Perfusion-occlusion apparatus and methods

Abstract

A perfusion-occlusion catheter provides an occluded region in a vessel to facilitate, for example, an anastomosis in the region, while providing a path for perfusing fluid (blood) through the path for delivery in the vessel downstream from the occluded region. According to one aspect of the invention, at least a portion of the catheter that effects vessel occlusion comprises a shield that when exposed to suture needles or like piercing instruments deflects or resists perforation.

1 . A perfusion-occlusion apparatus for use in occluding a portion of a lumen and perfusing fluid through the lumen, comprising: 
 a tube having at least one lumen, a proximal end and a distal end; and    first and second occlusion members provided in the vicinity of said distal end and spaced from one another to define an occlusion section having first, second and third portions, said first and second occlusion members being positioned in said first and third portions, at least a portion of said occlusion section comprising a shield that when contacted by suture needles or like piercing instruments deflects the same or resists perforation.    
     
     
         2 . The apparatus of  claim 1  wherein said second portion forms said shield.  
     
     
         3 . The apparatus of  claim 1  wherein said shield comprises an intermediate member coupled to said tube along said second portion and extending a substantial amount of the distance between said occlusion members.  
     
     
         4 . The apparatus of  claim 3  wherein said intermediate member comprises a plurality of rings disposed about said tube.  
     
     
         5 . The apparatus of  claim 4  wherein a plurality of said rings interlock with other ones of said rings.  
     
     
         6 . The apparatus of  claim 3  wherein said intermediate member comprises a coil.  
     
     
         7 . The apparatus of  claim 6  wherein said coil includes counterwound portions.  
     
     
         8 . The apparatus of  claim 3  wherein said intermediate member comprises a braided member disposed about said tube.  
     
     
         9 . The apparatus of  claim 3 , further including a layer of material surrounding said intermediate member.  
     
     
         10 . The apparatus of  claim 3  wherein said intermediate member is radiopaque.  
     
     
         11 . The apparatus of  claim 3  wherein said intermediate member comprises an optic fiber wound around said tube.  
     
     
         12 . The apparatus of  claim 11  further including a light source, said light source being optically coupled to said fiber.  
     
     
         13 . The apparatus of  claim 11  wherein said optic fiber is arranged to illuminate said first and second occlusion members.  
     
     
         14 . The apparatus of  claim 1 , further including an optic fiber optically coupled to at least one of said occlusion members for illuminating said occlusion member.  
     
     
         15 . The apparatus of  claim 1  wherein at least one of said first and second occlusion members forms said shield.  
     
     
         16 . The apparatus of  claim 15  wherein said shield comprises a plurality of overlapping elements at least disposed within one of said first and second occlusion members.  
     
     
         17 . The apparatus of  claim 16  wherein said overlapping elements are disposed in both of said first and second occlusion members.  
     
     
         18 . The apparatus of  claim 17  wherein said overlapping elements further surround said second portion.  
     
     
         19 . The apparatus of  claim 16  further including a balloon within at least one of said occlusion members, said overlapping elements extending around said balloon.  
     
     
         20 . The apparatus of  claim 19  wherein said overlapping elements form a substantially helical member when said balloon is expanded.  
     
     
         21 . The apparatus of  claim 19  wherein said overlapping elements form a substantially umbrella shaped member when said balloon is expanded.  
     
     
         22 . The apparatus of  claim 19  wherein said overlapping elements form a coil when said balloon is expanded.  
     
     
         23 . The apparatus of  claim 15  wherein at least one occlusion member includes an outer layer of material which surrounds said shield.  
     
     
         24 . The apparatus of  claim 1  wherein at least one of said first and second occlusion members comprise an inner and outer balloon and fluid disposed there between for sealing openings formed in said outer balloon.  
     
     
         25 . The apparatus of  claim 1  wherein said tube includes apertures formed therein proximal to said first occlusion member and distal to said second occlusion member.  
     
     
         26 . The apparatus of  claim 25  wherein said proximal apertures extend a minimum distance of about 4 cm from said first occlusion member.  
     
     
         27 . The apparatus of  claim 1  further including a pump adapted for coupling to said tube.  
     
     
         28 . The apparatus of  claim 1  wherein at least a portion of said tube includes three lumens.  
     
     
         29 . The apparatus of  claim 28  wherein two of said lumens are fluidly coupled to one another.  
     
     
         30 . The apparatus of  claim 29  further including a pump for driving fluid from one of said fluidly coupled lumens to the other.  
     
     
         31 . The apparatus of  claim 1  further including a one-way valve at one end of said tube.  
     
     
         32 . The apparatus of  claim 31  wherein said valve is a duck bill valve.  
     
     
         33 . The apparatus of  claim 1  wherein said tube includes a plurality of apertures formed distal to said second occlusion member, said tube and a plurality of said distal apertures each having a longitudinal axis, the angle formed between said longitudinal axis of said tube and the longitudinal axes of each of said plurality of distal apertures being less than or equal to ninety degrees.  
     
     
         34 . The apparatus of  claim 1  wherein said tube includes a plurality of apertures formed therein, proximal to said first occlusion member and extending from said first occlusion member a distance of about 4 to 7 cm in a direction away from said second portion.  
     
     
         35 . The apparatus of  claim 34  wherein said tube includes at least one opening distal to said second occlusion member and fluidly coupled to said apertures proximal to said first occlusion member, and said intermediate member being imperforate.  
     
     
         36 . A perfusion-occlusion system for use in occluding a portion of a vessel lumen and actively perfusing fluid through the vessel lumen comprising: 
 a catheter having a tube having at least one lumen and a proximal end and a distal end, and first and second occlusion members coupled to said tube and spaced from one another to provide an occlusion section in the vicinity of said distal end;    a catheter introducer sheath adapted to be inserted into a patient's vasculature; and    a pump adapted to be fluidly coupled to said tube and said introducer sheath for pumping fluid from said introducer sheath to the distal end of said tube.    
     
     
         37 . A perfusion-occlusion system for use in occluding a portion of a vessel lumen and actively perfusing fluid through the vessel lumen comprising: 
 a catheter having a tube having first, second and third lumens, a proximal end and a distal end, and first and second occlusion members coupled to said first lumen and spaced from one another to provide an occlusion section in the vicinity of said distal end, said second lumen having at least one opening proximal to said occlusion section and said third lumen having at least one discharge opening distal to said occlusion section; and    a pump fluidly coupled to said second and third lumens for driving fluid from said opening in said second lumen to said discharge opening in said third lumen.    
     
     
         38 . A surgical kit for preparing an anastomosis site comprising: 
 a catheter having a tube having at least one lumen and a proximal end and a distal end, at least first and second occlusion members coupled to said tube and spaced from one another to provide an occlusion section in the vicinity of said distal end, and a protective shield positioned about or within said occlusion section to substantially resist perforation of said tube from a surgical cutting instrument or like piercing instrument; and    instructions for use of said catheter for occluding a portion of a vessel lumen at the anastomosis site and perfusing fluid through the vessel lumen.    
     
     
         39 . A method for preparing an anastomosis site comprising the steps of: 
 (a) delivering a double balloon catheter downstream from an obstructed region in a vessel;    (b) expanding the balloons to occlude a region of the vessel downstream of said obstructed region where an anastomosis is to be performed; and    (c) actively perfusing blood from a blood supply source to a region downstream of said occluded section.    
     
     
         40 . The method of  claim 39  wherein actively perfusing blood includes drawing blood through the distal end of a catheter introducer sheath positioned in a patient's vasculature.  
     
     
         41 . The method of  claim 40  further including the step of recirculating the blood drawn from the catheter introducer sheath to a distal end of the balloon catheter through the use of a pump.  
     
     
         42 . The method of  claim 39  wherein actively perfusing blood includes drawing blood through the distal end of a guide catheter which is used to position the balloon catheter in the vessel.  
     
     
         43 . The method of  claim 39  wherein actively perfusing blood includes drawing blood through a needle which is inserted into the patient's vasculature.  
     
     
         44 . A method for performing an anastomosis comprising: 
 (a) delivering a double balloon catheter, having an occlusion section between two balloons, and having a protective shield about at least a portion of the occlusion section, downstream from an obstructed region in a first vessel;    (b) expanding the balloons to occlude a region of the vessel downstream of said obstructed region;    (c) perfusing fluid upstream of said obstructed region to an area downstream of the occluded region; and    (d) grafting a second vessel onto said first vessel in the occluded region.    
     
     
         45 . A method of preparing a vessel for an anastomosis comprising: 
 (a) positioning a double balloon catheter in a first vessel;    (b) forming an opening in a second vessel downstream from a blockage;    (c) introducing a portion of the catheter through the opening and positioning the catheter with one balloon in the first vessel and the second balloon in the second vessel;    (d) expanding the balloons; and    (e) perfusing fluid upstream of the first balloon downstream of the second balloon.    
     
     
         46 . A method for identifying a vessel region prepared for an anastomosis comprising: 
 (a) occluding a region of a vessel downstream from a blockage; and    (b) illuminating the region from a light source within the vessel.