Dual-layer drug-infused balloon and dual-layer drug-infused balloon dilation catheter

Abstract

The application belongs to the technical field of medical devices, and discloses a double-layer drug perfusion balloon and a double-layer drug perfusion balloon dilating catheter. The double-layer drug perfusion balloon comprises an inner balloon and an outer balloon sleeved on the inner balloon. The balloon body of the inner balloon is provided with a plurality of first fixed connection portions, the balloon body of the outer balloon is provided with a plurality of second fixed connection portions, the plurality of first fixed connection portions and the plurality of second fixed connection portions are arranged one by one and connected with each other to form a plurality of fixed connection areas, each fixed connection area is provided with a drug hole passage in a through manner, a drug cavity is formed around the inner balloon, the drug hole passage is communicated with the drug cavity, a filling cavity is formed around the inner balloon and the outer balloon, and the surface of the outer balloon forms a plurality of concave-convex structures when the filling cavity is inflated. The application can meet the requirement of continuous drug delivery, and can display the expansion state of a blood vessel in real time during the drug delivery.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a double-layered drug-infusing balloon and a double-layered drug-infusing balloon dilation catheter. Background Technology

[0002] Vascular diseases are among the major threats to human health, and balloon dilation catheters are commonly used instruments in interventional vascular procedures. With technological advancements, drug-eluting balloons have been designed. Their working principle is as follows: First, the inner balloon is inflated with contrast fluid to dilate the diseased vessel; then, some of the contrast fluid is aspirated to reduce the pressure in the inner balloon; next, an anti-proliferative drug (such as paclitaxel, rapamycin, or their derivatives) is infused into the gap between the inner and outer balloons, closing this channel and maintaining pressure between the inner and outer balloons to prevent backflow of the drug; finally, the inner balloon is further inflated with contrast fluid, forcing the drug through pores on the surface of the outer balloon into the blood vessel.

[0003] However, there are several drawbacks: Firstly, due to the overall outer diameter control requirements of the double-layer balloon, the available space between the inner and outer balloons is always very limited. This directly results in a significant upper limit to the total volume of drug that can be injected in a single operation. When faced with complex cases requiring a higher total drug dose to achieve sufficient anti-proliferative effects, a single administration often cannot meet the treatment needs. Even if the surgeon can supplement the drug administration by repeatedly injecting and pressurizing the balloon, it will significantly increase the number of surgical steps, prolong the overall balloon inflation time during the operation, and increase the patient's intraoperative risk. Secondly, during the administration of the drug to the outer balloon, only the expansion state of the inner balloon can be visualized in real time. Although contrast agents can be added to the drug solution to visualize the vascular administration state, the contrast agents flowing into the blood along with the drug solution will increase the metabolic burden on the kidneys, which may lead to the risk of contrast-induced nephropathy in patients with renal insufficiency, diabetic patients, and the elderly. Summary of the Invention

[0004] The purpose of this invention is to provide a double-layered drug-perfused balloon and a double-layered drug-perfused balloon dilation catheter, which can not only meet the requirements of continuous drug delivery, but also provide real-time visualization of the vascular drug delivery status, and the contrast agent will not flow into the blood.

[0005] To achieve this objective, the present invention adopts the following technical solution: A double-layered drug-inflation balloon includes an inner balloon and an outer balloon fitted over the inner balloon. The inner balloon has several first fixing joints, and the outer balloon has several second fixing joints. The first fixing joints and the second fixing joints are arranged in a one-to-one correspondence and connected to each other to form several fixing regions. Each fixing region is provided with a drug delivery channel. A drug delivery cavity is formed inside the inner balloon, and the drug delivery channel communicates with the drug delivery cavity. An inflation cavity is formed between the inner balloon and the outer balloon. The inflation cavity can expand to form several concave-convex structures on the surface of the outer balloon.

[0006] As an alternative to the bilayer drug infusion balloon, the inner balloon is a non-compliant balloon, and the material of the inner balloon includes at least one of polyethylene terephthalate, polyamide, polyurethane, and polytetrafluoroethylene; and / or the outer balloon is a semi-compliant balloon, and the material of the outer balloon includes at least one of polyether block amide, polyamide, and polyolefin.

[0007] As an alternative to the double-layered drug-inflation balloon, the cross-sectional shape of the fixing region is circular, and several fixing regions are uniformly arranged on the inner balloon along the circumference and / or axial direction of the inner balloon.

[0008] As an alternative to the double-layered drug-inflation balloon, the outer diameter of the fixation area is 0.5mm-5mm, and the center-to-center distance between two adjacent fixation areas is 1mm-10mm.

[0009] As an alternative to the double-layered drug infusion balloon, the number of drug delivery channels provided through the fixed area is 1-10.

[0010] As an alternative to the double-layered drug infusion balloon, the cross-sectional shape of the fixation area is elongated, and each fixation area is provided with 1-100 drug delivery channels at intervals.

[0011] As an alternative to a double-layered drug-inflation balloon, a plurality of fixation areas are provided at circumferential intervals along the inner layer of the balloon; and / or Several fixing areas are provided at intervals along the axial direction of the inner balloon.

[0012] As an alternative to the double-layered drug infusion balloon, the inner diameter of the drug delivery port is 5µm-300µm; and / or the diameter of the inner balloon is 0.1mm-2mm smaller than the diameter of the outer balloon, and the length of the inner balloon is 0.1mm-4mm shorter than the length of the outer balloon.

[0013] As an alternative to the double-layered drug-inflation balloon, several first fixing joints are disposed on the straight section of the inner balloon, and several second fixing joints are disposed on the straight section of the outer balloon. The first fixing joints and the second fixing joints are sealed together by glue or heat welding.

[0014] A double-layered drug-infusion balloon dilation catheter includes a drug delivery channel, an filling channel, and a double-layered drug-infusion balloon as described in any one of claims 1-9, wherein the drug delivery channel is connected to the drug delivery chamber, and the filling channel is connected to the filling chamber.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: The bilayer drug-inflation balloon provided by this invention includes an inner balloon located on the inside and an outer balloon located on the outside. A drug delivery chamber is formed inside the inner balloon, and an inflation chamber for filling contrast agent is formed between the inner and outer balloons. The inner balloon has several first fixing joints, and the outer balloon has several second fixing joints. The first and second fixing joints are arranged in a one-to-one correspondence and interconnected to form several fixing regions. Each fixing region has a through-hole channel for drug delivery, which communicates with the drug delivery chamber inside the inner balloon. Expansion of the inflation chamber allows the surface of the outer balloon to form several uneven structures. When the inner and outer balloons are inflated, the inner balloon's compliance is lower than the outer balloon's. The fixed areas of the inner and outer balloons pull on the expansion of the outer balloon, causing a depression in the fixed area and a bulge in the non-fixed area, creating an uneven structure on the outer balloon's surface. The bulges in the outer balloon concentrate stress to dilate the blood vessel, while the depressions create relatively low pressure and provide cushioning, thus reducing damage to the vascular intima. Furthermore, the medication inside the inner balloon is simultaneously subjected to perfusion force and pressure from the outer balloon, allowing it to be fully discharged through the drug delivery channel in the fixed area between the inner and outer balloons, achieving sufficient drug penetration into the blood vessel. Because the drug delivery port is located in the depression of the outer balloon, it not only prevents the lesion from blocking the drug outflow channel after balloon expansion, thus avoiding affecting drug delivery efficiency, but also prevents the drug from flowing freely towards both ends of the balloon due to the protrusion formed around the depression, reducing drug loss into the bloodstream and improving drug utilization. During drug delivery with the inner balloon, because the outer balloon is constantly expanded to support the blood vessel wall, the interior of the inner balloon serves as the drug delivery chamber, allowing for continuous drug delivery via external devices, simplifying the operator's operation. Furthermore, the contrast agent between the outer and inner balloons can provide real-time visualization of the blood vessel's expansion state during drug delivery, increasing the safety of the administration.

[0016] The double-layered drug-infusion balloon dilation catheter provided by the present invention includes a drug delivery channel, a filling channel, and the aforementioned double-layered drug-infusion balloon, so that the drug delivery channel is connected to the drug delivery chamber, and the filling channel is connected to the filling chamber. According to the actual use steps, the drug delivery channel is used to fill the drug delivery chamber, and the filling channel and the filling chamber are used to fill the contrast fluid. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of the present invention and these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the structure of a double-layer drug infusion balloon in an embodiment of the present invention; Figure 2 This is a schematic diagram of the inflation state of the double-layer drug-perfusion balloon in an embodiment of the present invention; Figure 3 This is a schematic diagram of another double-layer drug infusion balloon in an embodiment of the present invention; Figure 4 This is a schematic diagram of the structure of a double-layer drug infusion balloon dilation catheter according to an embodiment of the present invention.

[0019] Figure label: 1. Double-layered drug-infused balloon; 2. Tip tube; 3. Guidewire cannula; 31. Marking ring; 4. Distal inner cannula; 5. Distal outer cannula; 51. Guidewire orifice; 6. Proximal inner cannula; 7. Proximal outer cannula; 71. Marking band; 8. Catheter seat; 11. Inner balloon; 12. Outer balloon; 121. Protrusion; 13. Fixation area; 14. Drug delivery port. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of 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. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0021] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium; or the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0022] In the description of this invention, unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature being directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0023] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar components or components having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0024] To achieve continuous drug delivery while simultaneously monitoring the dilation of blood vessels in real time during administration, this embodiment provides a double-layered drug-perfused balloon and a double-layered drug-perfused balloon dilation catheter. These are primarily used for treating vascular lesions. Specifically, the drug delivered via the balloon acts on the lesion site, improving the degree of vascular stenosis and preventing restenosis. The following is combined with… Figures 1 to 4 The specific content of this embodiment will be described in detail. It should be noted that, in this embodiment, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther away from the operator.

[0025] like Figures 1 to 3As shown, the double-layered drug infusion balloon 1 provided in this embodiment includes an inner balloon 11 and an outer balloon 12 coaxially sleeved on the outside of the inner balloon 11. Specifically, the inner balloon 11 has several first fixed joints, and the outer balloon 12 has several second fixed joints. The first fixed joints and the second fixed joints are arranged one-to-one and connected to each other, thus forming several evenly distributed and firmly connected fixed areas 13 between the double balloons. Each fixed area 13 is processed to form a drug delivery channel 14 that is completely penetrated along the radial direction of the balloon by means of laser drilling or etching. The drug inlet of the drug delivery channel 14 is directly connected to the internal space of the inner balloon 11, and the drug outlet of the drug delivery channel 14 is located on the outer wall of the outer balloon 12, ensuring that the drug can flow in a directional manner along the drug delivery channel 14. The inner balloon 11 completely encloses an independent drug delivery chamber, within which all anti-proliferative drugs can be pre-stored. The outer surface of the inner balloon 11 and the inner surface of the outer balloon 12 together form a closed filling chamber for contrast agent. When contrast agent is injected into the filling chamber and the chamber expands, it not only creates several regularly distributed concave-convex structures on the outer surface of the outer balloon 12, but also allows for real-time visualization of the vascular dilation status.

[0026] In this embodiment, the inner balloon 11 exhibits strong dimensional stability and minimal expansion deformation during inflation; the outer balloon 12 can achieve greater elastic expansion under the same pressure. When the surgeon simultaneously inflates contrast fluid into the corresponding cavities of the inner balloon 11 and the outer balloon 12, the fixed area 13 between the two balloons firmly holds the corresponding position of the outer balloon 12 due to the lower compliance of the inner balloon 11 compared to the outer balloon 12, limiting the outward expansion of this area. Ultimately, the fixed connection position of the outer balloon 12 forms an inwardly concave structure, while the unfixed area 13 of the outer balloon 12 expands outward without restriction, forming regular protrusions 121. Finally, a continuous and uniformly distributed convex-concave-convex morphology is formed on the entire working section surface of the outer balloon 12.

[0027] This special surface texture structure first optimizes performance at the vascular dilation level: the outward protrusion 121 of the outer balloon 12 becomes the core area of ​​stress concentration, which can concentrate the output of dilation force during inflation, precisely acting on the narrowed lesion of the blood vessel, efficiently squeezing and shaping the atherosclerotic plaque, and achieving full unblocking of the vascular cavity; while the inward concave area of ​​the outer balloon 12 forms a relatively low-pressure buffer space, avoiding the instantaneous high-pressure impact on the blood vessel wall caused by traditional full-circumference uniform dilation balloons, avoiding excessive damage to the vascular intima during balloon dilation, making the vascular dilation process more gentle and safe. Regarding drug delivery performance: Since the outer balloon 12 remains fully inflated and adheres to the blood vessel wall, the inner balloon 11 can continuously deliver drugs through the drug delivery port 14. The drug solution in the inner balloon 11 is simultaneously subjected to the perfusion pushing force from inside the inner balloon 11 and the reverse auxiliary squeezing force generated by the elastic recoil of the outer balloon 12. It is uniformly discharged outward along the drug delivery port 14 of the fixed area 13, and finally penetrates into the blood vessel wall tissue of the lesion site. This completely solves the problems of insufficient drug delivery volume or the need for multiple drug deliverys, cumbersome operation, and increased risks associated with traditional perfusion balloons.

[0028] More importantly in this embodiment, the drug outlets of all drug delivery channels 14 are located entirely within the low-pressure region (i.e., the fixation region 13) of the inward-curving outer balloon 12. When the balloon expands and adheres to the vessel wall, the vessel wall only comes into close contact with the protrusions 121 of the outer balloon 12, without blocking the drug delivery channels located in the recessed position. This fundamentally solves the problem of reduced drug delivery efficiency and insufficient local drug delivery caused by the vessel wall blocking the drug delivery channels. At the same time, the protrusions 121 of the outer balloon 12 surrounding the recessed position also form a physical barrier similar to a micro-dam, effectively restricting the flow range of the drug delivery from the recessed channels. This significantly reduces the probability of the drug flowing randomly along the vessel axis towards both ends of the balloon and ultimately being lost into the bloodstream, allowing more drug to be directed to stay and penetrate into the diseased vessel wall, ultimately improving the overall drug utilization rate to a level far higher than that of traditional drug delivery balloons.

[0029] In addition, since the pressure medium filled in the outer balloon 12 is contrast fluid, it remains expanded and adhered during drug administration, which allows for real-time visualization of the dilation status of blood vessels, thereby increasing the safety of drug administration.

[0030] For example, the middle sections of both the inner balloon 11 and the outer balloon 12 are straight sections, and both ends of both the inner balloon 11 and the outer balloon 12 are tapered constricted sections. In the uninflated state, the diameter of the inner balloon 11 is 0-1 mm smaller than the diameter of the outer balloon 12, and its length is 0-1 mm shorter. Further, in this embodiment, several first fixing joints are disposed on the straight sections of the inner balloon 11, and several second fixing joints are disposed on the straight sections of the outer balloon 12. The first fixing joints and the second fixing joints are sealed and connected by adhesive or heat welding.

[0031] For example, the inner balloon 11 is a non-compliant balloon, and the material of the inner balloon 11 includes at least one of polyethylene terephthalate, polyamide, polyurethane, and polytetrafluoroethylene. The outer balloon 12 is a semi-compliant balloon, and the material of the outer balloon 12 includes at least one of polyether block amide, polyamide, and polyolefin. This selection of the semi-compliant outer balloon 12 forms a precise match with the non-compliant inner balloon 11 in terms of poor compliance: when the two balloons are inflated simultaneously, the non-compliant inner balloon 11 hardly deforms, firmly holding the outer balloon 12 in the fixed area 13, while the non-fixed area 13 of the semi-compliant outer balloon 12 can fully extend outward under pressure, ultimately precisely shaping the preset regular concave-convex surface structure.

[0032] In practical use, the dual-layer drug-perfused balloon 1 provided in this embodiment first inflates a certain amount of contrast fluid into the outer balloon 12 for visualization when the outer balloon 12 dilates the diseased blood vessel; then, an anti-proliferative drug solution (such as paclitaxel and its derivatives or rapamycin and its derivatives) is infused into the inner balloon 11. As the drug solution is continuously infused, the pressure of the inner balloon 11 increases, causing the outer balloon 12 to adhere to the wall of the diseased blood vessel, and then the outer balloon 12 is further inflated with contrast fluid. Because the compliance of the inner balloon 11 is lower than that of the outer balloon 12, the fixed area 13 of the straight section of the inner balloon 11 and the outer balloon 12 will pull on the expansion of the outer balloon 12, thus forming an uneven structure on the surface of the outer balloon 12. The protrusions 121 of the outer balloon 12 are used to dilate blood vessels, and the concave areas of the outer balloon 12 form a relatively low-pressure area, which can play a certain role in avoiding pressure and thus reducing the compression or friction damage of the outer balloon 12 on the vascular intima. The drug solution in the inner balloon 11 is simultaneously subjected to the perfusion force and the pressure of the outer balloon 12, and is discharged through the drug delivery port 14. After the administration of the drug-perfused balloon 1 is completed, the filling medium in the inner balloon 11 and the outer balloon 12 is withdrawn, and the balloon is withdrawn from the blood vessel.

[0033] Optionally, a flow-equalizing structure is added to the inner wall of the drug delivery channel 14. The flow-equalizing structure can be guide ridges arranged in a staggered pattern along the inner wall of the channel or continuous spiral microgrooves. By creating an irregular fluid path inside the originally smooth straight orifice, the original laminar flow state of the drug solution is altered. When the drug solution flows through the channel with the flow-equalizing structure under pushing pressure, the originally parallel flow of the drug solution will continuously collide with and bend back against the flow-equalizing structure. The drug solution, originally in a stratified flow state, will be fully agitated, ultimately forming a stable and controllable turbulent flow inside the channel, achieving thorough homogeneous mixing of the drug solution before it flows out of the channel.

[0034] For example, such as Figure 2 As shown, in one specific embodiment, the cross-sectional shape of the fixing region 13 is circular, and several fixing regions 13 are uniformly disposed on the inner balloon 11 along the circumference and / or axial direction. When the outer balloon 12 is inflated with a certain amount of contrast fluid and then expanded, multiple dot-shaped protrusions 121 are uniformly formed on the surface of the outer balloon 12. Exemplarily, the outer diameter of the fixing region 13 is 0.5mm-5mm, and the center distance between two adjacent fixing regions 13 is 1mm-10mm.

[0035] Furthermore, the fixed area 13 has 1-10 drug delivery channels 14. The number of drug delivery channels 14 can be adjusted according to the actual drug delivery situation, which helps to regulate the drug delivery flow rate.

[0036] Further, the inner diameter of the drug delivery port 14 is 5µm-300µm. Optionally, the inner diameter of the drug delivery port 14 can be 10µm-200µm. Even further, the diameter of the inner balloon 11 is 0.1mm-2mm smaller than the diameter of the outer balloon 12, and the length of the inner balloon 11 is 0.1mm-4mm shorter than the length of the outer balloon 12.

[0037] For example, such as Figure 3 As shown, in another specific embodiment, the cross-sectional shape of the fixing region 13 is elongated, and each fixing region 13 is provided with 1-100 drug delivery channels 14 at intervals. Further, several fixing regions 13 are provided at intervals along the circumference of the inner balloon 11, and several fixing regions 13 are provided at intervals along the axial direction of the inner balloon 11. When the outer balloon 12 is inflated with a certain amount of contrast fluid and then expanded, multiple elongated protrusions 121 are uniformly formed on the surface of the outer balloon 12. The fixing region 13 between two adjacent elongated protrusions 121 forms a depression, and the drug fluid in the inner balloon 11 flows into the depression through the drug delivery channels 14 of the fixing region 13.

[0038] Specifically, in this embodiment, each elongated fixing area 13 is provided with 8 drug delivery channels 14. In other embodiments, the drug delivery flow rate can be adjusted by opening a corresponding number of drug delivery channels 14 in the fixing area 13 according to the actual drug delivery situation.

[0039] like Figure 4 As shown, this embodiment also provides a double-layered drug-infusion balloon dilation catheter, which includes a drug delivery channel, an filling channel, and the aforementioned double-layered drug-infusion balloon 1. The drug delivery channel is connected to the drug delivery chamber, and the filling channel is connected to the filling chamber. During use, medication can be filled into the drug delivery chamber through the drug delivery channel according to the actual usage steps, and contrast fluid can be filled into the filling chamber through the filling channel.

[0040] For example, the double-layered drug-inflation balloon dilation catheter includes a tip tube 2, a guidewire tube 3, a distal outer tube 5, a distal inner tube 4 located inside the distal outer tube 5, a proximal outer tube 7, a proximal inner tube 6 located inside the proximal outer tube 7, and a catheter seat 8 having a drug infusion port and an inflation port. The guidewire tube 3 has a guidewire channel inside, and the catheter seat 8 is a Y-type Luer connector. The distal end of the double-layered drug-inflation balloon 1 is sealed and welded to the tip tube 2 and the guidewire tube 3. The proximal end of the inner balloon 11, the distal inner tube 4, the proximal inner tube 6, and the catheter seat 8 are sequentially connected (at least the distal inner tube 4 and the proximal inner tube 6 are provided with drug delivery channels inside); the proximal end of the outer balloon 12, the distal outer tube 5, the proximal outer tube 7, and the catheter seat 8 are sequentially connected (at least the distal outer tube 5 and the proximal outer tube 7 are provided with inflation channels inside). The proximal end of the guidewire 3 extends to the guidewire port 51 of the distal outer tube 5. A marking ring 31 is provided on the section of the guidewire 3 extending to the inner side of the inner balloon 11. A marking strip 71 is provided on the wall of the proximal inner tube 6 or the proximal outer tube 7. By adding the marking ring 31 and the marking strip 71, it is beneficial to monitor the delivery position of the double-layer drug infusion balloon dilation catheter in real time.

[0041] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A double-layered drug-inflation balloon, characterized in that, The device includes an inner balloon (11) and an outer balloon (12) fitted over the inner balloon (11). The inner balloon (11) has several first fixed joints, and the outer balloon (12) has several second fixed joints. The several first fixed joints and the several second fixed joints are arranged in a one-to-one correspondence and connected to each other to form several fixed regions (13). Each fixed region (13) is provided with a drug delivery channel (14). A drug delivery cavity is formed inside the inner balloon (11), and the drug delivery channel (14) communicates with the drug delivery cavity. An inflation cavity is formed between the inner balloon (11) and the outer balloon (12). The inflation cavity can expand to form several concave and convex structures on the surface of the outer balloon (12).

2. The double-layered drug-inflation balloon according to claim 1, characterized in that, The inner balloon (11) is a non-compliant balloon, and the material of the inner balloon (11) includes at least one of polyethylene terephthalate, polyamide, polyurethane, and polytetrafluoroethylene; and / or the outer balloon (12) is a semi-compliant balloon, and the material of the outer balloon (12) includes at least one of polyether block amide, polyamide, and polyolefin.

3. The double-layered drug-inflation balloon according to claim 1, characterized in that, The fixed area (13) has a circular cross-sectional shape, and several fixed areas (13) are uniformly arranged on the inner balloon (11) along the circumference and / or axial direction.

4. The double-layered drug-inflation balloon according to claim 3, characterized in that, The outer diameter of the fixed area (13) is 0.5mm-5mm, and the center distance between two adjacent fixed areas (13) is 1mm-10mm.

5. The double-layered drug-inflation balloon according to claim 3, characterized in that, The number of drug delivery channels (14) provided through the fixed area (13) is 1-10.

6. The double-layered drug-inflation balloon according to claim 1, characterized in that, The cross-sectional shape of the fixed area (13) is elongated, and each fixed area (13) is provided with 1-100 drug delivery channels (14) at intervals.

7. The double-layered drug-inflation balloon according to claim 6, characterized in that, A plurality of the fixation regions (13) are provided circumferentially along the inner balloon (11); and / or a plurality of the fixation regions (13) are provided axially along the inner balloon (11).

8. The double-layered drug-inflation balloon according to claim 1, characterized in that, The inner diameter of the drug delivery port (14) is 5um-300um; and / or the diameter of the inner balloon (11) is 0.1mm-2mm smaller than the diameter of the outer balloon (12), and the length of the inner balloon (11) is 0.1mm-4mm shorter than the length of the outer balloon (12).

9. The double-layered drug-inflation balloon according to any one of claims 1-8, characterized in that, Several first fixed joints are provided on the straight section of the inner balloon (11), and several second fixed joints are provided on the straight section of the outer balloon (12). The first fixed joints and the second fixed joints are sealed together by glue or heat welding.

10. A double-layered drug-infused balloon dilation catheter, characterized in that, It includes a drug delivery channel, a filling channel, and a double-layered drug infusion balloon as described in any one of claims 1-9, wherein the drug delivery channel is connected to the drug delivery chamber, and the filling channel is connected to the filling chamber.

Images