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 portion and a proximal portion, a balloon portion positioned on the distal portion, and a self expanding medical device positioned about the balloon portion. The medical device has a compressed state and an expanded state. A sheath couples the medical device in its compressed state about the balloon portion and has only a single opening in a wall of the sheath. When the balloon is expanded, the sheath is configured to (i) first rupture at the single opening, thereby allowing the medical device to self-expand and engage an inner wall of a vessel, and (ii) controllably continue the rupturing from the single opening to the proximal end of sheath, thereby allowing the medical device to expand to its expanded state and a portion of the medical device to engage an inner wall of the vessel.

What is claimed is: 
     
         1 . A delivery system for a self expanding medical device, 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 medical device positioned about the balloon portion, the medical device having a compressed state and an expanded state; and   a sheath coupling the medical device in its compressed state about the balloon portion, the sheath having a proximal end and a distal end, the sheath having only a single opening in a wall of the sheath between the proximal end and the distal end,   wherein, when the balloon is expanded, the sheath is configured to (i) first rupture at the single opening, thereby allowing the medical device to self-expand and engage an inner wall of a vessel, and (ii) controllably continue the rupturing from the single opening to the proximal end of sheath, thereby allowing the medical device to expand to its expanded state and a portion of the medical device to engage an inner wall of the vessel.   
     
     
         2 . The delivery system of  claim 1 , wherein the single opening is configured to provide an initial direction of separation of the sheath. 
     
     
         3 . The delivery system of  claim 1 , wherein the single opening is at the distal end of the sheath. 
     
     
         4 . The delivery system of  claim 3 , wherein the single opening is a cut extending longitudinally from the distal end of the sheath. 
     
     
         5 . The delivery system of  claim 4 , wherein the cut extends not more than approximately 5% of a length of the sheath. 
     
     
         6 . The delivery system of  claim 1 , wherein the single opening extends longitudinally relative to the sheath. 
     
     
         7 . The delivery system of  claim 1 , wherein the proximal end of the sheath is attached to the catheter at a location on the catheter proximal to the balloon portion such that the sheath remains attached to the catheter after the rupturing. 
     
     
         8 . The delivery system of  claim 1 , wherein the sheath is configured to remain in the vessel after the catheter is removed from the vessel. 
     
     
         9 . A method of inserting a self expanding medical device into a vessel, the method comprising:
 providing a 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 medical device positioned about the balloon portion, the medical device having a compressed state and an expanded state; and 
 a sheath coupling the medical device in its compressed state about the balloon portion, the sheath having a proximal end and a distal end, the sheath having only a single opening at the distal end of the sheath; 
   inserting the catheter into the vessel;   expanding the balloon portion such that the sheath is first ruptured at the single opening, thereby allowing the medical device to self-expand and engage an inner wall of the vessel;   controllably continuing the rupturing of the sheath from the single opening to the proximal end of sheath, thereby allowing the medical device to expand to its expanded state and a portion of the medical device engages an inner wall of the vessel;   deflating the balloon portion; and   withdrawing the catheter proximally through the expanded medical device whereby the medical device is deployed at the desired position in the vessel.   
     
     
         10 . The method of  claim 9 , wherein the step of providing a delivery system further includes providing the single opening extending longitudinally relative to the sheath such that, when the sheath is first ruptured at the single opening, the single opening provides an initial direction of separation of the sheath. 
     
     
         11 . The method of  claim 9 , wherein the step of providing a delivery system further includes providing the single opening at the distal end of the sheath. 
     
     
         12 . The method of  claim 11 , wherein the step of providing the single opening includes providing a cut extending longitudinally from the distal end of the sheath not more than approximately 5% of a length of the sheath. 
     
     
         13 . The method of  claim 9 , wherein the sheath remains in the vessel after the catheter is removed from the vessel. 
     
     
         14 . The method of  claim 9 , wherein the proximal end of the sheath is attached to the catheter at a location on the catheter proximal to the balloon portion and remains attached to the catheter after the rupturing such that the sheath is withdrawn from the vessel with the catheter. 
     
     
         15 . A method of making a delivery system for a self expanding medical device, the method comprising:
 providing a catheter having a distal portion and a proximal portion;   positioning a balloon portion on the distal portion of the catheter;   positioning a self expanding medical device about the balloon portion, the medical device having a compressed state and an expanded state;   providing a sheath having a proximal end and a distal end;   forming only a single opening in a wall of the sheath between the proximal end and the distal end; and   coupling the medical device in its compressed state about the balloon portion with a sheath,   when the balloon is expanded, the sheath is configured to (i) first rupture at the single opening, thereby allowing the medical device to self-expand and engage an inner wall of a vessel, and (ii) controllably continue the rupturing from the single opening to the proximal end of sheath, thereby allowing the medical device to expand to its expanded state and a portion of the medical device to engage an inner wall of the vessel.   
     
     
         16 . The method of  claim 15 , wherein the step of forming the single opening comprises forming the single opening extending longitudinally relative to the sheath such that, when the sheath is first ruptured at the single opening, the single opening is configured to provide an initial direction of separation of the sheath. 
     
     
         17 . The method of  claim 15 , wherein the step of forming the single opening comprises forming the single opening at the distal end of the sheath. 
     
     
         18 . The method of  claim 17 , wherein the step of forming the single opening comprises forming a cut extending longitudinally from the distal end of the sheath not more than approximately 5% of a length of the sheath. 
     
     
         19 . The method of  claim 15 , wherein the sheath is configured to remain in the vessel after the catheter is removed from the vessel. 
     
     
         20 . The method of  claim 15 , further comprising attaching the proximal end of the sheath to the catheter at a location on the catheter proximal to the balloon portion such that the sheath remains attached to the catheter after the rupturing.