CN201510568U - A heparin-coated extracorporeal circulation and cardiac assist device - Google Patents

Abstract

The utility model discloses an extracorporeal circulation and heart assist device with a heparin coating, which at least includes a connecting pipeline, an oxygenator, a blood storage device, a blood pump and a variable temperature box. The oxygenator, the blood storage device, the blood The pump and the thermostat are connected sequentially through connecting pipes; one end of the oxygenator is connected to the venous catheter through a connecting pipe, and one end of the thermostat is connected to the arterial catheter through a connecting pipe. The inner and outer material surfaces of the connecting pipe, the oxygenator A layer of compact heparin molecular layer is evenly coated on the surface of the inner material of the blood storage device. The device not only has good anticoagulant activity and biocompatibility, but also can maintain the mechanical strength and related properties of the device material itself, effectively reducing the postoperative inflammatory reaction of the operator's body.

Description

A heparin-coated extracorporeal circulation and cardiac assist device

technical field

The utility model belongs to the field of medical equipment and relates to an extracorporeal circulation and heart assisting device, in particular to a heparin-coated extracorporeal circulation and heart assisting device.

Background technique

Cardiac surgery using cardiopulmonary bypass and cardiac assist devices has become a routine method for treating heart disease. Usually extracorporeal circulation and cardiac assist equipment are mainly composed of oxygenator, blood reservoir, connecting pipeline, blood pump and other devices, and its constituent materials include polyethylene, polytetrafluoroethylene, polyester, polyvinyl chloride, silicone rubber, stainless steel, etc. Chemical material. Due to the poor biocompatibility of these artificial synthetic materials, when in direct contact with blood, it will lead to the activation of the intrinsic and extrinsic coagulation pathways, the formation of microthrombosis, inflammatory and immune rejection reactions, the release of toxic substances, and serious complications. disease, affecting the surgical effect.

At present, the method that can prevent and reduce blood coagulation is the application of anticoagulants, among which heparin is the most widely used one. Heparin is a water-soluble sulfated aminoglycan. It binds to antithrombin III and inhibits the activity of serine protease in the bypass pathway of blood coagulation to prevent the coagulation process. It has a strong inhibitory effect on coagulation activation in vivo, clinically It is mainly used in anticoagulant therapy and other aspects. In addition to having anticoagulant activity, heparin is a known inhibitor of complement. Cardiac surgery with cardiopulmonary bypass requires systemic heparinization to prevent blood coagulation, but systemic heparinization destroys the body's ability to regulate itself on blood coagulation, and can also cause complications such as bleeding and thrombus. Therefore, in order to avoid the complications of systemic heparinization and increase the biocompatibility of materials, researchers try to combine heparin molecules on the surface of artificial materials to replace the current systemic heparinization. At the same time, research results in recent years have shown that coating heparin on the surface of artificial materials can effectively improve the blood and biocompatibility of artificial materials, and reduce postoperative systemic inflammatory reactions.

Usually, the heparin coating on extracorporeal circulation and cardiac assist devices is mainly coated on the surface of the device through ionic bonding and covalent bonding. The way of ionic bonding is to use the property of heparin itself to contain a large amount of negative charges, introduce positively charged quaternary ammonium group coupling agents, surfactants or polymers containing cations on the surface of polymer materials, and then interact with heparin to make The surface of the material forms a heparinized layer by ionic bonding. However, due to the instability of ionic bonds, plasma macromolecules such as albumin with affinity can combine with heparin to cause heparin molecules to fall off. At the same time, the quaternary ammonium salts and surfactants used are usually biologically toxic, which limits the its scope of application. The covalent bond heparin binding method often requires that the surface to be bound has active groups that are prone to chemical reactions, and the selected active groups should not be easily inactivated by chemical modification during the binding process, which also limits its use. In addition, covalently bonded heparin molecules often lose their anticoagulant activity due to changes in their spatial structure. Therefore, the development of a bioactive heparin-coated extracorporeal circulation and heart assist device is of great significance for solving the problem of blood coagulation and inflammatory reactions caused by medical device materials.

Contents of the invention

In view of the defects or deficiencies in the above-mentioned technologies, the purpose of this utility model is to provide a heparin-coated extracorporeal circulation and heart assist device, which not only has good anticoagulant activity and biocompatibility, but also can maintain the material of the device Its own mechanical strength and related properties can effectively reduce the postoperative inflammatory response of patients.

In order to realize above-mentioned technical task, the utility model takes following technical scheme:

An extracorporeal circulation and heart assist device with a heparin coating, at least including connecting pipes, an oxygenator, a blood reservoir, a blood pump and a thermostat, the oxygenator, blood reservoir, blood pump and thermostat passing through The connecting pipes are connected in sequence; one end of the oxygenator is connected with the venous cannula through the connecting pipe, and one end of the variable temperature box is connected with the arterial cannula through the connecting pipe. It is characterized in that the inner and outer material surfaces of the connecting pipe, the oxygenator and A layer of heparin coating is evenly coated on the surface of the inner material of the blood storage container.

The thickness of the heparin coating evenly coated on the inner and outer material surfaces of the connecting pipeline, and the inner material surfaces of the oxygenator and the blood reservoir is 5 μm-0.5 mm.

In the extracorporeal circulation and heart assist device with heparin coating of the utility model, the heparin coating on its surface makes the surface of the medical device material in contact with blood have free amino space structure and positive charge through polyethylene imine coating method, and then the same The negative charge of the heparin molecule is ionically bonded, and the cross-linking agent can also be covalently bonded to the amino group in the heparin molecule, so that the heparin molecule is fixed on the surface of the device material. Polyethyleneimine is a high-molecular-weight cationic polymer with multiple active amino groups, which can be covalently bonded to the amino groups in the heparin molecule through a cross-linking agent, and can also be bonded in the form of ionic bonds. Water-insoluble molecular films are formed on the surface of medical device materials. The spatial structure of the active group of the heparin molecule faces away from the surface of the material, ensuring the biological activity of the heparin molecule. The heparin molecule of the utility model is combined at multiple sites on the surface of the material of the medical device in contact with the blood, has biological activity, and overcomes the defects of blood coagulation and inflammatory reaction caused by the existing equipment.

Description of drawings

Fig. 1 is the structural representation of the utility model.

Fig. 2 is an A-A sectional view of the connecting pipe 1 of the present invention.

FIG. 3 is an enlarged partial cross-sectional view of the oxygenator 2 of the present invention.

Fig. 4 is an enlarged partial cross-sectional view of the blood storage device 3 of the present invention.

The content of the invention of the utility model will be described in further detail below in conjunction with the accompanying drawings.

Detailed ways

Referring to Fig. 1-Fig. 4, the utility model has heparin-coated extracorporeal circulation and heart assisting device, at least includes connecting pipe 1, oxygenator 2, blood reservoir 3, blood pump 4 and variable temperature box 6, described oxygen Combiner 2, blood reservoir 3, blood pump 4 and temperature change box 6 are connected in sequence through connecting pipe 1; one end of oxygenator 2 is connected with venous cannula through connecting pipe 1, and one end of temperature changing box 6 is connected with arterial cannula through connecting pipe 1. The inner and outer material surfaces of the connecting pipeline 1, and the inner material of the oxygenator 2 and the blood reservoir 3 are evenly coated with a layer of heparin coating 5.

The thickness of the heparin coating evenly coated on the inner and outer material surfaces of the connecting pipeline, and the inner material surfaces of the oxygenator and the blood reservoir is 5 μm-0.5 mm.

The process of coating the compact heparin layer 5 evenly on the inner and outer material surfaces of the connecting pipeline 1 and the inner materials of the oxygenator 2 and the blood reservoir 3 is as follows:

The applied substances include heparin and polyethyleneimine, the mass ratio of heparin and polyethyleneimine is 1:50-50:1, and the optimum ratio is 1:5-5:1.

1) Clean medical equipment such as connecting pipe 1, oxygenator 2, and blood reservoir 3 with ethanol for 6 hours, and then with distilled water for 6 hours, and then air-dry or dry in a vacuum desiccator to obtain the cleaned equipment material surface.

2) Soak the connecting pipe 1, oxygenator 2, blood storage device 3 and other equipment materials in polyethyleneimine aqueous solution for 30 minutes, and fully dry them in a vacuum desiccator

3) Repeat step 2 three times

4) Soak the above-mentioned equipment materials in the heparin aqueous solution for 3 minutes, and fully dry them in a vacuum desiccator to obtain the surface of the extracorporeal circulation and heart assist device with a tight heparin coating, that is, on the tube wall 11' of the connecting tube 1 ( Figure 2) is coated with a layer of heparin molecular layer 5 in the direction of the inner and outer tube walls; a layer of heparin molecular layer 5 is coated on the inner surface of the oxygenator 2, and a layer of heparin molecular layer 5 is evenly coated on the inner material of the blood container 3 Tighten the heparin molecular layer5.

The following are the specific examples provided by the inventors. Refer to the following examples to carry out specific practical operations of the specific operation process of the present invention.

Example 1: One end of a 25 cm long medical polyvinyl chloride (inner diameter 1 cm) connection pipe 1 is sealed, and the other end is injected with 5% polyethyleneimine ethanol solution, and the remaining solution is poured out after 30 minutes in a water bath at 37° C. Repeat 3 times and dry under vacuum at room temperature.

Then pour 100ml of heparin aqueous solution with a mass fraction of 1% (pH = 1) into the pipeline, and a thin layer of white precipitates can be seen on the surface of the pipeline. After 3 minutes in a water bath at 37°C, pour out the remaining solution, and dry it under vacuum at room temperature for later use.

Example 2:

Close one end of a 25cm-long medical silicone rubber (1.2cm inner diameter) connecting pipe 1, inject the other end with 2.5% polyethyleneimine ethanol solution containing 5% glutaraldehyde, and pour out the remaining solution after 30 minutes in a water bath at 37°C. Repeat 3 times and dry under vacuum at room temperature.

Then pour 100ml of heparin aqueous solution with a mass fraction of 1% (pH=1) into the pipeline, bathe in water at 37°C for 3 minutes, pour out the remaining solution, and dry it under vacuum at room temperature for later use.

The extracorporeal circulation and heart assist device with heparin coating of the utility model, the results of in vitro coagulation performance test and cell culture analysis show that the anticoagulant activity and biocompatibility of the device are remarkable, the heparin molecules are firmly combined, and the cytotoxicity is slight ,Wide range of applications.

Claims (2)

1. An extracorporeal circulation and heart assist device with a heparin coating, at least including a connecting pipeline (1), an oxygenator (2), a blood reservoir (3), a blood pump (4) and a thermostat (6), The oxygenator (2), the blood reservoir (3), the blood pump (4) and the variable temperature box (6) are sequentially connected through the connecting pipe (1); one end of the oxygenator (2) is connected through the connecting pipe (1) It is connected with the venous cannula, and one end of the variable temperature box (6) is connected with the arterial cannula through the connecting pipe (1), and it is characterized in that, the inner and outer material surfaces of the connecting pipe (1), the oxygenator (2) and the A layer of heparin coating (5) is evenly coated on the inner material of the blood storage container (3). 2. have heparin coating extracorporeal circulation and cardiac assisting device as claimed in claim 1, it is characterized in that, described connecting pipeline (1) inner and outer material surface, oxygenator (2) and blood reservoir ( 3) The thickness of the uniformly coated heparin coating (5) on the inner material is 5 μm-0.5 mm.

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