Deployment system for an endoluminal device

Abstract

The present invention is directed to a deployment system for an endoluminal device. The deployment system includes a confining sheath placed around a compacted endoluminal device. A deployment line is provided in the system that is an integral extension of the sheath. As the deployment line is actuated, the sheath retracts from around the compacted endoluminal device. As the sheath retracts from around the endoluminal device, material from the sheath may be converted into deployment line. Once the sheath is retracted from around the compacted endoluminal device, the endoluminal device expands in configuration and repairs vascular or cardiac structures of an implant recipient. Any remaining sheath material is removed from the implantation site along with the deployment line.

1 . A deployment system for a self-expanding endoluminal device comprising 
 a removable sheath adapted to cover the endoluminal device, the sheath comprising a thin continuous film adapted to surround at least a portion of the endoluminal device and constrain the device in an introductory profile;    wherein the deployment system includes a deployment line integral with the sheath to effectuate device deployment; and    wherein upon deployment, the sheath separates from the endoluminal device through actuation of the deployment line, the sheath becoming removed from the device along with the deployment line.    
   
   
       2 . The deployment system of  claim 1  wherein the sheath splits to transform from the sheath to an elongated filament.  
   
   
       3 . The deployment system of  claim 2  wherein means is provided to aid in splitting from a sheath to the filament.  
   
   
       4 . The deployment system of  claim 2  wherein the means to aid in splitting comprises a splitter.  
   
   
       5 . The deployment system of  claim 2  wherein the means to aid in splitting comprises an engineered defect incorporated into the sheath—deployment line.  
   
   
       6 . The deployment system of  claim 1  wherein the sheath comprises a wall with a thickness of less than 0.05 mm.  
   
   
       7 . The deployment system of  claim 1  wherein the sheath comprises a continuous film that surrounds the endoluminal device in a double layer.  
   
   
       8 . The deployment system of  claim 7  wherein one layer of the double layer is placed over the other layer and one layer moves past the other layer upon deployment.  
   
   
       9 . The deployment system of  claim 1  that includes a single catheter shaft.  
   
   
       10 . The deployment system of  claim 9  wherein the catheter shaft extends distally beyond the endoluminal device in its introductory profile.  
   
   
       11 . The deployment system of  claim 9  further comprising a compressible construct placed between at least a portion of the self-expanding endoluminal device and the catheter.  
   
   
       12 . The deployment system of  claim 11  wherein the compressible construct is also resilient.  
   
   
       13 . The deployment system of  claim 1  wherein the length of sheath retracted from the self-expanding endoluminal device is substantially equal to the length of deployment line displaced during deployment of the self-expanding endoluminal device.  
   
   
       14 . The deployment system of  claim 9  wherein the length of sheath retracted from the self-expanding endoluminal device is essentially half the length of deployment line displaced during deployment of the self-expanding endoluminal device.  
   
   
       15 . The deployment system of  claim 1  wherein the sheath is not attached to a catheter shaft.  
   
   
       16 . A deployment system for a self-expanding endoluminal device comprising: 
 a self-expanding endoluminal device at least partially enclosed by a removable sheath; and    a deployment line integral with the removable sheath, wherein the removable sheath is convertible to the deployment line as the sheath is removed from the endoluminal device.    
   
   
       17 . The deployment system for a self-expanding endoluminal device of  claim 16  wherein the removable sheath is split to convert the sheath to the deployment line.  
   
   
       18 . The deployment system of  claim 16  wherein the sheath comprises a continuous film that surrounds the endoluminal device in a double layer.  
   
   
       19 . The deployment system of  claim 18  wherein the sheath is convertible to deployment line over at least a portion of the sheath length.  
   
   
       20 . The deployment system for a self-expanding endoluminal device of  claim 16  further comprising a catheter placed within the self-expanding endoluminal device.  
   
   
       21 . The deployment system of  claim 20  further comprising a compressible construct placed between at least a portion of the self-expanding endoluminal device and the catheter.  
   
   
       22 . The deployment system of  claim 21  wherein the compressible construct is also resilient.  
   
   
       23 . The deployment system for a self-expanding endoluminal device of  claim 20  wherein the catheter has a single lumen.  
   
   
       24 . The deployment system for a self-expanding endoluminal device of  claim 20  further comprising means on the catheter for initiating conversion of the removable sheath to the deployment line.  
   
   
       25 . The deployment system for a self-expanding endoluminal device of  claim 16  wherein the removable sheath is split by the means to initiate conversion of the removable sheath to the deployment line.  
   
   
       26 . The deployment system for a self-expanding endoluminal device of  claim 16  wherein the removable sheath is made of a polymeric material.  
   
   
       27 . The deployment system for a self-expanding endoluminal device of  claim 26  wherein the polymeric material includes a fluoropolymer.  
   
   
       28 . The deployment system for a self-expanding endoluminal device of  claim 26  wherein the fluoropolymer is polytetrafluoroethylene.  
   
   
       29 . The deployment system for a self-expanding endoluminal device of  claim 28  wherein the polytetrafluoroethylene is porous expanded polytetrafluoroethylene.  
   
   
       30 . The deployment system for a self-expanding endoluminal device of  claim 29  wherein the porous expanded polytetrafluoroethylene is in the form of a tube.  
   
   
       31 . The deployment system for a self-expanding endoluminal device of  claim 30  wherein the tube has a wall with a thickness of less than 0.05 mm.  
   
   
       32 . The deployment system for a self-expanding endoluminal device of  claim 16  wherein a first portion of the removable sheath substantially surrounds at least a portion of the self-expanding endoluminal device and a second portion of the removable sheath substantially covers the first portion.  
   
   
       33 . The deployment system for a self-expanding endoluminal device of  claim 32  wherein the deployment line is integral with the second portion of the removable sheath.  
   
   
       34 . The deployment system of  claim 16  wherein the sheath is not attached to a catheter shaft.  
   
   
       35 . A deployment system for a self-expanding endoluminal device comprising 
 a sheath adapted to cover the endoluminal device, the sheath comprising a thin continuous film adapted to surround at least a portion of the endoluminal device and constrain the device in an introductory profile;    wherein the deployment system includes a deployment line integral with the sheath to effectuate device deployment;    wherein upon deployment, the sheath separates from the endoluminal device through actuation of the deployment line, the sheath becoming removed from the device along with the deployment line; and    a compressible construct placed between the endoluminal device and a delivery catheter underlying the endoluminal device.    
   
   
       36 . The deployment system of  claim 35  wherein the sheath splits over at least a portion of its length to transform from the sheath to an elongated filament.  
   
   
       37 . The deployment system of  claim 36  wherein means is provided to aid in splitting from a sheath to the filament.  
   
   
       38 . The deployment system of  claim 36  wherein the means to aid in splitting comprises a splitter.  
   
   
       39 . The deployment system of  claim 36  wherein the means to aid in splitting comprises an engineered defect incorporated into the sheath—deployment line.  
   
   
       40 . The deployment system of  claim 35  wherein the sheath comprises a wall with a thickness of less than 0.05 mm.  
   
   
       41 . The deployment system of  claim 35  wherein the sheath comprises a continuous film that surrounds the endoluminal device in a double layer.  
   
   
       42 . The deployment system of  claim 41  wherein one layer of the double layer is placed over the other layer and one layer move past the other layer upon deployment.  
   
   
       43 . The deployment system of  claim 35  that includes a single catheter shaft.  
   
   
       44 . The deployment system of  claim 43  wherein the catheter shaft extends beyond the endoluminal device in its introductory profile.  
   
   
       45 . The deployment system of  claim 43  further comprising a compressible construct placed between at least a portion of the self-expanding endoluminal device and the catheter.  
   
   
       46 . The deployment system of  claim 45  wherein the compressible construct is also resilient.  
   
   
       47 . The deployment system of  claim 35  wherein the length of sheath retracted from the self-expanding endoluminal device is substantially equal to the length of deployment line displaced during deployment of the self-expanding endoluminal device.  
   
   
       48 . The deployment system of  claim 42  wherein the length of sheath retracted from the self-expanding endoluminal device is essentially half the length of deployment line displaced during deployment of the self-expanding endoluminal device.  
   
   
       49 . The deployment system of  claim 35  wherein the sheath is not attached to a catheter shaft.