Abstract:
Devices and to methods for thoracic drainage for a patient having an air fistula. A vacuum is produced in the pleural cavity of the patient by means of a suction device. In order to adjust the vacuum on the basis of objective criteria, a suitable size measure for the air fistula is determined and the vacuum produced by the suction device is controlled according to said size measure. An adaptive algorithm includes: (a) determining a first value of a size measure for the air fistula; (b) changing the vacuum by a first difference value; (c) determining a second value of the size measure after a first waiting period; (d) changing the vacuum by a second difference value having the opposite sign if the second measure is greater than the first measure; (e) repeating steps (a) to (d) after a second waiting period.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a divisional, under 35 USC §120, of U.S. patent application Ser. No. 14/122,406, filed Dec. 16, 2013, which is the United States national phase of International Patent Application No. PCT/CH2012/000117, filed May 24, 2012, which application claims priority of Switzerland Application No. 0909/11, filed May 27, 2011. The entire text of each of the priority applications is incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates to an appliance for thoracic drainage and to a corresponding method and computer program. 
       PRIOR ART 
       [0003]    In patients with defects on the lung surface, air losses in the thorax can occur which lead to the accumulation of air in the pleural space. A defect that leads to admission of air into the pleural space is generally designated below as an air fistula. Air fistulas are generally treated by thoracic drainage (pleural drainage), in which a vacuum is applied to the pleural space via a catheter leading into the pleural space. 
         [0004]    An important parameter for the characterization of the air fistula is the quantity of air that is aspirated through the drainage system per unit of time. This volumetric flow is sometimes designated below as fistula volume. The extent of this volumetric flow changes depending on the functional size of the defect on the lung surface. 
         [0005]    The primary goal in the treatment of patients with air fistulas is generally to minimize the length of time that the air fistula is present. Such minimization secondarily entails, in particular, a reduction in the duration of the thoracic drainage, in the risk of infection associated with the drainage, in the length of the hospital stay, and in the medical, nursing and technical labour required for treating the patient. 
         [0006]    One parameter that can positively or negatively influence the healing process of an air fistula is the level of the vacuum applied to the pleural space. At present, however, there are no standard treatment recommendations concerning the regulation of the vacuum in thoracic drainage systems for treating air fistulas. The pressure is in most cases decided on the basis of the physician&#39;s experience and is individually and manually adjusted once or twice a day by the physician during visits to the patient&#39;s bedside. 
         [0007]    According to U.S. Pat. No. 5,738,656, the vacuum of a thoracic drainage system is optimal when it leads to a maximum volumetric flow of the removed air. It should be noted in this connection that, with an increasing vacuum, the volumetric flow can also decrease again, the reason being that, if the vacuum is too high, there is the possibility of, e.g., peripheral lung parts or clots blocking the suction lumen. In clinical practice, however, fairly low vacuum values are in fact usually chosen. The vacuum is generally set manually by the physician, such that the lung is just expanded and the volumetric flow is as low as possible. 
         [0008]    It is conceivable in principle to determine the size parameter for the air fistula solely from measured values of the volumetric flow or solely from pressure measurements. A method that solely uses pressure measurements to determine a parameter for the size of an air fistula is proposed in US 2011/0071415 for example. In the latter document, a parameter for the size of the air fistula is determined by measuring the change of the pressure in the pleural space over time. In particular, said document proposes using the integral of the pressure over time as a parameter for the size of the air fistula. 
       DISCLOSURE OF THE INVENTION 
       [0009]    It is an object of the present invention to make available a more exact determination of the size of the air fistula than is possible in methods using solely the pressure or the volumetric flow. 
         [0010]    Therefore, the present invention makes available an appliance for thoracic drainage in patients with an air fistula, said appliance comprising: 
         [0011]    a suction device for generating a vacuum in the pleural space; 
         [0012]    a control device for controlling the suction device; 
         [0013]    a pressure gauge for measuring the generated vacuum; and 
         [0014]    a flow meter for measuring a volumetric flow, 
         [0015]    wherein the control device is configured to determine a size parameter for the air fistula by carrying out the following steps: 
         [0016]    using the pressure gauge to determine a measured value for the vacuum generated in the pleural space; 
         [0017]    using the flow meter to determine a measured value for the volumetric flow through the air fistula; 
         [0018]    calculating the size parameter from the measured values for the volumetric flow and the vacuum. 
         [0019]    Thus, the control device takes into consideration both the vacuum and also the volumetric flow in determining the size parameter for the air fistula. In this case, the control device thus mathematically links the measured values of the volumetric flow and of the vacuum to each other, in order thereby to allow a conclusion regarding the functional size of the air fistula. The term “functional size” is to be understood as the effective cross section through which air enters the pleural space. This permits a more exact determination of the size of the air fistula than is possible in methods using solely the pressure or the volumetric flow. This is based on the finding that, with a constant fistula size, a higher vacuum also leads to a higher volumetric flow. By linking the volumetric flow and the vacuum to each other, it is possible to take this relationship into account. In this way, it is possible to calculate a fistula size parameter that is less dependent on the applied vacuum than, for example, the volumetric flow alone. 
         [0020]    Such a determination of a parameter for the size of the air fistula is advantageous even independently of an automatic regulation of the vacuum. Thus, for example, the appliance can have a display device in order to visually present the parameter for the size of the air fistula as a diagnostic parameter (as numbers and/or in graph form). Alternatively or additionally, the appliance can have a memory in order to store the parameter for the size of the air fistula. The appliance can also have an interface in order to read out the parameter for the size of the air fistula. Each of these measures gives the medical personnel in charge of the treatment a more objective view of the course of treatment than is the case in the prior art. 
         [0021]    It is in particular preferable to calculate the size parameter in such a way that the result is at least approximately independent of the vacuum applied. To this end, the control device is preferably configured to calculate the size parameter for the air fistula by forming a variable which is substantially a function of the quotient from the measured value for the volumetric flow and the square root of the measured value for the vacuum. This is based on the finding that the quotient of the volumetric flow over the root of the vacuum pressure is generally directly proportional to the cross-sectional size of the air fistula. 
         [0022]    In particular, the size parameter can be calculated as follows: 
         [0000]    
       
         
           
             
               F 
               = 
               
                 
                   
                     c 
                      
                     log 
                   
                   n 
                 
                  
                 
                   ( 
                   
                     Q 
                     
                       p 
                     
                   
                   ) 
                 
               
             
             , 
           
         
       
     
         [0023]    where 
         [0024]    F is the size parameter for the air fistula, 
         [0025]    Q is the measured value for the volumetric flow, 
         [0026]    p is the measured value for the vacuum, 
         [0027]    c is a constant, preferably c=1, and 
         [0028]    n is a positive real number, preferably n=5. 
         [0029]    In this way, a dimensionless indicator F is made available which permits a very simple estimation of the fistula size. 
         [0030]    The term “vacuum” is always to be understood in this document as a negative pressure difference in relation to the atmospheric pressure. The expression “increasing the vacuum” is to be understood as meaning that the absolute value of this negative pressure difference is increased. The expression “lowering the vacuum” is to be understood as meaning that the absolute value of the negative pressure difference is reduced. All the figures given for pressure values relate hereinbelow to the respective absolute values. 
         [0031]    In a further embodiment of the invention, a thoracic drainage appliance is made available that permits an improved adjustment of the vacuum, in particular an adjustment that is more objective and is specific to the patient. 
         [0032]    In order to achieve this object, the control device is preferably configured to regulate the level of the vacuum generated by the suction device as a function of the determined size parameter. 
         [0033]    Whereas in the prior art the level of the aspirating vacuum is generally fixed manually by the physician, it is thus proposed that a suitable parameter indicating the functional size of the air fistula is determined and that the aspirating vacuum is set automatically on the basis of this parameter. By determining a parameter indicating the functional size of the air fistula, the healing process becomes more objective, and, since this size is used to control the suction device, said suction device is controlled automatically on the basis of the objective healing process. In this way, the healing process can be better documented and, in some cases, also made significantly shorter. 
         [0034]    In particular, the control device can be configured in such a way that, during its operation, it carries out a method having the following steps: 
         [0035]    (a) determining a first value of the size parameter indicating the size of the air fistula; 
         [0036]    (b) changing the vacuum by a first differential value; 
         [0037]    (c) determining a second value of the size parameter after a first waiting period; 
         [0038]    (d) changing the vacuum by a second differential value, which has an opposite sign compared to the first differential value, if the second value of the size parameter is greater than the first value of the size parameter; 
         [0039]    (e) repeating steps (a)-(d) after a second waiting period. 
         [0040]    In particular, the control device can increase the vacuum by the first differential value in step (b) and, accordingly, lower the vacuum by the second differential value in step (d) if appropriate. In this case, the appliance therefore automatically monitors, with an adaptive algorithm, whether the air fistula is becoming functionally larger or smaller during application of the vacuum increased by the first differential value. If the parameter indicating the functional size of the air fistula has become greater, the appliance concludes from this that the chosen vacuum value was too high and reduces this value by the second differential value. Otherwise, the vacuum is left unchanged. In this way, air fistulas whose functional size becomes smaller under an increased vacuum (“closing fistulas”) and air fistulas whose size becomes larger under an increased vacuum (“opening fistulas”) can be automatically detected and optimally treated. Alternatively of course, in step (b), the vacuum can also firstly be lowered and, accordingly, increased in step (d) if the air fistula becomes functionally larger during application of the vacuum lowered in step (b). 
         [0041]    In order to permit the automatic regulation, the control device preferably has a digital processor and a memory in which a computer program is stored which, when executed by the processor, causes the control device to carry out a corresponding automatic regulation. 
         [0042]    The measuring device for determining the size parameter for the air fistula preferably comprises a suitable pressure gauge for measuring the applied vacuum, as is known per se from the prior art, and a suitable flow meter for measuring the volumetric flow, as is also known per se from the prior art. A thoracic drainage appliance with such a pressure gauge and with such a flow meter is available, for example, under the name Thopaz™ from Medela AG, Baar, Switzerland. 
         [0043]    The size parameter for the air fistula is determined indirectly from the pressure and the volumetric flow. If a flow meter is present, the latter preferably directly measures the volumetric flow passing through the suction device. However, it is also conceivable in principle for the volumetric flow to be determined indirectly, e.g. by a measurement of the pressure difference between a proximal end and a distal end of the suction lumen through which the air is aspirated from the pleural space, and the volumetric flow can be calculated from this if the flow resistance of the suction lumen is known. Such a method is described in detail in U.S. Pat. No. 5,738,656 for example. 
         [0044]    Customary values for the initially applied vacuum are generally approximately 10-50 mbar (1-5 kPa), although it is also possible in some cases to depart from this range. The first differential value by which the vacuum is in each case increased or lowered in step (b) of the proposed method is preferably between 2 and 10 mbar, particularly preferably between 4 and 6 mbar, and can in particular be approximately 5 mbar. The second differential value is preferably greater than the first differential value, preferably greater than the first differential value by a factor of between 1.5 and 3, and can in particular be approximately twice as great as the first differential value. In other words, the vacuum in step (d) is preferably lowered to a value that is lower than the value that prevailed before the vacuum in step (b) was increased, if an increase was carried out in step (b). Alternatively, if the vacuum was lowered in step (b), the vacuum in step (d) is preferably increased to a value that is higher than the value that prevailed before step (b). In absolute figures, the second differential value is preferably between 5 and 20 mbar, particularly preferably between 8 and 12 mbar, and is in particular approximately 10 mbar. 
         [0045]    The first waiting period is preferably between 20 minutes and 3 hours, particularly preferably between 40 minutes and 1.5 hours, and can in particular be approximately 1 hour. The second waiting period is preferably longer than the first waiting period, preferably longer than the first waiting period by a factor of between 2 and 5, and can in particular be longer than the first waiting period by a factor of approximately 3. The second waiting period is preferably between 1 hour and 6 hours, particularly preferably between 2 hours and 4 hours, and can in particular be approximately 3 hours. 
         [0046]    The stated pressure differences and waiting periods are chosen such that an adjustment takes place several times a day and such that, within a defined observation period (e.g. within one shift of the nursing staff), a change in the size of the air fistula is probable on account of the changed pressure conditions. 
         [0047]    It is not necessary for the first and/or second waiting periods to be fixed, and instead they can, if appropriate, also be adapted dynamically. For example, the first waiting period in particular can be shortened if, after the increase in the vacuum value, the parameter for the fistula size increases above a predetermined alarm value. In this case, immediate reduction of the vacuum is indicated. The control unit can correspondingly be configured to monitor such an alarm value and, if appropriate, additionally output an alarm signal if the alarm value is exceeded. 
         [0048]    The appliance preferably has further features of the kind that are generally customary in thoracic drainage systems, in particular a secretion collection container through which the air aspirated by the suction device is passed in order to separate off liquid and solid bodily secretions. Moreover, a surge tank can be provided in the usual way in order to avoid a return flow of air into the pleural space. The appliance will generally have at least a first tube connection for attachment of a suction tube or suction catheter. Moreover, the appliance can have a second tube connection for attachment of an auxiliary tube or auxiliary catheter. The suction tube and the auxiliary tube are connected to each other, at least at their ends near the patient (the proximal ends), and the lumina delimited by the tubes communicate with each other. In particular, the pressure gauge can be connected to the second tube connection, such that the pressure measurement takes place via the auxiliary tube in an area near the patient, i.e. near the pleural space, without being distorted by the stream of aspirated air and bodily secretions. 
         [0049]    The present invention also makes available a method for thoracic drainage in patients with an air fistula, in which method a size parameter for the air fistula is determined as follows: 
         [0050]    determining a measured value for the vacuum generated in the pleural space; 
         [0051]    determining a measured value for the volumetric flow through the air fistula; 
         [0052]    and 
         [0053]    calculating the size parameter for the air fistula from the measured values for the volumetric flow and the vacuum. 
         [0054]    The size parameter that is determined in this way can be stored or output and/or used to regulate the vacuum. 
         [0055]    Furthermore, a method for thoracic drainage in a patient with an air fistula is disclosed, said method having the following steps: 
         [0056]    generating a vacuum in the pleural space by means of a suction device; 
         [0057]    determining a size parameter for the air fistula; and 
         [0058]    automatically regulating, in particular with computer control, the vacuum generated by the suction device as a function of this size parameter. 
         [0059]    Additionally, a method for thoracic drainage is disclosed in which a vacuum is applied to the pleural space of a patient with an air fistula, which method has the abovementioned steps (a)-(e). This method can be carried out manually, e.g. by a physician or by nursing staff. However, the method is preferably at least partially carried out automatically, i.e. at least the steps (a)-(d) are carried out automatically by a control device, in particular with computer control. 
         [0060]    The present invention further relates to a computer program with code for controlling an appliance for thoracic drainage in patients with an air fistula, said appliance comprising a suction device for generating a vacuum and a digital control device for controlling the suction device, wherein the code, when executed in the digital control device, causes the control device to carry out one of the abovementioned methods. 
         [0061]    The computer program can in particular be present in the form of a computer program product on a suitable data carrier, e.g. on a CD-ROM, on a flash memory, etc., or can be made available for download via a network. It can be present in any desired form, e.g. as source code, object code or machine code. 
         [0062]    Otherwise, as regards the method and the computer program, the same considerations as for the appliance also apply analogously, in particular as regards the determination and calculation of the size parameter for the air fistula and the considerations to the values of the first and second pressure difference and to the waiting periods. The method can also be carried out using other means than the appliance described above. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0063]    Preferred embodiments of the invention are described below with reference to the drawings, which serve only for explanatory purposes and are not to be interpreted as limiting the invention. In the drawings: 
           [0064]      FIG. 1  shows a schematic diagram of thoracic drainage; 
           [0065]      FIG. 2  shows an example of a suction appliance, of which the housing is shown partly in section in order to provide a view of the interior of the housing; 
           [0066]      FIG. 3  shows a schematic diagram illustrating the mode of operation of the suction appliance from  FIG. 2 ; and 
           [0067]      FIG. 4  shows a flow chart for a method according to the invention. 
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0068]      FIG. 1  illustrates schematically the principle of thoracic drainage. A patient has an air fistula  14  between a pulmonary lobe  13  and the pleural space  15 , which air fistula  14  may have occurred spontaneously or through injury or may be iatrogenic. Air passes through the air fistula from the lung into the pleural space  15 . In order to aspirate the air, a catheter  4  extends into the pleural space. This catheter  4  is connected via a tube system, with suction tube  3  and auxiliary tube  5 , to a suction appliance  20  with an exchangeable collecting container  2 . The collecting container serves to separate bodily secretions that reach the suction appliance  20  along with the aspirated air. 
         [0069]    An example of a suitable suction appliance known per se is illustrated in  FIG. 2 . The suction appliance  20  has a suction pump  1 , which is driven by an electric motor  23 . The electric motor  23  is controlled by a control device  9 . The control device  9  has operating and display elements in the form of a main switch  24  and of a touchscreen display  25 . The control device and the electric motor are supplied with power from an energy store in the form of rechargeable batteries  22 , such that the suction appliance is self-contained and portable. The suction appliance in  FIG. 2  is described in detail in WO 2007/128156, of which the entire content is incorporated by reference into the present description. A suction appliance of generally similar design is commercially available under the name Medela Thopaz™. 
         [0070]    The mode of operation of such a suction appliance is illustrated schematically in  FIG. 3 . The catheter  4  is located with its proximal end in the pleural space T. The catheter is connected to the proximal end of the suction tube  3  and of the auxiliary tube  5 . At its distal end, the suction tube  3  opens into the collecting container  2 . The latter is connected to the suction pump  1  in order to generate a vacuum in the collecting container  2 . A first pressure gauge  8  and a flow meter  10  are connected between the collecting container  2  and the suction pump  1  and measure the pressure in the collecting container  2  and the volumetric gas flow through the collecting container  2 . The distal end of the auxiliary tube is connected to a controllable valve  7  and to a second pressure gauge  6 . When the valve  7  is closed, no gas flows through the auxiliary tube  5 , and the pressure gauge  6  therefore substantially measures the pressure at the proximal end of the auxiliary tube  5 . This pressure corresponds substantially to the pressure in the pleural space T. The control device  9  receives signals from the pressure gauges  6 ,  8  and from the flow meter  10  and controls the suction pump  1  and the valve  7 . For further features of the suction appliance in  FIG. 3 , reference is made to WO 2005/061025, of which the entire content is herewith incorporated by reference into the present description. 
         [0071]    In a preferred embodiment, the control device  9  is a digital control device, i.e. this device comprises a digital processor and, interacting with the latter, a memory  90  in which a computer program is loaded for execution by the processor. When the program is executed, the control device  9  carries out the adaptive algorithm illustrated in  FIG. 4  and explained step by step below. 
         [0072]    Step  31 : Start. In this step, the suction appliance  20  is started up and an initial vacuum is set. 
         [0073]    Step  32 : Documentation of initial vacuum. The initial vacuum is provided with a time stamp and stored in the memory  90  of the control device  9  for documentation purposes. 
         [0074]    Step  33 : Determination of a first value of the fistula size. The control device  9  determines a first value of a parameter indicating the size of the air fistula. For this purpose, the control device, using the second pressure gauge  6 , measures the value of the vacuum present in the pleural space and, using the flow meter  10 , measures the volumetric flow passing through the suction tube  3  from the pleural space. From this, the control device determines a size parameter for the fistula according to the following equation: 
         [0000]    
       
         
           
             
               F 
               = 
               
                 
                   
                     c 
                      
                     log 
                   
                   n 
                 
                  
                 
                   ( 
                   
                     Q 
                     
                       p 
                     
                   
                   ) 
                 
               
             
             , 
           
         
       
     
         [0075]    where 
         [0076]    F is the size parameter for the air fistula, 
         [0077]    Q is the measured value for the volumetric flow (expressed in milliliters per minute), 
         [0078]    p is the measured value for the vacuum (expressed in mbar), 
         [0079]    c=1 and n=5. 
         [0080]    The result is generally a number between 0 and 5. This number is provided with a time stamp and stored in the memory  90  of the control device, likewise the values Q and p. 
         [0081]    Step  34 : Test of the fistula size. The size parameter is compared with a predetermined reference value (which can in particular be equal to 1). 
         [0082]    Step  35 : End. If the size parameter is smaller than or equal to the reference value, a corresponding end signal is output that tells the patient or the medical personnel that the air fistula is practically closed and the thoracic drainage can be expected to be completed. 
         [0083]    Step  36 : Vacuum increased by a first differential value. If the size parameter exceeds the reference value, the control device  9  increases the pump output such that the vacuum increases by 5 mbar. The new vacuum value is stored with time stamp in the memory  90 . 
         [0084]    Step  37 : First waiting period. In this period (e.g. one hour), the new vacuum value is maintained. The air fistula has the chance to react to the new vacuum value. 
         [0085]    Step  38 : Determination of the second value of the fistula size. This step proceeds exactly like step  33 . 
         [0086]    Step  39 : Comparison of fistula sizes before and after: The first and second values of the size parameter are read out from the memory  90  and compared with each other. If the second value is greater than the first value, a branch is made after step  40 , otherwise after step  41 . 
         [0087]    Step  40 : Vacuum lowered by a second differential value. If the second value is greater than the first value of the fistula parameter, the control device reduces the output of the suction pump until the vacuum has dropped by 10 mbar. Otherwise, the previous vacuum is maintained. The new vacuum value is stored with time stamp in the memory  90 . 
         [0088]    Step  41 : Second waiting period. In this period (3 hours), the vacuum is once again maintained. 
         [0089]    Steps  33 ,  34 ,  36 - 39  and  41  and, if appropriate, step  40  are now repeated in the same way until the method ends at step  35 . The stored values for the vacuum, the volumetric flow and the size parameter can be read out at any time via an interface or shown on the display. 
         [0090]    Compared to the customary clinical practice to date, the frequent adjustments of the vacuum mean that the healing process can be better monitored and ideally sped up. 
       Example 1 
     Closing Fistula 
       [0091]    In a patient 1 with an air fistula, the thoracic drainage system Thopaz™ was used. A vacuum of 10 mbar was initially set. This resulted in a volumetric flow of 100 ml/min. From this, a fistula size F=2.15 was calculated using the above equation (see step  33 ). The vacuum was then increased by 5 mbar to 15 mbar. After one hour, the volumetric flow was measured again. This was now 120 ml/min. From this, a fistula size F=2.13 was calculated. The fistula had therefore functionally decreased in size. The vacuum of 15 mbar was therefore maintained for a further 3 hours. 
       Example 2 
     Opening Fistula 
       [0092]    In a patient 2, an initial vacuum of 10 mbar was likewise set. In this patient also, this resulted in a volumetric flow of 100 ml/min, from which a fistula size F=2.15 was calculated. The vacuum was again increased by 5 mbar to 15 mbar, and the volumetric flow was measured after one hour. This was now 240 ml/min, corresponding to a fistula size F=2.56. The vacuum was therefore lowered by 10 mbar to just 5 mbar, and this value was maintained for a further 3 hours. 
         [0093]    It is clear that many modifications can be made to the appliances and methods that have been described above by way of example. Thus, the suction device can be any other kind of suction device than the electrical suction pump in  FIG. 2 , e.g. an attachment for a central hospital vacuum system, as long as the vacuum level can be adjusted by a suitable pressure control. Accordingly, the thoracic drainage system can also be of a completely different construction than that shown in  FIGS. 2 and 3 . A great many such systems are known from the prior art. 
         [0094]    The adaptive algorithm can also be modified or supplemented in many different ways. In particular, the differential values of the vacuum and the waiting periods chosen can also be different, e.g. dynamically adapted to measured values. Moreover, in addition to the fistula size, other parameters, e.g. the amount of liquid secretion, can also be measured automatically and used to automatically regulate the vacuum. 
         [0095]    It is possible in principle for steps  31 - 41  to be carried out completely manually, although an automated procedure is preferred. 
       LIST OF REFERENCE SIGNS 
       [0000]    
       
         
           
               1  suction pump 
               2  secretion container 
               3  suction tube 
               4  catheter 
               5  auxiliary tube 
               6  second pressure gauge 
               7  valve 
               8  first pressure gauge 
               9  control device 
               10  flow meter 
               12  air 
               13  pulmonary lobe 
               14  air fistula 
               15  pleural space 
               20  suction appliance 
               22  batteries 
               23  motor 
               24  main switch 
               25  touchscreen display 
               31 - 41  method steps