Vascular conduit and delivery system for open surgical placement

Abstract

A vascular conduit device and a delivery system for intraoperative repair damaged portion of an artery or vein and methods of use are provided. The device has a cylindrical body and may include a shaped member, such as a microbarb, configured to anchor into the tunica intima and the tunica media of the vessel wall, and not to the tunic adventitia and vasa vasorum. Various configurations and orientations of the microbarbs are provided, including microbarbs that are preferably aligned at an acute angle in the range of about 5 to 30 degrees and having a substantially parallel surface. The delivery system preferably has a translatable dilator tip that when retracted is configured to engage with the device during delivery. When the dilator tip is extended, the device can be implanted into the vessel wall. The vascular conduit device can be assembled during the emergency open surgical procedure.

1 . A device for intraoperative repair of a damaged portion of a body vessel, the body vessel having a vessel wall including a tunica intima, a tunica media, and a tunica adventitia, comprising:
 a tubular conduit having a wall defining a lumen about a longitudinal axis between a first axial end and a second axial end; and   a first connector and a second connector disposed at the respective first and second axial ends of the tubular conduit, each of the first and second connectors having a first portion engageable with the wall of the tubular conduit and a second portion having at least one shaped member extending radially therefrom, the at least one shaped member dimensioned and arranged along the second portion to penetrate and anchor into said tunica intima and tunica media of said vessel wall upon insertion of said device into said body vessel.   
   
   
       2 . The device of  claim 1 , wherein the first portion of at least one of the first and second connectors has at least one shaped member dimensioned and arranged along the first portion, the at least one shaped member of said first portion penetrable and anchorable into wall of the tubular conduit. 
   
   
       3 . The device of  claim 1 , wherein the at least one shaped member of the second portion of the first and second connectors comprises a plurality of microbarbs spaced along a circumference of the second portion, the microbarbs being dimensioned and arranged to penetrate and anchor into the tunica intima and tunica media of said vessel wall upon insertion of said device into said body vessel, and not into said tunica adventitia. 
   
   
       4 . The device of  claim 3 , wherein at least one of the microbarbs is aligned at an acute angle relative to the longitudinal axis. 
   
   
       5 . The device of  claim 4 , wherein said microbarb is aligned at an acute angle of about 5 degrees to about 30 degrees relative to the longitudinal axis. 
   
   
       6 . The device of  claim 4 , wherein said microbarb comprises a body having a first and second edge converging to form a tip region, a portion outside the tip region having a dullness configured to not cut the body vessel when said microbarb is engaged and the tip region having a surface generally parallel with the longitudinal axis, wherein said surface is arcuate. 
   
   
       7 . The device of  claim 4 , wherein the first portion of the first and second connectors comprises a plurality of microbarbs spaced along a circumference of the first portion, the microbarbs of the first portion penetrable and anchorable into the wall of the tubular conduit. 
   
   
       8 . The device of  claim 3 , wherein the microbarbs are spaced along the circumference of the tubular body to form at least one ring of microbarbs. 
   
   
       9 . The device of  claim 1 , wherein the tubular conduit comprises a flexible biocompatible material selected from the group consisting of expanded polytetrafluoroethylene, silicone, polyurethane, and polyamide. 
   
   
       10 . A delivery system for deploying a tubular medical device in a body vessel, the tubular medical device having a proximal end and a distal end and a lumen therebetween, the delivery system comprising:
 an elongated tubular member having a lumen about a longitudinal axis and a proximal end and a distal end, the elongated tubular member sized to extend through the lumen of said tubular medical device;   a handle attached to the proximal end of the elongated tubular member, the handle having a lumen about the longitudinal axis and a proximal end and a distal end, the lumen of the handle in communication with the lumen of the elongated tubular member;   a dilator tip disposed at the distal end of the elongated tubular member, the dilator tip sized and configured to receive the distal end of the elongated tubular member and to engage the distal end of said tubular medical device; and   a controller to manipulate the dilator tip disposed at the handle, the controller including a control member extending through the lumens of the respective elongated tubular member and the handle, the control member having a distal end attached to the dilator tip and a proximal end attached to the controller, wherein the controller is configured to retract the dilator tip in a proximal direction to a retracted position and to extend the dilator tip in a distal direction to an extended position.   
   
   
       11 . The delivery system of  claim 10 , wherein the dilator tip has a conical shape tapering from a blunt distal end to a proximal end, the dilator tip including a cavity with a proximal region being sized and configured to receive the distal end of the elongated tubular member and to engage the distal end of said tubular medical device. 
   
   
       12 . The delivery system of  claim 11 , wherein the proximal region of the dilator tip is configured to radially expand between a first cross-sectional area and a second cross-sectional area greater than the first cross-sectional area, wherein the first cross-sectional area is less than a cross-sectional area of the lumen of said tubular medical device, and the second cross-sectional area is greater than the cross-sectional area of the lumen of said tubular medical device. 
   
   
       13 . The delivery system of  claim 11 , wherein the proximal region of the dilator tip is configured to partially enclose the distal end of said tubular medical device when in the retracted position. 
   
   
       14 . The delivery system of  claim 11 , wherein the proximal region of the dilator tip is configured to apply a radially compressive force to the distal end of said tubular medical device when the dilator tip is in the retracted position, such that said tubular medical device is retained in a fixed position. 
   
   
       15 . The delivery system of  claim 11 , wherein said tubular medical device comprises a plurality of microbarbs spaced along a circumference at the distal end of said tubular medical device, and wherein the proximal region of the dilator tip is configured to partially enclose the microbarbs of said tubular medical device to protect the body vessel during deployment. 
   
   
       16 . The delivery system of  claim 11 , wherein the controller is movable between a first position to retract the dilator tip to the retracted position and a second position to extend the dilator tip to the extended position, and the controller further comprises a spring mechanism disposed within the lumen of the handle, the spring mechanism biased to an expanded configuration to retain the controller at the first position and being moveable to a compressed configuration to move the controller to the second position. 
   
   
       17 . The delivery system of  claim 16 , wherein the controller includes a lockable switch that is movable between a first position to allow the controller to move between the first and second positions and a second position to fix the controller at the second position. 
   
   
       18 . A method of delivering a medical device system for intraoperative repair of a damaged portion of a body vessel having a vessel wall defining a lumen, the steps comprising:
 providing a medical device system including a first connector and a second connector and a tubular conduit, the tubular conduit having a wall defining a lumen about a longitudinal axis between a first axial end and a second axial end, and the first and second connectors disposable with the respective first and second axial ends of the tubular conduit, each of the first and second connectors having a first portion engageable with the wall of the tubular conduit and a second portion having at least one shaped member dimensioned and arranged along the second portion to penetrate and to anchor into the vessel wall of said body vessel;   transecting said body vessel to form a first portion and a second portion of said body vessel;   deploying the first and second connectors of the medical device system into the respective first and second portions of said body vessel with a delivery system; and   engaging the tubular conduit to the first connector and the second connector to form the medical device system to repair the damaged portion of the body vessel intraoperatively.   
   
   
       19 . The method of  18 , wherein the delivery system comprises a dilator tip sized and configured to engage the at least one shaped member of the second portion of the respective first and second connectors, wherein the dilator tip is movable between a retracted position to engage with the at least one shaped member and an extended position to disengage from the at least one shaped member. 
   
   
       20 . The method of  18 , wherein the tubular conduit is engaged with the first connector and the first connector including the tubular conduit is deployed in to the first portion of said body vessel with the delivery system.