The pumping assembly of the catheter pump

Abstract

The present invention relates to the field of surface engineering technology of biomedical materials, and specifically relates to a pumping component of a catheter pump; it includes a pigtail tube, a blood inlet cage, a sleeve, and a blood outlet cage that are sequentially connected. At least a part of the inner surface and / or outer surface of the pumping component has a rough structure, and a lubricating liquid is introduced to the rough structure to form a film layer; the lubricating liquid includes one or a combination of medical polytetrafluoroethylene, perfluorotri-n-pentylamine, perfluoropolyether, oil, liquid paraffin, and vegetable oil. The beneficial effects of the present invention are as follows: introducing a lubricating coating on the pumping component of the catheter pump, the constructed smooth surface helps to improve the implantation safety of the catheter pump, reduce hemolysis and thrombosis problems, and reduce the adhesion of proteins in the organism to the interventional catheter pump, avoid the ingrowth of biological tissues, and at the same time facilitate the puncture surgery.

Description

Technical Field

[0001] The present invention relates to the technical field of surface and interface engineering of biomedical materials, and particularly relates to a pumping assembly of a catheter pump. Background Art

[0002] Catheter pumps are suitable for ventricular support of patients with cardiogenic shock or heart failure. Taking the left ventricle as an example, during percutaneous coronary intervention (PCI), the catheter pump can be percutaneously inserted into the heart. In short-term applications (≤4 days) or long-term applications (≥7 days), the built-in micro axial flow pump at the front end of the catheter pumps blood from the left ventricle into the aorta, providing a peak blood flow of up to 5 L / min, increasing cardiac output, assisting blood circulation, and maintaining the life of the patient.

[0003] The complex geometric structure and mechanical movement in the catheter pump are likely to cause mechanical damage to the blood, making blood cells undergo non-physiological stresses dozens of times higher than those in the normal human body, resulting in irreversible damage, mainly manifested as hemolysis, coagulation, bleeding, etc. At the same time, the outer surface of the implanted section of the catheter pump is prone to adsorb fibrinogen, and further adhere to platelets and red blood cells, showing undesirable tissue ingrowth or overgrowth. In addition, the existing catheter pump has a relatively high surface roughness and a relatively astringent feel, making it difficult to smoothly complete puncture on animals or humans during the Seldinger operation. Summary of the Invention

[0004] The purpose of the present invention is to provide a pumping assembly of a catheter pump, which has increased surface smoothness and implantation safety.

[0005] In order to achieve the above purpose, the present invention adopts the following technical solutions to achieve:

[0006] A pumping assembly of a catheter pump includes a pigtail tube, a blood inlet cage, a sleeve, and a blood outlet cage connected in sequence. At least a part of the inner surface and / or outer surface of the pumping assembly has a rough structure, and a lubricating liquid is introduced into the rough structure to form a film layer; the lubricating liquid includes one or a combination of medical polytetrafluoroethylene, perfluorotri-n-pentylamine, perfluoropolyether, oil, liquid paraffin, and vegetable oil.

[0007] In a preferred technical solution, a nickel-titanium memory alloy spring is embedded in the wall of the sleeve, and the spring extends from both ends of the sleeve and is welded to the blood inlet cage and the blood outlet cage respectively. A nickel-titanium metal wire is embedded in the proximal wall of the pigtail tube and is welded to the blood inlet cage, and each component is connected as a whole and the connection part has a smooth transition.

[0008] In a preferred technical solution, the rough structure is obtained by etching technology, sol-gel method or electrochemical deposition technology.

[0009] Preferred technical solution: The method for obtaining the rough structure is as follows: Immerse the pumping assembly in the silicification liquid, take it out after 30 minutes, rinse and dry it; preferably, immerse the pigtail tube and the sleeve in the silicification liquid.

[0010] Preferred technical solution: The silicification liquid is obtained by mixing tetramethyl orthosilicate aqueous solution and phosphate buffer solution in equal volume. The concentration of the tetramethyl orthosilicate aqueous solution is, for example, 1 mol / L, and the concentration of the phosphate buffer solution is, for example, 0.2 mol / L.

[0011] Preferred technical solution: The lubricating liquid includes component A and component B:

[0012] Among them, component A includes: polytetrafluoroethylene;

[0013] Component B includes: perfluorotri-n-pentylamine or perfluoropolyether or oil or liquid paraffin or vegetable oil.

[0014] Preferred technical solution: Component A includes: 35 - 40 parts of polytetrafluoroethylene, 1 - 5 parts of hydrophobic nano-SiO₂, 10 - 15 parts of polyethylene glycol 400, and 40 - 70 parts of absolute ethanol.

[0015] Preferred technical solution: The method for forming the film layer is as follows: The rough structure first contacts with polytetrafluoroethylene to form a first film layer, and after curing, it then contacts with perfluorotri-n-pentylamine, perfluoropolyether or oil, liquid paraffin or vegetable oil to form a second film layer.

[0016] Preferred technical solution: At least a part of the inner surface and / or outer surface of the pumping assembly has a rough structure in the form of texture, groove or dot matrix.

[0017] Preferred technical solution: Before, after or during the lubricating liquid is introduced to the rough structure, the rough structure pre-contacts with the active ingredient and forms a film layer.

[0018] Preferred technical solution: Before, after or during the lubricating liquid is introduced to the rough structure, the rough structure pre-contacts with the anticoagulant ingredient and forms a film layer.

[0019] Preferred technical solution: Before, after or during the lubricating liquid is introduced to the rough structure, the rough structure first contacts with the active ingredient and forms a film layer, and then contacts with the anticoagulant ingredient and forms a film layer.

[0020] Preferred technical solution: Before, after or during the lubricating liquid is introduced to the rough structure, the rough structure first contacts with the anticoagulant ingredient and forms a film layer, and then contacts with the active ingredient and forms a film layer.

[0021] In a preferred technical solution, the active ingredient is selected from one or a combination of fibrinogen, fibroin, collagen, and polypeptides.

[0022] In a preferred technical solution, the anticoagulant component is selected from one or a combination of unfractionated heparin, low molecular weight heparin, fondaparinux, factor Xa inhibitors, and thrombin inhibitors.

[0023] In a preferred technical solution, the coating method is selected from any one of spraying, dip coating, drop coating, spin coating, and bioprinting.

[0024] In a preferred technical solution, the thickness of the film layer is ≤ 0.15 mm.

[0025] In a preferred technical solution, the coating method is as follows:

[0026] (a) Immerse the pumping assembly in component A, soak it at 35 - 60 °C for 10 - 20 minutes, then take it out, let it dry naturally in a sterile environment for 5 - 10 minutes, then wash it with deionized water, and then dry it under vacuum at 80 - 100 °C for 30 - 60 minutes;

[0027] (b) Drop component B onto the pumping assembly obtained in step (a), tilt and rotate it to make the surface of the pumping assembly evenly and fully covered with component B.

[0028] The beneficial effects of the present invention are as follows: Introducing a lubricating coating on the pumping assembly of the catheter pump, the constructed smooth surface helps to improve the implantation safety of the catheter pump, reduce hemolysis and thrombus problems, and reduce the adhesion of proteins in the organism to the interventional catheter pump, avoiding the ingrowth of biological tissues. The roughened substrate surface treatment can provide porosity to stabilize the lubricating liquid covering layer. When the catheter pump is subjected to high-speed and long-term blood flow scouring of ≥ 6 L / min for ≥ 48 hours, the coating is also difficult to be carried away and lost by the external moving fluid, and the actual use performance of the coating is stable, while facilitating puncture surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a schematic structural diagram of the pumping assembly of the catheter pump in the embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0030] In order to make the technical means, creative features, achieved purposes, and effects of the present invention easy to understand, the present invention will be further clarified below with reference to specific drawings.

[0031] It should be noted that in the present invention, when an element is referred to as being "fixed to" another element, it can be directly on the other element or there can also be an intermediate element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are only for illustrative purposes and do not represent the only implementation.

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used in the description of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0033] In the present invention, the "proximal end" is defined as the end of the interventional medical device closer to the operator, and the "distal end" is defined as the end of the interventional medical device farther from the operator.

[0034] A pumping assembly of a catheter pump includes a pigtail tube 10, a blood inlet cage 20, a sleeve 30, and a blood outlet cage 40 connected in sequence. At least a part of the inner surface and / or the outer surface of the pumping assembly has a rough structure, and a lubricating liquid is introduced into the rough structure to form a film layer; the lubricating liquid includes one or more combinations of medical polytetrafluoroethylene, perfluorotri-n-pentylamine, perfluoropolyether, oil, liquid paraffin, and vegetable oil.

[0035] A nickel-titanium memory alloy spring (not shown in the figure) is embedded in the wall of the sleeve 30. The spring extends from both ends of the sleeve 30 and is welded to the blood inlet cage 20 and the blood outlet cage 30 respectively. A nickel-titanium wire (not shown in the figure) is embedded in the wall of the pigtail tube 10 and is welded to the blood inlet cage 20. Each component is connected as a whole and the connection is smoothly transitioned. The pumping assembly is welded as a whole through an improved structural and process design, which is beneficial to the subsequent application of the lubricating coating process. This is important. If the lubricating liquid is introduced first and then the pumping assembly is assembled, problems such as difficult connection and low connection strength will occur. When the catheter pump is applied to the heart through a tortuous circuit, the connectors are likely to fall off in the body, causing a fatal risk.

[0036] Roughened surface treatment on the substrate can provide porosity to stabilize the lubricating liquid coating. The rough structure can be obtained by etching technology, sol-gel method or electrochemical deposition technology, so that at least a part of the inner surface and / or outer surface of the pumping component has a rough structure in the form of texture, groove or lattice. As an example, the method for obtaining the rough structure of the present invention is: immersing the pumping component in the silicification liquid, taking it out after 30 minutes, rinsing and drying. Based on the metal material of the blood inlet cage 20 and the blood outlet cage 30 and their inherent surface smoothness, and also based on the requirements of the functions of the blood inlet cage 20 and the blood outlet cage 30 during the operation of the catheter pump for the structure, it is not suitable for further rough treatment. Preferably, only the pigtail tube and the sleeve can be selected to be immersed in the silicification liquid. As an example, the silicification liquid is obtained by mixing tetraethyl orthosilicate aqueous solution with a concentration of 1 mol / L and phosphate buffer solution with a concentration of 0.2 mol / L in equal volumes. In this way, the pigtail tube 10 and the sleeve 30 with rough SiO2 surfaces can be obtained. In addition, the roughening treatment method of the blood inlet cage 20 and the blood outlet cage 30 can also refer to surface etching using a nanosecond pulsed fiber laser. The cage-like surface is irradiated by the moving laser beam along two perpendicular directions through rotational scanning to form a micron-scale square column array.

[0037] The film layer can be covered with a lubricating liquid of a single component on the rough surface, or can be set as multiple layers. As a preferred method, the lubricating liquid includes component A and component B:

[0038] Among them, the component A includes: polytetrafluoroethylene;

[0039] The component B includes: perfluorotri-n-pentylamine or perfluoropolyether or oil or liquid paraffin or vegetable oil.

[0040] During use, the rough structure first contacts with polytetrafluoroethylene to form a first film layer. After curing, it then contacts with perfluorotri-n-pentylamine, perfluoropolyether, oil, liquid paraffin or vegetable oil to form a second film layer.

[0041] Polytetrafluoroethylene is usually in powder form. For the convenience of process operation, it can be suspended in a solution to facilitate casting into a film on the substrate, such as being dispersed in a mixed solution of polyethylene glycol 400 and absolute ethanol. The polytetrafluoroethylene coating has a smooth surface. To further ensure perfluorotri-n-pentylamine or perfluoropolyether or Oil, liquid paraffin or vegetable oil can be firmly attached to the substrate. The polytetrafluoroethylene coating may contain nano - SiO₂ component, such as the gas - phase hydrophobic nano - SiO₂ sold by Evonik Degussa GmbH, with the model number AEROSIL R 8200. As an example, the component A includes: 35 - 40 parts of polytetrafluoroethylene, 1 - 5 parts of hydrophobic nano - SiO₂, 10 - 15 parts of polyethylene glycol 400, and 40 - 70 parts of absolute ethanol. When in use, after preparing each component according to the formula and mixing them, they can be stirred and mixed for 1 - 3 hours under the water - bath condition of 50 - 80 °C, or mixed under the ultrasonic condition of 50 - 80 °C to make each component evenly dispersed.

[0042] Before, after or during the introduction of the lubricating liquid into the rough structure, the rough structure is pre - contacted with the active ingredient and forms a film layer, or the rough structure is pre - contacted with the anticoagulant ingredient and forms a film layer, or the rough structure is first contacted with the active ingredient and forms a film layer, and then contacted with the anticoagulant ingredient and forms a film layer, or the rough structure is first contacted with the anticoagulant ingredient and forms a film layer, and then contacted with the active ingredient and forms a film layer. As an example, the active ingredient is selected from one or more combinations of fibrinogen, fibroin, collagen, and polypeptides. As an example, the anticoagulant ingredient is selected from one or more combinations of unfractionated heparin, low - molecular - weight heparin, fondaparinux, factor Xa inhibitor, and thrombin inhibitor. The active ingredient provides a gel layer to facilitate the embedding of the lubricating liquid into the gel layer to achieve a more firm connection.

[0043] The contact or connection method between the film layer and the substrate can be the coating method, such as spraying, dip - coating, drop - coating, spin - coating or bioprinting technology, to achieve the coverage of the rough structure by the film layer. As an example, the present invention provides a coating method with the following steps:

[0044] (a) Immerse the pumping component in component A, soak it at 35 - 60 °C for 10 - 20 minutes, then take it out, naturally dry it in a sterile environment for 5 - 10 minutes, then wash it with deionized water, and then vacuum - dry it at 80 - 100 °C for 30 - 60 minutes;

[0045] (b) Drop component B on the pumping component obtained in step (a), tilt and rotate it to make the surface of the pumping component evenly and comprehensively covered by component B.

[0046] The coating amount or the film layer should not be too thick nor too thin. Preferably, the thickness of the coating ≤ 0.15 mm, which can provide a smooth surface to improve the implantation safety of the catheter pump, reduce hemolysis and thrombosis problems. At the same time, under the condition of high - speed and long - time blood flow scouring, this coating also ensures the stability of the actual use performance.

[0047] Example 1

[0048] A pumping assembly of a catheter pump is obtained by the following production method:

[0049] (1) Provide a pigtail tube 10, a blood inlet cage 20, a sleeve 30, and a blood outlet cage 40; a nickel-titanium memory alloy spring is embedded in the wall of the sleeve 30, and the spring extends out from both ends of the sleeve 30 and is welded to the blood inlet cage 20 and the blood outlet cage 40 respectively. A nickel-titanium wire is embedded in the proximal wall of the pigtail tube 10 and is welded to the blood inlet cage 20. Each component is connected into an integrated pumping assembly, and the connection parts are smoothly transitioned; the pumping assembly is ultrasonically cleaned in deionized water for 15 minutes and dried at 80 °C for 30 minutes;

[0050] (2) Immerse the pumping assembly in a silanization solution, and it can be flipped several times in the middle. Take it out after 30 minutes, let it stand on a bench for 10 minutes, then rinse it with deionized water and air-dry or vacuum-dry it for 20 minutes; the silanization solution is obtained by mixing a tetraethyl orthosilicate aqueous solution with a concentration of 1 mol / L and a phosphate buffer solution with a concentration of 0.2 mol / L in equal volumes;

[0051] (3) Prepare a lubricating liquid, including component A and component B. Component A includes: 35-40 parts of polytetrafluoroethylene, 1-5 parts of hydrophobic nano-SiO₂, 10-15 parts of polyethylene glycol 400, and 40-70 parts of absolute ethanol; before use, ultrasonically mix it under the water bath condition of about 65 °C to make each component uniformly mixed and dispersed; component B includes: oil;

[0052] (4) Immerse the pumping assembly in component A, soak it at a temperature of about 45 °C for 15 minutes, then take it out, naturally dry it for 10 minutes under negative pressure and in a sterile environment, then wash it with deionized water, and then vacuum-dry it at 85 °C for 45 minutes;

[0053] (5) Drop oil on the pumping assembly, tilt and rotate it to level the oil film, or brush the oil drop to make it uniformly and comprehensively cover the inner and outer surfaces of the pumping assembly;

[0054] (6) Let it stand for 15 minutes under negative pressure and in a sterile environment, then rinse it with deionized water, and then vacuum-dry it at 85 °C for 120 minutes.

[0055] Assemble the obtained pumping assembly with a motor 50 and a catheter 60 into an integrated unit to obtain a test sample 1.

[0056] Example 2

[0057] A pumping assembly of a catheter pump is obtained by the following production method:

[0058] (1) Provide a pigtail tube 10, a blood inlet cage 20, a cannula 30, and a blood outlet cage 40; a nickel-titanium shape memory alloy spring is embedded in the wall of the cannula 30, and the spring extends out from both ends of the cannula 30 and is welded to the blood inlet cage 20 and the blood outlet cage 40 respectively. A nickel-titanium wire is embedded in the proximal wall of the pigtail tube 10 and is welded to the blood inlet cage 20. All components are connected into one body to form a pumping assembly, and the connection parts have a smooth transition; the pumping assembly is ultrasonically cleaned in deionized water for 15 minutes and dried at 80 °C for 30 minutes;

[0059] (2) Immerse the pumping assembly in the silanization solution, and it can be flipped several times in the middle. After 30 minutes, take it out, let it stand on the bench for 10 minutes, and then rinse it with deionized water and air dry or vacuum dry it for 20 minutes; the silanization solution is obtained by mixing tetraethyl orthosilicate aqueous solution with a concentration of 1 mol / L and phosphate buffer solution with a concentration of 0.2 mol / L in equal volumes;

[0060] (3) Prepare a lubricating liquid, including component A and component B. Component A includes: 35 - 40 parts of polytetrafluoroethylene, 1 - 5 parts of hydrophobic nano-SiO₂, 10 - 15 parts of polyethylene glycol 400, and 40 - 70 parts of absolute ethanol; before use, ultrasonically mix it under the water bath condition of about 65 °C to make each component mixed and dispersed evenly; component B includes: perfluorotri-n-pentylamine;

[0061] (4) Immerse the pumping assembly in component A, under the condition of about 45 °C, soak it for about 15 minutes, then take it out, and naturally dry it for 5 - 10 minutes in a negative pressure and sterile environment, then wash it with deionized water, and then vacuum dry it at 85 °C for 45 minutes;

[0062] (5) Drop heparin solution on the pumping assembly, rotate to level the liquid and fully cover the surface, and let it stand in a sterile environment for 15 minutes;

[0063] (6) Drop component B on the pumping assembly, tilt and rotate it to make the oil film level and uniformly and comprehensively cover the surface of the pumping assembly;

[0064] (7) Let it stand in a negative pressure and sterile environment for 15 minutes, rinse it with deionized water, and then vacuum dry it at 85 °C for 120 minutes.

[0065] Assemble the obtained pumping assembly with a motor 50 and a catheter 60 into one body to obtain a test sample 2.

[0066] Example 3

[0067] A pumping assembly of a catheter pump is obtained by the following production method:

[0068] (1) Provide a pigtail tube 10, a blood inlet cage 20, a sleeve 30 and a blood outlet cage 40; a nickel-titanium shape memory alloy spring is embedded in the wall of the sleeve 30, and the spring extends from both ends of the sleeve 30 and is welded to the blood inlet cage 20 and the blood outlet cage 40 respectively. A nickel-titanium wire is embedded in the proximal wall of the pigtail tube 10 and is welded to the blood inlet cage 20. Each component is connected as a whole to form a pumping assembly, and the connection part has a smooth transition; the pumping assembly is ultrasonically cleaned in deionized water for 15 minutes and dried at 80 °C for 30 minutes;

[0069] (2) Immerse the pumping assembly in the silicification solution, and it can be turned over several times in the middle. Take it out after 30 minutes, let it stand on the bench for 10 minutes, and then rinse it with deionized water and air-dry or vacuum-dry it for 20 minutes; the silicification solution is obtained by mixing a tetraethyl orthosilicate aqueous solution with a concentration of 1 mol / L and a phosphate buffer solution with a concentration of 0.2 mol / L in equal volumes;

[0070] (3) Prepare a lubricating liquid, including component A and component B. Component A includes: 35-40 parts of polytetrafluoroethylene, 1-5 parts of hydrophobic nano-SiO₂, 10-15 parts of polyethylene glycol 400, and 40-70 parts of absolute ethanol; before use, ultrasonically mix it under the water bath condition of about 65 °C to make each component mixed and dispersed evenly; Component B includes: perfluoropolyether;

[0071] (4) Immerse the pumping assembly in component A, and under the condition of about 45 °C, soak it for about 15 minutes. Then take it out, naturally dry it in a negative pressure and sterile environment for 5-10 minutes, and then wash it with deionized water, and then vacuum-dry it at 85 °C for 45 minutes;

[0072] (5) Dilute the silk fibroin solution with water to 1 mg / mL, immerse the pumping assembly in the silk fibroin solution, take it out immediately after 1-5 s, and let it stand in a sterile environment at 60 °C for 15 minutes;

[0073] (6) Drop component B on the pumping assembly, tilt and rotate it so that the oil film levels and evenly and comprehensively covers the surface of the pumping assembly;

[0074] (7) Let it stand in a negative pressure and sterile environment for 15 minutes, rinse it with deionized water, and then vacuum-dry it at 85 °C for 120 minutes.

[0075] Assemble the obtained pumping assembly with a motor 50 and a catheter 60 as a whole to obtain a test sample 3.

[0076] Comparative Example 1

[0077] Provide a pigtail tube 10, a blood inlet cage 20, a sleeve 30 and a blood outlet cage 40; a nickel-titanium shape memory alloy spring is embedded in the tube wall of the sleeve 30, and the spring extends out from both ends of the sleeve 30 and is respectively welded to the blood inlet cage 20 and the blood outlet cage 40. A nickel-titanium wire is embedded in the proximal wall of the pigtail tube 10 and is welded to the blood inlet cage 20. Each component is connected into an integrated pumping assembly, and the connection part has a smooth transition. Then, the pumping assembly is assembled with a motor 50 and a catheter 60 into an integrated unit. The pumping assembly is ultrasonically cleaned in deionized water for 15 minutes and dried at 80°C for 30 minutes to obtain a test sample 4.

[0078] Comparative Example 2

[0079] Provide a pigtail tube 10, a blood inlet cage 20, a sleeve 30 and a blood outlet cage 40; assemble each component with a motor 50 and a catheter 60 into an integrated unit, ultrasonically clean it in deionized water for 15 minutes, and dry it at 80°C for 30 minutes to obtain a test sample 5.

[0080] Using pig blood as the flowing medium, build an in vitro simulated circulation loop. Respectively test the test samples 1-5 through the in vitro simulated circulation loop. The host computer controls the rotational speed of the samples to be 40000 rpm. After 7 days, take out the samples 1-5, observe the thrombosis and tissue in-growth conditions, and test and analyze the hemolysis, temperature rise and other conditions. The results are shown in the following table:

[0081] Sample Number Thrombus / Tissue Inward Growth Condition Hemolysis Index NIH Temperature Rise Test Sample 1 The inner and outer pipe walls are smooth, and no thrombus is seen 0.083 g / 100 L ≤2℃ Test Sample 2 The inner and outer pipe walls are smooth, and no thrombus is seen 0.078 g / 100 L ≤2℃ Test Sample 3 The inner and outer pipe walls are smooth, and no thrombus is seen 0.086 g / 100 L ≤2℃ Test Sample 4 There is a small amount of thrombus at the connection 0.19 g / 100 L ≤2℃ Test Sample 5 There is a small amount of thrombus at the connection 0.16 g / 100 L ≤2℃

[0082] The above shows and describes the basic principles, main features and characteristics of the present invention. Those skilled in the art of this industry should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and the specification only illustrates the principle of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A pumping assembly of a catheter pump, comprising a pigtail tube, a blood inlet cage, a sleeve and a blood outlet cage which are sequentially connected, characterized in that: At least a part of the inner surface and / or outer surface of the pumping assembly has a rough structure, and a lubricating liquid is introduced at the rough structure to form a film layer; the lubricating liquid includes component A and component B: Component A includes: 35-40 parts of polytetrafluoroethylene, 1-5 parts of hydrophobic nano-SiO2, 10-15 parts of polyethylene glycol 400, and 40-70 parts of absolute ethanol; Component B includes: perfluorotri-n-pentylamine or perfluoropolyether or Krytox® oil or liquid paraffin or vegetable oil; The coating method is as follows: (a) Immerse the pumping assembly in component A, soak for 10-20 minutes at 35-60 °C, then take it out, naturally dry for 5-10 minutes in a sterile environment, then wash with deionized water, and then vacuum dry at 80-100 °C for 30-60 minutes; (b) Drop component B on the pumping assembly obtained in step (a), tilt and rotate it so that the surface of the pumping assembly is evenly and comprehensively covered with component B.

2. The pumping assembly of the catheter pump according to claim 1, wherein: A nitinol memory alloy spring is embedded in the wall of the sleeve, and the spring extends from both ends of the sleeve and is welded to the blood inlet cage and the blood outlet cage respectively. A nitinol wire is embedded in the proximal wall of the pigtail tube and is welded to the blood inlet cage. All components are connected as a whole and the connection parts have a smooth transition.

3. The pumping assembly of the catheter pump according to claim 1, wherein: At least a part of the inner surface and / or outer surface of the pumping assembly has a rough structure in the form of texture, groove or dot matrix.

4. The pumping assembly of the catheter pump according to claim 1, characterized in that: Before, after or during the introduction of the lubricating liquid at the rough structure, the rough structure is pre-contacted with an active ingredient and / or an anticoagulant ingredient to form a film layer.

5. The pumping assembly of the catheter pump according to claim 4, wherein: The active ingredient is selected from one or more combinations of fibrinogen, silk fibroin, collagen, and polypeptide.

6. The pumping assembly of the catheter pump according to claim 4, characterized in that: The anticoagulant ingredient is selected from one or more combinations of unfractionated heparin, low molecular weight heparin, fondaparinux, factor Xa inhibitor, and thrombin inhibitor.

7. The pumping assembly of the catheter pump according to any one of claims 1-6, characterized in that, The method for forming the film layer is as follows: The rough structure is first contacted with polytetrafluoroethylene to form a first film layer, and after curing, it is then contacted with perfluorotri-n-pentylamine, perfluoropolyether, Krytox® oil, liquid paraffin or vegetable oil to form a second film layer; the thickness of the film layer ≤ 0.15 mm.

8. The pumping assembly of the catheter pump according to claim 1, characterized in that, The coating method is selected from any one of spraying, dip coating, drop coating, spin coating and bioprinting.

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