Implantation system with handle and catheter and method of use thereof

Abstract

A system for deploying an implantable medical device into a body lumen is disclosed. The system comprises a catheter having functional zones for stability, protection, flexibility, trackability and pushability. The system further comprises a device for deploying an implantable medical device with the catheter. A method for deploying an implantable medical device into a body lumen using the system is also disclosed.

1 . A catheter for deploying an implantable medical device, the catheter comprising:
 an elongated body having a distal end and a proximate end, said elongated body further comprising:   a stabilization zone at said distal end;   a protection zone located between said stabilization zone and said proximate end;   a flexibility zone located between said protection zone and said proximate end, wherein said protection zone is adapted to carry an implantable device;   a trackability zone located between said flexibility zone and said proximate end;   a pushability zone located between said trackability zone and said proximate end; and   a connector at said proximate end for connecting to a deployment device,   wherein said stabilization zone and said protection zone have a flexibility index of less than 3000 mN, said flexibility zone has a flexibility index of less than 3500 mN, said trackability zone has a flexibility index of less than 4500 mN, and said pushability zone has a flexibility index of less than 6000 mN.   
     
     
         2 . The catheter of  claim 1 , further comprising an implantable medical device affixed to the protection zone. 
     
     
         3 . The catheter of  claim 2 , wherein the implantable medical device is a stent. 
     
     
         4 . The catheter of  claim 1 , wherein the protection zone comprises an inflatable balloon for deploying the implantable medical device. 
     
     
         5 . The catheter of  claim 1 , wherein the stabilization zone is coated with or comprises an embedded radio-opaque substance. 
     
     
         6 . The catheter of  claim 1 , wherein the protection zone is coated with or comprises an embedded radio-opaque substance. 
     
     
         7 . The catheter of  claim 1 , wherein the flexibility zone is coated with or comprises an embedded radio-opaque substance. 
     
     
         8 . The catheter of  claim 1 , wherein the pushability zone is coated with or comprises an embedded radio-opaque substance. 
     
     
         9 . The catheter of  claim 1 , further comprising a transition area resided between two adjacent zones of different flexibility, wherein said transition area has a flexibility that is intermediate between the flexibilities of said two zones. 
     
     
         10 . The catheter of  claim 1 , wherein said stabilization zone comprises a tip that allows said catheter to move through a body lumen without damaging tissue lining of said body lumen. 
     
     
         11 . A method for deploying an implantable medical device comprising;
 advancing the catheter of  claim 2  into a body lumen,   attaching the proximal end of the catheter to an advancing device, the advancing device comprising:   a base member comprising   a base handle; and   a deployment extension having a distal end and a proximate end, the proximate end is connected to the base handle;   a first tubular member that fits over the deployment extension and is longitudinally slidable over the deployment extension, the first tubular member comprising:   a first tubular body with a distal end and a proximal end; and   a first handle for controlling movement of the first tubular member; and   a second tubular member that fits over the first tubular member and is longitudinally slidable over the first tubular member, the second tubular member comprising:   a second tubular body with a distal end and a proximal end; and   a second handle for controlling movement of the second tubular member, wherein the first handle is located between the base handle and the second   handle and wherein the distal ends of the deployment extension, the first tubular body, and the second tubular body are adapted to deploy an implantable medical device, and   retracting the first tubular member and the second tubular member towards the base member to deploy the implantable medical device in the body lumen.   
     
     
         12 . The method of  claim 11 , wherein the implantable medical device is a stent. 
     
     
         13 . The method of  claim 11 , further comprising attaching a viewing device to the base member. 
     
     
         14 . The method of  claim 13 , wherein the viewing device is an endoscope. 
     
     
         15 . The method of  claim 11 , wherein the body lumen is a blood vessel or a bile duct. 
     
     
         16 . A kit comprising:
 a catheter for deploying an implantable medical device, the catheter having a tip at its distal end and a connector at its proximate end and comprising a stabilization zone proximate to the tip, a protection zone proximate to the stabilization zone, a flexibility zone proximate to the protection zone, a pushability zone proximate to the flexibility zone and a strain relief area between the pushability zone and the connector, and   an advancing device, the advancing device comprising:   a base member comprising   a base handle; and   a deployment extension having a distal end and a proximate end, the proximate end is connected to the base handle;   a first tubular member that fits over the deployment extension and is longitudinally slidable over the deployment extension, the first tubular member comprising:   a first tubular body with a distal end and a proximal end; and   a first handle for controlling movement of the first tubular member; and   a second tubular member that fits over the first tubular member and is longitudinally slidable over the first tubular member, the second tubular member comprising:   a second tubular body with a distal end and a proximal end; and   a second handle for controlling movement of the second tubular member, wherein the first handle is located between the base handle and the second   handle and wherein the distal ends of the deployment extension, the first tubular body, and the second tubular body are adapted to deploy an implantable medical device.   
     
     
         17 . The kit of  claim 16 , further comprising an implantable medical device. 
     
     
         18 . The kit of  claim 16 , wherein the implantable medical device is a stent. 
     
     
         19 . The kit of  claim 16 , further comprising a viewing device attachable to the base member. 
     
     
         20 . The kit of  claim 16 , wherein the viewing device is an endoscope.