A self-anticoagulation double dilution plasma exchange system

Abstract

The present invention discloses a self-anticoagulation double dilution plasma exchange system, including a plasma separator, exogenous plasma, a front dilution pipeline, a back dilution pipeline, a blood inlet pipeline, a blood return pipeline and a plasma discarding pipeline; the blood inlet pipeline is connected to the front end of the plasma separator, the blood return pipeline is connected to the rear end of the plasma separator, and the two ends of the front dilution pipeline are respectively connected to the exogenous plasma and the blood return pipeline; the plasma discarding pipeline is connected to the plasma separator. A self-anticoagulation double dilution plasma exchange system disclosed in the present invention, exogenous plasma is connected to the blood pipeline from the upstream and downstream of the plasma separator respectively through the provided front dilution passage and the back dilution passage, which can use the citric acid in the exogenous plasma for self-anticoagulation, effectively prevent the coagulation of the plasma separator to achieve the self-anticoagulation of plasma exchange, avoid the complications caused by the use of additional anticoagulants, and ensure a high exchange efficiency and reduce the waste of exogenous plasma.

Description

Technical Field

[0001] The invention relates to the technical field of blood purification, and in particular to a self-anticoagulation double-dilution plasma exchange system. Background Art

[0002] Plasma exchange is one of the important means of purifying blood in the field of modern biomedical engineering industry. Plasma exchange has a wide range of clinical applications, involving a variety of diseases of the liver, kidneys, nerves, blood and other systems, especially for refractory and critical diseases. Plasma exchange technology is to draw the patient's blood out of the body, separate the plasma and cell components through a plasma exchanger, discard some pathogenic substances, metabolites and some autoimmune disease autoantibodies and toxins in the plasma, and return the cell components and an equal amount of plasma substitutes to the body to remove pathogenic and harmful factors in the body, improve the body's functional state and immune regulation, and restore the function of the affected organs to achieve the purpose of treatment. Plasma exchange technology plays an important role in severe liver failure, especially in patients with combined coagulation disorders. When patients with liver failure receive plasma exchange therapy, the current conventional anticoagulation methods are heparin anticoagulation, citrate anticoagulation or no anticoagulation strategy. However, since coagulation dysfunction often exists in liver failure, heparin anticoagulation has defects such as high bleeding risk. Citrate anticoagulation is suitable for patients with a higher risk of bleeding, but the disadvantage is that the liver's ability to metabolize citrate deteriorates during liver failure, which can easily cause metabolic complications such as ion disorders and citrate accumulation, which may aggravate hepatic encephalopathy. Citrate anticoagulation is used in the plasma exchange process of patients with liver failure, which is prone to the risk of citrate accumulation. Although patients with liver failure have abnormal coagulation function, the use of a no-anticoagulation strategy can still cause blockage of the pipeline and plasma separator, leading to premature termination of treatment.

[0003] Traditional technology uses post-dilution exchange, that is, connecting exogenous plasma from the downstream of the plasma separator to the blood circulation pipeline. The advantage is that the exchange efficiency is high, but the disadvantage is that additional anticoagulants are required and the complications caused by anticoagulants cannot be avoided.

[0004] Therefore, providing a plasma exchange system suitable for patients with liver failure has become an important topic that needs to be studied urgently. The same situation is also seen in patients with severe shock or severe hypoxemia who need plasma exchange. Summary of the invention

[0005] The present invention provides a self-anticoagulation double-dilution plasma exchange system to solve the above problems.

[0006] In order to achieve the above object, the technical solution of the present invention is:

[0007] A self-anticoagulation double dilution plasma exchange system comprises a plasma separator, exogenous plasma, a pre-dilution pipeline, a post-dilution pipeline, a blood inlet pipeline, a blood return pipeline and a plasma discarding pipeline;

[0008] The blood inlet line is connected to the front end of the plasma separator, the blood return line is connected to the rear end of the plasma separator, the two ends of the front dilution line are respectively connected to the exogenous plasma and the blood inlet line, and the two ends of the rear dilution line are respectively connected to the exogenous plasma and the blood return line;

[0009] The waste slurry pipeline is connected to the plasma separator;

[0010] Blood is input into the front end of the plasma separator through the inlet blood line. The plasma separator separates the plasma, and the separated waste plasma is discharged through the waste plasma line. At the same time, exogenous plasma is input into the inlet blood line through the pre-dilution line and into the return blood line through the post-dilution line.

[0011] Furthermore, a front displacement pump is provided on the front dilution pipeline, and a rear displacement pump is provided on the rear dilution pipeline;

[0012] The waste slurry pipeline is provided with a waste slurry pump.

[0013] Furthermore, a blood pump is provided on the blood supply line.

[0014] Furthermore, the blood return line is connected to a calcium supplement line, and a calcium pump is provided on the calcium supplement line, and calcium agent is pumped into the blood return line through the calcium supplement line.

[0015] Furthermore, the pre-dilution pipeline, the post-dilution pipeline, the blood inlet pipeline, the blood return pipeline, the slurry discarding pipeline and the calcium supplementation pipeline form an integrated extracorporeal circulation pipeline set.

[0016] Furthermore, it also includes a control system for realizing a self-anticoagulation double-dilution plasma exchange mode by controlling the operation of a blood pump, a post-exchange pump, a pre-exchange pump and a plasma discarding pump; the control system includes a plasma priming module for controlling the blood pump to priming plasma into the blood inlet line and controlling exogenous plasma to priming the pre-dilution line near the plasma separator.

[0017] Further, the blood flow rate in the blood guide line is set to a range of 70-150 ml / min, the initial value of the exogenous plasma flow rate in the pre-dilution line is 500-1200 ml / h, and the exogenous plasma flow rate in the post-dilution line is the difference between the total exogenous plasma flow rate and the exogenous plasma flow rate in the pre-dilution line;

[0018] The calcium agent in the calcium supplement pipeline is 10% calcium gluconate, and the initial flow rate range of the calcium pump is set to 20-80 ml / h.

[0019] The beneficial effects of the present invention are:

[0020] The present invention discloses a self-anticoagulation double-dilution plasma exchange system, in which exogenous plasma is connected to the blood pipeline simultaneously from the upstream and downstream of a plasma separator through a pre-dilution passage and a post-dilution passage respectively. The system can utilize citric acid in the exogenous plasma for self-anticoagulation, effectively preventing blood coagulation in the plasma separator to achieve self-anticoagulation of plasma exchange, avoiding complications caused by the use of additional anticoagulants, and ensuring a high exchange efficiency to reduce the waste of exogenous plasma. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0022] Figure 1 The figure is a schematic diagram of the structure of a self-anticoagulation double-dilution plasma exchange system disclosed in an embodiment of the present invention.

[0023] In the figure: 1. plasma separator; 2. exogenous plasma; 3. front dilution pipeline; 4. rear dilution pipeline; 5. blood inlet line; 6. blood return line; 7. plasma discard pipeline; 8. calcium supplement pipeline; 9. calcium pump; 10. front displacement pump; 11. rear displacement pump; 12. blood pump; 13. waste plasma; 14. control system; 15. first tube clamp; 16. second tube clamp; 17. third tube clamp; 18. fourth tube clamp; 19. plasma discard pump. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] like Figure 1 The present embodiment shows a self-anticoagulation double dilution plasma exchange system, comprising a plasma separator 1, exogenous plasma 2, a pre-dilution pipeline 3, a post-dilution pipeline 4, a blood inlet pipeline 5, a blood return pipeline 6, and a plasma discarding pipeline 7;

[0026] The blood supply line 5 is connected to the front end of the plasma separator 1, the blood return line 6 is connected to the rear end of the plasma separator 1, the two ends of the front dilution line 3 are respectively connected to the exogenous plasma 2 and the blood supply line 5, and the two ends of the rear dilution line 4 are respectively connected to the exogenous plasma 2 and the blood return line 6;

[0027] The waste slurry pipeline 7 is connected to the plasma separator 1;

[0028] Plasma is pumped into the plasma separator 1 via the blood inlet line 5 and the blood pump 12. The plasma separator 1 separates the plasma, and the separated waste plasma 13 is discharged from the waste plasma line 7. At the same time, exogenous plasma 2 is input into the blood inlet line 5 via the pre-dilution line 3 and input into the return blood line 6 via the post-dilution line 4.

[0029] The present invention discloses a self-anticoagulation double dilution plasma exchange system, in which blood is pumped into a plasma separator through a blood inlet line and a blood pump, and the plasma separator separates the waste plasma and discharges it from the waste plasma line, and exogenous plasma is connected to the blood line simultaneously from the upstream and downstream of the plasma separator through the provided pre-dilution path and post-dilution path, respectively, so that the citric acid in the exogenous plasma can be used for self-anticoagulation, effectively preventing the coagulation of the plasma separator to achieve the self-anticoagulation of plasma exchange, avoiding the complications caused by the use of additional anticoagulants, and ensuring a high exchange efficiency, reducing the waste of exogenous plasma. When the system is used for plasma exchange for patients with liver failure, severe shock or severe hypoxemia who are at risk of bleeding, it can prevent coagulation in the plasma separator, avoid fatal complications such as citric acid accumulation caused by the additional use of citric acid, and also ensure a high exchange efficiency.

[0030] Preferably, a front replacement pump 10 is provided on the front dilution pipeline 3, and a rear replacement pump 11 is provided on the rear dilution pipeline 4, for controlling the flow rate of the replacement fluid (exogenous plasma).

[0031] The waste plasma pipeline 7 is provided with a waste plasma pump 19 for adjusting the flow rate of waste plasma in the waste plasma pipeline 7 .

[0032] Preferably, a blood pump 12 is provided on the blood supply line 5 .

[0033] Preferably, the blood return line 6 is connected to a calcium supplement line 8, and a calcium pump 9 is provided on the calcium supplement line 8. Calcium is pumped into the blood return line 6 through the calcium supplement line 8 to ensure the concentration of ionized calcium in the replacement fluid, and the in vivo ionized calcium concentration and the in vitro ionized calcium concentration are dynamically monitored. The exogenous plasma flow rate can be adjusted by adjusting the front replacement pump and the rear replacement pump according to the in vitro ionized calcium concentration, and the calcium pump can be adjusted according to the in vivo ionized calcium concentration to adjust the pumping speed of the calcium.

[0034] Preferably, the pre-dilution pipeline 3, the post-dilution pipeline 4, the blood supply pipeline 5, the return blood pipeline 6, the plasma discarding pipeline 7 and the calcium supplementation pipeline 8 form an integrated extracorporeal circulation pipeline set. When in use, it is only necessary to connect the blood supply pipeline 5 and the return blood pipeline 6 to the patient's blood vessels, and then connect the exogenous plasma and the plasma separator to the extracorporeal circulation pipeline set, and then the plasma exchange system can be used for plasma purification, without the need to connect each pipeline separately and then purify it, which can greatly save installation time and improve the convenience of operation of the plasma exchange system.

[0035] Preferably, it also includes a control system 14, and the control system 14 includes a plasma pre-filling module, which is used to control the blood pump 12 to pre-fill plasma into the blood supply line 5 and control the exogenous plasma 2 to pre-fill the front dilution line 3 close to the plasma separator 1, that is, to pre-fill the blood supply line 5 with plasma and the front dilution line 3 with exogenous plasma; it can also control the operating speed of the front exchange pump 10 and the rear exchange pump 11. After the pre-filling is completed, the blood pump 12, the rear exchange pump 11 and the discarded plasma pump 19 are controlled by the control system 14 to realize the double dilution plasma exchange working mode, ensure the normal progress of the double dilution plasma exchange and ensure the exchange effect; it can also be controlled by the control system 14 to shut down the rear exchange pump or the front exchange pump according to actual needs, and the exchange system can be adjusted to the front dilution plasma exchange mode or the rear dilution plasma exchange mode. The applicability of this plasma exchange system is stronger.

[0036] Preferably, a first tube clamp 15 is provided on the front dilution pipeline between the front exchange pump 10 and the exogenous plasma 2; a second tube clamp 16 is provided on the rear dilution pipeline 4 between the rear exchange pump 11 and the exogenous plasma 2; the first tube clamp 15 is used to prevent the circulation of plasma in the front dilution pipeline 3, and the second tube clamp 16 is used to prevent the circulation of plasma in the rear dilution pipeline. When the exchange is completed, the second tube clamp 16 and the first tube clamp 15 clamp the pipeline, and then the various devices and pipelines are disassembled.

[0037] Preferably, a third tube clamp 17 is provided on the side of the inlet blood line 5 away from the plasma separator, and a fourth tube clamp 18 is provided on the side of the return blood line 6 away from the plasma separator; the third tube clamp 17 is used to clamp the inlet blood line 5, and the fourth tube clamp 18 is used to clamp the return blood line 6. When the replacement is completed, the third tube clamp 17 and the fourth tube clamp 18 clamp the pipelines, and then the other device components and pipelines are disassembled.

[0038] Preferably, the blood flow rate in the blood guide line 5 is set to a range of 70-150 ml / min, the initial value of the exogenous plasma flow rate in the front dilution line 3 is 500-1200 ml / h, and the exogenous plasma flow rate in the rear dilution line 4 is the difference between the total exogenous plasma flow rate and the exogenous plasma flow rate in the front dilution line 3;

[0039] The calcium agent in the calcium supplementation pipeline 8 is 10% calcium gluconate, and the initial flow rate range of the calcium pump 9 is set to 20-80 ml / h. By adjusting the initial parameters of the blood pump 12, the front exchange pump 10, the rear exchange pump 11 and the calcium pump 9, the normal operation of the double dilution plasma exchange system is ensured, and the effect and efficiency of plasma exchange are ensured.

[0040] Embodiment 1:

[0041] The initial value of the blood flow of the blood pump was set to 100 ml / min; the initial values ​​of the exogenous plasma flow of the pre-dilution line and the post-dilution line were set to 750 ml / h, the plasma exchange dose was 3000 ml, and the initial flow of calcium gluconate was set to 40 ml / h. Plasma exchange was performed on two patients with liver failure, A and B, respectively.

[0042] Comparative Example 1:

[0043] The difference between this comparative example and Example 1 is that in this comparative example, post-dilution exchange is adopted, that is, the exogenous plasma flow of the pre-dilution pump is set to 0 ml / h, the initial value of the post-dilution exogenous plasma flow is set to 1500 ml / h, the plasma exchange dose is 3000 ml, the initial value of the blood flow of the blood pump is set to 100 ml / min, 4% sodium citrate solution is used as an anticoagulant and pumped in from the front of the plasma separator, the initial rate is 120 ml / h, the initial flow of calcium gluconate is set to 80 ml / h, and plasma exchange is performed on two patients with liver failure, A and B, respectively.

[0044] Comparative Example 2:

[0045] The difference between this comparative example and Example 1 is that in this comparative example, pre-dilution replacement is adopted, that is, the exogenous plasma flow of the post-dilution pump is set to 0 ml / h, the initial value of the pre-dilution exogenous plasma flow is set to 1500 ml / h, the plasma replacement dose is 3000 ml, the initial value of the blood flow of the blood pump is set to 100 ml / min, and the initial flow of calcium gluconate is set to 40 ml / h, and plasma replacement is performed on Patient B.

[0046] The results are shown in Table 1 below:

[0047] Table 1 is the plasma exchange results of the embodiments and comparative examples

[0048]

[0049] Note: The degree of hepatitis A failure in the case is more severe, while the degree of hepatitis B failure in the case is less severe;

[0050] From Table 1 above, we can draw the following conclusions:

[0051] In terms of the degree of citrate accumulation, both patients who used traditional post-dilution plasma exchange had citrate accumulation (total calcium / ionized calcium>2.5), and the degree was severe, while patients who used pre-dilution plasma exchange and double-dilution plasma exchange of this system had mild to moderate citrate accumulation only in severe cases;

[0052] From the perspective of the dosage of the citrate anticoagulant used, the pre-dilution plasma exchange and the double-dilution plasma exchange system of the present invention do not require the additional use of citrate, while the post-dilution plasma exchange requires 120 (ml / h) of a 4% sodium citrate solution;

[0053] From the perspective of exchange efficiency, the bilirubin screening coefficients of the pre-dilution plasma exchange and the double-dilution plasma exchange system of the present invention are close to the bilirubin screening coefficients of the post-dilution exchange;

[0054] From the perspective of therapeutic effect, the percentage of serum bilirubin reduction in patients using the double dilution plasma exchange system of the present invention is higher than that of the pre-dilution exchange, and is close to that of the post-dilution exchange;

[0055] Therefore, in a self-anticoagulation double-dilution plasma exchange system disclosed in the present invention, blood is pumped into a plasma separator through a blood inlet line and a blood pump, the plasma separator separates the waste plasma and discharges it from a waste plasma line, and exogenous plasma is connected to the blood line simultaneously from the upstream and downstream of the plasma separator through the provided pre-dilution passage and post-dilution passage, respectively. The citric acid in the exogenous plasma can be used for self-anticoagulation, effectively preventing the coagulation of the plasma separator to achieve the self-anticoagulation of plasma exchange and avoid the complications caused by the use of additional anticoagulants, while ensuring a relatively high exchange efficiency and reducing the waste of exogenous plasma. When the system performs plasma exchange for patients with liver failure, severe shock or severe hypoxemia who are at risk of bleeding, it can prevent coagulation in the plasma separator and avoid fatal complications such as citrate accumulation caused by the additional use of citric acid, while also ensuring the exchange efficiency.

[0056] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A self-anticoagulation double dilution plasma exchange system, characterized in that: It includes a plasma separator (1), exogenous plasma (2), a pre-dilution pipeline (3), a post-dilution pipeline (4), a blood inlet pipeline (5), a blood return pipeline (6), and a plasma discarding pipeline (7); The blood supply line (5) is connected to the front end of the plasma separator (1), the blood return line (6) is connected to the rear end of the plasma separator (1), the two ends of the front dilution line (3) are respectively connected to the exogenous plasma (2) and the blood supply line (5), and the two ends of the rear dilution line (4) are respectively connected to the exogenous plasma (2) and the blood return line (6); The waste plasma pipeline (7) is connected to the plasma separator (1); Blood is input into the front end of a plasma separator (1) through a blood supply line, and the plasma separator separates plasma. The separated waste plasma (13) is discharged through a waste plasma line (7). Meanwhile, exogenous plasma (2) is input into the blood supply line (5) through a pre-dilution line (3), and then input into the return blood line (6) through a post-dilution line (4); Exogenous plasma is connected to the blood pipeline simultaneously from the upstream and downstream of the plasma separator through the set pre-dilution channel and post-dilution channel, and self-anticoagulation is performed using the citric acid in the exogenous plasma.

2. A self-anticoagulation double dilution plasma exchange system according to claim 1, characterized in that: The front dilution pipeline (3) is provided with a front displacement pump (10), and the rear dilution pipeline (4) is provided with a rear displacement pump (11); The waste slurry pipeline (7) is provided with a waste slurry pump (19).

3. A self-anticoagulation double dilution plasma exchange system according to claim 2, characterized in that: The blood supply line (5) is provided with a blood pump (12).

4. A self-anticoagulation double dilution plasma exchange system according to claim 1, characterized in that: The blood return line (6) is connected to a calcium supplement line (8), and a calcium pump (9) is provided on the calcium supplement line (8), and calcium agent is pumped into the blood return line (6) through the calcium supplement line (8).

5. A self-anticoagulation double dilution plasma exchange system according to claim 4, characterized in that: The pre-dilution pipeline (3), the post-dilution pipeline (4), the blood inlet pipeline (5), the blood return pipeline (6), the slurry discarding pipeline (7), and the calcium supplementation pipeline (8) form an integrated extracorporeal circulation pipeline set.

6. A self-anticoagulation double dilution plasma exchange system according to claim 3, characterized in that: It also includes a control system (14) for realizing a self-anticoagulation double dilution plasma exchange mode by controlling the operation of a blood pump (12), a post-exchange pump (11), a pre-exchange pump (10) and a plasma discarding pump (19); the control system (14) includes a plasma pre-filling module for controlling the blood pump (12) to pre-fill plasma into the blood supply line (5) and controlling exogenous plasma (2) to pre-fill into the pre-dilution line (3) near the plasma separator (1).

7. A self-anticoagulation double dilution plasma exchange system according to claim 4, characterized in that: The blood flow rate in the blood guide line (5) is set to a range of 70-150 ml / min, the initial value of the exogenous plasma flow rate in the front dilution line (3) is 500-1200 ml / h, and the exogenous plasma flow rate in the rear dilution line (4) is the difference between the total exogenous plasma flow rate and the exogenous plasma flow rate in the front dilution line (3); The calcium agent in the calcium supplementation pipeline (8) is 10% calcium gluconate, and the initial flow rate range of the calcium pump (9) is set to 20-80 ml / h.

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