Blood vessel occlusion device

Abstract

A direct-access device with a thin-profile balloon member is used to occlude a blood vessel. The device is ideally suited for occluding a patient's aorta during stopped-heart cardiac procedures. The device comprises a flexible, thin-profile balloon member which forms a balloon in combination with a tubular member, which inflates the thin-profile balloon member. Together, the balloon member and tubular member occlude a blood vessel. The balloon member is attached near the distal end of the tubular member. The width of the balloon member's outer peripheral contact area, which contacts the inner wall of the blood vessel, is substantially narrower than the balloon member's diameter. The balloon member is made of a low compliance material which prevents the balloon member from expanding by more than 40% radially and 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape. The balloon member comprises at least one pair of internal ribs which support the structure of the balloon member and prevent the balloon member from expanding longitudinally by more than 50%. The balloon member with internal ribs may be formed by dipping a mandrel, with grooves or channels formed therein, a number of times into liquid polyethylene, polyurethane or other similar material. The tubular member comprises a first lumen which carries blood between the patient and an external medical device. Another lumen is used to inflate and deflate the thin profile balloon member. Other lumens are used to measure blood pressure, introduce cardioplegia solution or drugs, and/or compensate for over-inflation of the balloon member. The tubular member is preferably bent near the distal end to allow the balloon member to be directly introduced into the blood vessel.

What is claimed:  
     
         1 . A method of occluding a blood vessel comprising: 
 directly inserting a flexible balloon member and a tubular member through an incision in the blood vessel with the balloon member in an uninflated, collapsed state during insertion, said balloon member having an outer peripheral contact width which comes in contact with the inner wall of the blood vessel during occlusion, said outer peripheral contact width being substantially narrower than the diameter of the balloon member, said tubular member combining with the balloon member to form an inflatable balloon; and    inflating the balloon member inside the blood vessel to occlude the blood vessel such that the balloon member contacts the inner wall of the blood vessel along a longitudinal length which is substantially less than the diameter of the balloon member.    
     
     
         2 . The method of  claim 1 , wherein the blood vessel is an aorta.  
     
     
         3 . The method of  claim 2 , further comprising: 
 perfusing blood through the tubular member and into the patient.    
     
     
         4 . The method of  claim 1 , further comprising: 
 monitoring blood pressure within the blood vessel using a lumen of the tubular member.    
     
     
         5 . The method of  claim 1  further comprising: 
 monitoring an amount of inflation within the balloon member using an external monitoring device.  
 
     
     
         6 . The method of  claim 5 , wherein the external monitoring device indicates when the balloon member comes in contact with the inner wall of the blood vessel during occlusion.  
     
     
         7 . A method of achieving cardiopulmonary bypass during an aortic coronary bypass procedure comprising: 
 inserting a balloon member attached to the distal end of a tubular member directly into an incision in a patient's aorta, said balloon member being maintained in an uninflated, collapsed state during insertion, said balloon member having an peripheral contact width which comes in contact with the inner wall of the aorta during occlusion, said outer peripheral contact width being substantially narrower than the diameter of the balloon member;    activating a heart-lung machine attached to the proximal end of the tubular member such that blood is perfused into the aorta; and    inflating the balloon member to occlude the aorta such that the balloon member contacts the inner wall of the aorta along a longitudinal length which is substantially less than the diameter of the balloon member.    
     
     
         8 . The method of  claim 7 , further comprising: 
 inserting a second balloon member attached to the distal end of a second tubular member through an incision made in the patient's superior vena cava, said second balloon member being maintained in an uninflated, collapsed state during insertion.    
     
     
         9 . The method of  claim 7 , further comprising: 
 introducing a cardioplegia solution into the patient's heart to stop the heart from beating; and    performing a bypass procedure on the aorta.    
     
     
         10 . The method of  claim 8 , wherein the first and second balloon members are inflated with saline solution.