Hemodialysis device, hemodiafiltration device, method and device for taking a sample and sampling kit for use in corresponding devices and method

Technical Field

The invention relates to a method for renal replacement therapy in the field of the device.

Background Art

Extracting blood dialysis patient in extracorporeal circulation of the blood, through the blood dialyzer (Haemodialysator) guiding and re-injected into the patient body. The kidney of the exchange of material similar to the material exchange. Blood dialyzer divided by two by a semi-permeable membrane of the chamber, one of the chamber flows through the blood, and another chamber flows through the cleaning liquid, the dialysis liquid. Therefore the blood dialyzer common on the market usually have thousands of hollow fiber, the fiber walls thereof to be exchanged is the semi-permeable material. The blood guided through the inner space of the hollow fiber, and the fiber gap usually dialysate in conveying and driven in the opposite direction.

The substance concentration of blood to the dialysate, such as electrolyte concentration, and healthy person's blood is equal to the substance concentration, so that the blood in the concentration of the corresponding normal level can be maintained. In the dialysate to be not included in the material is removed from the blood, such as creatinine (Kreatinin) or urea, the concentration gradient because these substances, in the semi-permeable membrane from the blood is removed by diffusion. By means of a pressure gradient, by convection and/or ultra-filtration from blood to remove excess moisture.

Blood dialyzer used for controlling this kind of process, the majority of the hemodialyzer also guarantees to properly component and the temperature of the water and concentrate to prepare the dialysate. This dialysate in the present blood dialysis cvvhdf apparatus for balancing also in the blood purification caused by high convection (hemodialytic cvvhdf). In the dialysis filter the blood, the blood during dialysis therapy, blood dialyzer through a large number of ultra-filtration (Ultrafiltrat) material removed from a patient's blood, almost all the amount of liquid removed by the replacement liquid fill. Therefore, modern special be used for the treatment of chronic renal failure in the apparatus of the instant is ready to use in treatment of the dialysate, the diverging from the dialysate circulating in the conduit is provided with one or more filtration stages, and of the dialyser the blood upstream and/or downstream with the extracorporeal blood circulation connection.

The dialysate concentrate water and usually be two through the blood dialyzer in order to pre-given proportion. At the same time in order to carry out dialysis, the dialysate is heated to near body temperature. Concentrate may be in liquid or solid form is stored in a relatively small container. Clinical is also generally connected to a central supply annular conduit system.

Not only here the proportion of ingredient water and the dialysate temperature and the requirements of a very high, purity degree of microorganisms is also very important. In order to meet and ensure that the requirements of the requirements of the standards and the microorganism (bacteria, endotoxin), through the sampling for control. Sampling is complex, because of the need to avoid possible mistakes the microbiological testing of secondary pollution.

Therefore, in order to carry out sampling need to use additional components. By the automatic closing of the sampling point of the baffle, for example made of silicon, these sampling point on the flow through the conduit. There are also T-shaped rubber leads the fitting of the sampling point, syringe without needle head can be connected to the sampling point rubber conduit member. In the entire solution to comply with stringent hygiene provisions are necessary, by sampling itself so as to prevent secondary pollution.

DE   103   36   539A1 describes a blood dialyzer for the use of the liquid sample in the T-shaped connecting piece, which can be simple replacement of the baffle. US   5630935 described is a water supply conduit for blood dialyzer the sampling valve.

DE   2838414C2 describes a ultra filter pump can be by means of fresh and used dialysate delivery to the specific sample port of the hemodialyzer. However, this requires additional conduit and joint (Anschluesse), in addition to their periodic cleaning.

Content of the invention

The task of this invention lies in the improvement of the type for hemodialysis, the improved manner of without expensive measures to the case of simple dialysate the sampling. The task of this invention is also to provide the corresponding sampling method. Finally, the subject of the invention is also to provide in such a device and method for use in a simple sample container.

According to the principle of this invention, with the dialysate circulating blood dialysis apparatus, with a dialysate circulating blood dialysis cvvhdf equipment, through the above-mentioned device and sampling assembly and for the combination of the dialysate to the blood dialysis apparatus and method for sampling of sampling used for dialysis of blood dialysis cvvhdf apparatus for sampling sampling process to complete. The invention is advantageous in respect of the embodiment of the part is that specific embodiment.

The blood dialysis with a dialysate circulating in the dialysate in the apparatus used for circulating the dialysate source and the outlet, for dialysate from said source to the 1st of the dialysate delivery conduit connection part, connecting parts from 2nd for dialysate to the dialysate diverted from the outlet conduit, in the dialysate circulating in the dialysate turnover of its pump delivery conduit and of the dialysate in the dialysate closed part 1st and 2nd reflecting closed part in the conduit, and also useful for controlling the pump device and 1st and 2nd the control unit of the closing part, wherein the 1st and 2nd is connected with the mode of formation of the components so that they are carried out with the hemodialysis treatment through the semi-permeable membrane into the dialysate and the blood chamber of the blood chamber of the dialyzer dialysate chamber is connected, so that the dialysate from the source through the dialysate delivery catheter (1 flows into the dialysate chamber, and chamber from the dialysate through the dialysate diverted from flowing to the outlet conduit, characterized in that the mode of formation of the the control unit in the automatic operation of the sampling of the control procedure of the control within the range of the 1st and 2nd closing part (20, 21) and the pump device, control a way that the pre-given amount of dialysate that is connected with the 1st or 2nd part of the sampling assembly, and it also has a closed part of the 1st delivery conduit upstream of diverging from the dialysate a bypass conduit, the bypass conduit is equipped with a 3rd and 2nd closed part into the dialysate closed part diverted from downstream of the conduit, wherein the downstream of the merge point the dialysate closed 4th reflecting part is provided in the conduit.

The dialysate circulating in the blood dialysis cvvhdf equipment of the dialysate circulating is used for the dialysate source and the outlet, for dialysate from said source to the 1st of the dialysate delivery conduit connection part, connecting parts from 2nd for dialysate to the dialysate diverted from the outlet of the conduit, the delivery conduit from the dialysate is connected with the 3rd of the diverging part of the replacement conduit, used in the dialysate circulating in the dialysate turnover of its pump delivery conduit and of the dialysate in the dialysate closed part 1st and 2nd in the conduit is diverted from the closed part and the substitution in the conduit closing part 5th, also is used to control the pump device closed part and 1st, 2nd and 5th closed part the control unit of the closing part, the connection part and the 2nd 1st the mode of formation of the connecting parts so that they are carried out when the blood dialysis cvvhdf treatment through the semi-permeable membrane into the dialysate and the blood chamber of the blood chamber of the dialyzer dialysate chamber is connected, so that the dialysate through the dialysate from the source flows into the dialysate chamber delivery conduit, and chamber from the dialysate through the dialysate diverted from flowing to the outlet conduit, the mode of formation of the connecting parts and 3rd in the treatment of the blood through the dialysis filter part of the conduit is connected with the 3rd the dialysate as a replacement to the blood of a patient, characterized in that the mode of formation of the the control unit in the automatic operation of the control program for the control within the range of a closing part 1st, 2nd and 5th closed part and closing part of the pump equipment, the control of the pre-given amount of dialysate is delivered to the and the 1st, 2nd or 3rd is connected with the connection component part of the sampling assembly, and it also has a closing part 1st delivery conduit upstream of diverging from the dialysate a bypass conduit, the bypass conduit closed part equipped with the 2nd and 3rd closed part into dialysate diverted from downstream of the conduit, wherein the merge point in the conduit downstream of the dialysate is diverted from 4th closing part.

The above-mentioned apparatus and the above-mentioned apparatus is used for being connected to a connecting part of the 1st, 2nd or 3rd connecting component after disinfection of the connecting element the combination of the sampling assembly, said sampling assembly is composed of the container and from the container to the container is connected with a conduit section of the part, wherein the container connecting part is adapted to be connected to connecting member 1st, 2nd or 3rd connecting element is connected with the component.

In the dialysate to the blood dialysis apparatus in the method of sampling, the blood dialysis apparatus has dialysate circulating, the dialysate circulating in the dialysate source and the outlet, for dialysate from said source to the 1st of the dialysate delivery conduit connection part, connecting parts from 2nd for dialysate to the dialysate diverted from the outlet conduit, used for working capital dialysate in the dialysate circulating in the dialysate pump unit and in the delivery conduit and the closed part 1st of dialysate in the conduit is diverted from 2nd closing part, the connection part and the 2nd 1st the mode of formation of the connecting parts so that they are carried out with the hemodialysis treatment through the semi-permeable membrane into the dialysate and the blood chamber of the blood chamber of the dialyzer dialysate chamber is connected, so that the dialysate through the dialysate from the source flows into the dialysate chamber delivery conduit, and chamber from the dialysate through the dialysate diverted from flowing to the outlet conduit, characterized by having the following method steps of: closing said 1st and 2nd closing part or the closed part of the 1st and 2nd kept closed, and is connected with the sampling assembly to the 1st or 2nd connecting part connecting element, is connected to the sampling assembly of the 1st or 2nd closed part of the closing part, actuating the pump device, the pre-given amount of dialysate flow into the sampling assembly, the closure or closing part 1st 2nd closing part, wherein it also has the closed part of the 1st delivery conduit upstream of diverging from the dialysate a bypass conduit, the bypass conduit is equipped with a 3rd and 2nd closed part into the dialysate closed part diverted from downstream of the conduit, wherein the downstream of the merge point the dialysate closed 4th reflecting part is provided in the conduit.

In the process for the blood dialysis cvvhdf equipment in the dialysate sampling method, this apparatus has dialysate circulating, the dialysate circulating in the dialysate source and the outlet, for dialysate from said source to the 1st of the dialysate delivery conduit connection part, connecting parts from 2nd for dialysate to the dialysate diverted from the outlet of the conduit, from the dialysate delivery catheter bifurcations to 3rd is connected with the part of the replacement conduit, used for working capital dialysate in the dialysate circulating in the dialysate pump unit and in the delivery conduit and the closed part 1st of dialysate in the conduit is diverted from 2nd closing part and replace a 5th closed part of the conduit, wherein the connection part and the 2nd 1st the mode of formation of the connecting parts so that they are carried out when the blood dialysis cvvhdf treatment through the semi-permeable membrane into the dialysate and the blood chamber of the blood chamber of the dialyzer dialysate chamber is connected, so that the dialysate through the dialysate from the source flows into the dialysate chamber delivery conduit, and chamber from the dialysate through the dialysate diverted from flowing to the outlet conduit, the mode of formation of the connecting parts and 3rd in the blood dialysis cvvhdf treatment through the dialysate as a replacement of the connection component is connected to the 3rd conduit to the patient's blood, which is characterized in that has the following method steps: 1st and 2nd closed part closed closed part or so that they are kept closed, or short is connected with the connection part and the 1st 2nd connecting member, closed closing part or the 5th 5th closing part kept closed, and is connected with the sampling assembly to the connecting component 3rd, 5th closing part is opened, actuating the pump device, so that the pre-given amount of dialysate flow into the sampling assembly, closed 5th closing part, wherein it also has a closing part 1st delivery conduit upstream of diverging from the dialysate a bypass conduit, the bypass conduit closed part equipped with the 2nd and 3rd closed part into dialysate diverted from downstream of the conduit, wherein the merge point in the conduit downstream of the dialysate is diverted from 4th closing part.

The invention is set up on the basis of the following observation, that is, the blood dialysis apparatus or hemodialytic cvvhdf device has some, can be used for the hemodialyzer connection or to provide replacement liquid joint can also be used directly in the sampling itself, because, these joint in the expansion is usually formed as a disposable extracorporeal blood circulation module for extracting samples directly before. These joint according to the mechanical cleaning programme disinfected regularly, and in the course of the dialysis treatment is flowing through these joint of the sample liquid to be analyzed.

Through appropriate sampling assembly of the joint can easily extract the sample, does not need special additional health measures, there is no risk of secondary pollution. In the apparatus except for the particular end of the sampling of the controlled process is not necessary outside of the existing in any change in the control unit.

Description of drawings

In the embodiment shown a schematic diagram of further description of the invention and other details. Wherein:

Figure 1 according to the invention the blood dialysis embodiment of the filtering device, and

Figure 2 according to the present invention the mode of execution of the sampling assembly.

Mode of execution

First by means of fig. 1 according to the present invention described the basic structure of the blood dialysis apparatus, wherein the diagram 1 of the shown blood dialysis cvvhdf apparatus 10 for the operation of the blood dialysis limited the therapeutic mode. According to the present invention is then described a blood dialysis cvvhdf operation of the apparatus.

In this no need to examine in detail, generally, in order to use in the blood dialysis apparatus actuator and sensor, the technicians of this field can be use a plurality of possible ways. Figure 1 only limited to the number shown in a small number of elements, these component to describe this invention has already sufficient.

During hemodialysis, extracorporeal circulation of the blood is delivered to the blood in the dialyzer 1. Blood dialyzer 1 in, usually realized in the form of many hollow fibre semi-permeable membrane 2 the 1st chamber 3 (blood chamber) (it is in-vitro blood a part of circulating) and 2nd chamber 4 (dialysate chamber) (which is a part of circulating dialysate) spaced. Through the semi-permeable membrane 2 will be removed from the blood to the dialysate to the substance, to be removed through the dialysate of reflecting material. At the same time the surplus through the pressure gradient to the liquid and by ultra-filtration from blood the dialysate is removed away. Finally can also be utilized on the contrary such as sodium ion diffusion gradient, the transfer of the substance in the dialysate and the blood.

The blood chamber 3 through two connecting sleeve with blood and blood diverted from the delivery conduit (not drawn) is connected with the conduit, dialysate chamber 4 through the two connecting sleeve 4a and 4b, and the blood dialysis and/or dialysis cvvhdf apparatus 10 the dialysate circulating dialysate delivery catheter 11 and dialysate diverted from conduit 12 is connected. Dialysate delivery catheter 11 from the dialysate source 13 for and the dialysate to the chamber 4 of the connecting sleeve 1st 4a connected with the connecting part 1st 14 ; dialysate diverted from conduit 12 for and the dialysate from the chamber 4 is connected with the 2nd sleeve 4b 2nd connected with the connecting member 15 to the outlet 16. Dialysate delivery catheter 11 is provided with a 1st in the pump unit 17, dialysate diverted from conduit 12 is provided with a 2nd in pump apparatus 18, in the process during the dialysis treatment for their control and working capital (umwaelzen) dialysate liquid discharge. These two pump unit 17 and 18 and the source 13 and outlet 16 in Figure 1 in that only as illustrative. Professional technicians familiar with a large number of solutions to realize them, pump equipment should be understood in a broad meaning. They can be used as a separate, the active delivery pump, however, is exactly the same as the following is also possible, with a separate ultrafiltration catheter use of the so-called balance chamber system (Bilanzkammersystem), as claimed by the Patent applicant, and in DE   2838414C2 are described in, is obviously relates to the application document content.

Common on the market in the blood dialyzer, connecting sleeve 4a and 4b are based on DIN   EN 1283 of manufacturing, wherein the 1st and 2nd is connected with the part 14 and 15 is the corresponding complementary, and usually in the form of so-called the Hansen coupler (Hansenkupplung). If there is no blood dialyzer 1 is connected to the blood dialysis apparatus 10, through the dialysate delivery catheter 11 and dialysate diverted from conduit 12 at the end of the elastic rubber hose section and the blood dialysis apparatus is connected with the outer of the two connecting parts 14 and 15, through the one integrated in the apparatus short connector 19 and the joint 19a and 19b short circuit. Through this way, the closed space is not formed under the condition of (Totraeumen), between the single blood treatment in the cleaning method, the cleaning solution can be used for flush and clean the whole dialysis liquid circulation. Only the blood dialyzer usually discarded after treatment. Circulating dialysate between the blood treatment substantially maintain this short-circuit state.

Dialysate delivery catheter 11 implemented for the switch valve is mounted in the closed part of the 1st (Verschlussmittel) 20, which is installed in the conduit driven dialysate similar 2nd closing part 21. Through the 1st and 2nd closing part 20 and 21 or can be interrupted the flow in the conduit.

In order to transport fresh dialysate to the blood dialyzer before the an additional filtering, dialysate delivery catheter 11 may be provided in sterile filter 1st 22. In order to improve the service life of the filter, and caused by the rupture and avoid the introduction of bacteria deposited in the filter, as shown in Figure 1, can be passed on in the blood dialysis apparatus usually available, is connected with the dialysate delivery catheter 11 and dialysate diverted from conduit 12 a bypass conduit 23 flushing filter. In order to activate the bypass, the bypass conduit 23 is connected with the 3rd in the closing member 24.

In particular, in the blood during dialysis therapy the case of a failure of the, bypass conduit 23 is in a safe state can be ensured. In this case the 1st and 2nd closing part 20 and 21 closed, 3rd closing part 24 open. Blood dialysis apparatus 10 can continue to continuously preparing, dialysate discharged, this makes the fault is eliminated more easily continue to carry out the treatment.

Bypass conduit 23 to the dialysate diverted from conduit 12 can be provided with the inlet of the 4th downstream of the closing part 25.

Blood dialysis apparatus 10 by the control unit 26 of the control and supervision. In this, a single of the equipment the control unit of the actuator and sensor 26 is connected with the signal line, but for the sake of concise and in Figure 1 there is no drawing the signal line.

If blood dialysis apparatus 10 should also be used for preparing the replacement liquid and can therefore be used as blood dialysis cvvhdf equipment, replacement conduit 100 from the dialysate delivery catheter 11 bifurcations, to 3rd connecting part 101. In fig. 1 shown in the 2nd embodiment through the sterile filter 102 realize the bifurcations, dialysate during treatment chamber 1st which flows through it, and therefore continuously flushing of chamber 1st. From the 2nd a sterile filter 102 2nd chamber bifurcations of the replacement conduit 100 5th connected to the closed part in 103. In order to the replacement catheter 100 is designed to be cleaning, can be equipped with connecting parts from the 3rd 101 to dialysate diverted from conduit 12 the flush catheter 104, wherein the mounting 6th closing part 105. In order to be able to connect the replacement catheter 100 with the extracorporeal circulation, in this case, is connected with the 3rd component 101 implemented for the T-shaped structure.

In order to blood processing, needs to be implemented as a disposable part of the, provided with a complementary connecting sleeve 5a leads the fitting of 5 and 3rd connecting part 101 is connected. If according to the in vitro circulating design another conduit 5b not end and is connected to the extracorporeal circulation, is in the appropriate position with the extracorporeal circulation is connected with it. In leads the fitting 5 can be in a pumping portion 5c for embedding implemented for the roller pump (Rollenpump) hematodialysis cvvhdf apparatus 10 the pump 106 in.

The control unit 26 through data line 28 and the input-output unit 27 is connected. Input-output unit 27 comprises activation control unit 26 in the part of the sampling control program.

In order to carry out according to the sampling method of the present invention, first of all only the pasteurized sampling component and the 1st, 2nd or 3rd connecting element 14, 15 or 101 is connected. The embodiment of the assembly of Figure 2.

Pasteurized sampling assembly 200 preferably implemented as a part of the container 201, of the part of the container through the conduit 202 leading to the container connecting part 203. Furthermore, in the conduit section 202 is in the position of the or suitable hose clamp is formed as part of the closed container, so that the sampling after the sampling assembly is closed. The closure cover of the sterilized 204 is also suitable for as a container closure member, closure cap 204 as pasteurized sampling assembly 200 to supply a part of. The use of the sampling after the closure 204 of the container connecting part 203 closed, the sample liquid can be ensured on the sent to the analytical laboratory will not be subject to pollution.

If sampling assembly 200 should be and the 1st or 2nd connecting part 14 or 15 is connected, the container connection member 203 is arranged to similar blood dialyzer 1 of the sleeve 4a, 4b according to the DIN   EN   1283 a connection port. When is connected to the 3rd connecting member 101 is, the connection is formed with the corresponding complementary of the connecting member, wherein according to manufacturers the use of different connector type. If the container is connected with the part 203 is equipped with two, for example, in the form of Y-shaped structure, according to the particular sampling assembly of the present invention with diversity. Also may provide, through removable adapter element also can form two connection types of compatibility.

Sampling assembly 200 in sterile form for avoiding the secondary pollution. If we can get rid of by contact with the outside of the pollution of the surface, so in this internal surface is a sterile, would be sufficient. The actual practice is the sampling assembly and completely in the outer package, then the flow in the outer.

In addition to being the embodiments of the structure of the other form is also possible. Therefore also can be applied to the connecting part of the with corresponding, the sterilized syringe.

The sampling assembly is connected to the blood dialysis cvvhdf apparatus 10 before, an operator by the corresponding input and output unit 27 of the input member the particular selection of the sampling control program. Therefore in view of the automatic operation of the control unit 26 of the program, can carry out the following description of the method step of options.

The 1st or 2nd connecting part is connected under the condition of 1st and 2nd program first closed closing part 20 and 21, if they have been closed, so that it is kept closed. Then the operator will be required through the input and output unit 27 is connected with a sampling assembly. If it is also necessary to select the application of the joint, in the sampling assembly 200 and the 1st or 2nd after connecting parts, the operator recognizes the input and output unit 27 of the connection. Therefore, the control unit 26 the control program in the sampling assembly is opened, a predetermined or selected 1st or 2nd closing part 20 or 21, and detects device 17, so that a predetermined amount of dialysate can flow into container 201. Then to open the closed part of the 1st or 2nd 20 or 21 closed again. At the input and the output unit 27 on the suspension of display sampling control program. The sampling assembly can now be removed.

In the invention set forth in the modified, hemodialytic cvvhdf device automatically provides text label, the text label can be placed in the sampling assembly and have been included the necessary data, such as device number and the sampling time point.

Sampling control program can be based on the blood dialysis cvvhdf the structure of the apparatus for sampling the use of different valve loop. In Figure 1 in the apparatus shown, the connecting part is connected to the 1st 14 under the condition of, all of the closing part are closed, and need to be opened for sampling only 1st closing part 20. On the contrary, the connecting part is connected to the 2nd 15 under the condition of, in addition to open the 2nd closing part 21 is connected with the delivery conduit to open the dialysate 11 and dialysate diverted from conduit 12 of the closing part in the conduit. In this, Figure 1 is shown in the embodiment of the, 3rd closed part in the opening 24, or open the replacement catheter 100 can be used under the condition of the by-pass conduit 23, 5th and 6th in the opening and closing part 103 and 105 under the condition of the use of irrigation conduit 104. 4th closing part 25 should be closed.

In the 1st and 2nd connecting member 14 and 15 under the condition of short, which is connected to the 3rd connecting member 101 is, 1st and 2nd can be opened also closing part 20 and 21. pipe nipple to this can be 19 joint 19a and 19b is provided with a sensor, the sensor is used for detecting the existence of the connection. Open 5th closing part 103 or open the 3rd and 6th closing part 24 and 105 in order to perform sampling.

Independent options have been implemented, input and output unit 27 of the routine the input and the output of the corresponding program can be used have been described earlier by the user simply activates the sampling program and single method step of confirming, and, where necessary, selecting the determined liquid direction and/or the connecting part, therefore, according to the present invention by means of blood dialysis or hemodialysis cvvhdf apparatus, according to the implementation of the method of the present invention is particularly user-friendly.

Through this invention, may be through the blood dialysis or hemodialysis cvvhdf device and dialysate can be used for simple sampling, without the need for installation of additional assembly and the high costs of no need for compliance with hygiene measures. At the same time effectively prevent secondary pollution. The same sampling assembly according to the present invention can be used as low-cost plastic articles, the mass aseptic production. By sampling assembly can be used with existing joint of the dialysate is connected with the long-term compatibility of the simple, is not easy to be polluted used for microbial inspection of the demand routine sampling the possibility of.