Catheter system having imaging, balloon angioplasty, and stent deployment capabilities, and method of use guided stent deployment

Abstract

A catheter system has a balloon angioplasty device disposed about a common lumen near its distal end. The balloon catheter is pre-fitted with a stent which is deployed when the balloon is inflated. The common lumen is in communication with multiple lumens within a proximal region of the catheter body to allow for positioning of the catheter over a movable guide wire and convenient delivery of imaging or interventional devices to a desired region of a body passageway being Treated. The procedure for stent deployment optionally includes steps of imaging a lumen by ultrasound before and after stent deployment to identify the site at which a stent is needed, to confirm that the stent is being and has been deployed at a longitudinal position which does not overlap a branched segment of the body passageway, and to ensure that the stent has been radially opened to an optimum diameter.

What is claimed is:  
     
         1 . A vascular catheter system for guided placement and implanting of a prosthesis within a body passageway, said system comprising: 
 a catheter body having proximal and distal ends, and a proximal and a distal region, the proximal region having at least two lumens and the distal region having a common lumen connected to and in communication with both lumens of the proximal region;    a balloon disposed about the common lumen; and    an expandable prosthesis associated with the balloon, said prosthesis having a first diameter which permits intraluminal delivery of the prosthesis into a body passageway and which places the prosthesis in close proximity to the balloon, and a second expanded diameter upon the application of radial, outwardly extending force from the interior of the prosthesis.    
     
     
         2 . The vascular catheter system of  claim 1 , further comprising a guidewire having a distal end, wherein the guidewire is positionable within the common lumen of the distal region so that the distal end of the guidewire can extend past the distal end of the catheter body.  
     
     
         3 . The vascular catheter system of  claim 1 , further comprising a removable imaging core having an elongate drive shaft adapted for positioning in the guidewire lumen of said catheter system, a transducer portion connected to a distal portion of the elongate drive shaft, and a proximal section connected to the proximal end of the elongate shaft for transmission of electrical signals from a proximal control apparatus to the transducer via the elongate drive shaft.  
     
     
         4 . A vascular catheter system for guided placement and implanting of a prosthesis within a body passageway, said system comprising: 
 a catheter body having proxiral and distal ends, and a proximal and a distal region, the proximal region having at least two lumens and the distal region having a common lumen connected to and in communication with both lumens of the proximal region;    means for retaining the prosthesis in close proximity to the distal region of said catheter body; and    an expandable prosthesis associated with said retaining means, said prosthesis having a first diameter which permits intraluminal delivery of the prosthesis into a body passageway and which places the prosthesis in close radial proximity to said catheter body, and a second expanded diameter upon removal of said retaining means.    
     
     
         5 . The vascular catheter system of  claim 4 , wherein said retaining means comprises a sheath disposed about the distal region of said catheter body.  
     
     
         6 . The vascular catheter system of  claim 5 , wherein the prosthesis is disposed between the catheter body and the sheath.  
     
     
         7 . The vascular catheter system of  claim 4 , further comprising a guidewire having a distal end, wherein the guidewire is positionable within the common lumen of the distal region so that the distal end of the guidewire can extend past the distal end of the catheter body.  
     
     
         8 . The vascular catheter system of  claim 4 , further comprising a removable imaging core having an elongate drive shaft adapted for positioning in the guidewire lumen of said catheter system, a transducer portion connected to a distal portion of the elongate drive shaft, and a proximal section connected to the proximal end of the elongate shaft for transmission of electrical signals from a proximal control apparatus to the transducer via the elongate drive shaft.  
     
     
         9 . A method for guided placement and implanting of a prosthesis within a body passageway using a catheter having proximal and distal regions, wherein the prosthesis is associated with the distal region of the catheter, said prosthesis having proximal and distal ends, said method comprising the steps of: 
 advancing the catheter into the body passageway until the prosthesis lies within a region of interest;    imaging by ultrasound from within the body passageway at least one of the proximal and distal ends of the prosthesis to ensure that the prosthesis is positioned at a desired location; and    expanding the prosthesis at the region of interest.    
     
     
         10 . The method of  claim 9 , wherein the catheter includes an angioplasty balloon disposed about the distal region and associated with the prosthesis.  
     
     
         11 . The method of  claim 10 , wherein the step of expanding the prosthesis includes inflating the balloon to controllably expand the prosthesis at the region of interest.  
     
     
         12 . The method of  claim 9 , wherein the catheter includes a sheath disposed about the distal region of the catheter body.  
     
     
         13 . The method of  claim 12 , wherein the step of expanding the prosthesis includes removing the sheath.  
     
     
         14 . The method of  claim 9 , wherein the body passageway is a blood vessel.  
     
     
         15 . The method of  claim 9 , wherein the prosthesis is a stent.  
     
     
         16 . The method of  claim 9 , wherein imaging is performed to ensure that the prosthesis is not positioned at a branching segment of the body passageway.  
     
     
         17 . The method of  claim 15 , wherein the stent comprises a wire mesh tube having a first collapsed diameter which permits the stent to be disposed upon the catheter, and inserted into the body passageway, wherein the wire mesh tube can be expanded to a second diameter.  
     
     
         18 . The method of  claim 11 , further comprising the steps of: 
 imaging the prothesis while disposed about the inflated balloon to determine a first diameter of the expanded prosthesis; and    imaging the prosthesis after deflating the balloon to determine a second diameter to ensure that the expanded prosthesis has a desired diameter.    
     
     
         19 . The method of  claim 13 , further comprising the step of imaging the prosthesis after removing the sheath to determine an expanded diameter and to ensure that the expanded prosthesis has a desired diameter.  
     
     
         20 . The method of  claim 19 , further comprising the step of expanding a second prosthesis within the prosthesis to enlarge the diameter.  
     
     
         21 . The method of  claim 9 , further comprising the step of advancing an imaging core through a lumen of the catheter and into the region of interest.  
     
     
         22 . The method of  claim 16 , further comprising the step of repositioning the prosthesis prior to expanding the prosthesis to avoid the branching segment of the body passageway.  
     
     
         23 . A method for implanting a prosthesis within a body passageway using a catheter having proximal and distal regions, and an angioplasty balloon disposed about the distal region, wherein the prosthesis is associated with said balloon, said method comprising the steps of: 
 positioning the catheter within the body passageway so that the angioplasty balloon lies within a region of interest;    inflating the balloon to controllably expand the prosthesis at the region of interest;    imaging the prosthesis while disposed about the inflated balloon to determine a first diameter of the expanded prosthesis;    deflating the balloon, whereby the prosthesis is allowed to recoil; and    imaging the prosthesis to determine a second diameter to ensure that the recoiled prosthesis has a diameter sufficiently large.    
     
     
         24 . The method of  claim 23 , wherein the body passageway is a blood vessel.  
     
     
         25 . The method of  claim 23 , wherein the prosthesis is a stent.  
     
     
         26 . The method of  claim 25 , wherein the stent comprises a wire mesh tube having a predetermined collapsed diameter which permits the stent to be disposed upon the catheter, and inserted into the body passageway, wherein the wire mesh tube can be expanded to the first diameter.  
     
     
         27 . The method of  claim 23 , wherein said prosthesis has proximal and distal ends, and wherein said method further comprises the step of imaging at least one of the proximal and distal ends of the prosthesis prior to expanding the prosthesis to ensure that the prosthesis is positioned at the desired location and not at a branching segment of the body passageway.  
     
     
         28 . The method of  claim 27 , further comprising the step of repositioning the prosthesis prior to expanding the prosthesis to avoid the branching segment of the body passageway.  
     
     
         29 . The method of  claim 23 , further comprising the steps of: 
 inflating the balloon to controllably expand the prosthesis at the region of interest;    imaging the prosthesis while disposed about the inflated balloon to determine a third diameter of the expanded prosthesis, said third diameter being greater than either of said first or said second diameters;    deflating the balloon, whereby the prosthesis is allowed to recoil; and    imaging the prosthesis to determine a fourth diameter which is larger than said second diameter.    
     
     
         30 . A method for implanting a prosthesis within a body passageway using a catheter having proximal and distal regions, wherein a first prosthesis is associated with the distal region, said method comprising the steps of: 
 positioning the catheter within the body passageway so that the first prosthesis lies within a region of interest;    expanding the first prosthesis at the region of interest; and    imaging the expanded prosthesis to determine a first diameter of the expanded prosthesis.    
     
     
         31 . The method of claim  30 , further comprising the step of expanding a second prosthesis within the first prosthesis to enlarge the diameter of said first prosthesis.