
     
     
         34 . The system of  claim 31 , further comprising a guide member extending from the sidewall of the elongated tubular member and defining a portion of the distal face, wherein the guide member decreases a diameter of the lumen to define an opening at the exit port. 
     
     
         35 . The system of  claim 31 , further comprising a pressure sensor configured to detect fluid pressure in the lumen in real time to indicate dissection status of a hydrodissection procedure. 
     
     
         36 . A system for separating two or more portions of a blood vessel wall, the system comprising:
 a dissection assembly comprising—
 a tubular elongated member having a distal region configured to be intravascularly delivered to a blood vessel, wherein the distal region includes a distal face configured to puncture the blood vessel wall and an exit port positioned along the distal face, wherein the distal face includes—
 a first portion extending distally from a distal-most edge of the exit port along the distal face to a distal-most edge of the distal face, the first portion having a first length, and 
 a second portion extending proximally from a proximal-most edge of the exit port to a proximal-most edge of the distal face, the second portion having a second length, 
 wherein the second length greater than the first length; 
 
 a sheath slidable over the distal most-edge of the elongated tubular member, the sheath having a blunt distal face configured to cover the distal-most edge and engage tissue along a periphery of a dissection pocket during vessel dissection; 
   a visualization catheter; and   a catheter including a dissection assembly lumen configured to slidably receive the dissection assembly and a visualization lumen configured to slidably receive the visualization catheter, the dissection assembly lumen being spaced radially apart from the visualization lumen.   
     
     
         37 . The system of claim  1  wherein the tubular elongated member is configured to be coupled to a pressurized fluid source to eject fluid through the exit port to separate the blood vessel wall into two portions while the proximal-most edge of the second portion of the distal face remains outside of the opening. 
     
     
         38 . The system of  claim 36  wherein:
 the tubular elongated member comprises a lumen extending therethrough and terminating at the exit port; and 
 the exit port has a first diameter and a longitudinal segment of the lumen proximal to the exit port has a second diameter greater than the first diameter. 
 
     
     
         39 . The system of  claim 36  wherein the catheter further comprises:
 an open trough having tissue engaging portions; 
 an expandable element positioned opposite the tissue engaging portions and having an expanded state; and 
 an expansion lumen extending through the catheter and in fluid communication with the expandable element, 
 wherein, when the expandable element is in the expanded state, the tissue engaging portions engage the blood vessel wall such that the blood vessel wall is at a known height relative to the dissection assembly lumen.