Minimally invasive revascularization apparatus and methods

Abstract

A bypass graft conduit is installed in the circulatory system of a patient using apparatus which facilitates performing most or all of the necessary work intraluminally (i.e., via lumens of the patient's circulatory system). A guide structure such as a wire is installed in the patient via circulatory system lumens so that a portion of the guide structure extends along the desired path of the bypass conduit, which bypass conduit path is outside the circulatory system as it exists prior to installation of the bypass graft. The bypass graft is then introduced into the patient along the guide structure and connected at each of its ends to the circulatory system using connectors that form fluid-tight annular openings from the bypass graft lumen into the adjacent circulatory system lumens. The guide structure is then pulled out of the patient.

The Invention Claimed Is  
     
         1 . Instrumentation for facilitating penetration of a side wall of a tubular body tissue conduit from the interior lumen of the conduit comprising: 
 a tubular structure which is axially insertable into and along the lumen of the conduit and which has an axial portion configured to deflect toward a first portion of the interior surface of the side wall from a second portion of the interior surface of the side wall which is axially spaced from the first portion and on the side of the side wall which is substantially opposite the first portion, the tubular structure having an axially extending interior passageway with an opening to the exterior of the tubular structure adjacent the first portion; and    a laterally flexible, longitudinal, tissue piercing structure configured to pierce a side wall of the tubular body tissue conduit and to project from the side wall through any adjacent tissue outside of the tubular body tissue conduit, wherein said tissue piercing structure is axially insertable into and along the passageway and which is axially reciprocable relative to the tubular structure so that it exits the opening toward the first portion when moved toward the opening.    
     
     
         2 . The instrumentation defined in  claim 1  wherein the tubular structure is configured to resiliently deflect toward the first portion.  
     
     
         3 . The instrumentation defined in  claim 2  wherein the passageway is configured to removably receive an alternative longitudinal structure which is laterally stiffer than the tissue piercing structure, and wherein the axial portion is further configured to substantially conform to an alignment of the alternative longitudinal structure, rather than deflect, in response to presence of the alternative longitudinal structure in the passageway in the axial portion.  
     
     
         4 . The instrumentation defined in  claim 1  further comprising: 
 radiologic marking of the axial portion.  
 
     
     
         5 . The instrumentation defined in  claim 1  further comprising: 
 radiologic marking of the opening.  
 
     
     
         6 . The instrumentation defined in  claim 1  wherein the axial portion is an axially medial portion of the tubular structure which is configured to arch toward the first portion from the second portion and from a third portion of the interior surface of the side wall which is on the same side of the side wall as the second portion, the second and third portions being axially spaced from the first portion in respective opposite axial directions from the first portion.  
     
     
         7 . The instrumentation defined in  claim 6  wherein the opening is a lateral branch of the passageway which extends in both axial directions past the opening.  
     
     
         8 . The instrumentation defined in  claim 1  wherein the tissue piercing structure comprises a radiologic material.  
     
     
         9 . A method of penetrating a side wall of a tubular body tissue conduit from the interior lumen of that conduit comprising: 
 inserting a first laterally flexible, but relatively stiff, longitudinal structure axially into and along the lumen;    inserting a second laterally flexible longitudinal structure axially into and along the lumen in engagement with the first structure so that the second structure substantially conforms to alignment of the first structure in the lumen, the second structure having an axial portion which, when not in engagement with the first structure, tends to deflect transversely in the lumen so that a part of the axial portion is adjacent to a first portion of the interior of the side wall of the conduit;    removing the second structure from engagement with the axial portion so that the axial portion can deflect; and    inserting a third laterally flexible, and relatively less stiff, longitudinal, tissue piercing structure axially into and along the lumen in engagement with the axial portion so that the third structure follows at least part of the axial portion and is thereby directed toward the first portion for piercing of the first portion of the interior of the side wall of the conduit to project from the side wall through any adjacent tissue outside of the tubular body tissue conduit by the third structure.    
     
     
         10 . Apparatus for use in medical treatment of a patient's tubular body conduit comprising: 
 an elongated, laterally flexible but resilient structure having (1) an axially medial portion configured for axial insertion into and along a lumen of the body conduit and also for axial reciprocation through an aperture in a side wall of the body conduit, and (2) an axially distal portion configured for passage along the lumen of the body conduit in either axial direction along that lumen from the aperture.    
     
     
         11 . The apparatus defined in  claim 10  wherein the medial portion is sufficiently laterally flexible so that a distal part of that portion can extend inside the lumen in a first length of the conduit which extends axially in a first direction from the aperture and so that a proximal part of that portion can extend axially along a path which is outside the first length of the conduit and which forms an acute angle with the first length of the conduit.  
     
     
         12 . The apparatus defined in  claim 11  wherein the medial portion is sufficiently resilient so that when the medial portion is pulled sufficiently far out of the lumen via the aperture that the distal portion remaining in the first length of the conduit is too short to be constrained by the first length of the conduit, the medial portion switches the distal portion into a second length of the conduit which extends axially in a second direction from the aperture.  
     
     
         13 . The apparatus defined in  claim 12  wherein the medial portion is additionally sufficiently laterally stiff to allow the medial portion to be used to push the distal portion axially along the lumen of the second length of the conduit from outside the conduit.  
     
     
         14 . The apparatus defined in  claim 10  wherein the distal portion forms an atraumatic distal end for the medial portion.  
     
     
         15 . The apparatus defined in  claim 10  wherein the medial portion comprises a metal wire.  
     
     
         16 . The apparatus defined in  claim 10  wherein the distal portion is radially enlarged relative to the medial portion.  
     
     
         17 . The apparatus defined in  claim 10  wherein the distal portion comprises radiologically viewable material.  
     
     
         18 . Apparatus for inserting a tubular graft into a side wall of a tubular body tissue conduit from outside the conduit comprising: 
 a hollow tubular shaft structure configured to receive a longitudinal guide structure axially along a lumen inside the shaft structure so that the shaft structure and the guide structure can slide axially relative to one another; and    a substantially conical tip structure disposed on an axial end portion of the shaft structure substantially concentrically with the shaft structure so that an apex of the conical tip structure points axially away from the shaft structure, an axial continuation of the lumen inside the shaft structure extending through the tip structure and out at the apex so that the guide structure can extend through the axial continuation and can slide axially relative to the axial continuation, the shaft structure being configured to receive the graft annularly around the shaft structure, and the tip structure including an annular recess which extends substantially annularly around the shaft structure, the recess being open in a direction that points away from the apex, and the recess having a radially outer side wall that is radially spaced from the shaft structure by an amount sufficient to allow an annular axial end portion of the graft to be received in the recess with the outer side wall radially outside the portion of the graft that is thus received in the recess.    
     
     
         19 . The apparatus defined in  claim 18  wherein the conical tip structure has a cone angle less than about 15°.  
     
     
         20 . The apparatus defined in  claim 18  wherein the conical tip structure has a cone angle in the range from about 5° to about 15°.  
     
     
         21 . The apparatus defined in  claim 18  wherein the conical tip structure has a cone angle in the range from about 5° to about 10°.  
     
     
         22 . The apparatus defined in  claim 18  wherein the tip structure is configured for passage through the side wall from outside the conduit starting with the apex of the tip structure.  
     
     
         23 . The apparatus defined in  claim 18  wherein the recess is configured to additionally receive at least an axial end portion of an annular graft connector which is annularly attached to an axial end portion of the graft.  
     
     
         24 . The apparatus defined in  claim 18  further comprising: 
 a radially expandable structure disposed substantially annularly around the shaft structure inside a graft around the shaft structure.  
 
     
     
         25 . The apparatus defined in  claim 24  wherein the expandable structure comprises: 
 an annular balloon.