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CN-122003259-A - Extracorporeal blood treatment apparatus

CN122003259ACN 122003259 ACN122003259 ACN 122003259ACN-122003259-A

Abstract

An extracorporeal blood treatment apparatus 1 comprises a fluid pump assembly (29) in which a sampling circuit (27) acts on the sampling circuit (27), the sampling circuit having a bypass line (28) connecting at least one supply line (9) to a waste line (10). The fluid pump assembly (29) is drivable in a first active state in which the fluid pump assembly (29) causes a fluid passing through the fluid circuit (8) to flow from the at least one supply line (9) to the waste line (10) via the bypass line (28), and in a second active state in which the fluid pump assembly (29) causes a fluid passing through the fluid circuit (8) to flow from the waste line (10) to the at least one supply line (9) via the bypass line (28), respectively. A concentrate sensor (30) is disposed on the bypass line (28) for monitoring the concentration of a substance in the fluid entering through the fluid circuit (8) that is detectable. The control unit (100) is operatively connected to the concentration sensor (30) and the fluid pump assembly (29) and is configured to drive the fluid pump assembly (29) in a first or second activated state, to receive a signal from the concentrate sensor (30) and to determine the concentration of the substance (Csup, ceff).

Inventors

  • Dominique Puchulin

Assignees

  • 甘布罗伦迪亚股份公司

Dates

Publication Date
20260508
Application Date
20241011
Priority Date
20231013

Claims (20)

  1. 1. An extracorporeal blood treatment apparatus (1) comprising: A filtration unit (2) having a primary chamber (3) and a secondary chamber (4) separated by a semi-permeable membrane (5); An extracorporeal blood circuit (6) comprising a blood extraction line (6 a) connected to an inlet (3 a) of the primary chamber (3) and a blood return line (6 b) connected to an outlet (3 b) of the primary chamber (3), the extracorporeal blood circuit (6) being configured to be connected to a patient (P); A blood pump (7) acting on the extracorporeal blood circuit (6) to pump blood through the extracorporeal blood circuit (6); A fluid circuit (8) comprising at least one supply line (9,16,17,18) and a waste line (10), at least one supply line (9,16,17,18) being connected to the inlet (4 a) of the secondary chamber (4) and/or to the extracorporeal blood circuit (6), the waste line (10) being connected to the outlet (4 b) of the secondary chamber (4); -a sampling circuit (27) comprising a bypass line (28) connecting at least one supply line (9,16,17,18) to the waste line (10); -a fluid pump assembly (29) acting on the sampling circuit (27) for controlling the fluid pump assembly (29) in a first active state in which the fluid pump assembly (29) causes at least one fluid passing through the fluid circuit (8) to flow from the at least one supply line (9,16,17,18) to the waste line (10) through the bypass line (28) and in a second active state in which the fluid pump assembly (29) causes at least one fluid passing through the fluid circuit (8) to flow from the waste line (10) to the at least one supply line (9,16,17,18) through the bypass line (28), respectively; a concentrate sensor (30) placed on the bypass line (28) for monitoring the concentration of at least one substance detectable into at least one fluid passing through the fluid circuit (8); A control unit (100) operatively connected to the concentration sensor (30) and the fluid pump assembly (29), the control unit (100) being configured to control the fluid pump assembly (29) in a first activated state or in a second activated state and to receive a signal from the concentrate sensor (30) and to determine the concentration (Csup, ceff) of the at least one substance.
  2. 2. Extracorporeal blood treatment apparatus according to claim 1, wherein the fluid circuit (8) comprises a source (11,19,21,23) of a supply fluid connected to one end of at least one supply line (9,16,17,18), a supply pump (13,20,22,24) acting on the at least one supply line (9,16,17,18) and a waste pump (14) acting on the waste line (10), wherein the at least one fluid is a supply fluid or a waste fluid flowing out of the secondary chamber (4), a control unit (100) being operatively connected to the supply pump (13,20,22,24) and the waste pump (14); Wherein the control unit (100) is configured to control the supply pump (13,20,22,24) and/or the waste liquid pump (14), and optionally to control the valve (32,33,35,37) to flow the supply fluid into the extracorporeal blood circuit (6) and/or the secondary chamber (4) and to flow the waste liquid fluid out of the secondary chamber (4); Wherein the control unit (100) is configured to: Driving the fluid pump assembly (29) in a first active state and acquiring a signal from the concentrate sensor (30) to determine the concentration (Csup) of at least one substance into the supply fluid, or The fluid pump assembly (29) is driven in a second activated state and signals from the concentrate sensor (30) are acquired to determine the concentration (Ceff) of at least one substance into the waste fluid.
  3. 3. Extracorporeal blood treatment apparatus according to claim 2, wherein the control unit (100) is configured to estimate the solute removal rate (J) of the at least one substance by: receiving a flow rate of the waste fluid (Qeff); Calculating a solute removal rate (J) from a concentration (Ceff) of at least one substance into the waste fluid and a flow rate (Qeff) of the waste fluid; Optionally, the program comprises: receiving a flow rate (Qsup) of at least one supply fluid; the solute removal rate (J) is also calculated from the concentration (Csup) of the at least one substance into the at least one supply fluid and the flow rate (Qsup) of the at least one supply fluid.
  4. 4. An extracorporeal blood treatment apparatus according to claim 3, wherein the control unit (100) is configured to estimate the clearance or dialysis rate (K/D) of the at least one substance by estimating the blood concentration (cb_est) of the same substance at the inlet (3 a) of the primary chamber (3) and calculating the clearance or dialysis rate (K/D) of the at least one substance from the solute removal rate (J) and the estimated blood concentration (cb_est) of the same substance at the inlet (3 a) of the primary chamber (3).
  5. 5. An extracorporeal blood treatment apparatus according to claim 4, wherein estimating the blood concentration (cb_est) of the same substance at the inlet (3 a) of the primary chamber (3) comprises ensuring a balance between the concentration (ceff_eq) of at least one substance entering the waste fluid and the blood concentration (Cb) of the same substance at the inlet (3 a) of the primary chamber (3) such that the concentration (Ceff) of at least one substance entering the waste fluid is equal to or proportional to the blood concentration (Cb) of at least one substance at the inlet (3 a) of the primary chamber (3), wherein the balance is ensured by varying the flow rate (Qsup) of at least one supply fluid and/or the flow rate (Qeff) of the waste fluid and/or the blood flow rate (Qb) set for the extracorporeal blood treatment.
  6. 6. Extracorporeal blood treatment apparatus according to claim 5, wherein the balance is ensured by waiting a stabilization time (t) after varying the flow rate (Qsup) of at least one of the supply fluid and/or the flow rate (Qeff) of the waste fluid and/or the flow rate (Qb) of the blood.
  7. 7. Extracorporeal blood treatment apparatus according to any of the preceding claims 5 or 6, wherein after estimating the blood concentration (cb_est) the control unit is configured or the method is used for moving the flow rate of at least one supply fluid Qsup and/or the flow rate of the waste fluid Qeff and/or the blood flow rate Qb back to the treatment value.
  8. 8. An extracorporeal blood treatment apparatus according to claim 4, wherein estimating the blood concentration (cb_est) of the same substance at the inlet (3 a) of the primary chamber (3) comprises recirculating at least a portion of the waste fluid from the outlet (4 b) of the secondary chamber (4) through the sampling circuit (27) and back to the inlet (4 a) of the secondary chamber (4), measuring the concentration of said substance in the recirculated waste fluid, optionally periodically measuring the concentration of said substance in the recirculated waste fluid, waiting until the concentration of said substance becomes stable or extrapolating the steady-state concentration of said substance, the estimated blood concentration (cb_est) of the substance at the inlet (3 a) of the primary chamber (3) being a steady-state concentration or extrapolating steady-state, optionally setting a valve in a suitable state to direct the waste fluid.
  9. 9. Extracorporeal blood treatment apparatus according to any of the preceding claims 1 to 8, wherein at least one supply line (9,16,17,18) comprises: A dialysis line (9) connected to the inlet of the secondary chamber (4), a dialysis pump (13) acting on the dialysis line (9) and a source (11) of dialysis fluid connected to one end of the dialysis line (9); And/or At least one supply line (9,16,17,18) comprises: At least one alternative infusion line (16, 17, 18) connected to the extracorporeal blood circuit or directly to the patient (P) upstream or downstream of the filtration unit (2); At least one alternative infusion pump (20, 22, 24) acting on the at least one alternative infusion line (16, 17, 18); at least one source (19, 21, 23) of substitution solution connected to one end of at least one substitution infusion line (16, 17, 18); Wherein the bypass line (28) connects at least one alternative infusion line (16, 17, 18) to the waste liquid line (10), or Wherein the bypass line (28) connects the dialysis line (9) to the waste line (10), and wherein the bypass line (28) further comprises a supply line (31,34,36) connecting the at least one alternative infusion line (16, 17, 18) to the bypass line (28) at a location between the dialysis line (9) and the concentrate sensor (30).
  10. 10. An extracorporeal blood treatment apparatus according to claim 2 or 3, wherein the fluid circuit (8) further comprises an auxiliary source (41) of an auxiliary fluid, the auxiliary source (41) of auxiliary fluid being connected to the bypass line (28) at a location between the at least one supply line (9,16,17,18) and the concentrate sensor (30), wherein the control unit (100) is configured to: A fluid pump assembly (29) is actuated and optionally configured to control a valve to flow auxiliary fluid through a bypass line (28).
  11. 11. Extracorporeal blood treatment apparatus according to claim 10, wherein the auxiliary fluid is a calibration fluid and the control unit (100) is configured to calibrate the concentrate sensor (100) when the auxiliary fluid flows through the bypass line (28).
  12. 12. The extracorporeal blood treatment apparatus according to any one of claims 1 to 11, wherein the control unit (100) is configured to control the extracorporeal blood treatment apparatus to perform an extracorporeal blood treatment on the patient (P) and to determine the concentration of the at least one substance or monitor the at least one substance during the extracorporeal blood treatment.
  13. 13. Extracorporeal blood treatment apparatus according to any of the preceding claims 1 to 12, wherein the fluid pump assembly (29) comprises a single reversible pump acting on the bypass line (28).
  14. 14. Extracorporeal blood treatment apparatus according to any of the preceding claims 1-12, wherein the fluid pump assembly (29) comprises a single pump (54) configured to pump in the same direction all the time, a first bypass branch (55) and a second bypass branch (56) connecting points of the bypass line (28) upstream and downstream of the single pump (54), and an assembly valve (57,58,59,60) placed on the first bypass branch (55), the second bypass branch (56) and the bypass line (28), wherein the control unit (100) is configured to control the assembly valve (57,58,59,60) to arrange the fluid pump assembly (29) in the first activated state or the second activated state.
  15. 15. Extracorporeal blood treatment apparatus according to any of the preceding claims 1 to 14, wherein the sampling circuit (27) is disposable or part of, or connectable to, a disposable set comprising the extracorporeal blood circuit (6) and the fluid circuit (8).
  16. 16. An extracorporeal blood treatment apparatus according to any of the preceding claims 1-15, wherein the at least one substance may be urea, creatinine, uric acid, glucose, electrolytes, lactate.
  17. 17. Extracorporeal blood treatment apparatus according to any of the preceding claims 1 to 16 in combination with claim 2, wherein the bypass line (28) is connected to the waste liquid line (10) downstream of the waste liquid pump (14).
  18. 18. Extracorporeal blood treatment apparatus according to any of the preceding claims 1 to 17 in combination with claim 2, the circulation circuit being defined by a bypass line (28), a portion of the waste liquid line (10), a portion of the dialysis line (9) and the secondary chamber (4). Wherein the circulation loop comprises a fluid pump assembly (29) and a waste pump (14).
  19. 19. Extracorporeal blood treatment apparatus according to any of the preceding claims 1 to 18 in combination with claim 9, wherein in the first activation state and/or in the second activation state the control unit (100) is configured to activate the dialysis pump (13), the fluid pump assembly (29) and the waste pump (14) simultaneously or to keep the dialysis pump (13), the fluid pump assembly (29) and the waste pump (14) activated.
  20. 20. An extracorporeal blood treatment apparatus according to any of the preceding claims 1 to 19 in combination with claim 9, the control unit (100) being configured to adjust the flow rate of the dialysis pump (13) upon triggering of the first activation state, And wherein, upon triggering the second activation state, the control unit (100) is configured to adjust the flow rate of the dialysis pump (13).

Description

Extracorporeal blood treatment apparatus Background The present disclosure relates to an extracorporeal blood treatment apparatus configured to perform an extracorporeal blood treatment, such as a dialysis fluid treatment. The human kidney system may fail for various reasons. Renal failure produces several physiological disorders. It is no longer possible to balance water and minerals or to excrete daily metabolic loads. Toxic metabolic end products such as urea, creatinine, uric acid, etc. may accumulate in the blood and tissues of patients. Dialysis is used to treat decline in renal function, most importantly renal failure. Dialysis removes waste, toxins and excess water from the body that would have been removed by a properly functioning kidney. Dialysis treatments for replacing kidney function are important to many people because such treatments are life-saving. Renal failure treatments include, for example, hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF). The device of the invention may also be used in the case of Continuous Renal Replacement Therapy (CRRT) with or without anticoagulation, e.g. CRRT with or without whole body anticoagulation (e.g. heparin)/with or without local anticoagulation (e.g. citrate). Regardless of the type of treatment and/or treatment involved, on-line sensing techniques play an important role in the efficient operation of the extracorporeal blood treatment apparatus. For example, the general concept of providing a single (e.g. concentration) sensor placed on a bypass line extending between fresh dialysis fluid and waste fluid and configured for measuring properties of fresh dialysis fluid and used dialysis fluid is known from some prior art documents. Patent document US2014190876 relates to a system and method that utilizes an adsorbent cartridge and quantifies the chemical changes that occur as the dialysate passes through the material layers of the cartridge as a means of determining the concentration of solutes in the solution flowing through the cartridge. The disclosed systems and methods can be used to manage blood urea and quantify urea clearance during dialysis treatments, which also include hemodialysis, hemodiafiltration, hemofiltration, and peritoneal dialysis. A fluid circuit equipped with a single conductivity sensor is effective on a bypass circuit in parallel with the dialyzer. The bypass circuit allows a portion of the dialysate around the dialyzer to be diverted to rejoin the flow path in the post-dialyzer flow path. Patent document US5399157 discloses a method and a device for checking the operation of one sensor located in the dialysis fluid circuit of an artificial kidney. The method comprises circulating a reference liquid having known properties in the extracorporeal blood circuit, checking at least one property of the dialysate passing through the sensor by means of a measurement, calculating a theoretical value of the at least one property of the reference liquid based on the measurement, comparing the calculated theoretical value with the known value of the property of the reference liquid, and concluding that the sensor is working properly after the measurement has been made when the calculated theoretical value is substantially equal to the known value. Patent document US5744031 discloses an artificial kidney comprising a measurement structure for measuring physical properties of fresh dialysis fluid and used fluid. The measuring arrangement is arranged in a line section common to a branch circuit to the supply line for fresh dialysis liquid and to a branch circuit to the drain line for used liquid. The occlusion structure allows liquid to circulate in only one or the other of the branch circuits. With this arrangement, it is possible to obtain a physical characteristic value of the patient's blood by calculation, and permanently adjust the operation of the kidney to the treatment target set by the doctor. Patent document US6623442 discloses a dialysis apparatus comprising a dialysis liquid circuit for circulating sodium chloride and sodium bicarbonate through a hemodialysis machine and a circuit for infusing a solution containing at least one ionic substance to a patient. The dialysis rate detector determines the actual dialysis rate of the hemodialysis machine against sodium and the flow rate detector determines the flow rate of the infusion solution such that the concentration of the substance in the patient tends to a desired concentration that is a function of the dialysis rate, the concentration of the substance in the infusion solution, and the desired concentration. Patent document US2014098359 discloses a method for monitoring a blood treatment of a patient, comprising the steps of irradiating a sample of a dialysis liquid used in the treatment with irradiation light of at least a first irradiation wavelength, detecting light emitted by the irradiated sample in at least a first detection wavelength, the detection wavelength