Systems and methods for effecting the total and partial occlusion of the aorta of a living being

Abstract

Disclosed are systems and method for effecting the total and partial occlusion of a blood vessel, e.g., the aorta. The systems include a balloon catheter, a reservoir for an inflation fluid, a switch, and a pressure regulator/accumulator. The systems are configured to operate in a first mode and a second mode as established by the switch. During the first mode the balloon is fully inflated by the inflation fluid to completely occlude the blood vessel. During the second mode the balloon is partially inflated so that blood can flow past the balloon in the blood vessel. The pressure regulator/accumulator includes a chamber for receipt of the inflation fluid during the second mode to automatically regulate the pressure within the balloon to a desired operating pressure. The system is configured to operate in a third mode to prime the pressure regulator/accumulator to establish a desired operating pressure in the second mode.

We claim: 
     
         1 . An endovascular system for selectively effecting the total and partial occlusion of a blood vessel of a living being, the vessel including blood therein, said system being configured for selective control by a user to operate in a first mode of operation and a second mode of operation, said system comprising:
 a catheter having a distal end portion and at least one lumen extending through at least a portion of said catheter, said at least one lumen being configured to be selectively coupled a fluid reservoir to have a metered volume of a sterile liquid introduced into said at least one lumen when said system is in said first mode of operation;   a balloon located adjacent said distal end portion of said catheter, said balloon having a hollow interior coupled to said at least one lumen for selective receipt of said sterile liquid from said fluid reservoir to result in the full inflation of said balloon when said system is in said first mode of operation, thereby completely occluding the vessel to preclude blood from flowing past said balloon when said system is in said first mode of operation; and   a pressure regulator operative in response to manual selection by the user to operate in said second mode of operation, said pressure regulator being configured when said system is in said second mode of operation to be coupled to said interior of said balloon via said at least one lumen to receive a portion of said sterile liquid from said balloon, whereupon said balloon is partially inflated to enable some blood in the vessel to flow past said balloon, said pressure regulator automatically regulating the pressure within said partially inflated balloon to a desired pressure when said system is in said second mode of operation.   
     
     
         2 . The system of  claim 1 , wherein said system is configurable so that said desired pressure is adjustable. 
     
     
         3 . The system of  claim 2 , wherein said pressure regulator comprises an expandable and collapsible chamber in which said sterile liquid is disposed, said expandable and collapsible chamber being configured to receive a predetermined volume of said sterile liquid introduced therein to result in the application of a predetermined amount of bias force on said predetermined volume of said sterile liquid, whereupon said adjustable desired pressure is produced in said partially inflated balloon. 
     
     
         4 . The system of  claim 3 , wherein said expandable and collapsible chamber comprises a resilient diaphragm. 
     
     
         5 . The system of  claim 4 , wherein said pressure regulator comprises a housing and wherein said resilient diaphragm is located within said housing. 
     
     
         6 . The system of  claim 1 , wherein said balloon is configured to apply pressure in the range of approximately 40-250 mm Hg to the blood in the vessel. 
     
     
         7 . The system of  claim 1 , wherein said at least one lumen comprises an inflation lumen and a pressure-monitoring lumen, and wherein said balloon includes a proximal end portion and a distal end portion, said hollow interior of said balloon being coupled to said inflation lumen at said distal end portion of said catheter, said pressure-monitoring lumen extending through said hollow interior of said balloon and exiting said balloon at said distal end portion of said balloon, said pressure monitoring lumen having a distal free end including a pressure-sensing opening. 
     
     
         8 . The system of  claim 7 , wherein said pressure-monitoring lumen includes a proximal end portion configured to be coupled to a measuring instrument to provide an indication of the pressure within the blood vessel at said pressure-sensing opening. 
     
     
         9 . The system of  claim 8 , wherein said distal free end comprises an atraumatic tip having a plurality of fingers located adjacent said pressure-sensing opening, said fingers projecting outwardly. 
     
     
         10 . The system of  claim 1 , wherein said system is configured to be in a third mode of operation wherein the fluid reservoir and said pressure regulator are in fluid communication with each other and isolated from said balloon. 
     
     
         11 . A catheter for a system for effecting the total and partial occlusion of a blood vessel of a living being, the vessel including blood therein, the system being configured for a first mode of operation and a second mode of operation, the first mode of operation occluding the blood vessel, the second mode of operation partially occluding the blood vessel, said catheter comprising:
 a distal end portion;   at least one lumen extending through at least a portion of said catheter, said at least one lumen being configured to be selectively coupled to a fluid reservoir to have a metered volume of a sterile liquid introduced into said at least one lumen to cause the system to be in the first mode of operation; and   a balloon located adjacent said distal end portion of said catheter, said balloon having a hollow interior coupled to said at least one lumen for selective receipt of the sterile liquid from the fluid reservoir to result in the full inflation of said balloon whereupon the system will be in the first mode of operation, thereby completely occluding the vessel to preclude blood from flowing past said balloon when said system is in said first mode of operation, said catheter being configured to be coupled to an accumulator when the system is in the second mode of operation whereupon the accumulator automatically receives a portion of the sterile liquid from said balloon to cause the balloon to be partially inflated to enable some blood in the vessel to flow past said balloon.   
     
     
         12 . The catheter of  claim 11 , wherein said balloon is configured to apply pressure in the range of approximately 40-250 mm Hg to the blood in the vessel. 
     
     
         13 . The catheter of  claim 11 , wherein said at least one lumen comprises an inflation lumen and a pressure-monitoring lumen, and wherein said balloon includes a proximal end portion and a distal end portion, said hollow interior of said balloon being coupled to said inflation lumen at said distal end portion of said catheter, said pressure-monitoring lumen extending through said hollow interior of said balloon and exiting said balloon at said distal end portion of said balloon, said pressure monitoring lumen having a distal free end including a pressure-sensing opening. 
     
     
         14 . The catheter of  claim 13 , wherein said pressure-monitoring lumen includes a proximal end portion configured to be coupled to a measuring instrument to provide an indication of the pressure within the blood vessel at said pressure-sensing opening. 
     
     
         15 . The catheter of  claim 13 , wherein said distal free end comprises an atraumatic tip having a plurality of fingers located adjacent said pressure-sensing opening, said fingers projecting outwardly. 
     
     
         16 . A method for effecting the total and partial occlusion of a blood vessel in the body of a living being, the blood vessel including blood therein, said method comprising:
 introducing a catheter into the blood vessel of the being, said catheter having a distal end portion and at least one lumen extending through at least a portion of said catheter and an inflatable balloon located adjacent said distal end portion and coupled to said at least one lumen;   selectively introducing a sterile liquid into said at least one lumen to fully inflate said balloon during a first mode of operation, whereupon said fully inflated balloon completely occludes the blood vessel to preclude blood from flowing past said balloon;   selectively coupling said balloon to a pressure regulator during a second mode of operation, whereupon said pressure regulator receives a portion of said sterile liquid from said balloon so that said balloon is partially inflated to enable some blood in the blood vessel to flow past said balloon, said pressure regulator automatically regulating the pressure within said balloon to a desired pressure during said second mode of operation.   
     
     
         17 . The method of  claim 16 , additionally comprising sensing the amount of pressure applied to the blood in the blood vessel by said balloon. 
     
     
         18 . The method of  claim 17 , wherein said desired pressure is adjustable. 
     
     
         19 . The method of  claim 18 , wherein said pressure regulator comprises an expandable and collapsible chamber in which said sterile liquid is disposed, said method additionally comprising introducing a predetermined volume of said sterile liquid into said expandable and collapsible chamber to result in the application of a predetermined amount of bias force on said predetermined volume of said sterile liquid, whereupon said adjustable desired pressure is produced in said partially inflated balloon. 
     
     
         20 . The method of  claim 19 , additionally comprising initially introducing said predetermined volume of said sterile liquid into said expandable and collapsible chamber to remove any air from within said expandable and collapsible chamber. 
     
     
         21 . The method of  claim 20 , wherein said expandable and collapsible chamber includes a resilient diaphragm configured to apply said predetermined amount of a bias force upon the introduction of said predetermined volume of said sterile liquid into said expandable chamber. 
     
     
         22 . The method of  claim 16 , wherein the body of the living being has an inferior portion and wherein said method additionally comprises re-perfusing the inferior portion of the being's body by radial infusion. 
     
     
         23 . The method of  claim 22 , wherein said re-perfusing is accomplished while said balloon is partially inflated. 
     
     
         24 . The method of  claim 16 , additionally comprising selectively removing said sterile liquid from said balloon to thereby deflate said balloon, whereupon said catheter can be removed from the body of the living being. 
     
     
         25 . The method of  claim 16 , wherein said blood vessel comprises the aorta.