Double-layer medicine balloon dilatation catheter

Abstract

The invention relates to a double-layer medicine balloon dilatation catheter which comprises a double-layer balloon, the double-layer balloon comprises an outer-layer balloon and an inner-layer balloon, the outer-layer balloon comprises a flexible medicine balloon, and the inner-layer balloon comprises a pressurizing supporting balloon; the double-layer balloon is connected with an outer tube, the outer tube comprises an inner-layer balloon pressurizing cavity and an outer-layer balloon pressurizing cavity, a buffering cavity is formed between the outer-layer balloon pressurizing cavity and the outer-layer balloon, and a pressurizing assembly is arranged at the near end of the outer tube; the outer-layer balloon comprises a frosted surface located on the outer side surface, and the spraying medicine is attached to and combined with the frosted surface; a shock wave emitter is arranged between the outer-layer balloon and the inner-layer balloon, and the shock wave emitter is arranged at the position, close to the connecting portion of the outer-layer balloon and the inner-layer balloon, of the balloon body and far away from the outer-layer balloon. Precise attachment of the medicine balloon on a diseased region can be achieved, loss of medicine in the conveying process is reduced, and meanwhile the treatment effect of the medicine acting on the diseased region is guaranteed.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a double-layer drug balloon dilatation catheter. Background Art

[0002] Drug-eluting stent implantation has gradually become a primary strategy for coronary interventional treatment. Whether it's PTCA or stent implantation, all interventional treatments for vascular stenosis or occlusion are associated with restenosis. A drug is applied to a balloon, which then expands, bringing it into full contact with the arterial intima, releasing the drug uniformly onto the damaged surface, effectively inhibiting intimal hyperplasia. Drug-eluting balloons are truly born out of necessity.

[0003] Existing drug-eluting balloon catheter technology uses a spray-coated process to deposit drugs onto the balloon surface, which are then delivered to the site of the stenosis. If a patient has severe calcification in their vascular tissue, using a balloon that is too large can cause endothelial tissue tears, leading to dissection and bleeding.

[0004] The existing double-layer drug-eluting balloon catheter is an innovative interventional therapy that utilizes a double-layer drug coating to enhance drug release efficiency and therapeutic efficacy within the vessel wall. The balloon surface is coated with a double layer of drug: an inner drug reservoir and an outer drug release layer. The inner reservoir can store high concentrations of drug, while the outer layer is designed with micropores or a lattice pattern to allow drug permeation.

[0005] The drug is sprayed onto the smooth surface of the balloon, and during balloon delivery, it suffers significant losses due to blood washout. Furthermore, conventional drug-eluting balloon dilatation catheters cannot adhere effectively to complex stenotic lesions characterized by multiple tissue stenosis, hyperplasia, and calcification. This is especially true for lesions with varying hardness and compliance, such as diffusely calcified lesions. The uneven adhesion of the drug balloon prevents the drug from evenly and fully reaching the subintimal layer. This is a key factor in the poor long-term efficacy of DCBs, leading to inadequate treatment, incomplete inhibition of cell proliferation, and an increased probability of later hyperplastic stenosis.

[0006] The existing double-layer drug-eluting balloon catheter design has significant limitations on the outer balloon manufacturing materials, the design is complex and difficult to translate into results, and the pore size or mesh size is difficult to operate and control. Summary of the Invention

[0007] The purpose of this application is to provide a double-layer drug balloon dilatation catheter that can achieve precise fitting of the drug balloon to the lesion site, reduce drug loss during delivery, and at the same time ensure the therapeutic effect of the drug acting on the lesion site.

[0008] To achieve the above object, the present invention provides a double-layer drug balloon dilation catheter, comprising a double-layer balloon, the double-layer balloon including an outer balloon and an inner balloon, the outer balloon including a flexible drug balloon, and the inner balloon including a pressurized support balloon;

[0009] The double-layer balloon is connected to an outer tube, the outer tube including an inner balloon pressurization chamber and an outer balloon pressurization chamber, a buffer chamber being provided between the outer balloon pressurization chamber and the outer balloon, and a pressurization assembly being 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 binds on the frosted surface;

[0011] A shock wave emitter is provided between the outer balloon and the inner balloon, the shock wave emitter being provided near the joint portion of the outer balloon and the inner balloon and away from the balloon body of the outer balloon.

[0012] In an optional embodiment, the pressurization assembly includes a pressure dividing knob provided at the proximal portion of the outer tube, the proximal end of the pressure dividing knob being connected to a locking cap, and the locking cap being used for externally connecting a balloon pressurization device.

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

[0014] In an optional embodiment, the pressurization assembly includes a pressurization pipeline and a pressurization valve group, the pressurization pipeline including an outer balloon pressurization pipe and an inner balloon pressurization pipe, the proximal end of the outer tube being connected to a Y-shaped handle, and the outer balloon pressurization pipe and the inner balloon pressurization pipe being respectively connected to two pressurization interfaces of the Y-shaped handle.

[0015] In an optional embodiment, the pressurization pipeline further includes a main pressurization pipe, the proximal end of the main pressurization pipe being connected to a locking cap, and the locking cap being used for externally connecting a balloon pressurization device;

[0016] The pressurization valve group includes an electromagnetic three-way valve provided on the main pressurization pipe, and a first pressurization solenoid valve and a second pressurization solenoid valve respectively provided on the outer balloon pressurization pipe and the inner balloon pressurization pipe;

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

[0018] The outer balloon inflation tube and the inner balloon inflation tube are respectively provided with pressure sensors, and the pressure sensors, the electromagnetic three-way valve, the first inflation electromagnetic valve and the second inflation electromagnetic valve are respectively electrically connected to a control system.

[0019] In an optional embodiment, the outer balloon includes an outer balloon proximal cone segment, an outer balloon distal cone segment, and an outer balloon body segment;

[0020] The hardness of the proximal cone section of the outer balloon and the distal cone section of the outer balloon is greater than the hardness of the outer balloon body section;

[0021] The hardness of the inner balloon is greater than the hardness of the proximal cone section of the outer balloon and the distal cone section of the outer balloon;

[0022] The material of the inner balloon, the outer balloon proximal cone section and the outer balloon distal cone section includes one or more of polyamide, Pebax or nylon, and the material of the outer balloon body section includes silicone material.

[0023] In an optional embodiment, the inner balloon includes an inner balloon proximal cone section, an inner balloon distal cone section, and an inner balloon body section;

[0024] A guide wire tube is passed through the inner side of the inner balloon, the inner balloon proximal cone section and the inner balloon distal cone section are respectively connected to the guide wire tube, and the proximal end of the inner balloon proximal cone section and the distal end of the inner balloon distal cone section are respectively provided with an inner balloon connecting section of at least one length, and the inner balloon connecting section is wrapped and connected to the guide wire tube;

[0025] The proximal end of the proximal cone section of the outer balloon and the distal end of the distal cone section of the outer balloon are respectively connected to the inner balloon connecting sections located on both sides of the inner balloon;

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

[0027] In an optional embodiment, relative to the axial direction of the dilatation catheter, the axial length of the proximal cone segment of the outer balloon is not less than the axial length of the inner balloon connecting segment located at the proximal end, and the axial length of the distal cone segment of the outer balloon is not less than the axial length of the inner balloon connecting segment located at the distal end, and the shock wave emitter includes a plurality of symmetrically arranged on both sides of the axial direction of the inner balloon, and are respectively arranged near the proximal connecting portion of the proximal cone segment of the outer balloon and the distal connecting portion of the distal cone segment of the outer balloon.

[0028] In an alternative 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 adhesively connected to the outer sidewalls of the inner balloon and the connecting section of the inner balloon, and converges 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 alternative 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 adopting the form of a double-layer balloon, the inner balloon can form an inflated support balloon to exert the internal inflated support effect, while the outer balloon can form a drug balloon to directly contact the diseased part of the blood vessel, ensuring the therapeutic effect of the drug at the diseased part.

[0032] Combined with constructing the outer surface of the outer balloon as a frosted surface and enabling the sprayed drug to adhere to the frosted surface, the binding degree of the drug on the frosted surface can be enhanced, making it not easy to fall off, thereby improving the situation of drug loss due to blood flushing.

[0033] By setting the outer tube connected to the double-layer balloon as a multi-chamber inflation tube, the inner balloon and the outer balloon can be inflated and expanded respectively under the action of the inflation component connected to the proximal end of the outer tube and the inflation device externally connected to the inflation component.

[0034] The buffer chamber provided between the outer balloon inflation chamber and the outer balloon can enable the outer balloon to be evenly expanded during the inflation process, improving the state of the inflation and expansion process.

[0035] By arranging a shock wave emitter between the outer balloon and the inner balloon, shock wave treatment can be realized, enabling the shock wave to be transmitted to the drug action site through the pressurized medium between the inner balloon and the outer balloon, achieving the double effects of drug treatment and shock wave treatment.

[0036] In the present invention, full consideration is given to both the therapeutic effect of the shock wave on the diseased part and the energy impact that the outer balloon can withstand. By arranging the shock wave emitter at a position close to the joint of the outer balloon and the inner balloon and far from the balloon body of the outer balloon, the pulsed energy of the shock wave can effectively act on the fitting part of the outer balloon on the diseased tissue, and the risk of rupture of the body structure of the outer balloon can be avoided.

[0037] The present invention can achieve precise fitting of the drug balloon at the diseased part, reduce the loss of the drug during the delivery process, and at the same time ensure the therapeutic effect of the drug acting on the diseased part.

[0038] Other features and advantages of the present application will be described in detail in the following specific implementation section. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] To more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and thus should not be regarded as limiting the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative efforts.

[0040] Figure 1 Structural schematic diagram of the double-layer drug balloon dilation catheter of the integrated pressurization component in the present invention;

[0041] Figure 2 Structural schematic diagram of the cooperation between the integrated pressurization component and the outer tube;

[0042] Figure 3 Structural schematic diagram of the double-layer drug balloon dilation catheter of the split pressurization component in the present invention;

[0043] Figure 4 Structural schematic diagram of the double-layer balloon;

[0044] Figure 5 Schematic diagram of the cooperation relationship between the existing balloon and the lesion site;

[0045] Figure 6 Schematic diagram of the fitting relationship between the double-layer balloon and the lesion site in the present application.

[0046] ICON:

[0047] 1 - Outer balloon; 11 - Proximal conical section of the outer balloon; 12 - Distal conical section of the outer balloon; 13 - Body section of the outer balloon;

[0048] 2 - Inner balloon; 21 - Proximal conical section of the inner balloon; 22 - Distal conical section of the inner balloon; 23 - Body section of the inner balloon; 24 - Connection section of the inner balloon; 25 - Marking ring;

[0049] 3 - Outer tube; 31 - Pressurization cavity for the inner balloon; 32 - Pressurization cavity for the outer balloon; 33 - Buffer cavity; 34 - Y-shaped handle;

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

[0051] 5 - Voltage dividing knob; 51 - Voltage dividing channel; 52 - Filling channel;

[0052] 6 - Locking cap;

[0053] 7 - Pressure - boosting pipeline; 71 - Outer balloon pressure - boosting tube; 72 - Inner balloon pressure - boosting tube; 73 - Main pressure - boosting pipe; 74 - Electromagnetic three - way valve; 75 - First pressure - boosting solenoid valve; 76 - Second pressure - boosting solenoid valve; 77 - Pressure sensor;

[0054] 8 - Guide wire tube;

[0055] 9 - Lesion site. Detailed implementation manners

[0056] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions in the embodiments of this application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of this application. Obviously, the described embodiments are some, but not all, of the embodiments of this application. Usually, the components of the embodiments of this application described and illustrated in the accompanying drawings here can be arranged and designed in various different configurations.

[0057] In the description of this application, it should be noted that the orientation or positional relationship indicated by terms such as "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of this application is usually placed during use. It is only for the convenience of describing this application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to this application. In addition, terms such as "first", "second", etc. are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance.

[0058] In the description of this application, it should also be noted that unless otherwise clearly specified and limited, the terms "set", "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific situations.

[0059] The double - layer drug - coated balloon dilation catheter in this application mainly improves the fitting of the drug - coated balloon dilation catheter to the stenotic lesion position by changing the necessary structure of the existing balloon dilation catheter, realizes the precise fitting of the drug - coated balloon at the lesion site, and at the same time can enhance the binding between the drug and the balloon surface, reducing the scouring loss of the drug during the balloon delivery process.

[0060] Furthermore, by setting a shock wave component, it is used to enhance the treatment effect on the lesion site 9 in combination with drug treatment.

[0061] See Figures 1-4, in the double-layer drug balloon dilation catheter of the present invention, the main structure includes a double-layer balloon. The double-layer balloon includes an outer balloon 1 and an inner balloon 2. The outer balloon 1 includes a flexible drug balloon, and the inner balloon 2 includes a pressurized support balloon.

[0062] The flexible drug balloon is mainly used to carry and spray drugs, and adaptively adheres to the lesion site 9 after the inner and outer balloons of the dilation catheter are fully inflated and expanded. The material of the flexible drug balloon is preferably silicone material, which can make the outer balloon 1 softer and better conform to the lesion site 9 after its inflation and expansion. Especially for lesions with different hardness and compliance such as diffuse calcified lesions, the flexible drug balloon made of silicone material can fully and completely adhere to the lesion sites 9 at different positions, so that the drugs on the outer surface of the drug balloon can fully act on the lesion site 9.

[0063] The pressurized support balloon included in the inner balloon 2 mainly provides a basis for the overall expansion of the double-layer drug balloon dilation catheter. Specifically, the expansion of the drug balloon is carried out on the basis of the inflation and expansion of the inner pressurized support balloon, so as to provide a basic space for the expansion of the drug balloon, reduce the deformation amount of the drug balloon, and then enable the drug balloon to be fully expanded under relatively small secondary pressurization conditions, avoiding the rupture risk of the flexible silicone material.

[0064] A outer tube 3 is connected to the proximal end of the double-layer balloon, which is mainly used to inject pressurized medium into the double-layer balloon and allow the guide wire to pass through the guide wire port on the outer tube 3.

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

[0066] Based on the structure that the outer balloon 1 is a flexible drug balloon, in order to keep the outer balloon 1 expanding relatively smoothly, a buffer chamber 33 is provided between the outer balloon pressurization chamber 32 and the outer balloon 1. Specifically, the buffer chamber 33 includes an annular chamber structure provided at the proximal part of the outer balloon 1. During the pressurization and expansion process of the outer balloon 1, the pressurized medium in liquid form first enters the buffer chamber 33, and then flows from the buffer chamber 33 of the annular chamber structure into the cavity of the outer balloon 1, thereby ensuring a relatively uniform inflation and expansion process of the outer balloon 1. Avoid the situation that the outer tube 3 has uneven pressure expansion during the pressurization process, resulting in poor wall attachment of the outer balloon 1.

[0067] In the present invention, a pressurization assembly is provided at the proximal end of the outer tube 3. The pressurization assembly conveys the externally input liquid pressurization medium into the pressurization cavity of the outer tube 3. At the same time, the pressurization assembly can also separately control the expansion of the two balloons, thereby meeting the actual application requirements of the step-by-step expansion of the double-layer drug balloon dilation catheter.

[0068] In order to improve the binding property of the sprayed drug on the surface of the drug balloon and reduce the loss caused by blood flow scouring, the outer balloon 1 in the present invention includes a frosted surface on the outer side surface, having a frosted effect with a relatively high roughness. During the drug spraying process, it can enable the drug to have a better binding property with the frosted outer surface made of silica gel material. Compared with the smooth surface of the existing drug balloon, it can greatly reduce the shedding of the drug and ensure the amount of drug acting on the lesion site 9.

[0069] In order to further ensure the effect of the drug acting on the lesion site 9 and enable the drug to reach the intima of the lesion site 9, the present invention also specifically sets a shock wave assembly for further infiltration of the drug. The shock wave assembly includes a shock wave emitter 4 disposed between the outer balloon 1 and the inner balloon 2. Combining with the liquid pressurization medium inside the outer balloon 1, it can transmit the shock wave emitted by the shock wave emitter 4 to the fitting position between the outer balloon 1 body and the lesion site 9, thereby ensuring the effect of the drug at the fitting site.

[0070] Considering that the outer balloon 1 is made of silica gel flexible material, in order to balance reducing the impact of the shock wave on the structure of the outer balloon 1, preventing the risk of rupture of the silica gel flexible material, and ensuring the infiltration treatment effect of the shock wave pulse energy on the drug, the rationality of the setting position of the shock wave assembly needs to be considered.

[0071] By disposing the shock wave emitter 4 near the joint position of the outer balloon 1 and the inner balloon 2 and away from the balloon body of the outer balloon 1, the above two factors can be balanced simultaneously to achieve good application.

[0072] The double-layer drug balloon dilation catheter in the present invention can effectively make the surface of the drug balloon fit on the complex and combined stenosis lesion site 9, and at the same time, under the condition of ensuring that the structure of the drug balloon is not affected, enable the drug sprayed on the outer surface of the outer balloon to achieve a good treatment effect.

[0073] Based on the step-by-step pressurization of the double-layer balloon, the pressurization assembly provided at the proximal end of the outer tube 3 in the present invention specifically includes two different setting forms: an integrated pressurization assembly and a split pressurization assembly.

[0074] In an embodiment of the integrated pressurization assembly, the pressurization assembly includes a pressure-dividing knob 5 disposed at the proximal part 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 externally connect to a balloon pressurization device. The pressure-dividing knob 5 is mainly used to control the on-off relationship between the pressurization device and two different pressurization chambers inside the outer tube 3, and thus selectively implement the pressurization operations of the two balloons step by step.

[0075] The pressure-dividing knob 5 is provided with a pressure-dividing channel 51. By rotating the pressure-dividing knob 5, the on-off state between the pressure-dividing channel 51 and the outer balloon pressurization chamber 32 can be controlled.

[0076] Specifically, the pressure-dividing knob 5 includes a pressure-dividing channel 51 and a filling channel 52 corresponding to the pressure-dividing channel 51. The filling channel 52 remains in a communicating state with the proximal pressurization device, while the pressure-dividing channel 51 can correspond to the outer balloon pressurization chamber 32 during the rotation of the pressure-dividing knob 5.

[0077] Thus, during the switching operation of rotating the pressure-dividing knob 5, the on-off control between the pressurization device and the outer balloon pressurization chamber 32 inside the outer tube 3 can be controlled.

[0078] In the present invention, the volume of the inner balloon pressurization chamber 31 inside the outer tube 3 is larger than the volume of the outer balloon pressurization chamber 32. Generally speaking, during the pressurization process, first, by completely connecting the filling channel 52 of the pressure-dividing knob 5 with the cavity of the inner balloon pressurization chamber 31, the inner balloon 2 is expanded under the action of a relatively high filling pressure, constituting the basic expansion space for the secondary expansion of the outer balloon 1.

[0079] Then, by rotating the pressure-dividing knob 5, the pressure-dividing channel 51 of the pressure-dividing knob 5 is connected to the cavity of the outer balloon pressurization chamber 32, and at the same time, the connection between the filling channel 52 and the inner balloon pressurization chamber 31 is maintained, so that the inner balloon 2 remains in a pressurized state with a relatively high filling pressure. Based on the expanded state formed by the previous pressurization of the inner balloon 2 and the flexible silicone material included in the outer balloon 1, the outer balloon 1 is expanded by a relatively low pressure-divided filling pressure. At the same time, compared with Figure 5 the poor balloon wall attachment state of the existing balloon shown, the flexible outer balloon 1 body can be adaptively and completely attached to the lesion site 9. See Figure 6 , thereby ensuring the attachment area between the outer balloon 1 and the lesion site 9. Further combined with the shock wave emitted by the shock wave assembly, the drug can penetrate into the inner membrane of the lesion site 9, and under the action of the pulsating impact energy, the drug can exert a good therapeutic effect.

[0080] In the present 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. When the rated bursting pressure of the inner balloon 2 is set at 6-12 atm, the preset pressure of the outer balloon 1 is in the range of 1-4 atm, and at this time, the pressurization value of the externally connected balloon inflation device is 7-16 atm.

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

[0082] In order to facilitate the connection of different pressurization pipes, 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 inflation interface for the inner balloon 2 and an inflation interface for the outer balloon 1. The inflation interface for the inner balloon 2 is communicated with the inner balloon pressurization cavity 31, and the inflation interface for the outer balloon 1 is communicated with the outer balloon pressurization cavity 32.

[0083] In the specific connection process, the outer balloon pressurization pipe 71 and the inflation interface for the outer balloon 1 are hermetically connected through a Luer connector, and the inner balloon pressurization pipe 72 and the inflation interface for the inner balloon 2 are hermetically connected through a Luer connector, which is conducive to the hermetic pressurization operation after connection.

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

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

[0086] Specifically, the electromagnetic three-way valve 74 is mainly used to control the overall filling on-off state of the pressurization assembly, and to switch and control the flow direction of the liquid filling medium to different pressurization pipes, so as to control the switching of 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] Through this kind of pipeline connection method and the setting of the electromagnetic three-way valve 74, it is possible to block or introduce the overall input of the liquid filling medium by closing or opening the middle inlet of the electromagnetic three-way valve 74.

[0089] Meanwhile, by controlling the opening and closing of the two branch outlets of the electromagnetic three-way valve 74, targeted step-by-step pressurization and expansion of different balloons are carried out.

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

[0091] During the specific pressurization process, by setting the filling pressures of different balloons in the control system, the pressure sensors 77 can transmit the real-time detected pressure values to the control system, and the control system switches the on-off states of the two branch outlets according to the preset filling pressures of different balloons.

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

[0093] During the pressurization control process, first, the control system controls to open the middle inlet of the electromagnetic three-way valve 74, and at the same time opens the branch outlet corresponding to the inner balloon pressurization tube 72 and the second pressurization solenoid valve 76 to pressurize the inner balloon 2. When the preset pressure of the inner balloon 2 is detected by the pressure sensor 77 on the inner balloon pressurization tube 72, the branch outlet and the second pressurization solenoid valve 76 are disconnected to maintain the pressurized 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 preset pressure of the outer balloon 1 is detected by the pressure sensor 77 on the outer balloon pressurization tube 71, the branch outlet and the first pressurization solenoid valve 75 are disconnected to complete the pressurization process.

[0094] Through the double-layer drug balloon dilation catheter with a split pressurization component in the present invention, automatic pressurization can be achieved, and automatic switching and on-off control of different pressurization tubes can be maintained, effectively improving the operation efficiency.

[0095] In order to minimize the influence of the pulse energy of the shock wave on the structure of the outer balloon 1, it is necessary to set different materials for different regions of the outer balloon 1.

[0096] The outer balloon 1 of the present invention includes an outer balloon proximal section 11, an outer balloon distal section 12, and an outer balloon body section 13. Furthermore, since the outer balloon 1 fits the lesion 9 primarily in the balloon body of the outer balloon 1, the hardness of the outer balloon proximal section 11 and the outer balloon distal section 12 is greater than the hardness of the outer balloon body section 13. This enables the outer balloon proximal section 11 and the outer balloon distal section 12 to withstand greater inflation pressure while protecting the outer balloon body section 13 in the inflated state.

[0097] As mentioned above, the filling pressure of the inner balloon 2 is much greater than that of the outer balloon 1, and it is necessary to consider making the outer balloon 1 undergo necessary expansion and deformation under a smaller filling pressure to ensure the expansion and fitting state of the outer balloon body section 13. By making the hardness of the inner balloon 2 greater than the hardness of the outer balloon proximal cone section 11 and the outer balloon distal cone section 12, the outer balloon proximal cone section 11 and the outer balloon distal cone section 12 can be expanded and deformed under a smaller filling pressure, while driving the outer balloon body section 13 to expand and move radially outward, which is beneficial to the fitting of the outer balloon body section 13 to the lesion site 9.

[0098] During the specific processing and manufacturing process, the materials of the inner balloon 2, the outer balloon proximal cone section 11 and the outer balloon distal cone section 12 include one or more of polyamide, Pebax or nylon materials, and the material of the outer balloon body section 13 includes silicone material, 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 an inner balloon proximal cone section 21 , an inner balloon distal cone section 22 and an inner balloon body section 23 .

[0100] A guide wire tube 8 is connected to the inner side of the inner balloon 2, and the inner balloon proximal cone section 21 and the inner balloon distal cone section 22 are respectively connected to the guide wire tube 8, and the proximal end of the inner balloon proximal cone section 21 and the distal end of the inner balloon distal cone section 22 are respectively provided with an inner balloon connecting section 24 of at least a certain length.

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

[0102] Specifically, the inner balloon connecting section 24 is wrapped around and connected to the outside of the guide wire tube 8 to achieve the assembled connection between the inner balloon 2 and the guide wire tube 8 .

[0103] The proximal part of the proximal conical section 11 of the outer balloon and the distal part of the distal conical section 12 of the outer balloon are respectively connected to the inner balloon connection sections 24 located on both sides of the inner balloon 2, realizing the assembly connection between the inner balloon 2 and the outer balloon 1.

[0104] By connecting the shock wave emitter 4 to the radially outer side of the inner balloon connection section 24, it can be made far away from the balloon body of the double-layer balloon, especially the outer balloon, reducing the destructive impact of the pulse energy of the shock wave on the outer balloon body section. At the same time, based on the liquid pressure medium between the inner balloon 2 and the outer balloon 1, the shock wave can be transmitted to the fitting position between the outer balloon and the lesion site 9, enhancing the therapeutic effect of the drug on the lesion site 9.

[0105] Based on the fact that the hardness of the proximal conical section 11 of the outer balloon and the distal conical section 12 of the outer balloon is greater than that of the outer balloon body section 13, the two conical sections can withstand the impact of the pulse energy of the shock wave. At the same time, in order to enable the two conical sections to form a protection for the outer balloon body section 13, relative to the axial direction of the dilation catheter, the axial length of the proximal conical section 11 of the outer balloon is not less than the axial length of the proximal inner balloon connection section 24, and the axial length of the distal conical section 12 of the outer balloon is not less than the axial length of the distal inner balloon connection section 24. Combined with the installation of the shock wave emitter 4 on the inner balloon connection section 24, the proximal conical section 11 of the outer balloon and the distal conical section 12 of the outer balloon can respectively cover the installation area of the shock wave emitter 4 in a semi-surrounding 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 section 13 can be reduced, effectively protecting the outer balloon body section 13 with higher flexibility and lower strength.

[0106] In order to ensure the action efficiency of the shock wave, the shock wave emitter 4 includes a plurality of symmetrically arranged on both axial sides of the inner balloon 2, and are respectively arranged near the proximal connection part of the proximal conical section 11 of the outer balloon and the distal connection part of the distal conical section 12 of the outer balloon. That is to say, the shock wave emitter 4 is made fully far away from the outer balloon body section 13 located in the middle, taking into account the protection of the outer balloon body section 13 and the action efficiency of the shock wave.

[0107] The shock wave emitter 4 specifically includes a shock wave electrode 41 and a connection wire 42. The connection wire 42 of the shock wave electrode 41 located at the distal end of the inner balloon 2 is attached and connected to the outer side walls of the inner balloon 2 and the inner balloon connection section 24, and converges with the connection 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 leading the connecting wire 42 out of the wire cavity of the outer tube 3, it can be connected to the externally arranged 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 meet the dual factors of maintaining the normal effect of the shock wave while taking into account the protection of the outer balloon body segment 13 and effectively acting on the lesion site 9.

[0109] Two developing rings 25 are provided inside the inner balloon 2 on the guide wire tube 8 , which can control and adjust the relative position of the double-layer drug balloon dilatation catheter and the lesion 9 through external real-time monitoring.

[0110] A hypotube is also connected to the proximal end of the outer tube 3 to provide a driving force during the delivery process. The drugs coated on the outer surface of the outer balloon 1 include paclitaxel or rapamycin, and no dispersants or other ingredients are added to avoid allergies and other discomfort / injury to patients caused by dispersants.

[0111] It should be noted that, unless there is any 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 the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. A double-layer drug balloon dilation catheter, characterized in that, It includes a double-layer balloon, the double-layer balloon includes an outer balloon and an inner balloon, the outer balloon includes a flexible drug balloon, and the inner balloon includes a pressurized support balloon; The double-layer balloon is connected to an outer tube, the outer tube includes an inner balloon pressurization chamber and an outer balloon pressurization chamber, a buffer chamber is provided between the outer balloon pressurization chamber and the outer balloon, and a pressurization assembly is provided at the proximal end of the outer tube; The outer balloon includes a frosted surface on the outer surface, and the sprayed drug adheres to the frosted surface; A shock wave emitter is provided between the outer balloon and the inner balloon, and the shock wave emitter is provided near the connection part of the outer balloon and the inner balloon and away from the balloon body of the outer balloon.

2. The double-layer drug balloon dilation catheter according to claim 1, wherein, The pressurization assembly includes a pressure dividing knob provided at the proximal part of the outer tube, a locking cap is connected to the proximal end of the pressure dividing knob, and the locking cap is used for externally connecting a balloon pressurization device.

3. The double-layer drug balloon dilation catheter according to claim 2, wherein, The pressure dividing knob is provided with a pressure dividing channel, and by rotating the pressure dividing knob, the on-off state of the pressure dividing channel and the outer balloon pressurization chamber can be controlled.

4. The double-layer drug balloon dilation catheter according to claim 1, wherein, The pressurization assembly includes a pressurization pipeline and a pressurization valve group, the pressurization pipeline includes an outer balloon pressurization pipe and an inner balloon pressurization pipe, the proximal end of the outer tube is connected to a Y-shaped handle, and the outer balloon pressurization pipe and the inner balloon pressurization pipe are respectively connected to the two pressurization interfaces of the Y-shaped handle.

5. The double-layer drug balloon dilation catheter according to claim 4, wherein The pressurization pipeline further includes a pressurization main pipe, a locking cap is connected to the proximal end of the pressurization main pipe, and the locking cap is used for externally connecting a balloon pressurization device; The pressurization valve group includes an electromagnetic three-way valve provided on the pressurization main pipe, and a first pressurization solenoid valve and a second pressurization solenoid valve respectively provided on the outer balloon pressurization pipe and the inner balloon pressurization pipe; The pressurization main pipe is connected to the middle inlet of the electromagnetic three-way valve, and the outer balloon pressurization pipe and the inner balloon pressurization pipe are respectively connected to the two branch outlets of the electromagnetic three-way valve; Pressure sensors are respectively provided on the outer balloon pressurization pipe and the inner balloon pressurization pipe, and the pressure sensors, the electromagnetic three-way valve, the first pressurization solenoid valve and the second pressurization solenoid valve are respectively electrically connected to a control system.

6. The double-layer drug balloon dilation catheter according to claim 1, wherein The outer balloon includes an outer balloon proximal conical section, an outer balloon distal conical section and an outer balloon body section; The hardness of the outer balloon proximal conical section and the outer balloon distal conical section is greater than the hardness of the outer balloon body section; The hardness of the inner balloon is greater than the hardness of the outer balloon proximal conical section and the outer balloon distal conical section; The materials of the inner balloon, the outer balloon proximal conical section and the outer balloon distal conical section include one or more of polyamide, Pebax or nylon materials, and the material of the outer balloon body section includes silicone material.

7. The double-layer drug balloon dilation catheter according to claim 6, wherein The inner balloon includes an inner balloon proximal conical section, an inner balloon distal conical section and an inner balloon body section; A guide wire tube is inserted through the inside of the inner balloon. The proximal conical section and the distal conical section of the inner balloon are respectively connected to the guide wire tube, and at least one section of the inner balloon connection section is provided at the proximal end of the proximal conical section of the inner balloon and the distal end of the distal conical section of the inner balloon. The inner balloon connection section is wrapped and connected to the guide wire tube. The proximal part of the proximal conical section of the outer balloon and the distal part of the distal conical section of the outer balloon are respectively connected to the inner balloon connection sections on both sides of the inner balloon. The shock wave emitter is connected to the radially outer side of the inner balloon connection section.

8. The double-layer drug balloon dilation catheter according to claim 7, wherein Relative to the axial direction of the dilation catheter, the axial length of the proximal conical section of the outer balloon is not less than the axial length of the inner balloon connection section at the proximal end, and the axial length of the distal conical section of the outer balloon is not less than the axial length of the inner balloon connection section at the distal end. The shock wave emitter includes a plurality of symmetrically arranged on both axial sides of the inner balloon and is respectively arranged near the proximal connection part of the proximal conical section of the outer balloon and the distal connection part of the distal conical section of the outer balloon.

9. The double-layer drug balloon dilation catheter according to claim 7, wherein The shock wave emitter includes a shock wave electrode and a connecting wire. The connecting wire of the shock wave electrode at the distal end of the inner balloon is attached and connected to the outer side walls of the inner balloon and the inner balloon connection section, and converges with the connecting wire of the shock wave electrode at the proximal end of the inner balloon and is then led out through the wire cavity of the outer tube.

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

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