Process for controlling an infusion device

• US 7,758,547 B2
• Filed: 04/13/2005
• Issued: 07/20/2010
• Est. Priority Date: 04/20/2004
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Cestari, Silvano, Tonelli, Claudio, Ligabue, Andrea
• Primary Examiner(s): Deak; Leslie R.
• Assistant Examiner(s): MARCETICH, ADAM M
• Application Number:
  US11/104,446
• Publication Number:
  US 20050234387A1
• Time in Patent Office: 1,924 Days
• Field of Search: 604/19, 604/500, 604/514, 604/65, 604/67, 604/118, 604/121, 604/66, 128/DIG.12, 128/DIG.13, 417/18, 417/25, 417/63, 222/55, 222/61, 222/63, 222/333
• US Class Current: 604/131
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A process comprises the phases of: activating a pusher, which exerts a push force on a plunger of a syringe containing the infusion liquid; measuring the push force by means of a load cell; comparing the push force with a maximum threshold; halting the pusher when the maximum threshold is exceeded; after a predetermined pause, restarting the pusher and emitting a consent signal indicating correct loading of the syringe if, within a certain time from the restart, the push force again exceeds the maximum threshold. The infusion device serves to inject an anticoagulant into an extracorporeal blood circuit. The control process guarantees against loss of infusion due to an incorrect initial loading of the syringe.

Claims

1. A process for controlling an infusion device, wherein the infusion device comprises a variable-volume container of the infusion liquid and an actuator for exerting an infusion force able to cause infusion of the liquid, the process comprising stages of:

activating the actuator;

determining at least a first value of a parameter indicating an infusion force;

verifying whether the first value satisfies a first predetermined relation with a first reference value;

emitting at least one command signal for generating a variation in the functioning of the actuator if the relation is satisfied, the at least one command signal comprising a first command signal to the actuator and a second command signal to the actuator, a predetermined time interval lapses between the stage of emitting a first signal and the stage of emitting a second signal;

determining at least a second value of a parameter indicating an infusion force;

verifying whether the second value satisfies a second predetermined relation with a second reference value; and

emitting a further signal in consequence of the verification of the at least a second value,

wherein the infusion liquid is a blood anticoagulant.

2. The process of claim 1, wherein the first command signal is a signal which blocks or slows down the actuator.

3. The process of claim 2, wherein the signal which blocks or slows down the actuator is emitted if the first relation is satisfied.

4. The process of claim 1, wherein the second command signal is a signal which activates or accelerates the actuator.

5. The process of claim 1, wherein the second command signal comprises an activation of the actuator for a predetermined duration.

6. The process of claim 1, wherein the second command signal comprises an activation of the actuator with an infusion force which is close to a maximum force available for the actuator.

7. The process of claim 1, wherein the further signal is a signal of consent or an alarm according to whether the second relation is satisfied or not.

8. The process of claim 1, wherein the parameter relating to the first value is also the parameter relating to the second value.

9. The process of claim 1, wherein the first predetermined relation is equal to the second predetermined relation.

10. The process of claim 1, wherein the first reference value is equal to the second reference value.

11. The process of claim 1, wherein the stages are automatically commanded by a controller.

12. The process of claim 1, wherein the stage of activation is performed on manual command by an operator, while other stages thereof are commanded automatically by a controller.

13. The process of claim 1, wherein the infusion device is operatively associated to an extracorporeal blood circuit.

14. The process of claim 1 used for checking the correct reciprocal positioning of said variable-volume container and said actuator.

15. A process for controlling an infusion device, wherein the infusion device comprises a variable-volume container of the infusion liquid and an actuator for exerting an infusion force able to cause infusion of the liquid, the process comprising stages of:

activating the actuator;

determining at least a first value of a parameter indicating an infusion force;

verifying whether the first value satisfies a first predetermined relation with a first reference value;

emitting at least one command signal for generating a variation in the functioning of the actuator if the relation is satisfied, the at least one command signal comprising a first command signal to the actuator and a second command signal to the actuator, a predetermined time interval lapses between the stage of emitting a first signal and the stage of emitting a second signal;

determining at least a second value of a parameter indicating an infusion force;

verifying whether the second value satisfies a second predetermined relation with a second reference value; and

emitting a further signal in consequence of the verification of the at least a second value,

wherein the infusion device is operatively associated to an extracorporeal blood circuit.

16. The process of claim 15, wherein the first command signal is a signal which blocks or slows down the actuator.

17. The process of claim 16, wherein the signal which blocks or slows down the actuator is emitted if the first relation is satisfied.

18. The process of claim 15, wherein the second command signal is a signal which activates or accelerates the actuator.

19. The process of claim 15, wherein the second command signal comprises an activation of the actuator for a predetermined duration.

20. The process of claim 15, wherein the second command signal comprises an activation of the actuator with an infusion force which is close to a maximum force available for the actuator.

21. The process of claim 15, wherein the further signal is a signal of consent or an alarm according to whether the second relation is satisfied or not.

22. The process of claim 15, wherein the parameter relating to the first value is also the parameter relating to the second value.

23. The process of claim 15, wherein the first predetermined relation is equal to the second predetermined relation.

24. The process of claim 15, wherein the first reference value is equal to the second reference value.

25. The process of claim 15, wherein the stages are automatically commanded by a controller.

26. The process of claim 15, wherein the stage of activation is performed on manual command by an operator, while other stages thereof are commanded automatically by a controller.

27. The process of claim 15 used for checking the correct reciprocal positioning of said variable-volume container and said actuator.

28. A process for controlling an infusion device, wherein the infusion device comprises a variable-volume container of the infusion liquid and an actuator for exerting an infusion force able to cause infusion of the liquid, the process comprising stages of:

activating the actuator;

determining at least a first value of a parameter indicating an infusion force;

verifying whether the first value satisfies a first predetermined relation with a first reference value;

emitting at least one command signal for generating a variation in the functioning of the actuator if the relation is satisfied, the at least one command signal comprising a first command signal to the actuator and a second command signal to the actuator, a predetermined time interval lapses between the stage of emitting a first signal and the stage of emitting a second signal;

determining at least a second value of a parameter indicating an infusion force;

verifying whether the second value satisfies a second predetermined relation with a second reference value; and

emitting a further signal in consequence of the verification of the at least a second value,

wherein the second command signal comprises an activation of the actuator with an infusion force which is close to a maximum force available for the actuator.

29. A tangible, machine-readable medium having instructions for at least one controller recorded thereon, the medium comprising:

instructions for activating an actuator;

instructions for determining at least a first value of a parameter indicating an infusion force;

instructions for verifying whether the first value satisfies a first predetermined relation with a first reference value;

instructions for emitting at least one command signal for generating a variation in the functioning of the actuator if the relation is satisfied, the at least one command signal comprising a first command signal to the actuator and a second command signal to the actuator, a predetermined time interval lapses between the stage of emitting a first signal and the stage of emitting a second signal, the second command signal comprising an activation of the actuator with an infusion force which is close to a maximum force available for the actuator;

instructions for determining at least a second value of a parameter indicating an infusion force;

instructions for verifying whether the second value satisfies a second predetermined relation with a second reference value; and

instructions for emitting a further signal in consequence of the verification of the at least a second value.

30. The medium of claim 29, wherein the medium comprises at least one of a means for magnetic and/or optical recording, a computer memory, an electrical or electromagnetic support, and a read-only memory.