Cardioplegia balloon cannula

Abstract

A cardioplegia occluder and methods of using the device during cardiac surgery are disclosed. The system typically includes a substantially rigid cannula with an occluder mounted on the distal region of the cannula that expands upon activation to occlude the aorta downstream of an infusion port which delivers cardioplegia solution to arrest the heart. Systems including cutting blades, blade guards, flanges, radiopaque markers and occluder aligners are also disclosed. In use, the distal end of the cannula is inserted through an incision into the aorta, the occluder is expanded and cardioplegia solution is infused upstream of the aorta to arrest the heart. The infusion port can alternately be used to aspirate cardioplegia or embolic debris or other unwanted material from the aorta.

We claim:  
     
         1 . A cardioplegia occluder for delivering cardioplegia to the aorta during cardiopulmonary bypass, comprising: 
 a cannula having a distal region comprised of a material of at least 90 Shore A hardness with an outer surface, a distal end adapted to enter the aorta, a proximal end adapted to receive cardioplegia solution, a longitudinal center axis, a cardioplegia lumen which extends distally from the proximal end and terminates and communicates with an infusion port in the distal region for delivery of cardioplegia solution to the aorta; and    an occluder mounted on the distal region of the cannula, the occluder expandable between a contracted condition and an expanded condition, having a longitudinal center axis, wherein the occluder, when contracted, is closely associated with the outer surface of the cannula, while the occluder expands upon activation to substantially occlude the aorta downstream of the infusion port,    wherein, during use, the occluder isolates the ascending aorta from the peripheral vasculature without substantial migration of the occluder within the ascending aorta.    
     
     
         2 . The cardioplegia occluder of    claim 1   , wherein the distal region of the cannula assumes a curved shape to allow self-centering.  
     
     
         3 . The cardioplegia occluder of    claim 1   , wherein the cannula is substantially rigid.  
     
     
         4 . The cardioplegia occluder of    claim 1   , wherein the distal region is comprised of a material of at least 92 Shore A hardness.  
     
     
         5 . The cardioplegia occluder of    claim 1   , wherein the distal region is comprised of a material of at least 95 Shore A hardness.  
     
     
         6 . The cardioplegia occluder of    claim 1   , wherein the material of the distal region is selected from the group consisting of PEBAX nylon, composite plastic with fibers, polyethylene reinforced with nitinol braid, stainless steel and nitinol.  
     
     
         7 . A cardioplegia occluder for delivering cardioplegia to the aorta during cardiopulmonary bypass, comprising: 
 a cannula disposed about a longitudinal center axis, the cannula having an outer diameter of no more than 6 millimeters, a distal region adapted to enter the aorta, an outer surface, a proximal end adapted to receive cardioplegia solution into a lumen which extends distally and terminates and communicates with an infusion port in the distal region for delivery of cardioplegia solution to the aorta; and    an occluder mounted on the distal region of the cannula, the occluder expandable between a contracted condition and an expanded condition, wherein the occluder, when contracted, is closely associated with the outer surface of the cannula, while the occluder expands upon activation to substantially occlude the aorta downstream of the infusion port,    wherein, during use, the occluder isolates the ascending aorta from the peripheral vasculature without substantial migration of the occluder within the ascending aorta.    
     
     
         8 . The cardioplegia occluder of    claim 7   , wherein the distal region of the cannula assumes a curved shape to allow self-centering.  
     
     
         9 . The cardioplegia occluder of    claim 7   , wherein the distal region is comprised of a material of at least 90 Shore A hardness.  
     
     
         10 . The cardioplegia occluder of    claim 7   , wherein the cannula is substantially rigid.  
     
     
         11 . A method for administering cardioplegia, comprising the steps of: 
 providing a cannula having proximal and distal ends, a proximal and a distal region, a balloon occluder mounted on the distal region and communicating with an inflation lumen extending proximal from the occluder, an infusion port on the cannula proximal the balloon, the port communicating with a cardioplegia lumen which extends proximally from the port, wherein the distal region of the cannula is comprised of a material of at least 90 Shore A hardness;    making an incision in the aorta;    inserting the distal end of the cannula and the occluder through the incision in the aorta;    expanding the occluder to occlude the aorta downstream of the infusion port; and    infusing cardioplegia solution through the port,    wherein the occluder isolates the ascending aorta from peripheral circulation without substantial migration within the ascending aorta.    
     
     
         12 . The method of    claim 11   , wherein the cannula is substantially rigid.  
     
     
         13 . The method of    claim 11   , further comprising the step of placing the patient on cardiopulmonary bypass.  
     
     
         14 . The method of    claim 11   , further comprising the steps of contracting the occluder and removing the cannula and the occluder from the aorta.  
     
     
         15 . The method of    claim 11   , further comprising the steps of performing a coronary artery bypass graft procedure.  
     
     
         16 . The method of    claim 11   , wherein the distal region of the cannula is bent at an angle of approximately 90 degrees.  
     
     
         17 . A method for administering cardioplegia, comprising the steps of: 
 providing a cannula disposed about a longitudinal center axis, the cannula having proximal and distal ends, a proximal and a distal region, an outer diameter of no more than 6 millimeters, a balloon occluder mounted on the distal region and communicating with an inflation lumen extending proximal from the occluder, an infusion port on the cannula proximal the balloon, the port communicating with a cardioplegia lumen which extends proximally from the port;    making an incision in the aorta;    inserting the distal end of the cannula and the occluder through the incision in the aorta;    expanding the occluder to occlude the aorta downstream of the infusion port; and    infusing cardioplegia solution through the port,    wherein the occluder isolates the ascending aorta from peripheral circulation without substantial migration within the ascending aorta.    
     
     
         18 . The method of    claim 17   , wherein the cannula is substantially rigid.  
     
     
         19 . The method of    claim 17   , further comprising the steps of contracting the occluder and removing the cannula and the occluder from the aorta.  
     
     
         20 . The method of    claim 17   , further comprising the steps of perfonning a coronary artery bypass graft procedure.