Delivery System And Method Of Use For Deployment Of Self-Expandable Vascular Device

Abstract

A delivery system for a self-expandable prosthesis includes a catheter having a distal end and a proximal end, a balloon positioned on the distal end of the catheter, a self-expandable prosthesis positioned on the balloon, and a sheath at least partially surrounding the self-expandable prosthesis. Upon inflation of the balloon, the sheath opens in a controllable manner, allowing the self-expandable prosthesis to be released. The sheath is either removed from the vessel or allowed to remain in the vessel.

1 . A delivery system for a self-expanding prosthesis, comprising: 
 a catheter having a distal portion and a proximal portion;    a balloon portion positioned near the distal portion of the catheter;    a self-expanding device having a compressed state and an expanded state positioned about the balloon portion; and    a sheath coupling the device in its compressed state about the balloon portion, the sheath having a proximal end and a distal end, the proximal end of the sheath fixed to the catheter at a location on the catheter proximal to the balloon portion,    wherein the self-expanding device comprises a flared portion and a stem portion that, in the expanded state, expand, respectively, to a first diameter and a second diameter, the first diameter being larger than the second diameter, and    wherein the self-expanding device is oriented about the balloon portion such that the flared portion is oriented toward the proximal portion of the catheter and the stem portion is oriented toward the distal portion of the catheter.    
     
     
         2 . The delivery system of  claim 1 , wherein the sheath comprises at least one opening for initiating separation of the sheath upon expansion of the balloon.  
     
     
         3 . The delivery system of  claim 2 , wherein the at least one opening is at a distal end of the sheath.  
     
     
         4 . The delivery system of  claim 2 , wherein the sheath comprises a low-friction material.  
     
     
         5 . The delivery system of  claim 1 , wherein the sheath comprises a biodegradable material.  
     
     
         6 . The delivery system of  claim 1 , further comprising: 
 a handle coupled to the sheath, the handle positioned near the proximal portion of the catheter.    
     
     
         7 . The delivery system of  claim 1 , wherein the sheath comprises an opening for initiating separation of the sheath, the opening being positioned a predetermined distance from a distal end of the sheath.  
     
     
         8 . The delivery system of  claim 1 , wherein: 
 the distal end of the sheath extends to a point on the catheter that is distal to the stem portion of the OPD.    
     
     
         9 . The delivery system of  claim 1 , wherein: 
 the distal end of the sheath extends to cover a part of the stem portion sufficient to prevent the stem portion from expanding,    wherein the sheath does not extend distally past a distal end of the stem portion.    
     
     
         10 . The delivery system of  claim 1 , wherein first diameter is from 20% to 100% larger than the second diameter.  
     
     
         11 . The delivery system of  claim 1 , wherein the sheath comprises at least one of: a low-friction material, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), PFA, ETFE, and a synthetic hydrogel polymer.  
     
     
         12 . A method of inserting a self expanding ostial protection device (OPD) into a side branch vessel from a main branch vessel at an ostium, the method comprising: 
 providing an OPD delivery system comprising: 
 a catheter having a distal portion and a proximal portion;  
 a balloon portion positioned on the distal portion of the catheter;  
 a self expanding OPD having a compressed state and an expanded state positioned about the balloon portion; and  
 a sheath coupling the OPD in its compressed state about the balloon portion, the sheath having a proximal end and a distal end, the distal end fixed to the catheter at a location on the catheter distal to the balloon portion;  
   inserting the catheter into a side branch vessel, from a main branch vessel, to a desired position in the side branch vessel;    expanding the balloon portion such that the sheath is ruptured and the OPD is allowed to expand to its expanded state and a portion of the OPD engages an inner wall of the side branch vessel;    deflating the balloon portion;    inserting the catheter distally further into the side branch vessel a distance sufficient to remove the ruptured sheath from between the expanded OPD and the side branch vessel wall; and    withdrawing the catheter proximally through the expanded OPD whereby the OPD is deployed at the desired position in the side branch vessel.    
     
     
         13 . The method of  claim 12 , further comprising: 
 providing at least one opening on the sheath for initiation of rupturing of the sheath upon expansion of the balloon portion.    
     
     
         14 . The method of  claim 13 , further comprising: 
 providing the at least one opening at the proximal end of the sheath.    
     
     
         15 . The method of  claim 14 , further comprising: 
 providing the at least one opening as a series of perforations substantially parallel with a longitudinal axis of the catheter.    
     
     
         16 . The method of  claim 12 , further comprising: 
 providing the sheath such that a first coefficient of friction between the sheath and the OPD is less than a second coefficient of friction between the OPD and the balloon portion.    
     
     
         17 . The method of  claim 12 , further comprising: 
 providing a sheath comprising at least one of: a low-friction material, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), PFA, ETFE, and a synthetic hydrogel polymer.    
     
     
         18 . A method of inserting a self expanding ostial protection device (OPD) into a side branch vessel from a main branch vessel at an ostium, the method comprising: 
 providing an OPD delivery system comprising: 
 a catheter having a distal portion and a proximal portion;  
 a balloon portion positioned on the distal portion of the catheter;  
 a self expanding OPD having a compressed state and an expanded state positioned about the balloon portion; and  
 a sheath coupling the OPD in its compressed state about the balloon portion, the sheath having a proximal end and a distal end, the proximal end fixed to the catheter at a location on the catheter proximal to the balloon portion,  
 wherein the self-expanding OPD comprises a flared portion and a stem portion that, in the expanded state, expand, respectively, to a first diameter and a second diameter, the first diameter being larger than the second diameter, and  
 wherein the self-expanding OPD is oriented about the balloon portion such that the flared portion is oriented toward the proximal portion of the catheter and the stem portion is oriented toward the distal portion of the catheter;  
   inserting the catheter into a side branch vessel, from a main branch vessel, to a desired position in the side branch vessel;    expanding the balloon portion such that the sheath is ruptured and the OPD is allowed to expand to its expanded state and a portion of the OPD engages an inner wall of the side branch vessel;    deflating the balloon portion; and    withdrawing the catheter proximally from the side branch vessel whereby the OPD is deployed at the desired position in the side branch vessel and the sheath is withdrawn from the side branch vessel.    
     
     
         19 . The method of  claim 18 , further comprising: 
 providing at least one opening on the sheath for initiation of rupturing of the sheath upon expansion of the balloon portion.    
     
     
         20 . The method of  claim 19 , further comprising: 
 providing the at least one opening at the proximal end of the sheath.    
     
     
         21 . The method of  claim 20 , further comprising: 
 providing the at least one opening as a series of perforations substantially parallel with a longitudinal axis of the catheter.    
     
     
         22 . The method of  claim 18 , further comprising: 
 providing a first series of linearly arranged perforations on the sheath running from the proximal end of the sheath toward the distal end,    wherein the first series of linearly arranged perforations are oriented substantially parallel with a longitudinal axis of the catheter.    
     
     
         23 . The method of  claim 22 , further comprising: 
 providing a second series of linearly arranged perforations on the sheath running from the proximal end of the sheath toward the distal end,    wherein the second series of linearly arranged perforations are oriented substantially parallel with a longitudinal axis of the catheter.    
     
     
         24 . The method of  claim 23 , further comprising: 
 providing the second series of linearly arranged perforations at point on a circumference of the sheath substantially opposite a location of the first series of perforations.    
     
     
         25 . The method of  claim 18 , further comprising: 
 providing the sheath such that a first coefficient of friction between the sheath and the OPD is less than a second coefficient of friction between the OPD and the balloon portion.    
     
     
         26 . The method of  claim 18 , further comprising: 
 providing a sheath comprising at least one of: a low-friction material, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), PFA, ETFE, and a synthetic hydrogel polymer.