Method for detecting an occlusion in an infusion line

• US 10,314,971 B2
• Filed: 11/09/2016
• Issued: 06/11/2019
• Est. Priority Date: 11/13/2015
• Status: Active Grant

• Current Assignee: Fresenius Vial SAS (Else Kröner-Fresenius-Stiftung)
• Original Assignee: Fresenius Vial SAS (Else Kröner-Fresenius-Stiftung)
• Inventors: Wolff, Remy
• Primary Examiner(s): Rivera Vargas, Manuel A
• Application Number:
  US15/769,654
• Publication Number:
  US 20180311434A1
• Time in Patent Office: 944 Days
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: G06F 30/20 Design optimisation, verification or simulation optimisation, verification or simulation of circuit designs G06F30/30

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.