Abstract:
A system and method for monitoring the arterial gas concentrations of a patient receiving percutaneous oxygenator support. The system comprises a percutaneous oxygenator for providing medical gases to the venous system of the patient via a catheter. Gases are also removed from the venous system via a catheter. The concentrations and flow rates of the gases provided and removed from the patient are monitored. A CPU analyzes the concentration and flow rate information to compute the arterial gas concentration of the patient.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention is directed to the field of blood gas monitoring, specifically the non-invasive monitoring of arterial blood gas concentration. 
       BACKGROUND OF THE INVENTION 
       [0002]    Percutaneous oxygenators have been described in the prior art for more than twenty years. As disclosed in U.S. Pat. No. 4,911,689 to Hattler, a percutaneous oxygenator comprises a number of hollow, gas-permeable fibers. This device is inserted through a single small incision into a patient&#39;s venous system. When an oxygen supply is attached to the device, oxygen flows through the hollow fibers and diffuses through the wall of the fibers into the patient&#39;s blood. Conversely, carbon dioxide from the blood diffuses back across the fiber wall, up the fibers and out of the system to the atmosphere. While improvements to this design have been made, to date, no percutaneous oxygenator is able to fully provide the necessary oxygenation required. At best performance, prior art oxygenators may supply 50%-70% of required metabolic oxygen. Therefore, it has been proposed that percutaneous oxygenators may be used to augment natural patient respiration or mechanical ventilation support already provided to the patient through the patient&#39;s airway. The augmentation of the natural patient respiration may allow a patient to avoid mechanical ventilation. For a patient who is already receiving mechanical ventilation support, the introduction of percutaneous oxygenator support would reduce the demand for aggressive ventilatory treatment. This is desirable due to the fact that aggressive ventilatory treatment may cause lung injury or increase the cardiac stresses on the patient. 
         [0003]    Percutaneous oxygenator technology is not limited in scope to merely the delivery of supplemental oxygen. The same catheterization technique of the patient with gas-permeable membrane fibers can be used to deliver a variety of medical gases intravenously into the patient&#39;s blood stream. This technique may be used to deliver anesthetic agent, or other medical gases such as carbon dioxide (CO 2 ), nitrogen (N), nitrous oxide (NO), or helium (He). 
         [0004]    Typically, when a patient is receiving ventilatory support, the effectiveness of this support is monitored using a spirometer and respiratory gas monitor such as the Datex-Ohmeda S5 Gas Analyzer. The data collected from the spirometer and gas monitor is used to monitor the composition, flow rates, and exchange rates of the gases inspired and expired by the patient. However, patients receiving mechanical ventilatory support often have compromised gas exchange in their lungs. A patient receiving supplemental percutaneous oxygenator support often results in the erroneous prediction or estimation of the patient&#39;s blood gas concentration due to mismatched blood-gas exchange and compromised gas diffusion across the alveoli. Solutions to this problem have been invasive and time-consuming. Typically, blood samples must be drawn intermittently and individually analyzed to assess the patient&#39;s actual blood gas concentration and evaluate the adequacy of the combined treatment. While systems have been developed to automatically sample and analyze the patient&#39;s blood gas concentration, such as that disclosed in U.S. Pat. No. 4,516,580 to Polanyi, these systems require the invasive arterial insertion of a costly multi-parameter, multi-sensor transducer. 
         [0005]    Despite improvements, all of the aforementioned systems are limited in their ability to continuously monitor a patient&#39;s blood gas concentration. All of these systems and methods require the taking of an actual blood sample. This inherently reduces the sampling rate of the patient&#39;s blood and additional time is required to compute the blood gas concentration. These delays produce a lag time that can inaccurately display the patient&#39;s blood gas concentration. 
         [0006]    It is therefore desirable for a system by which the blood gas concentration of a patient receiving both mechanical ventilation and percutaneous oxygenator support may be determined without the introduction of an invasive intravascular transducer. It is also desirable for a system by which components already used in conjunction with or associated with the mechanical ventilation and/or percutaneous oxygenation of a patient are used to determine patient blood gas concentration. 
       SUMMARY OF THE INVENTION 
       [0007]    An embodiment of the present invention is a system that comprises exchange catheter gas composition data, such as the composition and flow rates in and out of a percutaneous oxygenator to determine patient venous blood gas concentration resulting in continuous computation of patient arterial blood gas concentration. 
         [0008]    In a further embodiment of the present invention, the exchange catheter gas composition data combines with pre-existing gas analysis data from the mechanical ventilation system comprising gas analyzer and spirometry data to continuously compute cardiac output trending, blood gas exchange analysis, and arterial gas concentrations. 
         [0009]    It is a further aspect of the present invention that the present invention provides a continuous and noninvasive solution to the computation of arterial blood gas concentration. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The drawings illustrate the best mode presently contemplated of carrying out the invention. In the drawings: 
           [0011]      FIG. 1  is a schematic diagram of the patient analysis system of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0012]      FIG. 1  depicts a schematic diagram of a patient receiving both mechanical ventilation as well as percutaneous oxygenator support. The patient  10  receives mechanical ventilation support from a ventilator  12  via a patient interface  14  such as a face mask or endotracheal tube. The patient&#39;s mechanical ventilation support is augmented by a percutaneous oxygenator  16  which introduces an additional supply of oxygen to the patient venous blood via a gas exchange catheter  18  which is inserted into the patient&#39;s superior or inferior vena cava. 
         [0013]    In a typical clinical setting where a patient is undergoing mechanical ventilation support the ventilator  12  is used in conjunction with a spirometer  20  and a gas analyzer  22  which receive samples of the gas inspired and expired by the patient  10  via a gas sampling tube  24 . Alternatively, mainstream gas analyzers that measure gas concentration directly from the patient gas stream without having the gases sampled via a tube may also be used. The spirometer  20  monitors the volume and flow rate of the air that is inspired and expired by the patient. The gas analyzer  22  derives the concentrations of the different component gases breathed by the patient  10 . 
         [0014]    Referring back to the present invention as depicted in  FIG. 1 , a CPU  26  collects data from a variety of sources including the ventilator  12 , percutaneous oxygenator  16 , the spirometer  20 , and the gas analyzer  22 . Then the CPU processes this data through a series of algorithms  28  by which the patient&#39;s blood gas concentration  30  is derived. 
         [0015]    The present invention will be described in consideration of the exchange of oxygen to the venous blood stream and the related computation of the oxygen exchange and arterial oxygen concentration. However, it is understood that a similar device arrangement and method can be used to compute other gas exchanges and arterial concentrations, such as carbon dioxide (CO 2 ), nitrogen (N), nitrous oxide (NO), helium (He), carbon monoxide (CO), or anesthetic gases. As previously stated, the CPU  26  receives data relating to the patient&#39;s blood gas concentration from a variety of sources connected to the patient. As the ventilator provides inspiratory support to the patient  14 , the concentration of inspired oxygen  32  is provided to CPU  26 . The spirometer  20  provides data to the CPU  26  representing the inspiratory flow rate  34  and the expiratory flow rate  36 . The gas analyzer  22  provides CPU  26  with data representative of the concentration of expired oxygen  38  of the patient  10 . 
         [0016]    As additional oxygen support is provided to the patient by the percutaneous oxygenator  16 , the individual flow rates of the component gases entering the catheter  18  are known either by the manual control settings of the gases by the clinician or by the measurement of the gas concentration and flow rate by a separate component downstream (not pictured). The gas concentration and flow rate data, namely the concentration of oxygen going into the catheter  40  and the flow rate of oxygen into the catheter  42  are sent to CPU  26 . As gases exit the distal end of the catheter  18 , the concentration of the component gases are determined by a second gas analyzer  44  that provides data representative of the concentration of oxygen  46  coming out of the catheter  18  to CPU  26 . The total flow of the gases out of the catheter  18  is measured by a flow sensor  48  and is provided to the CPU  26  as the total flow out of the catheter  50 . 
         [0017]    The CPU  26  uses the data that it has received, as described above, with a variety of algorithms to be herein described further. By using the law of conservation of mass, the gas exchange and arterial oxygen concentration can be computed as herein described. Included Table I is a summary of the variables used in the following equations, a description of the variable, the source of this value, and an associated reference number if applicable. 
         [0000]    
       
         
               
               
               
               
             
           
               
                 TABLE I 
               
               
                   
               
               
                   
                   
                   
                 Ref. 
               
               
                 Variables 
                 Description 
                 Source 
                 # 
               
               
                   
               
             
             
               
                 V h   
                 Effective gas exchange volume 
                 Calculated (Eq. 1) 
                 — 
               
               
                   
                 of the intravenous gas 
               
               
                   
                 exchange catheter 
               
               
                 C O2out   
                 Concentration of O2 out of the 
                 Gas Analyzer (44) 
                 46 
               
               
                   
                 catheter 
               
               
                 F O2in   
                 Flow of O2 into the catheter 
                 P.O. (16) 
                 42 
               
               
                 F tot _out 
                 Total Flow out of the catheter 
                 Flow Sensor (48) 
                 50 
               
               
                 K eff   
                 Gas equilibration coefficient 
                 Constant/Known 
                 — 
               
               
                 C venousO2   
                 Concentration of venous O2 
                 Calculated (Eq. 2) 
                 — 
               
               
                 CO 
                 Average Cardiac Output 
                 Calculated (Eq. 3) 
                 — 
               
               
                 C artO2   
                 Average Concentration of 
                 Calculated (Eq. 7) 
                 30 
               
               
                   
                 arterial O2 
               
               
                 C inspO2   
                 Concentration of inspired O2 
                 Ventilator (12) 
                 32 
               
               
                 F insp   
                 Flow of inspired gases 
                 Spirometer (20) 
                 34 
               
               
                 C expO2   
                 Concentration of expired O2 
                 Gas Analyzer (22) 
                 38 
               
               
                 C O2in   
                 Concentration of O2 into the 
                 P.O. (16) 
                 40 
               
               
                   
                 catheter 
               
               
                 C returnO2   
                 Concentration of venous 
                 Calculated (Eq. 6) 
                 — 
               
               
                   
                 return O2 
               
               
                 F exp   
                 Flow of expired gases 
                 Spirometer (20) 
                 36 
               
               
                   
               
             
          
         
       
     
         [0018]    By definition, the mixed venous concentration of oxygen entering the right atria can be computed using the gas equilibration coefficient, K eff , which is known to the system by the design or calibration of the percutaneous oxygenator  16 , 
         [0000]    
       
         
           
             
               
                 
                   
                     
                       V 
                       h 
                     
                     * 
                     
                       
                          
                         
                           ( 
                           
                             C 
                             
                               
                                 O 
                                 2 
                               
                                
                               out 
                             
                           
                           ) 
                         
                       
                       
                          
                         t 
                       
                     
                   
                   = 
                   
                     
                       F 
                       
                         
                           O 
                           2 
                         
                          
                         i 
                          
                         
                             
                         
                          
                         n 
                       
                     
                     - 
                     
                       [ 
                       
                         
                           C 
                           
                             
                               O 
                               2 
                             
                              
                             out 
                           
                         
                         * 
                         
                           F 
                           tot_out 
                         
                       
                       ] 
                     
                     - 
                     
                       
                         K 
                         eff 
                       
                       * 
                       
                         [ 
                         
                           
                             C 
                             
                               
                                 O 
                                 2 
                               
                                
                               out 
                             
                           
                           - 
                           
                             C 
                             
                               
                                 venous 
                                  
                                 O 
                               
                               2 
                             
                           
                         
                         ] 
                       
                     
                   
                 
               
               
                 
                   ( 
                   
                     Eq 
                     . 
                     
                         
                     
                      
                     1 
                   
                   ) 
                 
               
             
           
         
       
     
         [0019]    At steady state and in the catheter flow condition labeled as  — 1, the derivative of C O2out     —     1  with respect to time, tends to zero, giving the steady state concentration of the venous blood to the right atria to be: 
         [0000]        C   venousO     2—     1 =( C   O     2     out     —     1   −F   tot     —     out )− F   O     2     in     —     1   +K   eff   *C   O     2     out   (Eq. 2) 
         [0020]    Now considering the gas exchange in the lungs, by integrating over a breath, the arterial oxygen concentration can be found by solving the following integral equation: 
         [0000]      ∫( CO*C   artO     2   ) dt =∫( CO*C   venousO     2—     1   +C   inspO     2     *F   insp   −C   expO     2     *F   exp ) dt   (Eq. 3) 
       Where CO is the cardiac output and can be found by using two different settings of C O2in    42  or F O2in    40 . 
       [0021]    Now assuming that the concentration of O 2  in the catheter is being altered from a condition — 1 to condition — 2, and set in a duration that is much shorter than the recirculation time of blood, but is sufficiently long for a steady state to settle, the uptake of O2 surrounding the compartment around the catheter  18  and the vena cava at a steady state in the two conditions are described by the two gas mass balance equations, 
         [0000]      ∫( F   O     2     in     —     1 −( C   O     2     out     —     1   *F   tot     —     out     —     1 )) dt =∫( CO *( C   returnO     2     −C   venousO     2—     1 )) dt   (Eq. 4) 
         [0000]      ∫( F   O     2     in     —     2 −( C   O     2     out     —     2   *F   tot     —     out     —     2 )) dt =∫( CO *( C   returnO     2     −C   venousO     2—     2 )) dt   (Eq. 5) 
         [0000]    Where the indices  — 1 and  — 2 indicate the settings or measurements under condition — 1 and condition — 2, respectively, of the oxygen concentration into the catheter  18 . C returnO2  is the flow averaged concentration of mixed venous blood in the superior or inferior vena cava and remains constant during the two settings of O2 concentration into the catheter. Furthermore, assuming that the gas flow and concentration into the catheter  18 , C returnO2  and cardiac output (CO) are constant over the two integral period, the integral expression may be removed from the integration and multiplied by the duration and can be divided out from both sides of the equations. 
         [0022]    By subtracting the equation in condition — 1 from the equation in condition — 2, the unknown variable C returnO2  is eliminated and after rearranging the resulting equation, the cardiac output is obtained: 
         [0000]    
       
         
           
             
               
                 
                   CO 
                   = 
                   
                     
                       
                         
                           
                             ( 
                             
                               
                                 ( 
                                 
                                   
                                     F 
                                     
                                       
                                         O 
                                         2 
                                       
                                        
                                       in_ 
                                        
                                       1 
                                     
                                   
                                   - 
                                   
                                     ( 
                                     
                                       
                                         C 
                                         
                                           
                                             O 
                                             2 
                                           
                                            
                                           out_ 
                                            
                                           1 
                                         
                                       
                                       * 
                                       
                                         F 
                                         
                                           tot_out 
                                            
                                           _ 
                                            
                                           1 
                                         
                                       
                                     
                                     ) 
                                   
                                 
                                 ) 
                               
                               - 
                             
                           
                         
                       
                       
                         
                           
                             ( 
                             
                               ( 
                               
                                 
                                   F 
                                   
                                     
                                       O 
                                       2 
                                     
                                      
                                     in_ 
                                      
                                     2 
                                   
                                 
                                 - 
                                 
                                   ( 
                                   
                                     
                                       C 
                                       
                                         
                                           O 
                                           2 
                                         
                                          
                                         out_ 
                                          
                                         2 
                                       
                                     
                                     * 
                                     
                                       F 
                                       
                                         tot_out 
                                          
                                         _ 
                                          
                                         2 
                                       
                                     
                                   
                                   ) 
                                 
                               
                               ) 
                             
                             ) 
                           
                         
                       
                     
                     
                       ( 
                       
                         
                           C 
                           
                             venous 
                              
                             
                                 
                             
                              
                             
                               O 
                               2 
                             
                              
                             _ 
                              
                             2 
                           
                         
                         - 
                         
                           C 
                           
                             venous 
                              
                             
                                 
                             
                              
                             
                               O 
                               2 
                             
                              
                             _ 
                              
                             1 
                           
                         
                       
                       ) 
                     
                   
                 
               
               
                 
                   ( 
                   
                     Eq 
                     . 
                     
                         
                     
                      
                     6 
                   
                   ) 
                 
               
             
           
         
       
     
         [0023]    By substituting the cardiac output calculated in Equation 6 back into the arterial blood gas equation, with C venousO2  computed from Equation 2, solving Equation 3 yields the concentration of arterial oxygen  30 , as shown in Equation 7. 
         [0000]    
       
         
           
             
               
                 
                   
                     C 
                     
                       art 
                        
                       
                           
                       
                        
                       
                         O 
                         2 
                       
                     
                   
                   = 
                   
                     
                       
                         ∫ 
                         
                           ( 
                           
                             
                               CO 
                               * 
                               
                                 C 
                                 
                                   venous 
                                    
                                   
                                       
                                   
                                    
                                   
                                     O 
                                     2 
                                   
                                    
                                   _ 
                                    
                                   1 
                                 
                               
                             
                             + 
                             
                               
                                 C 
                                 
                                   insp 
                                    
                                   
                                       
                                   
                                    
                                   
                                     O 
                                     2 
                                   
                                 
                               
                               * 
                             
                           
                         
                       
                       
                         
                           
                             
                               F 
                               insp 
                             
                             - 
                             
                               
                                 C 
                                 
                                   exp 
                                    
                                   
                                       
                                   
                                    
                                   
                                     O 
                                     2 
                                   
                                 
                               
                               * 
                               
                                 F 
                                 exp 
                               
                             
                           
                           ) 
                         
                          
                         
                            
                           t 
                         
                       
                     
                     
                       ∫ 
                       
                         
                           ( 
                           CO 
                           ) 
                         
                          
                         
                            
                           t 
                         
                       
                     
                   
                 
               
               
                 
                   ( 
                   
                     Eq 
                     . 
                     
                         
                     
                      
                     7 
                   
                   ) 
                 
               
             
           
         
       
     
         [0024]    The arterial concentration of CO2, C artCO2 , can be derived by perturbing the inflow of gases, F O2in , and solving a set of similarly derived equations except for the substitution of CO2 concentrations, such as C CO2out  and C venousCO2 , for the corresponding O2 concentrations. 
         [0025]    In an embodiment of the present invention, the CPU  26  further uses the derived patient blood gas concentrations  30  to control the operation of the percutaneous oxygenator  16  or the ventilator  12 . For example, if the patient&#39;s blood gas concentration of oxygen becomes too low, the CPU may automatically adjust the oxygen concentration or the flow rate of oxygen supplied to the patient  10  by the percutaneous oxygenator  16 . It is also understood that the operational controls of the ventilator  12  may be adjusted to raise the oxygen concentration in the patient&#39;s blood. The CPU  26  may adjust the respiratory rate, respiratory pressure, positive end expiratory pressure (PEEP), or the concentration of supplemental oxygen supplied by the ventilator  12 . It is under stood that this automated control may be used in the control of other gases supplied to the patient as herein described. Furthermore, it is understood that in an embodiment of the present invention, CPU  26  may signal or alarm a clinician to initiate changes in the operational parameters of the percutaneous oxygenator  16  or ventilator  12  instead of automatedly performing these functions. 
         [0026]    The advantage of this invention is that the oxygen and carbon dioxide gas exchange, and the arterial concentrations of oxygen and carbon dioxide can be computed continuously and trended without an additional arterial blood gas monitor. This reduces the cost of assessing the progression of a gas exchange therapy and replaces the time consuming and slow responding laboratory blood gas sample analysis. Therefore, the present invention provides an accurate, non-invasive approach to continuously monitoring arterial oxygenation levels of a patient receiving both mechanical ventilatory support and percutaneous oxygenation support. 
         [0027]    This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to make and use the invention. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements of insubstantial difference from the literal language of the claims. 
         [0028]    Various alternatives and embodiments are contemplated as being with in the scope of the following claims, particularly pointing out and distinctly claiming the subject matter regarded as the invention.