A drug-eluting balloon

Abstract

The present invention provides a drug-eluting balloon comprising a balloon body; the balloon body has multiple configurations. In a first configuration, the outer surface of the balloon body is provided with a groove; the surface of the groove is coated with a drug; in a second configuration, the groove is folded along the axial direction of the balloon body so that the two ends of the groove contact each other. Compared with the prior art, the drug-eluting balloon provided by the present invention allows the drug to be sprayed locally on the balloon, preventing excess drug from diffusing into the bloodstream and improving drug utilization. Furthermore, the drug-eluting balloon encapsulates the drug within the groove, minimizing drug loss during use and enabling drug release upon reaching the target lesion, thereby reducing the side effects of drug diffusion in blood vessels on the human body. Therefore, the present invention is simple to operate and has significant therapeutic effects.

Description

Technical Field

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

[0002] Interventional therapy, as an important clinical treatment system, has been proven to offer advantages such as safety, low injury rates, and significant therapeutic effects. Drug-eluting balloons are a newly emerging interventional procedure for treating vascular stenosis. The principle is to introduce a drug-coated balloon containing anti-proliferative drugs into the blood vessels, expand it, and interact with the lesions in the endothelium, thereby reducing the risk of re-stenosis.

[0003] Currently, most drug-eluting balloons are made by spraying the drug and then winding the balloon. This will cause drug loss during balloon delivery, resulting in a decrease in concentration from the proximal end to the distal end, so that when the target lesion is reached, insufficient drug is provided to prevent vascular stenosis. In addition, some drug-eluting balloons will add a layer of sustained-release agent or protective film on the balloon surface after spraying the drug to reduce the amount of drug loss during the balloon's entry into the blood vessel. This type of drug balloon will slow down the drug release rate, but considering that the balloon cannot be left in the blood vessel for a long time, this method will also reduce the treatment effect.

[0004] Therefore, there is a need for a balloon that reduces drug loss during clinical use and can release sufficient drugs to improve the effectiveness of the procedure. Summary of the Invention

[0005] In view of this, the technical problem to be solved by the present invention is to provide a drug balloon with low drug loss and sufficient drug release.

[0006] The present invention provides a drug balloon, comprising a balloon body;

[0007] The balloon body has multiple forms.

[0008] In the first embodiment, a groove is provided on the outer surface of the balloon body, and the distance between the sidewalls on both sides of the groove and the center of the groove decreases in the radially outward direction thereof; and the surface of the groove is coated with a drug;

[0009] In the second configuration, the groove is folded along the axial direction of the balloon body, and both ends of the groove are in contact with each other;

[0010] The axial length of the groove in the second form is smaller than the axial length of the groove in the first form.

[0011] Preferably, the angles between the side walls of the groove at both ends along the axial direction of the balloon body and the axial direction are independently 30° to 90°.

[0012] Preferably, a protrusion is provided on the bottom surface of the groove, and the protrusion is bent or curved along the axial extension direction of the balloon body;

[0013] And / or, the protrusion on the bottom surface of the groove is arranged along the circumferential direction of the balloon body.

[0014] Preferably, when the balloon body is in the first form, the bend of the bottom surface of the groove along the axial extension direction of the balloon body has a vertex angle of 30° to 150°.

[0015] Preferably, when the balloon body is in the first shape, the length of the groove is 1 / 4 to 1 / 2 of the length of the balloon body;

[0016] and / or, the center of the balloon body is located in the groove;

[0017] And / or, the distances from the center of the balloon body to the intersections of the side walls at both ends of the groove along the axial direction of the balloon body and the bottom surface of the groove are independently 0 to 50 mm, and preferably not all 0.

[0018] Preferably, it further comprises a bundle sleeve; the bundle sleeve is sleeved outside the balloon after the two ends of the groove are in contact along the axial direction of the balloon body.

[0019] Preferably, it further comprises an inner tube; the inner tube is arranged in the balloon body and passes through the entire balloon body; the two ends of the inner tube are connected to the two ends of the balloon body; the inner tube comprises a highly elastic inner tube.

[0020] Preferably, the length of the highly elastic inner tube is greater than or equal to the length of the groove;

[0021] And / or, the highly elastic inner tube is selected from a rubber inner tube, a polyurethane inner tube or a spring inner tube;

[0022] And / or, the wall of the spring inner tube is a multi-layer structure and is provided with a spring.

[0023] Preferably, the inner tube is provided with developing rings at positions corresponding to both ends of the effective length of the balloon body.

[0024] Preferably, it further comprises a clamping mechanism; the clamping mechanism is provided at both ends of the balloon body and is used for the transformation of the balloon body from the first shape to the second shape.

[0025] The present invention provides a drug-eluting balloon comprising a balloon body; the balloon body has multiple configurations. In a first configuration, the outer surface of the balloon body is provided with a groove; the surface of the groove is coated with a drug; in a second configuration, the groove is folded along the axial direction of the balloon body so that the two ends of the groove contact each other. Compared with the prior art, the drug-eluting balloon provided by the present invention allows the drug to be sprayed locally on the balloon, preventing excess drug from diffusing into the bloodstream and improving drug utilization. Furthermore, the drug-eluting balloon encapsulates the drug within the groove, minimizing drug loss during use and enabling drug release upon reaching the target lesion, thereby reducing the side effects of drug diffusion in blood vessels on the human body. Therefore, the present invention is simple to operate and has significant therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A schematic structural diagram of the drug balloon provided by the present invention;

[0027] Figure 2 A schematic diagram of the structure of the drug balloon provided by the present invention;

[0028] Figure 3 This is a schematic diagram of the overall structure of the drug-coated balloon device provided by the present invention;

[0029] Figure 4 A schematic diagram of the structure of a drug-coated balloon provided by the present invention;

[0030] Figure 5 It is a partial appearance schematic diagram and cross-sectional view of the balloon body after being pressed by a mold;

[0031] Figure 6 It is a partial appearance schematic diagram and cross-sectional view of the balloon body after being pressed by a mold;

[0032] Figure 7 This is a schematic diagram of the structure of the drug balloon after the sheath is installed provided by the present invention;

[0033] Figure 8 This is a schematic diagram of a balloon having a high-elastic inner tube with a spring disposed in the middle of the tube wall after being pressed by a mold;

[0034] Figure 9 A schematic structural diagram of the drug balloon provided by the present invention;

[0035] Figure 10 A schematic diagram of the overall structure of the drug balloon device provided by the present invention;

[0036] Figure 11 A schematic diagram of the drug balloon and the clamping mechanism provided by the present invention;

[0037] Figure 12 A schematic structural diagram of a drug balloon and a mold embodiment provided by the present invention;

[0038] Figure 13 This is a schematic structural diagram of the drug balloon and another mold embodiment provided by the present invention. DETAILED DESCRIPTION

[0039] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0040] The present invention provides a drug balloon, including a balloon body; the balloon body has multiple forms. In the first form, the outer surface of the balloon body is provided with a groove; the surface of the groove is coated with medicine; in the second form, the groove is folded along the axial direction of the balloon body so that the two ends of the groove are in contact.

[0041] See also Figure 1 , Figure 1 and Figure 2 This is a schematic diagram of the structure of the drug-eluting balloon provided by the present invention. Figure 2 represents the balloon body, 3 represents the inner tube, 4 represents the highly elastic inner tube, 5 represents the groove, and 6 represents the bent protrusion and depression structure. Figures a and b represent the sidewall of the groove, b represent the bottom surface of the groove, c represent the top angle of the bent structure, L represents half the length of the groove, and d represent the tip.

[0042] The balloon body of the drug-eluting balloon provided herein can be compliant, semi-compliant, or non-compliant. Semi-compliant or non-compliant balloons are preferred. This means that after being compressed, the balloon will not automatically return to its previous shape unless inflated with air or saline. Commonly used materials for non-compliant or semi-compliant balloons include polyamide (PA), polyether block polyamide (Pebax), or a blend of the two.

[0043] The balloon body has multiple forms, wherein the first form is as follows Figure 1 As shown, the outer surface of the balloon body is provided with a groove; the length of the groove is preferably 1 / 4 to 1 / 2 of the length of the balloon body, more preferably 1 / 3 to 1 / 2; the center of the balloon body is preferably located in the groove; the distance from the center of the balloon body to the intersection of the side walls of the two ends of the groove along the axial direction of the balloon body and the bottom surface of the groove is independently preferably 0 to 50 mm (as shown in FIG. Figure 1, and are not 0 at the same time, more preferably 10-30 mm, and even more preferably 10-15 mm; the center of the balloon body and the center of the groove may or may not coincide; in a specific embodiment provided by the present invention, the center of the groove coincides with the center of the balloon, which facilitates positioning of the groove, i.e., the area where the drug is coated, after the balloon is expanded in the blood vessel; in the present invention, the bottom surface and the sidewalls of the groove are preferably coated with drugs; the drugs are drugs that can inhibit cell endothelial proliferation well known to those skilled in the art, and there are no special restrictions. In the embodiments provided by the present invention, rapamycin or paclitaxel are used as examples for illustration; in the present invention, it is preferred that the balloon body is filled with gas and is in an expanded state, that is, the balloon is in another form, which is basically the same as the expanded state of the balloon in the blood vessel, and then the drug is coated on the surface of the balloon body, and then the surface of the balloon body coated with the drug is pressed into a groove by a mold; see Figure 3 and Figure 4 , Figure 3 This is a schematic diagram of the overall structure of the balloon device after coating with drugs. Figure 4 Schematic diagram of the drug-coated balloon structure, where 1 is the drug, 2 is the balloon body, and 3 is the inner tube.

[0044] The second form of the balloon body provided by the present invention is as follows Figure 2 As shown, the groove is folded along the axial direction of the balloon body so that the two ends of the groove are in contact; the distance between the side walls on both sides of the groove and the center of the groove becomes smaller along the radial outward direction. As a preferred embodiment, the distance between the two side walls and the center of the groove gradually becomes smaller, that is, the side walls are smoothly transitioned curved surfaces, and the angles between the side walls at both ends of the groove along the axial direction of the balloon body and the axial direction are preferably 30°~90°, more preferably 30°~85°; for easy folding, the bottom surface of the groove is preferably provided with a protrusion along the axial extension direction of the balloon body, and the protrusion is bent or bent along the axial extension direction of the balloon body, and the protrusion is formed by pressing a mold; the axial compression of the groove can be achieved by the axially bent protrusion; when bent, the top angle of the bend (such as Figure 1 、 6 The angle (shown in c) is preferably 30°~150°, more preferably 60°~150°, further preferably 80°~150°, and most preferably 80°~135°; in the present invention, the protrusions of the groove are arranged along the circumferential direction of the groove, that is, the circumferential direction of the balloon body. The circumferentially arranged protrusions can be arranged continuously or at intervals, and there is no special limitation. See Figure 5 and Figure 6 , Figure 5 and Figure 6The following is a partial schematic diagram and cross-sectional view of the balloon body after being pressed by the mold. The circumferentially arranged protrusions can reduce the radial dimension of the balloon when the mold is pressed down, that is, it can shrink in the radial direction. The angle of the apex angle of the circumferentially arranged protrusions is set according to the ratio of the radial dimension reduction and the number of protrusions. As an embodiment, the circumferentially arranged protrusions and the axial bends of the protrusions are both set in corresponding shapes on the mold and formed by the mold pressing, see Figure 12 In addition, combined with Figure 5 、 Figure 6 The circumferentially arranged protrusion refers to a protruding structure formed on the bottom surface of the groove when the balloon is in the second form. The cross-section of the circumferentially arranged protrusion is preferably triangular. Of course, in other embodiments, it can also be a semicircular shape, etc., which can achieve the reduction of the radial size of the balloon and can cooperate with the axial bending to achieve axial compression.

[0045] See also Figure 12 , 13 is a mold, which includes multiple different blocks in the circumferential direction. Multiple blocks are spliced together to form the mold as a whole, and the inner wall of the mold has at least a structural shape corresponding to the groove of the balloon body.

[0046] See also Figure 13 , Figure 13 Figure 2 illustrates another embodiment of the mold of the present invention. This mold 14 comprises three parts: a first mold body 14-1, a second mold body 14-2, and a third mold body 14-3. During the molding process, when demolding, the second mold body 14-2 moves outward first, followed by the first mold body 14-1 and the third mold body 14-3 moving diagonally outward. This mold structure and demolding method allows for better demolding while preventing damage to the protrusions on the surface of the balloon groove.

[0047] In order to ensure that the axially folded grooves are not expanded by gas during subsequent radial folding and to ensure that the drug is wrapped in the axially stacked grooves, it is preferred to further include a sheath; the sheath is placed outside the balloon after the two ends of the grooves are in contact along the axial direction of the balloon body; the material of the sheath is preferably metal or polymer material; the length of the sheath is preferably 10-15 mm; the thickness of the sheath is preferably 0.3-1 mm; the sheath can be removed before the balloon is covered with the balloon protective sheath. Figure 7 , Figure 7 The schematic structural diagram of the drug balloon provided by the present invention is that the balloon is in the third form, wherein 9 is a sheath.

[0048] According to the present invention, the drug balloon preferably also includes an inner tube; the inner tube is arranged in the balloon body and passes through the entire balloon body; as a preferred embodiment of the present invention, the two ends of the inner tube are connected to the two ends of the balloon body; in order to achieve the folding of the groove on the balloon body, the inner tube preferably includes a high-elastic inner tube; the length of the high-elastic inner tube can be the same as the length of the inner tube, that is, the entire inner tube is a high-elastic inner tube, or it can be less than the length of the inner tube, and there is no special restriction, but the length of the high-elastic inner tube is preferably greater than or equal to the length of the groove; as a preferred embodiment of the present invention, when the high-elastic inner tube is less than the length of the inner tube, the high-elastic inner tube can be connected to the conventional inner tube by gluing, heat welding or laser welding; the high-elastic inner tube is preferably a rubber inner tube, a polyurethane inner tube or a spring inner tube; the tube wall of the spring inner tube is a multi-layer structure and is provided with a spring; as a preferred embodiment of the present invention, the tube wall of the spring inner tube is preferably a film or sheet tube covered with an elastic film or sheet tube on the inner and outer surfaces of the spring; the material of the film or sheet tube is preferably polytetrafluoroethylene (PTFE), polylactic acid (PLLA), Poly-L-lactide-caprolactone (PLCL), poly-lactic-co-glycolic acid (PLGA), or PLGC; see Figure 8 , Figure 8 This is a schematic diagram of a balloon having a high-elastic inner tube with a spring arranged in the middle of the tube wall after being pressed by a mold, wherein 7 is the spring and 8 is the elastic coating.

[0049] As another preferred embodiment provided by the present invention, the drug balloon provided by the present invention preferably further includes a clamping mechanism, and the inner tube includes a highly elastic inner tube; the highly elastic inner tube is the same as described above and will not be described in detail here; the clamping mechanism is preferably provided at both ends of the balloon body, i.e., on both sides of the non-groove structure of the balloon body, and more preferably provided at the connection portion between the balloon body and the inner tube or at both ends of the outer side of the balloon body; the clamping mechanism compresses the balloon body from both sides toward the center, thereby causing the center of the balloon body to deform and compress. At this time, the elastic inner tube will elastically contract axially and will not bend due to the shortening of the axial distance. See Figure 11 , Figure 11 The clamping structure of the present invention is shown. The clamping mechanisms on the left and right sides of the balloon each include multiple clamping portions 12, each shaped essentially like the ends of the balloon body. Each clamping portion 12 is equipped with a drive mechanism (not shown) that drives the clamping portion 12 to retract inward, clamping and enveloping the two sides of the balloon so that the inner cavity walls formed by the clamping portions substantially abut the outer walls of the balloon. The drive mechanism then moves from the sides of the balloon toward the center, compressing the balloon, thereby deforming and compressing the center of the balloon body, transforming it from a first configuration to a second configuration.

[0050] In the embodiment provided by the present invention, the elastic inner tube, under the elastic force and / or by clamping the two sides of the balloon through the clamping mechanism, squeezes the balloon toward the center, causing the balloon to shrink axially, the groove part to fold, and change from the first form to the second form.

[0051] In order to effectively monitor the position and length of the balloon after entering the blood vessel, the inner tube is preferably provided with developing rings at positions corresponding to the two ends of the effective length of the balloon body; the developing rings are preferably platinum-iridium alloy or X-ray developable material; the mounting method of the developing rings is preferably bonding, ring forging or other suitable methods, more preferably ring forging; in a preferred embodiment provided by the present invention, the highly elastic inner tube is located between two developing rings.

[0052] The drug balloon provided by the present invention preferably further includes an outer tube, which is communicated with the inner tube; the distal end of the outer tube is connected to the proximal end of the inner tube.

[0053] The drug balloon provided by the present invention preferably further includes a catheter seat, and the outer tube is connected to the catheter seat; the proximal end of the outer tube is connected to the distal end of the catheter seat.

[0054] The drug balloon provided by the present invention preferably also includes a Tip head, such as Figure 1 As shown in d, the Tip is placed on the portion where the distal end of the balloon body is connected to the distal end of the inner tube to reduce damage to the blood vessels.

[0055] In the present invention, unless otherwise specified, the distal end is the end of the balloon that is away from the operator during operation, which is well known to those skilled in the art, and the proximal end is the end that is close to the operator.

[0056] The drug balloon provided by the present invention preferably further includes a balloon protective cover, wherein the balloon body is radially folded and then wrapped in the balloon protective cover. Figure 9 and Figure 10 , Figure 9 This is a schematic diagram of the structure of the drug balloon provided by the present invention. Figure 10 The schematic diagram of the overall structure of the drug balloon device provided by the present invention is that the balloon is in the fourth form, wherein 10 is the balloon protective cover and 11 is the wrapped drug portion.

[0057] On the one hand, the drug balloon provided by the present invention allows the drug to be sprayed locally on the balloon, preventing excess drug from diffusing in the blood and improving the utilization rate of the drug; on the other hand, the drug balloon wraps the drug in the groove, which reduces the loss of drug during use and can be released when it reaches the target lesion, reducing the side effects of the drug diffusing in the blood vessels on the human body. Therefore, the invention is simple to operate and has obvious therapeutic effects.

[0058] The present invention also provides a method for preparing the above-mentioned drug balloon, comprising: spraying the drug on the surface of the balloon body, then pressing the drug-sprayed part into a groove with a mold, folding it in the axial direction of the balloon body, wrapping the drug in the raised and recessed structures of the groove, and reducing the length of the balloon accordingly; putting a bundle sleeve on the axially folded part of the balloon to ensure that the axially folded balloon is not expanded by gas during radial folding, and ensuring that the drug is wrapped in the axially stacked balloon; using a balloon folding machine to fold and compress the balloon radially, removing the bundle sleeve after completion, and installing a balloon sheath tube on the entire balloon body.

[0059] In the present invention, the folding compression force is preferably 20-400 psi.

[0060] To further illustrate the present invention, a drug balloon provided by the present invention is described in detail below with reference to examples.

[0061] The reagents used in the following examples are all commercially available.

[0062] Example 1

[0063] The inner tube portion of the bladder body is made of polyurethane material and connected to the outer inner tube of the bladder body by welding;

[0064] The balloon catheter consists of a balloon, a developing ring, a tip, an inner tube, an outer tube, a catheter seat and a diffusion stress tube;

[0065] The balloon is inflated with gas, with an inflation pressure of approximately 20 psi.

[0066] The drug sprayer sprays 25 mm on the balloon body of the balloon catheter, that is, the spraying position extends 12.5 mm to both sides from the center of the balloon;

[0067] After the spraying is completed, after the drug crystals are solidified on the surface of the capsule, the drug portion capsule is pressed into Figure 1 As shown in Figure 5, the angle between the groove side angle, i.e., the angle between the side wall a and the axial direction, is 85°. The balloon containing the drug is folded along the axial direction at the center of the balloon so that the drug is coated in the sawtooth convex and concave structure. The convex top angle c is 135° (as shown in Figure 5). Figure 1 、 5 , 6), then the elastic inner tube is subjected to elastic force and / or clamps the two sides of the balloon through the clamping mechanism, squeezing the balloon toward the center, causing the balloon to shrink axially and the groove part to fold. The balloon after shrinkage is as shown Figure 2 As shown;

[0068] Put a sleeve (such as Figure 7 (As shown in Figure 9), the material is a stainless steel ring with a wall thickness of 0.1 mm and a length of 28 mm. The balloon at the axial fold is tightly attached to the inner tube through a cuff;

[0069] Perform the final folding of the balloon, i.e. radial folding and compression. Set the folding temperature to 30°C, the folding force to 130psi, the compression temperature to 40°C, the compression force to 160psi, and at the same time, apply negative pressure to the balloon. After folding is completed, remove the above-mentioned bundle and put a balloon protective cover (such as Figure 9 As shown in Figure 10), the balloon catheter finally obtained is as shown in Figure 10. Figure 10 shown. Specific embodiment 2

[0071] The inner tube portion of the capsule is connected to the outer inner tube of the capsule by welding using a spring;

[0072] The spring in the balloon is an elastic material covered with polytetrafluoroethylene, such as Figure 8 As shown in Figure 8;

[0073] The balloon catheter is assembled from a balloon, a developing ring, a tip, an inner tube, an outer tube, a catheter seat and a diffusion stress tube;

[0074] The balloon is inflated with gas, with an inflation pressure of approximately 20 psi.

[0075] The drug sprayer sprays 15 mm on the balloon body of the balloon catheter, that is, the spraying position extends 7.5 mm from the center of the balloon to both sides;

[0076] After the spraying is completed, after the drug crystals are solidified on the surface of the capsule, the drug portion capsule is pressed into Figure 1 As shown in Figure 5, the angle between the groove side angle, i.e., the angle between the side wall a and the axial direction, is 30°. The balloon containing the drug is folded along the axial direction at the center of the balloon so that the drug is coated in the sawtooth convex and concave structure (as shown in Figure 5). Figure 1 6), then the highly elastic inner tube clamps the two sides of the balloon under elastic force and / or through the clamping mechanism, squeezes the balloon toward the center, and causes the balloon to shrink axially, and the groove part is folded. The balloon after shrinkage is as shown in FIG. Figure 2 As shown;

[0077] Put the bundle tube (such as Figure 7 9), made of high-density polyethylene (HDPE), with a wall thickness of 0.3 mm and a length of 17 mm. The balloon at the axial fold is attached to the inner tube through the bundle tube;

[0078] The balloon is finally folded, i.e. radially folded and compressed. The folding temperature is set to 30°C, the folding force is 100 psi, the compression temperature is set to 40°C, and the compression force is set to 130 psi. At the same time, negative pressure is applied to the balloon. After the folding is completed, the above-mentioned bundle is removed and the balloon protective cover is put on the balloon body. The balloon catheter is finally obtained as shown in FIG. Figure 10As shown, Figure 9 10 and 11 are the states of the balloon protective cover and the drug capsule after folding and wrapping, respectively.

[0079] Example 3

[0080] In the above embodiment, the shape of the groove portion after being compressed by the mold has multiple protrusions in the circumferential direction. The protrusions are bent and extended on the outer surface of the balloon. The protrusions arranged in the circumferential direction can be closely distributed in the axial direction of the balloon, such as Figure 5 As shown, they can also be distributed circumferentially, such as Figure 6 shown.

[0081] Example 4

[0082] When the balloon is pressed down by the mold, axially contracted or squeezed, and finally folded, negative pressure is applied to the balloon. The pressure value is set according to the change in balloon volume.

Claims

1. A drug balloon, characterized in that: including a balloon body; The balloon body has multiple forms. In the first embodiment, a groove is provided on the outer surface of the balloon body, and the distance between the sidewalls on both sides of the groove and the center of the groove decreases in the radially outward direction thereof; and the surface of the groove is coated with a drug; In the second configuration, the groove is folded along the axial direction of the balloon body, and both ends of the groove are in contact with each other; The axial length of the groove in the second form is smaller than the axial length of the groove in the first form.

2. The drug balloon according to claim 1, characterized in that: The angles between the side walls of the groove at both ends along the axial direction of the balloon body and the axial direction are independently 30° to 90°.

3. The drug balloon according to claim 1, characterized in that: The bottom surface of the groove is provided with a protrusion, and the protrusion is bent or curved along the axial extension direction of the balloon body; And / or, the protrusion on the bottom surface of the groove is arranged along the circumferential direction of the balloon body.

4. The drug balloon according to claim 3, characterized in that: When the balloon body is in the first form, the bend formed on the bottom surface of the groove along the axial extension direction of the balloon body has a vertex angle of 30° to 150°.

5. The drug balloon according to claim 1, characterized in that: When the balloon body is in the first shape, the length of the groove is 1 / 4 to 1 / 2 of the length of the balloon body; and / or, the center of the balloon body is located in the groove; And / or, the distances between the center of the balloon body and the intersections of the side walls at both ends of the groove along the axial direction of the balloon body and the bottom surface of the groove are independently 0 to 50 mm.

6. The drug balloon according to claim 1, characterized in that: It also includes a bundle sleeve; the bundle sleeve is sleeved outside the balloon after the two ends of the groove are in contact along the axial direction of the balloon body.

7. The drug balloon according to claim 1, characterized in that: It also includes an inner tube; the inner tube is arranged in the balloon body and runs through the entire balloon body; the two ends of the inner tube are connected to the two ends of the balloon body; the inner tube includes a high-elasticity inner tube.

8. The drug balloon according to claim 7, characterized in that: The length of the highly elastic inner tube is greater than or equal to the length of the groove; And / or, the highly elastic inner tube is selected from a rubber inner tube, a polyurethane inner tube or a spring inner tube; And / or, the wall of the spring inner tube is a multi-layer structure and is provided with a spring.

9. The drug balloon according to claim 7, characterized in that: The inner tube is provided with developing rings at positions corresponding to both ends of the effective length of the balloon body.

10. The drug balloon according to claim 1, characterized in that: It also includes a clamping mechanism; the clamping mechanism is arranged at both ends of the balloon body and is used for the transformation of the balloon body from the first form to the second form.

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