Infusion apparatus

• US 8,728,020 B2
• Filed: 10/04/2007
• Issued: 05/20/2014
• Est. Priority Date: 10/04/2007
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Caleffi, Luca, Sakota, Ranko, Franzoni, Giuseppe
• Primary Examiner(s): Su, Susan
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US12/681,487
• Publication Number:
  US 20100280430A1
• Time in Patent Office: 2,420 Days
• Field of Search: 604/5.01, 604/8
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/16845 by weight
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

In an infusion apparatus, an infusion line (4) connects a container (2) of an infusion fluid to an extracorporeal blood circuit (23). A first valve (6) closes the infusion line downstream of an infusion pump (5). An expansion chamber (9), provided with a pressure sensor (10), is arranged between the infusion pump and the first valve. A second valve (8) closes a vent line (7) of the expansion chamber. The processor closes the first valve when the container is emptied. After replacement with a new and full container, the processor restarts the pump and selectively opens the first valve or the second valve according to the increase in pressure measured in the expansion chamber.

Claims

1. An infusion apparatus comprising:

at least a batch container containing an infusion fluid;

an infusion line having a first end which is connected to the batch container and a second end which is configured to supply the infusion fluid, the second end of the infusion line being directly connected to a blood withdrawal line or a blood return line;

an infusion pump operating on the infusion line and configured for circulation of the infusion fluid from the first end of the infusion line to the second end of the infusion line;

a first valve designed to open and close the infusion line between the pump and the second end;

a gas-liquid separator arranged in an intermediate tract of the infusion line extending between the infusion pump and the first valve;

a vent line having a first end which is connected to the gas-liquid separator and a second discharge end which is opposite the first end, the second discharge end of the vent line being directly connected to an element selected from the group of elements consisting of;

the batch container of the infusion fluid,

an initial tract of the infusion line comprised between the batch container and the infusion pump,

an aspiration device,

a fluid transport line connected to a fluid chamber of a blood treatment device having a semipermeable membrane which separates the fluid chamber from a blood chamber, and

a used fluid discharge line of a hemo(dia)filtration apparatus;

a second valve designed to open and close the vent line;

a first pressure sensor configured for emitting a first signal indicative of pressure in the intermediate tract;

a control unit programmed to;

close the first valve and the second valve,

activate the infusion pump,

receive the first signal,

determine at least one pressure change value based on the first signal,

compare the pressure change value with at least one reference value, and

open either the first valve or the second valve depending upon the outcome of the comparison.

2. The apparatus of claim 1, wherein the control unit is configured to open the first valve or the second valve according to whether the pressure change value is greater or, respectively, lower than the reference value.

3. The apparatus of claim 1, wherein the control unit is configured to determine the pressure change value in the intermediate tract during a predetermined change of another parameter while the pump is activated.

4. The apparatus of claim 3, wherein the another parameter is selected from the group of parameters consisting of the time, the volume/weight of fluid displaced by the pump, the displacement of a mobile element of the pump, and a weight of the batch container of the infusion fluid.

5. The apparatus of claim 3, wherein the pressure change value is placed in relation with or normalised with respect to said another parameter.

6. The apparatus of claim 1, wherein the gas-liquid separator comprises an expansion chamber.

7. The apparatus of claim 1, wherein the first end of the vent line is connected with or engaged to a top of the gas-liquid separator.

8. The apparatus of claim 1, wherein the first pressure sensor is associated to the gas-liquid separator.

9. The apparatus of claim 1, wherein the second end of the infusion line is connected to an extracorporeal blood circuit of an apparatus for extracorporeal blood treatment.

10. The apparatus of claim 1, comprising a weight sensor which emits a signal indicating a weight of the batch container, the control unit being programmed to perform the following stages:

opening the first valve, closing the second valve, activating the pump with the first valve open and the second valve closed, acquiring at least a weight value of the batch container, comparing the weight value with a reference weight value, and signalling a faulty situation and/or stopping the pump and/or closing the first valve according to a result of the comparison.

11. The apparatus of claim 10, wherein the reference weight value comprises a previously acquired weight value of the batch container and wherein comparing comprises assessing whether the weight of the batch container is no longer decreasing, or wherein the reference weight value comprises a predefined value indicative of the weight of the empty fluid batch container.

12. The apparatus of claim 1, wherein the infusion pump is a volumetric pump.

13. The apparatus of claim 1, wherein the infusion pump is an occlusive pump.

14. The apparatus of claim 1, comprising a second pressure sensor for emitting a second signal indicating the pressure in an initial tract of the infusion line comprised between the batch container and the infusion pump.

15. The apparatus of claim 14, wherein the control unit is programmed to:

acquire at least a pressure value in the initial tract supplied by the second pressure sensor, compare the pressure value in the initial tract with a reference value, and signal a faulty situation and/or stop the pump and/or close the first valve according to the comparison.

16. An infusion apparatus comprising:

an infusion line having a first end which is configured to be connected to a source of infusion fluid and a second end which is configured to supply the infusion fluid;

an infusion pump operating on the infusion line and configured for circulation of the infusion fluid from the first end to the second end;

a first valve designed to open and close the infusion line between the pump and the second end;

a gas-liquid separator arranged in an intermediate tract of the infusion line extending between the infusion pump and the first valve;

a vent line having a first end which is connected to the gas-liquid separator and a second end which is opposite the first end, the second end of the vent line being directly connected to an element selected from the group of elements consisting of;

the source of infusion fluid,

an initial tract of the infusion line comprised between the first end of the infusion line and the infusion pump,

an aspiration device,

a fluid transport line connected to a fluid chamber of a blood treatment device having a semipermeable membrane which separates the fluid chamber from a blood chamber, and

a used fluid discharge line of a hemo(dia)filtration apparatus;

a second valve designed to open and close the vent line;

a first pressure sensor configured for emitting a first signal indicative of pressure in the intermediate tract;

a control unit programmed to;

close the first valve and the second valve,

activate the pump while said first and second valves are closed,

determine at least a value of pressure change in the intermediate tract taking place during a predetermined variation of another parameter while the pump is activated,

compare the above-mentioned pressure change value with a reference value, and

open either the first valve or the second valve according to the comparison.

17. The apparatus of claim 16 wherein the another parameter is selected from the group consisting of:

the volume of fluid pumped by the infusion pump, a parameter indicative of this volume, the time, the displacement of a mobile element of the infusion pump, and the weight of a container of the infusion fluid.

18. An infusion apparatus comprising:

an infusion line having a first end which is configured to be connected to a source of infusion fluid and a second end which is configured to supply the infusion fluid;

an infusion pump operating on the infusion line and configured for circulation of the infusion fluid from the first end to the second end;

a first valve designed to open and close the infusion line between the pump and the second end;

a gas-liquid separator arranged in an intermediate tract of the infusion line extending between the infusion pump and the first valve;

a vent line having a first end which is connected to the gas-liquid separator and a second end which is opposite the first end;

a second valve designed to open and close the vent line;

a first pressure sensor configured for emitting a first signal indicative of pressure in the intermediate tract;

a second pressure sensor for emitting a second signal indicating the pressure in an initial tract of the infusion line comprised between the first end of the infusion line and the infusion pump;

a control unit programmed to;

close the first valve and the second valve,

activate the pump while said first and second valves are closed,

determine at least a value of pressure change in the intermediate tract taking place during a predetermined variation of another parameter while the pump is activated,

compare the above-mentioned pressure change value with a reference value, and

open either the first valve or the second valve according to the comparison.

19. An infusion apparatus comprising:

at least a batch container containing an infusion fluid;

an infusion line having a first end which is connected to the batch container and a second end which is configured to supply the infusion fluid, the second end of the infusion line being directly connected to a blood withdrawal line or a blood return line;

an infusion pump operating on the infusion line and configured for circulation of the infusion fluid from the first end of the infusion line to the second end of the infusion line;

a first valve designed to open and close the infusion line between the pump and the second end;

a gas-liquid separator arranged in an intermediate tract of the infusion line extending between the infusion pump and the first valve;

a vent line having a first end which is connected to the gas-liquid separator and a second discharge end which is opposite the first end;

a second valve designed to open and close the vent line;

a first pressure sensor configured for emitting a first signal indicative of pressure in the intermediate tract;

a second pressure sensor for emitting a second signal indicating the pressure in an initial tract of the infusion line comprised between the batch container and the infusion pump;

a control unit programmed to;

close the first valve and the second valve,

activate the infusion pump,

receive the first signal,

determine at least one pressure change value based on the first signal,

compare the pressure change value with at least one reference value, and

open either the first valve or the second valve depending upon the outcome of the comparison.

20. The apparatus of claim 19, wherein the control unit is configured to open the first valve or the second valve according to whether the pressure change value is greater or, respectively, lower than the reference value.

21. The apparatus of claim 19, wherein the control unit is configured to determine the pressure change value in the intermediate tract during a predetermined change of another parameter while the pump is activated.

22. The apparatus of claim 21, wherein the another parameter is selected from the group of parameters consisting of the time, the volume/weight of fluid displaced by the pump, the displacement of a mobile element of the pump, and a weight of the batch container of the infusion fluid.

23. The apparatus of claim 21, wherein the pressure change value is placed in relation with or normalised with respect to said another parameter.

24. The apparatus of claim 19, wherein the gas-liquid separator comprises an expansion chamber.

25. The apparatus of claim 19, wherein the first end of the vent line is connected with or engaged to a top of the gas-liquid separator.

26. The apparatus of claim 19, wherein the first pressure sensor is associated to the gas-liquid separator.

27. The apparatus of claim 19, wherein the second end of the infusion line is connected to an extracorporeal blood circuit of an apparatus for extracorporeal blood treatment.

28. The apparatus of claim 19, comprising a weight sensor which emits a signal indicating a weight of the batch container, the control unit being programmed to perform the following stages:

opening the first valve, closing the second valve, activating the pump with the first valve open and the second valve closed, acquiring at least a weight value of the batch container, comparing the weight value with a reference weight value, and signalling a faulty situation and/or stopping the pump and/or closing the first valve according to a result of the comparison.

29. The apparatus of claim 28, wherein the reference weight value comprises a previously acquired weight value of the batch container and wherein comparing comprises assessing whether the weight of the batch container is no longer decreasing, or wherein the reference weight value comprises a predefined value indicative of the weight of the empty fluid batch container.

30. The apparatus of claim 19, wherein the infusion pump is a volumetric pump.

31. The apparatus of claim 19, wherein the infusion pump is an occlusive pump.

32. The apparatus of claim 19, wherein the control unit is programmed to:

acquire at least a pressure value in the initial tract supplied by the second pressure sensor, compare the pressure value in the initial tract with a reference value, and signal a faulty situation and/or stop the pump and/or close the first valve according to the comparison.