A drug balloon catheter

Abstract

The present invention provides a drug balloon catheter, comprising: a balloon, a push rod and a catheter base connected in sequence; the balloon comprises a balloon head, a balloon body and a marking band; the surface of the balloon body is covered with a drug coating, and the marking bands are arranged on both sides of the drug coating; the push rod is a hollow structure, and an inner cavity through which a guide wire can pass is provided throughout the entire length, and the balloon slides along the guide wire; the catheter base is connected to the push rod through a Y-shaped interface, and is provided with a guide wire port and a pressure pump port. The drug balloon catheter adopts a specific structure and connection relationship, and cooperates with a specific drug coating to achieve overall good interaction, and can attach the drug to the outer surface of the balloon as firmly as possible. At the same time, the drug-loaded drug on the outer surface of the balloon reduces the loss of the drug being washed by the blood in the blood vessels during the process of sending the balloon to the lesion site through the catheter, thereby solving the problems of low drug transfer efficiency and short sustained release drug efficacy period of the drug balloon after it is delivered to the lesion site.

Description

Technical Field

[0001] The present invention relates to the technical field of medical materials, and more particularly to a drug balloon catheter. Background Art

[0002] Peripheral arterial disease (PAD) refers to the narrowing or blockage of peripheral arteries and obstruction of blood flow due to atherosclerosis, resulting in symptoms and signs of ischemia. Peripheral arteries refer to blood vessels other than cardiovascular and cerebral arteries, but the majority of this disease occurs in the lower limbs, so peripheral arterial disease usually refers specifically to arteriosclerotic occlusive disease of the lower limb arteries. Lower limb arteriosclerosis obliterans (ASO) refers to a chronic progressive disease caused by arteriosclerosis, intimal thickening, lumen stenosis or occlusion of the lower limb blood supply arteries, insufficient blood supply to the affected limbs, and clinical manifestations such as intermittent claudication, hypothermia, pain, and even ulcers or necrosis of the lower limbs. It is often a manifestation of systemic arteriosclerotic vascular lesions in the lower limb arteries. The main cause of ASO is atherosclerosis.

[0003] With the development of interventional surgery and devices, many centers choose endovascular treatment as the preferred revascularization method because it has lower morbidity and mortality than surgery, and can be replaced by open surgery if the treatment fails. When intermittent claudication affects the quality of life, exercise or drug therapy is ineffective, and clinical characteristics suggest that endovascular treatment can improve patient symptoms and has a good risk-benefit ratio, endovascular treatment is the preferred treatment option. There are many endovascular technologies for the treatment of ASO, such as percutaneous balloon angioplasty (PTA), stent implantation, plaque resection, laser angioplasty, cutting balloon, drug balloon, cryoballoon, and thrombolytic therapy or thrombectomy.

[0004] In recent years, drug-coated balloon (DCB) has been widely used in the field of coronary artery and peripheral intervention in Europe as a new interventional treatment technology. In China, many DCB products have been or will be put into clinical use. The emergence of DCB provides a new option for the treatment of peripheral arterial disease in China.

[0005] At present, several drug balloons launched in China and abroad all use drugs and excipients to coat the balloons together, and the excipients are used to control the firmness of the drug coating. However, this drug coating will introduce one or more substances in addition to the effective drugs, and there is a certain probability that it will cause safety problems such as allergies or adverse irritation reactions in the human body. While the drug coating is released quickly, a lot of drugs will be washed away by the blood during the delivery process, and very few drugs will act locally. By increasing the drug loading of the balloon coating, the amount of drug absorption can be increased locally, but a large amount of excess drug flows to the distal end of the blood vessel, affecting the health of the patient. In addition, because the expansion time of ordinary drug balloon dilatation catheters is short, the drug is not easy to be released, and the blood vessels will quickly rebound to their original state after the ordinary balloon is withdrawn due to the loss of support, so the current ordinary drug balloon dilatation catheters face many problems and difficulties.

[0006] In summary, in order to better treat lower limb arteriosclerosis obliterans, there is an urgent need in clinical practice for a product that can increase the sustained release period of drugs within the blood vessel wall and greatly reduce drug loss during balloon intervention. Summary of the invention

[0007] In view of this, the object of the present invention is to provide a drug balloon catheter, which can attach the drug to the outer surface of the balloon as firmly as possible, and at the same time reduce the loss of the drug by blood washing in the blood vessels during the process of delivering the balloon to the lesion site through the catheter, thereby solving the problems of low drug transfer efficiency and short sustained release drug efficacy period of the drug balloon after it is delivered to the lesion site.

[0008] The present invention provides a drug balloon catheter, comprising:

[0009] The balloon, the push rod and the catheter base are connected in sequence;

[0010] The balloon comprises a balloon head, a balloon body and a marking band; the surface of the balloon body is covered with a drug coating, and the marking bands are arranged on both sides of the drug coating;

[0011] The push rod is a hollow structure, with an inner cavity through which a guide wire can pass, and the balloon slides along the guide wire;

[0012] The catheter base is connected to the push rod through a Y-shaped interface and is provided with a guide wire port and a pressure pump port.

[0013] Preferably, the drug coating is prepared from drug-loaded microspheres, a plasticizer and an amphiphilic liposome excipient; and the drug-loaded microspheres are prepared from drugs that inhibit intimal hyperplasia and a degradable polymer.

[0014] Preferably, the thickness of the drug coating is 10 μm to 20 μm; the particle size of the drug-loaded microspheres is 0.5 μm to 10 μm; the concentration of the drug for inhibiting intimal hyperplasia in the drug coating is 2 μg / mm 2 ~5μg / mm 2 .

[0015] Preferably, the plasticizer is selected from one or more of glycerol, ethanol, dimethyl sulfoxide, ethyl lactate, benzyl alcohol, benzyl benzoate, polyethylene oxide, vitamin E, tocopherol, liquid PEG, triethyl citrate, tributyl citrate, acetyl tributyl citrate, acetyl triethyl citrate, dibutyl phthalate, dibutyl sebacate, dimethyl phthalate, triacetin, and propylene glycol;

[0016] The amphiphilic liposome excipient is selected from one or more of dextran, polysorbate, sorbitol, and lac ammonium salt;

[0017] The drug for inhibiting intimal hyperplasia is selected from one or more of nimustine, carmustine, fluorouracil, fluguanidine, gemcitabine, daunorubicin, doxorubicin, rapamycin, paclitaxel, vinblastine, topotecan, aminoglutethimide, sirolimus, everolimus, and zotarolimus;

[0018] The degradable polymer is selected from one or more of polylactic acid, polyglycolic acid, polyvinylidene fluoride-hexafluoropropylene, polydioxanone, polycaprolactone, polyphosphazene, collagen, gelatin, chitosan, glycosaminoglycan, polyracemic lactide-glycolide, polylactide-caprolactone, monomethoxy polyethylene glycol polyracemic lactic acid-glycolic acid copolymer, polyethylene glycol polyracemic lactic acid-glycolic acid copolymer, and polytrimethylene carbonate.

[0019] Preferably, the preparation method of the drug coating is specifically as follows:

[0020] The drug-loaded microspheres, plasticizer and amphiphilic liposome excipient are mixed, ultrasonically shaken for 0.5 h to 1.5 h, and then filtered to obtain a spray solution;

[0021] The spray solution is atomized into droplets, which are then sprayed onto the surface of the balloon through a carrier gas, and dried to obtain a drug coating.

[0022] Preferably, the spraying chamber temperature is 15°C~30°C, the spraying chamber humidity is ≤70%, the air pressure is 1psi~2psi, the flow rate is 0.01mL / min~0.1mL / min, the spraying temperature is 30°C~50°C, and the spraying height is 10mm~80mm.

[0023] Preferably, the drying temperature is 40°C to 60°C, and the drying time is 20min to 40min.

[0024] Preferably, the preparation method of the drug-loaded microspheres is specifically as follows:

[0025] dissolving a drug for inhibiting intimal hyperplasia and a degradable polymer in a solvent to obtain a drug solution;

[0026] The drug solution is subjected to supercritical drying to obtain drug-loaded microspheres.

[0027] Preferably, the dosage ratio of the drug for inhibiting intimal hyperplasia, the degradable polymer and the solvent is (1 mg to 2 mg): 1 mg: (20 ml to 30 ml);

[0028] The solvent is selected from one or more of methanol, acetone, isopropanol, methyl vinyl ketone, dimethyl sulfoxide, ethyl acetate, acetonitrile, tetrahydrofuran, dichloromethane, chloroform, n-heptane, methyl acetate, and butyl acetate.

[0029] Preferably, the supercritical drying temperature is 35° C. to 40° C., the pressure is 5 MPa to 15 MPa, CO2 liquid is used, the filling flow rate is 14 LPM to 16 LPM, and the discharge flow rate is 8 LPM to 12 LPM.

[0030] The present invention provides a drug balloon catheter, comprising: a balloon, a push rod and a catheter base connected in sequence; the balloon comprises a balloon head, a balloon body and a marking band; the surface of the balloon body is covered with a drug coating, and the marking bands are arranged on both sides of the drug coating; the push rod is a hollow structure, and an inner cavity through which a guide wire can pass is provided throughout the entire length, and the balloon slides along the guide wire; the catheter base is connected to the push rod through a Y-shaped interface, and is provided with a guide wire port and a pressure pump port. Compared with the prior art, the drug balloon catheter provided by the present invention adopts a specific structure and connection relationship, and cooperates with a specific drug coating to achieve overall better interaction, and can attach the drug to the outer surface of the balloon as firmly as possible. At the same time, the drug-loaded drug on the outer surface of the balloon reduces the loss of the drug being washed by the blood in the blood vessels during the process of delivering the balloon to the lesion site through the catheter, thereby solving the problems of low drug transfer efficiency and short sustained release drug efficacy period of the drug balloon after it is delivered to the lesion site. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic diagram of the structure of a drug balloon catheter in an embodiment of the present invention;

[0032] Figure 2 Schematic diagram of the drug coating of the drug balloon catheter in an embodiment of the present invention;

[0033] Figure 3 The combined state of the drug and the biodegradable polymer in the embodiment of the present invention (SEM);

[0034] Figure 4The combined state (SEM) of the drug-loaded microspheres and the amphiphilic liposome excipient in the embodiment of the present invention;

[0035] Figure 5 This is an operation flow chart of a supercritical point dryer in an embodiment of the present invention;

[0036] Figure 6 This is the drug release curve of Passeo-18 Lux drug balloon in the comparative example;

[0037] Figure 7 This is the drug release curve of the embodiment of the present invention. DETAILED DESCRIPTION

[0038] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only 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.

[0039] The present invention provides a drug balloon catheter, comprising:

[0040] The balloon, the push rod and the catheter base are connected in sequence;

[0041] The balloon comprises a balloon head, a balloon body and a marking band; the surface of the balloon body is covered with a drug coating, and the marking bands are arranged on both sides of the drug coating;

[0042] The push rod is a hollow structure, with an inner cavity through which a guide wire can pass, and the balloon slides along the guide wire;

[0043] The catheter base is connected to the push rod through a Y-shaped interface and is provided with a guide wire port and a pressure pump port.

[0044] In the present invention, the drug balloon catheter is composed of a coaxial integral exchange (OTW) catheter with a drug-coated balloon fixed at the distal tip, the balloon is coated with a drug coating, and the drug coating is evenly distributed over the entire working length of the balloon. The main functional characteristic of the drug coating formula is to release the drug into the tissue of the blood vessel wall during the expansion process.

[0045] In the present invention, the drug balloon catheter adopts an OTW balloon, which is mostly used for CTO lesions; the drug balloon catheter comprises a balloon, a push rod and a catheter base which are connected in sequence.

[0046] In the present invention, the balloon comprises a balloon head, a balloon body and a marking band; the surface of the balloon body is covered with a drug coating, and the marking bands are arranged on both sides of the drug coating.

[0047] In the present invention, the push rod is a hollow structure, and an inner cavity through which a guide wire can pass is provided throughout its entire length, and the balloon slides along the guide wire.

[0048] In the present invention, the catheter base is connected to the push rod through a Y-shaped interface and is provided with a guide wire port and a pressure pump port.

[0049] In the present invention, the drug coating is preferably prepared from drug-loaded microspheres, plasticizers and amphiphilic liposome excipients; the drug-loaded microspheres can increase the sustained release period of the drug, and are preferably prepared from drugs that inhibit intimal hyperplasia and degradable polymers.

[0050] In the present invention, the thickness of the drug coating is preferably 10 μm to 20 μm, more preferably 14 μm to 16 μm; the particle size of the drug-loaded microspheres is preferably 0.5 μm to 10 μm, more preferably 1 μm to 5 μm; the concentration of the drug for inhibiting intimal hyperplasia in the drug coating is preferably 2 μg / mm 2 ~5μg / mm 2 , more preferably 3 μg / mm 2 ~4μg / mm 2 .

[0051] In the present invention, the addition of the plasticizer can prevent cracks or brittleness of the coating during inflation, and is preferably selected from one or more of glycerol, ethanol, dimethyl sulfoxide, ethyl lactate, benzyl alcohol, benzyl benzoate, polyethylene oxide, vitamin E, tocopherol, liquid PEG, triethyl citrate, tributyl citrate, acetyl tributyl citrate, acetyl triethyl citrate, dibutyl phthalate, dibutyl sebacate, dimethyl phthalate, triacetin, and propylene glycol, and more preferably ethanol. The present invention has no particular restrictions on the source of the plasticizer, and commercially available products well known to those skilled in the art can be used.

[0052] In the present invention, the amphiphilic liposome excipient uniformly adsorbs the drug-loaded microspheres on the balloon surface and plays a protective role during the balloon insertion and expansion process, and is preferably selected from one or more of dextran, polysorbate, sorbitol, and lac ammonium salt, and more preferably polysorbate. The present invention has no special restrictions on the source of the amphiphilic liposome excipient, and commercially available products well known to those skilled in the art can be used. In the present invention, the amphiphilic liposome excipient can improve the drug transfer efficiency and reduce drug loss.

[0053] In the present invention, the drug for inhibiting intimal hyperplasia is preferably selected from one or more of nimustine, carmustine, fluorouracil, fluguanidine, gemcitabine, daunorubicin, doxorubicin, rapamycin, paclitaxel, vinblastine, topotecan, aminoglutethimide, sirolimus, everolimus, and zotarolimus, more preferably rapamycin and / or paclitaxel, and even more preferably rapamycin. The present invention has no particular restrictions on the source of the drug for inhibiting intimal hyperplasia, and commercially available products well known to those skilled in the art can be used.

[0054] In the present invention, the degradable polymer is preferably selected from one or more of polylactic acid, polyglycolic acid, polyvinylidene fluoride-hexafluoropropylene, polydioxanone, polycaprolactone, polyphosphazene, collagen, gelatin, chitosan, glycosaminoglycan, polyracemic lactide-glycolide, polylactide-caprolactone, monomethoxy polyethylene glycol polyracemic lactic acid-glycolic acid copolymer, polyethylene glycol polyracemic lactic acid-glycolic acid copolymer, and polytrimethylene carbonate, and more preferably polyvinylidene fluoride-hexafluoropropylene. The present invention has no particular restrictions on the source of the degradable polymer, and commercially available products well known to those skilled in the art can be used.

[0055] In the present invention, the preparation method of the drug coating is preferably as follows:

[0056] The drug-loaded microspheres, plasticizer and amphiphilic liposome excipient are mixed, ultrasonically shaken for 0.5 h to 1.5 h, and then filtered to obtain a spray solution;

[0057] The spray solution is atomized into droplets, which are then sprayed onto the surface of the balloon through a carrier gas, and dried to obtain a drug coating.

[0058] In the present invention, the spraying process is preferably carried out in a spraying chamber, the temperature of the spraying chamber is preferably 15°C~30°C, more preferably 20°C~29°C, the humidity of the spraying chamber is preferably ≤70%, more preferably ≤60%, the air pressure is preferably 1psi~2psi, more preferably 1.3psi~1.5psi, the flow rate is preferably 0.01mL / min~0.1mL / min, more preferably 0.04mL / min~0.06mL / min, the spraying temperature is preferably 30°C~50°C, and the spraying height is preferably 10mm~80mm.

[0059] In the present invention, the drying temperature is preferably 40° C. to 60° C., more preferably 50° C., and the drying time is preferably 20 min to 40 min, more preferably 30 min.

[0060] In the present invention, the method for preparing the drug-loaded microspheres is preferably as follows:

[0061] dissolving a drug for inhibiting intimal hyperplasia and a degradable polymer in a solvent to obtain a drug solution;

[0062] The drug solution is subjected to supercritical drying to obtain drug-loaded microspheres.

[0063] In the present invention, the dosage ratio of the drug for inhibiting intimal hyperplasia, the degradable polymer and the solvent is preferably (1 mg to 2 mg): 1 mg: (20 ml to 30 ml).

[0064] In the present invention, the solvent is preferably selected from one or more of methanol, acetone, isopropanol, methyl vinyl ketone, dimethyl sulfoxide, ethyl acetate, acetonitrile, tetrahydrofuran, dichloromethane, chloroform, n-heptane, methyl acetate, and butyl acetate, and is more preferably tetrahydrofuran. The present invention has no particular restrictions on the source of the solvent, and commercially available products known to those skilled in the art can be used.

[0065] In the present invention, the temperature of the supercritical drying is preferably 35°C~40°C, the pressure is preferably 5MPa~15MPa, more preferably 9MPa~11MPa, CO2 liquid is used, the filling flow rate is preferably 14LPM~16LPM, and the discharge flow rate is preferably 8LPM~12LPM.

[0066] On this basis, the present invention first dissolves the drug and the degradable polymer in a solvent to obtain a drug solution, then collects drug-loaded microspheres with a required particle size through supercritical drying technology, mixes them into a solution containing an excipient, and adds a plasticizer to obtain a drug spray solution; finally, the drug spray solution is sprayed onto the surface of the balloon through an ultrasonic nozzle of a drug spray device, and the drug-coated balloon is obtained after drying.

[0067] The present invention has the following beneficial effects:

[0068] Currently, balloon angioplasty is the mainstream method for treating peripheral arterial disease. Compared with drug-eluting stents (DES), the drug balloon of the drug balloon catheter provided by the present invention is for short-term contact and is not covered by metal foreign matter, thereby greatly reducing the risks of intimal hyperplasia and thrombosis. The present invention combines rapamycin with a biodegradable polymer to form tens of thousands of drug-loaded microspheres, thereby achieving consistent and predictable drug release. It has the ability to continuously release drugs and the retention time of drugs in the blood vessel wall comparable to DES technology.

[0069] At the same time, the drug balloon provided by the present invention is compared with similar products. Domestic similar products use drugs and excipients to coat the balloon together, and the excipients are used to control the firmness of the drug coating; however, this drug coating will introduce one or more substances other than the effective drug, and there is a certain probability of causing safety problems such as allergic or adverse irritation reactions in the human body; and while the drug coating is released quickly, a lot of drugs will be washed away by the blood during the delivery process, and very little drug will act locally; the present invention uses a proprietary amphiphilic excipient as a carrier, which combines the drug-loaded microspheres to the balloon surface, playing a protective role during balloon insertion and expansion; while improving the drug transfer efficiency, it reduces drug loss during balloon intervention, and maximizes the drug uptake by cells in the vascular wall.

[0070] The present invention provides a drug balloon catheter, comprising: a balloon, a push rod and a catheter base connected in sequence; the balloon comprises a balloon head, a balloon body and a marking band; the surface of the balloon body is covered with a drug coating, and the marking bands are arranged on both sides of the drug coating; the push rod is a hollow structure, and an inner cavity through which a guide wire can pass is provided throughout the entire length, and the balloon slides along the guide wire; the catheter base is connected to the push rod through a Y-shaped interface, and is provided with a guide wire port and a pressure pump port. Compared with the prior art, the drug balloon catheter provided by the present invention adopts a specific structure and connection relationship, and cooperates with a specific drug coating to achieve overall better interaction, and can attach the drug to the outer surface of the balloon as firmly as possible. At the same time, the drug-loaded drug on the outer surface of the balloon reduces the loss of the drug being washed by the blood in the blood vessels during the process of delivering the balloon to the lesion site through the catheter, thereby solving the problems of low drug transfer efficiency and short sustained release drug efficacy period of the drug balloon after it is delivered to the lesion site.

[0071] In order to further illustrate the present invention, the following examples are provided for detailed description. Example

[0072] See also Figure 1 , Figure 1 Schematic diagram of the structure of a drug balloon catheter in an embodiment of the present invention; the drug balloon catheter is composed of a coaxial integral exchange (OTW) catheter with a drug-coated balloon fixed at the distal head end, including a balloon head, a balloon body, a marking band, a push rod, and a catheter seat; the catheter seat is connected to the push rod through a Y-shaped interface, and is provided with a guide wire port and a pressure pump port; the push rod is a hollow structure without a metal core, and has an inner cavity through the entire length for the guide wire to pass, and the balloon slides along the guide wire; the drug coating covers the surface of the balloon body, and the marking bands are arranged on both sides of the drug coating; when in use, water or air is injected into the drug balloon catheter through a pressure pump to expand the balloon, and the balloon continuously acts on the blood vessel wall at the stenotic site, so that the blood vessel generates external tension around the entire circumference, thereby rapidly expanding the stenotic lumen.

[0073] See also Figure 2 , Figure 2 Schematic diagram of the drug coating of the drug balloon catheter in the embodiment of the present invention; the total drug concentration in the drug coating is 3 μg / mm 2 ~4μg / mm 2 .

[0074] The preparation method is as follows:

[0075] (1) Dissolve 150 mg of rapamycin and 100 mg of the biodegradable polymer polyvinylidene fluoride-hexafluoropropylene in 25 ml of tetrahydrofuran solvent to obtain a drug solution; then inject the fully dissolved solution into a desktop supercritical point dryer for supercritical drying (see the operation process for details). Figure 5 ), the corresponding process parameters are shown in Table 1, and the drug-loaded microspheres ( Figure 3 The collected drug-loaded microspheres were mixed with 1 wt% polysorbate aqueous solution and dissolved in 10 ml of ethanol, ultrasonically shaken for 1 h, and filtered to obtain a spray solution.

[0076]

[0077] (2) Place the spray solution in the drug supply device of the spray equipment, atomize the drug solution supplied by the drug supply system into uniform droplets through the ultrasonic generator, and then spray the liquid mist onto the balloon through the carrier gas to obtain a fine, uniform and firm drug coating ( Figure 4 ); the corresponding spraying process parameters are shown in Table 2. After spraying, the balloon is placed in a special drying oven for drying at a temperature of 50°C and a drying time of 30 minutes to obtain a drug coating.

[0078]

[0079] The information on the preparation of the drug coating in the examples of the present invention is shown in Table 3 below.

[0080]

[0081] The drug release rate of the drug-coated balloon catheter provided by the present invention is shown in Table 4 below, and the drug release cycle of the drug-coated balloon catheter provided by the present invention is shown in Table 4 below. Figures 6 and 7 .

[0082]

[0083] Experimental results show that the paclitaxel drug-coated balloon Passeo-18 Lux launched by Biotronik for the treatment of lower extremity arterial disease has been verified to have a rapid release of paclitaxel in the blood vessels within one week, and the drug release lasts for nearly 1 month ( Figure 6The coating technology of the present invention provides an optimal delivery mechanism, ensuring minimal drug loss during product delivery and balloon dilation. Experiments have shown that the drug balloon dilation catheter prepared by the present invention for peripheral vascular dissection can increase drug release time to 3 months ( Figure 7 ), greatly improving the effectiveness of continuous treatment.

[0084] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A drug balloon catheter, characterized in that: include: The balloon, the push rod and the catheter base are connected in sequence; The balloon comprises a balloon head, a balloon body and a marker band; the surface of the balloon body is covered with a drug coating, and the marker bands are arranged on both sides of the drug coating; the drug coating is prepared from drug-loaded microspheres, a plasticizer and an amphiphilic liposome excipient; the drug-loaded microspheres are prepared from drugs that inhibit intimal hyperplasia and a degradable polymer; The plasticizer is ethanol; The amphiphilic liposome excipient is polysorbate; The degradable polymer is polyvinylidene fluoride-hexafluoropropylene; The push rod is a hollow structure, with an inner cavity through which a guide wire can pass, and the balloon slides along the guide wire; The catheter base is connected to the push rod via a Y-shaped interface and is provided with a guide wire port and a pressure pump port; The preparation method of the drug-loaded microspheres is specifically as follows: dissolving a drug for inhibiting intimal hyperplasia and a degradable polymer in a solvent to obtain a drug solution; The drug solution is subjected to supercritical drying to obtain drug-loaded microspheres; The dosage ratio of the drug for inhibiting intimal hyperplasia, the degradable polymer and the solvent is (1 mg to 2 mg): 1 mg: (20 ml to 30 ml); The solvent is selected from one or more of methanol, acetone, isopropanol, methyl vinyl ketone, dimethyl sulfoxide, ethyl acetate, acetonitrile, tetrahydrofuran, dichloromethane, chloroform, n-heptane, methyl acetate, and butyl acetate; The supercritical drying temperature is 35° C. to 40° C., the pressure is 5 MPa to 15 MPa, CO2 liquid is used, the filling flow rate is 14 LPM to 16 LPM, and the discharge flow rate is 8 LPM to 12 LPM.

2. The drug balloon catheter according to claim 1, characterized in that: The thickness of the drug coating is 10 μm to 20 μm; the particle size of the drug-loaded microspheres is 0.5 μm to 10 μm; the concentration of the drug for inhibiting intimal hyperplasia in the drug coating is 2 μg / mm 2 ~5μg / mm 2 .

3. The drug balloon catheter according to claim 1, characterized in that: The drug for inhibiting intimal hyperplasia is selected from one or more of nimustine, carmustine, fluorouracil, fluguanidine, gemcitabine, daunorubicin, doxorubicin, rapamycin, paclitaxel, vinblastine, topotecan, aminoglutethimide, sirolimus, everolimus, and zotarolimus.

4. The drug balloon catheter according to claim 1, characterized in that: The preparation method of the drug coating is specifically as follows: The drug-loaded microspheres, plasticizer and amphiphilic liposome excipient are mixed, ultrasonically shaken for 0.5 h to 1.5 h, and then filtered to obtain a spray solution; The spray solution is atomized into droplets, which are then sprayed onto the surface of the balloon through a carrier gas, and dried to obtain a drug coating.

5. The drug balloon catheter according to claim 4, characterized in that: The spraying chamber temperature is 15°C to 30°C, the spraying chamber humidity is ≤70%, the air pressure is 1psi to 2psi, the flow rate is 0.01mL / min to 0.1mL / min, the spraying temperature is 30°C to 50°C, and the spraying height is 10mm to 80mm.

6. The drug balloon catheter according to claim 4, characterized in that: The drying temperature is 40° C. to 60° C., and the drying time is 20 min to 40 min.

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