System and method for low profile occlusion balloon catheter

Abstract

An occlusion catheter system includes an inflation catheter member and an occlusion balloon. The proximal and distal balloon ends are connected to the inflation catheter between the proximal and distal catheter ends. A distal pressure sensor is attached to the inflation catheter member between the proximal balloon end and the atraumatic tip. An inflatable spine is connected to the inflation catheter. The proximal spine end is connected to the inflation catheter near the proximal balloon end and the distal spine end is connected to the inflation catheter near the distal balloon end. The occlusion balloon and the inflatable spine are configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in a partially inflated configuration.

1 - 3 . (canceled) 
     
     
         4 . An occlusion catheter system for at least partial occlusion of an aorta having an internal aortic wall, the occlusion catheter system comprising:
 an inflation hub;   a proximal catheter member extending from the inflation hub;   a distal catheter member distally terminating with an atraumatic tip;   an occlusion balloon interposed between the proximal catheter member and the distal catheter member, the occlusion balloon defining an external balloon surface and an internal balloon space;   a stiffener member extending from the inflation hub, through the proximal catheter member and the occlusion balloon and into the distal catheter member;   an inflation lumen defined between the stiffener member and the proximal catheter member, the inflation lumen extending between, and being in fluid communication with, the inflation hub at a proximal end of the inflation lumen and the internal balloon space at a distal end of the inflation lumen;   a pressure sensor configured to measure central aortic pressure upstream of the occlusion balloon or downstream of the occlusion balloon;   a control hub in communication with the pressure sensor and having a display screen configured to display central aortic pressure measurements received from the pressure sensor; and   a pump in selective fluid communication with the inflation hub and configured to at least one of introduce or withdraw a pressurized fluid from the internal balloon space,   whereby at least portions of the external balloon surface is configured to contact the internal aortic wall upon introduction of the pressurized fluid via the pump, through the inflation hub, the inflation lumen and into the internal balloon space.   
     
     
         5 . The occlusion catheter system of  claim 4 , wherein the distal catheter member includes a distal port fluidly communicating an exterior of the occlusion catheter system with the pressure sensor, the pressure sensor being positioned remotely from distal port and configured to measure central aortic pressure upstream of the occlusion balloon. 
     
     
         6 . The occlusion catheter system of  claim 5 , wherein the distal port is positioned proximate, or on, the atraumatic tip. 
     
     
         7 . The occlusion catheter system of  claim 5 , wherein the stiffener member defines an internal lumen in fluid communication with the inflation hub at a proximal end of the stiffener member and with the distal port at a distal end of the stiffener member. 
     
     
         8 . The occlusion catheter system of  claim 7 , wherein the inflation hub comprises a first port in fluid communication with the inflation lumen and a second port in fluid communication with the internal lumen of the stiffener member. 
     
     
         9 . The occlusion catheter system of  claim 4 , wherein the pressure sensor is positioned along the distal catheter member and configured to measure central aortic pressure upstream of the occlusion balloon. 
     
     
         10 . The occlusion catheter system of  claim 9 , wherein the control hub is mounted to the proximal catheter member and the pressure sensor is in wired connection with the control hub through the distal catheter member, the occlusion balloon and the proximal catheter member. 
     
     
         11 . The occlusion catheter system of  claim 9 , wherein the pressure sensor is a first pressure sensor and further comprising a second pressure sensor positioned along the proximal catheter member and configured to measure central aortic pressure downstream of the occlusion balloon. 
     
     
         12 . The occlusion catheter system of  claim 11 , wherein:
 the control hub is mounted to the proximal catheter member,   the first pressure sensor is in wired connection with the control hub through the distal catheter member, the occlusion balloon and the proximal catheter member, and   the second pressure sensor is in wired connection with the control hub through the proximal catheter member.   
     
     
         13 . The occlusion catheter system of  claim 11 , further comprising a controller configured to receive the central aortic pressure measurement upstream of the occlusion balloon and the central aortic pressure measurement downstream of the occlusion balloon and to communicate with the pump to maintain at least one of (i) a target pressure upstream of the occlusion balloon, (ii) a target pressure downstream of the occlusion balloon, (iii) a target pressure ratio between the upstream and downstream central aortic pressure measurements or (iv) a target pressure ratio between the upstream and downstream central aortic pressure measurements within a range, by continually adjusting a volume of fluid introduced into the internal balloon space. 
     
     
         14 . The occlusion catheter system of  claim 4 , wherein the control hub is mounted to the proximal catheter member. 
     
     
         15 . The occlusion catheter system of  claim 14 , wherein the control hub further comprises a controller and a power source, the controller being configured to receive the central aortic pressure measurements from the pressure sensor and communicate with the pump to at least one of introduce or withdraw the pressurized fluid from the internal balloon space. 
     
     
         16 . The occlusion catheter system of  claim 15 , wherein the control hub further includes the pump. 
     
     
         17 . The occlusion catheter system of  claim 4 , further comprising a controller configured to receive the central aortic pressure measurements from the pressure sensor and communicate with the pump to at least one of introduce or withdraw the pressurized fluid from the internal balloon space. 
     
     
         18 . The occlusion catheter system of  claim 4 , wherein the occlusion balloon is a first balloon and further comprising at least a second, independently inflatable balloon. 
     
     
         19 . The occlusion catheter system of  claim 18 , wherein the first and second balloons are interposed between the proximal catheter member and the distal catheter member. 
     
     
         20 . The occlusion catheter system of  claim 4 , wherein the occlusion balloon includes an internal flow channel selectively fluidly communicating an upstream portion of the aorta with a downstream portion of the aorta to selectively permit partial flow of blood past the occlusion balloon. 
     
     
         21 . The occlusion catheter system of  claim 4 , wherein the pressure sensor is positioned along the proximal catheter member and configured to measure central aortic pressure downstream of the occlusion balloon. 
     
     
         22 . The occlusion catheter system of  claim 4 , wherein the pump comprises a syringe. 
     
     
         23 . The occlusion catheter system of  claim 4 , wherein the stiffener member is comprised of nitinol. 
     
     
         24 . A control system for an occlusion catheter system having an occlusion balloon for at least partial occlusion of a patient vessel and at least one pressure sensor configured to acquire data representing one or more blood pressure values in the vessel upstream or downstream of the occlusion balloon, the control system comprising:
 a pump configured to introduce fluid and withdraw fluid from the occlusion balloon;   a controller in electrical communication with the pump and the at least one pressure sensor, the controller being configured to:
 i. receive the data from the at least one pressure sensor, and 
 ii. in an auto mode of operation:
 (a) receive at least one pressure setpoint value, and 
 (b) control, using the pump, an amount of fluid in the occlusion balloon to bring the one or more blood pressure values to the at least one pressure setpoint value or maintain the one or more blood pressure values at the at least one pressure setpoint value. 
 
   
     
     
         25 . The control system of  claim 24 , wherein the one or more blood pressure values acquired by the at least one pressure sensor include a mean arterial pressure (MAP) value in the vessel upstream or downstream of the occlusion balloon. 
     
     
         26 . The control system of  claim 25 , wherein the one or more blood pressure values include the MAP value in the vessel upstream of the occlusion balloon and the MAP value in the vessel downstream of the occlusion balloon, and the at least one pressure setpoint value includes an upstream MAP setpoint value and a downstream MAP setpoint value. 
     
     
         27 . The control system of  claim 24 , wherein the controller is further configured to receive a selection of the at least one setpoint value from a user. 
     
     
         28 . The control system of  claim 24 , wherein the controller includes a manual mode of operation in which the controller is configured to permit manual introduction and withdrawal of the fluid from the occlusion balloon. 
     
     
         29 . The control system of  claim 24 , wherein the controller includes a manual plus alert mode of operation in which the controller is configured to permit manual introduction and withdrawal of the fluid from the occlusion balloon and to provide a visual and/or audible alarm when the one or more blood pressure values exceed one or more pre-set parameters. 
     
     
         30 . The control system of  claim 24 , wherein the controller is further configured to output the data received from the at least one pressure sensor to an external device. 
     
     
         31 . The control system of  claim 24 , wherein the pump and the controller are arranged in a common housing. 
     
     
         32 . The control system of  claim 25 , wherein:
 the one or more blood pressure values acquired by the at least one pressure sensor include the MAP value in the vessel upstream of the occlusion balloon and the MAP value in the vessel downstream of the occlusion balloon;   the at least one pressure setpoint value includes a range of pressure ratios between the MAP value in the vessel upstream of the occlusion balloon and the MAP value in the vessel downstream of the occlusion balloon; and   in the auto mode of operation, the controller is configured to bring a ratio between the MAP values in the vessel upstream and downstream of the occlusion balloon within the range.