DIALYSIS MACHINE FOR PERITONEAL DIALYSIS

Abstract

The invention relates to an apparatus for carrying out a peritoneal dialysis treatment comprising a reservoir for fresh dialysis fluid, a connector for connecting to a peritoneal catheter of a patient, a drain for consumed dialysis fluid, and a control unit connected to actuators, wherein the apparatus is configured to carry out a plurality of consecutive inflow-dwell-outflow cycles for a treatment on the basis of a prescription stored in the control unit, in which inflow-dwell-outflow cycles dialysis fluid is supplied to the patient from the reservoir and is led off through the outflow again after the elapse of a specific dwell time in the peritoneum of the patient, and wherein the apparatus is further configured to already replace a portion of the dialysis fluid present in the peritoneum of the patient with fresh dialysis fluid from the reservoir before the elapse of the dwell time in at least one cycle if, in at least one preceding cycle, the volume of fresh dialysis fluid provided in accordance with the prescription for this preceding cycle was not completely consumed.

Claims

1. An apparatus for carrying out a peritoneal dialysis treatment comprising a reservoir for fresh dialysis fluid, a connector for connecting to a peritoneal catheter of a patient, a drain for consumed dialysis fluid, and a control unit connected to actuators, wherein the apparatus is configured to carry out a plurality of consecutive inflow-dwell-outflow cycles for a treatment on the basis of a prescription stored in the control unit, in which inflow-dwell-outflow cycles dialysis fluid is supplied to the patient from the reservoir and is led off through the outflow again after the elapse of a dwell time in the peritoneum of the patient, wherein the apparatus is further configured to already replace a portion of the dialysis fluid present in the peritoneum of the patient with fresh dialysis fluid from the reservoir before the elapse of the dwell time in at least one cycle if, in at least one preceding cycle, the volume of fresh dialysis fluid provided in accordance with the prescription for this preceding cycle was not completely consumed.

2. The apparatus in accordance with claim 1, wherein a maximum of 50%, of the total volume of dialysis fluid present in the peritoneum is replaced as part of a premature partial replacement.

3. The apparatus in accordance with claim 2 wherein the dwell time is not extended or reduced by the premature partial replacement; and/or in that the total volume of dialysis fluid present in the peritoneum of the patient is not changed by the premature partial replacement.

4. The apparatus in accordance with claim 2, wherein the premature partial replacement is carried out in a plurality of inflow and removal steps and/or with a maximum of 200 ml being supplied with each inflow step.

5. The apparatus in accordance with claim 2 wherein the premature replacement is only carried out after the elapse of at least 50% of the provided dwell time and/or that the premature replacement is ended before the elapse of a maximum of 80% of the provided dwell time.

6. The apparatus in accordance with claim 1 wherein the apparatus is configured to already replace a portion of the dialysis fluid present in the peritoneum of the patient in a plurality of cycles over the course of the treatment with fresh dialysis fluid from the reservoir before the elapse of the dwell time.

7. The apparatus in accordance with claim 1 wherein the apparatus is configured only to start a partial replacement cycle when the dwell tie provided for the respective cycle in accordance with the prescription exceeds a minimum time.

8. An apparatus for carrying out a peritoneal dialysis treatment comprising a reservoir for fresh dialysis fluid, a connector for connecting to a peritoneal catheter of a patient, a drain for consumed dialysis fluid, and a control unit connected to actuators, wherein the apparatus is configured to carry out a plurality of consecutive cycles for one treatment on the basis of a prescription stored in the control unit, in which inflow-dwell-outflow cycles dialysis fluid is supplied to the patient from the reservoir and is led off through the drain again after the elapse of a dwell time in the peritoneum of the patient, wherein the apparatus is further configured to increase the total inflow volume in at least one cycle if, in at least one preceding cycle, the volume of fresh dialysis fluid provided in accordance with the prescription for this preceding cycle was not completely consumed.

9. The apparatus in accordance with claim 1 wherein a maximum volume of dialysis fluid that may be present in the peritoneum of the patient is fixed in the control unit and that the incomplete consumption of the volume of fresh dialysis solution provided for the preceding cycle results from the fact that the complete consumption would have led to an exceeding of the maximum volume.

10. The apparatus in accordance with claim 2, wherein the apparatus is configured to supply the patient with the total volume of dialysis fluid provided in accordance with the prescription in the course of the treatment, with any difference quantity that is not supplied as part of the regular inflow phases being completely supplied as part of the premature replacement during the at least one or more cycles.

11. The apparatus in accordance with claim 1, wherein a maximum of 30% of the total volume of dialysis fluid present in the peritoneum is replaced as part of a premature partial replacement.

12. The apparatus in accordance with claim 1, wherein a maximum of 20% of the total volume of dialysis fluid present in the peritoneum is replaced as part of a premature partial replacement.

13. The apparatus in accordance with claim 2, wherein the premature partial replacement is carried out in a plurality of inflow and removal steps directly consecutive.

14. The apparatus in accordance with claim 2, wherein the premature partial replacement is carried out in a plurality of inflow and removal steps with at least five inflow steps being provided.

15. The apparatus in accordance with claim 2, wherein the apparatus is configured to supply the patient with the total volume of dialysis fluid provided in accordance with the prescription in the course of the treatment, with any difference quantity that is not supplied as part of the regular inflow phases being completely supplied on a basis of a consideration of the maximum volume, as part of the premature replacement during the at least one or more cycles.

16. The apparatus of claim 8, wherein the apparatus is further configured to already replace a portion of the dialysis fluid present in the peritoneum of the patient with fresh dialysis fluid from the reservoir before the elapse of the dwell time in at least one cycle if, in at least one preceding cycle, the volume of fresh dialysis fluid provided in accordance with the prescription for this preceding cycle was not completely consumed.

Description

[0032] Further details and advantages of the invention result from the experiments and embodiments described in the following with reference to the Figures. There are shown in the Figures:

[0033] FIG. 1: a schematic representation of a process of an automated peritoneal dialysis treatment, wherein the permitted residual volume is set relatively high in relation to the permitted patient volume and the dialysis solution is therefore not completely consumed;

[0034] FIG. 2: a schematic representation of a process of an automated peritoneal dialysis treatment with a profiled prescription, wherein solution A is prescribed for inflow 1, solution B for inflow 2, and solution C for the last inflow (profiled solutions), and wherein the inflow volumes and the dwell times for the two cycles also vary (profiled volumes and profiled dwell times);

[0035] FIG. 3: a schematic representation of the convergence of residual solution present in the peritoneum of the patient and fresh solution during the inflow;

[0036] FIG. 4: a schematic representation of the mixing of the residual solution and the fresh solution;

[0037] FIG. 5: a schematic representation of a resorption curve for a solute replaced during a peritoneal dialysis treatment;

[0038] FIG. 6: different resorption curves for different solutes;

[0039] FIG. 7: a filling volume time diagram for a process management in a peritoneal dialysis treatment using a device in accordance with the invention;

[0040] FIG. 8: a representation showing the effectiveness of the UF generation for solutions having glucose concentrations of 3.86%, 2.27%, and 1.50%;

[0041] FIG. 9: illustration of the effectiveness of a mixed solution of fresh and consumed dialysis solution;

[0042] FIG. 10: a filling volume time diagram for an alternative process management in a peritoneal dialysis treatment using a device in accordance with the invention;

[0043] FIG. 11: an exemplary representation of portions of the partial replacement volume in the peritoneum;

[0044] FIG. 12: a filling volume time diagram for a further process management in a peritoneal dialysis treatment using a device in accordance with the invention; and

[0045] FIG. 13: a filling volume time diagram for yet another process management in a peritoneal dialysis treatment using a device in accordance with the invention.

[0046] The advantages of the invention can best be explained with reference to the following considerations. As can be recognized from FIG. 3, a present residual solution 20 and a fresh solution 10 converge in each new cycle in the peritoneum 2 of the patient 1 during the inflow of fresh dialysis solution 10. The residual solution 20 is formed by residual fluid of the preceding cycle and is composed of the previously administered dialyzate fluid and ultrafiltration fluid. The mass transport properties of the residual solution 20 differ from those of the fresh solution 10. Looked at in isolation, it is even conceivable that the residual solution 20 provides a resorption. The question arises as to how fast the two solutions 10 and 20 mix with one another in the abdomen and what properties this mixed solution has. During the inflow, a portion of the fresh dialyzate solution 10 mixes with the residual solution 20 due to the inward flow. The subsequently beginning diffusion has the effect that a concentration balance of the two solutions 10 and 20 has taken place at a time x. A homogeneous mixed solution 30 will presumably be present in the peritoneum 2 after a relatively short time period, as shown in FIG. 4.

[0047] A resorption curve such as shown by way of example in FIG. 5 provides a statement on the effectiveness of the detoxification during the dwell phase. The time progression of the resorption curve depends on whether the patient is a high transporter or a low transporter. A high transport capacity here means that a concentration equalization of the dissolved particles quickly takes place between the blood and the dialyzate, in accordance with a steep curve progression at the start and a fast reaching of a steady state. The steepness of the resorption curve further depends on the glucose concentration or on the kind of solution used. As can be seen from FIG. 6, different substances have different resorption curves. They are generally flat and approximately linear for large molecules such as proteins and insulin.

[0048] It is common to all the resorption curves for smaller molecules that the concentration gradient has a relatively high and linear progression at the start of the dwell phase. This means that the effective mass transport remains constant in the initial time. The dependence of the mass transport on the administered inflow volume is not shown in FIG. 6. It is rather assumed in the representations that the patient has been ideally filled with fresh solution. In reality, however, the properties of the residual solution 20 and its amount would also have to be taken into account. It must at least be assumed that there is a deterioration of the mass transport properties with respect to the idealized observations of FIG. 6 due to the influence of the residual solution.

[0049] Provision is now made in accordance with the present invention to use inflow volume that is not needed in order to replace small portions of the begun solution of the peritoneum during the dwell phase to achieve an additional mass transport. This concept is visualized in FIG. 7, with the y axis showing the filling volume in the peritoneum of the patient. Within the framework of the example shown, the permitted residual volume is fixed at 1000 ml (lower horizontal line) and the permitted patient volume is fixed at 3400 ml (upper horizontal line). The prescription is shown by the theoretical (lower) treatment curve and does not take account of any residual volume. Within the framework of the actual treatment in accordance with the higher treatment curve, dialysis fluid actually planned in accordance with the prescription always remains when the prescribed inflow volume together with the residual volume still present in the peritoneum before the start of the respective inflow phase would result in a total volume that exceeds the permitted patient volume. In the example shown, a respective additional partial replacement takes place during the dwell phase in cycles 4, 6, and 8, with the unused and thus excess inflow solution being consumed in so doing. This is symbolized by the serrated lines. No partial replacement takes place in the odd cycles because the dwell times are smaller in relation so that the use of the available excess volume in these cycles would be less effective. No residual volume is yet available in cycle 2.

[0050] Within the framework of the invention, the partial replacement should always take place during a dwell phase. Preferred times for the start of a partial replacement start after the elapse of approximately half the dwell time and end on the elapse of approximately 80% of the dwell time since in the normal case the dialyzate is no longer as effective at this time as at the start of the treatment and, on the other hand, the refreshed solution can still sufficiently develop its effect.

[0051] In an example, the prescribed inflow volume can amount to 3000 ml and the residual volume can be fixed at 50%, that is, 1500 ml. The maximum volume is set at 110%, that is, 3300 ml. If a new inflow phase is started directly on a reaching of the residual volume, a maximum of only 1800 ml may therefore flow into the patient. The percentage portion of the residual solution thus amounts to (1500/3300)*100%=45%. Since the effectiveness of dialysis solutions drops with the dwell time in the peritoneum, as can be seen from the relationship shown in FIG. 8, this can have significant effects on the treatment efficiency.

[0052] Under the assumption that the residual fluid is only composed of dialyzate (no UF portion) that has on average been present in the abdomen for approximately 2 h, an effectiveness of the mixed solution results for the constellation named in the example that is between the effectiveness of fresh dialysis solution in total and the 45/55 mixture. This is illustrated graphically in FIG. 9 where the effectiveness of the removal for UV volumes (=UF effectiveness) is shown for the fresh solution. The UF effectiveness of the residual solution results from the UF effectiveness curve of the fresh solution shifted to the left by 2 hours. The effectiveness of the mixed solution results through an additive superposition while using the assumption that the mix relationship amounts to approximately 50% as in the above sample calculation. In reality, the residual solution will still contain ultrafiltration volume that has an effectiveness of zero. It is therefore achieved by the partial replacement of the solution in accordance with the invention that the blood-dialyzate concentration gradient is increased and the effectiveness of the treatment thus increases.

[0053] An alternative to the routine likewise in accordance with the invention shown in FIG. 7 is shown in FIG. 10. The partial replacement cycles there start with an inflow to generally avoid outflow pressure problems. The volume of the previous inflow phase can be reduced by the volume of the inflow for the partial replacement cycle in this variant, as has been shown in the Figure.

[0054] The partial replacement is distributed over a plurality of cycles in both the embodiment of FIG. 7 and in the embodiment of FIG. 10. This has efficiency reasons, on the one hand; on the other hand, the situation with respect to the existing residual volume can, however, also change in the course of the treatment. Dialysis solution thus may have to be discarded, for example, if problems occur or if pumps are repositioned.

[0055] It can be meaningful within the framework of the invention to design the effective partial replacement volume during the partial replacement process to be as high as possible. The proportion of the fresh solution in the peritoneum is shown in FIG. 11, while using the above sample calculation, in dependence on the number and volume of the partial replacement cycles. Once the regular inflow had been administered, 550 ml fresh solution and 450 ml residual solution were present in the abdomen of the patient. The higher the replacement volumes, the higher the proportion of fresh solution at the end, as can be seen from the following Table 1 that reflects the values of the diagram of FIG. 11.

TABLE-US-00001 TABLE 1 Partial replacement Fresh solution in the Fresh solution in the cycles abdomen beforehand abdomen afterward 10 × 100 ml  550 ml 843 ml 5 × 200 ml 550 ml 852 ml 2 × 500 ml 550 ml 887 ml

[0056] A further embodiment of the invention is shown in FIG. 12. Partial replacement processes are only carried out as part of two cycles in this embodiment. It may not make any sense to generate a partial replacement cycle for cycles having short dwell times due to the short residence time.

[0057] Provision is made in variant of the concept in accordance with the invention that unused inflow solution is alternatively or additionally used to slightly increase inflows, as can be seen from the representation in FIG. 13. The maximum permitted patient volume may naturally not be exceeded here. This variant of the process management could be advantageous for adapted prescriptions since cycles having small and large inflow volumes alternate in this treatment form. The cycles with the small inflow volumes could be raised within predefined limits of, for example, 10%.

[0058] Advantages of the concept in accordance with the invention comprise hardly any or at least less fluid being conducted to the drainage. The total connected solution volume can be sensibly consumed for the treatment. Time-intensive and know-how intensive workarounds such as the preparation of tidal prescriptions or subsequent editing are no longer required. The disadvantages of the workarounds are compensated. The adaptation takes place very dynamically and in dependence on the situation. The efficiency of the treatment is increased. The patient cannot be overfilled. No time delays for treatments are required. No additional disturbances are to be expected so that the patient does not have to be woken up due to the process management. The concept works with profiled treatments.