New drug 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, for example A61F2 / 958, and in particular to a new type of drug balloon catheter capable of controlling drug release and its use. [Background technology]

[0002] Currently, 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 essential functions, and even vascular blockage, threatening life. Currently, the most widely used treatment for cardiovascular disease is percutaneous transluminal angioplasty, which mainly uses drug-eluting stents and drug-eluting balloons. Here, drug-eluting balloons use a balloon catheter to minimally invasively deliver antiproliferative drugs to the vascular lesion, and then expand the balloon to transfer the drugs to the inner wall of the blood vessel. The dual effects of balloon expansion and antiproliferative drugs treat vascular stenosis, effectively inhibiting 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 human blood vessels are important data before and after treatment. Clinical image data analysis has shown that because human blood vessels are cone-shaped, the diameters of the proximal and distal ends of the blood vessels at the lesion site are not consistent. If the balloon diameter is expanded to match the larger end of the blood vessel, it will be over-expanded and the smaller end of the blood vessel will tear, damaging the blood vessel. However, the drug coating of conventional drug-resistant balloons has a single release rate, which causes the drug to accumulate further downstream of the blood vessel over a period of time, potentially causing vascular toxicity. A fast release rate will exacerbate this toxic reaction. A slow release rate will reduce the concentration of the active drug in the lesion site and weaken the anti-stenosis effect. Furthermore, in the blood-flowing environment where the drug-resistant balloon is located, the drug coating layer on the surface will easily be washed away, thereby reducing the balloon's therapeutic effect on the lesion. If the coating layer contains many particles and is large in size, it may also pose a potential risk of vascular occlusion.

[0004] Chinese patent application CN108378964 A discloses a medicated balloon, spraying a drug coating with different drug loading densities on the balloon surface to reduce drug toxicity. Chinese patent application CN107670163A discloses a medicated balloon dilation catheter and its manufacturing method and use. The technology alleviates the problem of uneven drug concentration in blood vessels over a short period of time by spraying coating layers with different drug loadings on the proximal and distal ends of the balloon. However, this technology requires strict control of the drug coating spraying process, resulting in poor drug immobilization, short drug retention in the bloodstream, and short therapeutic effects. In these two patent applications, although the drug dosages on the balloon are different, the drug release cycle is consistent. Over a certain period of time, the amount of drug downstream 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] To solve the above technical problems, the present invention first provides a new type of drug balloon catheter with controllable drug release, which can control the drug release cycle to solve the problem of toxic reactions caused downstream of the blood vessel, while at the same time extending the drug release cycle, effectively treating vascular laceration caused by excessive dilation, and improving the long-term efficacy of drug treatment.

[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 catheters 2 are provided on both sides of the balloon 1, and the catheters 2 are 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 and in parallel along the surface of the balloon 1, dividing the surface of the balloon 1 into a three-tiered 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 an active drug, an adhesive, a sustained-release agent, and a polyol-based material.

[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, 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 derivatives thereof in combination with one or more of them.

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

[0016] Furthermore, the adhesive is used to enhance the adhesion of the drug to the blood vessel, reduce 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 substance may be selected from any one or a combination of several of PEG-hyaluronic acid copolymer, poly(lactic acid-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] Furthermore, 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 polyhydroxy substance is any one or a combination of several of PEG, chitosan, and cyclodextrin.

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

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

[0024] Furthermore, in the drug coating, 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.

[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 to 90,000, and the number average molecular weight of PLGA is 1,000 to 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 all different for the first drug coating, the second drug coating, and the third drug coating.

[0031] In this application, the long molecular chains of mPEG-PLGA copolymer are used to encapsulate the active drug, and the polar groups, such as -NH-, -O-, -OH, and C=O, form intermolecular hydrogen bonds or conjugates with the polar groups or ring structures of the active drug, immobilizing the active drug within the crosslinked structure formed by the mPEG-PLGA copolymer. The degree of crosslinking of the structure can be adjusted by adjusting the molecular weight of mPEG and PLGA in the mPEG-PLGA copolymer molecule, and the release rate of the drug can be further controlled. If the molecular weight of PLGA is too large, more energy is required for the decomposition of the mPEG-PLGA copolymer, which will extend the residence time of the active drug in the vascular wall. However, if the molecular weight is too large, the drug release concentration will decrease in a short period of time. If the molecular weight is too low, the therapeutic effect on vascular lacerations 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 agent, causing the active agent to easily flow with the blood, resulting in a short residence time on the vascular wall, a large amount of drug released in a short period of time, and 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 on the drug balloon should be different, and further, the drug release rate and release period of the first drug coating, the second drug coating, and the third drug coating can be controlled, thereby improving the sustained drug release effect, extending the effective treatment time, and avoiding vascular toxic reactions.

[0032] Furthermore, in this application, the number-average molecular weight of PLGA in the mPEG-PLGA copolymer in the first drug coating, the second drug coating, and the third drug coating is not strictly defined, but it is only necessary to maintain that the number-average molecular weights of PLGA in the mPEG-PLGA copolymer in the three coating layers are not the same. Therefore, the coating layers in the drug balloon have 24 different combination methods and can be arranged according to the conditions of vascular calcification and laceration.

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

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

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

[0036] Furthermore, 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 its number average molecular weight 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 can be simply by 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 can then be sprayed onto the surface of the balloon.

[0039] Furthermore, 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 to 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 may be 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 catheters described herein are 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, thereby solving the problem of toxic reactions caused downstream of the blood vessel. Furthermore, it can effectively extend the drug release cycle at the vascular laceration site, solve the laceration caused by excessive vasodilation, and effectively inhibit the proliferation of vascular smooth muscle cells, reduce the incidence of restenosis, and alleviate inflammatory reactions.

[0047] 2. The drug balloon of this application is designed with three coatings, each with 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, thereby extending the adhesion and retention time of the drug on the blood vessel wall and providing continuous treatment at the vascular laceration site.

[0048] 3. In the coating of this application, the sustained-release agent can effectively encapsulate the active agent and control the release rate. The adhesive can interact with the active agent intermolecularly and enhance its adhesive strength to the vascular wall through its functional groups. The polyol-based substance, with its excellent hydrophilicity, activates the coating and releases the drug within it. By utilizing the interactions of each component in the coating material, the amount of drug released and the adhesive strength to the vascular wall can be effectively controlled, reducing the loss of the active agent due to blood washing. The balloon is excellent for treating vascular lacerations. [Brief explanation of the drawings]

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

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

[0051] The raw materials of the first drug coating 31 were, by weight, 50 parts rapamycin, 40 parts soybean lecithin, 30 parts mPEG-PLGA copolymer, and 30 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 8,000, and the drug loading of the first drug coating was 4 μg / mm 2 and

[0052] The raw materials of the second drug coating 32 were, by weight, 60 parts rapamycin, 50 parts soybean 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 were, by weight, 50 parts rapamycin, 40 parts soybean lecithin, 20 parts mPEG-PLGA copolymer, and 30 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 110,000, and the drug loading of the third drug coating was 4 μg / mm 2 and

[0054] The first, second, and third drug coatings are prepared as follows: the raw materials for each coating are mixed and dissolved in ethyl acetate, and the mixture is homogeneously mixed so that the raw materials account for 50% by weight and the ethyl acetate solution accounts for 50% by weight. Then, the mixture is ultrasonically processed into microspheres with an average diameter of 3 μm, which are then sprayed onto the desired location on the surface of the balloon.

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

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

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

[0058] The raw materials of the second drug coating 32 were, by weight, 60 parts rapamycin, 50 parts soybean 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 were, by weight, 80 parts rapamycin, 70 parts soybean lecithin, 60 parts mPEG-PLGA copolymer, and 60 parts PEG, the number average molecular weight of the PEG was 10,000, the number average molecular weight of the mPEG-PLGA copolymer was 60,000, and the number average molecular weight of the PLGA was 120,000, and the drug loading of the third drug coating was 8 μg / mm 2 and

[0060] The first, second, and third drug coatings are prepared as follows: the raw materials for each coating are mixed and dissolved in ethyl acetate, and the mixture is homogeneously mixed so that the raw materials account for 70% by weight and the ethyl acetate solution accounts for 30% by weight. Then, the mixture is ultrasonically processed into microspheres with an average diameter of 8 μm, which are then sprayed onto the desired location on the surface of the balloon.

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

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

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

[0064] The raw materials of the second drug coating 32 were, by weight, 40 parts rapamycin, 30 parts soybean 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 were, by weight, 70 parts rapamycin, 50 parts soybean lecithin, 50 parts mPEG-PLGA copolymer, and 50 parts PEG, the number average molecular weight of the PEG was 8,000, the number average molecular weight of the mPEG-PLGA copolymer was 40,000, and the number average molecular weight of the PLGA was 50,000, and the drug loading of the third drug coating layer was 6 μg / mm 2 and

[0066] The first, second, and third drug coatings are prepared as follows: the raw materials for each coating are mixed and dissolved in ethyl acetate, and the mixture is homogeneously mixed so that the raw materials account for 20% by weight and the ethyl acetate solution accounts for 80% by weight. Then, the mixture is ultrasonically processed into microspheres with an average diameter of 0.05 μm, which are then sprayed onto the desired location on the surface of the balloon.

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

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

[0069] Performance Test Method

[0070] Animal experiments will be conducted to verify the sustained release effect of drugs loaded with mPEG-PLGA of different molecular weights. Using a miniature pig animal model, drugs loaded with mPEG-PLGA of different molecular weights will be administered to the pig animal model, with timings set at 0 (immediate), 30 days, 60 days, and 90 days. Drug testing will be performed on the blood vessels by removing the pig vascular model.

[0071] The experimental subjects were miniature pig models weighing 25 to 45 kg. The experimental product contained 6 μg / mm 2 This is a drug balloon loaded with mPEG-PLGA of different molecular weights.

[0072] The experimental method is as follows.

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

[0074] (2) At 0 (immediate), 30, 60, and 90 days, the corresponding pigs were sacrificed, and the blood vessels were removed to measure the drug content. The measurement results characterized the ratio of the drug released 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] As can be seen from the above results, the higher the number-average molecular weight of PLGA in mPEG-PLGA, the higher the sustained drug release effect. When applied to drug coatings on balloon catheters, it can effectively reduce the drug release rate and, by varying the drug release rate of balloon catheters, achieve timely drug treatment in the early stage of vascular laceration and sustained drug release in the later stage to achieve a sustained therapeutic effect. The drug coating does not cause vascular toxic reactions. This specification includes the disclosures of Appendices 1 to 10 below. <Appendix 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, and 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. <Appendix 2> The drug balloon catheter described in Appendix 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 substance. <Appendix 3> The drug balloon catheter according to Appendix 2, characterized in that the raw materials of the drug coating (3) contain, by weight, 20 to 100 parts of an active drug, 10 to 80 parts of an adhesive, 5 to 65 parts of a sustained-release agent, and 5 to 70 parts of a polyol-based substance. <Appendix 4> In the drug coating (3), the amount of the active drug carried is 1 to 10 μg / mm 2 4. The drug balloon catheter according to claim 3, <Appendix 5> The drug balloon catheter described in Appendix 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. <Appendix 6> The drug balloon catheter described in Appendix 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. <Appendix 7> 7. The drug balloon catheter of claim 6, wherein the sustained-release agent is an mPEG-PLGA copolymer. <Appendix 8> The drug balloon catheter according to Appendix 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. <Appendix 9> A drug balloon catheter as described in Appendix 8, characterized in that the number average molecular weights of the 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). <Appendix 10> Use of a drug-containing balloon catheter according to any one of appendices 1 to 9 for vasodilation.

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, and 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 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, and the drug release rates in the first drug coating (31), the second drug coating (32), and the third drug coating (33) are different; The raw material of the drug coating (3) includes a sustained-release agent, which is an mPEG-PLGA copolymer, and 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. The number-average molecular weights of PLGA in the mPEG-PLGA copolymers for the first drug coating (31), the second drug coating (32), and the third drug coating (33) are all different. A new drug balloon catheter capable of controlling drug release.

2. 2. The drug balloon catheter of claim 1, wherein the raw materials of the drug coating (3) further comprise an active drug, an adhesive, and a polyol-based substance, and the adhesive is used to enhance the adhesion of the drug to the blood vessel, suppress the loss of the active drug due to blood washing, and improve the therapeutic effect and duration of the drug on the blood vessel.

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

4. The drug balloon catheter according to claim 3, characterized in that the drug coating (3) has an active drug loading of 1 to 10 μg / mm 2 .

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

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