Prosthesis deployment device with translucent distal end

Abstract

A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including a translucent inner liner running the complete catheter length, and three outer layers including a translucent distal layer, an opaque medial layer and an opaque proximal outer layer. The outer layers are adjacent one another and are bonded to the liner. A braid composed of helically wound metal filaments is disposed between the liner and the proximal and medial outer layers, and includes a distal portion between the liner and a proximal portion of the distal outer layer. The liner and distal outer layer provide a translucent distal region of the catheter that is adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained. Radiopaque markers can be mounted to the outer catheter and to an inner catheter used to deploy the prosthesis, to afford a combined visual and fluoroscopic monitoring for enhanced accuracy in positioning the prosthesis, both before and during its deployment.

What is claimed is:  
     
         1 . A prosthesis delivery and viewing device, including: 
 an elongate, flexible catheter having a tubular catheter wall defining a catheter lumen, said catheter body along a distal end region thereof being adapted to substantially surround a body insertable prosthesis and thereby releasably retain the prosthesis within the catheter lumen;    wherein the catheter wall, at least along the distal end region, is translucent to allow an optical viewing of the body insertable prosthesis through the catheter wall when the prosthesis is so retained.    
     
     
         2 . The device of  claim 1  further including: 
 a prosthesis release component mounted movably with respect to the catheter to effect a release of the prosthesis from within the catheter lumen.  
 
     
     
         3 . The device of  claim 2  wherein: 
 the prosthesis release component includes an elongate, flexible member disposed inside the catheter lumen and adapted to move the prosthesis distally relative to the catheter to effect the release.  
 
     
     
         4 . The device of  claim 3  wherein: 
 a distal end of the flexible member is disposed proximally of the prosthesis when the prosthesis is so retained.  
 
     
     
         5 . The device of  claim 3  wherein: 
 the flexible member has a distal end portion surrounded by the prosthesis when the prosthesis is so retained.  
 
     
     
         6 . The device of  claim 1  wherein: 
 the prosthesis is radially self-expanding, and when so retained is confined in a radially compressed state.  
 
     
     
         7 . The prosthesis of  claim 1  further including: 
 an optical viewing device positionable proximate the distal end of the catheter to facilitate said optical viewing.  
 
     
     
         8 . The device of  claim 1  wherein: 
 the catheter wall is more flexible along the distal end region as compared to a remaining portion of the catheter disposed proximally of the distal end region.  
 
     
     
         9 . The device of  claim 1  wherein: 
 the catheter wall is translucent substantially over an entire length of the catheter.  
 
     
     
         10 . The device of  claim 1  wherein: 
 a remaining portion of the catheter disposed proximally of the distal end region is opaque.  
 
     
     
         11 . The device of  claim 1  further including: 
 a metal reinforcing structure integral with the catheter wall, at least along a remaining portion of the catheter wall disposed proximally of the distal end region.  
 
     
     
         12 . The device of  claim 1  wherein: 
 the catheter wall includes a translucent inner tubular layer, a translucent first outer tubular layer surrounding the inner tubular layer along a distal end portion of the inner tubular layer, and a second outer tubular layer surrounding the inner tubular layer and disposed proximally of the first outer tubular layer.  
 
     
     
         13 . The device of  claim 12  wherein: 
 the second outer tubular layer is opaque.  
 
     
     
         14 . The device of  claim 12  wherein: 
 the first outer tubular layer is more flexible than the second outer tubular layer.  
 
     
     
         15 . The device of  claim 12  further including: 
 a radiopaque marker disposed near a distal end of the catheter wall and between the inner tubular layer and the first outer tubular layer.  
 
     
     
         16 . The device of  claim 12  further including: 
 a metal reinforcing structure disposed between the inner tubular layer and the second outer tubular layer.  
 
     
     
         17 . The device of  claim 16  wherein: 
 the metallic reinforcing structure includes a plurality of helically wound and interbraided filaments.  
 
     
     
         18 . A catheter for deploying a body insertable prosthesis, including: 
 an elongate, flexible, translucent inner tubular body;    a flexible, translucent first outer tube surrounding and integral with a distal end region of the inner tubular body; and    an elongate, flexible second outer tube surrounding the inner tubular body, integral with the inner tubular body, and disposed proximally of the first outer tube.    
     
     
         19 . The catheter of  claim 18  further including: 
 a flexible third outer tube disposed between, and in contact with, the first outer tube and the second outer tube.  
 
     
     
         20 . The catheter of  claim 18  wherein: 
 the second outer tube is opaque.  
 
     
     
         21 . The catheter of  claim 18  further including: 
 a radiopaque marker disposed between the inner tubular body and the first outer tube, and further disposed proximate respective distal ends of the inner tubular body and the first outer tube.  
 
     
     
         22 . The catheter of  claim 18  including: 
 a reinforcing structure disposed between the inner tubular body and the second outer tube.  
 
     
     
         23 . The catheter of  claim 22  wherein: 
 said reinforcing structure further is disposed between the inner tubular body and a proximal portion of the first outer tube.  
 
     
     
         24 . The catheter of  claim 22  wherein: 
 the reinforcing structure comprises helically wound metal filaments interbraided with one another.  
 
     
     
         25 . The catheter of  claim 18  wherein: 
 the first outer tube is more flexible than the second outer tube.  
 
     
     
         26 . The catheter of  claim 18  further including: 
 a radially self-expanding prosthesis disposed within the inner tubular body, in substantial axial alignment with the first outer tube, and constrained in a radially compressed state.  
 
     
     
         27 . The catheter of  claim 18  further including: 
 a prosthesis release component mounted movably relative to the inner tubular body.  
 
     
     
         28 . The device of  claim 27  wherein: 
 the prosthesis release component includes an elongate, flexible member contained inside the inner tubular body.  
 
     
     
         29 . A process for deploying a radially self-expanding prosthesis within a body lumen, including: 
 disposing a radially self-expanding prosthesis in a radially compressed state within a catheter, surrounded by a tubular wall of the catheter along a distal end region of the catheter;    moving the catheter intraluminally to position the distal end region of the catheter near a selected prosthesis deployment site within a body lumen;    with the catheter distal end region so positioned, initiating a release of the prosthesis from the catheter, and during said release, using an optical viewing device to optically view at least a proximal portion of the prosthesis through the catheter wall, to visually monitor a location of the prosthesis; and    after completing the release of the prosthesis, proximally withdrawing the catheter to leave the prosthesis disposed within the body lumen.    
     
     
         30 . The process of  claim 29  wherein: 
 the initiating of the release of the prosthesis comprises positioning an elongate prosthesis release member in contact with the prosthesis, and moving the tubular catheter proximally while using the release member to substantially prevent the prosthesis from moving proximally with the catheter.  
 
     
     
         31 . The process of  claim 30  further including: 
 while visually monitoring a location of the prosthesis, further monitoring a position of the elongate prosthesis release member relative to the catheter.  
 
     
     
         32 . The process of  claim 29  further including: 
 before initiating a release of the prosthesis, using a visible indicium on the tubular catheter to approximate a location of the proximal portion of the prosthesis with respect to the body lumen.  
 
     
     
         33 . A prosthesis delivery and deployment catheter, including: 
 an elongate, flexible inner tubular body;    a flexible first outer tube surrounding and integral with a distal end region of the inner tubular body; and    an elongate, flexible second outer tube surrounding the inner tubular body, integral with the inner tubular body, and disposed proximally of the first outer tube;    wherein the first outer tube is more flexible than the second outer tube, and extends axially less than one-fourth of the length of the inner tubular body, and wherein the second outer tube extends axially at least three-fourths of the length of the inner tubular body.    
     
     
         34 . The catheter of  claim 33  wherein: 
 the second outer tube has a durometer hardness greater than that of the first outer tube.  
 
     
     
         35 . The catheter of  claim 33  further including: 
 a flexible third outer tube disposed between, and in contact with, the first outer tube and the second outer tube.  
 
     
     
         36 . The catheter of  claim 35  wherein: 
 the second outer tube and the third outer tube are opaque, and the inner tubular body and the first outer tubing are translucent.