A double-layer drug balloon dilation catheter

Abstract

This application relates to a dual-layer drug-eluting balloon dilation catheter, comprising a dual-layer balloon, including an outer balloon and an inner balloon. The outer balloon includes a flexible drug-eluting balloon, and the inner balloon includes a pressure-supporting balloon. An outer tube connects the dual-layer balloons, and the outer tube includes both an inner balloon pressure chamber and an outer balloon pressure chamber. A buffer chamber is provided between the outer balloon pressure chamber and the outer balloon. A pressure-increasing component is located at the proximal end of the outer tube. The outer balloon includes a frosted surface on its outer side, onto which a sprayed drug adheres. A shockwave emitter is positioned between the outer and inner balloons, near the junction of the outer and inner balloons and away from the outer balloon body. This invention enables precise placement of the drug-eluting balloon at the lesion site, reducing drug loss during delivery while ensuring the therapeutic effect of the drug at the lesion site.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a double-layered drug-eluting balloon dilation catheter. Background Technology

[0002] Drug-eluting stents are gradually becoming the main strategy for interventional treatment of coronary artery disease. Whether it's PTCA or stent implantation, all interventional treatments targeting vascular stenosis or occlusion are accompanied by restenosis. By applying a drug to a balloon and then dilating it, the drug is brought into complete contact with the arterial intima, uniformly releasing the drug onto the damaged intimal surface, thus better inhibiting intimal hyperplasia. Drug-eluting balloons are a true solution to this problem.

[0003] In current drug-eluting balloon catheter technology, medication is applied to the surface of the balloon via a spraying process and then delivered to the site of the stenosis. If the patient has severe calcification of the vascular tissue, choosing an oversized balloon may cause tearing or damage to the vascular endothelium, leading to dissection and bleeding.

[0004] The existing double-layer drug-eluting balloon catheter is an innovative interventional treatment method. Through double-layer drug coating technology, it improves the release efficiency and therapeutic effect of drugs within the blood vessel wall. The balloon surface employs a double-layer drug coating design: an inner drug reservoir and an outer drug release layer. The inner drug reservoir can store a high concentration of drug, while the outer drug layer is designed with micropores or a mesh structure for external drug permeation.

[0005] The medication is sprayed onto the smooth surface of the balloon, resulting in significant loss due to blood flushing during delivery. Furthermore, for complex lesions involving multiple tissue stenosis, hyperplasia, and calcification, conventional drug-eluting balloon dilation catheters cannot effectively adhere to the lesion wall, especially in lesions with varying hardness and compliance, such as diffuse calcification. This uneven adherence leads to inconsistent and insufficient drug delivery to the subendothelial region, a major reason for the poor long-term efficacy of DCB (dilation balloon dilation), resulting in inadequate treatment, incomplete inhibition of cell proliferation, and an increased probability of later hyperplasia and stenosis.

[0006] Existing double-layer drug-eluting balloon catheter designs have significant limitations in the materials used to manufacture the outer balloon, are complex to design and difficult to commercialize, and have poor control over the aperture or mesh size. Summary of the Invention

[0007] The purpose of this application is to provide a double-layered drug-eluting balloon dilation catheter that can achieve precise fit of the drug balloon to the lesion site, reduce drug loss during delivery, and ensure the therapeutic effect of the drug acting on the lesion site.

[0008] To achieve the above objectives, the present invention provides a double-layered drug-eluting balloon dilation catheter, comprising a double-layered balloon, wherein the double-layered balloon includes an outer balloon and an inner balloon, the outer balloon includes a flexible drug-eluting balloon, and the inner balloon includes a pressure-supporting balloon;

[0009] The double-layer balloon is connected to an outer tube, which includes an inner balloon inflation chamber and an outer balloon inflation chamber. A buffer chamber is provided between the outer balloon inflation chamber and the outer balloon. An inflation assembly is provided at the proximal end of the outer tube.

[0010] The outer balloon includes a frosted surface on its outer surface, and the sprayed drug adheres to and bonds to the frosted surface;

[0011] A shock wave emitter is provided between the outer balloon and the inner balloon. The shock wave emitter is located on the balloon body near the junction of the outer balloon and the inner balloon and away from the outer balloon.

[0012] In an optional embodiment, the inflator assembly includes a pressure-dividing knob disposed at the proximal end of the outer tube, the proximal end of which is connected to a locking cap for connecting an external balloon inflator.

[0013] In an optional embodiment, the pressure-dividing knob is provided with a pressure-dividing channel, and the on / off state of the pressure-dividing channel and the outer balloon inflation chamber can be controlled by rotating the pressure-dividing knob.

[0014] In an optional embodiment, the pressurization assembly includes a pressurization line and a pressurization valve group. The pressurization line includes an outer balloon pressurization tube and an inner balloon pressurization tube. The proximal end of the outer tube is connected to a Y-shaped handle. The outer balloon pressurization tube and the inner balloon pressurization tube are respectively connected to two pressurization ports of the Y-shaped handle.

[0015] In an optional embodiment, the pressurization line further includes a main pressurization tube, the proximal end of which is connected to a locking cap for connecting an external balloon pressurization device.

[0016] The pressurization valve assembly includes a solenoid three-way valve disposed on the pressurization main pipe, and a first pressurization solenoid valve and a second pressurization solenoid valve disposed on the outer balloon pressurization tube and the inner balloon pressurization tube, respectively.

[0017] The main pressurization tube is connected to the middle inlet of the electromagnetic three-way valve, and the outer balloon pressurization tube and the inner balloon pressurization tube are respectively connected to the two branch outlets of the electromagnetic three-way valve.

[0018] Pressure sensors are respectively installed on the outer balloon inflation tube and the inner balloon inflation tube. The pressure sensors, the solenoid three-way valve, the first inflation solenoid valve and the second inflation solenoid valve are electrically connected to the control system.

[0019] In an optional embodiment, the outer balloon includes a proximal conical segment, a distal conical segment, and a body segment.

[0020] The hardness of the proximal and distal segments of the outer balloon is greater than that of the main body segment of the outer balloon.

[0021] The inner balloon has a higher hardness than the proximal cone segment and the distal cone segment of the outer balloon.

[0022] The inner balloon, the proximal cone segment of the outer balloon, and the distal cone segment of the outer balloon are made of one or more materials including polyamide, Pebax, or nylon, and the outer balloon body segment is made of silicone.

[0023] In an optional embodiment, the inner balloon includes a proximal conical segment, a distal conical segment, and a body segment.

[0024] A guidewire is inserted through the inner side of the inner balloon. The proximal conical segment and the distal conical segment of the inner balloon are respectively connected to the guidewire. The proximal end of the proximal conical segment and the distal end of the distal conical segment of the inner balloon are respectively provided with an inner balloon connecting segment of at least one length. The inner balloon connecting segment is wrapped and connected to the guidewire.

[0025] The proximal portion of the proximal cone segment of the outer balloon and the distal portion of the distal cone segment of the outer balloon are respectively connected to the connecting segments of the inner balloon located on both sides of the inner balloon.

[0026] The shock wave emitter is connected radially to the outer side of the inner balloon connection section.

[0027] In an optional embodiment, relative to the axis of the dilation catheter, the axial length of the proximal conical segment of the outer balloon is not less than the axial length of the inner balloon connecting segment located proximally, and the axial length of the distal conical segment of the outer balloon is not less than the axial length of the inner balloon connecting segment located distally. The shock wave emitter includes a plurality of units symmetrically arranged on both sides of the axial direction of the inner balloon, and respectively located near the proximal junction of the proximal conical segment of the outer balloon and the distal junction of the distal conical segment of the outer balloon.

[0028] In an optional embodiment, the shock wave emitter includes a shock wave electrode and a connecting wire. The connecting wire of the shock wave electrode located at the distal end of the inner balloon is attached to the outer wall of the inner balloon and the connecting section of the inner balloon, and merges with the connecting wire of the shock wave electrode located at the proximal end of the inner balloon and is then led out through the wire cavity of the outer tube.

[0029] In an optional embodiment, the inflation pressure of the inner balloon is 6-12 atm;

[0030] The inflation pressure of the outer balloon is 1-4 atm.

[0031] By designing a double-layered balloon, the inner balloon can function as a pressure-supporting balloon, maximizing its internal pressure-supporting effect, while the outer balloon can function as a drug-eluting balloon, directly contacting the lesion site in the blood vessel to ensure the drug's effectiveness at the lesion site.

[0032] By constructing the outer surface of the outer balloon as a frosted surface and allowing the sprayed drug to adhere to the frosted surface, the degree of drug adhesion to the frosted surface can be enhanced, making it less likely to fall off, thereby improving the situation of drug loss through blood flushing.

[0033] By setting the outer tube connected to the double-layer balloon as a multi-lumen inflation tube, the inner and outer balloons can be inflated by the inflation assembly connected to the proximal end of the outer tube and the inflation device connected to the inflation assembly.

[0034] The buffer chamber between the outer balloon inflation chamber and the outer balloon itself allows the outer balloon to expand uniformly during inflation, improving the inflation and expansion process.

[0035] By placing a shock wave emitter between the outer and inner balloons, shock wave therapy can be achieved. The shock wave can be transmitted to the drug action site through the pressurization medium between the inner and outer balloons, realizing a dual effect of drug therapy and shock wave therapy.

[0036] This invention fully considers both the therapeutic effect of shock waves on the lesion site and the energy impact that the outer balloon can withstand. By placing the shock wave emitter near the junction of the outer and inner balloons and away from the balloon body of the outer balloon, the pulse energy of the shock wave can be effectively applied to the contact area of ​​the outer balloon with the lesion tissue, while avoiding the risk of rupture of the outer balloon body structure.

[0037] This invention enables precise placement of the drug-eluting balloon at the lesion site, reducing drug loss during delivery while ensuring the therapeutic effect of the drug at the lesion site.

[0038] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0039] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0040] Figure 1 This is a schematic diagram of the structure of the double-layered drug-eluting balloon dilation catheter of the integrated pressurization assembly in this invention;

[0041] Figure 2 A schematic diagram of the integrated pressurization assembly and the outer tube.

[0042] Figure 3 This is a schematic diagram of the structure of the double-layered drug-eluting balloon dilation catheter of the split-type pressurization assembly in this invention;

[0043] Figure 4 This is a schematic diagram of the structure of a double-layered balloon;

[0044] Figure 5 This is a schematic diagram illustrating the relationship between existing balloons and the lesion site;

[0045] Figure 6 This is a schematic diagram showing the fit between the double-layered balloon and the lesion site in this application.

[0046] icon:

[0047] 1-Outer balloon; 11-Proximal cone segment of outer balloon; 12-Distal cone segment of outer balloon; 13-Body segment of outer balloon;

[0048] 2-Inner balloon; 21-Proximal cone segment of inner balloon; 22-Distal cone segment of inner balloon; 23-Body segment of inner balloon; 24-Connecting segment of inner balloon; 25-Contrast ring;

[0049] 3-Outer tube; 31-Inner balloon inflation chamber; 32-Outer balloon inflation chamber; 33-Buffer chamber; 34-Y-shaped handle;

[0050] 4-Shock wave emitter; 41-Shock wave electrode; 42-Connecting wire;

[0051] 5 - Pressure divider knob; 51 - Pressure divider channel; 52 - Filling channel;

[0052] 6- Locking cap;

[0053] 7-Pressure line; 71-Outer balloon pressure line; 72-Inner balloon pressure line; 73-Main pressure line; 74-Solenoid three-way valve; 75-First pressure solenoid valve; 76-Second pressure solenoid valve; 77-Pressure sensor;

[0054] 8-Guide wire tube;

[0055] 9. Lesion site. Detailed Implementation

[0056] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0057] In the description of this application, it should be noted that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are used only for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0058] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "setup" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0059] The double-layered drug-eluting balloon dilatation catheter in this application mainly improves the fit between the drug-eluting balloon dilatation catheter and the stenotic lesion by changing the necessary structure of the existing balloon dilatation catheter, so as to achieve precise fit of the drug balloon at the lesion site. At the same time, it can enhance the binding between the drug and the balloon surface and reduce the erosion loss of the drug during the balloon delivery process.

[0060] Furthermore, by incorporating a shockwave component, the therapeutic effect on the lesion site 9 can be enhanced in conjunction with drug therapy.

[0061] See Figures 1-4The double-layered drug-eluting balloon dilation catheter of the present invention has a main structure including a double-layered balloon, which includes an outer balloon 1 and an inner balloon 2. The outer balloon 1 includes a flexible drug-eluting balloon, and the inner balloon 2 includes a pressure-supporting balloon.

[0062] The flexible drug-eluting balloon is mainly used to carry the sprayed drug and adaptively fits the lesion site 9 after both balloons inside and outside the dilation catheter are fully inflated. The flexible drug-eluting balloon is preferably made of silicone, which makes the outer balloon 1 more flexible and can better conform to the lesion site 9 after it is inflated. Especially for lesions with different hardness and compliance, such as diffuse calcified lesions, the flexible drug-eluting balloon made of silicone can fully and completely conform to the lesion site 9 in different locations, so that the drug on the outer surface of the drug-eluting balloon can fully act on the lesion site 9.

[0063] The inner balloon 2 includes a pressure-supporting balloon, which mainly provides the basis for the overall expansion of the double-layer drug-eluting balloon dilation catheter. Specifically, the expansion of the drug-eluting balloon is carried out on the basis of the expansion of the inner pressure-supporting balloon, thereby providing a basic space for the expansion of the drug-eluting balloon, reducing the deformation of the drug-eluting balloon, and enabling the drug-eluting balloon to expand fully under relatively small secondary pressure conditions, avoiding the risk of rupture of the flexible silicone material.

[0064] The proximal end of the double-layer balloon is connected to an outer tube 3, which is mainly used to inflate the double-layer balloon with a pressurizing medium and to allow the guidewire to pass through the guidewire port on the outer tube 3.

[0065] The outer tube 3 specifically includes an inner balloon inflation chamber 31 and an outer balloon inflation chamber 32, which correspond to the inflation of the inner balloon 2 and the outer balloon 1, respectively. Specifically, the inner balloon inflation chamber 31 communicates with the cavity of the inner balloon 2, and the outer balloon inflation chamber 32 communicates with the cavity of the outer balloon 1.

[0066] Based on the structure of the outer balloon 1 as a flexible drug-eluting balloon, a buffer cavity 33 is provided between the outer balloon inflation chamber 32 and the outer balloon 1 to ensure relatively stable expansion of the outer balloon 1. Specifically, the buffer cavity 33 includes an annular cavity structure located at the proximal end of the outer balloon 1. During the inflation and expansion process of the outer balloon 1, the liquid inflation medium first enters the buffer cavity 33, and then flows from the annular cavity structure of the buffer cavity 33 into the balloon cavity of the outer balloon 1, thereby ensuring that the outer balloon 1 undergoes a relatively uniform expansion process. This avoids the situation where uneven pressure expansion during the inflation process of the outer tube 3 leads to poor adhesion of the outer balloon 1 to the wall.

[0067] In this invention, a pressurization assembly is provided at the proximal end of the outer tube 3. The pressurization assembly delivers the externally input liquid pressurization medium to the pressurization chamber of the outer tube 3. At the same time, the pressurization assembly can also control the separate expansion of the two balloons, thereby meeting the practical application requirements of the step-by-step expansion of the double-layer drug balloon dilation catheter.

[0068] In order to improve the adhesion of the sprayed drug to the surface of the drug-eluting balloon and reduce blood flow erosion loss, the outer balloon 1 of the present invention includes a frosted surface on the outer surface, which has a high roughness and a frosted effect. During the drug spraying process, the drug can have better adhesion to the frosted outer surface of the silicone material. Compared with the smooth surface of existing drug-eluting balloons, it can greatly reduce drug shedding and ensure the amount of drug acting on the lesion site 9.

[0069] To further ensure the effectiveness of the drug at the lesion site 9 and enable the drug to reach the inner membrane of the lesion site 9, the present invention also specifically sets up a shock wave assembly for further drug penetration. The shock wave assembly includes a shock wave emitter 4 disposed between the outer balloon 1 and the inner balloon 2. Combined with the liquid pressurization medium inside the outer balloon 1, the shock wave emitted by the shock wave emitter 4 can be transmitted to the contact position between the outer balloon 1 and the lesion site 9, thereby ensuring the effectiveness of the drug at the contact position.

[0070] From the perspective of the outer balloon 1 including the flexible silicone material, in order to reduce the impact of shock waves on the structure of the outer balloon 1, prevent the risk of rupture of the flexible silicone material, and ensure the therapeutic effect of shock wave pulse energy on drug penetration, it is necessary to consider the rationality of the shock wave component placement.

[0071] By placing the shock wave emitter 4 near the junction of the outer balloon 1 and the inner balloon 2 and away from the outer balloon 1 in the balloon body, both of the above factors can be taken into account, achieving good application.

[0072] The double-layered drug-eluting balloon dilation catheter of this invention can effectively make the surface of the drug-eluting balloon adhere to the complex stenotic lesion site 9, while ensuring that the drug sprayed on the outer surface of the outer balloon achieves a good therapeutic effect without affecting the structure of the drug-eluting balloon.

[0073] Based on the step-by-step inflation of the double-layer balloon, the inflation assembly set at the proximal end of the outer tube 3 in this invention specifically includes two different configuration forms: an integrated inflation assembly and a separate inflation assembly.

[0074] In the implementation of the integrated inflation assembly, the inflation assembly includes a pressure-dividing knob 5 located near the proximal end of the outer tube 3. A locking cap 6 is connected to the proximal end of the pressure-dividing knob 5, and the locking cap 6 is used to connect an external balloon inflation device. The pressure-dividing knob 5 is mainly used to control the on / off relationship between the inflation device and two different inflation chambers inside the outer tube 3, thereby selectively performing the inflation operation of the two balloons in stages.

[0075] The pressure dividing knob 5 is equipped with a pressure dividing channel 51. By rotating the pressure dividing knob 5, the on / off state of the pressure dividing channel 51 and the outer balloon inflation chamber 32 can be controlled.

[0076] Specifically, the pressure distribution knob 5 includes a pressure distribution channel 51 and an inflation channel 52 corresponding to the pressure distribution channel 51. The inflation channel 52 is connected to the proximal inflation device, while the pressure distribution channel 51 can be aligned with the outer balloon inflation chamber 32 during the rotation of the pressure distribution knob 5.

[0077] Therefore, the switching operation of the pressure divider knob 5 can control the on / off control of the pressurization device and the outer balloon pressurization chamber 32 inside the outer tube 3.

[0078] In this invention, the volume of the inner balloon inflation chamber 31 inside the outer tube 3 is larger than the volume of the outer balloon inflation chamber 32. Generally speaking, during the inflation process, the inner balloon 2 is expanded under the action of a higher inflation pressure by first connecting the inflation channel 52 of the pressure divider knob 5 to the cavity of the inner balloon inflation chamber 31, thus forming the basic expansion space for the secondary expansion of the outer balloon 1.

[0079] Then, by rotating the pressure divider knob 5, the pressure divider channel 51 of the pressure divider knob 5 is connected to the cavity of the outer balloon inflation chamber 32, while maintaining the connection between the inflation channel 52 and the inner balloon inflation chamber 31. This keeps the inner balloon 2 in a high inflation pressure state. Based on the expansion state formed by the previous inflation and expansion of the inner balloon 2, and the flexible silicone material included in the outer balloon 1, the outer balloon 1 is expanded and inflated by the lower pressure after pressure division. At the same time, compared to... Figure 5 The existing balloon exhibiting poor apposition, as shown, allows for adaptive and complete apposition of the flexible outer balloon body 1 to the lesion site 9. (See [reference]). Figure 6 This ensures the adhesion area between the outer balloon 1 and the lesion site 9, and further, combined with the shock wave emitted by the shock wave assembly, allows the drug to penetrate into the inner membrane of the lesion site 9, and under the action of pulsating impact energy, the drug can exert a good therapeutic effect.

[0080] In this invention, the inflation pressure of the inner balloon 2 is 6-12 atm, and the inflation pressure of the outer balloon 1 is 1-4 atm. With the rated burst pressure of the inner balloon 2 set at 6-12 atm, the preset pressure of the outer balloon 1 is in the range of 1-4 atm, and the pressure applied by the external balloon inflation device is 7-16 atm.

[0081] In the implementation of the split-type inflation assembly, the inflation assembly includes an inflation pipeline 7 and an inflation valve group. The inflation pipeline 7 includes an outer balloon inflation tube 71 and an inner balloon inflation tube 72. The outer balloon inflation tube 71 and the inner balloon inflation tube 72 are respectively used to connect with the outer balloon inflation chamber 32 and the inner balloon inflation chamber 31 in the outer tube 3.

[0082] In order to facilitate the connection of different inflation tubes, a Y-shaped handle 34 is connected to the proximal end of the outer tube 3. The Y-shaped handle 34 is provided with an inner balloon 2 inflation port and an outer balloon 1 inflation port. The inner balloon 2 inflation port is connected to the inner balloon inflation chamber 31, and the outer balloon 1 inflation port is connected to the outer balloon inflation chamber 32.

[0083] During the specific connection process, the outer balloon inflation tube 71 and the outer balloon 1 inflation interface are connected in a sealed manner through a Luer connector, and the inner balloon inflation tube 72 and the inner balloon 2 inflation interface are connected in a sealed manner through a Luer connector, which facilitates the sealed inflation operation after connection.

[0084] From the perspective of external input of liquid pressurizing medium, pressurizing line 7 also includes pressurizing main pipe 73, and a locking cap 6 is connected to the proximal end of pressurizing main pipe 73. The locking cap 6 is used to connect an external balloon pressurizing device.

[0085] The pressurization valve assembly includes a solenoid three-way valve 74 disposed at the distal end of the pressurization main pipe 73, and a first pressurization solenoid valve 75 and a second pressurization solenoid valve 76 disposed on the outer balloon pressurization tube 71 and the inner balloon pressurization tube 72, respectively.

[0086] Specifically, the electromagnetic three-way valve 74 is mainly used to control the overall filling on / off state of the pressurization assembly, as well as to switch the flow direction of the liquid filling medium to different pressurization tubes, thereby controlling the filling of different balloons.

[0087] Based on this, the main pressurization pipe 73 is connected to the middle inlet of the electromagnetic three-way valve 74, and the outer balloon pressurization pipe 71 and the inner balloon pressurization pipe 72 are respectively connected to the two branch outlets of the electromagnetic three-way valve 74.

[0088] With this pipeline connection method and the setting of the electromagnetic three-way valve 74, the overall input of liquid filling medium can be blocked or introduced by closing or opening the inlet of the electromagnetic three-way valve 74.

[0089] At the same time, by controlling the opening and closing of the two branch outlets of the electromagnetic three-way valve 74, different balloons can be inflated and expanded in stages.

[0090] Furthermore, pressure sensors 77 are respectively installed on the outer balloon inflation tube 71 and the inner balloon inflation tube 72, and the pressure sensors 77 and the solenoid three-way valve 74 are electrically connected to the control system.

[0091] During the actual inflation process, by setting different inflation pressures for the balloons in the control system, the pressure sensor 77 can transmit the pressure value detected in real time to the control system, and the control system can switch the on / off state of the two branch outlets according to the preset inflation pressure of different balloons.

[0092] The purpose of the first pressurization solenoid valve 75 and the second pressurization solenoid valve 76 is to provide secondary protection for the opening and closing of the outer balloon pressurization tube 71 and the inner balloon pressurization tube 72. By also electrically connecting the first pressurization solenoid valve 75 and the second pressurization solenoid valve 76 to the control system, they can be kept in a synchronized opening and closing state with the two branch outlets.

[0093] During the pressurization control process, the middle inlet of the solenoid three-way valve 74 is first opened by the control system, and the branch outlet corresponding to the inner balloon pressurization tube 72 and the second pressurization solenoid valve 76 are opened simultaneously to pressurize the inner balloon 2. When the pressure sensor 77 on the inner balloon pressurization tube 72 detects that the preset pressure of the inner balloon 2 has been reached, the branch outlet and the second pressurization solenoid valve 76 are disconnected to maintain the pressurization state of the inner balloon 2. At the same time, the branch outlet corresponding to the outer balloon pressurization tube 71 and the first pressurization solenoid valve 75 are opened to pressurize the outer balloon 1. When the pressure sensor 77 on the outer balloon pressurization tube 71 detects that the preset pressure of the outer balloon 1 has been reached, the branch outlet and the first pressurization solenoid valve 75 are disconnected to complete the pressurization process.

[0094] The dual-layer drug balloon dilation catheter of the split-type inflation assembly in this invention can achieve automatic inflation and maintain automatic switching and on / off control of different inflation tubes, effectively improving operational efficiency.

[0095] In order to minimize the impact of the shock wave pulse energy on the structure of the outer balloon 1, it is necessary to partition the outer balloon 1 with different materials.

[0096] The outer balloon 1 of this invention includes a proximal conical segment 11, a distal conical segment 12, and a main body segment 13. Furthermore, since the outer balloon 1 adheres primarily to the lesion site 9 within the main body segment of the outer balloon 1, the hardness of the proximal conical segment 11 and the distal conical segment 12 is greater than that of the main body segment 13. This allows the proximal conical segment 11 and the distal conical segment 12 to withstand greater inflation pressure, while simultaneously protecting the main body segment 13 under inflated conditions.

[0097] Given that the inflation pressure of the inner balloon 2 is much greater than that of the outer balloon 1, as mentioned above, it is necessary to consider causing the outer balloon 1 to undergo necessary expansion deformation under a smaller inflation pressure to ensure the expansion and fit of the outer balloon body segment 13. By making the hardness of the inner balloon 2 greater than that of the proximal cone segment 11 and the distal cone segment 12 of the outer balloon, the proximal cone segment 11 and the distal cone segment 12 of the outer balloon can be expanded and deformed under a smaller inflation pressure. At the same time, the outer balloon body segment 13 is driven to expand and move outward radially, which is beneficial to the fit of the outer balloon body segment 13 with the lesion site 9.

[0098] In the specific manufacturing process, the inner balloon 2, the proximal cone segment 11 of the outer balloon, and the distal cone segment 12 of the outer balloon are made of one or more materials such as polyamide, Pebax, or nylon, and the outer balloon body segment 13 is made of silicone, which can form the above-mentioned different hardness distribution states.

[0099] From the perspective of the assembly of the inner balloon 2 and the outer balloon 1, the inner balloon 2 includes the proximal cone segment 21, the distal cone segment 22, and the body segment 23 of the inner balloon.

[0100] A guidewire 8 is inserted through the inner side of the inner balloon 2. The proximal cone segment 21 and the distal cone segment 22 of the inner balloon are respectively connected to the guidewire 8. At least one length of inner balloon connecting segment 24 is provided at the proximal end of the proximal cone segment 21 and the distal end of the distal cone segment 22 of the inner balloon.

[0101] The inner balloon connecting section 24 is mainly used to connect the inner balloon 2 to the guide wire tube 8, and the outer balloon 1 to the inner balloon. On the other hand, it is also used to connect the shock wave emitter 4 to the inner balloon connecting section 24.

[0102] Specifically, the inner balloon connecting section 24 is wrapped around the outside of the guidewire 8 to achieve the assembly connection between the inner balloon 2 and the guidewire 8.

[0103] The proximal portion of the outer balloon proximal cone segment 11 and the distal portion of the outer balloon distal cone segment 12 are respectively connected to the inner balloon connecting segments 24 located on both sides of the inner balloon 2, thereby realizing the assembly connection between the inner balloon 2 and the outer balloon 1.

[0104] By connecting the shock wave emitter 4 radially outward to the inner balloon connecting section 24, it can be moved away from the balloon body of the double-layer balloon, especially the outer balloon, reducing the destructive impact of the shock wave pulse energy on the outer balloon body section. Simultaneously, based on the liquid inflation medium between the inner balloon 2 and the outer balloon 1, the shock wave can be transmitted to the contact point between the outer balloon and the lesion site 9, enhancing the therapeutic effect of the drug on the lesion site 9.

[0105] Because the hardness of the proximal conical segment 11 and distal conical segment 12 of the outer balloon is greater than that of the outer balloon body segment 13, the two conical segments can withstand the pulse energy impact of the shock wave. At the same time, in order to enable the two conical segments to form protection for the outer balloon body segment 13, the axial length of the proximal conical segment 11 of the outer balloon is not less than the axial length of the inner balloon connecting segment 24 located at the proximal end relative to the axis of the dilation catheter, and the axial length of the distal conical segment 12 of the outer balloon is not less than the axial length of the inner balloon connecting segment 24 located at the distal end. Combined with the installation of the shock wave emitter 4 on the inner balloon connecting segment 24, the proximal conical segment 11 and distal conical segment 12 of the outer balloon can respectively cover the installation area of ​​the shock wave emitter 4 in a semi-enclosed state. On the one hand, the shock wave can be transmitted to the middle position of the outer balloon, and on the other hand, the direct impact of the shock wave on the outer balloon body segment 13 can be reduced, effectively protecting the outer balloon body segment 13, which has higher flexibility and lower strength.

[0106] To ensure the effectiveness of the shock wave, the shock wave emitter 4 includes multiple units symmetrically arranged on both sides of the inner balloon 2 along the axial direction, and respectively close to the proximal junction of the proximal cone segment 11 and the distal junction of the distal cone segment 12 of the outer balloon. In other words, the shock wave emitter 4 is positioned far away from the outer balloon body segment 13 located in the middle, thus balancing the protection of the outer balloon body segment 13 and the effectiveness of the shock wave.

[0107] The shock wave emitter 4 specifically includes a shock wave electrode 41 and a connecting wire 42. The connecting wire 42 of the shock wave electrode 41 located at the distal end of the inner balloon 2 is attached to the outer wall of the inner balloon 2 and the inner balloon connecting section 24, and merges with the connecting wire 42 of the shock wave electrode 41 located at the proximal end of the inner balloon 2 and is then led out through the wire cavity of the outer tube 3.

[0108] By extending the connecting wire 42 out of the wire cavity of the outer tube 3, it can be connected to the externally installed shock wave control device. By adjusting the frequency of the shock wave control device, the pulse energy of the shock wave can be adjusted to maintain the normal function of the shock wave while taking into account both the protection of the outer balloon body segment 13 and the effective action on the lesion site 9.

[0109] The guidewire 8 has two imaging rings 25 located inside the inner balloon 2, which can control and adjust the relative position of the double-layer drug balloon dilation catheter and the lesion site 9 through external real-time monitoring.

[0110] A hypotube is also connected to the proximal part of the outer tube 3 to facilitate the delivery process. The drugs coated on the outer surface of the outer balloon 1 include paclitaxel or rapamycin, without the addition of any dispersants or other ingredients, to avoid allergies and other discomfort / damage to patients caused by dispersants.

[0111] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0112] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A double-layered drug-eluting balloon dilation catheter, characterized in that, The device includes a double-layered balloon, which comprises an outer balloon and an inner balloon. The outer balloon comprises a flexible drug-eluting balloon, and the inner balloon comprises a pressure-supporting balloon. The double-layer balloon is connected to an outer tube, which includes an inner balloon inflation chamber and an outer balloon inflation chamber. A buffer chamber is provided between the outer balloon inflation chamber and the outer balloon. An inflation assembly is provided at the proximal end of the outer tube. The buffer cavity includes an annular cavity structure disposed at the proximal part of the outer balloon; The outer balloon includes a frosted surface on its outer surface, and the sprayed drug adheres to and bonds to the frosted surface; A shock wave emitter is provided between the outer balloon and the inner balloon. The shock wave emitter is located on the balloon body near the junction of the outer balloon and the inner balloon and away from the outer balloon. The outer balloon includes a proximal conical segment, a distal conical segment, and a main body segment. The hardness of the proximal and distal segments of the outer balloon is greater than that of the main body segment of the outer balloon. The inner balloon has a harder texture than the proximal and distal segments of the outer balloon.

2. The double-layered drug-eluting balloon dilation catheter according to claim 1, characterized in that, The inflator assembly includes a pressure-dividing knob located at the proximal end of the outer tube, and a locking cap is connected to the proximal end of the pressure-dividing knob. The locking cap is used to connect an external balloon inflator.

3. The double-layered drug-eluting balloon dilation catheter according to claim 2, characterized in that, The pressure-dividing knob is provided with a pressure-dividing channel, and the opening and closing status of the pressure-dividing channel and the outer balloon inflation chamber can be controlled by rotating the pressure-dividing knob.

4. The double-layered drug-eluting balloon dilation catheter according to claim 1, characterized in that, The inflator assembly includes an inflator line and an inflator valve group. The inflator line includes an outer balloon inflator line and an inner balloon inflator line. The proximal end of the outer tube is connected to a Y-shaped handle. The outer balloon inflator line and the inner balloon inflator line are respectively connected to two inflator ports of the Y-shaped handle.

5. The double-layered drug-eluting balloon dilation catheter according to claim 4, characterized in that, The pressurization line also includes a main pressurization tube, the proximal end of which is connected to a locking cap, which is used to connect an external balloon pressurization device. The pressurization valve assembly includes a solenoid three-way valve disposed on the pressurization main pipe, and a first pressurization solenoid valve and a second pressurization solenoid valve disposed on the outer balloon pressurization tube and the inner balloon pressurization tube, respectively. The main pressurization tube is connected to the middle inlet of the electromagnetic three-way valve, and the outer balloon pressurization tube and the inner balloon pressurization tube are respectively connected to the two branch outlets of the electromagnetic three-way valve. Pressure sensors are respectively installed on the outer balloon inflation tube and the inner balloon inflation tube. The pressure sensors, the solenoid three-way valve, the first inflation solenoid valve and the second inflation solenoid valve are electrically connected to the control system.

6. The double-layered drug-eluting balloon dilation catheter according to claim 1, characterized in that, The inner balloon, the proximal cone segment of the outer balloon, and the distal cone segment of the outer balloon are made of one or more materials including polyamide, Pebax, or nylon, and the outer balloon body segment is made of silicone.

7. The double-layered drug-eluting balloon dilation catheter according to claim 6, characterized in that, The inner balloon includes a proximal conical segment, a distal conical segment, and a body segment. A guidewire is inserted through the inner side of the inner balloon. The proximal conical segment and the distal conical segment of the inner balloon are respectively connected to the guidewire. The proximal end of the proximal conical segment and the distal end of the distal conical segment of the inner balloon are respectively provided with an inner balloon connecting segment of at least one length. The inner balloon connecting segment is wrapped and connected to the guidewire. The proximal portion of the proximal cone segment of the outer balloon and the distal portion of the distal cone segment of the outer balloon are respectively connected to the connecting segments of the inner balloon located on both sides of the inner balloon. The shock wave emitter is connected radially to the outer side of the inner balloon connection section.

8. The double-layered drug-eluting balloon dilation catheter according to claim 7, characterized in that, Relative to the axis of the dilation catheter, the axial length of the proximal conical segment of the outer balloon is not less than the axial length of the inner balloon connecting segment located proximally, and the axial length of the distal conical segment of the outer balloon is not less than the axial length of the inner balloon connecting segment located distally. The shock wave emitter includes a plurality of units symmetrically arranged on both sides of the axial direction of the inner balloon, and respectively located near the proximal connection point of the proximal conical segment of the outer balloon and the distal connection point of the distal conical segment of the outer balloon.

9. The double-layered drug-eluting balloon dilation catheter according to claim 7, characterized in that, The shock wave emitter includes a shock wave electrode and connecting wires. The connecting wire of the shock wave electrode located at the distal end of the inner balloon is attached to the outer wall of the inner balloon and the connecting section of the inner balloon, and merges with the connecting wire of the shock wave electrode located at the proximal end of the inner balloon and is then led out through the wire cavity of the outer tube.

10. The double-layered drug-eluting balloon dilation catheter according to claim 1, characterized in that, The inner balloon is inflated at a pressure of 6-12 atm; The inflation pressure of the outer balloon is 1-4 atm.

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