CN210750527U

CN210750527U - System for indirectly monitoring level of extracorporeal circulation ionized calcium

Info

Publication number: CN210750527U
Application number: CN201920538819.1U
Authority: CN
Inventors: 丁峰; 张琪
Original assignee: Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
Current assignee: Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
Priority date: 2019-04-19
Filing date: 2019-04-19
Publication date: 2020-06-16
Anticipated expiration: 2029-04-19

Abstract

The utility model relates to a blood treatment field especially relates to a system of indirect monitoring extracorporal circulatory system ionized calcium level. The utility model provides a system for indirect monitoring extracorporeal circulation ionic calcium level, including the extracorporeal circulation pipeline, be equipped with blood purification device on the extracorporeal circulation pipeline, blood purification device includes hemodialysis device and/or blood filtration device, blood purification device's upper reaches are equipped with anticoagulant and introduce the pipeline, blood purification device's low reaches are equipped with calcium ion and introduce the pipeline, the last effluent liquid that is equipped with of blood purification device draws forth the pipeline, the effluent liquid is drawn forth and is equipped with calcium ion concentration detection device on the pipeline. The utility model provides a system of indirect monitoring extracorporeal circulation ionized calcium level can reduce patient's blood and lose, avoids the device and the biocompatible hidden danger of blood contact, makes ionized calcium's monitoring more convenient timely, has guaranteed that the safety of CRRT treatment is effective.

Description

System for indirectly monitoring level of extracorporeal circulation ionized calcium

Technical Field

The utility model relates to a blood treatment field especially relates to a system of indirect monitoring extracorporal circulatory system ionized calcium level.

Background

Citrate anticoagulation has been widely used in Continuous Renal Replacement Therapy (CRRT). Citric acid reduces the level of ionized calcium in vitro by chelating with ionized calcium in vitro circulation, thereby achieving the anticoagulation effect. Compared with heparin anticoagulation, the anticoagulant heparin anticoagulant filter can effectively prolong the service life of the filter, simultaneously reduce the bleeding risk of patients with severe bleeding tendency and ensure the safety of CRRT treatment. Thus, the kdigo (reagent transfusion Global outlet) guidelines recommend that CRRT is the most preferred citrate anticoagulation for patients without contraindications for citrate anticoagulation.

SUMMERY OF THE UTILITY MODEL

In view of the above-mentioned shortcomings of the prior art, it is an object of the present invention to provide a system for indirectly monitoring the level of ionized calcium in extracorporeal circulation, which solves the problems of the prior art.

In order to achieve the above and other related objects, the present invention provides a system for indirectly monitoring the level of ionic calcium in extracorporeal circulation, comprising an extracorporeal circulation pipeline, wherein a blood purification device is disposed on the extracorporeal circulation pipeline, the blood purification device comprises a hemodialysis device and/or a hemofiltration device, an anticoagulant liquid introducing pipeline is disposed at the upstream of the blood purification device, a calcium ion introducing pipeline is disposed at the downstream of the blood purification device, an effluent liquid leading-out pipeline is disposed on the blood purification device, and a calcium ion concentration detection device is disposed on the effluent liquid leading-out pipeline;

when the blood purification device comprises a hemodialysis device, a dialysate introduction pipeline is also arranged on the blood purification device;

when the blood purification device comprises a blood filtration device, a replacement fluid introducing pipeline is arranged on an extracorporeal circulation pipeline at the upstream and/or the downstream of the blood purification device.

In some embodiments of the present invention, the anti-coagulation liquid is introduced into the pipeline, the flow rate of the anti-coagulation liquid is less than or equal to 500ml/h, the anti-coagulation liquid includes an anticoagulant therein, the concentration of the anticoagulant in the anti-coagulation liquid is 20-50g/L, the anticoagulant is preferably selected from one or more combinations of citric acid or salts thereof, and preferably, the salt of citric acid in the anti-coagulation liquid is preferably selected from sodium citrate.

The utility model discloses in some embodiments, in the calcium ion inlet line, the flow of calcium ion supplementary liquid is 5-50mL/h, including the calcium salt in the calcium ion supplementary liquid, the calcium salt is preferably selected from the combination of one or more in calcium chloride, the calcium gluconate, more preferably, the concentration of calcium salt is 0.1 ~ 1g/10mL, and is further preferred, when the calcium salt is selected from the calcium chloride, the concentration of calcium chloride is 0.3 ~ 0.6g/10mL in the calcium ion supplementary liquid, when the calcium salt is selected from the calcium gluconate, the concentration of calcium gluconate is less than or equal to 2g/10mL in the calcium ion supplementary liquid.

In some embodiments of the invention, the membrane area of the purification device is 0.5-2.5m²。

In some embodiments of the present invention, the dialysate is introduced into the tube at a flow rate of 1-5L/h, and the dialysate comprises Na⁺、K⁺、Mg²⁺、Cl^-Glucose, HCO₃ ^-One or more of the above.

In some embodiments of the present invention, the dialysate contains Na⁺The concentration of (a) is 125-150mmol/L, K⁺The concentration of (B) is less than or equal to 4.5mmol/L, Mg²⁺The concentration of (A) is less than or equal to 1mmol/L, Cl^-The concentration of (A) is 90-120mmol/L, the concentration of glucose is less than or equal to 110mmol/L, HCO₃ ^-The concentration of (A) is 20-45 mmol/L.

In some embodiments of the present invention, the total flow rate of the replacement fluid introduced into the pipeline is 1-5L/h, and the replacement fluid comprises Na⁺、K⁺、Mg²⁺、Cl^-Glucose, HCO₃ ^-One or more of the above.

In some embodiments of the present invention, Na is present in the replacement liquid⁺Concentration of (2)Is 125-150mmol/L, K⁺The concentration of (B) is less than or equal to 4.5mmol/L, Mg²⁺The concentration of (A) is less than or equal to 1mmol/L, Cl^-The concentration of (A) is 90-120mmol/L, the concentration of glucose is less than or equal to 110mmol/L, HCO₃ ^-The concentration of (A) is 20-45 mmol/L.

In some embodiments of the present invention, the amount of blood introduced into the extracorporeal circulation circuit is 50 to 250 mL/min.

In some embodiments of the present invention, when a replacement fluid introduction line is provided on the extracorporeal circulation line upstream of the blood purification apparatus according to the flow direction of blood, the replacement fluid introduction line is located between the anticoagulation fluid introduction line and the blood purification apparatus;

when a replacement liquid introducing pipeline is arranged on the extracorporeal circulation pipeline at the downstream of the blood purification device, the replacement liquid introducing pipeline is positioned between the blood purification device and the calcium ion introducing pipeline.

The utility model discloses in some embodiments, still include blood calcium ion accounting device behind the filter, blood calcium ion accounting device behind the filter is arranged in calculating the blood calcium ion concentration behind the obtaining filter according to the calcium ion concentration in the effluent liquid that calcium ion concentration detection device detected the acquisition, blood calcium ion accounting device behind the filter is connected with calcium ion concentration detection device electricity.

Drawings

Fig. 1 is a schematic diagram showing the correlation between effluent ionized calcium and the concentration of ionized calcium in the blood after the filter in the embodiment of the present invention using Pearson correlation analysis; fig. B, CVVH mode; FIG. C, CVVHDF mode; fig. D, CVVHD mode.

FIG. 2 is a schematic diagram showing the consistency of the embodiment of the present invention in the method of comparing the ionized calcium concentration of effluent and the ionized calcium concentration of blood after filter detection by the Bland-Altman method, wherein, the diagram A shows all CRRT modes; fig. B, CVVH mode; FIG. C, CVVHDF mode; fig. D, CVVHD mode.

Fig. 3 shows a schematic diagram of the CVVH mode of the blood purification apparatus.

Fig. 4 shows a schematic diagram of a CVVHD model of the blood purification apparatus.

Fig. 5 shows a schematic diagram of the CVVHDF mode of the blood purification apparatus.

Description of the element reference numerals

1 extracorporeal circulation pipeline

2 blood purification device

21 hemodialysis device

22 blood filtration device

3 anti-coagulation liquid introducing pipeline

4 calcium ion introducing pipeline

5 effluent liquid outlet pipeline

6 calcium ion concentration detection device

7 dialysate introduction line

8 replacement liquid introducing pipeline

9 Pump body

Detailed Description

And utility model inventor through a large amount of practical studies, the unexpected discovery has the correlation in CRRT treatment, and the concentration of calcium ion in the effluent liquid and the calcium ion concentration in the blood behind the filter can reach the calcium ion concentration in the blood behind the monitoring filter through the concentration that detects the calcium ion in the effluent liquid to a new hemodialysis filtration method and system have been provided, have accomplished the utility model discloses on this basis.

The utility model discloses a first aspect provides a system of indirect monitoring extracorporeal circulation ionic calcium level, including extracorporeal circulation pipeline 1, be equipped with blood purification device 2 on the extracorporeal circulation pipeline 1, blood purification device 2 includes hemodialysis unit 21 and/or blood filtration device 22, the upper reaches of blood purification device 2 are equipped with anticoagulant liquid introduction pipeline 3, the low reaches of blood purification device 2 are equipped with calcium ion introduction pipeline 4, be equipped with effluent liquid extraction pipeline 5 on the blood purification device 2, be equipped with calcium ion concentration detection device 6 on effluent liquid extraction pipeline 5;

when the blood purification device 2 comprises a hemodialysis device 21, a dialysate introduction pipeline 7 is also arranged on the blood purification device 2;

when the blood purification apparatus 2 includes the blood filtration apparatus 22, the extracorporeal circulation line 1 upstream and/or downstream of the blood purification apparatus 2 is provided with a substitution liquid introduction line 8.

The utility model provides an among the system of indirect monitoring extracorporal circulatory system ion calcium level, calcium ion concentration detection device 6 mainly used detects the calcium ion concentration of effluent in effluent extraction pipeline 5, and through the calcium ion concentration information who obtains, because to specific equipment, there is the correlation in the concentration of the calcium ion in the effluent and the calcium ion concentration in the blood behind the filter, for example, generally for linear correlation, so through the standard curve that obtains in advance, can convert the calcium ion concentration that obtains in the blood behind the filter through the concentration of the calcium ion in the effluent. The effluent outlet line 5 may be any suitable hemodialysis tube and related accessories, and a person skilled in the art may select a suitable calcium ion concentration detection device 6 for detecting the calcium ion concentration of the effluent in the effluent outlet line 5, for example, a detection instrument using colorimetry, fluorescence, electrode method, or the like. In a preferred embodiment of the present invention, the calcium ion concentration detecting device 6 is selected from a biochemical analyzer.

The utility model provides an among the system of indirect monitoring extracorporeal circulation ionized calcium level, can include blood purification device 2, blood purification device 2 includes hemodialysis unit 21 and/or hemofiltration device 22, promptly blood purification device 2 can have hemodialysis function or hemofiltration function respectively usually, or have hemodialysis function and hemofiltration function simultaneously to can be selective carry out hemodialysis or hemofiltration, or carry out hemodialysis and hemofiltration simultaneously. In a specific embodiment of the present invention, the blood purification apparatus 2 may be a dialyzer, and the dialyzer may have a function of CVVH, CVVHD, CVVHDF, or the like. The blood purification apparatus 2 is typically located in an extracorporeal circuit 1, the extracorporeal circuit 1 being typically adapted to receive blood to be purified and to return purified blood to the patient, e.g. the part of the extracorporeal circuit 1 located upstream of the blood purification apparatus 2, into which blood to be treated can be introduced so as to be subjected to hemodialysis and/or hemofiltration, the part of the extracorporeal circuit 1 located downstream of the blood purification apparatus 2, into which blood to be treated can be led, and the blood to be treated can be returned to the patient, the extracorporeal circuit 1 being a variety of suitable hemodialysis tubes and related accessories. Methods and devices for dialyzing and/or filtering blood should be known to those skilled in the art. For example, hemodialysis generally refers to the introduction of a patient's blood into the blood compartment of a dialyzer (e.g., through an arterial vessel, and, for example, may be delivered through pump body 9), treatment methods in which the diffusion through the dialyzer membrane removes certain substances dissolved in the blood from the blood, and the treated blood may be returned to the patient (e.g., through a venous blood vessel), and more particularly, when the blood purification apparatus 2 includes a hemodialysis apparatus 21, as shown in fig. 4, a dialysate introduction line 7 is further provided on the blood purification apparatus 2, and dialysate can be introduced into the hemodialysis apparatus 21 through the dialysate introduction line 7, the specific substances dissolved in the blood can diffuse into the dialysate through the semipermeable membrane in the hemodialysis unit 21, the dialysate introduction line 7 can be any of a variety of suitable hemodialysis tubing and related accessories. As a further example, hemofiltration generally refers to the introduction of blood to be treated (e.g., the patient's blood) into a filtration device (e.g., through an arterial vessel, and further, for example, through a pump body 9), and removes by convection the specific substances dissolved in the blood, the blood subjected to the treatment can be returned to the patient (for example, through a venous blood vessel), more specifically, when said blood purification apparatus 2 comprises a hemofiltration apparatus 22, as shown in fig. 3, a replacement fluid introduction line 8 is provided in the extracorporeal circulation line 1 upstream and/or downstream of the blood purification apparatus 2, the replacement fluid can be introduced into the extracorporeal circulation through the replacement fluid introduction line, the substitution fluid introduction line 8 can be any suitable hemodialysis tube and associated accessories, mixed with the blood to be treated and/or the blood after being subjected to treatment. For another example, when the blood purification apparatus 2 includes a hemodialysis apparatus 21 and a hemofiltration apparatus 22, as shown in fig. 5, a dialysate introduction line 7 is further provided on the blood purification apparatus 2, dialysate can be introduced into the blood purification apparatus 2 through the dialysate introduction line 7, and a specific substance dissolved in blood can be dispersed into the dialysate through a semipermeable membrane in the blood purification apparatus 2, and a substitution fluid introduction line 8 is provided on the extracorporeal circulation line 1 upstream and/or downstream of the blood purification apparatus 2, and a substitution fluid can be introduced into extracorporeal circulation through the substitution fluid introduction line to be mixed with blood to be treated and/or blood subjected to treatment.

As mentioned above, the method of dialyzing blood should be known to the person skilled in the art, who can select suitable hemodialysis setting parameters according to need, for example, the hemodialysis unit 21 can be a dialyzer, and the membrane area of the hemodialysis unit 21 can be 0.5-2.5m²、0.5-1.0m²、1.0-1.5m²、1.5-2.0m²Or 2.0-2.5m²The dialysate is introduced into the line 7 at a flow rate of 1-5L/h, 1-2L/h, 2-3L/h, 3-4L/h, or 4-5L/h, and may comprise Na⁺、K⁺、Mg²⁺、Cl^-Glucose, HCO₃ ^-In the dialysate, Na⁺The concentration can be 125-150mmol/L, 125-130mmol/L, 130-135mmol/L, 135-140mmol/L, 140-145mmol/L, or 145-150mmol/L, K⁺The concentration of (B) may be 4.5mmol/L, 0.1-0.5mmol/L, 0.5-1.0mmol/L, 1.0-1.5mmol/L, 1.5-2.0mmol/L, 2.0-2.5mmol/L, 2.5-3.0mmol/L, 3.0-3.5mmol/L, 3.5-4.0mmol/L, or 4.0-4.5mmol/L, Mg²⁺The concentration of (B) may be 1mmol/L or less, 0.1 to 0.2mmol/L, 0.2 to 0.4mmol/L, 0.4 to 0.6mmol/L, 0.6 to 0.8mmol/L, or 0.8 to 1mmol/L, Cl^-The concentration of the glucose can be 90-120mmol/L, 90-100mmol/L, 100-110mmol/L or 110-120mmol/L, and the concentration of the glucose can be less than or equal to 110mmol/L, less than or equal to 10mmol/L, 10-30mmol/L, 30-50mmol/L, 50-70mmol/L, 70-90mmol/L, or 90-110mmol/L, HCO₃ ^-The concentration of (b) can be 20-45mmol/L, 20-25mmol/L, 25-30mmol/L, 30-35mmol/L, 35-40mmol/L, or 40-45mmol/L, and the introduction amount of the blood in the portion of the hemodialysis device 21 in the extracorporeal circulation circuit 1 can be 50-250ml/h, 50-100ml/h, 100-150ml/h, 150-200ml/h, or 200-250 ml/h.

As mentioned above, the method of filtering blood should be known to the person skilled in the art, who can choose the appropriate settings of hemofiltration according to need, for example, the hemofiltration device 22 can be an air-permeable device and the membrane area of the hemofiltration device 22 can be 0.5-2.5m²、0.5-1.0m²、1.0-1.5m²、1.5-2.0m²Or 2.0-2.5m²The total flow rate of the replacement liquid introduced into the pipeline 8 can be 1-5L/h, 1-2L/h, 2-3L/h, 3-4L/h or 4-5L/h, and the replacement liquid can comprise Na⁺、K⁺、Mg²⁺、Cl^-Glucose, HCO₃ ^-One or more of Na and Na in the substitution solution⁺The concentration of the (C) is 130-150mmol/L, 130-135mmol/L, 135-140mmol/L, 140-145mmol/L, or 145-150mmol/L, K⁺The concentration of (B) is not more than 4.5mmol/L, not more than 0.1mmol/L, 0.1-0.5mmol/L, 0.5-1.0mmol/L, 1.0-1.5mmol/L, 1.5-2.0mmol/L, 2.0-2.5mmol/L, 2.5-3.0mmol/L, 3.0-3.5mmol/L, 3.5-4.0mmol/L, or 4.0-4.5mmol/L, Mg²⁺The concentration of (B) is not more than 0.8mmol/L, not more than 0.1mmol/L, 0.1-0.2mmol/L, 0.2-0.4mmol/L, 0.4-0.6mmol/L, or 0.6-0.8mmol/L, Cl^-The concentration of the glucose is 100-120mmol/L, 100-110mmol/L or 110-120mmol/L, the concentration of the glucose is less than or equal to 110mmol/L, less than or equal to 10mmol/L, 10-30mmol/L, 30-50mmol/L, 50-70mmol/L, 70-90mmol/L or 90-110mmol/L, HCO₃ ^-Is 20-40mmol/L, 20-25mmol/L, 25-30mmol/L, 30-35mmol/L, or 35-40mmol/L, the introduction amount of the blood in the portion of the hemofiltration device 22 in the extracorporeal circulation circuit 1 can be 50-250ml/h, 50-100ml/h, 100-150ml/h, 150-200ml/h, or 200-250 ml/h. In a preferred embodiment of the present invention, the extracorporeal circulation circuit1 according to the flowing direction of blood, when a replacement fluid introducing pipeline 8 is arranged on the extracorporeal circulation pipeline 1 at the upstream of the blood purification device 2, the replacement fluid introducing pipeline 8 is positioned between the anticoagulant introducing pipeline 3 and the blood purification device 2; when the extracorporeal circulation line 1 downstream of the blood purification apparatus 2 is provided with a replacement fluid introduction line 8, the replacement fluid introduction line 8 is located between the blood purification apparatus 2 and the calcium ion introduction line 4.

As mentioned above, the method of simultaneously performing dialysis and filtration on blood should be known to those skilled in the art, and those skilled in the art can select suitable setting parameters according to the needs, for example, when the blood purification apparatus 2 has both dialysis and filtration functions, the membrane area of the blood purification apparatus 2 can be 0.5-2.5m²、0.5-1.0m²、1.0-1.5m²、1.5-2.0 m²Or 2.0-2.5m²(ii) a For another example, when the blood purification device 2 has both dialysis and filtration functions, the introduced amount of blood in the extracorporeal circulation circuit 1 can be 50-250ml/h, 50-100ml/h, 100-; the parameters of the dialysate, the replacement fluid, etc. can be set as described above.

The utility model provides an among the system of indirect monitoring extracorporal circulatory system ionic calcium level, blood purification device 2's upper reaches are equipped with anticoagulation liquid and introduce pipeline 3, anticoagulation liquid introduces pipeline 3 and is used for introducing anticoagulation liquid usually to can introduce the extracorporal circulatory system pipeline 1 with appropriate amount anticoagulant in, more specifically in introducing pending blood, anticoagulation liquid introduces pipeline 3 can be various applicable hemodialysis pipe and relevant annex. A person skilled in the art can select a suitable setting parameter of the anticoagulant liquid according to needs, for example, the anticoagulant liquid is introduced into the pipeline 3, and the flow rate of the anticoagulant liquid can be less than or equal to 500ml/h, less than or equal to 10ml/h, 10-30 ml/h, 30-50 ml/h, 50-100ml/h, 100-200 ml/h, 200-300 ml/h, 300-400 ml/h, or 400-500 ml/h. For another example, the anticoagulant is included in the anticoagulant, the anticoagulant can be preferably selected from one or more of citric acid or salts thereof, and preferably, the salt of citric acid in the anticoagulant is preferably selected from sodium citrate. As another example, the anticoagulant concentration in the anticoagulant may be 20-50g/L, 20-30g/L, 30-40g/L, or 40-50 g/L. In a preferred embodiment of the present invention, the anticoagulant is selected from sodium citrate, and the concentration of sodium citrate in the anticoagulant is 40 g/L. In another preferred embodiment of the present invention, the anticoagulant is selected from the group consisting of citric acid and sodium citrate, and the concentration of sodium citrate in the anticoagulant is 22g/L and the concentration of citric acid is 8 g/L.

The utility model provides an among the system of indirect monitoring extracorporeal circulation ion calcium level, blood purification device 2's low reaches are equipped with calcium ion and introduce pipeline 4, calcium ion introduces pipeline 4 can be used for introducing the calcium ion replenisher to can introduce the appropriate amount of calcium ion and stand dialysis and/or filter in the blood after handling, calcium ion introduces pipeline 4 can be various suitable hemodialysis pipe and relevant annex. The skilled person can select suitable setting parameters of the calcium ion supplementing liquid according to the needs, for example, the flow rate of the calcium ion supplementing liquid in the calcium ion introducing pipeline 4 can be 5-50ml/h, 5-10ml/h, 10-20ml/h, 20-30ml/h, 30-40ml/h, or 40-50 ml/h. For another example, the calcium ion replenisher typically includes a calcium salt, which may be selected from one or more of calcium chloride, calcium gluconate, and the like. For another example, the concentration of the calcium salt in the calcium ion supplementary liquid may be 0.1 to 1g/10mL, 0.1 to 0.2g/10mL, 0.2 to 0.4g/10mL, 0.4 to 0.6g/10mL, 0.6 to 0.8g/10mL, or 0.8 to 1g/10mL, and in a preferred embodiment of the present invention, when the calcium salt is selected from calcium chloride, the concentration of the calcium chloride in the calcium ion supplementary liquid may be 0.3 to 0.6g/10mL, 0.3 to 0.4g/10mL, 0.4 to 0.5g/10mL, or 0.5 to 0.6g/10mL, specifically 0.3g/10mL, 0.5g/10mL, 0.6g/10mL, 1g/20mL, or the like; in another preferred embodiment of the present invention, when the calcium salt is selected from calcium gluconate, the concentration of calcium gluconate in the calcium ion supplementary liquid may be less than or equal to 2g/10mL, less than or equal to 0.5g/10mL, 0.5-1g/10mL, 1-1.5g/10mL, or 1.5-2 g/10 mL.

The utility model provides an among the system of indirect monitoring extracorporeal circulation ionic calcium level, pump body 9 can be located extracorporeal circulation pipeline 1, the fluidic flow in its mainly used drive extracorporeal circulation pipeline 1, pump body 9 can be located blood purification device 2's upper reaches usually. In a preferred embodiment of the present invention, the pump body 9 is located between the anticoagulation liquid introduction line 3 and the blood purification device 2. In another preferred embodiment of the present invention, when the upstream line of the blood purification apparatus is provided with the replacement fluid introduction line 8, the pump body 9 is located between the anticoagulation fluid introduction line 3 and the replacement fluid introduction line 8.

The utility model provides an in the system of indirect monitoring extracorporal circulatory system ion calcium level, can also include blood calcium ion accounting device behind the filter, blood calcium ion accounting device behind the filter is used for calculating the blood calcium ion concentration behind the acquisition filter according to the calcium ion concentration in the effluent liquid that 6 detection of calcium ion concentration detection device obtained usually, blood calcium ion accounting device behind the filter is connected with 6 electricity of calcium ion concentration detection device. The computing device may be, for example, a computer, a single chip, etc., and may typically include a processor, memory, etc.

The utility model provides an among the system of indirect monitoring extracorporal circulatory system ion calcium level, can also include display device, display device can be used for showing calcium ion concentration in the effluent liquid that 6 detection of calcium ion concentration detection device obtained and/or through filter after blood calcium ion computational device calculate obtain filter after blood calcium ion concentration, display device is usually with filter after blood calcium ion computational device and/or filter after blood calcium ion computational device electricity is connected, display device can be for example display etc..

The second aspect of the present invention provides a hemodiafiltration method, comprising: hemodialysis and/or hemofiltration is administered to the blood to be treated, the calcium ion concentration of the effluent in the effluent outlet line being monitored, so that the calcium ion concentration in the blood after the filter can be obtained from the calcium ion concentration in the effluent, in particular by administering hemodialysis and/or hemofiltration to the blood to be treated by a system for indirect monitoring of the level of ionized calcium in extracorporeal circulation as described above. From the obtained calcium ion concentration information, since there is a correlation, for example, a generally linear correlation, between the calcium ion concentration in the effluent and the calcium ion concentration in the blood after the filter for a specific apparatus, the calcium ion concentration in the blood after the filter can be obtained by conversion from the calcium ion concentration in the effluent by the previously obtained standard curve.

In the hemodiafiltration method provided by the present invention, the blood to be treated is generally derived from an individual to be administered with hemodialysis and/or hemofiltration, and the individual is generally an animal to which hemodialysis and/or hemofiltration can be administered, and specifically may include, but is not limited to, humans, non-human primates, mammals, dogs, cats, horses, sheep, pigs, cows, etc.

When citric acid is used for anticoagulation, the ionized calcium level must be closely monitored so as to avoid filter coagulation from influencing dialysis effect and safety. The literature reports that the ionized calcium level needs to be maintained at 0.25-0.4 mmol/l to be fully anticoagulated. It is generally recommended to detect the concentration of ionized calcium in the blood after the filter, but different CRRT models affect the concentration of ionized calcium in the filter, such as predilution continuous venous hemofiltration (CVVH) and continuous venous hemodiafiltration (CVVHDF), and there is a question of whether blood sampling after the filter is the most ideal detection point. Secondly, frequent bedside blood sampling aggravates blood loss of critically ill patients to a certain extent, and in addition, increases the workload of medical care personnel. The utility model discloses the inventor discovers in long-term practice, there is highly uniform correlation in the concentration of the calcium ion in the effluent liquid and the calcium ion concentration in the blood behind the filter, can effectively replace ion calcium concentration behind the detection filter through detecting effluent liquid ion calcium concentration, thereby can detect waste liquid ion calcium concentration and can reduce patient's blood and lose, avoid the device and the biocompatible hidden danger of blood contact, make the monitoring of ion calcium more convenient timely, the safety and efficiency of CRRT treatment has been guaranteed, help the extensive popularization of CRRT treatment.

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

It is to be understood that the processing equipment or apparatus not specifically identified in the following examples is conventional in the art.

Furthermore, it is to be understood that one or more method steps mentioned in the present application do not exclude that other method steps may also be present before or after the combined steps or that other method steps may also be inserted between these explicitly mentioned steps, unless otherwise indicated; it is also to be understood that references to a combined connection between one or more devices/apparatus in the present disclosure are not to preclude the presence or addition of further devices/apparatus before or after the combined device/apparatus, unless otherwise indicated. Moreover, unless otherwise indicated, the numbering of the various method steps is merely a convenient tool for identifying the various method steps, and is not intended to limit the order in which the method steps may be arranged or the scope of the invention which may be practiced.

Example 1

The method comprises the following steps:

effective topical citrate anticoagulation for 17 cases of 8 adult patients treated by CRRT at ninth national Hospital affiliated to Shanghai transportation university from 4 to 12 months in 2018. There were effectively 48 pairs of simultaneous post-filter blood and effluent samples, 22 pairs in CVVH mode, 15 pairs in CVVHD mode, and 11 pairs in CVVHDF mode.

Femoral vein or internal jugular vein temporary catheterization of CU-23122-F/CU-25122-F (Arrow International Inc., Chihuahuahuahua, Mexico) is used to establish vascular access. The CRRT model is AQUARIUS (Edwards Lifesciences LLC, Irvine, USA) using a filter REMALO II-HF1200 (glycerol-free polysulfone membrane, membrane area 1.25 m)²Medivators inc, Minneapolis, USA). The blood flow is set to 180-220mL/min according to the condition of the patient. The flow rate of the dialyzate is 2-4L/h, the CVVH adopts a pre-dilution or post-dilution mode,CVVHDF was all in post-dilution mode with total displacement fluid flow 4L/h. The ultrafiltration volume is determined by the patient condition. Formula of dialysate and replacement fluid: 3000ml of physiological saline, 1000ml of sterile water for injection, 250ml of 5% sodium bicarbonate solution, 10ml of 10% potassium chloride, 10ml of 25% magnesium sulfate solution, 3.2ml of 50% glucose, and Na in both the dialysate and the substitution solution⁺142mmol/L，K⁺3.1mmol/L，Mg²⁺0.75mmol/L，Cl^-111mmol/L, glucose 13mmol/L, HCO₃ ^-34.5 mmol/l. The arterial segment of the circulation pipeline adopts blood preservation solution ACD-A (sodium citrate 22g/L, citric acid 8g/L) for citrate anticoagulation, the venous segment is supplemented with 5% Calcium chloride, the flow rate is calculated according to a previously established two-stage Calcium supplement model, and the citric acid and 5% Calcium chloride dosage are calculated according to the weight, CRRT mode, blood flow rate, dialysate flow rate, outflow fluid flow rate, total blood protein, total blood Calcium level, hematocrit and the like of a patient (refer to Yu W, Zhuang F, Ma S, Fan Q, Zhu M, Ding F, Optimized Calcium supplement Approach for Regional arterial occlusion. nephron, 141(2),119-127 (2019)).

Ionic calcium levels in the post-filter blood and effluent were determined simultaneously using an i-STAT 300 biochemical instrument (Abbott Laboratories, Abbott Park, IL, USA). Blood was collected 1h after the start of CRRT. Properly adjusting the ACD-A infusion speed to reach different ionized calcium concentrations, stabilizing for 5min after adjustment, synchronously taking blood and effluent liquid samples after the filter, and immediately adjusting to the original ACD-A infusion speed after sampling to ensure that the ionized calcium concentration is maintained at 0.25-0.4 mmol/l.

The initial condition of the patient before CRRT, including age, sex, etiology, etc., is also recorded. The blood biochemical indexes of all patients, such as liver function, blood routine, kidney function, total blood calcium level and the like, are completed by routine detection of the laboratory department of the ninth national hospital in Shanghai.

The relevant data was analyzed using SPSS 21.0. Normal distribution data is described using mean. + -. standard deviation. Correlation of the blood with effluent ionic calcium was compared using Pearson correlation analysis. The consistency of the results of the two methods was analyzed by the Bland-Altman method. P <0.05 is considered clinically significant.

As a result:

1) the baseline data for 8 patients are shown in table 1. Wherein the male accounts for 75 percent, and the average age is 69.5 +/-13.1 years. The liver function is basically normal or slightly damaged, and no obvious contraindication of citric acid anticoagulation is provided. The reasons for receiving CRRT are 3 persons with acute exacerbation based on chronic kidney disease, 3 persons with acute kidney injury, 1 person with maintenance hemodialysis, 1 person with heart failure.

TABLE 1 Pre-CRRT Baseline data for selected patients

ALT glutamate pyruvate transaminase; AST aspartate aminotransferase; CRRT continuous renal replacement therapy

2) A total of 48 pairs of simultaneous specimens containing post-filter plasma calcium and effluent plasma calcium were analyzed. Wherein the concentration of ionized calcium in blood after filtering is 0.42 + -0.12 mmol/l, and the concentration of ionized calcium in effluent is 0.39 + -0.11 mmol/l. In Pearson correlation analysis, the concentration of ionized calcium in the effluent was closely correlated with the concentration of ionized calcium in the blood after the filter in all CRRT models (r-0.9641, p < 0.0001). When analyzed separately in the same CRRT model, there is a close correlation between the two of the three models. As in CVVH, CVVHDF, CVVHD modes, the correlations of both are r-0.9438, r-0.9791 and r-0.9849, respectively, with p both <0.0001 (fig. 1).

3) The consistency of the results of the two methods was further analyzed by the Bland-Altman method. In all CRRT modes, the difference between effluent ionized calcium concentration and post-filter ionized calcium concentration was 0.0225 with a 95% confidence interval of-0.0435 to 0.0885. The difference between the two in the CVVH patterns was 0.0332 with a 95% confidence interval of-0.0356 to 0.1020. The difference between the two in CVVHDF pattern was 0.0082 with a 95% confidence interval of-0.0278 to 0.0441. The difference between the two in the CVVHD patterns was 0.0173 with a 95% confidence interval of-0.0547 to 0.0893 (FIG. 2).

To sum up, the utility model discloses various shortcomings in the prior art have effectively been overcome and high industry value has.

The above embodiments are merely illustrative of the principles and effects of the present invention, and are not to be construed as limiting the invention. Modifications and variations can be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which may be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims

1. A system for indirectly monitoring the level of ionic calcium in extracorporeal circulation comprises an extracorporeal circulation pipeline and is characterized in that a blood purification device is arranged on the extracorporeal circulation pipeline and comprises a hemodialysis device and/or a hemofiltration device, an anticoagulant liquid introducing pipeline is arranged at the upstream of the blood purification device, a calcium ion introducing pipeline is arranged at the downstream of the blood purification device, an effluent liquid leading-out pipeline is arranged on the blood purification device, and a calcium ion concentration detection device is arranged on the effluent liquid leading-out pipeline;

2. The system for indirectly monitoring the level of ionized calcium in extracorporeal circulation according to claim 1, wherein the anticoagulant is introduced into the line at a flow rate of 500ml/h or less, and the anticoagulant is included in the anticoagulant;

the calcium ions are introduced into the pipeline, the flow rate of the calcium ion supplementing liquid is 5-50ml/h, and the calcium ion supplementing liquid comprises calcium salt.

3. The system for indirectly monitoring the level of ionized calcium in extracorporeal circulation according to claim 1, wherein the membrane area of the purification apparatus is 0.5-2.5m²。

4. The system for indirectly monitoring the level of ionized calcium in extracorporeal circulation according to claim 1, wherein the dialysate introduction line has a dialysate flow rate of 1 to 5L/h.

5. The system for indirectly monitoring the level of ionized calcium in extracorporeal circulation of claim 1, wherein the total flow rate of the substitution fluid is 1-5L/h into the line.

6. The system for indirectly monitoring the level of ionized calcium in extracorporeal circulation according to claim 1, wherein the amount of blood introduced into the extracorporeal circulation circuit is 50-250 mL/min.

7. The system of claim 1, wherein the extracorporeal circulation circuit is configured to provide a replacement fluid introduction line between the anticoagulant introduction line and the blood purification apparatus when the extracorporeal circulation circuit is upstream of the blood purification apparatus in terms of the direction of blood flow;

8. The system for indirectly monitoring the level of ionized calcium in extracorporeal circulation according to claim 1, further comprising a post-filter blood calcium ion calculating means for calculating the concentration of post-filter blood calcium ions based on the concentration of calcium ions in the effluent obtained by the detection of the calcium ion concentration detecting means, wherein the post-filter blood calcium ion calculating means is electrically connected to the calcium ion concentration detecting means.