Mobile Extracorporeal Life Support Systems and Related Methods

Abstract

Extracorporeal life support (ECLS) systems, devices and methods wherein a portable ECLS device is used to deliver cardiovascular support to a humans or animal patient (or harvested organ(s)) during pre-hospital or inter-hospital transport.

1 .- 59 . (cancelled) 
     
     
         60 . An extracorporeal system comprising a conduit, a pump, a monitoring unit, a controller and a bubble sensor, wherein:
 the pump circulates fluid through the conduit;   the bubble sensor senses when a gas-liquid transition occurs within the conduit;   the bubble sensor transmits a signal to at least the monitoring unit when a gas-liquid transition is sensed and the monitoring unit is programmed to issue an alarm or notification in response to the sensing of a gas-liquid transition by the bubble sensor;   the controller is programmed to cause the system to take at least one remedial action in response to the sensing of a gas-liquid transition by the bubble sensor; and   wherein the controller is further programmed to perform a system test and a bubble sensor test while the conduit is initially being primed with fluid or during priming of the conduit with fluid and to provide a bubble sensor test failure indication and a system test failure indication;   wherein the bubble sensor test failure indication is separate from the system test failure indication.   
     
     
         61 . A system according to  claim 60  wherein a single gas-liquid transition occurs in the conduit during priming of the conduit and the bubble sensor test is timed to detect that single gas-liquid transition. 
     
     
         62 . A system according to  claim 60  wherein multiple gas liquid transitions occur during priming, of the conduit and the bubble sensor test is timed to detect at least one of the gas-liquid transitions. 
     
     
         63 . A system according to  claim 60  wherein gas is volitionally introduced into the conduit to create at least one gas-liquid transition for purposes of conducting the bubble sensor test. 
     
     
         64 . A system according to  claim 60  wherein the bubble sensor test and system test are performed sequentially. 
     
     
         65 . An extracorporeal device comprising:
 a pump;   a bubble detector; and   a controller, the controller being programmed to perform a system test and a bubble detector test during priming of the extracorporeal device and to cause a system test alarm or notification to be emitted if the system test fails and to cause a bubble detector test alarm or notification to be emitted if the bubble detector test fails, and wherein the bubble detector test alarm or notification is emitted separately from the system test alarm or notification in the event that both the system test and bubble detector test are failed.   
     
     
         66 . A device according to  claim 65  wherein a single gas-liquid transition occurs in a conduit during priming and the bubble detector test is timed to detect that single gas-liquid transition. 
     
     
         67 . A device according to  claim 65  wherein multiple gas liquid transitions occur during priming and the bubble detector test is timed to detect at least one of the gas-liquid transitions. 
     
     
         68 . A device according to  claim 65  wherein gas is volitionally introduced into a conduit of the device to create at least one gas-liquid transition for purposes of conducting the bubble detector test. 
     
     
         69 . A device according to  claim 65  wherein the bubble detector test and system test are performed sequentially. 
     
     
         70 . A device according to  claim 65  wherein the extracorporeal device comprises an inlet which is connectable to vasculature of a human or animal subject or harvested organ(s); an outlet which is also connectable to the vasculature of the subject or organ(s); and gas exchange apparatus operable to a) receive deoxygenated blood from the vasculature via the inlet, b) oxygenate the blood and c) infuse the oxygenated blood into the vasculature via the outlet. 
     
     
         71 . A system according to  claim 60  wherein:
 after being primed with fluid, the conduit is connectable to a subject's body and, when the conduit is so connected, the pump is operable to create negative pressure within the conduit to thereby withdraw a body fluid from the subject's body through the conduit; 
 the system further comprises a pressure or flow sensor which senses pressure or flow within the conduit and transmits indicia of the sensed pressure or flow to the controller; and 
 the controller is programmed to determine when the sensed pressure or flow has fallen below a predetermined minimum and to thereafter issue one or more control signals to the pump causing the pump to slow or stop until the sensed pressure or flow has risen above the predetermined minimum, 
 
     
     
         72 . A system according to  claim 71  wherein the pressure or flow sensor is located on the conduit and the controller is programed to receive and process one or more signals from the sensor and to control the pump based on said signals. 
     
     
         73 . A system according to  claim 71 , further comprising a user interface, wherein a warning message is displayed on the user interface if the controller issues one or more control signals to the pump which cause the pump to slow or stop based on signals received from the sensor. 
     
     
         74 . A system according to  claim 71  wherein sensor feedback control may be turned on or off. 
     
     
         75 . A system according to  claim 65  further comprising:
 an inlet which is connectable to vasculature of a human or animal subject or harvested organ(s); 
 an outlet which is also connectable to the vasculature of the subject or harvested organ(s); and 
 gas exchange apparatus operable to a) receive deoxygenated blood from the vasculature via the inlet, b) oxygenate the blood and c) infuse the oxygenated blood into the vasculature via the outlet. 
 
     
     
         76 . A system according to  claim 65  wherein:
 the system further comprises a conduit that is connectable to a subject's body; 
 the pump is operable to create negative pressure within the conduit to thereby withdraw a body fluid from the subject's body through the conduit; 
 the system further comprises a pressure or flow sensor which senses pressure or flow within the conduit and transmits indicia of the sensed pressure or flow to the controller; and 
 the controller is programmed to determine when the sensed pressure or flow has fallen below a predetermined minimum and to thereafter issue one or more control signals to the pump causing the pump to slow or stop until the sensed pressure or flow has risen above the predetermined minimum. 
 
     
     
         77 . A system according to  claim 76  wherein the pressure or flow sensor is located on the conduit and the controller is programed to receive and process one or more signals from the sensor and to control the pump based on said signals, 
     
     
         78 . A system according to  claim 76 , further comprising a user interface, wherein a warning message is displayed on the user interface if the controller issues one or more control signals to the pump which cause the pump to slow or stop based on signals received from the sensor, 
     
     
         79 . A system according to  claim 76  wherein sensor feedback control may be turned on or off.