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CN-115697431-B - Device for extracorporeal blood treatment and method for administering a nutritional product in a device for extracorporeal blood treatment

CN115697431BCN 115697431 BCN115697431 BCN 115697431BCN-115697431-B

Abstract

An apparatus for extracorporeal blood treatment for chronic treatment comprises a nutrition bag (33) containing a nutrition liquid, a weighing device (36) configured to determine the weight (W) of the nutrition bag (33), and a nutrition line (34) for infusion of the nutrition liquid into a blood circuit (7) or into the vascular system of a patient. The ultrafiltration device (30) is configured to remove fluid from the patient through a semipermeable membrane (5) of the filtration unit (2), and the sensor (31, 32) is configured to determine an ultrafiltration rate (UFR). A control unit (100) connected to the ultrafiltration device (30), the weighing device (33) and the sensors (31, 32) is programmed for receiving the patient prescription and controlling the ultrafiltration device (30) to achieve the patient prescription based on the weight (W) and the ultrafiltration rate (UFR).

Inventors

  • P. Rowati

Assignees

  • 甘布罗伦迪亚股份公司

Dates

Publication Date
20260512
Application Date
20210409
Priority Date
20200409

Claims (20)

  1. 1. An apparatus for extracorporeal blood treatment for chronic treatment, comprising: A main body (37); A filtration unit (2) having a main chamber (3) and a sub-chamber (4) separated by a semipermeable membrane (5); A blood circuit coupled with the filtration unit (2) and comprising a blood collection line (6) and a blood circuit (7), the blood collection line (6) being connected with an inlet (3 a) of the main chamber (3), the blood circuit (7) being connected with an outlet (3 b) of the main chamber (3), the blood collection line (6) and the blood circuit (7) being configured to be connected with a cardiovascular system of a patient; a blood pump (10) supported by the body (37) and configured to be coupled with a pump portion of the blood circuit; A dialysis circuit comprising a dialysis supply line (11) for fresh dialysis liquid and a dialysis filtering out line (12) for spent dialysis liquid, the dialysis supply line (11) being connected to the inlet (4 a) of the secondary chamber (4), the dialysis filtering out line (12) being connected to the outlet (4 b) of the secondary chamber (4); -a preparation device (13) for preparing the fresh dialysis fluid, wherein the preparation device (13) comprises a preparation line connected to a liquid source and at least one concentrate container, wherein the containers are located on a respective infusion line preset to supply the preparation line with a substance, wherein the preparation device (13) is connected to the dialysis supply line (11) and comprises a regulating device (14) for regulating the composition of the fresh dialysis fluid; a nutritional liquid comprising a mixture of protein, carbohydrate, and fat; at least one nutrient bag (33) containing the nutrient solution; A nutrition line (34) having a first end in fluid communication with the nutrition bag (33) and a second end for infusion of the nutrition liquid into the circuit blood vessel (7) or directly into the patient's vascular system; An infusion pump (35) coupled with the nutrient line (34) to deliver a feed rate (Q nutr ) of the nutrient solution through the nutrient line (34), wherein the infusion pump is attached to the body (37); at least one sensing element (36) being a weighing device configured to provide the weight of the at least one nutrition bag (33) and configured to provide a first signal related to the actual flow rate in the nutrition line; An ultrafiltration device (30) configured to effect removal of fluid from the patient through the semipermeable membrane (5); At least one sensor (31, 32) comprising at least one flow meter placed on at least one of the dialysis supply line (11) and the dialysis filtering line (12), the at least one sensor (31, 32) being configured to provide a second signal related to an ultrafiltration rate (UFR) and to detect one of: -the difference between the amount or flow rate of fresh dialysis fluid prepared by the preparation device (13) and entering the filtration unit (2) and the amount or flow rate of spent dialysis fluid leaving the filtration unit (2); a difference between the quantity or flow rate of fresh dialysis fluid prepared by the preparation device (13) and infused into the blood circuit and the quantity or flow rate of spent dialysis fluid leaving the filtration unit (2), and The difference between the amount or flow rate of fresh dialysis fluid prepared by the preparation device (13) and entering the filtration unit (2) and the blood circuit and the amount or flow rate of spent dialysis fluid leaving the filtration unit (2), Wherein the blood circuit, the nutrition line (34) and the filtration unit (2) are disposable and detachably coupled with the main body (37), and wherein the blood circuit and the nutrition line (34) are coupled with the blood pump (10) and the infusion pump (35), respectively; wherein the dialysis circuit is non-disposable and integrated in the body (37); -a control unit (100) comprised in said main body (37) or supported by said main body (37) and connected at least to said ultrafiltration device (30), to said infusion pump (35), to said sensing element (36) and to said at least one sensor (31, 32), and programmed for: receiving a patient prescription comprising two parameters: total patient weight loss to be achieved at the end of blood treatment (WL target ); total processing time (T), and Said ultrafiltration rate (UFR); receiving a weight signal from the weighing device and determining a first parameter (W) related to an actual flow rate in the nutrition line; Collecting a second signal from said at least one sensor (31, 32) and determining a second parameter (FR) as an ultrafiltration rate (UFR); -controlling the infusion pump (35); -controlling the ultrafiltration device (30) based on the first parameter (W) and the second parameter (FR) to achieve the patient prescription such that the patient Weight Loss (WL) at the end of the blood treatment matches the total patient weight loss (WL target ) to be achieved at the end of the blood treatment.
  2. 2. The device according to claim 1, wherein the control unit (100) is programmed for calculating and/or storing data relating to the nutritional liquid administered during the extracorporeal blood treatment.
  3. 3. The apparatus of claim 1 or 2, wherein the feed rate (Q nutr ) of the nutrient solution during blood treatment is between 50 ml/h and 500 ml/h.
  4. 4. The apparatus according to claim 1 or 2, wherein the first parameter (W) is the instantaneous weight (W (t)) of the nutrition bag (33), wherein the second parameter (FR) is the ultrafiltration rate (UFR).
  5. 5. A device according to claim 3, wherein the first parameter (W) is the instantaneous weight (W (t)) of the nutrition bag (33), wherein the second parameter (FR) is the ultrafiltration rate (UFR).
  6. 6. The apparatus according to claim 4, wherein a net ultrafiltration rate (nUFR) is calculated by calculating a feed rate (Q nutr ) of the nutritional liquid from the weight (W (t)) of the nutritional bag (33) and by subtracting the feed rate (Q nutr ) from the ultrafiltration rate (UFR), wherein the ultrafiltration device (30) is controlled such that the net ultrafiltration rate (nUFR) matches a desired net ultrafiltration rate (nUFR target ).
  7. 7. The apparatus according to claim 4, wherein the instantaneous patient weight loss (WL (t)) is calculated by integrating the instantaneous ultrafiltration rate (UFR) and by subtracting the weight (W (t)) of the instantaneous nutrition bag (33) from the integrated rate (UFR), wherein the ultrafiltration device (30) is controlled such that the patient Weight Loss (WL) matches the total patient weight loss (WL target ) at the end of the blood treatment.
  8. 8. The apparatus according to claim 1 or 2, wherein the at least one sensor (31, 32) comprises at least one flow meter placed on at least one of the dialysis supply line (11) and the dialysis filtering line (12), wherein the second signal is a signal from the at least one flow meter.
  9. 9. The apparatus according to claim 1 or 2, wherein the nutrition line comprises a pump section (39), a feed pipe section (40) connected to an inlet of the pump section (39), a delivery pipe section (41) connected to an outlet of the pump section (39), and at least one rigid portion (44), the at least one rigid portion (44) comprising two pump connectors (44 a) for receiving opposite ends of the pump section (39), a delivery pipe section connector (44 c) for receiving one end of the delivery pipe section (41), and a feed pipe section connector (44 b) for receiving one end of the feed pipe section (40), Wherein the feed tube section and/or the delivery tube section comprises respective detachable connectors (42, 43), the detachable connectors (43) of the delivery tube section (41) being connectable with corresponding counter connectors on a degassing chamber (8) on the return vessel circuit (7).
  10. 10. An apparatus according to claim 3, wherein the nutrition line comprises a pump section (39), a feed pipe section (40) connected to an inlet of the pump section (39), a delivery pipe section (41) connected to an outlet of the pump section (39), and at least one rigid portion (44), the at least one rigid portion (44) comprising two pump connectors (44 a) for receiving opposite ends of the pump section (39), a delivery pipe section connector (44 c) for receiving one end of the delivery pipe section (41), and a feed pipe section connector (44 b) for receiving one end of the feed pipe section (40), Wherein the feed tube section and/or the delivery tube section comprises respective detachable connectors (42, 43), the detachable connectors (43) of the delivery tube section (41) being connectable with corresponding counter connectors on a degassing chamber (8) on the return vessel circuit (7).
  11. 11. The apparatus according to claim 4, wherein the nutrition line comprises a pump section (39), a feed pipe section (40) connected to an inlet of the pump section (39), a delivery pipe section (41) connected to an outlet of the pump section (39), and at least one rigid portion (44), the at least one rigid portion (44) comprising two pump connectors (44 a) for receiving opposite ends of the pump section (39), a delivery pipe section connector (44 c) for receiving one end of the delivery pipe section (41), and a feed pipe section connector (44 b) for receiving one end of the feed pipe section (40), Wherein the feed tube section and/or the delivery tube section comprises respective detachable connectors (42, 43), the detachable connectors (43) of the delivery tube section (41) being connectable with corresponding counter connectors on a degassing chamber (8) on the return vessel circuit (7).
  12. 12. The device according to claim 2, comprising a display screen (38) connected to the control unit (100), wherein the control unit (100) is programmed for displaying data related to the nutritional liquid on the display screen (38).
  13. 13. The apparatus of claim 5, wherein a net ultrafiltration rate (nUFR) is calculated by calculating a feed rate (Q nutr ) of the nutrient solution from a weight (W (t)) of the nutrient bag (33) and by subtracting the feed rate (Q nutr ) from the ultrafiltration rate (UFR), wherein the ultrafiltration device (30) is controlled such that the net ultrafiltration rate (nUFR) matches a desired net ultrafiltration rate (nUFR target ); The device comprises a display screen (38) connected to the control unit (100), wherein the control unit (100) is programmed for displaying data relating to the nutritional liquid on the display screen (38).
  14. 14. The apparatus according to claim 5, wherein the instantaneous patient weight loss (WL (t)) is calculated by integrating the instantaneous ultrafiltration rate (UFR) and by subtracting the weight (W (t)) of the instantaneous nutrition bag (33) from the integrated rate (UFR), wherein the ultrafiltration device (30) is controlled such that the patient Weight Loss (WL) matches the total patient weight loss (WL target ) at the end of the blood treatment; The device comprises a display screen (38) connected to the control unit (100), wherein the control unit (100) is programmed for displaying data relating to the nutritional liquid on the display screen (38).
  15. 15. The device according to claim 10, comprising a display screen (38) connected to the control unit (100), wherein the control unit (100) is programmed for displaying data related to the nutritional liquid on the display screen (38).
  16. 16. The device according to claim 1 or 2, wherein the infusion pump (35) and the blood pump (10) are peristaltic pumps.
  17. 17. The apparatus according to claim 1 or 2, wherein the ultrafiltration device (30) comprises at least one dialysis pump coupled with a dialysis supply line (11) and/or a dialysis filtering line (12), wherein the at least one dialysis pump is mounted on the body (37).
  18. 18. The apparatus according to claim 1 or 2, wherein the sensor (31, 32) for providing a second signal related to ultrafiltration rate (UFR) takes into account the net amount/flow rate of fresh dialysis fluid prepared by the preparation device (13) and not the fresh dialysis fluid fed to, removed from and infused into the blood circuit.
  19. 19. The device according to claim 1 or 2, wherein the device comprises an infusion line (11 ') branching off from the dialysis supply line (11) for infusing fresh dialysis fluid into the blood circuit, the sensor (31, 32) being configured to provide a second signal related to an ultrafiltration rate (UFR), the sensor (31, 32) being operated at least upstream of a branch of the infusion line (11 ') to take into account the fresh dialysis fluid fed through the dialysis supply line (11) to the filtration unit (2) or/and through the infusion line (11 ') to one or both of the blood circuits.
  20. 20. The apparatus of claim 1 or 2, wherein the at least one sensor comprises: A flow meter placed on the dialysis supply line and another flow meter placed on the dialysis filter line, the control unit being configured to receive signals from both flow meters to determine a flow difference between the dialysis fluid supplied to the supply line and the dialysis fluid removed by the dialysis filter line, or A differential flow meter is placed on the dialysis supply line and the dialysis filter line to detect a flow difference between the dialysis supply line and the dialysis filter line.

Description

Device for extracorporeal blood treatment and method for administering a nutritional product in a device for extracorporeal blood treatment Technical Field The present invention relates to a device for extracorporeal blood treatment and a method of administering a nutritional product in a device for extracorporeal blood treatment. Extracorporeal blood treatment involves removing blood from a patient, treating the blood externally to the patient, and then returning the treated blood to the patient. Extracorporeal blood treatment is typically used to extract undesirable substances or molecules from the patient's blood and add the desired substances or molecules to the blood. Extracorporeal blood treatment is used for patients who are not able to effectively remove substances from the blood, such as patients with temporary or permanent renal failure. These and other patients may receive extracorporeal blood treatment to add or remove substances from the blood, maintain acid-base balance or remove excess body fluids, or perform, for example, an extracorporeal gas exchange process. In particular, the present invention relates to a chronic (long-term) Hemodialysis (HD) treatment system for treating chronic renal failure patients. HD therapy is typically performed several times per week (e.g., 3 times per week), with each treatment having an average duration of several hours (e.g., 3.5 to 4.5 hours). During treatment, the patient has two passages (arteries/veins), blood flow into/out of the body, wherein the average blood flow is typically 250ml/min to 400ml/min. Background An apparatus for chronic (long-term) Hemodialysis (HD) treatment includes a device for on-line preparation of a dialysate and/or a replacement fluid. The device comprises one, two or more concentrate containers, which are located on respective injection lines, which are pre-arranged to supply a preparation line connected to a water source and located upstream of the dialysis line with substances such as electrolytes, buffers or other substances. The concentrate container may comprise a liquid or solid concentrate (e.g., a powder). Among patients undergoing chronic hemodialysis, the national kidney foundation currently suggests that patients undergoing hemodialysis have a daily protein intake of 1.2g/kg or more. When malnutrition occurs, a stepwise approach for treatment is used, first with dietary consultation and dietary adjustment, then with oral nutritional supplements, then with enteral nutritional supplements (typically consisting of a mixture of amino acids, glucose and lipids) or parenteral nutritional supplements (if needed). In hemodialysis, it is known to administer an enteral parenteral nutrition (IDPN) infusion by intravenous access to a patient several minutes after the start of the dialysis, for example, and to continue for the remainder of the dialysis process. This is achieved by special means such as bags, special tubing and manually operated pumps. This requires additional nurse effort. Furthermore, dialysis treatment parameters are manually corrected based on the experience of the operator, measurements, or knowledge of the additional fluid/weight infused in this way. Manual correction of dialysis treatment parameters does not allow accurate calculation of the mass balance of the patient. This is also a cumbersome invasive solution, which is generally not well accepted by patients/users. It is an object of the present invention to provide a device for extracorporeal blood treatment which alleviates, minimises or remedies the above-mentioned disadvantages. It is an object of the present description to provide an extracorporeal blood treatment apparatus and a method of administering a nutritional product in an apparatus for extracorporeal blood treatment, which are capable of taking into account the administered nutritional product to properly manage the mass balance of a patient during the treatment. The object of the present invention is to better control the administration of nutritional products during treatment. Another object of the present description is to control the administration of a nutritional product by the same apparatus for extracorporeal blood treatment. Another object of the present description is to reduce the workload of nurses. It is a further object of the present description to reduce the complexity of the apparatus for extracorporeal blood treatment while administering a nutritional product. Another object is to improve the comfort of the patient undergoing the treatment Document US5776345 is also known. The present document discloses a machine for acute treatment having a blood circuit to which a plurality of infusion lines can infuse a liquid. The dialysate container, the collection liquid container, the replacement liquid container and the anticoagulant container are connected with a scale for weighing the contents. The replacement fluid adds substances to the blood to adjust the pH of the blood, sup