Method and apparatus for determining the quantity of oremic toxins removed by a hemodialysis treatment

• US 5,725,773 A
• Filed: 11/09/1995
• Issued: 03/10/1998
• Est. Priority Date: 11/12/1994
• Status: Expired due to Term

• Current Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Inventors: Polaschegg, Hans-Dietrich
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/555,526
• Time in Patent Office: 852 Days
• Field of Search: 210/87, 210/88, 210/89, 210/91, 210/92, 210/93, 210/96.2, 210/97, 210/138, 210/139, 210/141, 210/143, 210/321.65, 210/321.69, 210/321.71, 210/636, 210/646, 210/647 , 210/739, 210/929, 210/194, 210/257.2, 604/4-6, 604/31, 204/415, 205/780.5, 205/793, 15/104.05, 134/22.1, 134/22.11, 134/166 R, 134/166 C, 137/563, 137/572, 285/130, 285/150, 422/68.1, 436/108, 436/180, 436/808
• US Class Current: 210/636
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/168 Sterilisation or cleaning before or after use
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1688 with recirculation of the sterilising fluid
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 1/3647 with recirculation of the priming solution
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

An apparatus and a method are provided for collecting samples of used dialysate during hemodialysis treatments. A fluid sample is branched off from the main flow of used dialysate into a sample receiving container. The branching off of the sample flow, i.e. withdrawal of the fluid sample, is either time- or volume-controlled so that during the course of a dialysis treatment a predetermined number of fluid samples are withdrawn, whereby the total sample volume has a prescribed ratio relative to the total volume of used dialysate. The recirculation and sample withdrawal conduit is selectively attachable to the sample receiving container for sample collection, or to the inlet of the hemodialysis device to form a recirculation loop for a disinfection cycle. A disinfectant cartridge can be interposed between the recirculation conduit and the hemodialysis device inlet.

Claims

1. A hemodialysis device for carrying out a dialysis treatment using a dialyzer, collecting a portion of used dialysis fluid as a fluid sample during said treatment, and carrying out a recirculating disinfection cycle separately from said dialysis treatment by circulating a disinfecting medium through a disinfection recirculation conduit branch,

said device including a fresh fluid conduit with a fluid inlet arrangement at its upstream end, a used fluid conduit with a fluid outlet at its downstream end, and a fluid sampling and recirculating apparatus connected to said fluid outlet,

wherein said fresh fluid conduit and said used fluid conduit are arranged and adapted to have a dialyzer connected therebetween during said dialysis .treatment with said fresh fluid conduit upstream from the dialyzer and said used fluid conduit downstream from the dialyzer,

wherein said fluid sampling and recirculating apparatus comprises a drain conduit, a sampling and recirculating conduit with a first plug-in connector member at a downstream end thereof, a switching valve arrangement connected to said fluid outlet and selectively connecting said fluid outlet for fluid flow to said drain conduit or to said sampling and recirculating conduit in exclusive alternating succession, a control unit connected for control signal transmission to said valve arrangement, and a fluid sample receiving container with a second plug-in connector member adapted to be connectable with said first plug-in connector member to collect in said container said portion of said used dialysis fluid as said fluid sample during said dialysis treatment, and

wherein said fluid inlet arrangement includes a third plug-in connector member adapted to be connectable with said first plug-in connector member to circulate said disinfecting medium through a recirculation conduit branch, which is formed by a combination of at least said valve arrangement, said sampling and recirculating conduit including said first plug-in connector member, and said fluid inlet arrangement including said third plug-in connector member.

2. The hemodialysis device of claim 1, wherein said switching valve arrangement comprises a conduit branching member connected to said fluid outlet, an outlet valve connected between said branching member and said drain conduit, and a sample withdrawal valve connected between said branching member and said sampling and recirculating conduit, wherein said control unit is connected for control signal transmission to said outlet valve and to said sample withdrawal valve to alternatingly control said valves in time succession so that respectively one of said valves is open while the other of said valves is closed.

3. The hemodialysis device of claim 2, wherein said control unit controls said outlet valve and said sample withdrawal valve in a fixed time interval relationship relative to each other.

4. The hemodialysis device of claim 2, further comprising a volume measuring device connected for signal transmission to said control unit and interposed in said used fluid conduit to measure the volume of used fluid flowing through said used fluid conduit during an outlet valve open interval, wherein said control unit controls said sample withdrawal valve, during a sample withdrawal valve open interval directly following said outlet valve open interval, dependent upon said measured volume of used fluid.

5. The hemodialysis device of claim 4, wherein said control unit calculates a time duration of said sample withdrawal valve open interval based on said measured volume of used fluid.

6. The hemodialysis device of claim 4, wherein said volume measuring device comprises a balance chamber interposed in said used fluid conduit, wherein said control unit controls said outlet valve and said sample withdrawal valve based on a ratio of integer multiples of a volume of said balance chamber.

7. The hemodialysis device of claim 2, further comprising another valve having an inlet connected to said branching member and having an outlet, another conduit connected to said outlet of said another valve, and another plug-in connector member provided on a downstream end of said another conduit.

8. The hemodialysis device of claim 1, further comprising a sensor arranged to sense a connected state of said first plug-in connector member with said third plug-in connector member.

9. The hemodialysis device of claim 1, further comprising a container containing a disinfecting or cleaning solution concentrate and having an inlet connector member and an outlet connector member, wherein said first plug-in connector member and said inlet connector member are adapted to be connected together, and said third plug-in connector member and said outlet connector member are adapted to be connected together, so that said container containing a disinfecting or cleaning solution concentrate can be interposed between said sampling and recirculating conduit and said fluid inlet arrangement.

10. The hemodialysis device of claim 1, wherein said fluid inlet arrangement comprises a dialysis fluid preparation unit with a dialysis fluid outlet port connected to said upstream end of said fresh fluid conduit, a dialysis fluid concentrate inlet port, and a water inlet port, and comprises a water inlet container connected to said water inlet port, wherein said third plug-in connector member is arranged on said water inlet container.

11. The hemodialysis device of claim 1, wherein said first plug-in connector member comprises a lockable plug body and a fluid tapping needle protruding therefrom, said second plug-in connector member comprises a membrane that can be pierced by said fluid tapping needle, and said third plug-in connector member comprises a counter connector member adapted to be engaged by said lockable plug body.

12. The hemodialysis device of claim 1, further comprising a safety valve arranged at said third plug-in connector member.

13. The hemodialysis device of claim 1, wherein said fluid sample receiving container comprises a bag that is substantially non-permeable to gases.

14. A method for carrying out a controlled partial dialysate collection during a dialysis treatment and carrying out a recirculating disinfection cycle separately from said dialysis treatment in a hemodialysis device including a switching valve arrangement with an inlet port, a drain outlet port and a sampling outlet port, an element selected from the group consisting of a dialyzer and a shunt conduit connected upstream of said inlet port, and a dialysate fluid inlet arrangement connected upstream of said element selected from the group consisting of a dialyzer and a shunt conduit,

said method comprising

during said dialysis treatment:

flowing used dialysate into said inlet port, alternatingly switching said valve arrangement so that said dialysate flowing into said inlet port alternatingly flows out of said drain outlet port during at least one drain period and out of said sampling outlet port during at least one sampling period, and collecting as a dialysate sample said dialysate flowing out of said sampling outlet port; and

during said disinfection cycle connecting said outlet port to said fluid inlet arrangement, flowing disinfecting medium into said inlet port of said valve arrangement, and switching said valve arrangement so that said disinfecting medium flowing into said inlet port flows out of said sampling outlet port and to said fluid inlet arrangement.

15. The method of claim 14, wherein said hemodialysis device further includes a through-flow measuring device for said used dialysate arranged downstream of said element selected from the group consisting of a dialyzer and a shunt conduit, wherein said drain period has a prescribed fixed duration, and further comprising calculating the duration of said sampling period based on the quantity of said used dialysate measured by said through-flow measuring device during said drain period.

16. The method of claim 14, wherein said hemodialysis device further includes a through-flow measuring device for said used dialysate arranged downstream of said element selected from the group consisting of a dialyzer and a shunt conduit, wherein said switching of said valve arrangement is carried out so as to end said drain period and begin said sampling period when a predefined quantity of said used dialysate has been measured by said through-flow measuring device during said drain period.

17. The method of claim 16, wherein said measuring device comprises a balance chamber, and wherein said switching of said valve arrangement is carried out responsive to and when a predefined number of balance chamber strokes has been carried out.

18. The method of claim 14, wherein each said at least one sampling period has a predefined first fixed duration, each said at least one drain period has a predefined second fixed duration, and a respective one of said at least one sampling period and a respective one of said at least one drain period together make up a sample withdrawal time interval having a predefined third fixed duration equal to the sum of said first duration and said second duration.

19. The method of claim 18, further comprising calculating said predefined third fixed duration of said sample withdrawal time interval from a total duration of said dialysis treatment and a prescribed number of samples to be withdrawn during said dialysis treatment.

20. The method of claim 18, further comprising calculating said first fixed duration of said sampling period from the ratio of a prescribed total sample volume of said dialysate sample to be collected relative to a total dialysate volume flowing into said inlet port of said valve arrangement during said dialysis treatment, multiplied by said third fixed duration of said sample withdrawal time interval.

21. A method of operating a hemodialysis apparatus including a dialysate inlet arrangement, a valve arrangement having an inlet port, a drain outlet port and a sampling outlet port, at least one of a dialyzer and a shunt conduit connected between said dialysate inlet arrangement and said inlet port of said valve arrangement, a dialysate sample collecting container and a recirculation branch conduit selectively connecting said sampling outlet port for fluid flow to said dialysate inlet arrangement and to said dialysate sample collecting container, comprising the following steps:

during a dialysis treatment;

flowing dialysate from said inlet arrangement through said dialyzer and into said inlet port, and then alternately flowing a first portion of said dialysate out of said sampling outlet port and into said dialysate sample collecting container during at least one sampling period and flowing a second portion of said dialysate out of said drain outlet port during at least one drain period; and

during a recirculating disinfection cycle;

flowing a disinfecting medium through said at least one of said dialyzer and said shunt conduit, into said inlet port, out of said sampling outlet port, through said recirculation branch conduit and to said dialysate inlet arrangement.

22. A hemodialysis apparatus for partial dialysate collection during a dialysis treatment and for recirculation disinfection during a disinfecting cycle, comprising a dialysate inlet arrangement, a used dialysate conduit, at least one of a dialyzer and a shunt conduit interposed between said inlet arrangement and said used dialysate conduit, a dialysate sample collection container, a recirculation fluid flow branch selectively connecting said used dialysate conduit to said dialysate inlet arrangement and to said dialysate sample collecting container, a drain conduit selectively connected to said used dialysate conduit,

first means interposed between said used dialysate conduit and said recirculation fluid flow branch and said drain conduit for selectively directing a first portion of used dialysate from said used dialysate conduit to said recirculation fluid flow branch and a second portion of said used dialysate from said used dialysate conduit to said drain conduit during said dialysis treatment and for directing a disinfecting medium from said used dialysate conduit to said recirculation fluid flow branch during said disinfecting cycle, and

second means interposed in said recirculation fluid flow branch for directing said first portion of said used dialysate into said dialysate sample collection container during said dialysis treatment and for directing said disinfecting medium into said dialysate inlet arrangement during said disinfecting cycle.

23. A hemodialysis device including a fresh fluid conduit with a fluid inlet arrangement at its upstream end, a used fluid conduit with a fluid outlet at its downstream end, and a fluid sampling and recirculating apparatus connected to said fluid outlet, wherein said apparatus comprises a drain conduit, a sampling and recirculating conduit with a first-plug-in connector member at a downstream end thereof, a switching valve arrangement connected to said fluid outlet and selectively connecting said fluid outlet for fluid flow to said drain conduit or to said sampling and recirculating conduit in exclusive alternating succession, a control unit connected for control signal transmission to said valve arrangement, and a fluid sample receiving container with a second plug-in connector member adapted to be connectable with said first plug-in connector member, and wherein said fluid inlet arrangement comprises a dialysis fluid preparation unit having a dialysis fluid outlet port connected to said upstream end of said fresh fluid conduit, a dialysis fluid concentrate inlet port, and a water inlet port, and a water inlet container that is connected to said water inlet port and that has a third plug-in connector member adapted to be connectable with said first plug-in connector member.