Hemostatic system and components for extracorporeal circuit

Abstract

A method and system for use in the course of extracorporeal blood flow, e.g., cardiopulmonary bypass, dialysis, and angioplasty procedures, in order to reduce or minimize inflammation, excessive bleeding, and other undesirable side effects. The system can include one or more automated blood parameter sensor modules and one or more blood parameter regulating modules. The system is particularly well suited to monitor and/or regulate blood parameters that include blood analytes (e.g., biomolecules, drugs or metabolites) as well as blood functions (e.g., clotting time, fibrinolytic activity, immune response). The system is particularly well suited for use in the management of clotting (e.g., heparin/protamine) and bleeding (e.g., aprotinin).

1 . A system for use in combination with an extracorporeal blood flow circuit, the system comprising: 
 a) one or more automated sensor modules adapted to monitor, directly or indirectly, the presence of a serine protease factor, and    b) one or more regulating modules adapted to administer a protease inhibitor to a patient, wherein the sensor and regulating modules provide a real time monitor to determine effectiveness of the protease inhibitor administration.    
   
   
       2 . A method for monitoring the activity of a protease inhibitor in a patient during cardiopulmonary bypass procedure comprising the steps of: 
 a) administering to the patient a protease inhibitor;    b) placing the patient on a cardiopulmonary bypass circuit that comprises the system of  claim 1;     c) while the patient is on the cardiopulmonary bypass circuit, withdrawing a portion of blood from the circuit;    d) measuring a serine protease factor inhibited by the protease inhibitor in the withdrawn portion of blood;    e) repeating steps c) and d) during the cardiopulmonary bypass procedure; and    f) providing a real-time display responsive to the measured serine protease factor as an indicator of protease inhibitor activity during the cardiopulmonary bypass procedure.    
   
   
       3 . A method according to  claim 2  wherein the method comprises: 
 a) providing an extracorporeal blood flow circuit comprising, in the order of blood flow, a reservoir, a pump, and oxygenator, a filter, together with associated tubing, connectors and controls;    b) providing a system comprising one or more automated sensor modules adapted to monitor, directly or indirectly, the presence of the serine protease factor inhibited by the protease inhibitor; and    c) employing the sensor module(s) to monitor one or more blood parameters.    
   
   
       4 . A method according to  claim 3  wherein the sensor module provides semicontinuous and/or continuous sampling of the blood, in order to provide substantially realtime digital output readings of the monitored parameter.  
   
   
       5 . A method according to  claim 3  further comprising one or more regulating modules adapted to affect the presence, concentration and/or activity of one or more blood parameters.  
   
   
       6 . A method according to  claim 2  wherein the real time display is used to establish a dosing regimen for the protease inhibitor.  
   
   
       7 . A method according to  claim 2  wherein the protease inhibitor comprises aprotinin and the inhibited serine protease factor comprises kallikrein.  
   
   
       8 . A method according  claim 3  wherein at least one sensor module adapted to incorporate flow injection analysis (“FIA”) techniques, and that comprises: i) a blood withdrawal component with in-line access, ii) an analytical component, and iii) a readout component.  
   
   
       9 . A method according to  claim 8  wherein the sensor module provides semicontinuous and/or continuous sampling of the blood, in order to provide substantially realtime digital output readings of the monitored parameter.