Drug-coated balloon based on built-in ring laser controlled release and coating method thereof

Abstract

The invention relates to the technical field of drug-coated balloons, and provides a drug-coated balloon based on built-in ring laser controlled release, the drug-coated balloon comprises a catheter main body, a balloon, a drug coating, a laser generator, a ring laser optical fiber and an optical fiber speed controller, the balloon is arranged at one end of the catheter main body, the balloon is provided with a developing mark point, and the drug coating is arranged on the developing mark point. The balloon is arranged on one side of the catheter body, the drug coating is arranged on the balloon, the optical fiber speed controller is arranged on the other side of the catheter body, the ring laser optical fiber is arranged between the optical fiber speed controller and the catheter body and between the optical fiber speed controller and the balloon in a penetrating mode, and the laser generator is connected with the end of the optical fiber. The physical state or chemical property of the drug coating is accurately controlled through energy of laser, so that accurate release of drugs is achieved, the utilization rate of the drugs is increased, and the treatment effect is ensured.

Description

Technical Field

[0001] The invention relates to the technical field of drug-coated balloons, and in particular to a drug-coated balloon based on built-in ring laser controlled release and a coating method thereof. Background Art

[0002] Cardiovascular and cerebrovascular diseases have a high incidence rate and high mortality and disability rates, and have become the world's major health threat. Drug-coated balloon angioplasty is one of the important treatment methods. Through interventional surgery, the balloon is delivered to the diseased blood vessel, and then the balloon is expanded to open the narrow and occluded blood vessel, restore blood flow, and stick the drug on the surface of the balloon to the blood vessel wall to inhibit intimal hyperplasia and prevent restenosis of the blood vessel.

[0003] However, the current drug-coated balloons still have deficiencies in terms of controllability and accuracy of drug release. Specifically, due to the insufficient adhesion between the drug coating and the balloon surface, the drug coating is easy to fall off during the balloon folding process, and the drug coating may further rupture, fall off and be washed away by blood during the process of delivery to the lesion and during the expansion stage before contact with the target lesion tissue. Based on this, the present application is specially proposed. Summary of the invention

[0004] The present application proposes a drug-coated balloon and a coating method thereof based on internal ring laser controlled release to solve the technical problems of poor adhesion between the drug coating and the balloon and high loss rate of the drug coating in the prior art. The above technical objectives of the present invention are achieved through the following technical solutions: To achieve the above-mentioned purpose, the technical solution adopted by the present invention is: a drug-coated balloon based on built-in ring laser controlled release, comprising a catheter body, a balloon, a drug coating, a laser generator, a ring laser optical fiber and an optical fiber speed controller, wherein the balloon is arranged at one end of the catheter body, a developing marking point is provided on the balloon, the drug coating is arranged on the balloon, the optical fiber speed controller is arranged on the other side of the catheter body, the ring laser optical fiber is arranged between the optical fiber speed controller and the catheter body and the balloon, and the laser generator is connected to the end of the optical fiber.

[0005] Furthermore, a guide tube is provided through the balloon, and a cavity is provided in the guide tube which is connected with the outside and allows the guide wire and the ring laser optical fiber to pass through.

[0006] Furthermore, the fiber speed controller regulates the retraction speed of the ring laser fiber, and the total time for the ring laser fiber to retract at a uniform speed between the development marks is less than 2 minutes.

[0007] Furthermore, the laser generator is a near-infrared laser generator.

[0008] Furthermore, the drug coating comprises polydopamine, lauric acid and functional drugs.

[0009] Furthermore, the functional drugs in the drug coating include antithrombotic drugs, cell growth inhibitors, immunosuppressants, anti-inflammatory drugs, statins for lowering blood lipids and preventing and treating atherosclerosis, and drugs with endothelial protection function.

[0010] Furthermore, the ring laser fiber is sent into the balloon from the entrance of the guide tube and reaches the development mark point of the balloon. The light will appear as an annular light spot at the exit of the ring laser fiber, and the annular light spot will spread in all directions.

[0011] A coating method thereof, wherein the drug coating is adhered to the balloon surface by co-deposition of polydopamine, lauric acid and functional drugs.

[0012] One or more of the above technical solutions in the embodiments of the present invention have at least the following technical effects or advantages: Through the chemical bonding method, the therapeutic drug is firmly attached to the balloon surface to reduce the loss during the balloon approach. At the same time, based on the technology of built-in ring laser controlled release, the power, irradiation time and position of the laser can be precisely controlled to achieve rapid and targeted release of drugs, improve the transfer rate and utilization of drugs at the lesion site, and ultimately improve the therapeutic effect of balloon catheter dilatation. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0014] Figure 1 A schematic diagram of the structure provided by an embodiment of the present invention; Figure 2 A schematic structural diagram of a balloon is provided for an embodiment of the present invention.

[0015] In the figure: 1. Catheter body; 2. Balloon; 3. Drug coating; 4. Laser generator; 5. Ring laser fiber; 6. Fiber speed controller; 7. Guide tube; 8. Development mark. DETAILED DESCRIPTION

[0016] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to be used to explain the present invention, and should not be construed as limiting the present invention.

[0017] In the description of the present invention, it should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present invention 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 on the present invention.

[0018] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0019] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like 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 a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0020] Please see attached Figure 1-2 A drug-coated balloon based on built-in ring laser controlled release includes a catheter body, a balloon, a drug coating, a laser generator, a ring laser optical fiber and an optical fiber speed controller. The balloon is arranged at one end of the catheter body, a development marking point is provided on the balloon, the drug coating is arranged on the balloon, the optical fiber speed controller is arranged on the other side of the catheter body, the ring laser optical fiber is arranged between the optical fiber speed controller and the catheter body and the balloon, and the laser generator is connected to the end of the optical fiber.

[0021] Using the above technical solution, the catheter body serves as the interface part of the entire device. The catheter body is responsible for connecting the various components together to ensure the integrity and functionality of the entire system. It provides a connection point with external equipment. The balloon is the main carrier for drug release. The balloon can be expanded to a predetermined size under the action of a pressure pump, so that it clings to the blood vessel wall to achieve local release of the drug. The drug coating is set on the surface of the balloon to release the drug when the balloon is expanded. The laser generator is used to activate the ring laser fiber in the balloon when needed to achieve precise controlled release of the drug.

[0022] When the drug needs to be released, the controller activates the laser generator, which transmits the energy to the ring laser fiber inside the balloon through optical fiber. The ring laser fiber will heat up after receiving the laser energy, thereby changing the physical state or chemical properties of the drug coating and achieving precise controlled release of the drug.

[0023] When the catheter is sent into the lesion, the laser generator emits near-infrared laser to the designated position at the far end of the balloon through the optical fiber. Due to the ring laser emitted by the end of the optical fiber, the light forms a ring spot at the optical fiber outlet and spreads around, evenly heating the phase change material (lauric acid) on the balloon surface. As the optical fiber withdraws at a uniform speed between the development marks, the drug coating on the balloon surface changes from solid to liquid under photothermal stimulation, detaches from the balloon and is released to the lesion. This control method ensures the precise release and uniform distribution of the drug.

[0024] In some embodiments, a guide tube is provided through the balloon, and a lumen is provided in the guide tube that is connected to the outside world for the guide wire and the ring laser fiber to pass through. The guide wire is used to guide the catheter to the lesion site, while the ring laser fiber is responsible for the precise release of the drug. The lumen in the guide tube is connected to the outside world, ensuring that the optical fiber and the guide wire can enter and exit smoothly.

[0025] In some embodiments, the fiber speed controller regulates the retraction speed of the ring laser fiber, and the total time for the ring laser fiber to be uniformly retracted between the development marks is less than 2 minutes. The fiber speed controller ensures the uniform release of the drug at the lesion site by precisely regulating the retraction speed of the fiber. During the uniform retraction of the fiber, the annular spot continuously heats the drug coating on the balloon surface, causing it to gradually melt and release into the surrounding tissue. This control method not only improves the release efficiency of the drug, but also reduces drug waste and side effects.

[0026] In some embodiments, the laser generator is a near-infrared laser generator. Near-infrared light has strong penetrating power and can penetrate the drug coating on the balloon surface and the surrounding tissues to directly heat the phase change material lauric acid. Lauric acid, with its low melting point (approximately 44°C), can achieve precise drug release without causing thermal damage to the surrounding tissues. In addition, this process also effectively prevents the deformation of the balloon catheter caused by high temperature.

[0027] In some embodiments, the drug coating includes polydopamine, lauric acid and functional drugs; the functional drugs in the drug coating include antithrombotic drugs, cell growth inhibitors, immunosuppressants, anti-inflammatory drugs, statins for lowering blood lipids and preventing and treating atherosclerosis, drugs with endothelial protection, etc. Polydopamine has super strong adhesion and can firmly load functional drugs on the surface of the balloon. Lauric acid, as a phase change material, can melt and release functional drugs under photothermal stimulation. Functional drugs are selected according to treatment needs, such as antithrombotic drugs, cell growth inhibitors, immunosuppressants, anti-inflammatory drugs, statins for lowering blood lipids and preventing and treating atherosclerosis, drugs with endothelial protection, etc. The design of this composite coating not only improves the loading capacity and stability of the drug, but also realizes the precise release and targeted treatment of the drug.

[0028] In some embodiments, the lauric acid in the drug coating melts at low temperature after being stimulated by the intracavitary ring laser. After the ring laser is withdrawn, the liquid lauric acid solidifies again to form a hydrophobic film on the blood vessel wall. The lauric acid hydrophobic film formed on the blood vessel wall isolates the blood vessel wall from direct contact with the blood, which not only reduces the blood flow washing of the drug attached to the blood vessel wall, but also reduces the exposure of the subendothelial collagen, thereby reducing platelet aggregation, monocyte activation and activation of inflammatory response.

[0029] In some embodiments, the ring laser fiber is sent into the balloon from the entrance of the guide tube and reaches the imaging mark point of the balloon. The light will present a ring light spot at the exit of the ring laser fiber, and the ring light spot will spread in all directions. The ring laser fiber is sent into the balloon through the entrance of the guide tube and accurately reaches the imaging mark point. Under the action of the ring light spot emitted by the end of the fiber, the drug coating on the surface of the balloon is evenly heated and gradually melted. As the fiber is withdrawn, the drug is gradually released to the lesion. This control method ensures the precise release and uniform distribution of the drug, while avoiding drug waste and side effects.

[0030] In some embodiments, a coating method thereof, the drug coating is adhered to the balloon surface by a co-deposition method of polydopamine, lauric acid, and functional drugs. The co-deposition method is a technique for depositing multiple substances on the surface of a substrate at the same time. In this embodiment, polydopamine, lauric acid, and functional drugs are firmly loaded on the balloon surface by a co-deposition method. The adhesion of polydopamine enables the drug coating to fit tightly on the balloon, while lauric acid, as a phase change material, melts under photothermal stimulation and releases the functional drug. This coating method not only increases the loading capacity and stability of the drug, but also achieves precise release and targeted therapy of the drug.

[0031] It should be understood that the above specific embodiments of the present invention are only used to illustrate or explain the principles of the present invention, and do not constitute a limitation of the present invention. Therefore, any modifications, equivalent substitutions, improvements, etc. made without departing from the spirit and scope of the present invention should be included in the protection scope of the present invention. In addition, the appended claims of the present invention are intended to cover all changes and modifications that fall within the scope and boundaries of the appended claims, or the equivalent forms of such scope and boundaries.

Claims

1. A drug-coated balloon based on built-in ring laser controlled release, characterized in that: It comprises a catheter body, a balloon, a drug coating, a laser generator, a ring laser optical fiber and an optical fiber speed controller, wherein the balloon is arranged at one end of the catheter body, a developing mark point is arranged on the balloon, the drug coating is arranged on the balloon, the optical fiber speed controller is arranged at the other side of the catheter body, the ring laser optical fiber is arranged between the optical fiber speed controller, the catheter body and the balloon, and the laser generator is connected to the end of the optical fiber; a guide tube is arranged inside the balloon, and a cavity is arranged inside the guide tube, which is connected to the outside world for the guide wire and the ring laser optical fiber to penetrate; The ring laser fiber is sent into the balloon from the entrance of the guide tube and reaches the development mark point of the balloon. The light will appear as a ring light spot at the exit of the ring laser fiber, and the ring light spot will spread in all directions.

2. The drug-coated balloon based on internal ring laser controlled release according to claim 1, characterized in that: The fiber speed controller regulates the retraction speed of the ring laser fiber, and the total time for the ring laser fiber to retract at a uniform speed between the development marks is less than 2 minutes.

3. The drug-coated balloon based on internal ring laser controlled release according to claim 1, characterized in that: The laser generator is a near-infrared laser generator.

4. The drug-coated balloon based on internal ring laser controlled release according to claim 1, characterized in that: The drug coating comprises polydopamine, lauric acid and functional drugs.

5. The drug-coated balloon based on internal ring laser controlled release according to claim 1, characterized in that: The functional drugs in the drug coating include antithrombotic drugs, cell growth inhibitors, immunosuppressants, anti-inflammatory drugs, statins for lowering blood lipids and preventing and treating atherosclerosis, and drugs with endothelial protection function.

6. A coating method thereof, according to any one of claims 1 to 5, wherein the drug-coated balloon based on internal ring laser controlled release is characterized in that: The drug coating is adhered to the balloon surface by co-deposition of polydopamine, lauric acid and functional drugs.

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