A drug balloon catheter that can maintain distal blood supply

Abstract

The application discloses a drug balloon catheter which can keep the blood supply of the distal end, comprising a tip tube, a balloon, an inner tube and an outer tube, the proximal end of the balloon is fixed on the outer tube and the distal end of the balloon is fixed on the tip tube, the inner tube extends out of the outer tube and passes through the hollow cavity of the balloon, the distal end of the inner tube extends out of the balloon and communicates with the tip tube, and the drug balloon catheter further comprises a blood flow anti-blocking mechanism which is used for forming a blood flow passage which passes through the section where the balloon is located and communicates with the blood vessel in the drug balloon catheter. The application can keep the blood supply of the distal end through the blood flow passage without blocking the blood vessel during the interventional therapy, avoids the ischemia of the distal end, has a longer interventional therapy time, fully releases the drug, and is not easy to rebound and contract after the interventional therapy is completed.

Description

Technical Field

[0001] This invention relates to the technical field of angioplasty, specifically to a drug-eluting balloon catheter that can maintain distal blood supply. Background Technology

[0002] For vascular diseases, balloon angioplasty is one of the most commonly used treatments. Traditional balloon angioplasty is often accompanied by vascular damage. For example, during balloon dilation, the proximal and distal diameters of the balloon are larger than the central diameter, a phenomenon known as the "dog bone effect." This leads to excessive dilation of the vessels contacting both ends of the balloon, causing damage to the vessel wall and accelerating longitudinal elongation of the balloon, resulting in vascular dissection (>30%). It can also trigger acute vascular occlusion at the lesion site (5%–12%) and postoperative restenosis (50%). Vascular dissection, acute vascular occlusion, and vessel wall damage are all vascular traumas caused by traditional balloon angioplasty.

[0003] Currently, there are methods to optimize traditional balloon angioplasty by adding microblades to the surface of the balloon to form a cutting balloon. This method has indeed shown effectiveness in clinical practice. When the cutting balloon inflates, it opens the blocked blood vessel by cutting and compressing the plaque. However, it also increases the damage to the inner wall of the blood vessel.

[0004] Because traditional balloon angioplasty causes a lot of vascular damage, it is often used as an initial treatment for vascular diseases. Drug-eluting stents are often implanted after the treatment, but drug-eluting stents still lead to complications such as high in-stent restenosis rates.

[0005] Drug-coated balloon dilatation catheters, as a new generation of minimally invasive technology for treating vascular stenosis, have received increasing attention, and the concept of "intervention without implantation" is gradually gaining popularity. For example, patent document CN102939125A discloses an angioplasty balloon with an elastic restraint structure. When the balloon inflates, the elastic restraint structure draws evenly distributed square areas on the balloon, forming a "pillow" pattern. This balloon has a restrained inflation shape, which can reduce vascular damage. However, compared with drug-eluting stents, the duration of action of drug-coated balloon dilatation catheters at the lesion site is very short and must be strictly controlled. This is because once the balloon expands at the lesion site, it will block the blood vessel, and blood cannot pass through for a short time, which can easily cause distal ischemia. For this reason, the dilation time of existing drug-coated balloon dilatation catheters is generally very short, resulting in insufficient drug release. After the balloon is in place for a short time and then withdrawn, the blood vessel is very likely to spring back to its original shape. Summary of the Invention

[0006] The technical objective of this invention is to provide a drug-eluting balloon catheter that can maintain distal blood supply, thereby solving the problem of poor treatment efficacy caused by obstructing blood flow when existing interventional drug-eluting balloon catheters are used in blood vessels.

[0007] The specific technical solution of the present invention is as follows: A drug-eluting balloon catheter capable of maintaining distal blood supply includes a tip tube, a balloon, an inner tube, and an outer tube. The proximal end of the balloon is fixed to the outer tube, and its distal end is fixed to the tip tube. The inner tube extends out of the outer tube and passes through the hollow cavity of the balloon. The distal end of the inner tube extends out of the balloon and communicates with the tip tube. The catheter also includes a blood flow anti-blocking mechanism, which forms a blood flow path within the drug-eluting balloon catheter that passes through the segment containing the balloon and communicates with a blood vessel. The drug-eluting balloon catheter further includes a hypotube, a catheter reinforcement, and a catheter seat. The distal end of the hypotube is fixed to the proximal end of the outer tube, the distal end of the catheter reinforcement is fixed to the proximal end of the hypotube, and its proximal end is fixed to the catheter seat.

[0008] Traditional drug-eluting balloon catheters have significant drawbacks. When they work in a blood vessel, the balloon dilates the vessel, temporarily blocking blood flow and easily causing distal ischemia, which may lead to complications. Therefore, the actual intervention time of traditional drug-eluting balloon catheters is relatively short and needs to be strictly controlled. This results in insufficient and inadequate release of the drug coating, greatly reducing the therapeutic effect. The drug coating itself is also underutilized and wasted. Similarly, due to the limited treatment time, the dilation and unblocking effect on the blood vessel is also insufficient, and the blood vessel often rebounds and constricts again after withdrawal. This technical solution improves upon existing drug-eluting balloon catheters by incorporating a blood flow anti-blockage mechanism. This mechanism creates a blood flow pathway within the catheter, ensuring that the blood vessel remains unblocked even during balloon dilation. This eliminates the traditional time limitations of drug-eluting balloon catheter intervention, effectively alleviating distal ischemia, reducing the likelihood of complications, and significantly extending the drug delivery time. Compared to the past, the ample delivery time allows for complete release of the same drug dosage, effectively reducing the drug load, increasing the drug transfer rate, and minimizing drug coating loss during introduction and withdrawal.

[0009] Preferably, the blood flow blocking mechanism includes several proximal blood supply holes, and there is a common connection between the inner tube and the outer tube. The proximal blood supply holes are provided on the common connection. The proximal blood supply holes are connected to the inner tube through the outer tube. The space between the inner tube and the outer tube where there is no common connection is a pressure chamber communicating with the inner cavity of the balloon.

[0010] Blood flows from the proximal blood supply port into the lumen of the inner tube, i.e., the guidewire lumen, passes through the section where the balloon is located, and finally exits from the opening of the tip tube, or conversely, from the opening of the tip tube and exits from the proximal blood supply port. This forms an internal blood flow pathway that traditional drug-eluting balloon catheters do not have. That is, there is no problem of temporary vascular obstruction after balloon dilation. This temporary internal blood flow pathway allows the drug-eluting balloon to have a longer intervention time, ensuring sufficient and adequate drug delivery, while avoiding prolonged distal ischemia, preventing complications, and effectively improving treatment outcomes.

[0011] Preferably, the inlet angle of the proximal blood supply port is 0 to 180 degrees.

[0012] The inlet angle of the proximal blood supply port is the horizontal angle between the central axis of the port and the surrounding surface, which is designed to facilitate the flow of blood to the distal end and reduce blood flow resistance.

[0013] Preferably, the inlet angle of the proximal blood supply port is 45 degrees.

[0014] The inlet angle of the proximal blood supply port is the horizontal angle between the central axis of the channel and the surrounding surface. Considering the goal of more easily guiding blood flow to the distal end and reducing blood flow resistance, 45 degrees is a suitable setting. The inner surface of the proximal blood supply port can be coated with a hydrophilic coating, which can also optimize guidance and reduce resistance.

[0015] Preferably, the proximal blood supply holes are arranged in an array.

[0016] The arrangement of the proximal blood supply hole array makes the opening section more regular and uniform, thereby minimizing the impact of reduced pipe strength caused by the opening, making the pipe section with opening evenly stressed, and preventing the pipe from bending or even breaking during transportation.

[0017] Preferably, the proximal blood supply holes are arranged in multiple staggered rows.

[0018] From the perspective of minimizing the impact of reduced pipe strength due to openings, the staggered arrangement of the proximal blood supply holes is the preferred configuration, resulting in more balanced stress on the pipe section and better protection against bending and breakage.

[0019] Preferably, the proximal blood supply hole is a hole with a circular or polygonal cross-section.

[0020] Circular holes are the standard choice because they are simple and easy to make, with a diameter controlled between 0.05 and 0.5 mm.

[0021] Preferably, the inner tube has a blood supply hole marking section on the section before the proximal blood supply hole.

[0022] The blood supply port marker is located closer to the proximal end of the inner tube than the proximal blood supply port. In addition to serving as a position reference for the proximal blood supply port, it also mainly works with the guidewire to provide guidance. For example, after the balloon is in place, the guidewire is retracted to the blood supply port marker, at which point the balloon can begin to expand to treat the diseased blood vessel. At this time, blood can flow normally into the inner tube through the proximal blood supply port without being obstructed by the guidewire.

[0023] Preferably, there is another common connection portion between the inner tube and the outer tube, located before the blood supply port marking portion. This other common connection portion is provided with a guide wire insertion hole, which is opened from the outer tube into the inner tube.

[0024] The guidewire insertion hole allows for quick and convenient insertion or removal of the guidewire.

[0025] Preferably, the side of the tip tube is provided with a distal blood supply port.

[0026] The distal blood supply port can serve as an additional blood flow inlet / outlet to ensure the continuity of the blood flow path and sufficient blood flow.

[0027] Preferably, the inner tube is provided with a support tube segment, which is filled in the hollow cavity section of the balloon, and the support tube segment is used to resist the pressure of the balloon and remain unchanged.

[0028] After the balloon inflates in the blood vessel, it exerts a significant compressive force on the tube within its hollow cavity. The supporting tube segment is designed to address this situation, ensuring that the inner tube section (which is essentially equivalent to the supporting tube segment) within the hollow cavity of the balloon maintains its normal shape and is not deformed after inflation, thus ensuring normal and unobstructed blood flow. Conversely, it also prevents the balloon from sinking into the hollow cavity, allowing it to effectively dilate the blood vessel under the support of the supporting tube segment, ensuring sufficient contact with the blood vessel wall, and maximizing the effectiveness of the drug coating.

[0029] Preferably, the support tube section includes an inner layer, a middle layer, and an outer layer, wherein the inner layer and the outer layer are polymer material layers, and the middle layer is a metal skeleton layer.

[0030] Preferably, the middle layer is mainly composed of interwoven metal wires.

[0031] Preferably, the braiding angle of the metal wire is β and 0°<β≤90°.

[0032] Preferably, the middle layer is a spiral metal wire.

[0033] Preferably, the diameter of the spiral metal wire is 0.01~1mm.

[0034] Preferably, the pitch of the spiral metal wire is 0.01~1mm.

[0035] Preferably, the support tube section has an axially multi-circle bulging shape.

[0036] The axial multi-ringed inflated shape resembles a caterpillar, primarily to enhance resistance to compression. This is especially true for balloons constrained by a metal mesh. As the balloon expands and is restrained by the mesh, it develops uneven areas, also exhibiting a multi-ringed inflated shape. The shape of the supporting tube segment is designed to better adapt to the balloon's stress, resulting in a better fit, stable position, and intact preservation of its original shape. Conversely, this also prevents the balloon from collapsing into the hollow cavity. Instead, the supporting tube segment provides better dilation of the blood vessel, ensuring more thorough contact with the vessel wall and allowing the drug coating to exert its effect more effectively.

[0037] Preferably, the support tube section is provided with a balloon length marking section.

[0038] Preferably, the inner tube is a single-layer or multi-layer medical catheter integrally formed.

[0039] In another form where the inner tube does not have the supporting tube section, it can be a single-layer or multi-layer medical catheter, which is simpler to manufacture and process.

[0040] Preferably, the drug-eluting balloon catheter further includes a metal mesh wrapped around the balloon, with both ends of the metal mesh fixed to the balloon.

[0041] The metal mesh constrains and segments the balloon to eliminate the "dog bone" effect commonly seen when using a balloon alone to dilate blood vessels in clinical practice. This, combined with the balloon's ability to cut plaque at the diseased blood vessel, ensures both the balloon's dilation effect and the metal mesh's plaque-cutting effect. During the intervention, as the diseased blood vessel becomes clearer, more and more blood flows between the constrained balloon surface and the vessel wall. This, combined with the blood flow pathway within the balloon catheter, greatly alleviates distal ischemia, further extending the intervention time and allowing for more thorough medication administration and cutting, significantly improving treatment efficacy.

[0042] The present invention has the following technical advantages:

[0043] 1) After the balloon is inflated, the blood flow anti-blockage mechanism ensures that a stable and unobstructed blood flow path is formed inside the balloon catheter, ensuring that the blood flow at both ends of the balloon is not blocked, avoiding distal ischemia, and reducing the occurrence of complications;

[0044] 2) The presence of the blood flow anti-blockage mechanism prolongs the interventional treatment time and provides stable support for the balloon from the inside, enhancing the balloon's top-attachment effect to the blood vessel wall, which in turn prolongs the drug delivery time and increases the contact area of ​​the drug coating. Compared with traditional drug balloons, it achieves a lower drug loading capacity and a higher drug transfer rate.

[0045] 3) The presence of the blood flow anti-blockage mechanism prolongs the interventional treatment time and provides stable support for the balloon from the inside, enhancing the balloon's top-attachment effect on the blood vessel wall, which in turn enhances the plaque-cutting effect of the metal mesh outside the balloon.

[0046] 4) The presence of the blood flow anti-blockage mechanism prolongs the interventional treatment time, making the balloon's expansion and shaping of the blood vessels at the lesion site more durable and stable, and the blood vessels are less likely to retract after the balloon is withdrawn. Attached Figure Description

[0047] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present invention;

[0048] Figure 2 This is a schematic diagram of the overall structure of an embodiment of the present invention;

[0049] Figure 3 This is a schematic diagram of the structure of the inner and outer tubes and the common connection part in an embodiment of the present invention;

[0050] Figure 4 This is a schematic diagram of the proximal blood supply port and its inlet angle in an embodiment of the present invention;

[0051] Figure 5 This is a schematic diagram of the structure of the proximal blood supply holes arranged in multiple staggered rows in an embodiment of the present invention;

[0052] Figure 6 This is a schematic diagram of the supporting pipe section in an embodiment of the present invention;

[0053] Figure 7 This is a schematic diagram of the structure of the middle layer of the support pipe section in an embodiment of the present invention, which is presented by multiple metal wires interlaced and woven together.

[0054] Figure 8 This is a schematic diagram of the structure of the middle layer of the support pipe section in an embodiment of the present invention, which is presented in the form of a single spiral metal wire;

[0055] Figure 9 This is a schematic diagram of the structure of the support pipe segment in an embodiment of the present invention, which presents an axially multi-circle bulging shape.

[0056] Figure 10 This is a schematic diagram of the structure of the inner and outer tubes of the present invention, which are presented in the form of a double-lumen tube.

[0057] The names of the parts corresponding to the numbers in the figure are as follows: 1-Tip tube, 2-Balloon, 3-Balloon length marking section, 4-Metal mesh, 5-Blood supply port marking section, 6-Supporting tube segment, 61-Inner layer, 62-Middle layer, 63-Outer layer, 7-Proximal blood supply port, 8-Inner tube, 9-Outer tube, 10-Guidewire insertion port, 11-Thiopogon tube, 12-Marking tape, 13-Catheter reinforcement, 14-Catheter seat, 15-Guidewire, a-Common connection section, b-Inflation chamber, α-Inlet angle of proximal blood supply port 7, β-Braiding angle of metal wire. Detailed Implementation

[0058] The present invention will be further described below with reference to the accompanying drawings and specific embodiments:

[0059] See Figure 1 , Figure 2 An embodiment of a drug-eluting balloon catheter capable of maintaining distal blood supply includes a tip tube 1, a balloon 2, a metal mesh 4, an inner tube 8, an outer tube 9, a hypotube 11, a catheter reinforcement 13, and a catheter seat 14. The inner tube 8 is disposed within the outer tube 9. The proximal end of the balloon 2 is fixed to the outer tube 9, while its distal end is fixed to the tip tube 1. The metal mesh 4 surrounds the balloon 2, with both ends fixed to the balloon 2. The inner tube 8 extends out of the outer tube 9 and passes through the hollow cavity of the balloon 2. The distal end of the inner tube 8 extends out of the balloon 2 and communicates with the tip tube 1. The distal end of the hypotube 11 is fixed to the proximal end of the outer tube 9, and a marking band is provided on the hypotube 11. The distal end of the catheter reinforcement 13 is fixed to the proximal end of the hypotube 11, while its proximal end is fixed to the catheter seat 14. It also includes a blood flow anti-blocking mechanism for creating a blood flow path within the drug-eluting balloon catheter that passes through the segment containing the balloon 2 and communicates with a blood vessel.

[0060] Combination Figure 1 , Figure 2 , Figure 3 Specifically, the blood flow blocking mechanism includes several proximal blood supply ports 7. A common connection portion a exists between the inner tube 8 and the outer tube 9. This common connection portion a has proximal blood supply ports 7, which connect to the inner tube 8 via the outer tube 9. The space between the inner tube 8 and the outer tube 9 without the common connection portion a is a pressure chamber b communicating with the inner cavity of the balloon 2. The pressure chamber b is used to inflate the balloon 2. This common connection portion a can be achieved by welding, gluing, or other methods. In practice, this common connection portion a can be an arc-shaped interlayer sandwiched between the inner tube 8 and the outer tube 9, with an approximate angle range of 45 to 270 degrees. Figure 3 A diagram is provided, indicating that the opening of the proximal blood supply port 7 should be convenient and effective. In actual production and processing, the inner tube 8 is eccentric rather than concentric with the outer tube 9, as shown below. Figure 3As shown, this is to meet the need for a common connection between the two. It is worth mentioning that the inner tube 8 and the outer tube 9 can be two independent tubes, or they can be used as... Figure 10 The dual-lumen tube is a replacement.

[0061] The inlet angle of the proximal blood supply port 7 is 0~180 degrees (excluding 0 degrees and 180 degrees), which is the horizontal angle of the central axis of the channel. Figure 4 The value of α is 45 degrees. The channel of the proximal blood supply port 7 is inclined from top to bottom toward the balloon 2, which can effectively guide blood flow and reduce resistance. To further improve this effect, a hydrophilic coating can be applied to the inner surface of the proximal blood supply port 7.

[0062] The proximal blood supply holes 7 are arranged in multiple staggered rows, such as Figure 5 The diagram shows two adjacent rows with interlaced spacing. While the openings reduce the strength of the tubing, this distribution of proximal blood supply holes 7 minimizes this effect, ensuring uniform stress on the tube section with openings and preventing bending and breakage during use. It is also more effective than the alternative square array arrangement (omitted, no diagram shown). The proximal blood supply holes are typically circular, with a diameter ranging from 0.05 to 0.5 mm; various hole sizes can be mixed.

[0063] The inner tube 8 has a blood supply port marking section 5 on the section before the proximal blood supply port 7, which can... Figure 1 , Figure 2 As seen in the image, the blood supply port marking section 5 can be used as a reference for the position of the proximal blood supply port 7, and in conjunction with the guide wire 15, ensures that the guide wire 15 has been retracted to a position that does not obstruct the flow of blood through the proximal blood supply port 7. In addition, there is another common connection section a between the inner tube 8 and the outer tube 9, located before the blood supply port marking section 5. This other common connection section a is provided with a guide wire insertion hole 10, which leads from the outer tube 9 into the inner tube 8. This other common connection section a can also be achieved by welding, gluing, or other methods.

[0064] One or more distal blood supply holes may be provided on the side of the tip tube 1 (not shown in the attached figure). The distal blood supply holes serve as additional blood flow through the opening, supplementing the opening of the tip tube 1, ensuring unobstructed blood flow and increasing blood flow.

[0065] In some embodiments, the inner tube 8 is a single-layer or multi-layer medical catheter integrally formed. It is made of a flexible material with pressure resistance and bending resistance. In this embodiment, PI tube is more suitable as the inner tube 8 because it has excellent deformation resistance and can meet the requirements of flexibility, which can effectively ensure the unobstructed blood flow path. Other options include single-layer nylon tubes, three-layer PEBAX / LLDPE / HDPE or NYLON / LLDPE / HDPE tubes, or other existing medical tubes that are the same or similar to those commonly used in the art.

[0066] In other embodiments, the inner tube 8 is not a single, integrally molded tube of the same material. Instead, a special section is designed within the hollow cavity of the balloon 2, while the remaining portion remains the aforementioned single-layer or multi-layer medical catheter. Figure 1 , Figure 2 As can be seen, the inner tube 8 is provided with a support tube segment 6. The support tube segment 6 has the properties of pressure resistance, bending resistance and high flexibility. It can withstand pressure of more than 25 atm without deformation. It is used to protect the inner tube 8 from bending and deformation, and ensure that the blood flow path is not blocked. At the same time, it provides strong support for the balloon from the inside, so that the balloon 2 has a better expansion and apposition effect on the blood vessel wall. It also makes the metal mesh 4 outside the balloon 2 have a better effect on plaque cutting.

[0067] The support tube segment 6 is filled in the hollow cavity of the balloon 2. The support tube segment 6 is part of the inner tube 8. Both ends of the support tube segment 6 are fixed to the rest of the inner tube 8 (or the proximal end of the support tube segment 6 is fixed to the proximal end of the inner tube 8, while the distal end of the support tube segment 6 is directly fixed to the tip tube 1). The length of the support tube segment 6 is basically equal to the length of the hollow cavity of the balloon 2. In actual production, the end of the rest of the inner tube 8 (or the proximal end of the tip tube 1) is allowed to extend slightly into the hollow cavity of the balloon 2 and then be fixed to the support tube segment 6. Alternatively, the end of the support tube segment 6 can extend slightly out of the hollow cavity of the balloon 2 and be fixed to the rest of the inner tube 8 (or the proximal end of the tip tube 1).

[0068] Further details can be found here. Figure 6 The support pipe section 6 includes an inner layer 61, a middle layer 62, and an outer layer 63. The inner layer 61 and outer layer 63 are polymer material layers, such as PTFE, nylon, and PEBAX. The middle layer 62 is a metal skeleton layer, such as 316L or 304 stainless steel. There are two suitable manufacturing methods for the metal skeleton layer: one is composed of interwoven metal wires, see... Figure 7 The braiding angle of the metal wire is 0~90 degrees (excluding 0 degrees), which is β in the diagram; another type is a spiral metal wire, see Figure 8The diameter of the spiral metal wire varies from 0.01 to 1 mm, and the pitch of the spiral metal wire varies from 0.01 to 1 mm. The support tube section 6 is equipped with a balloon length marking section 3 to conveniently and intuitively provide reference information on the balloon length.

[0069] Furthermore, the support pipe segment 6 has an axially multi-ringed bulging shape, resembling the form of a caterpillar, such as... Figure 9 As shown, this shape can be achieved by processing only the outer layer 63, which provides more effective pressure resistance and better compatibility with the metal mesh balloon. Because the balloon constrained by the metal mesh also has multiple inflated sections—that is, the circumferential rings of the metal mesh form raised sections—the circumferential rings restrict and compress the balloon, creating boundaries between adjacent raised sections. This perfectly matches the force distribution of the similarly shaped support tube segment 6 (a matching pattern of raised sections to raised sections and recessed sections to recessed sections), providing excellent support for the balloon and a stable and effective expansion and shaping effect on the blood vessel wall.

[0070] Those skilled in the art should understand that the embodiments of the present invention described above and shown in the accompanying drawings are merely examples and do not limit the scope of the invention. The objectives of the present invention have been fully and effectively achieved. The functional and structural principles of the present invention have been demonstrated and explained in the embodiments, and any modifications or variations of the implementation of the present invention may be made without departing from these principles.

Claims

1. A drug-eluting balloon catheter capable of maintaining distal blood supply, comprising a tip tube (1), a balloon (2), an inner tube (8), and an outer tube (9), wherein the proximal end of the balloon (2) is fixed to the outer tube (9) and its distal end is fixed to the tip tube (1), the inner tube (8) extends out of the outer tube (9) and passes through the hollow cavity of the balloon (2), and the distal end of the inner tube (8) extends out of the balloon (2) and communicates with the tip tube (1), characterized in that: It also includes a blood flow blocking mechanism, which is used to form a blood flow path in the drug balloon catheter that passes through the section where the balloon (2) is located and communicates with the blood vessel; The inner tube (8) is provided with a support tube section (6), which is filled in the hollow cavity of the balloon (2). The support tube section (6) is used to resist the pressure of the balloon (2) on its own hollow cavity and remain unchanged. The support tube section (6) includes an inner layer (61), a middle layer (62) and an outer layer (63). The inner layer (61) and the outer layer (63) are polymer material layers. The middle layer (62) is a metal skeleton layer. The middle layer (62) is mainly composed of interlaced metal wires. The weaving angle of the metal wires is 0 to 90 degrees. The support tube section (6) has a multi-turn bulging shape in the axial direction. The drug-eluting balloon catheter also includes a metal mesh (4), which wraps around the balloon (2), and the two ends of the metal mesh (4) are fixed to the balloon (2); The balloon constrained by the metal mesh also has multiple bulging sections, that is, the circumferential rings of the metal mesh are the protruding parts. The circumferential rings restrict and compress the balloon to form the boundary between adjacent protruding parts. The force can be matched with the support tube section (6) of similar shape. The protrusions correspond to the protrusions and the depressions correspond to the depressions.

2. The drug-eluting balloon catheter according to claim 1, characterized in that: The blood flow blocking mechanism includes several proximal blood supply ports (7). There is a common connection part (a) between the inner tube (8) and the outer tube (9). The proximal blood supply ports (7) are provided on the common connection part (a). The proximal blood supply ports (7) are connected to the inner tube (8) through the outer tube (9). The space between the inner tube (8) and the outer tube (9) where the common connection part (a) does not exist is a pressure chamber (b) that communicates with the inner cavity of the balloon (2).

3. The drug-eluting balloon catheter according to claim 2, characterized in that: The inlet angle of the proximal blood supply port (7) is 0 to 180 degrees.

4. The drug-eluting balloon catheter according to claim 3, characterized in that: The inlet angle of the proximal blood supply port (7) is 45 degrees.

5. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 2, characterized in that: The proximal blood supply holes (7) are arranged in an array.

6. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 2, characterized in that: The proximal blood supply holes (7) are arranged in multiple staggered rows.

7. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 2, characterized in that: The proximal blood supply hole (7) is a hole with a circular or polygonal cross-section.

8. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 2, characterized in that: The inner tube (8) is provided with a blood supply hole marking section (5) in the section before the proximal blood supply hole (7).

9. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 8, characterized in that: There is another common connection part (b) between the inner tube (8) and the outer tube (9), located before the blood supply hole marking part (5). The other common connection part (b) is provided with a guide wire insertion hole (10), which is connected to the inner tube (8) through the outer tube (9).

10. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 2, characterized in that: The side of the tip tube (1) is provided with several distal blood supply holes.

11. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 1, characterized in that: The middle layer (62) is a spiral metal wire.

12. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 11, characterized in that: The diameter of the spiral metal wire is 0.01 to 1 mm.

13. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 12, characterized in that: The pitch of the spiral metal wire is 0.01 to 1 mm.

14. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 1, characterized in that: The support tube section (6) is provided with a balloon length marking section (3).

15. A drug-eluting balloon catheter capable of maintaining distal blood supply according to claim 2, characterized in that: The inner tube (8) is a single-layer or multi-layer medical catheter integrally formed.

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