A new type of drug-releasing balloon catheter capable of controlling drug release and its use

Abstract

The present application provides a new type of drug-infused balloon catheter with controlled drug release, comprising a balloon (1), a catheter (2) and a drug coating (3), the surface of the balloon (1) is coated with a drug coating (3), the drug coating (3) is divided into a first drug coating (31), a second drug coating (32) and a third drug coating (33), the drug release rates of the first drug coating (31), the second drug coating (32) and the third drug coating (33) are different, the drug release cycle is controlled to solve the problem of toxic reactions caused downstream of the blood vessel, and at the same time, the drug release cycle is extended, effectively treating blood vessel laceration caused by excessive expansion, and improving the long-term effect of drug therapy.

Description

[Technical field]

[0001] The present invention relates to the technical field of medical devices, e.g. A61F2 / 958, in particular to a new type of drug balloon catheter capable of controlling drug release and its use. [Background technology]

[0002] At present, cardiovascular disease has become the most fatal disease threatening human health. Cardiovascular disease mainly manifests as vascular stenosis, which leads to insufficient blood supply to some organs, loss of original function, and even vascular blockage, threatening life. At present, the most widely used treatment for cardiovascular disease is percutaneous transluminal angioplasty, which currently mainly uses drug-eluting stents and drug balloons, where the drug balloon uses a balloon catheter to deliver antiproliferative drugs to the vascular lesion in a minimally invasive manner, and the balloon expands to transfer the drug in the balloon to the inner wall of the blood vessel, so that the dual effects of balloon expansion and antiproliferative drugs can be used to treat vascular stenosis, effectively inhibiting the excessive proliferation of smooth muscle cells, reducing the incidence of restenosis, eliminating the need for stent placement, and reducing the risk of bleeding.

[0003] The shape and dimensions of the blood vessels in the human body are important data before and after treatment. Clinical image data analysis shows that, because human blood vessels are cone-shaped, the diameters of the proximal and distal ends of the blood vessels in the lesion area are not consistent. If the diameter of the balloon is expanded to match the larger end of the blood vessel, it will be overexpanded and the smaller end of the blood vessel will tear, damaging the blood vessel. However, the release rate of the drug coating of the traditional drug balloon is single, and in a certain period, the drug will further accumulate on the downstream side of the blood vessel, which may cause vascular toxicity. If the release rate is too fast, this toxic reaction will be aggravated. If the release rate is too slow, the concentration of the active drug in the lesion area will be low, and the stenosis inhibition effect will be weak. In addition, in the blood flowing environment where the drug balloon is located, the drug coating layer on the surface will be easily washed away, thus reducing the therapeutic effect of the balloon on the lesion. If there are many particles in the coating layer and the dimension is large, it may also cause the potential risk of vascular occlusion.

[0004] Chinese patent application CN108378964 A discloses a drug balloon, and sprays drug coatings with different drug loading densities on the surface of the balloon to reduce drug toxicity; Chinese patent application CN107670163A discloses a drug balloon dilation catheter and its manufacturing method and use; the technology reduces the problem of uneven drug concentration in blood vessels in a short time by spraying coating layers carrying different amounts of drugs on the proximal and distal ends of the balloon, but this technology requires strict control of the spraying process of the drug coating, and the drug immobilization effect is small, the duration in blood is short, and the therapeutic effect is not long-lasting. In the above two patent applications, although the drug dosage in the balloon is different, the drug release cycle is consistent, and in a certain period of time, the amount of drug on the downstream side of the blood vessel increases rapidly, still causing vascular toxicity; after a certain period of time, the amount of drug at the vascular laceration site decreases, and the therapeutic effect also decreases. Summary of the Invention

[0005] In order to solve the above technical problems, the present invention first provides a new type of drug-release balloon catheter that can control drug release, and by controlling the drug release cycle, solves the problem of toxic reactions caused downstream of the blood vessel, and at the same time extends the drug release cycle, effectively treats vascular laceration caused by excessive expansion, and improves the long-term effect of drug therapy.

[0006] Furthermore, the drug balloon catheter includes a balloon 1, a catheter 2, and a drug coating 3, and the drug coating 3 is applied to the surface of the balloon 1, and the drug coating 3 is divided into a first drug coating 31, a second drug coating 32, and a third drug coating 33.

[0007] Furthermore, the catheter 2 is provided on both sides of the balloon 1, and the catheter 2 is connected to the two apical ends of the balloon 1.

[0008] Furthermore, the first drug coating 31, the second drug coating 32 and the third drug coating 33 are arranged horizontally in parallel along the surface of the balloon 1, dividing the surface of the balloon 1 into a three-stage structure.

[0009] Preferably, the release rates of the drugs in the first drug coating 31, second drug coating 32 and third drug coating 33 are different.

[0010] Furthermore, the raw materials of the drug coating 3 include active drugs, adhesives, sustained release agents, and polyol-based materials.

[0011] Further, the raw materials of the drug coating include, by weight, 20-100 parts of active drug, 10-80 parts of adhesive, 5-65 parts of sustained release agent, and 5-70 parts of polyol-based material.

[0012] Preferably, the ingredients of the drug coating 3 include 20-80 parts active drug, 10-70 parts adhesive, 5-60 parts sustained release agent, and 5-60 parts polyol-based material.

[0013] Additionally, the active agents are used to inhibit smooth muscle cell proliferation, reduce intimal hyperplasia, and reduce the incidence of restenosis and inflammatory responses, and include, but are not limited to, rapamycin, taxol, zotarolimus, heparin, hirudin, aspirin, dexamethasone, and any combination of one or more of their derivatives.

[0014] Preferably, the active agent is selected from the group consisting of rapamycin, taxol, heparin, hirudin and a combination of one or more of their derivatives.

[0015] Furthermore, the drug coating layer has an active drug loading of 1 to 10 μg / mm 2 It is.

[0016] Furthermore, the adhesive is used to enhance the adhesion of the drug to the blood vessel, inhibit the loss of the active drug due to blood washing away, and improve the therapeutic effect and durability of the drug on the blood vessel.

[0017] Furthermore, the adhesive is selected from at least one of an ester-based substance, an amide-based substance, a liposome, a carboxylic acid-based substance, and a polyhydroxy-based substance.

[0018] Furthermore, the ester-based material is selected from any one or a combination of several of PEG-hyaluronic acid copolymer, poly(lactic-co-glycolic acid) (PLGA), PEG-PLGA block copolymer, polylactide, polysorbate 80, polyhydroxyalkanoate, polylactic acid, polyvinyl acetate, polyhydroxybutyric acid valeric acid copolymer, and sebacic acid copolymer.

[0019] Further, the amide-based substance is selected from any one or a combination of several of iopromide, polyvinylpyrrolidone, polyamide, chitosan-modified polyamide, amino acid, N-[3-(2-dibutylaminoethyl)-1H-indol-5-yl]naphthalene-1-sulfonamide, and N-[3-(2-diethylaminoethyl)-1H-indol-5-yl]-trans-β-styrenesulfonamide, and is preferably iopromide.

[0020] Furthermore, the carboxylic acid-based substance is selected from any one or a combination of several of tannic acid, shellac, hyaluronic acid, and salts thereof.

[0021] Furthermore, the polyhydroxyl-based material is any one or a combination of several of PEG, chitosan, and cyclodextrin.

[0022] Further, the liposome may be selected from any one or combination of soy lecithin, lecithin, cholesterol, cephalin, distearoylphosphatidylcholine, dimyristoylphosphatidylcholine, and modifications thereof.

[0023] In a preferred embodiment, the liposome is soy lecithin or cholesterol.

[0024] Further, in the drug coating, the sustained release agent is any one or a combination of several of mPEG-PLGA copolymer, poly-3-hydroxybutyrate, hydroxybutyrate-hydroxyvalerate copolymer, sodium alginate hydrogel, chitosan, cellulose, pectin, and alkyl glycoside.

[0025] Preferably, the sustained release agent is any one or a combination of several of mPEG-PLGA copolymer, hydroxybutyric acid-hydroxyvaleric acid copolymer, and sodium alginate hydrogel.

[0026] In a preferred embodiment, the sustained release agent is an mPEG-PLGA copolymer.

[0027] Furthermore, in the mPEG-PLGA copolymer, the number average molecular weight of mPEG is 4,000-90,000, and the number average molecular weight of PLGA is 1,000-150,000.

[0028] Furthermore, in the mPEG-PLGA copolymer, the number average molecular weight of mPEG is 5,000 to 80,000, and the number average molecular weight of PLGA is any one or a combination of several of 1,000 to 3,000, 3,000 to 5,000, 5,000 to 10,000, 50,000 to 70,000, and 100,000 to 120,000.

[0029] Preferably, in the mPEG-PLGA copolymer, the number average molecular weight of mPEG is 5,000 to 60,000, and the number average molecular weight of PLGA is any one or a combination of several of 5,000 to 10,000, 50,000 to 70,000, and 100,000 to 120,000.

[0030] Furthermore, the number average molecular weights of the PLGA in the mPEG-PLGA copolymer are different for the first drug coating, the second drug coating, and the third drug coating.

[0031] In the present application, the long molecular chain of mPEG-PLGA copolymer is used to encapsulate the active agent, and the polar groups of the active agent, such as -NH-, -O-, -OH, C=O, form intermolecular hydrogen bonds or conjugates with the polar groups or ring structures of the active agent, so that the active agent is immobilized in the crosslinked structure formed by the mPEG-PLGA copolymer, and the degree of crosslinking of the structure is adjusted by adjusting the molecular weight of mPEG and PLGA in the mPEG-PLGA copolymer molecule, and the release rate of the drug is further controlled. If the molecular weight of PLGA is too large, more energy is required for the decomposition of the mPEG-PLGA copolymer, and the residence time of the active agent in the vascular wall is also extended. However, if the molecular weight is too large, the drug release concentration will be reduced in a short period of time. If the molecular weight is too low, the therapeutic effect on vascular laceration will be poor; if the molecular weight is too small, the crosslinked molecular chains of the mPEG-PLGA copolymer will not be sufficient to encapsulate the active drug, so that the active drug will easily flow with the blood, have a short residence time in the vascular wall, release a large amount of drug in a short time, and have a short duration of action. Based on this, the present application specifies that the molecular weights of the mPEG-PLGA copolymers used in the first drug coating, the second drug coating, and the third drug coating in the drug balloon are different, and further realize the control of the drug release rate and release cycle in the first drug coating, the second drug coating, and the third drug coating, so as to improve the sustained release effect of the drug, extend the effective treatment time, and avoid toxic vascular reactions.

[0032] Furthermore, the present application does not strictly define the number average molecular weight of PLGA of the mPEG-PLGA copolymer in the first drug coating, the second drug coating and the third drug coating, but only requires that the number average molecular weights of PLGA of the mPEG-PLGA copolymer in the three coating layers are not identical, therefore, the coating layers in the drug balloon have 24 different combination methods and can be arranged according to the situation of vascular calcification and laceration.

[0033] In one embodiment, in the first drug coating of the balloon catheter, the number average molecular weight of PLGA of the mPEG-PLGA copolymer is 5,000 to 10,000, in the second drug coating, the number average molecular weight of PLGA of the mPEG-PLGA copolymer is 50,000 to 70,000, and in the third drug coating, the number average molecular weight of PLGA of the mPEG-PLGA copolymer is 100,000 to 120,000, and it is only necessary to place the third coating (i.e., the end where the number average molecular weight of PLGA of the mPEG-PLGA copolymer is the highest) on the end where the vascular laceration is severe.

[0034] In another embodiment, in the first drug coating of the balloon catheter, the number average molecular weight of PLGA of the mPEG-PLGA copolymer is 50,000 to 70,000, in the second drug coating, the number average molecular weight of PLGA of the mPEG-PLGA copolymer is 5,000 to 10,000, and in the third drug coating, the number average molecular weight of PLGA of the mPEG-PLGA copolymer is 100,000 to 120,000, and it is only necessary to place the third coating (i.e., the end where the number average molecular weight of PLGA of the mPEG-PLGA copolymer is the highest) on the end where the vascular laceration is severe.

[0035] In another embodiment, in the first drug coating of the balloon catheter, the number average molecular weight of the PLGA of the mPEG-PLGA copolymer is 100,000-120,000, in the second drug coating, the number average molecular weight of the PLGA of the mPEG-PLGA copolymer is 5,000-10,000, and in the third drug coating, the number average molecular weight of the PLGA of the mPEG-PLGA copolymer is 50,000-70,000, and the first coating layer only needs to be placed at the end where the vascular laceration is severe, and can also be placed according to needs.

[0036] Further, the polyol-based substance is selected from any one or a combination of several of polyvinyl alcohol, mannitol, sorbitol, xylitol, resveratrol, and pentaerythritol.

[0037] Preferably, the polyol-based substance is polyvinyl alcohol, and the number average molecular weight thereof is 5,000 to 60,000, more preferably 8,000 to 30,000.

[0038] Furthermore, the preparation method of the first drug coating, the second drug coating and the third drug coating only requires dissolving the raw materials of the coating layers in an organic solvent, mixing them uniformly, and ultrasonically preparing them into the form of microspheres, which are then sprayed onto the surface of the balloon.

[0039] Further, the organic solvent includes, but is not limited to, at least one of ethyl alcohol, glycerin, isopropanol, ethyl ether, acetone, ethyl acetate, and ethyl formate.

[0040] Furthermore, the organic solvent accounts for 30-80% of the total amount of the organic solvent and the coating raw materials.

[0041] Furthermore, the average diameter of the microspheres is 10 μm, preferably 0.05 to 8 μm.

[0042] Furthermore, in the present application, the structure of the drug balloon is not particularly limited, and it is a commercially available ordinary balloon.

[0043] Furthermore, in the present application, the form of the drug balloon catheter is not particularly limited, and includes any one of OTW and RX, but is not limited thereto.

[0044] Furthermore, the balloon catheter described herein is adapted for vasodilation.

[0045] Beneficial effects

[0046] 1. The balloon catheter provided by the present application can control the drug release cycle without changing the drug dosage, solve the problem of toxic reactions caused downstream of the blood vessel, and effectively extend the drug release cycle at the vascular laceration site, solve the laceration caused by excessive vasodilation, effectively inhibit the proliferation of vascular smooth muscle cells, reduce the incidence of restenosis, and reduce inflammatory reactions.

[0047] 2. The drug balloon of the present application is designed with three coatings, each of which has a different drug release rate. Furthermore, the molecular weight of the sustained-release agent mPEG-PLGA copolymer in the drug coating can be controlled to control the drug release level in each coating, so as to extend the adhesion and retention time of the drug in the vascular wall and provide continuous treatment for the vascular laceration site.

[0048] 3. In the coating of this application, the sustained-release agent can effectively encapsulate the active drug and control the release rate; the adhesive can interact with the active drug intermolecularly and increase its adhesive force to the vascular wall through its functional group; the polyol-based substance has excellent hydrophilicity and activates the coating to release the drug inside; the interaction between each component in the coating material can be utilized to effectively control the amount of drug released and the adhesive force to the vascular wall, and reduce the loss of the active drug due to blood washing; and the balloon is excellent for treating vascular laceration sites. [Brief description of the drawings]

[0049] [Figure 1] FIG. 1 is a schematic diagram of a drug balloon catheter of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0050] Example 1 This embodiment provides a medicinal balloon catheter including a balloon 1, a catheter 2, and a medicinal coating 3. The medicinal coating 3 is applied to the surface of the balloon 1, and the medicinal coating 3 is divided into a first medicinal coating 31, a second medicinal coating 32, and a third medicinal coating 33.

[0051] The raw materials of the first drug coating 31 are, by weight, 50 parts of rapamycin, 40 parts of soybean lecithin, 30 parts of mPEG-PLGA copolymer, and 30 parts of PEG, the number average molecular weight of the PEG is 20,000, the number average molecular weight of the mPEG-PLGA copolymer is 32,000, and the number average molecular weight of the PLGA is 8,000, and the drug loading of the first drug coating is 4 μg / mm 2 and

[0052] The raw materials of the second drug coating 32, by weight, were 60 parts rapamycin, 50 parts soy lecithin, 20 parts mPEG-PLGA copolymer, and 20 parts PEG, the number average molecular weight of the PEG was 20,000, the number average molecular weight of the mPEG-PLGA copolymer was 32,000, and the number average molecular weight of the PLGA was 60,000, and the drug loading of the second drug coating was 5 μg / mm 2 and

[0053] The raw materials of the third drug coating 33 are, by weight, 50 parts of rapamycin, 40 parts of soy lecithin, 20 parts of mPEG-PLGA copolymer, and 30 parts of PEG. The number average molecular weight of the PEG is 20,000. The number average molecular weight of the mPEG-PLGA copolymer is 32,000 and the number average molecular weight of the PLGA is 110,000. The drug loading of the third drug coating is 4 μg / mm 2 and

[0054] The preparation method of the first drug coating, the second drug coating and the third drug coating is as follows: the raw materials of each coating are mixed respectively, dissolved in ethyl acetate, and mixed uniformly so that the mass of the raw materials accounts for 50% and the mass of the ethyl acetate solution accounts for 50%, and then ultrasonically molded into the form of microspheres, the average diameter of the microspheres is 3 μm, which can then be simply sprayed onto a predetermined position on the surface of the balloon.

[0055] The measurement standard of parts by weight above is uniform. Example 2

[0056] This embodiment provides a medicinal balloon catheter including a balloon 1, a catheter 2, and a medicinal coating 3. The medicinal coating 3 is applied to the surface of the balloon 1, and the medicinal coating 3 is divided into a first medicinal coating 31, a second medicinal coating 32, and a third medicinal coating 33.

[0057] The raw materials of the first drug coating 31 are, by weight, 20 parts of rapamycin, 10 parts of soybean lecithin, 5 parts of mPEG-PLGA copolymer, and 5 parts of PEG, the number average molecular weight of the PEG is 30,000, the number average molecular weight of the mPEG-PLGA copolymer is 5,000, and the number average molecular weight of the PLGA is 50,000, and the drug loading of the first drug coating is 2 μg / mm 2 and

[0058] The raw materials of the second drug coating 32, by weight, were 60 parts rapamycin, 50 parts soy lecithin, 30 parts mPEG-PLGA copolymer, and 30 parts PEG, the number average molecular weight of the PEG was 5000, the number average molecular weight of the mPEG-PLGA copolymer was 5000, and the number average molecular weight of the PLGA was 10000, and the drug loading of the second drug coating was 6 μg / mm 2 and

[0059] The raw materials of the third drug coating 33 are, by weight, 80 parts of rapamycin, 70 parts of soybean lecithin, 60 parts of mPEG-PLGA copolymer, and 60 parts of PEG. The number average molecular weight of the PEG is 10,000. The number average molecular weight of the mPEG-PLGA copolymer is 60,000. The number average molecular weight of the PLGA is 120,000. The drug loading of the third drug coating is 8 μg / mm 2 and

[0060] The preparation method of the first drug coating, the second drug coating and the third drug coating is as follows: the raw materials of each coating are mixed respectively, dissolved in ethyl acetate, and mixed uniformly such that the mass of the raw materials accounts for 70% and the mass of the ethyl acetate solution accounts for 30%, and then ultrasonically molded into the form of microspheres, the average diameter of the microspheres is 8 μm, which can then be sprayed onto a predetermined position on the surface of the balloon.

[0061] The measurement standard of parts by weight above is uniform. Example 3

[0062] This embodiment provides a medicinal balloon catheter including a balloon 1, a catheter 2, and a medicinal coating 3. The medicinal coating 3 is applied to the surface of the balloon 1, and the medicinal coating 3 is divided into a first medicinal coating 31, a second medicinal coating 32, and a third medicinal coating 33.

[0063] The raw materials of the first drug coating 31 are, by weight, 30 parts of rapamycin, 10 parts of soybean lecithin, 15 parts of mPEG-PLGA copolymer, and 10 parts of PEG. The number average molecular weight of the PEG is 10,000. The number average molecular weight of the mPEG-PLGA copolymer is 10,000 and the number average molecular weight of the PLGA is 100,000. The drug loading of the first drug coating is 3.5 μg / mm 2 and

[0064] The raw materials of the second drug coating 32, by weight, were 40 parts rapamycin, 30 parts soy lecithin, 30 parts mPEG-PLGA copolymer, and 5 parts PEG, the number average molecular weight of the PEG was 5000, the number average molecular weight of the mPEG-PLGA copolymer was 20000, and the number average molecular weight of the PLGA was 5000, and the drug loading of the second drug coating was 6 μg / mm 2 and

[0065] The raw materials of the third drug coating 33 are, by weight, 70 parts of rapamycin, 50 parts of soybean lecithin, 50 parts of mPEG-PLGA copolymer, and 50 parts of PEG. The number average molecular weight of the PEG is 8,000. The number average molecular weight of the mPEG-PLGA copolymer is 40,000. The number average molecular weight of the PLGA is 50,000. The drug loading of the third drug coating layer is 6 μg / mm 2 and

[0066] The preparation method of the first drug coating, the second drug coating and the third drug coating is as follows: the raw materials of each coating are mixed respectively, dissolved in ethyl acetate, and mixed uniformly so that the mass of the raw materials accounts for 20% and the mass of the ethyl acetate solution accounts for 80%, and then ultrasonically molded into the form of microspheres, the average diameter of the microspheres is 0.05 μm, which can then be sprayed onto a predetermined position on the surface of the balloon.

[0067] The measurement standard of parts by weight above is uniform.

[0068] Both the PEG and mPEG-PLGA copolymers are purchased from Evonik.

[0069] Performance Test Method

[0070] The sustained release effect of drugs carrying mPEG-PLGA with different molecular weights is verified through animal experiments. Using a miniature pig animal model, drugs carrying mPEG-PLGA with different molecular weights are administered into the pig animal model, and the timing is set to 0 (immediate), 30 days, 60 days, and 90 days. Drug tests are performed on the blood vessels by removing the pig vascular model.

[0071] The experimental subjects were miniature pig animal models weighing 25 to 45 kg. The experimental product contained 6 μg / mm 2 These are drug balloons carrying mPEG-PLGA with different molecular weights.

[0072] The experimental method is as follows.

[0073] (1) Four porcine animal models were selected, corresponding to the timing of 0 (immediate), 30 days, 60 days, and 90 days, respectively. Experimental products of PLGA with number average molecular weights of 60,000, 8,000, and 110,000 were implanted into the cardiovascular RCA, LCX, and LAD of the porcine animal models, respectively.

[0074] (2) At 0 (immediate), 30, 60, and 90 days, the corresponding pigs were killed and the blood vessels were removed to measure the drug content. The measurement results characterize the ratio of the drug release amount in the blood vessel wall to the drug on the surface of the balloon before implantation, and the results are shown in Table 1.

[0075] [Table 1]

[0076] It can be seen from the above results that the higher the number average molecular weight of PLGA in mPEG-PLGA, the higher the sustained drug release effect. When applied to the drug coating of balloon catheters, it can effectively reduce the drug release rate, and the drug release rate of the balloon catheter can be different, so as to realize timely drug treatment in the early stage of vascular laceration, and sustained drug release in the later stage to achieve a sustained therapeutic effect, and the drug coating will not cause vascular toxic reactions.

Claims

1. A new type of drug-containing balloon catheter capable of controlling drug release, comprising a balloon, a catheter, and a drug coating, wherein a drug coating (3) is applied to the surface of the balloon, the drug coating (3) is divided into a first drug coating (31), a second drug coating (32), and a third drug coating (33), and the drug release rates in the first drug coating (31), the second drug coating (32), and the third drug coating (33) are different.

2. The drug balloon catheter of claim 1, characterized in that the raw materials of the drug coating (3) include an active drug, an adhesive, a sustained release agent, and a polyol-based material.

3. The drug balloon catheter of claim 2, wherein the raw materials of the drug coating (3) include, by weight, 20-100 parts of active drug, 10-80 parts of adhesive, 5-65 parts of sustained release agent, and 5-70 parts of polyol-based material.

4. In the drug coating (3), the loading of the active drug is 1 to 10 μg / mm ２ The drug balloon catheter according to claim 3,

5. The drug balloon catheter according to claim 2, characterized in that in the drug coating (3), the adhesive is selected from at least one of an ester-based substance, an amide-based substance, and a liposome.

6. The drug balloon catheter according to claim 2, characterized in that in the drug coating (3), the sustained release agent is any one or a combination of several of mPEG-PLGA copolymer, poly-3-hydroxybutyric acid, hydroxybutyric acid-hydroxyvaleric acid copolymer, sodium alginate hydrogel, chitosan, cellulose, pectin, and alkyl glycoside.

7. The drug balloon catheter according to claim 6, wherein the sustained release agent is an mPEG-PLGA copolymer.

8. The medicinal balloon catheter according to claim 7, characterized in that in the mPEG-PLGA copolymer, the number average molecular weight of mPEG is 5,000 to 80,000, and the number average molecular weight of PLGA is any one or a combination of several of 1,000 to 3,000, 3,000 to 5,000, 5,000 to 10,000, 50,000 to 70,000, and 100,000 to 120,000.

9. The drug balloon catheter of claim 8, wherein the number average molecular weights of PLGA in the mPEG-PLGA copolymer are all different for the first drug coating (31), the second drug coating (32) and the third drug coating (33).

10. Use of the drug balloon catheter according to any one of claims 1 to 9 in vasodilation.

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