Process for analyzing pressure variation in a perfusion apparatus comprising several units

• US 6,834,242 B2
• Filed: 03/16/2001
• Issued: 12/21/2004
• Est. Priority Date: 03/16/2000
• Status: Expired due to Term

• Current Assignee: Fresenius Vial SAS (Else Kröner-Fresenius-Stiftung)
• Original Assignee: Fresenius Vial SAS (Else Kröner-Fresenius-Stiftung)
• Inventors: Wolff, Rémi, Rondelet, Jean-Claude
• Primary Examiner(s): SHAH, KAMINI S
• Application Number:
  US09/809,189
• Publication Number:
  US 20010023345A1
• Time in Patent Office: 1,376 Days
• Field of Search: 604/154, 604/155, 702/50
• US Class Current: 702/50
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• 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 5/16854 by monitoring line pressure

Abstract

The invention concerns a method to analyze the pressure variation in a perfusion device including multiple perfusion modules each equipped with a pump to deliver a liquid to be perfused in a line placed downstream from the pump as well as a means to measure the pressure in the line, with junction points enabling connection of certain lines among each other or certain lines with lines from units outside the perfusion device. This process consists first in determining whether there is an acceptable explanation for a pressure variation (increase or reduction in the flow rate in a module) and whether this variation concerns modules other than that which detected it first, and which ones, to then act on the perfusion device according to the result of this analysis, either by modifying the analytical parameters in the various modules affected if the pressure variation has an acceptable explanation or by simultaneously stopping all the modules affected by this variation in flow rate and by dealing with the source of the malfunction (rupture or obstruction).

Claims

1. Method for analysis of the pressure variation in a perfusion device,

said perfusion device comprising a plurality of perfusion modules i each equipped with a pump to deliver a liquid to be perfused in a line i placed downstream from the pump as well as with means for measuring the pressure in the line i,

at least one junction point enabling connection of at least one of the lines i with (a) at least another of the lines i or (b) at least one line from at least one unit external to the perfusion device,

wherein said method comprises:

detecting, among lines i of modules i, a variation of pressure Pk in a line k of a module k, and

determining, among modules i other than module k, an involvement of one or several modules j in this pressure variation, by an analytical process.

2. Method according to claim 1, wherein the analytical process includes a search for data indicating a modification of flow rate in a module j.

3. Method according to claim 2, wherein when a message indicating a modification of flow rate in a module j has been found, parameters for analysis of the module k are modified at least as long as the modification of the flow rate in the module j lasts.

4. Method according to claim 1, wherein the analytical process includes a comparison of a slope of a pressure curve of each line i with a slope of a pressure curve of the line k to determine lines j which are potentially connected to the line k by a junction point and which may also be affected by a pressure variation.

5. Method according to claim 2, wherein the analytical process includes a comparison of a slope of a pressure curve of each line i with a slope of a pressure curve of the line k to determine lines j which are potentially connected to the line k by a junction point and which may also be affected by a pressure variation.

6. Method according to claim 3, wherein the analytical process includes a comparison of a slope of a pressure curve of each line i with a slope of a pressure curve of the line k to determine lines j which are potentially connected to the line k by a junction point and which may also be affected by a pressure variation.

7. Method according to claim 1, wherein the analytical process includes a comparison of a rate of pressure increase in the line k with a theoretical rate that it should have if an obstruction developed in the line k upstream from any junction point with another line i.

8. Method according to claim 2, wherein the analytical process includes a comparison of a rate of pressure increase in the line k with a theoretical rate that it should have if an obstruction developed in the line upstream from any junction point with another line i.

9. Method according to claim 3, wherein the analytical process includes a comparison of a rate of pressure increase in the line k with a theoretical rate that it should have if an obstruction developed in the line upstream from any junction point with another line i.

10. Method according to claim 4, wherein the analytical process includes a comparison of a rate of pressure increase in the line k with a theoretical rate that it should have if an obstruction developed in the line upstream from any junction point with another line i.

11. Method according to claim 5, wherein the analytical process includes a comparison of a rate of pressure increase in the line k with a theoretical rate that it should have if an obstruction developed in the line upstream from any junction point with another line i.

12. Method according to claim 6, wherein the analytical process includes a comparison of a rate of pressure increase in the line k with a theoretical rate that it should have if an obstruction developed in the line upstream from any junction point with another line i.

13. Method according to claim 10, wherein the analytical process includes a calculation of a theoretical rate of pressure increase which should be observed in the line k in the event of an obstruction downstream from junction points with the lines j and a comparison of the rate of pressure increase in the line k with this theoretical rate.

14. Method according to claim 11, wherein the analytical process includes a calculation of a theoretical rate of pressure increase which should be observed in the line k in the event of an obstruction downstream from junction points with the lines j and a comparison of the rate of pressure increase in the line k with this theoretical rate.

15. Method according to claim 12, wherein the analytical process includes a calculation of a theoretical rate of pressure increase which should be observed in the line k in the event of an obstruction downstream from junction points with the lines j and a comparison of the rate of pressure increase in the line k with this theoretical rate.

16. Method according to claim 1, wherein a pressure Pi in each line i is measured at regular intervals, and measurements are stored in a history file starting at the latest at a time when a pressure variation is detected in a the line k.

17. Method according to claim 1, wherein the analytical process is initiated when a pressure Pk in a the line k reaches a threshold value established for each pump.

18. Method according to claim 7, wherein when the results of the analytical process lead to a conclusion that a rupture or an obstruction has developed downstream from a pump k, the pump k is stopped.

19. Method according to claim 18, wherein pumps j connected to the pump k by their respective lines at junction points located upstream from a rupture or the obstruction are also stopped.

20. Method according to claim 18, wherein, when an obstruction is detected, each pump j which has been stopped is operated in reverse for a period of time Δ

tj, at a reverse flow rate RQj proportional to the initial flow rate Qj at a time of normal operation.

21. Method according to claim 20, wherein the periods of time Δ

tj during which the pumps affected by the obstruction operate in reverse at the reverse flow rate RQJ are selected identical for all said pumps and equal

22. Method according to claim 20, wherein each pump j affected operates in reverse until a pressure determined on its line j has dropped below an established threshold Plj.

23. Method according to claim 1, wherein a result of the analytical process is displayed in form of a connection diagram of the various lines.

25. Method according to claim 1, comprising determining by the analytical process at least one of the following:

(a) whether the pressure variation in line k of module k is explained in another module, (b) whether line k of module k is connected to other lines, (c) whether an obstruction has occurred and whether it affects one or a plurality of lines.

26. Method according to claim 1, further comprising acting on the perfusion device by (a) modifying analytical parameters of modules j affected by the pressure variation in line k of module k, or (b) stopping all of the modules j.

24. Perfusion device comprising:

a plurality of perfusion modules i each equipped with a pump to deliver a liquid to be perfused in a line i placed downstream from the pump as well as means for measuring the pressure in the line i,

at least one junction point enabling connection of at least one of the lines i with (a) at least another of the lines i or (b) at least one line from at least one unit external to the perfusion device,

the modules i being capable of exchanging data among each other or with a base unit, and

means for analyzing the pressure variation in the perfusion device by detecting, among lines i of modules i, a variation of pressure Pk in a line k of a module k, and determining, among modules i other than module k, an involvement of one or several modules j in this pressure variation, using an analytical process.

27. Device according to claim 24, wherein the analyzing means determines by the analytical process at least one of the following:

(a) whether the pressure variation in line k of module k is explained in another module, (b) whether line k of module k is connected to other lines, (c) whether an obstruction has occurred and whether it affects one or a plurality of lines.

28. Device according to claim 24, further comprising means for acting on the perfusion device by (a) modifying analytical parameters of modules j affected by the pressure variation in line k of module k, or (b) stopping all of the modules j.