Method and apparatus for deployment of an endoluminal device

Abstract

An introducer deploys an endoluminal device in a distal location from a proximal location. The introducer comprises a retrograde portion, an anterograde portion axially moveable relative to the retrograde portion, a shaft having a distal tip and an anterograde sheath attached to the distal tip, and anchoring means in at least one of the retrograde portion or the anterograde portion for anchoring the device during deployment from its proximal end to its distal end. An inner sheath may be mounted concentrically over the shaft with the endoluminal device mounted concentrically over the inner sheath. The anchoring device may comprise an inflatable balloon mounted radially inside the retrograde portion, a tether, or an extended portion of the endoluminal device confined by a notch in the interface of two sheaths in the retrograde portion of the introducer, or may comprise a holder in the anterograde portion.

1 . A method for deployment of an endoluminal device in a distal location in a body lumen from a proximal location, the method comprising the steps of:
 inserting an introducer into the body lumen, the introducer comprising a retrograde portion; an anterograde portion; a shaft having a distal tip; an inner sheath mounted concentrically over the shaft with the endoluminal device mounted concentrically over the inner sheath; and an anterograde sheath proximally attached to the shaft distal tip, mounted over the endoluminal device in the anterograde portion of the introducer, and axially moveable relative to the inner sheath;   aligning the introducer in a deployment location;   extending the shaft to distally advance the anterograde sheath to deploy at least a proximal portion of the endoluminal device; and   removing the introducer from the body lumen.   
     
     
         2 . The method of  claim 1 , wherein the introducer further comprises anchoring means in the anterograde portion for anchoring the endoluminal device during deployment of the device from a proximal end to a distal end of the device, the method comprising aligning the proximal end of the device with the deployment location and confining the endoluminal device between the anchoring means and the advancing anterograde sheath. 
     
     
         3 . The method of  claim 1 , wherein the introducer further comprises anchoring means in the retrograde portion for anchoring the endoluminal device during deployment of the device from a proximal end to a distal end of the device, the method comprising aligning the proximal end of the device with the deployment location, anchoring the proximal end, and releasing proximal end prior to or concurrently with removing the introducer from the body lumen. 
     
     
         4 . The method of  claim 3 , wherein the anchoring means comprises an inflatable balloon, and the method further comprises inflating the balloon prior to extending the shaft to distally advance the anterograde sheath and deflating the balloon after extending the shaft to distally advance the anterograde sheath. 
     
     
         5 . The method of  claim 4 , further comprising a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath and extending axially over the proximal end of the endoluminal device and the balloon, the method further comprising retracting the retrograde sheath prior to inflating the balloon, and inflating the balloon to anchor the proximal end of the endoluminal device against the body lumen. 
     
     
         6 . The method of  claim 4 , further comprising a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath and extending axially over the proximal end of the endoluminal device and the balloon, the method further comprising inflating the balloon to anchor the proximal end of the endoluminal device against the retrograde sheath and then retracting the retrograde sheath after deflating the balloon. 
     
     
         7 . The method of  claim 3 , wherein the anchoring means comprises a tether releasably attached to the proximal end of the endoluminal device, the method comprising separating the tether from the endoluminal device prior to removing the introducer from the body lumen. 
     
     
         8 . The method of  claim 7 , wherein the introducer further comprises a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath; a medial sheath mounted concentrically between the inner sheath and the retrograde sheath in the retrograde portion of the introducer and terminating proximally of the proximal end of the endoluminal device; and the anchoring means comprises a tether releasably attached to the proximal end of the endoluminal device and non-releasably attached to a distal end of the retrograde sheath, the method comprising retracting the retrograde sheath to separate the tether from the endoluminal device prior to removing the introducer from the body lumen. 
     
     
         9 . The method of  claim 8 , wherein a portion of the retrograde sheath extends over a portion of the endoluminal device, the method comprising retracting the portion of the retrograde sheath extending over the endoluminal device prior to extending the shaft to distally advance the anterograde sheath. 
     
     
         10 . The method of  claim 7 , wherein the introducer further comprises a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath and the anchoring means comprises a tether releasably attached to the proximal end of the endoluminal device and non-releasably attached the inner sheath, the method comprising separating the tether from the endoluminal device while removing the introducer from the body lumen. 
     
     
         11 . The method of  claim 3 , wherein the introducer further comprises a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath; a medial sheath mounted concentrically between the inner sheath and the retrograde sheath in the retrograde portion of the introducer and terminating proximally of the proximal end of the endoluminal device; and the anchoring means comprises a proximally extended portion of the endoluminal device and a notch in one or both of the medial sheath and the retrograde sheath, the method further comprising releasably confining the extended portion between the retrograde sheath and the medial sheath until after extending the shaft to distally advance the anterograde sheath, and then retracting the retrograde sheath relative to the medial sheath a distance sufficient to release the extended portion from the notch. 
     
     
         12 . The method of  claim 11 , wherein the retrograde sheath extends over a retrograde portion of the endoluminal device, the method comprising retracting the portion of the retrograde sheath extending over the endoluminal device prior to extending the shaft to distally advance the anterograde sheath. 
     
     
         13 . The method of  claim 3 , wherein the introducer further comprises a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath and the anchoring means comprises a proximally extended portion of the endoluminal device and a notch in one or both of the inner sheath and the retrograde sheath, the method further comprising releasably confining the extended portion between the retrograde sheath and the inner sheath until after extending the shaft to distally advance the anterograde sheath, and then retracting the retrograde sheath relative to the inner sheath sufficient to release the extended portion from the notch. 
     
     
         14 . A method for deployment of an endoluminal device in a distal location in a body lumen from a proximal location, the method comprising the steps of:
 inserting an introducer into the body lumen having a lumen wall, the introducer comprising a retrograde portion, an anterograde portion comprising a distal tip and an anterograde sheath attached proximally to the distal tip, a shaft attached to the distal tip and extending concentrically through a central lumen defined by the anterograde portion and retrograde portion, an endoluminal device mounted concentrically over the shaft in the central lumen and having a distal end contained by the anterograde portion and a proximal end contained by the retrograde portion, an inflatable balloon mounted inside the retrograde portion for anchoring the endoluminal device during deployment of the device, and a proximally retractable retrograde sheath extending distally over the balloon and the proximal end of the endoluminal device;   aligning the proximal end of the endoluminal device in a deployment location;   inflating the balloon to anchor the proximal end of the endoluminal device; and   extending the shaft to distally advance the anterograde sheath to deploy a portion of the endoluminal device.   
     
     
         15 . The method of  claim 14 , further comprising a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath and extending axially over the proximal end of the endoluminal device and the balloon, the method further comprising retracting the retrograde sheath prior to inflating the balloon, and inflating the balloon to anchor the proximal end of the endoluminal device against the body lumen. 
     
     
         16 . The method of  claim 14 , further comprising a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath and extending axially over the proximal end of the endoluminal device and the balloon, the method further comprising inflating the balloon to anchor the proximal end of the endoluminal device against the retrograde sheath and then retracting the retrograde sheath after deflating the balloon. 
     
     
         17 . A method for deployment of an endoluminal device in a distal location in a body lumen from a proximal location, the method comprising the steps of:
 inserting an introducer into the body lumen, the introducer comprising a retrograde portion; an anterograde portion; a shaft having a distal tip; an inner sheath mounted concentrically over the shaft with the endoluminal device mounted concentrically over the inner sheath; and an anterograde sheath proximally attached to the shaft distal tip, mounted over the endoluminal device in the anterograde portion of the introducer, and axially moveable relative to the inner sheath; and a tether releasably attached to the proximal end of the endoluminal device for anchoring the endoluminal device during deployment of the device;   aligning the proximal end of the device with the deployment location;   anchoring the proximal end of the endoluminal device with the tether;   extending the shaft to distally advance the anterograde sheath to deploy at least a proximal portion of the endoluminal device; and   removing the introducer from the body lumen.   
     
     
         18 . The method of  claim 17 , wherein the introducer further comprises a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath; a medial sheath mounted concentrically between the inner sheath and the retrograde sheath in the retrograde portion of the introducer and terminating proximally of the proximal end of the endoluminal device; and the tether releasably attached to the proximal end of the endoluminal device and non-releasably attached to a distal end of the retrograde sheath, the method comprising retracting the retrograde sheath to separate the tether from the endoluminal device prior to removing the introducer from the body lumen. 
     
     
         19 . The method of  claim 18 , wherein a portion of the retrograde sheath extends over a portion of the endoluminal device, the method comprising retracting the portion of the retrograde sheath extending over the endoluminal device prior to extending the shaft to distally advance the anterograde sheath. 
     
     
         20 . The method of  claim 17 , wherein the introducer further comprises a proximally retractable retrograde sheath mounted concentrically over the shaft and inner sheath and the tether releasably attached to the proximal end of the endoluminal device and non-releasably attached the inner sheath, the method comprising separating the tether from the endoluminal device while removing the introducer from the body lumen.