CN221490939U - An integrated self-anticoagulation hemodialyzer - Google Patents

Abstract

The utility model discloses an integrated self-anticoagulation hemodialyzer, belonging to the technical field of blood purification equipment, comprising an anticoagulation microsphere column and a dialyzer which are arranged in sequence, wherein the anticoagulation microsphere column and the dialyzer are connected via a connector; the upper end of the anticoagulation microsphere column is connected with a first cover, and the upper end of the first cover is provided with a first sealing joint; the lower end of the dialyzer is connected with a second cover, and the lower end of the second cover is provided with a second sealing joint; the utility model makes anticoagulation microspheres and dialysis materials into a column, and then effectively connects the two by providing a connector, thereby effectively increasing the connection convenience between the anticoagulation microsphere column and the hemodialyzer, and can also increase the connection tightness through the connector, thereby improving the sealing effect of the connection, and avoiding pipeline slippage or leakage that affects the use effect.

Description

An integrated self-anticoagulation hemodialyzer

Technical Field

The utility model relates to the technical field of blood purification equipment, in particular to an integrated self-anticoagulation hemodialyzer.

Background Art

Chronic kidney disease is a chronic kidney structure and function disorder caused by various reasons. When chronic kidney disease develops to the end stage, it manifests as uremia. For patients with uremia, the most commonly used treatment is still hemodialysis. At present, there are about 1 million patients with uremia in my country, and the number of this group is still growing rapidly at a rate of 10% to 20% per year, so the demand for hemodialysis is also increasing.

Hemodialysis requires blood to be drawn out of the body, and blood is prone to coagulation outside the body. At the same time, the hemodialysis materials and devices used in the treatment can also cause coagulation, so anticoagulation is a key issue in hemodialysis treatment. So far, the hemodialyzers used in clinical practice cannot provide anticoagulation function, and additional anticoagulants are required to maintain the patency of the extracorporeal blood circulation circuit. The anticoagulants used in hemodialysis are mostly heparin aqueous solutions, but heparin entering the blood will inactivate some coagulation factors and thrombin, resulting in delayed recovery of hemostasis and even causing massive bleeding in the body.

Chinese patent application number 201910081977.3, patent name: A self-anticoagulation double-layer activated carbon blood perfusion device and blood perfusion method, discloses a method for hemodialysis using a gel microsphere anticoagulation layer and an activated carbon adsorption layer. Although this patent provides an effective perfusion device for hemodialysis, its industrial application is still immature.

Utility Model Content

The purpose of the utility model is to provide an integrated self-anticoagulation hemodialyzer to solve the above problems.

In order to achieve the above-mentioned purpose, the technical solution adopted by the utility model is as follows: an integrated self-anticoagulating blood dialyzer includes an anticoagulating microsphere column and a dialyzer arranged in sequence, and the anticoagulating microsphere column and the dialyzer are connected by a connecting piece; the anticoagulating microsphere column includes an anticoagulating microsphere column body, and the upper end of the anticoagulating microsphere column body is connected to a first cover, and the middle of the upper end of the first cover is protruding and provided with a first sealing joint for connecting to the arterial port in the dialysis pipeline; the dialyzer includes a dialyzer body, and the lower end of the dialyzer body is connected to a second cover, and the middle of the lower end of the second cover is protruding and provided with a second sealing joint for connecting to the venous port in the dialysis pipeline.

As a preferred technical solution: the upper end of the connector is connected to the anticoagulant microsphere column through threaded sealing, and a sealing ring is provided between the anticoagulant microsphere column and the connector, which can improve the sealing effect of the connection.

As a preferred technical solution: the lower end of the connector is connected to the dialyzer through a threaded seal, and a sealing ring is provided between the connector and the dialyzer, which can improve the sealing effect of the connection.

As a preferred technical solution: the upper end of the anticoagulant microsphere column body is sealed and connected to the first cover via a thread, and a sealing ring is provided between the anticoagulant microsphere column body and the first cover, which can improve the sealing effect of the connection.

As a preferred technical solution: the lower end of the dialyzer body is connected to the second cover by threaded sealing, and a sealing ring is provided between the dialyzer body and the second cover, which can improve the sealing effect of the connection.

As a preferred technical solution: the anticoagulant microsphere column is filled with a plurality of gel microspheres with anticoagulant effect; the gel microspheres are made of engineering plastics; the volume of the anticoagulant microsphere column is 60-120 mL, and the diameter of the gel microspheres is 300-1000 μm.

The preparation method of the gel microspheres is prior art, such as the method disclosed in the aforementioned CN201910081977.3.

As a preferred technical solution: the dialyzer is formed by potting a plurality of hollow fiber membranes; the diameter of the hollow fiber membrane is 200-300 μm.

The dialyzer may also be formed by encapsulating other existing materials having dialysis function.

Using solid anticoagulant microspheres instead of liquid anticoagulants can avoid the risk of massive bleeding caused by the return of anticoagulants into the body and improve the safety of the blood purification treatment process. Combining solid anticoagulant microspheres with dialyzers to design an "integrated" heparin-free hemodialyzer can promote the industrialization and clinical application of new hemodialyzers, which is conducive to the development of my country's hemodialyzer market and has high social and economic value.

Compared with the prior art, the utility model has the following advantages: the utility model can effectively increase the convenience of connection between the anticoagulant microsphere column and the hemodialyzer by making the anticoagulant microspheres and the dialysis material into a column and then effectively connecting the two by setting a connecting piece. The connecting piece can also increase the tightness of the connection and improve the sealing effect of the connection to avoid pipe slippage or leakage that affects the use effect.

The utility model can maximize the functions of both by assembling the solid anticoagulant with the dialyzer. Similarly, the Zhao Qiang team of Huazhong University of Science and Technology proposed "A core liquid modification method for preparing anticoagulant hollow fiber membrane and its application", which introduces carboxyl and sulfonic acid groups on the surface of the hollow fiber membrane to achieve the purpose of anticoagulation. This modification method is bound to affect the flux and toxin removal efficiency of the hollow fiber membrane, and the number of carboxyl and sulfonic acid groups that can be introduced on the surface of the hollow fiber membrane is limited, and the anticoagulant function cannot be maximized. The integrated self-anticoagulant hemodialyzer proposed in this application can maximize the anticoagulant function and toxin removal function by assembling the solid microsphere anticoagulant and the dialyzer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic structural diagram of an integrated self-anticoagulation hemodialyzer according to an embodiment of the present invention;

In the figure: 1. anticoagulant microsphere column; 2. connector; 3. dialyzer; 4. first cover; 5. first sealing joint; 6. second cover; 7. second sealing joint.

FIG2 is a cross-sectional view of the connecting member in FIG1 ;

FIG. 3 is a top view of the connecting member in FIG. 1 .

Implementation

The utility model will be further described below in conjunction with the accompanying drawings. In order to clearly and completely describe the purpose and technical solution of the utility model and make its advantages more clear, the utility model will be further described in detail below in conjunction with the accompanying drawings. It should be understood that the specific embodiments described here are part of the embodiments of the utility model, not all of them, and are only used to explain the embodiments of the present invention, and are not used to limit the utility model. All other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the utility model.

An integrated self-anticoagulation hemodialyzer comprises an anticoagulation microsphere column 1, a connector 2 and a dialyzer 3;

The utility model allows the blood of patients with renal dysfunction to pass through the anticoagulant microsphere column 1 and the dialyzer 3 in sequence to achieve the purpose of blood purification, wherein, firstly, the anticoagulant microsphere column 1 enhances the anti-thrombotic ability of the blood during the purification process, thereby ensuring the smooth progress of blood purification; then, the dialyzer 3 dialyzes urea, uric acid, creatinine, alkaline phosphatase, potassium, small molecular guanidine substances, acidic substances, and medium molecular toxin β ₂ -microglobulin in the blood to finally achieve the purpose of blood purification, thereby avoiding the risk of coagulation disorder caused by the use of heparin anticoagulation in patients with renal dysfunction, improving the safety of hemodialysis treatment, and greatly reducing the cost of treatment.

The anticoagulant microsphere column 1 is filled with a plurality of gel microspheres having an anticoagulant effect, and the volume of the anticoagulant microsphere column 1 is 60-120 mL; the microspheres are made of engineering plastics; and the diameter of the gel microspheres is 300-1000 μm.

In order to effectively enhance the anticoagulant effect of blood, preferably, the anticoagulant microsphere column of the present invention is filled with gel microspheres, and the gel microsphere anticoagulant layer can be fixed with a mesh structure; a plurality of gel microspheres are filled in the mesh structure to form a gel microsphere anticoagulant layer; preferably, the volume of the gel microsphere anticoagulant layer is 60-120 mL; the diameter of each microsphere in the gel microsphere anticoagulant layer is 300-1000 μm, thereby ensuring sufficient anticoagulant treatment.

To ensure the normal blood perfusion, the blood first contacts the gel microspheres with anticoagulant effect. The preparation method of the gel microspheres is as follows: first, a polymer A solution with good biocompatibility is prepared, and the polymer A can be polyethersulfone, polyurethane, polystyrene, polysulfone, polymethyl methacrylate, etc.; then the solution is filled into the electrostatic spray ball device, and a voltage is applied. Under the action of the voltage, the polymer solution is dripped into the coagulation bath containing monomers in the form of microspheres. The coagulation bath contains carboxylic acid monomers, sulfonic acid monomers, deionized water, crosslinking agents, and initiators. During the phase transition process, the organic solvent N,N-dimethylacetamide in the microspheres is rapidly replaced by the reaction solution to obtain skeleton microspheres. Subsequently, the skeleton microspheres are heated to induce a crosslinking reaction to obtain gel microspheres.

The main function of the anticoagulation column is to prevent thrombosis and ensure that there is no coagulation in the subsequent dialysis process; the volume of the anticoagulation column is 60-120 mL; the polymer material with good biocompatibility in the anticoagulation column is engineering plastic, the crosslinking agent can be ethylene glycol dimethacrylate (EGDMA) or N,N-methylenebisacrylamide (MBA), etc.; the initiator can be ammonium persulfate (APS) or azobisisobutyronitrile (AIBN), etc.; the molar ratio of carboxylic acid monomers and sulfonic acid monomers in the microspheres can be 0.25 to 4. The diameter of the gel microspheres is 300-1000 μm; the fixing method of this layer is stainless steel mesh, polycarbonate PC mesh or polypropylene PP mesh;

Preparation example of gel microspheres: The diameter of the gel microspheres is 300 μm, MBA is a cross-linking agent, APS is an initiator, the chemical ratio of carboxylic acid monomer (polyacrylic acid) and sulfonic acid monomer (2-acrylamide-2-methylpropanesulfonic acid) is 1:4, the reaction temperature is 80 °C, the reaction time is 1.5 h, the hemolysis rate is 0.1%, the APTT (activated partial thromboplastin time) time is 600 s, and the TT (thrombin time in human plasma in vitro) time is 180 s. The above effect data refers to the coagulation time data and hemolysis rate measured only by the anticoagulation column, and there is no dialyzer during the test. Similarly, there is no anticoagulation layer in the preparation example of the dialyzer below. Preparation example of dialyzer: A 16% polyethersulfone solution is used to prepare the hollow fiber membrane, the coagulation bath is an ethanol solution, and the diameter of a single hollow fiber is 200 μm. The dialysis for 2 h has a significant effect on urea, uric acid, creatinine, potassium, and β ₂

-The clearance rates of microglobulin were 75%, 69%, 64%, 59%, and 53%, and the hemolysis rate was 0.2%.

Examples 1-4

An integrated self-anticoagulation dialyzer, see Figure 1, includes an anticoagulation microsphere column 1, a connector 2 and a dialyzer 3, wherein the anticoagulation microsphere column 1 and the dialyzer 3 are connected via the connector 2, wherein, as shown in Figure 2, the overall appearance of the connector is cylindrical, and an internal thread structure is processed inside, which can be connected to the anticoagulation microsphere column 1 and the dialyzer 3 column. According to the different diameters of the anticoagulation microsphere column 1 and the dialyzer 3 column, a connector 2 with internal threads of different diameters at both ends can be designed. As shown in Figure 3, a small hole is provided in the middle of the connector 2 to facilitate liquid transmission; specifically, the upper end of the connector 2 is connected to the anticoagulation microsphere column 1 via a threaded seal, a sealing ring is provided between the anticoagulation microsphere column 1 and the connector 2, and the lower end of the connector 2 is connected to the dialyzer 3 via a threaded seal, and the connector 2 and the dialyzer 3 is provided with a sealing ring; the anticoagulant microsphere column 1 includes an anticoagulant microsphere column body, the upper end of the anticoagulant microsphere column body is connected to a first sealing cover 4, the upper end of the anticoagulant microsphere column body is sealed with the first sealing cover 4 by a thread, a sealing ring is provided between the anticoagulant microsphere column body and the first sealing cover 4, and a first sealing joint 5 for connecting to an arterial port in a dialysis pipeline is protruded in the middle of the upper end of the first sealing cover 4; the dialyzer 3 includes a dialyzer body, the lower end of the dialyzer body is connected to a second sealing cover 6, the lower end of the dialyzer body is sealed with the second sealing cover 6 by a thread, a sealing ring is provided between the dialyzer body and the second sealing cover 6, and a second sealing joint 7 for connecting to a venous port in a dialysis pipeline is protruded in the middle of the lower end of the second sealing cover 6;

The anticoagulant microsphere volume, microsphere diameter, raw material ratio, etc. of each embodiment are shown in Table 1. The hemoperfusion device of the utility model was used to purify the blood of patients with renal dysfunction for 2 h, and the purification ability of the hemoperfusion device of the present invention was analyzed. The specific data of the purification effect are shown in Table 2 below.

Table 1 Anticoagulant column volume and dialyzer total surface area of each embodiment

Anticoagulant column volume (mL) Total surface area of dialyzer (m ² ) Example 1 120 0.8 Example 2 100 0.8 Example 3 80 0.8 Example 4 60 0.8

Table 2 The purification effect of blood after using the dialyzer of each embodiment

Hemolysis rate APTT(s) TT(s) Urea Uric acid Creatinine Potassium β ₂ -microglobulin Before purification 0% 43 17 100% 100% 100% 100% 100% Example 1 0.1% 600 180 32.6% 10.2% 25.6% 45.6% 42.2% Example 2 0.2% 560 140 35.7% 12.4% 26.3% 46.2% 43.1% Example 3 0.1% 500 120 36.1% 13.7% 27.3% 47.7% 44.5% Example 4 0.2% 450 100 54% 14.1% 28.3% 48.1% 44.9%

As can be seen from the above table, the various indicators of the patient's blood after being treated by the dialyzer of the utility model have dropped significantly, indicating that the dialyzer of the utility model has a good blood purification effect. After blood purification, the coagulation time basically returns to normal and no hemolysis occurs, indicating that the perfusion device of the utility model has high safety for patients with renal dysfunction. In addition, the utility model avoids the use of a large amount of heparin, reduces the risk of coagulation dysfunction in patients with liver failure, and saves resource costs, achieving safe and effective purification of blood.

Claims (7)

1. An integral type is from anticoagulation hemodialysis ware, its characterized in that: the anti-coagulation microsphere column comprises an anti-coagulation microsphere column body (1) and a dialyzer (3) which are sequentially arranged, wherein the anti-coagulation microsphere column body (1) is connected with the dialyzer (3) through a connecting piece (2); the anti-coagulation microsphere column (1) comprises an anti-coagulation microsphere column main body, wherein the upper end of the anti-coagulation microsphere column main body is connected with a first sealing cover (4), and a first sealing joint (5) used for being connected with an arterial port in a dialysis pipeline is convexly arranged in the middle of the upper end of the first sealing cover (4); the dialyzer (3) comprises a dialyzer main body, the lower end of the dialyzer main body is connected with a second sealing cover (6), and a second sealing joint (7) used for being connected with a venous port in a dialysis pipeline is arranged in the middle of the lower end of the second sealing cover (6) in a protruding mode.

2. The integrated self-anticoagulation hemodialyzer of claim 1, wherein: the upper end of the connecting piece (2) is connected with an anti-coagulation microsphere column body (1) in a threaded sealing way, and a sealing ring is arranged between the anti-coagulation microsphere column body (1) and the connecting piece (2).

3. The integrated self-anticoagulation hemodialyzer of claim 1, wherein: the lower end of the connecting piece (2) is connected with the dialyzer (3) in a threaded sealing way, and a sealing ring is arranged between the connecting piece (2) and the dialyzer (3).

4. The integrated self-anticoagulation hemodialyzer of claim 1, wherein: the upper end of the anticoagulation microsphere column body is connected with the first sealing cover (4) in a threaded sealing way, and a sealing ring is arranged between the anticoagulation microsphere column body and the first sealing cover (4).

5. The integrated self-anticoagulation hemodialyzer of claim 1, wherein: the lower end of the dialyzer main body is connected with the second sealing cover (6) in a threaded sealing way, and a sealing ring is arranged between the dialyzer main body and the second sealing cover (6).

6. The integrated self-anticoagulation hemodialyzer of claim 1, wherein: the anticoagulation microsphere column (1) is filled with a plurality of gel microspheres with anticoagulation effect; the gel microspheres are made of engineering plastics; the volume of the anticoagulation microsphere column (1) is 60-120 mL, and the diameter of the gel microsphere is 300-1000 mu m.

7. The integrated self-anticoagulation hemodialyzer of claim 1, wherein: the dialyzer (3) is formed by filling and sealing a plurality of hollow fiber membranes; the diameter of the hollow fiber membrane is 200-300 mu m.