Drug balloon dilatation catheter and use method thereof

Abstract

The invention relates to a medicine balloon dilatation catheter and a using method thereof.The medicine balloon dilatation catheter comprises an inner tube, an outer tube, a balloon, medicine patches and a supporting mechanism, the supporting mechanism comprises a supporting piece and a push-pull piece which have an initial state and a supporting state, the supporting piece is provided with a plurality of supporting parts which are arranged corresponding to the medicine patches and located in the balloon, and the push-pull piece is arranged on the outer tube; when the supporting piece is in an initial state, the supporting part is straightened and is not in contact with the balloon; when the supporting piece is in the supporting state, the supporting part arches outwards and can jack up the medicine patch corresponding to the supporting part outwards. The supporting part on the supporting mechanism arches outwards and jacks up the medicine patch, on one hand, the medicine patch can be attached to the lesion blood vessel wall in advance, so that medicine is released in advance, and inflammation caused by blood vessel opening is relieved; on the other hand, part of the balloon wall is anchored on the blood vessel wall, so that the balloon is prevented from shifting in the expansion process, and the stability is better.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a drug balloon dilatation catheter and a method for using the same. Background Art

[0002] Drug balloon dilatation is a new technology that uses a balloon to fully dilate the diseased blood vessels, making it in direct contact with the diseased blood vessels and releasing drugs. Common drug balloon dilatation catheters include a balloon, an inner tube, an outer tube and a tube seat. The surface of the balloon is coated with drugs. The medium is filled into the balloon through the pressure port on the tube seat, and the balloon is pressurized to expand. After the balloon expands, it squeezes the narrowed plaque of the blood vessel and adheres to the inner wall of the blood vessel. The drugs on it can be released and act on the diseased blood vessels, thereby inhibiting the proliferation of the endothelium of the blood vessel wall and reducing the occurrence of the disease.

[0003] However, existing drug-eluting balloon catheters may have the risk of slipping during operation, especially in areas with complex vascular morphology or high blood flow velocity. In addition, existing drug-eluting balloon catheters require the balloon to be expanded and contact the diseased blood vessel before the drug on the balloon surface can act on the diseased blood vessel, which is easy to cause vascular inflammation for damaged blood vessels. Summary of the invention

[0004] The purpose of the present invention is to provide a novel drug balloon dilatation catheter and a use method thereof.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is:

[0006] A drug balloon dilatation catheter comprises an inner tube, an outer tube and a balloon, wherein a portion of the inner tube is inserted into the interior of the balloon, the outer tube is sleeved on the outer side of the inner tube and a lumen is formed between the outer tube and the inner tube, the lumen can be used to transmit a filling medium into the balloon to drive the balloon to expand or contract, and the drug balloon dilatation catheter also comprises:

[0007] a drug patch having a plurality of patches arranged outside the balloon;

[0008] A support mechanism, the support mechanism includes a support member with an initial state and a support state and a push-pull member movably arranged in the cavity, the support member has a plurality of support parts corresponding to the drug patch and located in the balloon, when the support member is in the initial state, the support part is straightened and does not contact the balloon; when the support member is in the support state, the support part arches outward and can push outward the corresponding drug patch, one end of the support member is connected to the inner tube, and the other end is connected to the push-pull member, and the support member is controlled by the push-pull member and can switch between the support state and the initial state.

[0009] The present invention provides a support mechanism, and the support part on the support mechanism can be controllably arched outward and lift up the drug patch. On the one hand, part of the balloon wall can be anchored on the blood vessel wall, thereby increasing the connection stability between the balloon and the blood vessel wall and preventing the balloon from shifting during the expansion process; on the other hand, the drug patch can be pre-attached to the diseased blood vessel wall, thereby pre-releasing the drug and alleviating the inflammation caused by the expansion of the blood vessel.

[0010] Preferably, the support member also has a plurality of support rings arranged along the axial direction of the inner tube, the support rings are sleeved on the outside of the inner tube, the support ring located at the farthest end is fixedly connected to the inner tube, and the support ring located at the nearest end is connected to the push-pull member, and the other support rings except the farthest end support ring can slide relative to the inner tube, and one or more of the support parts are connected between two adjacent support rings.

[0011] In some embodiments, the support portion includes a first support arm and a second support arm that are rotatably connected, and ends of the first support arm and the second support arm that are away from each other are respectively connected to two adjacent support rings corresponding thereto.

[0012] In some embodiments, when a plurality of the support portions are disposed between two adjacent support rings, the plurality of support portions between the two adjacent support rings are arranged around the axis of the inner tube.

[0013] In some embodiments, the numbers of support portions between two different adjacent support rings are the same or different.

[0014] In some embodiments, the support portion and the support portion adjacent thereto and located at the proximal end and / or the distal end are arranged alternately.

[0015] Preferably, when the support member is in a supporting state, the support portion arches outwards to form a triangle.

[0016] Preferably, the support member is integrally formed.

[0017] In some embodiments, the support member is integrally formed by laser engraving technology.

[0018] Preferably, the support member is made of stainless steel.

[0019] Preferably, the drug patch includes a first patch connected to the balloon at its circumferential side and a second patch located between the first patch and the balloon and loaded with drugs, and the first patch is provided with a plurality of micropores for releasing the drugs.

[0020] Further preferably, the first patch completely covers the second patch with a certain margin left around it.

[0021] In some embodiments, the first patch and the second patch are circular.

[0022] In some embodiments, the first patch is made of polyethylene or polylactic acid.

[0023] In some embodiments, the second patch is made of sodium alginate or polyvinyl alcohol.

[0024] In some embodiments, the drug is selected from one or more of antiproliferative drugs (including but not limited to paclitaxel) and antithrombotic drugs (including but not limited to sirolimus).

[0025] Furthermore, the drug is sirolimus. Sirolimus is relatively stable at room temperature and has a good sustained release effect, and can continuously inhibit the proliferation of vascular smooth muscle cells and reduce the occurrence of restenosis.

[0026] Preferably, the preparation method of the drug patch comprises the following steps:

[0027] S1. Distribute the drug evenly on the surface of the second patch by dipping or spraying.

[0028] S2, covering the first patch on the outside of the second patch, using a local hot melt tool or a hot melt head to heat the periphery of the first patch (the area outside the second patch) to fuse the first patch to the balloon surface;

[0029] S3, heat shrinking and fixing the drug patch, including using a low-temperature hot air machine to evenly blow the first patch to shrink it and make it close to the balloon surface. When the first patch shrinks, the internal drug patch will be fixed on the balloon surface. The hot air temperature should be controlled within a range that does not affect the stability of the drug (usually not more than 50-60°C).

[0030] Further preferably, the method for preparing the drug patch further comprises performing micropore processing on the first patch. The micropore processing can be performed by laser drilling or other micropore forming operations.

[0031] In some implementations, the microporous treatment is performed before the first patch covers the second patch.

[0032] In some implementations, after the heat shrinking and fixing, the first patch is subjected to the micro-hole treatment.

[0033] Preferably, the drug balloon dilatation catheter also includes a driving mechanism, which includes a handle connected to the outer tube and / or the inner tube and a transmission member and a driving assembly arranged on the handle, the transmission member is connected between the push-pull member and the driving assembly and is controlled by the driving assembly, and the transmission member can move with the push-pull member to switch the support member between the support state and the initial state.

[0034] The present invention also provides a method for using the above-mentioned drug balloon dilatation catheter, which comprises the following steps:

[0035] (1) placing the balloon at the site of vascular lesions;

[0036] (2) controlling the movement of the push-pull member to switch the support member from an initial state to a support state, and maintaining the support member in the support state to perform pre-release of the drug;

[0037] (3) introducing a filling medium into the balloon through the cavity to cause the balloon to expand outward and maintain the expansion;

[0038] (4) Controlling the movement of the push-pull member to switch the support member from the support state to the initial state, allowing the filling medium in the balloon to flow out through the cavity, causing the balloon to shrink, and then withdrawing the balloon.

[0039] Preferably, the height of the balloon wall in the expanded state is controlled to be no lower than the height of the support portion.

[0040] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:

[0041] The drug balloon dilatation catheter of the present invention comprises an inner tube, an outer tube, a balloon, a drug patch and a supporting mechanism, wherein the supporting portion on the supporting mechanism can arch outward and lift up the drug patch, which, on the one hand, anchors part of the balloon wall to the blood vessel wall to prevent displacement of the balloon during the dilation process, thereby providing better stability; on the other hand, the drug patch can be pre-attached to the diseased blood vessel wall, thereby achieving pre-release of the drug and alleviating inflammation caused by the expansion of the blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0043] Figure 1 It is a schematic structural diagram of the drug balloon dilatation catheter of Example 1;

[0044] Figure 2 It is a schematic structural diagram of the distal end portion of the drug balloon dilatation catheter of Example 1;

[0045] Figure 3 A perspective view of the distal end portion of the drug balloon dilatation catheter of Example 1;

[0046] Figure 4 is a cross-sectional view of the distal end portion of the drug balloon dilatation catheter of Example 1, wherein the support member is in an initial state;

[0047] Figure 5 It is a cross-sectional view of the distal end portion of the drug balloon dilatation catheter of Example 1, wherein the support member is in a supporting state and the balloon is in a contracted state;

[0048] Figure 6 It is a cross-sectional view of the distal end portion of the drug balloon dilatation catheter of Example 1, wherein the support member is in a supporting state and the balloon is in an expanded state;

[0049] Figure 7 is a schematic structural diagram of the support member of Example 1 in an initial state;

[0050] Figure 8 It is a structural schematic diagram of the support member of Example 1 in a supporting state;

[0051] Fig. 9 It is a structural schematic diagram of the support part and the support ring of Example 1;

[0052] Fig.10 is a schematic diagram of a half-section structure of the medicine patch of Example 1;

[0053] Fig.11 is a cross-sectional view of the driving mechanism of Example 1;

[0054] Fig.12 This is a physical model diagram of the distal end portion of the drug balloon dilatation catheter of Example 1;

[0055] Among them: 1. Balloon;

[0056] 2. Drug patch; 21. First patch; 211. Adhesive area; 212. Permeation area; 22. Second patch;

[0057] 3. Support mechanism; 31. Support member; 311. Support ring; 312. Support portion; 3121. First support arm; 3122. Second support arm;

[0058] 4. Inner tube;

[0059] 5. External management;

[0060] 6. driving mechanism; 61. handle; 62. transmission tube; 63. cam; 64. transmission rod; 65. operating part; 66. first rotating wheel; 67. second rotating wheel;

[0061] 7. Guide wire. DETAILED DESCRIPTION

[0062] In the following, only some exemplary embodiments are briefly described. As those skilled in the art will appreciate, the described embodiments may be modified in various ways without departing from the spirit or scope of the embodiments of the present invention. Therefore, the drawings and descriptions are considered to be exemplary and non-restrictive in nature.

[0063] In the description of the embodiments of the present invention, it should be understood that the terms "distal", "proximal", etc. indicate positions or positional relationships defined by the position of the drug balloon dilatation catheter when in use, wherein the side close to the operator is the proximal end, and the side away from the operator is the distal end. This is only for the convenience of describing the embodiments of the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the embodiments of the present invention.

[0064] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0065] In the embodiments of the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes the first feature being directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0066] The disclosure below provides many different embodiments or examples to implement different structures of the embodiments of the present invention. In order to simplify the disclosure of the embodiments of the present invention, the parts and settings of specific examples are described below. Of course, they are only examples, and the purpose is not to limit the embodiments of the present invention. In addition, the embodiments of the present invention can repeat reference numbers and / or reference letters in different examples, and this repetition is for the purpose of simplification and clarity, which itself does not indicate the relationship between the various embodiments and / or settings discussed.

[0067] Existing drug balloon dilatation catheters usually expand narrowed blood vessels outward by inflating the balloon, while at the same time applying the drug on the balloon to the inner wall of the blood vessel. This type of dilatation catheter has the following problems: first, due to the influence of blood flow, the balloon is prone to slipping during the process of dilating the blood vessel, making it difficult to accurately act on the target lesion location; second, it is difficult to achieve local pressurization and drug release, which can easily lead to poor treatment effects and increased risk of restenosis of the blood vessel. In response to the above problems, the present invention provides a drug balloon dilatation catheter, which, by providing a support mechanism, enables the drug patch on the balloon to be lifted to a designated position for drug release according to demand, thereby preventing the balloon from sliding due to the influence of blood flow, etc., and achieving drug patch positioning. In addition, the drug patch is released in advance in the narrow blood vessel to treat the blood vessel wall, which can relieve inflammation caused by the expansion of the blood vessel. The embodiments of the present invention are described in detail below in conjunction with the accompanying drawings.

[0068] Example 1

[0069] A drug-eluting balloon dilatation catheter, such as Figures 1 to 12 As shown, it includes a balloon 1, an inner tube 4, an outer tube 5, a drug patch 2 and a supporting mechanism 3.

[0070] The balloon 1 can expand or contract along its radial direction. The specific structure thereof can refer to the prior art and is not particularly limited in the present invention.

[0071] A portion of the inner tube 4 is inserted into the balloon 1, specifically, the distal end of the inner tube 4 is inserted into the balloon 1 and fixedly connected to the distal end of the balloon 1. The outer tube 5 is sleeved on the outside of the inner tube 4, and its distal end is inserted into the balloon 1 and fixedly connected to the proximal end of the balloon 1. A cavity is formed between the outer tube 5 and the inner tube 4, and the cavity can be used to transmit a filling medium into the balloon 1 to drive the balloon 1 to expand or contract. The filling medium refers to the prior art, and as an example, it can be physiological saline, contrast agent, etc.

[0072] The support mechanism 3 includes a support member 31 having an initial state and a support state and a push-pull member movably arranged in the cavity. As an example, the push-pull member can be a tube member that is sleeved on the outer tube and contacts or is connected to the proximal end of the support member 31. The push-pull member can slide controllably along the axial direction of the inner tube 4.

[0073] See Figure to Fig. 9As shown, the support member 31 includes a plurality of support rings 311 and support portions 312. The plurality of support rings 311 are sleeved on the inner tube 4 and arranged in sequence along the axial direction of the inner tube 4. The support ring 311 at the farthest end is fixedly connected to the inner tube 4, and the other support rings 311 except the farthest end support ring 311 can slide relative to the inner tube 4. One or more support portions 312 are connected between two adjacent support rings 311. When a plurality of support portions 312 are arranged between two adjacent support rings 311, the plurality of support portions 312 are evenly arranged around the axis of the inner tube 4. Preferably, 2 to 4 support portions 312 are connected between two adjacent support rings 311. The number of support portions 312 between two different adjacent support rings 311 is the same or different. In this embodiment, the number of support portions 312 between two different adjacent support rings 311 is the same, and the support portion 312 located between the same two adjacent support rings 311 and the support portion 312 adjacent to it and located at the proximal end and / or the distal end are arranged alternately. Typically, the support portion 312 is located inside the balloon 1, and in an initial state, the support portion 312 is straightened and does not contact the balloon 1; when the support member 31 switches from the initial state to the support state, the other support rings 311 except the farthest support ring 311 slide toward the distal end relative to the inner tube 4, causing the support portion 312 to arch outward, thereby pushing outward the wall of the balloon 1 in contact with it, anchoring the wall of the balloon 1 in the narrow area to prevent the balloon 1 from sliding.

[0074] As a preferred example, the support portion 312 is arched outwardly in a triangular shape. Specifically, the support portion 312 includes a first support arm 3121 and a second support arm 3122 that are rotatably connected, and the ends of the first support arm 3121 and the second support arm 3122 that are away from each other are respectively connected to two adjacent support rings 311 corresponding thereto. When the support ring 311 slides toward the distal end relative to the inner tube 4, the support ring 311 squeezes the support portion 312, so that the connection between the first support arm 3121 and the second support arm 3122 moves in a direction away from the axis of the inner tube 4, that is, arches outward, thereby pushing part of the balloon 1 wall to a preset position; when the support ring 311 slides in the opposite direction, the support ring 311 pulls the support portion 312 to straighten it.

[0075] The support member 31 is preferably integrally formed, for example, integrally formed by laser engraving technology. Preferably, the support member 31 is made of a stainless steel pipe.

[0076] The support ring 311 at the nearest end of the support member 31 is connected to the push-pull member. Driven by the push-pull member, the support member 31 can switch between the initial state and the support state.

[0077] See also Figures 1 to 3The drug patch 2 has multiple drug patches 2 arranged on the outside of the balloon 1, which are preferably arranged corresponding to the support portion 312 and are located in the outer area of ​​the balloon 1 wall contacted by the support portion 312 when it is in a supporting state, so that when the support portion 312 arches outward, it can push outward the corresponding drug patch 2.

[0078] Further, see Fig.10 , the drug patch 2 includes a first patch 21 and a second patch 22. The first patch 21 includes a permeation zone 212 located in the middle and an adhesive zone 211 located around the permeation zone 212, the permeation zone 212 is provided with a plurality of micropores for releasing drugs, and the adhesive zone 211 is bonded to the balloon 1 by a hot melt process or glue. Preferably, the first patch 21 is made of polyethylene (PE) or polylactic acid (PLA), which have good biocompatibility and can achieve heat shrinkage and hot melting at a relatively low temperature. The second patch 22 is located between the first patch 21 and the balloon 1 and carries a drug, which is preferably a material with good drug adsorption capacity and biocompatibility, such as sodium alginate, polyvinyl alcohol (PVA) or other biodegradable polymers. Drugs include but are not limited to antiproliferative drugs (such as paclitaxel) or antithrombotic drugs (such as sirolimus).

[0079] See also Figure 1 and Fig.11 The drug-eluting balloon dilatation catheter also includes a driving mechanism 6, which includes a handle 61 connected to the outer tube 5 and / or the inner tube 4, and a transmission member and a driving assembly arranged on the handle 61. The transmission member is connected between the push-pull member and the driving assembly and is controlled by the driving assembly. The transmission member can move axially along the inner tube 4 with the push-pull member to switch the support member 31 between the supporting state and the initial state.

[0080] In this embodiment, the proximal ends of the inner tube 4 and the outer tube 5 are connected to the handle 61 and the proximal end of the inner tube 4 extends out of the outer tube 5. The handle 61 has a pressure chamber connected to the cavity and used to pass the filling medium, and a guide wire chamber connected to the inner tube 4 and used to pass the guide wire 7. The transmission member includes a transmission tube 62 threadedly connected to the handle 61 and located between the inner tube 4 and the outer tube 5, a cam 63 connected to the transmission tube 62, and a transmission rod 64 fixedly connected to the cam 63. When the transmission rod 64 is rotated, the cam 63 thereon rotates and drives the transmission tube 62 to move helically along the axial direction of the inner tube 4, thereby driving the push-pull rod to move axially along the inner tube 4. The driving assembly includes an operating part 65, a first rotating wheel 66 and a second rotating wheel 67, wherein the second rotating wheel 67 is fixedly connected to the proximal end of the transmission rod 64; the first rotating wheel 66 is meshed between the operating part 65 and the second rotating wheel 67, and has a plurality of rotating wheels distributed on the outer periphery of the second rotating wheel 67. The operating part 65 is rotated, and driven by the operating part 65, the first rotating wheel 66 rotates and drives the second rotating wheel 67 to rotate, and the second rotating wheel 67 rotates and drives the transmission rod 64, so that the cam 63 on the transmission rod 64 drives the transmission tube 62 to spirally move along the axial direction of the inner tube 4. Of course, the driving mechanism 6 can also be other structures in the prior art.

[0081] Working principle:

[0082] (1) placing the balloon 1 at the site of vascular lesions;

[0083] (2) Controlling the movement of the push-pull member to switch the support member 31 from the initial state to the support state, and keeping the support member 31 in the support state, specifically includes rotating the operating part 65, the operating part 65 drives the first rotating wheel 66 to rotate with the second rotating wheel 67, and the second rotating wheel 67 rotates while driving the transmission rod 64 and the cam 63 to rotate synchronously, thereby driving the first transmission tube 62 to move spirally toward the distal end, and then pushing the push-pull rod to move toward the distal end along the axial direction of the inner tube 4, so that the support part 312 arches outward and lifts the drug patch 2, so that the drug patch 2 acts on the narrow area to achieve the pre-release of the drug;

[0084] (3) introducing a filling medium into the balloon 1 through the cavity to expand the balloon outward and maintain the expansion, specifically including introducing a filling medium into the balloon 1 through the inflation cavity to expand the balloon 1 until the height of the balloon wall of the balloon 1 in the expanded state is greater than the height of the support portion 312, that is, the balloon wall is located outside the support portion 312;

[0085] (4) Controlling the movement of the push-pull member to switch the support member 31 from the support state to the initial state, specifically including reversely rotating the operating part 65 to switch the support member 31 from the support state to the initial state, passing the filling medium in the balloon through the filling port to shrink the balloon, and then withdrawing the balloon.

[0086] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A drug balloon dilatation catheter, comprising an inner tube (4), an outer tube (5) and a balloon (1), wherein a portion of the inner tube (4) is inserted into the interior of the balloon (1), the outer tube (5) is sleeved on the outer side of the inner tube (4) and a cavity is formed between the outer tube (5) and the inner tube (4), wherein the cavity can be used to transmit a filling medium into the balloon (1) to drive the balloon (1) to expand or contract, characterized in that: The drug balloon dilatation catheter also includes: A drug patch (2), the drug patch (2) having a plurality of patches arranged outside the balloon (1); A support mechanism (3), the support mechanism (3) comprising a support member (31) having an initial state and a support state and a push-pull member movably arranged in the cavity, the support member (31) having a plurality of support portions (312) arranged corresponding to the drug patch (2) and located in the balloon (1), when the support member (31) is in the initial state, the support portion (312) is straightened and does not contact the balloon (1); when the support member (31) is in the support state, the support portion (312) arches outward and can push outward the corresponding drug patch (2), one end of the support member (31) is connected to the inner tube (4), and the other end is connected to the push-pull member, and the support member (31) is controlled by the push-pull member and can switch between the support state and the initial state.

2. The drug balloon dilatation catheter according to claim 1, characterized in that: The support member (31) further comprises a plurality of support rings (311) arranged at intervals along the axial direction of the inner tube (4); the support rings (311) are sleeved on the outer side of the inner tube (4); the support ring (311) located at the farthest end is fixedly connected to the inner tube (4); the support ring (311) located at the nearest end is connected to the push-pull member; the other support rings (311) except the farthest end support ring (311) can slide relative to the inner tube (4); and one or more support portions (312) are connected between two adjacent support rings (311).

3. The drug balloon dilatation catheter according to claim 2, characterized in that: The support portion (312) comprises a first support arm (3121) and a second support arm (3122) which are rotatably connected, and ends of the first support arm (3121) and the second support arm (3122) which are away from each other are respectively connected to two adjacent support rings (311) corresponding thereto; and / or, When a plurality of the support portions (312) are provided between the two adjacent support rings (311), the plurality of support portions (312) between the two adjacent support rings (311) are arranged around the axis of the inner tube (4); and / or, The number of support portions (312) between two different adjacent support rings (311) is the same or different; and / or, The support portion (312) and the support portion (312) adjacent thereto and located at the proximal end and / or the distal end are arranged in a staggered manner.

4. The drug balloon dilatation catheter according to claim 1, characterized in that: When the support member (31) is in a supporting state, the support portion (312) arches outwards to form a triangle.

5. The drug balloon dilatation catheter according to claim 1, characterized in that: The support member (31) is integrally formed; and / or, The support member (31) is made of stainless steel.

6. The drug-eluting balloon dilatation catheter according to claim 1, characterized in that: The drug patch (2) comprises a first patch (21) connected to the balloon (1) on its circumferential side and a second patch (22) located between the first patch (21) and the balloon (1) and loaded with drugs, wherein the first patch (21) is provided with a plurality of micropores for releasing the drugs.

7. The drug balloon dilatation catheter according to claim 6, characterized in that: The material of the first patch (21) is polyethylene or polylactic acid; and / or, The material of the second patch (22) is sodium alginate or polyvinyl alcohol; and / or, The drug is selected from one or more of antiproliferative drugs and antithrombotic drugs.

8. The drug-eluting balloon dilatation catheter according to claim 1, characterized in that: The drug balloon dilatation catheter also includes a driving mechanism (6), which includes a handle (61) connected to the outer tube (5) and / or the inner tube (4) and a transmission member and a driving assembly arranged on the handle (61), wherein the transmission member is connected between the push-pull member and the driving assembly and is controlled by the driving assembly, and the transmission member can move with the push-pull member to switch the support member (31) between the support state and the initial state.

9. The method for using the drug balloon dilatation catheter according to any one of claims 1 to 8, characterized in that: The method of use comprises the following steps: (1) placing the balloon (1) at the site of vascular lesions; (2) controlling the movement of the push-pull member to switch the support member (31) from an initial state to a support state, and maintaining the support member (31) in the support state to perform pre-release of the drug; (3) introducing a filling medium into the balloon (1) through the cavity, so that the balloon (1) expands outward and maintains the expansion; (4) Controlling the movement of the push-pull member to switch the support member (31) from the support state to the initial state, allowing the filling medium in the balloon (1) to flow out through the cavity, causing the balloon (1) to shrink, and then withdrawing the balloon (1).

10. The method of use according to claim 9, characterized in that: The height of the balloon wall of the balloon (1) in the expanded state is controlled to be not lower than the height of the support portion (312).

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