Method for detecting an occlusion in an infusion line

Abstract

A method for detecting an occlusion in an infusion line (3) connected to an infusion device (1) comprises: measuring a force (F) applied to a piston (21) by a pusher device (12) of an infusion device (1) for moving the piston (21) along a movement direction (X) into a cylindrical tube (20) in order to deliver a medical fluid from the cylindrical tube (21) towards an infusion line (3) connected to the cylindrical tube (20); calculating, from the measured force (F), a value indicative of a pressure (P) in the cylindrical tube (20), wherein for calculating said value indicative of said pressure (P) a frictional force value (F0) indicative of a friction of the piston (21) relative to the cylindrical tube (20) is taken into account; and comparing said value indicative of said pressure (P) to a threshold value to determine whether an occlusion is present in the infusion line (3). Herein, the frictional force value (F0) is determined using a mathematical model modelling the friction of the piston (21) relative to the cylindrical tube (20) in dependence on the position of the piston (21) relative to the cylindrical tube (20) along the movement direction (X) and in dependence on the velocity by which the piston (21) is moved relative to the cylindrical tube (3). In this way a method for reliably detecting an occlusion in an infusion line during an infusion process is provided.

Claims

1. A method for detecting an occlusion in an infusion line connected to an infusion device, comprising: measuring a force applied to a piston by a pusher device of an infusion device during an infusion operation performed by the 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, calculating, from the measured force, a value indicative of a pressure in the cylindrical tube, 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, comparing said value indicative of said pressure to a threshold value to determine whether an occlusion is present in the infusion line during the infusion operation performed by the infusion device, wherein the frictional force value is determined using a mathematical model modelling the friction of the piston relative to the cylindrical tube in dependence on a position of the piston relative to the cylindrical tube along the movement direction and in dependence on a velocity by which the piston is moved relative to the cylindrical tube.

2. The method according to claim 1, wherein the model includes 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.

3. The method according to claim 2, wherein the model models the velocity dependent term by using an equation including terms for a Coulomb friction, a Stribeck friction and/or a viscous friction.

4. The method according to claim 2, wherein the velocity dependent term, for a velocity below a first velocity value and/or for a velocity above a second velocity value, assumes a constant value.

5. The method according to claim 2, wherein the velocity dependent term, for a velocity in between a first velocity value and a second velocity value, linearly changes in dependence on the velocity.

6. The method according to claim 2, wherein the position dependent term includes a position-dependent coefficient, which is multiplied with a term including the velocity dependent term to obtain the frictional force value for a current position of the piston relative to the cylindrical tube.

7. A method for detecting an occlusion in an infusion line connected to an infusion device, comprising: measuring a force applied to a piston by a pusher device of an infusion device during an infusion operation performed by the 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, calculating, from the measured force, a value indicative of a pressure in the cylindrical tube, wherein for calculating said value indicative of said pressure a frictional force value indicative of a friction of the piston within the cylindrical tube is taken into account, comparing said value indicative of said pressure to a threshold value to determine whether an occlusion is present in the infusion line during the infusion operation performed by the infusion device, 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.

8. The method according to claim 7, wherein said position prior to the current position is a position for which the slope value is outside of the predetermined range.

9. The method according to claim 7, wherein the slope value is determined from the difference of the measured force at the current position and the measured force at a position prior to the current position.

10. The method according to claim 7, wherein, if the slope value does not lie within said predetermined range, the frictional force value is assumed to equal the measured force at the current position of the piston.

11. The method according to claim 7, wherein the predetermined range is bounded by a minimum slope smaller than an expected slope and a maximum slope larger than the expected slope.

12. The method according to claim 7, wherein the expected slope is determined taking a compliance of the cylindrical tube, a compliance of the infusion line, a stiffness of the pusher device and/or a dimension of the cylindrical tube into account.

13. The method according to claim 12, wherein values for the compliance of the cylindrical tube, the compliance of the infusion line, the stiffness of the pusher device and/or the dimension of the cylindrical tube are stored in the infusion device for at least one syringe used on the infusion device.

14. The method according to claim 7, wherein a prealarm is triggered if the slope value lies within a predetermined range.

15. A method for detecting an occlusion in an infusion line connected to an infusion device, comprising (a) 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, calculating, from the measured force, a value indicative of a pressure in the cylindrical tube, 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, comparing said value indicative of said pressure to a threshold value to determine whether an occlusion is present in the infusion line, wherein the frictional force value is determined using a mathematical model modelling the friction of the piston relative to the cylindrical tube in dependence on a position of the piston relative to the cylindrical tube along the movement direction and in dependence on a velocity by which the piston is moved relative to the cylindrical tube; and (b) 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, calculating, from the measured force, a value indicative of a pressure in the cylindrical tube, wherein for calculating said value indicative of said pressure a frictional force value indicative of a friction of the piston within the cylindrical tube is taken into account, comparing said value indicative of said pressure to a threshold value to determine whether an occlusion is present in the infusion line, 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, wherein the steps of (a) and (b) are carried out in parallel during an infusion operation performed by the infusion device.

16. The method according to claim 15, wherein an alarm is triggered if it is determined with at least one of (a) and (b) that said value indicative of the pressure is above said threshold value.

Description

(1) The idea underlying the invention shall subsequently be described in more detail with respect to the embodiments shown in the figures. Herein:

(2) FIG. 1 shows a view of an embodiment of an infusion device in the shape of a syringe pump;

(3) 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;

(4) FIG. 3 a schematic view of the syringe, as the piston is moved out of the cylindrical tube;

(5) 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;

(6) FIG. 5 a graphical view of the dependence of the frictional force on the velocity;

(7) FIG. 6 a view of a linearized model of the frictional force in dependence on the velocity;

(8) FIG. 7A-7D schematic views of different syringes having different characteristics;

(9) FIG. 8A-8D graphical views of the frictional force dependent on the position for the different syringes according to FIG. 7A to 7D;

(10) FIG. 9 a view of a simplified dependence of the frictional force on the position;

(11) FIG. 10 a view of the modelled frictional force in dependence on the position, for different velocities;

(12) FIG. 11 a view of the measured force over position;

(13) FIG. 12 a view of the derivative of the measured force according to FIG. 11; and

(14) FIG. 13 a view of the measured force in the occurrence of an occlusion.

(15) 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.

(16) 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.

(17) 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.

(18) 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.

(19) 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.

(20) 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.

(21) 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.

(22) In particular, the pressure in the cylindrical tube 20 depends on the measured force F according to the following relation:

(23) $P=\frac{F-F_0}{S}.$

(24) Herein, P denotes the pressure, F denotes the measured force, F.sub.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.

(25) By determining the pressure P in this way and by comparing the determined pressure P to a predefined threshold P.sub.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.sub.thres, it is concluded that an occlusion is present.

(26) 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.sub.0 cannot be determined in an easy way. In particular, the frictional force component F.sub.0 may vary in dependence on the specific syringe 2 used on the system, wherein the frictional force component F.sub.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.

(27) The methods described subsequently deal with the determination of the frictional force component F.sub.0. Herein, within a first method a model-based approached is used to determine the frictional force component F.sub.0. In a second method an approach based on measurements is used, assuming that the frictional force component F.sub.0 equals the measured force as long as no occlusion is present in the system.

(28) 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.Math.S+F.sub.0

(29) 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.sup.2), and F.sub.0 is the frictional force between the moving part of the syringe (the piston 21) and the fixed part (the cylindrical tube 20).

(30) 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.Math.SF.sub.0

(31) 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).

(32) The frictional force component F.sub.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.

(33) 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.

(34) In the following, two methods are described, providing different approaches to obtain an estimate of the frictional force F.sub.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.

(35) Within the absolute pressure method the frictional force F.sub.0 is estimated using a model.

(36) 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 K1-K3 indicate the force F (in gram force (gf)) for different velocities of the piston 21. Curve K1 for example indicates the position dependence of the force F for a low velocity, K2 for a medium velocity and K3 for a high velocity.

(37) As visible from FIG. 4, for a high velocity (curve K3) 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 K1 for example corresponds to a velocity of 2.5.Math.10.sup.6 m/s, curve K2 corresponds for example to a velocity of 2.5.Math.10.sup.5 m/s, and curve K3 corresponds for example to a velocity of 2.5.Math.10.sup.4 m/s.

(38) 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.

(39) To model the frictional force, a model can be used including a term for a velocity dependent force component F.sub.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.sub.0(i)=F.sub.pr+(F.sub.0,velocityF.sub.pr).Math.Pos_coef(i)

(40) Herein, F.sub.0(i) is the frictional at the position i, F.sub.pr is a preload force, F.sub.0,velocity is the velocity dependent term, and Pos_coef(i) is the position dependent coefficient.

(41) The velocity dependent term F.sub.0,velocity can be modeled according to the following equation:
F.sub.0,velocity=F.sub.C+(F.sub.brkF.sub.C).Math.e.sup.(C.sup.v.sup..Math.v)+f.sub.vfr.Math.v

(42) Herein, the first term F.sub.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.sub.brk is the breakaway force, C.sub.v is a so-called transition approximation coefficient, and f.sub.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.

(43) The parameter C.sub.v (denoted as the transition approximation coefficient) in the second term representing the Stribeck friction can be chosen for example according to curve K3 in FIG. 4, i.e. according to the minimum force at a velocity of 2.5.Math.10.sup.4 m/s:

(44) $C_v=\frac{4}{2.5.Math.{10}^{-4}m\text{/}s}=1.28.Math.{10}^{-4}s\text{/}m$

(45) F.sub.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.sub.C=F.sub.pr+f.sub.cfr.Math.P,
f.sub.cfr being the Coulomb friction Coefficient. If it is assumed that the pressure P has no impact on the friction force this becomes:
F.sub.C=F.sub.pr
and one obtains for the velocity dependent term:
F.sub.0,velocity=F.sub.pr+(F.sub.brkF.sub.pr).Math.e.sup.(C.sup.v.sup..Math.v)+f.sub.vfr.Math.v

(46) 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:

(47) When v [mm/h]<v.sub.transit [mm/h] then
F.sub.0,velocity[gf]=F.sub.brk[gf] When v [mm/h] [v.sub.transit[mm/h], v.sub.max[mm/h]] then
F.sub.0,velocity[gf]=F.sub.pr+a[gf/(mm/h)].Math.v[mm/h]+b[gf] where

(48) $\{\begin{array}{c}a\left[\mathrm{gf}\text{/}\left(\mathrm{mm}\text{/}h\right)\right]=\frac{F_{\mathrm{brk}}\left[\mathrm{gf}\right]-F_{\mathrm{pr}}\left[\mathrm{gf}\right]}{v_{\mathrm{transit}}\left[\mathrm{mm}\text{/}h\right]-v_{\max }\left[\mathrm{mm}\text{/}h\right]}\\ b\left[\mathrm{gf}\right]=-a\left[\mathrm{gf}\text{/}\left(\mathrm{mm}\text{/}h\right)\right].Math.v_{\max }\left[\mathrm{mm}\text{/}h\right]\end{array}$ When v[mm/h]>v.sub.max[mm/h] then
F.sub.0,velocity[gf]=F.sub.pr[gf]

(49) Hence, when the velocity v is below a first velocity called v.sub.transit, the velocity dependent term assumes the value of F.sub.brk. If the velocity the is above a second velocity called v.sub.max, the velocity dependent term assumes the value F.sub.pr. And for a velocity in between the first velocity and the second velocity the velocity dependent term changes linearly.

(50) 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.

(51) TABLE-US-00001 TABLE 1 Parameter Value Preload force F.sub.pr 1.1 N Coulomb friction Coefficient F.sub.cfr 0.1 N/bar Coulomb friction force F.sub.C 1.1 N Breakaway friction force F.sub.brk 3.2 N Viscous friction coefficient F.sub.vfr 100 N/(m/s) Transition approx. coeff. C.sub.v 1.28E+04 s/m

(52) The velocity dependent term is an estimate of the behavior of the frictional force F.sub.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.

(53) 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.

(54) 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.

(55) 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 X1, X2, . . . 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.

(56) 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+ (RH), at H+ (RH), and at H+ (RH)). 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.

(57) For these points the coefficients can for example be as shown in Table 2:

(58) TABLE-US-00002 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

(59) The computed velocity-and-position-dependent frictional force F.sub.0 according to the equation
F.sub.0(i)=F.sub.pr+(F.sub.0,velocityF.sub.pr).Math.Pos_coef(i)
then comes out as shown in FIG. 10 for different velocities (curves F1 to F5, curve F1 corresponding to the lowest velocity and curve F5 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.

(60) In particular, it comes out that if v [mm/h]<v.sub.transit[M m/h] then
F.sub.0(i)[gf]=F.sub.pr[gf]+(F.sub.brk[gf]F.sub.pr[gf]).Math.Pos_coef(i) if v[mm/h] [v.sub.tansit[mm/h], v.sub.max[mm/h]] then
F.sub.0(i)[gf]=F.sub.pr[gf]+(a[gf/(mm/h)].Math.v[mm/h]+b[gf]).Math.Pos_Coef(i) where

(61) $\{\begin{array}{c}a\left[\mathrm{gf}\text{/}\left(\mathrm{mm}\text{/}h\right)\right]=\frac{F_{\mathrm{brk}}\left[\mathrm{gf}\right]-F_{\mathrm{pr}}\left[\mathrm{gf}\right]}{v_{\mathrm{transit}}\left[\mathrm{mm}\text{/}h\right]-v_{\max }\left[\mathrm{mm}\text{/}h\right]}\\ b\left[\mathrm{gf}\right]=-a\left[\mathrm{gf}\text{/}\left(\mathrm{mm}\text{/}h\right)\right].Math.v_{\max }\left[\mathrm{mm}\text{/}h\right]\end{array}$ and if v[mm/h]>v.sub.max[mm/h] then
F.sub.0(i)[gf]=F.sub.pr[gf]

(62) 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.

(63) 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.

(64) 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.

(65) 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.sub.0 except when the observed force evolution looks like the expected evolution in case of an occlusion.

(66) (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.

(67) 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.)

(68) 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.

(69) 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.

(70) 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).

(71) 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:

(72) $\mathrm{Expected\_slope}\left(i\right)\left[\mathrm{bar}\text{/}\mathrm{ml}\right]=\frac{\mathrm{dP}\left(i\right)\left[\mathrm{bar}\right]}{\mathrm{dVolume}\left(i\right)\left[\mathrm{ml}\right]}$

(73) The expected slope is equivalent to a volumetric stiffness, which is the inverse of the system compliance. One can therefore write

(74) $\frac{1}{\mathrm{Volumetric\_Stiffness}\left[\mathrm{bar}\text{/}\mathrm{ml}\right]}=\underset{k=1}{\overset{3}{.Math.}}\frac{1}{\mathrm{Volumetric\_Stiffness}\left(k\right)\left[\mathrm{bar}\text{/}\mathrm{ml}\right]}$$\mathrm{Where}$$\{\begin{array}{c}\mathrm{Volumetric\_Stiffness}\left(1\right)\left[\mathrm{bar}\text{/}\mathrm{ml}\right]=\frac{1}{\mathrm{Syringe\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]}\\ \mathrm{Volumetric\_Stiffness}\left(2\right)\left[\mathrm{bar}\text{/}\mathrm{ml}\right]=\frac{1}{\mathrm{Line\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]}\\ \mathrm{Volumetric\_Stiffness}\left(3\right)\left[\mathrm{bar}\text{/}\mathrm{ml}\right]=\frac{100.Math.\mathrm{Pusher\_Stiffness}\left[\mathrm{gf}\text{/}\mathrm{mm}\right]}{{\mathrm{Syringe\_Surface}\left[{\mathrm{mm}}^2\right]}^2}\end{array}$
and the expected slope comes out to be:

(75) $\mathrm{Expected\_slope}\left[\mathrm{bar}\text{/}\mathrm{ml}\right]=\frac{1}{\begin{array}{c}\mathrm{Syringe\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]+\mathrm{Line\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]+\\ \frac{{\mathrm{Syringe\_Surface}\left[{\mathrm{mm}}^2\right]}^2}{100.Math.\mathrm{Pusher\_Stiffness}\left[\mathrm{gf}\text{/}\mathrm{mm}\right]}\end{array}}$

(76) This can be converted to a slope by millimeter, assuming that for a different syringe 1 mm is equivalent to (syringe_Surface S [mm.sup.2]/1000) ml:

(77) $\mathrm{Expected\_slope}\left[\mathrm{bar}\text{/}\mathrm{mm}\right]=\frac{\mathrm{Syringe\_Surface}\left[{\mathrm{mm}}^2\right]}{\begin{array}{c}1000.Math.\left(\mathrm{Syringe\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]+\mathrm{Line\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]\right)+\\ 10.Math.\frac{{\mathrm{Syringe\_Surface}\left[{\mathrm{mm}}^2\right]}^2}{\mathrm{Pusher\_Stiffness}\left[\mathrm{gf}\text{/}\mathrm{mm}\right]}\end{array}}$

(78) We can also convert this slope to gf/mm. Assuming that for a given syringe F[gf]=10.2*P[bar]*S[mm.sup.2], the slope in bar/mm can be converted into a slope in gf/mm:

(79) 0$\mathrm{Expected\_slope}\left[\mathrm{gf}\text{/}\mathrm{mm}\right]=\frac{0.0102.Math.{\mathrm{Syringe\_Surface}\left[{\mathrm{mm}}^2\right]}^2}{\begin{array}{c}\left(\mathrm{Syringe\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]+\mathrm{Line\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]\right)+\\ \frac{{\mathrm{Syringe\_Surface}\left[{\mathrm{mm}}^2\right]}^2}{\mathrm{Pusher\_Stiffness}\left[\mathrm{gf}\text{/}\mathrm{mm}\right]}\end{array}}$

(80) Example parameter values for a 5 cc syringe of a particular brand and a particular infusion device are summarized in Table 3:

(81) TABLE-US-00003 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.sup.2

(82) 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]

(83) This expected slope is independent of the flow rate.

(84) 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.

(85) To provide a range of tolerance, a maximum slope and a minimum slope shall be determined.

(86) To determine the maximum slope the following considerations are made:

(87) 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=>syringe_Surface S=23.76 mm.sup.2 Max_expected_slope_bar/ml=Pusher_Stiffness/(10S)=39 bar/mm

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

(89) 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

(90) This provides an estimate of the maximum slope, providing an upper boundary for a range around the expected slope.

(91) To obtain an estimate of the minimum slope the following considerations are made:

(92) 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=>syringe_Surface=545.7 mm.sup.2

(93) 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.

(94) 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

(95) Hence, the range for the slope can be assumed as summarized in Table 4:

(96) TABLE-US-00004 TABLE 4 Minimum expected Typical expected Maximum expected Slope slope Slope 0.12 bar/mm 0.5 bar/mm 1.6 bar/mm

(97) 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:

(98) $\mathrm{Expected\_slope}\left[\mathrm{bar}\text{/}\mathrm{mm}\right]=\frac{\mathrm{Syringe\_Surface}\left[{\mathrm{mm}}^2\right]}{\begin{array}{c}1000.Math.\left(\mathrm{Syringe\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]+\mathrm{Line\_Compliance}\left[\mathrm{ml}\text{/}\mathrm{bar}\right]\right)+\\ 10.Math.\frac{{\mathrm{Syringe\_Surface}\left[{\mathrm{mm}}^2\right]}^2}{\mathrm{Pusher\_Stiffness}\left[\mathrm{gf}\text{/}\mathrm{mm}\right]}\end{array}}$

(99) 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.

(100) 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.

(101) 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.

(102) 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.

(103) 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.sub.0 is equal to the measured force F. The frictional force F.sub.0 hence tracks the measured force F.

(104) 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.sub.0 is frozen at the measured force value at the last position X1 at which the slope did not fall into said range (see FIG. 13). The friction force F.sub.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.

(105) This scenario is shown in FIG. 13, where it is visible that the measured force F rises for positions beyond the position X1. Beyond the position X1, for example at the position X2, the slope is within the predefined range, such that the frictional force F.sub.0 is held fixed at the measured force value F associated with the position X1.

(106) If the slope of the measured force F for subsequent positions once more falls out of the range, the frictional force F.sub.0 again is set to the measured force F and hence tracks the measured force F.

(107) In this regard it is to be noted that the comparison of the slope 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 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.

(108) 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.

(109) 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.

(110) The invention is not limited to the embodiments described above, but may be carried out in an entirely different way.

(111) 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.

(112) 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

(113) 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 Slope F (Measured) force F Derivative of measured force F1-F5 Curve of friction force K1-K3 Curves P Pressure S Surface X, X Movement direction X1, X2 Position