Patent Publication Number: US-10314971-B2

Title: Method for detecting an occlusion in an infusion line

Description:
The present application is a U.S. National Stage of PCT International Patent Application No. PCT/EP2016/077033, filed Nov. 9, 2016, which claims priority to EP Application No. 15306807, filed Nov. 13, 2015, both of which are hereby incorporated herein by reference. 
     The invention relates to a method for detecting an occlusion in an infusion line according to the preamble of claim  1 . 
     In a method for detecting an occlusion in an infusion line of this kind a force applied to a piston by a pusher device of an infusion device for moving the piston along a movement direction into a cylindrical tube in order to deliver a medical fluid from the cylindrical tube towards an infusion line connected to the cylindrical tube is measured. From the measured force a value indicative of a pressure in the cylindrical tube is calculated, wherein for calculating said value indicative of said pressure a frictional force value indicative of a friction of the piston relative to the cylindrical tube is taken into account. By comparing said value indicative of said pressure to a threshold value it can then be determined whether an occlusion is present in the infusion line or not. 
     Medication in a fluid state can be infused into a patient using an infusion line. The infusion line is connected to a fluid source such as a syringe that stores the medication. The medication can be pushed out of the syringe through the infusion line towards the patient using a pusher device of an infusion device such as a syringe pump acting onto the syringe for continuously pushing a piston into a cylindrical tube in order to deliver medication from the cylindrical tube of the syringe via the infusion line towards the patient. 
     During such an infusion process an occlusion may occur in the infusion line, which, in some cases, may cause severe injury to the patient. There hence is a need to reliably detect an occlusion occurring in an infusion line, in order to avoid injuries resulting from occluded infusion lines. 
     From the state of the art methods for detecting an occlusion in an infusion line during an infusion process are known that are based on the assumption that an occlusion causes a raise of the pressure in the infusion line. An increased pressure in turn causes the force to be applied to the syringe by a means of pumping device for pushing the medication through the infusion line towards the patient to increase. By monitoring the force applied to the syringe, hence, the actual pressure in the infusion line can be deduced and accordingly, if the actual pressure exceeds a threshold value, an alarm signal indicative of an occlusion can be triggered. 
     More sophisticated methods additionally take into account the frictional force of the syringe, such as the frictional force between the piston and the cylindrical tube of the syringe, when the piston is moving in the cylindrical tube. Indeed the total force required to push the liquid through an infusion line comprises a frictional force component, resulting from the friction occurring when the piston is moved in the cylindrical tube, and a pressure component resulting from the pressure in the infusion line. In some methods known in the art, the frictional force is assumed to be constant during the infusion process. For a given syringe type a constant value is then preset for the frictional force. For calculating the pressure inside the infusion line, hence, the force applied to the syringe is thus corrected for the frictional force using a constant value. 
     However, the frictional force is not necessarily constant for all syringes of a specific syringe type and/or throughout the entire infusion process, but can vary for example over the length of the cylindrical tube in which the piston is longitudinally moved. For example, if the internal diameter of the cylindrical tube slightly decreases when moving the piston in the cylindrical tube, the frictional force between the piston and the inner wall of the cylindrical tube will increase and vice versa. In addition, the inner surface of the cylindrical tube may have varying characteristics over the length of the cylindrical tube. If the variation of the frictional force resulting thereform is not taken into account and the true frictional force is higher than the preset (constant) value for the frictional force, the true pressure in the infusion line is smaller than the determined pressure. An overpressure may thus be detected which truly is not present, possibly leading to a false alarm. On the other hand, if the true frictional force is smaller than the preset (constant) value for the frictional force, the true pressure in the infusion line is higher than the determined pressure, in which case an overpressure resulting from an occlusion in the infusion line may not be detected. 
     The reliability of a method for detecting an occlusion that presumes that the frictional force component throughout the infusion process is constant is thus limited. However, a reliable method for detecting an occlusion may be of particular relevance, especially in neonate and pediatric care. 
     It is an object of the instant invention to provide a method for reliably detecting an occlusion in an infusion line during an infusion process. 
     This object is achieved by the method for detecting an occlusion in an infusion line during an infusion process comprising the features of claim  1 . 
     Accordingly, the frictional force value is determined using a mathematical model modelling the friction of the piston relative to the cylindrical tube in dependence on the position of the piston relative to the cylindrical tube along the movement direction and in dependence on the velocity by which the piston is moved relative to the cylindrical tube. 
     The frictional force value hence is determined using a mathematical model. Typically, the frictional force value may depend on
         the syringe size, brand, model and batch,   the pushing velocity,   the position of the piston on its full travel range,   the temperature,   the waiting time between syringe preparation and the start of an infusion process,   the liquid used for infusion, and   the pressure in the syringe.       

     The different factors herein have a different impact on the frictional force, wherein it generally can be assumed that the syringe size, brand, model and batch as well as the pushing velocity and the position of the piston relative to the cylindrical tube of the syringe have the largest influence. 
     The model hence aims at modelling the frictional force in particular in dependence on the velocity and the position, wherein the modelling, in one embodiment, may be such that particular characteristics of a particular syringe used for an infusion process are taken into account for modelling the frictional force in dependence on the velocity and the position. 
     Herein, characteristic parameters for a syringe having an influence on the frictional force in dependence of the velocity and the position may be stored in a database of the infusion device, such that the model can be adjusted for a particular syringe used on an infusion device for computing the frictional force in dependence on the velocity and the position of the piston relative to the cylindrical tube of the syringe during an infusion process. 
     The model is used to obtain an estimate of a frictional force value dependent on the position of the piston relative to the cylindrical tube along the movement direction and dependent on the velocity by which the piston is moved relative to the cylindrical tube during an infusion process. The velocity herein is directly linked to the flow rate which shall be achieved during an infusion process, i.e. the rate at which a fluid contained in the cylindrical tube is to be administered to the patient. 
     The model, in one embodiment, may for example include a velocity dependent term modelling the dependence of the frictional force on the velocity of the piston relative to the cylindrical tube and a position dependent term modelling the dependence of the frictional force on the position of the piston relative to the cylindrical tube. 
     For example, the frictional force value for a position i may be determined according to the following equation:
 
 F   0 ( i )= F   pr +( F   0,velocity   −F   pr )· Pos _coef( i )
 
     Herein, F 0 (i) denotes the frictional force value at the position i. F pr  denotes a preload force. F 0,velocity  denotes the velocity dependent term, and Pos_coef(i) denotes the position dependent term. 
     Generally, the velocity dependent term depends on the velocity by which the piston is moved relative to the cylindrical tube. At a constant flow rate during an infusion process the velocity of the piston will be constant, and the velocity dependent term assumes a value associated with this velocity. 
     The position dependent term in turn varies with position. The variation herein is largely influenced by the variation of the friction of the piston within the cylindrical tube, for example due to geometrical changes of the cylindrical tube along the travel range of the piston inside of the cylindrical tube. 
     The velocity dependent term may be computed for example using an equation including terms for a Coulomb friction, a Stribeck friction and/or a viscous friction. For example, the velocity dependent term may be modelled according to the following equation:
 
 F   0,velocity   =F   C +( F   brk   −F   C )· e   (−C     v     ·v)   +f   vfr   ·v  
 
     Herein, F C  is a coulomb friction force, F brk  is a breakaway friction force, C v  is a transition approximation coefficient, v is the velocity, and F vfr  is a viscous friction coefficient. 
     The coulomb friction can be computed by the relation
 
 F   C   =F   pr   +f   cfr   ·P  
 
wherein F pr  is the preload force, f cfr  is the coulomb friction coefficient, and P is the pressure. Assuming that the pressure P has no impact on the friction force, this relation can be simplified to
 
 F   C   =F   pr  
 
such that the coulomb friction force F C  equals the preload force F pr .
 
     The above stated equation for the velocity dependent term can be simplified by neglecting the viscous effect due to the viscous friction coefficient f cfr  and by linearizing the second term indicating the Stribeck friction. 
     Hence, one arrives at a relation in which the velocity dependent term assumes a constant value for a velocity below a first velocity value and/or for a velocity above a second velocity value. Within the range in between the first velocity value and the second velocity value it then can be assumed that the velocity dependent term changes linearly. This mathematically can be expressed as follows:
         if v [mm/h]&lt;v transit  [mm/h] then
 
 F   0,velocity [ gf ]= F   brk [ gf ]
   if v [mm/h] ϵ[v transit [mm/h], v max [mm/h]] then
 
 F   0,velocity [ gf ]= F   pr   +a [ gf /(mm/h)]· v [mm/h]+ b [ gf ]
   where       

     
       
         
           
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     if v[mm/h]&gt;v max [mm/h] then
 
 F   0,velocity [ gf ]= F   pr [ gf ]
 
     The position dependent term changes with position and may be expressed simply by a list of coefficients. The coefficients can be defined for a multiplicity of discrete position values, wherein it can be interpolated between discrete positions to obtain a coefficient value for a position in between two neighboring discrete positions. 
     By multiplying the position-dependent coefficient with a term including the velocity dependent term, the position dependent frictional force value is obtained as already stated above according to the following relation:
 
 F   0 ( i )= F   pr +( F   0,velociy   −F   pr )· Pos _coef( i )
 
     The frictional force value at a specific position determined in this way can be used to calculate the pressure within the cylindrical tube, which corresponds to the pressure in the infusion line. By comparing the pressure (or generally a value indicative of the pressure) to a predefined threshold value it can then be determined whether an occlusion has occurred, such that an alarm can be triggered. 
     The parameters stated above, for example the Coulomb friction coefficient, the viscous friction coefficient, the breakaway friction force and the preload force, depend on the particular syringe used on the system. Hence, the system may store different parameters for different syringes, such that the model can use the specific parameters applicable for a particular syringe used on the system for an infusion process. 
     The object is also achieved by the method comprising the features of claim  7 . The method comprises:
         determining, at a current position of the piston, a slope value associated with the measured force at the current position of the piston as the piston is moved along the movement direction, and   if the slope value lies within a predetermined range, assuming that the frictional force value is equal to the measured force at a position prior to the current position for calculating said value indicative of said pressure.       

     Hence, within the method the frictional force value is not determined using a model, but directly determined from the measured force. Herein, it generally is assumed that the frictional force value is equal to the measured force if no occlusion is present on the infusion line. Thus, it is assumed that the pressure within the infusion line is zero if no occlusion is present, such that the measured force is substantially due to friction experienced by the piston as the piston is moved in the cylindrical tube. 
     As the piston is moved in the cylindrical tube, a slope value associated with the measured force at the current position is calculated and monitored. If it is found that the slope value falls into a predetermined range bounded by a minimum slope and a maximum slope, it is assumed that a rise in the measured force (indicated by the slope) is not due to the frictional force and its variation, but likely is due to an occlusion on the infusion line. Hence, if it is found that the slope value falls into the predetermined range, the frictional force value is no longer set to the measured force, but the frictional force value is set to a measured force value which was obtained at a position prior to the current position. The frictional force value hence no longer tracks the measured force, but is held fixed at the measured force value at a position prior to the current position. 
     In one embodiment, said position prior to the current position equals the position at which the slope value last was outside of the predetermined range. Hence, if it is first found that the slope of the measured force falls into the predetermined range, the frictional force value is held fixed at the measured force value for the position immediately prior to the current position (for which the slope did not fall into the range), and is held fixed at this measured force value as long as the slope of the measured force remains within the predetermined range for subsequent measurements at subsequent positions. 
     In this regard it is to be noted that the measured force is generally measured at discrete intervals, for example at discrete positions or at discrete measurement times. Herein, since the piston is moved continuously relative to the cylindrical tube, a measurement time relates to a specific position, such that generally one can be interchanged with the above. 
     The slope value generally can be determined as the derivative of the measured force. This can be computed for example by taking the difference of the measured force at the current position and the measured force at a position prior to the current position, for example at a position immediately prior to the current position, i.e. the last measurement position prior to the current position. 
     If it is found that the slope does not fall into the predetermined range, it is assumed that no occlusion is present, and hence the frictional force value is assumed to equal the measured force at the current position of the piston. Hence, the frictional force value tracks the measured force, assuming that the measured force substantially is due to friction occurring when moving the piston relative to the cylindrical tube. 
     The instant method is based on the finding that for a particular system using a particular syringe in connection with a particular infusion line the pressure inside the line will rise at a specific slope determined by the characteristics of the infusion line and the syringe. Hence, by observing the slope, it can be determined whether the slope of the measured force is close to the slope that is expected in case of an occlusion or not. Hence, by monitoring whether the slope of the measured force falls into a range around the expected slope, it in principle can be detected whether an occlusion is present or not. 
     In this regard, if the slope of the measured force is below the predetermined range, it can be assumed that no occlusion is present, as the pressure in the infusion line does not rise excessively. If the slope of the measured force is above the predetermined range, it can be assumed that the rise of the slope is not due to an occlusion, but it is due to other factors, for example to other devices or means causing a pressure change within the system, for example when a second infusion device is present in the system. 
     The predetermined range is generally determined by a tolerance range around the expected slope, and hence is bound by a minimum slope smaller than the expected slope and a maximum slope larger than the expected slope. 
     The expected slope herein can be computed taking characteristics of the system into account. Characteristics can be stored for example in a database of the infusion device, such that the expected slope can be computed prior to the start of an infusion process when a particular syringe in connection with a particular infusion line is to be used for an infusion process and correspondingly is identified to the system by user, for example a nurse. 
     The expected slope is for example influenced by the compliance of the cylindrical tube, the compliance of the infusion line, a stiffness of the pusher device and/or a dimension of the cylindrical tube. The compliance herein indicates a measure for the expansibility of the system, for example the expansibility of the cylindrical tube of the syringe used on the infusion device or the expansibility of the infusion line connected to the cylindrical tube. Generally, the compliance indicates the change of volume for a change in pressure and accordingly is stated for example in ml/bar. With respect to for example the infusion line, the compliance indicates by what volume the infusion line expands if the pressure increases by a certain margin. 
     For different syringes and different infusion lines, different characteristic values, for example compliance values, can be stored in the system, such that a particular set of values is chosen to compute the expected slope if a particular syringe in connection with a particular infusion line is to be used for an infusion process. 
     Herein, also the minimum slope bounding the predetermined range at its lower end and the maximum slope bounding the predetermined range at its upper end can be determined from those characteristics. 
     In one embodiment, a prealarm is triggered if the slope value lies within a predetermined range. The predetermined range herein may be equal to the aforementioned range which is used to determine the frictional force value. It however is also possible that the predetermined range triggering the prealarm differs from the range with which the slope value is compared for determining the frictional force value. 
     This aspect is based on the finding that an alarm may be triggered from the comparison of the slope value with an expected slope alone. If the slope value is within a tolerance range about the expected slope value, this may indicate that an occlusion has occurred. 
     This comparison may trigger a prealarm, i.e. a warning prior to an actual occlusion alarm, to warn a user at an early stage that an occlusion has occurred. 
     This method in principle can be employed also independently from the above noted method. In this case a method for detecting an occlusion in an infusion line connected to an infusion device generally comprises:
         measuring a force applied to a piston by a pusher device of an infusion device for moving the piston along a movement direction into a cylindrical tube in order to deliver a medical fluid from the cylindrical tube towards an infusion line connected to the cylindrical tube,   determining, at a current position of the piston, a slope value associated with the measured force at the current position of the piston as the piston is moved along the movement direction, and   if the slope value lies within a predetermined range, triggering an alarm.       

     As described above, as the piston is moved in the cylindrical tube, a slope value associated with the measured force at the current position is calculated and monitored. If it is found that the slope value falls into a predetermined range bounded by a minimum slope and a maximum slope, it is assumed that a rise in the measured force (indicated by the slope) is not due to a frictional force and its variation, but likely is due to an occlusion on the infusion line. Hence, if it is found that the slope value falls into the predetermined range, it is assumed that an occlusion is present and an alarm is triggered accordingly. 
     The slope value generally can be determined as the derivative of the measured force. This can be computed for example by taking the difference of the measured force at the current position and the measured force at a position prior to the current position, for example at a position immediately prior to the current position, i.e. the last measurement position prior to the current position. 
     If it is found that the slope value does not fall into the predetermined range, it is assumed that no occlusion is present, and hence no alarm is triggered, or an alarm which has been triggered before is cancelled. 
     The methods described above can be used by themselves to determine whether an occlusion is present on an infusion line or not. Hence, each method by itself can be implemented in an infusion device, and can be used to monitor an infusion process in order to trigger an alarm in case it is found that an occlusion may be present on the infusion line. 
     In a beneficial embodiment, the methods however are used in combination. Hence, both methods are implemented on an infusion device, and during an infusion process both methods are used to determine an estimate of the frictional force in order to monitor whether an occlusion may be present on an infusion line or not. In this way a robust technique is provided for detecting an occlusion. In particular, in certain scenarios one method may be more sensitive than the other, such that it is made sure that an occlusion is reliably detected by using the methods in combination. 
     Herein, an alarm may be triggered if it is determined with at least one of said methods that said value indicative of the pressure is above said threshold value. Hence, the frictional force value is determined by both methods, and by using the two different frictional force values determined by the two methods, two estimates of the pressure inside the infusion line are derived. By comparing these estimates of the pressure to the predefined threshold value, it can be determined whether, at least for one method, it is found that an occlusion is present on the infusion line. 
    
    
     
       The idea underlying the invention shall subsequently be described in more detail with respect to the embodiments shown in the figures. Herein: 
         FIG. 1  shows a view of an embodiment of an infusion device in the shape of a syringe pump; 
         FIG. 2  shows a schematic view of a syringe comprising a cylindrical tube and a piston moved into the cylindrical tube for pushing a liquid contained in the cylindrical tube towards an infusion line; 
         FIG. 3  a schematic view of the syringe, as the piston is moved out of the cylindrical tube; 
         FIG. 4  a graphical view of a measured force as a function of the position, for different velocities by which the piston is moved relative to the cylindrical tube; 
         FIG. 5  a graphical view of the dependence of the frictional force on the velocity; 
         FIG. 6  a view of a linearized model of the frictional force in dependence on the velocity; 
         FIG. 7A-7D  schematic views of different syringes having different characteristics; 
         FIG. 8A-8D  graphical views of the frictional force dependent on the position for the different syringes according to  FIG. 7A to 7D ; 
         FIG. 9  a view of a simplified dependence of the frictional force on the position; 
         FIG. 10  a view of the modelled frictional force in dependence on the position, for different velocities; 
         FIG. 11  a view of the measured force over position; 
         FIG. 12  a view of the derivative of the measured force according to  FIG. 11 ; and 
         FIG. 13  a view of the measured force in the occurrence of an occlusion. 
     
    
    
       FIG. 1  shows an infusion device  1  in the shape of a syringe pump having a housing  10  and a receptacle  11  arranged on the housing  10  to receive a syringe  2  therein. 
     The syringe  2  comprises a cylindrical tube  20  which, when installing the syringe  2  on the infusion device  1 , contains a medical liquid, for example a medication or a solution for the parenteral feeding, to be infused to a patient. The cylindrical tube  20  is connected, via a connector  200 , to an infusion line  3  which may extend from the syringe  2  towards a patient for infusing the medical liquid to the patient. 
     For installing the syringe  2  on the receptacle  11  of the infusion device  1 , the cylindrical tube  20  of the syringe  2  is placed in the receptacle  11  and is mechanically connected to the housing  10  by means of a fixation device  110 . By means of the fixation device  110 , for example constituted by a releasable clamp element, the cylindrical tube  20  is secured within the receptacle  11  such that the cylindrical tube  20  is held in position on the receptacle  11 . 
     The syringe  2  comprises a piston  21  which, for delivering medical fluid contained in the cylindrical tube  20 , can be pushed into the cylindrical tube  20  in a pushing direction X. For this, the infusion device  1  comprises a pusher device  12  movably arranged within a guide device  120  and connected to a suitable drive mechanism via a connecting rod  121 . 
     For operating the infusion device  1 , the syringe  2  is installed on the infusion device  1  and, for performing an infusion process, the pusher device  12  is electrically moved in the pushing direction X to move the piston  21  into the cylindrical tube  20  for delivering the medical fluid contained in the cylindrical tube  20  via the infusion line  3  towards the patient. 
     Generally, if during an infusion process an occlusion occurs on the infusion line  3  connected to the cylindrical tube  20  of the syringe to, the pressure in the infusion line will rise. To detect an occlusion, hence, the pressure in the infusion line  3  can be observed, and when an abnormal rise in pressure is found it can be concluded that an occlusion is present. 
     To observe the pressure in the infusion line  3 , the force F applied to the piston head  210  of the piston  21  by means of the pusher device  12  is measured by a sensor placed in between the pusher device  12  and the piston head  210 . The force F measured in this way allows for an indirect measurement of the pressure within the cylindrical tube  20 , which generally equals the pressure in the infusion line  3 . 
     In particular, the pressure in the cylindrical tube  20  depends on the measured force F according to the following relation: 
     
       
         
           
             P 
             = 
             
               
                 
                   F 
                   - 
                   
                     F 
                     0 
                   
                 
                 S 
               
               . 
             
           
         
       
     
     Herein, P denotes the pressure, F denotes the measured force, F 0  denotes a frictional force component and S denotes the effective surface by which the piston  21  acts onto the liquid contained in the cylindrical tube  20 . The effective surface S is substantially determined by the inner diameter of the cylindrical tube  20 . 
     By determining the pressure P in this way and by comparing the determined pressure P to a predefined threshold P thres  it can then be concluded whether an occlusion is present in the infusion line  3  or not. In particular, if it is found that the pressure P rises above the threshold P thres , it is concluded that an occlusion is present. 
     Whereas F is measured and S is known from the geometrical dimensions of the cylindrical tube  20  of the syringe  2 , the frictional force component F 0  cannot be determined in an easy way. In particular, the frictional force component F 0  may vary in dependence on the specific syringe  2  used on the system, wherein the frictional force component F 0  generally is dependent on the position of the piston  21  within the cylindrical tube  20  and on the velocity by which the piston  21  is moved relative to the cylindrical tube  20  during an infusion process. 
     The methods described subsequently deal with the determination of the frictional force component F 0 . Herein, within a first method a model-based approached is used to determine the frictional force component F 0 . In a second method an approach based on measurements is used, assuming that the frictional force component F 0  equals the measured force as long as no occlusion is present in the system. 
     Generally, if the pusher device  12  acts onto the piston  21  in the pushing direction X to push the piston  21  into the cylindrical tube  20 , as schematically shown in  FIG. 2 , the force F acting onto the piston  21  and measured at the piston head  210  relates to the pressure as follows:
 
 F=P·S+F   0  
 
     Herein, P is the pressure inside the cylindrical tube  20  of the syringe  2  (in mbar), S is the effective surface determined by the inner diameter of the syringe (in mm 2 ), and F 0  is the frictional force between the moving part of the syringe (the piston  21 ) and the fixed part (the cylindrical tube  20 ). 
     When the piston  21  is instead moved backwards (for example during an occlusion release) in the opposite direction X′ as indicated in  FIG. 3 , the force F relates to the pressure as follows:
 
 F=P·S−F   0  
 
     Generally, F is measured during an infusion process by a sensor in between the pusher device  12  and piston head  210 . The effective surface S is stored in a database of the infusion device  1  (generally, the inner diameter of the syringe will be registered in the pump such that by identifying the syringe prior to an infusion process the surface S can be determined). 
     The frictional force component F 0  depends at least on the following parameters (sorted approximately by their relevance for the frictional force):
         the syringe brand, model and batch   the pushing velocity,   the position of the piston on its full travel range,   the temperature,   the waiting time between syringe preparation and infusion start,   the liquid inside the syringe, and   the pressure.       

     It is to be noted that the catheter size, the extension line diameter and length and the drug viscosity generally can be considered to have no influence on the frictional force. But these parameters may of course have an influence on the pressure. 
     In the following, two methods are described, providing different approaches to obtain an estimate of the frictional force F 0  in dependence on the velocity by which the piston  21  is moved relative to the cylindrical tube  20  and on the position of the piston  21  relative to the cylindrical tube  20 . A first method herein is denoted as “absolute pressure” method, whereas a second method is denoted as “relative pressure” method. 
     Within the “absolute pressure” method the frictional force F 0  is estimated using a model. 
     A graphical view of the (overall) force F as measured when pushing the piston  21  into the cylindrical tube  20  is shown in  FIG. 4 . Herein, different curves K 1 -K 3  indicate the force F (in gram force (gf)) for different velocities of the piston  21 . Curve K 1  for example indicates the position dependence of the force F for a low velocity, K 2  for a medium velocity and K 3  for a high velocity. 
     As visible from  FIG. 4 , for a high velocity (curve K 3 ) the force F is almost constant over the entire travel range of the piston  21 . As the velocity decreases, however, the force F becomes more and more position dependent, exhibiting a bulge towards the middle of the travel range. Curve K 1  for example corresponds to a velocity of 2.5·10 −6  m/s, curve K 2  corresponds for example to a velocity of 2.5·10 −5  m/s, and curve K 3  corresponds for example to a velocity of 2.5·10 −4  m/s. 
     Hence, it can be concluded that the frictional force component generally cannot be assumed as constant, but shows a strong dependency on the position as well as on the velocity by which the piston  21  is moved relative to the cylindrical tube  20 . 
     To model the frictional force, a model can be used including a term for a velocity dependent force component F 0,velocity  and a position dependent term in the shape of a position coefficient Pos_Coef(i), i being the position of the piston  21  relative to the cylindrical tube  20 , as follows:
 
 F   0 ( i )= F   pr +( F   0,velocity   −F   pr )· Pos _coef( i )
 
     Herein, F 0 (i) is the frictional at the position i, F pr  is a preload force, F 0,velocity  is the velocity dependent term, and Pos_coef(i) is the position dependent coefficient. 
     The velocity dependent term F 0,velocity  can be modeled according to the following equation:
 
 F   0,velocity   =F   C +( F   brk   −F   C )· e   (−C     v     ·v)   +f   vfr   ·v  
 
     Herein, the first term F C  represents a term for the Coulomb friction (dry friction), the second term represents the Stribeck friction and the third term represents the viscous friction. F brk  is the breakaway force, C v  is a so-called transition approximation coefficient, and f vfr  is a viscous friction coefficient. The velocity dependent term of the frictional force is shown in  FIG. 5  in dependence on the velocity v. 
     The parameter C v  (denoted as the transition approximation coefficient) in the second term representing the Stribeck friction can be chosen for example according to curve K 3  in  FIG. 4 , i.e. according to the minimum force at a velocity of 2.5·10 −4  m/s: 
     
       
         
           
             
               C 
               v 
             
             = 
             
               
                 4 
                 
                   
                     2.5 
                     · 
                     
                       10 
                       
                         - 
                         4 
                       
                     
                   
                   ⁢ 
                   
                       
                   
                   ⁢ 
                   m 
                   ⁢ 
                   
                     / 
                   
                   ⁢ 
                   s 
                 
               
               = 
               
                 
                   1.28 
                   · 
                   
                     10 
                     
                       - 
                       4 
                     
                   
                 
                 ⁢ 
                 
                     
                 
                 ⁢ 
                 s 
                 ⁢ 
                 
                   / 
                 
                 ⁢ 
                 m 
               
             
           
         
       
     
     F C  is the Coulomb friction force (which is the friction that opposes motion with a constant force at any velocity) and can be described by the following equation:
 
 F   C   =F   pr   +f   cfr   ·P,  
 
f cfr  being the Coulomb friction Coefficient. If it is assumed that the pressure P has no impact on the friction force this becomes:
 
 F   C   =F   pr  
 
and one obtains for the velocity dependent term:
 
 F   0,velocity   =F   pr +( F   brk   −F   pr )· e   (−C     v     ·v)   +f   vfr   ·v  
 
     This can be simplified by neglecting the viscous effect and by applying a linearization for the Stribeck term as follows, also shown in  FIG. 6 : 
     When v [mm/h]&lt;v transit  [mm/h] then
 
 F   0,velocity [ gf ]= F   brk [ gf ]
         When v [mm/h] ϵ[v transit [mm/h], v max [mm/h]] then
 
 F   0,velocity [ gf ]= F   pr   +a [ gf /(mm/h)]· v [mm/h]+ b [ gf ]
   where       

     
       
         
           
             { 
             
               
                 
                   
                     
                       
                         a 
                         ⁡ 
                         
                           [ 
                           
                             gf 
                             ⁢ 
                             
                               / 
                             
                             ⁢ 
                             
                               ( 
                               
                                 mm 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 h 
                               
                               ) 
                             
                           
                           ] 
                         
                       
                       = 
                       
                         
                           
                             
                               F 
                               brk 
                             
                             ⁡ 
                             
                               [ 
                               gf 
                               ] 
                             
                           
                           - 
                           
                             
                               F 
                               pr 
                             
                             ⁡ 
                             
                               [ 
                               gf 
                               ] 
                             
                           
                         
                         
                           
                             
                               v 
                               transit 
                             
                             ⁡ 
                             
                               [ 
                               
                                 mm 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 h 
                               
                               ] 
                             
                           
                           - 
                           
                             
                               v 
                               max 
                             
                             ⁡ 
                             
                               [ 
                               
                                 mm 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 h 
                               
                               ] 
                             
                           
                         
                       
                     
                   
                 
                 
                   
                     
                       
                         b 
                         ⁡ 
                         
                           [ 
                           gf 
                           ] 
                         
                       
                       = 
                       
                         
                           - 
                           
                             a 
                             [ 
                             
                               gf 
                               ⁢ 
                               
                                 / 
                               
                               ⁢ 
                               
                                 ( 
                                 
                                   mm 
                                   ⁢ 
                                   
                                     / 
                                   
                                   ⁢ 
                                   h 
                                 
                                 ) 
                               
                             
                             ] 
                           
                         
                         · 
                         
                           
                             v 
                             max 
                           
                           ⁡ 
                           
                             [ 
                             
                               mm 
                               ⁢ 
                               
                                 / 
                               
                               ⁢ 
                               h 
                             
                             ] 
                           
                         
                       
                     
                   
                 
               
                 
             
           
         
       
         
         
           
             When v[mm/h]&gt;v max [mm/h] then
 
 F   0,velocity [ gf ]= F   pr [ gf ]
 
           
         
       
    
     Hence, when the velocity v is below a first velocity called v transit , the velocity dependent term assumes the value of F brk . If the velocity the is above a second velocity called v max , the velocity dependent term assumes the value F pr . And for a velocity in between the first velocity and the second velocity the velocity dependent term changes linearly. 
     In an example the parameters used in the equations may assume the values according to Table 1 as below. These parameters may for example correspond to a syringe having a volume of 5 cc. 
     
       
         
           
               
               
               
             
               
                 TABLE 1 
               
               
                   
               
               
                   
                 Parameter 
                 Value 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
               
            
               
                   
                 Preload force 
                 F pr   
                 1.1 
                 N 
               
               
                   
                 Coulomb friction Coefficient 
                 F cfr   
                 0.1 
                 N/bar 
               
               
                   
                 Coulomb friction force 
                 F C   
                 1.1 
                 N 
               
               
                   
                 Breakaway friction force 
                 F brk   
                 3.2 
                 N 
               
               
                   
                 Viscous friction coefficient 
                 F vfr   
                 100 
                 N/(m/s) 
               
               
                   
                 Transition approx. coeff. 
                 C v   
                 1.28E+04 
                 s/m 
               
               
                   
               
            
           
         
       
     
     The velocity dependent term is an estimate of the behavior of the frictional force F 0  in dependence on the velocity. To include also the influence of the position,  FIGS. 7A to 7D and 8A to 8D  shall be considered. 
     As visible from  FIG. 7A to 7D , the structural characteristics in particular of the cylindrical tube  20  may vary along the travel range of the piston  21  relative to the cylindrical tube  20 . In particular, the cylindrical tube  20  may not exhibit a constant diameter, but the diameter may change over position, i.e. it may decrease or increase, as shown in particular in  FIG. 7B to 7D . From such structural variations, a variation of the frictional force over the position may arise, as schematically shown in  FIG. 8A to 8D . 
     Hence, for a particular syringe of a particular model, a particular batch, a particular volume and a particular brand a very specific dependence of the frictional force on the position may arise. Hence, the dependence of the frictional force on the position is parametrized for different syringes and stored in a database of the infusion device  1  for the different syringes. 
     For example, a particular syringe may have a dependence of the frictional force on the position as shown in  FIG. 9 . This can be parameterized by storing coefficient values for discrete positions X 1 , X 2 , . . . modeling the behavior of the frictional force. For example, each syringe can be characterized by coefficient values at five points, wherein it is interpolated between the coefficient values for positions in between two neighboring points. 
     For example, coefficients can be stored for a position at which the syringe is fully empty (position H), for a position in which the syringe assumes its nominal capacity (position R), and at three points in between (at H+¼ (R−H), at H+½ (R−H), and at H+¼ (R−H)). For example for a 5 cc syringe these positions may equal H=13.81 mm, 24.98 mm, 36.16 mm, 47.33 mm, and R=58.5 mm. 
     For these points the coefficients can for example be as shown in Table 2: 
     
       
         
           
               
               
               
             
               
                 TABLE 2 
               
               
                   
               
               
                 Position 
                 Position Coef 
                 Example 
               
               
                   
               
             
            
               
                 0 
                 Pos_Coef(0) 
                 Pos_Coef(0) = 0.25 
               
               
                 1 
                 Pos_Coef(1) 
                 Pos_Coef(1) = 0.85 
               
               
                 2 
                 Pos_Coef(2) 
                 Pos_Coef(2) = 1 
               
               
                 3 
                 Pos_Coef(3) 
                 Pos_Coef(3) = 0.8 
               
               
                 4 
                 Pos_Coef(4) 
                 Pos_Coef(4) = 0.1 
               
               
                   
               
            
           
         
       
     
     The computed velocity-and-position-dependent frictional force F 0  according to the equation
 
 F   0 ( i )= F   pr +( F   0,velocity   −F   pr )· Pos _coef( i )
 
then comes out as shown in  FIG. 10  for different velocities (curves F 1  to F 5 , curve F 1  corresponding to the lowest velocity and curve F 5  to the highest velocity) for the example of a 5 cc syringe according to the parameters of Tables 1 and 2 as above. A close resemblance to the actually measured force F ( FIG. 4 ) can be recognized.
 
     In particular, it comes out that
         if v [mm/h]&lt;v transit [M m/h] then
 
 F   0 ( i )[ gf ]= F   pr [ gf ]+( F   brk [ gf ]− F   pr [ gf ])· Pos _coef( i )
   if v[mm/h] ϵ[v tansit [mm/h], v max [mm/h]] then
 
 F   0 ( i )[ gf ]= F   pr [ gf ]+( a [ gf /(mm/h)]· v [mm/h]+ b [ gf ])· Pos _Coef( i )
   where       

     
       
         
           
             { 
             
               
                 
                   
                     
                       
                         a 
                         ⁡ 
                         
                           [ 
                           
                             gf 
                             ⁢ 
                             
                               / 
                             
                             ⁢ 
                             
                               ( 
                               
                                 mm 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 h 
                               
                               ) 
                             
                           
                           ] 
                         
                       
                       = 
                       
                         
                           
                             
                               F 
                               brk 
                             
                             ⁡ 
                             
                               [ 
                               gf 
                               ] 
                             
                           
                           - 
                           
                             
                               F 
                               pr 
                             
                             ⁡ 
                             
                               [ 
                               gf 
                               ] 
                             
                           
                         
                         
                           
                             
                               v 
                               transit 
                             
                             ⁡ 
                             
                               [ 
                               
                                 mm 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 h 
                               
                               ] 
                             
                           
                           - 
                           
                             
                               v 
                               max 
                             
                             ⁡ 
                             
                               [ 
                               
                                 mm 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 h 
                               
                               ] 
                             
                           
                         
                       
                     
                   
                 
                 
                   
                     
                       
                         b 
                         ⁡ 
                         
                           [ 
                           gf 
                           ] 
                         
                       
                       = 
                       
                         
                           - 
                           
                             a 
                             [ 
                             
                               gf 
                               ⁢ 
                               
                                 / 
                               
                               ⁢ 
                               
                                 ( 
                                 
                                   mm 
                                   ⁢ 
                                   
                                     / 
                                   
                                   ⁢ 
                                   h 
                                 
                                 ) 
                               
                             
                             ] 
                           
                         
                         · 
                         
                           
                             v 
                             max 
                           
                           ⁡ 
                           
                             [ 
                             
                               mm 
                               ⁢ 
                               
                                 / 
                               
                               ⁢ 
                               h 
                             
                             ] 
                           
                         
                       
                     
                   
                 
               
                 
             
           
         
       
         
         
           
             and if v[mm/h]&gt;v max [mm/h] then
 
 F   0 ( i )[ gf ]= F   pr [ gf ]
 
           
         
       
    
     The frictional force determined by this method can then be used for determining the pressure during an actual infusion process such that the pressure can be compared to a threshold in order to conclude whether an occlusion on the infusion line  3  is present or not. 
     The method is functional by itself and by itself can be used to determine the frictional force in order to get an accurate estimate of the pressure within the infusion line  3 . 
     Another method denoted as the “relative pressure” method makes use of the assumptions that
         the infusion device  1  is the only pumping source acting onto the infusion line  3 , and   the only pressure to be observed stems from a direct occlusion.       

     The method relies on the principle to measure and monitor the force F necessary to push the piston  21 , and to consider the measured force F as the normal frictional force F 0  except when the observed force evolution looks like the expected evolution in case of an occlusion. 
     (As the above-noted two hypotheses will not be always fulfilled, the “relative pressure” method will not give a reliable pressure value in case of for example multiline infusion systems or in case of another external device providing pressure. The “relative pressure” method hence not necessarily is meant to replace the “absolute pressure” method as described above, but may serve as in addition providing accurate results if the assumptions are true. 
     It is likely that for many scenarios the assumptions are fulfilled such that the method described below will give very exact and reliable results, for example for the neonatal therapy which requires a very good sensitivity and accuracy.) 
     In general, within the method the force is continuously measured, and in case no occlusion is present the frictional force is assumed to equal the measured force. However, if a slope of the measured force is detected which falls into a predefined range around an expected slope, it is assumed that the corresponding rise in the measured force is due to an occlusion. 
     This is based on the finding that an occlusion in a particular system will generally cause a rise of the measured force according to a rather well-defined slope, which can be determined when mechanical characteristics of the system such as the compliance of the infusion line  3 , the compliance of the cylindrical tube  20  and the stiffness of the mechanical system of the pusher device  12  are known. If a detected slope of the measured force resembles the expected slope indicative of an occlusion, it is concluded that an occlusion may be present. 
     The expected slope is the theoretical slope that the pressure should follow in case the line is occluded at the catheter level. It depends on:
         the flowrate,   the syringe mechanical properties (especially the syringe stopper stiffness),   the syringe pump mechanical properties (especially the pusher stiffness),   the infusion line mechanical properties (the tube compliance).   the fluid properties (which can be neglected if it is assumed that the fluid to be pumped is an incompressible liquid).       

     The pressure slope can either be expressed referring to time or referring to volume. Expressing the expected slope with reference to volume, the expected slope at a position i comes out to be: 
     
       
         
           
             
               Expected_slope 
               ⁢ 
               
                 
                   ( 
                   i 
                   ) 
                 
                 ⁡ 
                 
                   [ 
                   
                     bar 
                     ⁢ 
                     
                       / 
                     
                     ⁢ 
                     ml 
                   
                   ] 
                 
               
             
             = 
             
               
                 
                   dP 
                   ⁡ 
                   
                     ( 
                     i 
                     ) 
                   
                 
                 ⁡ 
                 
                   [ 
                   bar 
                   ] 
                 
               
               
                 
                   dVolume 
                   ⁡ 
                   
                     ( 
                     i 
                     ) 
                   
                 
                 ⁡ 
                 
                   [ 
                   ml 
                   ] 
                 
               
             
           
         
       
     
     The expected slope is equivalent to a volumetric stiffness, which is the inverse of the system compliance. One can therefore write 
               1     Volumetric_Stiffness   ⁢           [     bar   ⁢     /     ⁢   ml     ]       =       ∑     k   =   1     3     ⁢     1     Volumetric_Stiffness   ⁢           ⁢       (   k   )     ⁡     [     bar   ⁢     /     ⁢   ml     ]                                 ⁢   Where               {             Volumetric_Stiffness   ⁢           ⁢       (   1   )     ⁡     [     bar   ⁢     /     ⁢   ml     ]         =     1     Syringe_Compliance   ⁢           [     ml   ⁢     /     ⁢   bar     ]                     Volumetric_Stiffness   ⁢           ⁢       (   2   )     ⁡     [     bar   ⁢     /     ⁢   ml     ]         =     1     Line_Compliance   ⁢           [     ml   ⁢     /     ⁢   bar     ]                     Volumetric_Stiffness   ⁢           ⁢       (   3   )     ⁡     [     bar   ⁢     /     ⁢   ml     ]         =       100   ·     Pusher_Stiffness   ⁢           [     gf   ⁢     /     ⁢   mm     ]           Syringe_Surface   ⁡     [     mm   2     ]       2                     
and the expected slope comes out to be:
 
     
       
         
           
             
               Expected_slope 
               ⁡ 
               
                 [ 
                 
                   bar 
                   ⁢ 
                   
                     / 
                   
                   ⁢ 
                   ml 
                 
                 ] 
               
             
             = 
             
               1 
               
                 
                   
                     
                       
                         Syringe_Compliance 
                         ⁢ 
                         
                             
                         
                         [ 
                         
                           ml 
                           ⁢ 
                           
                             / 
                           
                           ⁢ 
                           bar 
                         
                         ] 
                       
                       + 
                       
                         Line_Compliance 
                         ⁢ 
                         
                             
                         
                         [ 
                         
                           ml 
                           ⁢ 
                           
                             / 
                           
                           ⁢ 
                           bar 
                         
                         ] 
                       
                       + 
                     
                   
                 
                 
                   
                     
                       
                         
                           Syringe_Surface 
                           ⁢ 
                           
                               
                           
                           [ 
                           
                             mm 
                             2 
                           
                           ] 
                         
                         2 
                       
                       
                         100 
                         · 
                         
                           Pusher_Stiffness 
                           ⁢ 
                           
                               
                           
                           [ 
                           
                             gf 
                             ⁢ 
                             
                               / 
                             
                             ⁢ 
                             mm 
                           
                           ] 
                         
                       
                     
                   
                 
               
             
           
         
       
     
     This can be converted to a slope by millimeter, assuming that for a different syringe 1 mm is equivalent to (syringe_Surface S [mm 2 ]/1000) ml: 
     
       
         
           
             
               Expected_slope 
               ⁢ 
               
                   
               
               [ 
               
                 bar 
                 ⁢ 
                 
                   / 
                 
                 ⁢ 
                 mm 
               
               ] 
             
             = 
             
               
                 Syringe_Surface 
                 ⁢ 
                 
                     
                 
                 [ 
                 
                   mm 
                   2 
                 
                 ] 
               
               
                 
                   
                     
                       
                         1000 
                         · 
                         
                           ( 
                           
                             
                               Syringe_Compliance 
                               ⁢ 
                               
                                   
                               
                               [ 
                               
                                 ml 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 bar 
                               
                               ] 
                             
                             + 
                             
                               Line_Compliance 
                               ⁢ 
                               
                                   
                               
                               [ 
                               
                                 ml 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 bar 
                               
                               ] 
                             
                           
                           ) 
                         
                       
                       + 
                     
                   
                 
                 
                   
                     
                       10 
                       · 
                       
                         
                           
                             Syringe_Surface 
                             ⁢ 
                             
                                 
                             
                             [ 
                             
                               mm 
                               2 
                             
                             ] 
                           
                           2 
                         
                         
                           Pusher_Stiffness 
                           ⁢ 
                           
                               
                           
                           [ 
                           
                             gf 
                             ⁢ 
                             
                               / 
                             
                             ⁢ 
                             mm 
                           
                           ] 
                         
                       
                     
                   
                 
               
             
           
         
       
     
     We can also convert this slope to gf/mm. Assuming that for a given syringe F[gf]=10.2*P[bar]*S[mm 2 ], the slope in bar/mm can be converted into a slope in gf/mm: 
     
       
         
           
             
               Expected_slope 
               ⁢ 
               
                   
               
               [ 
               
                 gf 
                 ⁢ 
                 
                   / 
                 
                 ⁢ 
                 mm 
               
               ] 
             
             = 
             
               
                 0.0102 
                 · 
                 
                   
                     Syringe_Surface 
                     ⁢ 
                     
                         
                     
                     [ 
                     
                       mm 
                       2 
                     
                     ] 
                   
                   2 
                 
               
               
                 
                   
                     
                       
                         ( 
                         
                           
                             Syringe_Compliance 
                             ⁢ 
                             
                                 
                             
                             [ 
                             
                               ml 
                               ⁢ 
                               
                                 / 
                               
                               ⁢ 
                               bar 
                             
                             ] 
                           
                           + 
                           
                             Line_Compliance 
                             ⁢ 
                             
                                 
                             
                             [ 
                             
                               ml 
                               ⁢ 
                               
                                 / 
                               
                               ⁢ 
                               bar 
                             
                             ] 
                           
                         
                         ) 
                       
                       + 
                     
                   
                 
                 
                   
                     
                       
                         
                           Syringe_Surface 
                           ⁢ 
                           
                               
                           
                           [ 
                           
                             mm 
                             2 
                           
                           ] 
                         
                         2 
                       
                       
                         Pusher_Stiffness 
                         ⁢ 
                         
                             
                         
                         [ 
                         
                           gf 
                           ⁢ 
                           
                             / 
                           
                           ⁢ 
                           mm 
                         
                         ] 
                       
                     
                   
                 
               
             
           
         
       
     
     Example parameter values for a 5 cc syringe of a particular brand and a particular infusion device are summarized in Table 3: 
     
       
         
           
               
               
               
             
               
                 TABLE 3 
               
               
                   
               
               
                   
                 Parameter 
                 Value 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 Syringe_Compliance 
                 0.0566 
                 ml/bar 
               
               
                   
                 Line_Compliance 
                 0.145 
                 ml/bar 
               
               
                   
                 Pusher_Stiffness 
                 9279 
                 gf/mm 
               
               
                   
                 Syringe inner diameter 
                 11.87 
                 mm 
               
               
                   
                 Syringe surface S 
                 110.66 
                 mm 2   
               
               
                   
               
            
           
         
       
     
     Using these parameters, the following values for the expected slope are obtained:
         Expected_Slope [bar/ml]=4.65 [bar/ml]   Expected_Slope [bar/mm]=0.514 [bar/mm]   Expected_Slope [gf/mm]=568.8 [gf/mm]       

     This expected slope is independent of the flow rate. 
     Thus, it can be assumed that the expected slope in case of an occlusion will be close to 0.5 bar/mm for the particular syringe and the particular infusion device for which the parameters are valid. 
     To provide a range of tolerance, a maximum slope and a minimum slope shall be determined. 
     To determine the maximum slope the following considerations are made: 
     If the syringe and the infusion line were infinitly rigid, the slope would be given by the pusher stiffness and the smallest syringe:
         Inner diameter=5.5 mm=&gt;syringe_Surface S=23.76 mm 2      Max_expected_slope_bar/ml=Pusher_Stiffness/( 10 S)=39 bar/mm       

     If the standard line compliance is occluded, one gets:
         Max_Expected_Slope_bar/mm=0.16 bar/mm       

     If one considers a very rigid neonatal line with a compliance ten times lower:
         Line_Compliance=0.0145 ml/bar,
 
one obtains:
   Max_Expected_Slope_bar/mm=1.6 bar/mm       

     This provides an estimate of the maximum slope, providing an upper boundary for a range around the expected slope. 
     To obtain an estimate of the minimum slope the following considerations are made: 
     For a large volume syringe, for example a 50 cc syringe, the compliance is about 0.8 ml/bar.
         syringe_Compliance=0.64 ml/bar   Line_Compliance=0.145 ml/bar   Pusher_Stiffness=9279 gf/mm   syringe_InnerD=26.36 mm=&gt;syringe_Surface=545.7 mm 2          

     From these parameters one obtains for the expected slope:
         Expected_Slope_bar/mm=0.49 bar/mm   Expected_Slope_gf/mm=2674 gf/mm
 
which is very closed to 0.51 bar/mm obtained above for a 5 cc syringe.
       

     If one assumes a very soft syringe having a compliance three times higher than the considered 50 cc syringe and a diameter of 20 mm, and if further an extension line three times more compliant than the standard line is assumed, one obtains an estimate of a minimum expected slope as follows:
         Min_Expected_Slope_bar/mm=0.12 bar/mm       

     Hence, the range for the slope can be assumed as summarized in Table 4: 
     
       
         
           
               
               
               
             
               
                 TABLE 4 
               
               
                   
               
               
                 Minimum expected 
                 Typical expected 
                 Maximum expected 
               
               
                 Slope 
                 slope 
                 Slope 
               
               
                   
               
             
            
               
                 0.12 bar/mm 
                 0.5 bar/mm 
                 1.6 bar/mm 
               
               
                   
               
            
           
         
       
     
     During an infusion process, in particular at each start of infusion process, the expected slope is computed according to the following equation for the particular parameters of the infusion line, the syringe and the device in use: 
     
       
         
           
             
               Expected_slope 
               ⁢ 
               
                   
               
               [ 
               
                 bar 
                 ⁢ 
                 
                   / 
                 
                 ⁢ 
                 mm 
               
               ] 
             
             = 
             
               
                 Syringe_Surface 
                 ⁢ 
                 
                     
                 
                 [ 
                 
                   mm 
                   2 
                 
                 ] 
               
               
                 
                   
                     
                       
                         1000 
                         · 
                         
                           ( 
                           
                             
                               Syringe_Compliance 
                               ⁢ 
                               
                                   
                               
                               [ 
                               
                                 ml 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 bar 
                               
                               ] 
                             
                             + 
                             
                               Line_Compliance 
                               ⁢ 
                               
                                   
                               
                               [ 
                               
                                 ml 
                                 ⁢ 
                                 
                                   / 
                                 
                                 ⁢ 
                                 bar 
                               
                               ] 
                             
                           
                           ) 
                         
                       
                       + 
                     
                   
                 
                 
                   
                     
                       10 
                       · 
                       
                         
                           
                             Syringe_Surface 
                             ⁢ 
                             
                                 
                             
                             [ 
                             
                               mm 
                               2 
                             
                             ] 
                           
                           2 
                         
                         
                           Pusher_Stiffness 
                           ⁢ 
                           
                               
                           
                           [ 
                           
                             gf 
                             ⁢ 
                             
                               / 
                             
                             ⁢ 
                             mm 
                           
                           ] 
                         
                       
                     
                   
                 
               
             
           
         
       
     
     In test measurements it was found that the expected slope in case of an occlusion is well distinguished from any slope that usually arises during a normal infusion process when no occlusion is present.  FIG. 11  shows a measured force F over the entire travel range of a piston  21  during an infusion process in case no occlusion is present.  FIG. 12  shows the derivative F′ of the measured force F. As visible, the values of the derivative lie in between 150 gf/mm and +200 gf/mm, which lies well outside of the expected slope (which in the above example is at 568.8 gf/mm). In particular, the expected slope for the occurrence of an occlusion seems to be well higher than any slope observed during a regular infusion process without an occlusion being present. 
     Hence, it should be possible to distinguish between an occlusion (indicated by a slope close to the expected slope) and the evolution of the frictional force over the travel range of the piston  21 . 
     Based on the expected slope and the predefined range bounding the expected slope, which are determined prior to the infusion process, the method is now carried out in the following way. 
     During an infusion process the force F is measured, as it is shown in  FIG. 13 . At the same time the slope of the measured force F is determined, for example by taking the difference between the measured force F at a current position and the position immediately prior to the current position, wherein also in averaging may take place to smooth the curve of the measured force F. 
     If it is found that the slope does not fall into the range between the minimum slope and the maximum slope about the expected slope as defined above, it is assumed that the frictional force F 0  is equal to the measured force F. The frictional force F 0  hence tracks the measured force F. 
     If it however is found that the slope falls into the range in between the minimum slope and the maximum slope about the expected slope as defined above, the frictional force F 0  is frozen at the measured force value at the last position X 1  at which the slope did not fall into said range (see  FIG. 13 ). The friction force F 0  thus obtained is used to calculate the pressure, and the calculated pressure is compared to the threshold value. If the threshold is exceeded, an alarm is triggered. 
     This scenario is shown in  FIG. 13 , where it is visible that the measured force F rises for positions beyond the position X 1 . Beyond the position X 1 , for example at the position X 2 , the slope Δ is within the predefined range, such that the frictional force F 0  is held fixed at the measured force value F associated with the position X 1 . 
     If the slope Δ of the measured force F for subsequent positions once more falls out of the range, the frictional force F 0  again is set to the measured force F and hence tracks the measured force F. 
     In this regard it is to be noted that the comparison of the slope Δ to the predetermined range bounded by the minimum slope and the maximum slope about the expected slope as defined above can be used by itself to trigger an alarm. Hence, if it is found that the slope Δ falls within the predetermined range, a so called prealarm can be triggered, warning a user at an early stage that an occlusion has occurred. This can be employed in principle independently of any of the methods described above as an independent method to trigger an occlusion alarm. 
     The alarm herein may be a prealarm, i.e. a low priority alarm giving an early warning, but having a smaller relevance than an actual occlusion alarm triggered when it is found that an occlusion is present with a high level of confidence. 
     The “absolute pressure” method as described above and the relative pressure method as described above may beneficially be used in combination. The relative pressure method may offer an increased accuracy in case the assumptions on which the method are based (no other infusion devices present and no other sources causing a rise of pressure than an occlusion) are true. In case the assumptions are not true, the absolute pressure method may offer a reliable detection of an occlusion. 
     The invention is not limited to the embodiments described above, but may be carried out in an entirely different way. 
     In particular, it is not actually necessary that the pressure is calculated, but it generally is sufficient to determine a value proportional to (or generally indicative of) the pressure, which can then be compared to a suitable threshold for determining whether an occlusion has occurred. 
     Also, within the method as described above generally position and time can be interchanged. At a constant velocity position and time are linearly dependent. 
     LIST OF REFERENCE NUMERALS 
     
         
           1  Infusion device 
           10  Housing 
           11  Receptacle 
           110  Fixation device 
           12  Pusher device 
           120  Guide device 
           121  Connecting rod 
           2  syringe 
           20  Cylinder tube 
           200  Connector 
           21  Piston 
           210  Piston head 
           211  Piston member 
           3  Infusion line 
         χ Slope 
         F (Measured) force 
         F′ Derivative of measured force 
         F 1 -F 5  Curve of friction force 
         K 1 -K 3  Curves 
         P Pressure 
         S Surface 
         X, X′ Movement direction 
         X 1 , X 2  Position