A gradient expanding coronary dilation balloon and method of use

Abstract

The present application relates to the technical field of medical equipment, and discloses a gradient expansion coronary expansion balloon and a use method, which comprises a main balloon body, the side surface of the main balloon body is respectively provided with a front end auxiliary balloon body and a rear end auxiliary balloon body along the axial direction thereof, the front end auxiliary balloon body is used for forming support for the normal blood vessel at the distal end of the lesion segment, and the rear end auxiliary balloon body is used for forming support for the normal blood vessel at the proximal end of the lesion segment, so as to realize gradient support in cooperation with the main balloon body, and a multi-cavity delivery catheter extending along the axial direction of the main balloon body is arranged on the main balloon body. The present application can form gradient support for the blood vessel at the lesion segment and the proximal end and the distal end of the lesion segment, avoids the rapid elastic retraction of the blood vessel wall to the lesion segment after the balloon is deflated, increases the effective surface area of the drug carrying, realizes the precise local delivery of high-dose drugs, and can independently adjust the inflation pressure of the main balloon body, the front end auxiliary balloon body and the rear end auxiliary balloon body.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a gradient dilation coronary artery dilation balloon and its usage method. Background Technology

[0002] The coronary dilation balloon is a core medical device in percutaneous coronary intervention (PCI) for coronary heart disease. PCI is used to treat atherosclerotic coronary heart disease, especially acute myocardial infarction and severe coronary artery stenosis. The balloon is suitable for different types of coronary artery stenosis, including calcified stenosis, eccentric stenosis, and diffuse stenosis. The balloon can not only be used independently to dilate mild stenosis, but also as a pre-operative aid in stent implantation to pre-dilate the narrowed lumen, creating conditions for stent delivery.

[0003] Coronary artery dilation balloons require the use of coronary guidewires and a dedicated pressure pump. The procedure begins with establishing a vascular access via radial or femoral artery puncture. The guidewire is then advanced to the distal end of the stenotic lesion and through the lesion segment. The folded balloon is then delivered along the guidewire to the lesion site. Intraoperative coronary angiography confirms the alignment of the balloon with the lesion segment. Once accurate positioning is confirmed, a contrast agent-saline solution is injected through the inflation channel at the balloon's tail. The inflation pressure is adjusted using a dedicated pressure pump to radially inflate the balloon and apply uniform mechanical pressure to the stenotic vessel wall, forcing the atherosclerotic plaque to compress or the vessel wall to elastically expand, thereby restoring patency. For drug-eluting balloons, the balloon surface is pre-coated with anti-proliferative drugs such as paclitaxel or zotamoxetine. As the balloon inflates and adheres to the vessel wall, the drugs are passively diffused to the intima, achieving local drug delivery and inhibiting vascular smooth muscle cell proliferation, thus reducing the incidence of restenosis.

[0004] Currently, single-balloon dilation lacks a gradient support structure, and can only apply radial pressure to the diseased segment of the vessel. The normal vessel segments proximal and distal to the diseased segment lack additional support, which reduces the effectiveness of maintaining luminal patency. At the same time, the surface of the drug-eluting balloon is a smooth structure, which limits the effective drug-carrying surface area. The drug can only adhere to the outer surface of the balloon, and during dilation, the drug is prone to slippage due to the sliding between the balloon and the vessel wall, making it impossible to achieve precise local delivery of high-dose drugs.

[0005] Therefore, the purpose of this invention is to provide a gradient dilation coronary artery dilation balloon and its usage method to overcome the shortcomings of the prior art. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a gradient-dilation coronary artery dilation balloon and its usage method, which solves the problem that current single balloon dilation lacks a gradient support structure, can only apply radial pressure to the diseased segment of the blood vessel, and has no additional support for the normal blood vessel segments proximal and distal to the diseased segment.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] The first aspect of the present invention provides a gradient dilation coronary artery dilation balloon, comprising a main balloon body, wherein a front auxiliary balloon body and a rear auxiliary balloon body are disposed on the side surface of the main balloon body, the front auxiliary balloon body is used to support normal blood vessels distal to the lesion segment, and the rear auxiliary balloon body is used to support normal blood vessels proximal to the lesion segment, so as to cooperate with the main balloon body to achieve gradient support; a multi-lumen delivery catheter extending along its axial direction is disposed on the main balloon body, and a first air delivery tube, a second air delivery tube and a third air delivery tube are respectively disposed in the multi-lumen delivery catheter for independently adjusting the inflation of the corresponding balloon body; the first air delivery tube is connected to the main balloon body, the second air delivery tube is connected to the front auxiliary balloon body, and the third air delivery tube is connected to the rear auxiliary balloon body;

[0009] The outer surface of the main balloon body is provided with a main balloon groove, the outer surface of the front auxiliary balloon body is provided with a first auxiliary balloon groove, and the outer surface of the rear auxiliary balloon body is provided with a second auxiliary balloon groove. The main balloon groove, the first auxiliary balloon groove, and the second auxiliary balloon groove are used to increase the effective surface area for drug carrying and form a drug storage area, thereby reducing drug loss during expansion and achieving precise delivery.

[0010] Preferably, the right end of the main balloon body is fixedly connected to a delivery tube fixing buckle via a balloon delivery tube.

[0011] Preferably, the first air delivery tube, the second air delivery tube, and the third air delivery tube all pass through the balloon delivery conduit and the delivery conduit fixing buckle in sequence.

[0012] Preferably, there are two front-end auxiliary balloons, and the two front-end auxiliary balloons are connected by a first connecting tube.

[0013] Preferably, there are two rear-end auxiliary balloons, and the two rear-end auxiliary balloons are connected by a second connecting tube.

[0014] Preferably, a first balloon dilation pressure pump is fixedly connected to the end of the first air delivery pipe away from the delivery conduit fixing buckle.

[0015] Preferably, a second balloon dilation pressure pump is fixedly connected to the end of the second air delivery pipe away from the delivery conduit fixing buckle.

[0016] Preferably, a third balloon dilation pressure pump is fixedly connected to the end of the third air delivery pipe away from the delivery conduit fixing buckle.

[0017] Preferably, there are multiple main balloon grooves, first auxiliary balloon grooves, and second auxiliary balloon grooves, which are evenly distributed in a ring along the circumference of the corresponding balloon body.

[0018] A second aspect of the present invention provides a method for using a gradient-dilation coronary artery dilation balloon, comprising the following steps:

[0019] S1. The antiproliferative drug is evenly coated into the main balloon groove of the main balloon body, the first auxiliary balloon groove of the front auxiliary balloon body, and the second auxiliary balloon groove of the rear auxiliary balloon body, ensuring that the drug is fully filled in the main balloon groove, the first auxiliary balloon groove, and the second auxiliary balloon groove and the surface is flat. At the same time, the antiproliferative drug is coated on the surface of the main balloon body, the front auxiliary balloon body, and the rear auxiliary balloon body to complete the drug loading.

[0020] S2. Insert the coronary guidewire into the stenotic lesion site of the patient's coronary artery and through the lesion segment. Push the main balloon body, the front auxiliary balloon body, and the rear auxiliary balloon body along the guidewire. Confirm through intraoperative coronary angiography that the main balloon body is aligned with the lesion segment, the front auxiliary balloon body is located in the distal vessel of the lesion segment, and the rear auxiliary balloon body is located in the proximal vessel of the lesion segment.

[0021] S3. Start the third balloon dilation pressure pump and inflate the rear auxiliary balloon through the third air delivery tube, so that the rear auxiliary balloon expands and forms stable support for the proximal blood vessel of the lesion segment. During the expansion process, the drug in the groove of the second auxiliary balloon and the surface of the rear auxiliary balloon are released simultaneously to the proximal blood vessel wall of the lesion segment.

[0022] S4. Start the first balloon dilation pressure pump to inflate the main balloon body through the first air delivery tube, so that the main balloon body expands and dilates the narrowed lesion segment of the blood vessel. The drugs in the groove of the main balloon and on the surface of the main balloon body are released simultaneously to the blood vessel wall in the core area of ​​the lesion.

[0023] S5. Start the second balloon dilation pressure pump and inflate the front auxiliary balloon body through the second air delivery tube, so that the front auxiliary balloon body expands and forms stable support for the distal blood vessel of the lesion segment. During the expansion process, the drug in the groove of the first auxiliary balloon and the surface of the front auxiliary balloon body are released simultaneously to the distal blood vessel wall of the lesion segment.

[0024] S6. After maintaining the inflation of the main balloon body, the front auxiliary balloon body, and the rear auxiliary balloon body for 40-50 seconds, turn off the first balloon dilation pressure pump, the second balloon dilation pressure pump, and the third balloon dilation pressure pump in sequence, and remove the inflation medium from each balloon body. Then, slowly withdraw the main balloon body, the front auxiliary balloon body, and the rear auxiliary balloon body from the patient's body along the guidewire.

[0025] This invention provides a gradient-dilation coronary artery dilation balloon and its method of use. It has the following beneficial effects:

[0026] 1. This invention, by setting up a main balloon body, an anterior auxiliary balloon body, a posterior auxiliary balloon body, a first air delivery tube, a second air delivery tube, and a third air delivery tube, can form gradient support for the coronary artery lesion segment and the blood vessels at the proximal and distal ends of the lesion segment. This avoids the rapid elastic recoil of the blood vessel wall towards the lesion segment after balloon deflation. In eccentric stenosis and soft plaque lesions, it reduces the postoperative recoil of the lumen diameter and improves the maintenance effect of lumen patency.

[0027] 2. By setting a main balloon groove, a first auxiliary balloon groove, and a second auxiliary balloon groove, the present invention increases the effective surface area for drug delivery. At the same time, the main balloon groove, the first auxiliary balloon groove, and the second auxiliary balloon groove can form a drug storage area, reducing drug loss due to the sliding of the balloon and the blood vessel wall during expansion, and achieving precise local delivery of high-dose drugs.

[0028] 3. By setting up a first air supply tube, a second air supply tube, and a third air supply tube that are respectively connected to the main balloon body, the front auxiliary balloon body, and the rear auxiliary balloon body, the invention can independently adjust the inflation pressure and expansion rhythm of the main balloon body, the front auxiliary balloon body, and the rear auxiliary balloon body, avoiding inflation interference between balloons and improving the accuracy and safety of coronary artery dilation operation. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0030] Figure 2 This is a schematic diagram of the main balloon structure of the present invention;

[0031] Figure 3 This is a left view of the main balloon body of the present invention;

[0032] Figure 4 This is a schematic diagram of the structure of the first balloon dilation pressure pump of the present invention.

[0033] The components include: 1. Main balloon body; 2. Front auxiliary balloon body; 3. Rear auxiliary balloon body; 4. Multi-lumen delivery catheter; 5. First air delivery tube; 6. Second air delivery tube; 7. Third air delivery tube; 8. Main balloon groove; 9. First auxiliary balloon groove; 10. Second auxiliary balloon groove; 11. Balloon delivery catheter; 12. Delivery catheter fixing buckle; 13. First balloon dilation pressure pump; 14. Second balloon dilation pressure pump; 15. Third balloon dilation pressure pump; 16. First connecting tube; 17. Second connecting tube. Detailed Implementation

[0034] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] Please see the appendix Figure 1 - Appendix Figure 4 This invention provides a gradient dilation coronary artery dilation balloon, including a main balloon body 1. The side surface of the main balloon body 1 is provided with a front auxiliary balloon body 2 and a rear auxiliary balloon body 3. The front auxiliary balloon body 2 is used to support the normal blood vessels distal to the lesion segment, and the rear auxiliary balloon body 3 is used to support the normal blood vessels proximal to the lesion segment, so as to cooperate with the main balloon body 1 to achieve gradient support.

[0036] Specifically, by setting an anterior auxiliary balloon body 2 and a posterior auxiliary balloon body 3 at both ends of the main balloon body 1 along its axial direction, a gradient support structure is constructed, providing proximal support, lesion dilation, and distal support. When the main balloon body 1 reaches the target position, the main balloon body 1, the anterior auxiliary balloon body 2, and the posterior auxiliary balloon body 3 can act on the lesion segment and the normal blood vessels at both ends, respectively. When the main balloon body 1 dilates the lesion segment, the anterior auxiliary balloon body 2 and the posterior auxiliary balloon body 3 can provide stable support for the normal blood vessel segment, counteracting the elastic recoil force of the blood vessel wall itself. After the main balloon body 1 deflates, it delays the compression of the normal blood vessel towards the lesion segment, reducing the postoperative recoil of the lumen diameter and improving the long-term maintenance effect of lumen patency. The operation method of pushing the coronary dilation balloon along the guidewire to the target position is existing technology in this field. The core improvement of this invention lies in the structural design of the main balloon body 1, rather than the pushing method itself.

[0037] The main balloon body 1 is equipped with a multi-lumen delivery conduit 4 extending along its axial direction. The multi-lumen delivery conduit 4 is respectively provided with a first air delivery tube 5, a second air delivery tube 6 and a third air delivery tube 7 for independently adjusting the inflation of the corresponding balloon. The first air delivery tube 5 is connected to the main balloon body 1, the second air delivery tube 6 is connected to the front auxiliary balloon body 2, and the third air delivery tube 7 is connected to the rear auxiliary balloon body 3.

[0038] Specifically, the first air supply tube 5, the second air supply tube 6, and the third air supply tube 7 are respectively connected to the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3, so that the inflation process of the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 can be adjusted independently. During use, the inflation pressure, inflation speed, and expansion rhythm of the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 can be precisely adjusted according to the surgical needs.

[0039] The outer surface of the main balloon body 1 is provided with a main balloon groove 8, the outer surface of the front auxiliary balloon body 2 is provided with a first auxiliary balloon groove 9, and the outer surface of the rear auxiliary balloon body 3 is provided with a second auxiliary balloon groove 10. The main balloon groove 8, the first auxiliary balloon groove 9, and the second auxiliary balloon groove 10 are used to increase the effective surface area for drug carrying and form a drug storage area, reduce drug loss during expansion, and achieve precise delivery. There are multiple main balloon grooves 8, first auxiliary balloon grooves 9, and second auxiliary balloon grooves 10, and they are evenly distributed in a ring along the circumference of the corresponding balloon body.

[0040] Specifically, traditional drug-eluting balloons have a smooth surface, and the drug-carrying surface area is only the outer surface area of ​​the balloon, limiting the effective drug loading capacity. Furthermore, during expansion, the relative sliding between the balloon and the blood vessel wall can cause the drug adhering to the surface to detach. Multiple annularly distributed main balloon grooves 8, first auxiliary balloon grooves 9, and second auxiliary balloon grooves 10 can increase the surface area of ​​the front auxiliary balloon 2 and rear auxiliary balloon 3 at both ends of the main balloon body 1 along its axial direction, thereby improving the drug loading capacity and providing a structural basis for high-dose drug delivery. Meanwhile, the main balloon groove 8, the first auxiliary balloon groove 9, and the second auxiliary balloon groove 10 form independent drug storage areas. Drugs can be filled inside the main balloon groove 8, the first auxiliary balloon groove 9, and the second auxiliary balloon groove 10. When the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 are in contact with the blood vessel wall, the drugs in the main balloon groove 8, the first auxiliary balloon groove 9, and the second auxiliary balloon groove 10 are not easily dislodged due to sliding. At the same time, when the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 expand and exert pressure on the blood vessel wall, the drugs in the main balloon groove 8, the first auxiliary balloon groove 9, and the second auxiliary balloon groove 10 are slowly and evenly released onto the surface of the blood vessel wall.

[0041] The ring-shaped distribution ensures uniform drug distribution around the blood vessel, avoiding drug delivery blind spots and further improving the accuracy of drug delivery. This allows the lesion area to receive sufficient drug action, enhancing postoperative anti-proliferative effects and reducing the risk of restenosis. The depth and width of the main balloon groove 8, the first auxiliary balloon groove 9, and the second auxiliary balloon groove 10 are optimized to ensure sufficient drug storage while preventing uneven stress during inflation of the main balloon body 1, the anterior auxiliary balloon body 2, and the posterior auxiliary balloon body 3 due to excessive depth of these grooves. This ensures structural stability during the expansion of the main balloon body 1, the anterior auxiliary balloon body 2, and the posterior auxiliary balloon body 3.

[0042] The right end of the main balloon body 1 is fixedly connected to the balloon delivery tube 11 by a delivery tube fixing buckle 12. The first air delivery tube 5, the second air delivery tube 6, and the third air delivery tube 7 all pass through the balloon delivery tube 11 and the delivery tube fixing buckle 12 in sequence.

[0043] Specifically, the balloon delivery catheter 11 serves to guide and protect the air delivery tube, while ensuring the smooth advancement of the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 within the blood vessel. The delivery catheter fixing buckle 12 is used to fix the structure, preventing balloon displacement due to movement or shaking of the air delivery tube during surgical procedures, which could affect surgical precision. Both the balloon delivery catheter 11 and the delivery catheter fixing buckle 12 are existing technologies and will not be described in detail here. The design of the first air delivery tube 5, the second air delivery tube 6, and the third air delivery tube 7 passing sequentially through the balloon delivery catheter 11 and the delivery catheter fixing buckle 12 makes the entire balloon structure more compact, reducing the space occupied within the blood vessel and minimizing irritation to the blood vessel.

[0044] There are two front-end auxiliary balloons 2, which are connected by a first connecting tube 16. There are also two rear-end auxiliary balloons 3, which are connected by a second connecting tube 17.

[0045] Specifically, two anterior auxiliary balloons 2 are configured and connected by a first connecting tube 16, and two posterior auxiliary balloons 3 are configured and connected by a second connecting tube 17. The two parallel anterior auxiliary balloons 2 can form a wider support area at the distal end of the lesion segment. Combined with the connecting effect of the first connecting tube 16, the inflation states of the two anterior auxiliary balloons 2 can be kept synchronized, avoiding support displacement caused by uneven pressure in a single balloon. The two posterior auxiliary balloons 3, connected by the second connecting tube 17, can enhance the stability and coverage of the proximal support of the lesion segment.

[0046] The first air delivery tube 5 is fixedly connected to a first balloon dilation pressure pump 13 at one end away from the delivery conduit fixing buckle 12; the second air delivery tube 6 is fixedly connected to a second balloon dilation pressure pump 14 at one end away from the delivery conduit fixing buckle 12; and the third air delivery tube 7 is fixedly connected to a third balloon dilation pressure pump 15 at one end away from the delivery conduit fixing buckle 12.

[0047] Specifically, during use, the third balloon dilation pressure pump 15 is activated, inflating the rear auxiliary balloon 3 through the third air delivery tube 7, causing the rear auxiliary balloon 3 to expand and provide stable support to the proximal vessel of the lesion segment. During the expansion, the medication on the groove 10 of the second auxiliary balloon and the surface of the rear auxiliary balloon 3 is simultaneously released to the proximal vessel wall of the lesion segment. The first balloon dilation pressure pump 13 is activated, inflating the main balloon body 1 through the first air delivery tube 5, causing the main balloon body 1 to expand and dilate the narrowed lesion segment vessel. The medication on the groove 8 of the main balloon and the surface of the main balloon body 1 is simultaneously released to the vessel wall of the core area of ​​the lesion. The second balloon dilation pressure pump 14 is activated, inflating the front auxiliary balloon 2 through the second air delivery tube 6, causing the front auxiliary balloon 2 to expand and provide stable support to the distal vessel of the lesion segment. During the expansion, the medication on the groove 9 of the first auxiliary balloon and the surface of the front auxiliary balloon 2 is simultaneously released to the distal vessel wall of the lesion segment.

[0048] The independent pressure pumps 13, 14, and 15 of the first balloon dilation pump allow for independent adjustment of the inflation pressure and expansion rhythm of the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3, avoiding inflation interference between balloons and improving the accuracy and safety of coronary artery dilation operations. The inflation pressure of the first balloon dilation pump 13, the second balloon dilation pump 14, and the third balloon dilation pump 15 can be observed in real time through the high-definition pressure monitoring display screen built into the pump, and it is also equipped with a pressure change curve recording function. Pressure monitoring allows medical staff to intuitively grasp the pressure rise rate and stable state. It should be noted that the pressure monitoring device with high-definition digital display and pressure curve recording function is existing technology in the field of coronary artery dilation devices.

[0049] The method of using a gradient-expanding coronary artery dilation balloon described below can be referred to in conjunction with the method described above.

[0050] A method for using a gradient-dilation coronary artery dilation balloon includes the following steps:

[0051] S1. The antiproliferative drug is evenly coated in the main balloon groove 8 of the main balloon body 1, the first auxiliary balloon groove 9 of the front auxiliary balloon body 2, and the second auxiliary balloon groove 10 of the rear auxiliary balloon body 3, ensuring that the drug is fully filled in the main balloon groove 8, the first auxiliary balloon groove 9, and the second auxiliary balloon groove 10 and the surface is flat. At the same time, the antiproliferative drug is coated on the surface of the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 to complete the drug loading.

[0052] S2. Insert the coronary guidewire into the stenotic lesion site of the patient's coronary artery and through the lesion segment. Push the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 along the guidewire. Confirm through intraoperative coronary angiography that the main balloon body 1 is aligned with the lesion segment, the front auxiliary balloon body 2 is located in the distal vessel of the lesion segment, and the rear auxiliary balloon body 3 is located in the proximal vessel of the lesion segment.

[0053] S3. Start the third balloon dilation pressure pump 15, and inflate the rear auxiliary balloon 3 through the third air delivery tube 7, so that the rear auxiliary balloon 3 expands and forms stable support for the proximal blood vessel of the lesion segment. During the expansion process, the drug in the groove 10 of the second auxiliary balloon and the surface of the rear auxiliary balloon 3 are released simultaneously to the proximal blood vessel wall of the lesion segment.

[0054] S4. Start the first balloon dilation pressure pump 13, inflate the main balloon body 1 through the first air delivery tube 5, so that the main balloon body 1 expands and dilates the narrowed lesion segment of the blood vessel, and the drugs in the main balloon groove 8 and the surface of the main balloon body 1 are released simultaneously to the blood vessel wall in the core area of ​​the lesion.

[0055] S5. Start the second balloon dilation pressure pump 14 and inflate the front auxiliary balloon 2 through the second air supply tube 6, so that the front auxiliary balloon 2 expands and forms stable support for the distal blood vessel of the lesion segment. During the expansion process, the drug in the groove 9 of the first auxiliary balloon and the surface of the front auxiliary balloon 2 are released simultaneously to the distal blood vessel wall of the lesion segment.

[0056] S6. After maintaining the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 inflated state for 40-50 seconds, turn off the first balloon dilation pressure pump 13, the second balloon dilation pressure pump 14, and the third balloon dilation pressure pump 15 in sequence, and remove the inflation medium from each balloon body. Then, slowly withdraw the main balloon body 1, the front auxiliary balloon body 2, and the rear auxiliary balloon body 3 from the patient's body along the guidewire.

Claims

1. A gradient-dilatation coronary artery dilation balloon, comprising a main balloon body (1), characterized in that, The main balloon body (1) has a front auxiliary balloon body (2) and a rear auxiliary balloon body (3) on its side surface. The front auxiliary balloon body (2) is used to support the normal blood vessels distal to the lesion segment, and the rear auxiliary balloon body (3) is used to support the normal blood vessels proximal to the lesion segment, so as to cooperate with the main balloon body (1) to achieve gradient support. The main balloon body (1) is equipped with a multi-lumen delivery catheter (4) extending along its axis. The multi-lumen delivery catheter (4) is respectively provided with a first air delivery tube (5), a second air delivery tube (6) and a third air delivery tube (7) for independently adjusting the inflation of the corresponding balloon body. The first air delivery tube (5) is connected to the main balloon body (1), the second air delivery tube (6) is connected to the front auxiliary balloon body (2), and the third air delivery tube (7) is connected to the rear auxiliary balloon body (3). The outer surface of the main balloon body (1) is provided with a main balloon groove (8), the outer surface of the front auxiliary balloon body (2) is provided with a first auxiliary balloon groove (9), and the outer surface of the rear auxiliary balloon body (3) is provided with a second auxiliary balloon groove (10). The main balloon groove (8), the first auxiliary balloon groove (9) and the second auxiliary balloon groove (10) are used to increase the effective surface area for drug carrying and form a drug storage area, thereby reducing drug loss during expansion and achieving precise delivery.

2. The gradient dilation coronary artery dilation balloon according to claim 1, characterized in that, The right end of the main balloon body (1) is fixedly connected to a delivery tube fixing buckle (12) via a balloon delivery tube (11).

3. The gradient dilation coronary artery dilation balloon according to claim 2, characterized in that, The first air delivery tube (5), the second air delivery tube (6), and the third air delivery tube (7) all pass through the balloon delivery tube (11) and the delivery tube fixing buckle (12) in sequence.

4. The gradient dilation coronary artery dilation balloon according to claim 1, characterized in that, The number of the front-end auxiliary balloons (2) is two, and the two front-end auxiliary balloons (2) are connected by a first connecting tube (16).

5. The gradient dilation coronary artery dilation balloon according to claim 1, characterized in that, The number of the rear-end auxiliary balloons (3) is two, and the two rear-end auxiliary balloons (3) are connected by a second connecting tube (17).

6. The gradient dilation coronary artery dilation balloon according to claim 1, characterized in that, The first balloon dilation pressure pump (13) is fixedly connected to the end of the first air delivery pipe (5) away from the delivery conduit fixing buckle (12).

7. The gradient dilation coronary artery dilation balloon according to claim 1, characterized in that, The second air delivery tube (6) is fixedly connected to a second balloon dilation pressure pump (14) at the end away from the delivery conduit fixing buckle (12).

8. The gradient dilation coronary artery dilation balloon according to claim 1, characterized in that, The third air delivery tube (7) is fixedly connected to a third balloon dilation pressure pump (15) at the end away from the delivery conduit fixing buckle (12).

9. The gradient dilation coronary artery dilation balloon according to claim 1, characterized in that, The number of the main balloon groove (8), the first auxiliary balloon groove (9), and the second auxiliary balloon groove (10) are all multiple, and they are evenly distributed in a ring along the circumference of the corresponding balloon body.

10. A method for using a gradient-dilation coronary artery dilation balloon, characterized in that, Applying the gradient dilation coronary artery dilation balloon according to any one of claims 1-9, the method includes the following steps: S1. The antiproliferative drug is evenly coated in the main balloon groove (8) of the main balloon body (1), the first auxiliary balloon groove (9) of the front auxiliary balloon body (2) and the second auxiliary balloon groove (10) of the rear auxiliary balloon body (3), to ensure that the drug is fully filled in the main balloon groove (8), the first auxiliary balloon groove (9) and the second auxiliary balloon groove (10) and the surface is flat. At the same time, the antiproliferative drug is coated on the surface of the main balloon body (1), the front auxiliary balloon body (2) and the rear auxiliary balloon body (3) to complete the drug loading. S2. Insert the coronary guidewire into the stenotic lesion site of the patient's coronary artery and through the lesion segment. Push the main balloon body (1), the front auxiliary balloon body (2), and the rear auxiliary balloon body (3) along the guidewire. Confirm through intraoperative coronary angiography that the main balloon body (1) is aligned with the lesion segment, the front auxiliary balloon body (2) is located in the distal vessel of the lesion segment, and the rear auxiliary balloon body (3) is located in the proximal vessel of the lesion segment. S3. Start the third balloon dilation pressure pump (15) and inflate the rear auxiliary balloon (3) through the third air delivery tube (7) to expand the rear auxiliary balloon (3) and form a stable support for the proximal blood vessel of the lesion segment. During the expansion process, the drugs on the groove (10) of the second auxiliary balloon and the surface of the rear auxiliary balloon (3) are released simultaneously to the proximal blood vessel wall of the lesion segment. S4. Start the first balloon dilation pressure pump (13) and inflate the main balloon body (1) through the first air delivery tube (5) to expand the main balloon body (1) and dilate the narrowed lesion segment of the blood vessel. The drugs in the main balloon groove (8) and on the surface of the main balloon body (1) are released simultaneously to the blood vessel wall in the core area of ​​the lesion. S5. Start the second balloon dilation pressure pump (14) and inflate the front auxiliary balloon (2) through the second air delivery tube (6) to expand the front auxiliary balloon (2) and provide stable support to the distal blood vessel of the lesion segment. During the expansion process, the drugs on the groove (9) of the first auxiliary balloon and the surface of the front auxiliary balloon (2) are released simultaneously to the distal blood vessel wall of the lesion segment. S6. After maintaining the main balloon body (1), the front auxiliary balloon body (2), and the rear auxiliary balloon body (3) inflated for 40-50 seconds, turn off the first balloon dilation pressure pump (13), the second balloon dilation pressure pump (14), and the third balloon dilation pressure pump (15) in sequence, and remove the inflation medium from each balloon body. Then, slowly withdraw the main balloon body (1), the front auxiliary balloon body (2), and the rear auxiliary balloon body (3) from the patient's body along the guidewire.

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