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EP-4739367-A1 - COMPOSITION FOR DIALYSIS SOLUTION, AND SENSOR UNIT

EP4739367A1EP 4739367 A1EP4739367 A1EP 4739367A1EP-4739367-A1

Abstract

The invention relates to improving quality assurance during provision and use of dialysis solutions. According to the invention, precursor compositions for dialysis solutions are mixed with a coding substance and corresponding sensors are made available through the use of which the specifications of the used compositions can be ascertained by means of the coding substance and can be communicated to the treatment machine.

Inventors

  • MAIERHOFER, ANDREAS

Assignees

  • Fresenius Medical Care Deutschland GmbH

Dates

Publication Date
20260513
Application Date
20240624

Claims (15)

  1. Claims 1. Composition comprising a salt mixture for producing a physiological dialysis solution and at least one coding agent for coding at least one specification of this composition.
  2. 2. Composition according to claim 1, wherein the composition is a dry or liquid concentrate for a dialysis solution.
  3. 3. A composition according to any one of the preceding claims, wherein the specification or specifications are selected from concentrations of ingredients, manufacturer identity, batch number and expiry date.
  4. 4. Composition according to one of the preceding claims, wherein the coding is based on the chemical composition and/or the concentration of the coding agent and/or the concentration ratio of several coding agents.
  5. 5. A composition according to any one of the preceding claims, wherein the coding agents are selected from polypeptides, polynucleotides, urea, uric acid, creatinine, amino acids, phosphate, zinc or selenium.
  6. 6. Sensor unit for coding a specification of a composition comprising at least one connection point and at least one output for the composition, which are fluidically connectable via at least one connecting line, at least one sensor for determining a coding means and a control unit configured to receive the sensor result and to convert the sensor result according to an assignment into a code which corresponds to at least one specification of the composition.
  7. 7. Sensor unit according to claim 6, wherein valves are arranged in the connecting lines, and wherein the valves establish or interrupt the fluidic connection in the connecting line in response to a signal from the control unit.
  8. 8. Sensor unit according to one of claims 6 or 7, wherein the sensor determines the chemical composition of the coding agent.
  9. 9. Sensor unit according to one of claims 6 or 7, wherein the sensor determines the concentration of the coding agent(s).
  10. 10. Sensor unit according to one of claims 6 to 9, wherein the assignment of the sensor result to a specification is transmitted to the control unit from an external storage unit wirelessly or by cable.
  11. 11. Sensor unit according to one of claims 6 to 10, wherein the sensor unit comprises a storage unit in which the assignment of the sensor results to the corresponding specifications is stored.
  12. 12. Sensor unit according to one of claims 6 to 11, wherein the sensor unit is part of a central supply system for concentrates.
  13. 13. Sensor unit according to one of claims 6 to 11, wherein the sensor unit is part of a mixing unit for producing the dialysis solution.
  14. 14. Sensor unit according to one of claims 6 to 11, wherein the sensor unit is part of a dialysis treatment machine.
  15. 15. Method for determining a specification by using a composition according to one of claims 1 to 5 and coding by means of a sensor unit according to one of claims 6 to 14.

Description

230007WO01 Fresenius Medical Care Deutschland GmbH D-61352 Bad Homburg ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ Composition for dialysis solution and sensor unit ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ Technical field The invention relates to compositions for producing dialysis solutions which contain a coding agent and devices for detecting these coding agents. Background When the kidneys lose function, patients are dependent on the regular removal of the toxins which accumulate in the body through blood purification therapies. This includes various procedures such as hemodialysis (HD) and hemofiltration (HF) or combinations of both, as well as peritoneal dialysis. This involves an exchange between the patient's blood and a rinsing solution. In HD and HF, this exchange takes place via a synthetic membrane in a dialyzer, and in peritoneal dialysis via the patient's peritoneum. The typical components of such a rinsing solution, generally called dialysis solution in blood purification processes, are salts of sodium, potassium, calcium and magnesium with chloride, bicarbonate, acetate and citrate as anions and glucose. In clinical use, the doctor can choose between different dialysis solutions in which the concentrations of individual components vary. The composition of the dialysis solution, i.e. the type and concentration of the substances it contains, is crucial for tolerability and therapeutic effectiveness. This influence is particularly important when using therapeutic control procedures in which the composition of the dialysis solution is automatically adjusted by the machine. As the efficiency of dialysis treatment increases in terms of dialysis duration and the extent of the exchange, described by clearance, the influence of the composition of the dialysis solution on the composition of substances in the patient's blood and body water is increased. The composition most suitable for the patient is prescribed by the doctor. The consistency of this prescription with the dialysis solution provided by the treatment machine is therefore essential for the well-being of the patient. Therefore, when using or providing rinsing solution or dialysis solution on the treatment machine, effective quality assurance measures are necessary to ensure that the correct composition is connected to the treatment machine. In addition, special requirements may be placed on the quality of the rinsing solution for certain treatment procedures, and the treatment machine will only release the solution if these requirements are met. The rinsing solution or dialysis solution can be provided in different ways. The solution can be provided ready-to-use in bags or similar containers. This type of provision is usually used for peritoneal dialysis. In practice, HD and HF blood purification processes are used to produce the dialysis solution continuously by mixing one or more concentrates and ultrapure water directly in the treatment device. These concentrates can be in solid or liquid form. They can be connected to suitable extraction devices in bags or canisters directly on the treatment machine. Alternatively, the concentrates can be fed from central supply lines to the individual treatment machines. The composition or the quality criteria used in production are shown on the label on the product packaging in written form, barcode, RFID tag. The user can read this label, or suitable reading devices on the treatment device can read the information and compare it with the respective requirements. This type of labeling of the dialysis solutions or concentrates can lead to errors in the provision of the respective dialysis solution according to the prescription. Errors can occur when the user checks the labels. The user himself can bypass the quality control via the label attached to the container by filling already used, empty containers with concentrates of a different composition. When the concentrates are provided via a central supply line, the user cannot check the containers themselves. The lines can be mixed up and errors can therefore occur in the composition of the rinsing solution for the respective patient. The object of the invention is to provide compositions, devices and methods that enable the composition to be identified when using dialysis compositions by providing the information for quality assurance using coding means as components of the composition, i.e. the dialysis solution or concentrate itself. This can also be used to enable dialysis treatment processes in a controlled manner. Summary of the invention According to the teaching of the present invention, this object is achieved by a composition according to claim 1, a sensor unit according to claim 6 and a method according to claim 15. Particular embodiments are the subject of the dependent claims. The invention relates to a composition comprising a salt mixture for producing a phys