Extracorporeal treatment device with automatic emptying of waste bag

• US 7,588,722 B2
• Filed: 06/23/2004
• Issued: 09/15/2009
• Est. Priority Date: 06/25/2003
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Chevallet, Jacques
• Primary Examiner(s): Deak; Leslie R
• Assistant Examiner(s): Wiest; Philip R
• Application Number:
  US10/873,191
• Publication Number:
  US 20040267183A1
• Time in Patent Office: 1,910 Days
• Field of Search: 422 44- 48, 604 401- 616, 210/86, 210/104, 210/134, 210/137, 210/116, 210/257.2, 210/321.2, 210/321.3, 210/321.65
• US Class Current: 422/44
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1643 with weighing of fresh and used dialysis fluid
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2205/3396 Reservoirs being alternately filled and emptied for measuring flow rate or delivered volume

Abstract

The invention relates to a blood treatment device by extracorporeal circulation comprising a filter having a primary chamber and a secondary chamber separated by a semi-permeable membrane; a blood circuit comprising an arterial line intended to come from the patient, the filter'"'"'s primary chamber and the venous line intended to return to the patient; a dialysate circuit comprising the filter'"'"'s secondary chamber and at least a drain line for circulating the waste intended to come from the filter and intended to go to a drain; a first bag in fluid communication with the drain line; at least a first gravimetric weighing means linked to the first bag, fluid flow rate adjustment means acting on the drain line; a control unit linked to the first gravimetric weighing means and with the fluid flow rate adjustment means; a second bag in fluid communication with the drain line, the control unit being capable of receiving weight signals from the first gravimetric weighing means and of controlling the fluid flow rate adjustment means to load one of the bags with liquid while the other bag unloads liquid, and vice-versa.

The invention also relates to a single-use drain line for use in a treatment device according to the invention.

Claims

1. A blood treatment device by extracorporeal circulation comprising:

a filter having a primary chamber and a secondary chamber separated by a semi-permeable membrane,

a blood circuit having an arterial line intended to draw blood from a patient, the filter'"'"'s primary chamber and a venous line intended to return blood to the patient,

a dialysate circuit comprising the filter'"'"'s secondary chamber and at least one drain line for directing to a drain waste liquid coming from the filter'"'"'s secondary chamber,

a first bag in fluid communication with the drain line, a second bag in fluid communication with the drain line,

at least one first gravimetric weighing means linked to the first bag,

the drain line including;

one conduit connecting the filter to the drain, said conduit being the only conduit connecting the filter to the drain;

a first branch connecting the first bag to the conduit, said first branch being the only branch connecting the first bag to the conduit;

a second branch connecting the second bag to the conduit, said second branch being the only branch connecting the second bag to the conduit;

said first and second branches being the only elements connected to and in fluid communication with the conduit between the filter and the drain;

the second branch being connected to the conduit upstream of the first branch according to the flow within the conduit;

fluid flow rate adjustment means acting on the drain line comprising;

a first adjustment organ acting upstream of the first and second bags,

a second adjustment organ acting on the conduit between the first branch and the second branch; and

a third adjustment organ acting downstream of the first and second bags,

a control unit linked to the first gravimetric weighing means and to the fluid flow rate adjustment means, the control unit being configured to;

control the first adjustment organ to ensure the presence of a substantially continuous flow rate during the treatment,

receive weight signals from the first gravimetric weighing means and,

control the fluid flow rate adjustment means to load one of the first and second bags with liquid while the other of the first and second bags unloads liquid, and vice-versa by using first and second threshold values determined by the first gravimetric weighing means

wherein the first bag is placed lower than the second bag, such that the control unit is configured to load the first bag in priority with respect to the second bag, and unload the second bag into the first bag by gravity, by opening the second adjustment organ.

2. A device according to claim 1, wherein the control unit is capable of calculating, from the received weight signals, the amount of liquid coming from the filter and entering the drain line.

3. A device according to claim 1, wherein each branch comprises a line with two respective terminal connections.

4. A device according to claim 3, wherein the adjustment means comprises a fourth adjustment organ acting on the first branch between the two connections.

5. A device according to claim 4, wherein the first and fourth adjustment organs are peristaltic pumps and the second and third adjustment organs are valves.

6. A device according to claim 4, wherein the control unit is capable of controlling the flow rate adjustment organs according to the two following alternating steps:

in a first step;

the control unit orders the closing of the second adjustment organ, the opening of the third adjustment organ, the activation of the fourth adjustment organ in the bag-to-conduit direction,

in a second step;

the control unit orders the opening of the second adjustment organ, the closing of the third adjustment organ, the activation of the fourth adjustment organ in the conduit-to-bag direction.

7. A device according to claim 1, wherein each branch comprises a direct connection between the drain line and a bag opening.

8. A device according to claim 1, wherein first and third adjustment organs are peristaltic pumps, and the second adjustment organ is a valve.

9. A device according to claim 8, wherein the control unit is capable of controlling the adjustment organs according to the two following alternating steps:

in a first step;

the control unit controls the opening of the second adjustment organ and the stopping of the third adjustment organ to load the second bag and unload the first bag into the drain,

in a second step;

the control unit controls the opening of the first adjustment organ and the stopping of the third adjustment organ to unload the second bag and load the first bag.

10. A device according to claim 1 or 2, wherein the second adjustment organ comprises a hydraulic system having six ports distributed as follows:

a first input port in fluid communication with the input portion of the drain line to be linked to the filter,

a second output port in fluid communication with the output portion of the drain line to be linked to the drain,

a third input port and a fourth output port each in fluid communication with the first bag,

a fifth input port and a sixth output port each in fluid communication with the second bag.

11. A device according to claim 10, wherein the hydraulic system of the second adjustment organ comprises:

a first line putting the first input port into fluid communication with each of two output ports intended to communicate with each bag,

two clamps placed respectively on each portion of the first line connected to said two output ports,

and

a second line putting the second output port into fluid communication with each of two input ports intended to communicate with each bag,

two other clamps placed respectively on each portion of the second line connected to said two input ports.

12. A device according to claim 11, wherein the control unit simultaneously controls the clamps of the second adjustment organ so that the following two steps are alternated during the operation:

in a first step;

the second bag is loaded with liquid while the first bag unloads to the drain,

in a second step;

the first bag is loaded with liquid while the second bag unloads to the drain,

and wherein the third adjustment organ ensures a substantially continuous flow rate.

13. A device according to claim 10, wherein the hydraulic system of the second adjustment organ comprises:

a first line putting the first input port into fluid communication with each of two output ports intended to communicate with each bag and a first three-way valve capable of having the two following alternated positions;

first position;

putting the first input port into fluid communication with the third output port at the first bag,

second position;

putting the first input port into fluid communication with the fifth output port at the second bag,

a second line putting the second output port into fluid communication with each of two input ports intended to communicate with each bag and a second three-way valve capable of having the two corresponding following alternated positions;

first position;

putting the second output port into fluid communication with the sixth input port, at the second bag,

second position;

putting the second output port into fluid communication with the fourth input port, at the first bag.

14. A device according to claim 13, wherein the control unit simultaneously controls the clamps of the second adjustment organ so that the following two steps are alternated during the operation:

in a first step;

the second bag is loaded with liquid while the first bag unloads to the drain,

in a second step;

the first bag is loaded with liquid while the second bag unloads to the drain,

and wherein the third adjustment organ ensures a substantially continuous flow rate.

15. A device according to claim 1 comprising a second gravimetric weighing means linked to the second bag and linked to the control unit.

16. A device according to claim 1 or 15, wherein the control unit is capable of calculating the amount of fluid coming from the filter and entering the drain line from the weight signals received from the first or second gravimetric weighing means or from both the first and second gravimetric weighing means.

17. A device according to claim 1 or 15, wherein the control unit is capable of:

receiving weight information from the first or second gravimetric weighing means or from both the first and second gravimetric weighing means,

calculating the actual fluid flow rate coming from the filter and comparing it with a required flow rate, and

controlling the actual fluid flow rate by the adjustment means to approach the required fluid flow rate coming from the filter.

18. A device according to claim 1 or 15, wherein the control unit is capable of:

receiving weight information from the first or second gravimetric weighing means or from both the first and second gravimetric weighing means,

independently determining the filling status of each bag,

controlling, from the filling status of each bag, an alternated and successive bag loading and unloading procedure.

19. A device according to claim 15, wherein the control unit is capable of activating a control procedure comprising the following two alternated steps:

in a first step;

controlling the actual flow rate of the adjustment means according to the required flow rate profile and the weight information coming from at least the first gravimetric weighing means,

in a second step;

controlling the actual flow rate of the adjustment means according to the required flow rate profile and the weight information coming from the first and second gravimetric weighing means.

20. A device according to claim 19, wherein the control unit is capable of activating a control procedure comprising two alternated steps and in that the control of the actual flow rate of the adjustment means during the first step is also performed according to the weight information of the second gravimetric weighing means.

21. A device according to claim 1 or 15, wherein the control unit is capable of:

receiving weight information from the first gravimetric weighing means and/or from the second gravimetric weighing means,

detecting the maximum and minimum threshold values for each of the bags P_1mini, P_1maxi, P_2mini, P_2maxi,

controlling from the threshold values a bag loading and unloading procedure according to the following steps;

loading of one bag and unloading of the other bag,

detection of a limit threshold,

unloading of one bag and loading of the other bag,

detection of another limit threshold.

22. An automatic draining method run on a device according to claim 1 comprising:

the step of controlling the first adjustment organ to ensure the presence of a substantially continuous flow rate during the treatment, and two alternated successive steps;

a first step wherein the first bag is loaded, only through the first branch, with a waste liquid and the second bag is unloaded, only through the second branch, of waste liquid to the drain in output of the drain line, this step stopping as soon as one of the first and second bags reaches a first measured weight threshold,

a second step wherein the first bag is unloaded, only through the first branch, of waste liquid to the drain in output of the drain line and the second bag is loaded, only through the second branch, of waste liquid, this step stopping as soon as one of the first and second bags reaches a second measured weight threshold,

wherein all the fluid coming from the first adjustment organ is conveyed to the third adjustment organ and passes exclusively through the conduit between the filter and the drain.

23. A method according to the claim 22 comprising the step of calculating, from the received weight signals, the amount of liquid coming from the filter and entering the drain line.

24. A method according to the claim 22 wherein the apparatus comprises a third adjustment organ acting downstream of the two bags and wherein the method comprises the control by the control unit of the adjustment organs according to the two following alternating steps:

in a first step;

the opening of the second adjustment organ and the stopping of the third adjustment organ to load the second bag and unload the first bag into the drain,

in a second step;

the opening of the first adjustment organ and the stopping of the third adjustment organ to unload the second bag and load the first bag.)

25. A method according to the claim 22, wherein the device comprises a second gravimetric weighting means linked to the second bag and linked to the control unit, and wherein the method comprises following steps:

calculating the amount of fluid coming from the filter and entering the drain line from the weight signals received from the first gravimetric weighing means and/or from the second gravimetric weighing means.

26. A method according to the claim 22, wherein the device comprises a second gravimetric weighting means linked to the second bag and linked to the control unit, and wherein the method comprises following steps:

receiving weight information from the first gravimetric weighing means, the second gravimetric weighing means, or both the first and second gravimetric weighing means,

calculating the actual fluid flow rate coming from the filter and comparing it with a required flow rate,

controlling the actual fluid flow rate by the adjustment means to approach the required fluid flow rate coming from the filter.

27. A method according to the claim 22, wherein the device comprises a second gravimetric weighting means linked to the second bag and linked to the control unit, and wherein the method comprises following steps:

receiving weight information from the first gravimetric weighing means, the second gravimetric weighing means, or both the first and second gravimetric weighing means,

independently determining the filling status of each bag,

controlling, from the filling status of each bag, an alternated and successive bag loading and unloading procedure.

28. A method according to the claim 22, wherein the device comprises a second gravimetric weighting means linked to the second bag and linked to the control unit, and wherein the method comprises following steps:

in a first step;

controlling the actual flow rate of the adjustment means according to the required flow rate profile and the weight information coming from at least the first gravimetric weighing means,

in a second step;

controlling the actual flow rate of the adjustment means according to the required flow rate profile and the weight information coming from the first and second gravimetric weighing means.

29. Method according to the claim 22, wherein the device comprises a second gravimetric weighting means linked to the second bag and linked to the control unit, and wherein the method comprises following steps:

receiving weight information from the first gravimetric weighing means, the second gravimetric weighing means, or both the first and second gravimetric weighing means,

detecting the maximum and minimum threshold values for each of the bags P_1mini, P_1maxi, P_2mini, P_2maxi,

controlling from the threshold values a bag loading and unloading procedure according to the following steps;

loading of one bag and unloading of the other bag,

detection of a limit threshold,

unloading of one bag and loading of the other bag,

detection of another limit threshold.