Integral aortic arch infusion clamp having pressure ports

Abstract

An improved catheter and method for infusing blood to the heart, clamping the aorta and delivering a cardioplegia solution. A single catheter ( 10, 100 ) is used having a unique balloon ( 102, 162, 172 ) for ccluding the aorta 12 In a first embodiment, a single catheter ( 10 ) is transthoracically inserted upwardly in the aorta to infuse oxygenated blood into the ascending aorta via an infusion opening ( 46 ) terminating at the distal end ( 32 ), with cardioplegia solution being delivered via openings ( 42 ) defined closely adjacent the balloon ( 40 ) on the proximal side of the balloon. In a second and third embodiment, a single catheter ( 100 ) is transthoracically and femorally inserted, respectively, inserted into the aorta to infuse blood via openings ( 102 ) into the ascending aorta proximate the Brachiocephalie Artery, and deliver cardioplegia solution via the distal opening ( 104 ) downward toward the aortic base. A fourth lumen ( 90,140 ) is provided in both catheters for sensing aortic root pressure in combination with a pressure meter ( 92 ) to first ascertain if the balloon is sufficiently inflated and properly occluding the aorta, and second to ascertain proper function of the aortic valve during cardioplegia delivery. The balloon ( 202, 231 ) is preferably filled with a partitioned resilient material ( 204 ) to permit varying diameters of the balloon and occlude body passageways having varying diameters and curvatures, and may be elongated ( 262 ) to improve occlusion.

We claim:  
     
         1 . A method of providing cardiopulmonary bypass pump support during heart surgery, wherein the heart has an ascending aorta, an aortic base, an aortic valve, an aortic arch, a coronary artery, and a Brachiocephalie Artery, comprising the steps of: 
 a) inserting an infusion catheter having a proximal end and a distal end into the ascending aorta, the catheter having a first lumen, a second lumen, and an expandable balloon near said distal end, said catheter having a cardioplegia opening in fluid communication with said first lumen and located adjacent said balloon between said balloon and said catheter proximal end, said catheter having a pressure sensing opening in fluid communication with said second lumen and located between said balloon and said catheter proximal end;    b) advancing said infusion catheter upwardly into said ascending aorta such that said balloon is positioned above the aortic base and said catheter distal end is positioned toward said aortic arch, said cardioplegia opening and said pressure sensing opening being positioned near said aortic valve;    c) expanding said balloon to occlude said aorta; and    d) sensing pressure in said aorta via said pressure sensing opening after expanding said balloon in said step c) to ascertain the effectiveness of occlusion by said balloon.    
     
     
         2 . The method as specified in    claim 1    further comprising the step of delivering cardioplegia solution to said heart via said catheter first lumen while sensing pressure proximate said aortic valve via said pressure sensing opening.  
     
     
         3 . The method as specified in    claim 1    wherein said balloon is positioned in said step b) such that said balloon is positioned between the aortic base and the Brachiocephalie Artery.  
     
     
         4 . The method as specified in    claim 1   , wherein said infusion catheter further comprises a third lumen having an infusion opening located at said catheter distal end and distal of said balloon, further comprising the step of infusing oxygenated blood into said aorta via said third lumen through said infusion opening.  
     
     
         5 . A method of providing cardiopulmonary bypass pump support during heart surgery, wherein the heart has an ascending aorta, an aortic base, an aortic valve, an aortic arch and a Brachiocephalie Artery, comprising the steps of: 
 a) inserting an infusion catheter having a proximal end and a distal end into the ascending aorta, the catheter having a first lumen, a second lumen, and an expandable balloon near said distal end, said catheter having a cardioplegia opening in fluid communication with said first lumen and located at said catheter distal end, said catheter having a pressure sensing opening in fluid communication with said second lumen and located between said balloon and said catheter distal end;    b) advancing said infusion catheter downwardly into said ascending aorta such that said balloon is positioned above the aortic base and said catheter distal end including said pressure sensing opening is positioned near said aortic valve, said infusion opening being positioned toward said aortic arch;    c) expanding said balloon to occlude said aorta; and    d) sensing pressure in said aorta between said expanded balloon and said aortic valve via said pressure sensing opening to ascertain the effectiveness of occlusion by said balloon.    
     
     
         6 . The method as specified in    claim 5    further comprising the step of delivering said cardioplegia solution to said heart via said catheter first lumen while sensing pressure proximate said aortic valve via said pressure sensing opening.  
     
     
         7 . The method as specified in    claim 5    wherein said balloon is positioned in said step b) between the aortic base and the Brachiocephalie Artery.  
     
     
         8 . The method as specified in    claim 5    wherein said catheter further comprises a third lumen and an infusion opening in fluid communication with said third lumen and located proximal said balloon, further comprising the step of infusing oxygenated blood into said aorta via said third lumen through said infusion opening.  
     
     
         9 . The method as specified in    claim 8    wherein said catheter is inserted femorally into the aorta.  
     
     
         10 . An infusion catheter having a catheter body extending between a proximal end and a distal end, said catheter body having a first lumen, a second lumen, a third lumen, and a fourth lumen, said catheter body having a balloon disposed near said distal end and in communication with said first lumen, said second lumen extending to a distal opening located distal of said balloon, said third lumen having at least one opening disposed adjacent said balloon and positioned between said balloon and said catheter proximal end, said fourth lumen terminating at a pressure sensing opening disposed adjacent said balloon.  
     
     
         11 . An infusion catheter as specified in    claim 10    further comprising, in combination, a pressure meter coupled to said fourth lumen.  
     
     
         12 . The infusion catheter as specified in    claim 10    wherein said pressure sensing opening is disposed between said balloon and said catheter distal end.  
     
     
         13 . The infusion catheter as specified in    claim 10    wherein said pressure sensing opening is disposed between said balloon and said catheter proximal end.  
     
     
         14 . The infusion catheter as specified in    claim 10    wherein said pressure sensing opening is defined less than  3  inches from said catheter distal end.  
     
     
         15 . The infusion catheter as specified in    claim 12    wherein said third lumen has a diameter sufficiently large to accommodate blood flow therethrough at a rate sufficient to perfuse a human body.  
     
     
         16 . The infusion catheter as specified in    claim 13    wherein said second lumen has a diameter sufficiently large to accommodate blood flow therethrough at a rate sufficient to perfuse a human body.  
     
     
         17 . The infusion catheter as specified in    claim 10    wherein said balloon is defined by a balloon member disposed about said catheter body, and having a midsection and proximal and distal sidewalls, said balloon member midsection being more resilient than the sidewalls of the balloon member.  
     
     
         18 . The infusion catheter as specified in    claim 17    wherein said balloon member sidewalls have a greater thickness than said balloon member midsection.  
     
     
         19 . The infusion catheter as specified in    claim 18    wherein said balloon member midsection is elongated.  
     
     
         20 . A catheter having a catheter body and a balloon member disposed thereabout to form a balloon, said balloon member having a midsection and proximal and distal portions disposed about said catheter body, said balloon member midsection being more resilient than said balloon member proximal and distal portions.  
     
     
         21 . The infusion catheter as specified in    claim 20    wherein said balloon member distal and proximal portions have a greater thickness than said balloon member midsection.  
     
     
         22 . The infusion catheter as specified in    claim 20    wherein said balloon member midsection is elongated.  
     
     
         23 . An infusion catheter having a catheter body extending between a proximal end and a distal end, said catheter body having a first lumen, a second lumen, a third lumen, and a fourth lumen, said catheter body having a balloon disposed near said distal end and in communication with said first lumen, said second lumen extending to a distal opening located distal of said balloon, said third lumen having at least one opening disposed proximal and adjacent said balloon, said fourth lumen terminating at a pressure sensing opening disposed proximal of said balloon.  
     
     
         24 . An infusion catheter as specified in    claim 23    further comprising, in combination, a pressure meter coupled to said fourth lumen.  
     
     
         25 . The infusion catheter as specified in    claim 23    wherein said second lumen has a diameter sufficiently large to perfuse a human body.  
     
     
         26 . An infusion catheter having a catheter body extending between a proximal end and a distal end, said catheter body having a first lumen, a second lumen, a third lumen, and a fourth lumen, said catheter body having a balloon disposed near said distal end and in communication with said first lumen, said second lumen extending to a distal opening located distal of said balloon, said third lumen having at least one opening disposed proximal said balloon and having a diameter sufficiently large to perfuse a human body, said fourth lumen having a pressure sensing opening disposed distal said balloon.  
     
     
         27 . An infusion catheter as specified in    claim 26    further comprising, in combination, a pressure meter coupled to said fourth lumen.  
     
     
         28 . An infusion catheter having a catheter body extending between a proximal end and a distal end, said catheter body having a first lumen, a second lumen, a third lumen, and a fourth lumen, said catheter body having a balloon disposed near said distal end and in communication with said first lumen, said second lumen extending to a distal opening located distal of said balloon, said third lumen having at least one opening positioned between said balloon and said catheter proximal end, said fourth lumen terminating at a pressure sensing opening disposed near said balloon, wherein one of said second lumen or said third lumen is sufficiently large to perfuse a human body and is offset from an axial center of said catheter.  
     
     
         29 . An infusion catheter as specified in    claim 28    further comprising, in combination, a pressure meter coupled to said fourth lumen.  
     
     
         30 . An infusion catheter for use with a body vessel, comprising: 
 a catheter body extending between a proximal end and a distal end, said catheter body having a first lumen, a second lumen, a third lumen, and a fourth lumen, said catheter body having a balloon disposed near said distal end and in communication with said first lumen, said second lumen having a diameter sufficiently large to perfuse a human heart, said fourth lumen terminating at a pressure sensing opening, and    means coupled to said fourth lumen for detecting the effectiveness of occlusion of the vessel by said balloon while inflating said balloon.    
     
     
         31 . The infusion catheter as specified in    claim 31    wherein said second lumen extends to an infusion opening disposed distal of said balloon, said third lumen extending to an opening proximal of said balloon, said pressure sensing opening being located proximal said balloon.  
     
     
         32 . The infusion catheter as specified in    claim 31    wherein said second lumen extends to an infusion opening disposed proximal said balloon, said third lumen extending to an opening distal said balloon, said pressure sensing opening being located distal said balloon.  
     
     
         33 . A device for use with a body vessel, comprising: 
 a catheter body;    a balloon disposed about said catheter body;    a pressure sensing lumen extending within said catheter body to a pressure sensing opening; and    means coupled to said pressure sensing lumen for detecting the effectiveness of occlusion of the vessel by said balloon via said pressure sensing opening.