A drug-eluting balloon catheter system with vibration

Abstract

The present invention discloses a drug-eluting balloon catheter system with vibration. The system includes an elongate member and an inflatable balloon. The interior of the balloon is hollow and provided with a vibration structure unit. The outer surface of the balloon is covered with a drug. When the balloon is inflated, the drug covered on the surface contacts the blood vessel wall and enters a vibrating state. A lumen is provided in the elongate member, and the lumen communicates with the interior of the balloon and is filled with gas or liquid. Preferably, it further includes a vibration source based on ultrasonic wave or electrohydraulic effect. When the balloon is in an inflated state, the drug on the surface of the balloon will closely adhere to the blood vessel wall, and then the vibration promotes the absorption of the drug. The present invention can enable the drug of the drug-eluting balloon to be better and faster absorbed by the human blood vessel wall, improving the treatment effect.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a drug-eluting balloon catheter system with vibration. Background Art

[0002] Cardiovascular stenosis is one of the main causes of coronary heart disease. Percutaneous Coronary Intervention (PCI) is an important means for treating cardiovascular stenosis. In addition, PCI can also be used to treat peripheral vascular diseases, such as carotid artery stenosis, Budd-Chiari syndrome, deep vein thrombosis, upper and lower limb artery stenosis, hemoptysis, gastrointestinal bleeding, etc. With the increasing number of stents used, the problem of in-stent restenosis (ISR) has become increasingly serious. 5-60% of the treated patients will have vascular restenosis in the short and medium term, which severely restricts the development of PCI. In addition,

[0003] As a minimally invasive treatment method, endovascular interventional diagnosis and treatment has developed rapidly in recent years with the progress of imaging equipment and the introduction and improvement of new interventional devices. Through endovascular interventional treatment, doctors can already handle more and more complex lesions, with an increasing number of clinical cases and a wider range of diseases involved.

[0004] Particularly, in recent years, a new technology for preventing vascular restenosis after interventional treatment - drug balloon - has emerged. It is a technology that coats an anti-vascular intimal hyperplasia drug on the surface of the balloon. When the balloon reaches the blood vessel wall at the lesion site, the balloon is inflated and contacts the intima of the blood vessel wall, and then the drug is released into the local blood vessel wall. The drug plays an anti-vascular intimal hyperplasia role locally, thereby preventing restenosis after vascular intervention. Research on its clinical application shows that the drug balloon has good curative effects when treating ISR lesions, and can be used to treat small vessel lesions, bifurcation lesions, some primary lesions of tubular arteries, and patients who cannot tolerate or are not suitable for long-term oral administration of dual antiplatelet drugs.

[0005] Since the drug balloon blocks blood flow when it is in an inflated state, how to improve the absorption speed and absorption effect of the drug is very crucial and necessary for the drug-eluting balloon treatment.

[0006] Therefore, those skilled in the art are committed to developing a drug-eluting balloon catheter system with vibration to solve the problem of poor drug absorption effect of the balloon in the prior art. Summary of the Invention

[0007] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is how to improve the absorption speed and absorption effect of the drug on the balloon surface.

[0008] To achieve the above object, the present invention provides a drug-eluting balloon catheter system with vibration, the system comprising an elongate member and an inflatable balloon;

[0009] The interior of the balloon is hollow and provided with a vibration structure unit, and the outer surface of the balloon is covered with a drug. When the balloon is filled and inflated, the drug on the surface comes into contact with the blood vessel wall, and the balloon enters a vibration state;

[0010] The elongate member has a lumen therein, the lumen communicating with the interior of the balloon and filled with a gas or a liquid.

[0011] Further, the vibration structure unit includes: an ultrasonic vibration or a hydrodynamic cavitation vibration structure.

[0012] Further, the balloon is filled with one or both of a contrast agent or a physiological saline solution to inflate the balloon.

[0013] Further, when the vibration structure unit is a hydrodynamic cavitation vibration structure, the interior of the balloon contains a discharge electrode.

[0014] Further, the discharge electrode is connected to an external voltage pulse through the elongate member, and a discharge channel can be generated between the discharge electrodes.

[0015] Further, during the vibration state, the balloon continuously maintains an inflated state.

[0016] Further, the duration of the inflated state of the balloon is 10 to 180 seconds.

[0017] Further, when the vibration structure unit is an ultrasonic vibration structure, the interior of the balloon further contains a transducer for converting electrical energy into ultrasonic vibration.

[0018] Further, the drug includes paclitaxel or sirolimus.

[0019] Further, the drug is provided to be sprayed on the surface of the balloon to form a drug coating, and the concentration of the drug coating is 0.1 to 6 μg / mm 2 .

[0020] By adding a vibration structure to the structure of the drug-eluting balloon, the present invention can greatly improve the absorption speed and effect of the drug after the drug on the surface of the balloon closely adheres to the blood vessel wall.

[0021] The following will further illustrate the concept, specific structure and technical effects of the present invention with reference to the accompanying drawings to fully understand the purpose, features and effects of the present invention. Description of the Drawings

[0022] Figure 1 is a schematic structural view of a drug - eluting balloon catheter system according to a preferred embodiment of the present invention;

[0023] Figure 2 is a schematic structural view of a drug - eluting balloon catheter system according to another preferred embodiment of the present invention. Detailed implementation manners

[0024] The following introduces multiple preferred embodiments of the present invention with reference to the accompanying drawings of the specification to make its technical content clearer and easier to understand. The present invention can be embodied in many different forms of embodiments, and the protection scope of the present invention is not limited to the embodiments mentioned in the text.

[0025] In the drawings, components with the same structure are denoted by the same numerical reference signs, and components with similar structures or functions everywhere are denoted by similar numerical reference signs. The size and thickness of each component shown in the drawings are arbitrarily shown, and the present invention does not limit the size and thickness of each component. To make the illustration clearer, the thickness of some parts in the drawings is appropriately exaggerated.

[0026] As Figure 1 shown is a schematic structural view of a drug - eluting balloon catheter system according to a preferred embodiment of the present invention, which includes a balloon 1, an elongate member 2, and a vibration structure unit 4.

[0027] The balloon 1 is configured as an expandable balloon, especially an expandable balloon for angioplasty, made of block polyether amide resin or nylon. Among them, block polyether amide resin (Pebax) is a nylon elastomer material with excellent performance and is very suitable for application in the medical device field, especially the drug - inflated balloon in angioplasty. The surface of the balloon 1 is covered with a drug, and the drug includes paclitaxel, rapamycin, etc., which are mainly used for cardiovascular treatment. Drugs such as paclitaxel are applied by spraying technology to form a drug coating on the surface of the balloon, and the concentration of the drug coating is 0.1 to 6 μg / mm 2 , preferably the concentration of the drug coating is 3 μg / mm 2 .

[0028] When the balloon 1 is filled and inflated, the drug on the surface will be in close contact with the blood vessel wall 3, achieving the effect of releasing the drug to the blood vessel wall. When the balloon 1 is filled and inflated, it will enter a vibrating state, and vibration can accelerate the diffusion and absorption of the drug, improving the treatment effect.

[0029] The slender member 2 is a hollow tubular structure, which is partially arranged inside the balloon 1. The lumen of the slender member 2 is connected with the inside of the balloon 1 and can be filled with gas or liquid. In this specific preferred embodiment, the vibration structure unit 4 adopts an ultrasonic vibration structure, which can be specifically an ultrasonic transducer, which can convert ultrasonic waves into high-frequency mechanical vibrations. Without affecting the effect, other structures based on the ultrasonic principle or other structures based on the principle of liquid-electric effect can also be used. The function of the slender member 2 is to wrap and protect the conductive wire, and conduct the external vibration source into the vibration structure unit 4, such as conducting external electrical energy to the transducer to generate high-frequency mechanical vibrations, such as ultrasonic vibrations.

[0030] Furthermore, the slender member 2 may include an inner lumen tube, a distal tube, a transition tube, a sea wave tube, a stress support structure and a handle, etc. The inner lumen tube is mainly placed inside the balloon 1, the distal tube is used to connect the inner lumen tube and the transition tube, and the sea wave tube is used to connect the transition tube and the stress support structure.

[0031] When the balloon 1 enters the designated position of the blood vessel, the balloon 1 can be inflated and expanded by injecting contrast solution or saline or a mixture of the two. Since the drug balloon will block the blood flow when it is in an expanded and inflated state, otherwise it may cause myocardial ischemia, the continuous filling time of the balloon 1 in the present invention is set to no more than 40 seconds.

[0032] exist Figure 2 , a schematic diagram of the structure of a drug eluting balloon catheter system of another preferred embodiment of the present invention is shown. Vibration can be generated based on the hydroelectric effect. In this case, an electrode pair 5 needs to be arranged inside the balloon and the balloon is filled with liquid. The electrode pair 5 includes at least one positive electrode and one negative electrode, and there is a gap between the positive electrode and the negative electrode. The slender member is used to transmit the voltage pulse generated by the external power supply to the electrode pair 5. Under the action of the high voltage and strong electric field, the electrons in the liquid between the electrodes are accelerated and ionize the liquid molecules near the electrodes, thereby forming a discharge channel between the electrode pair 5 and the liquid is broken down. The generation of the discharge current causes the liquid to vaporize and expand, thereby generating vibration.

[0033] The electrode pair 5 can be attached to the surface of the slender member, and can be set along the extension direction of the slender member or in a vertical direction. When set along the extension direction of the slender member, the diameter of the slender member can be well controlled to expand the application scenario.

[0034] The vibration state of the balloon can be that after the balloon remains in a fully inflated state, by adjusting an external control source, the vibration frequency and vibration time of the balloon are controlled to cause small-amplitude and high-frequency vibrations on the balloon surface. In addition, the shape of the balloon can be designed to have a concave structure. Using a design with a concave structure can prevent the blood vessels from being continuously blocked and ensure blood supply to organs such as the myocardium. However, this mode cannot ensure that the balloon surface continuously adheres to the blood vessel wall.

[0035] In addition, the system of the present invention can also include various control circuits or add sensors, etc. For example, a temperature sensor is provided on the surface or inside of the drug balloon, and the upper and lower limits of the temperature are set in cooperation with an external control circuit. When the temperature is too high, the generation of the heat source can be cut off to protect the blood vessel tissue from being damaged by the heat source generated by the vibration structure unit.

[0036] An amplitude sensor can also be provided to monitor and detect the vibration amplitude, and cooperate with an external control circuit to control the vibration amplitude and frequency. When it is detected that the vibration amplitude is too large or the frequency is too fast, the input of the vibration source or the output of the vibration structure unit can be reduced to prevent damage to the cardiovascular wall caused by vibration. When it is detected that the vibration amplitude becomes smaller or the frequency is on the low side, the input of the vibration source or the output of the vibration structure unit can be increased to prevent poor drug absorption due to insufficient vibration.

[0037] The control circuit can be controlled by the feedback circuit and CPU or MCU attached to the system of the present invention itself to achieve the functions of portability and light weight. It can also be connected to an external device through a transfer socket provided in the system, and various parameters and instructions are controlled through the external device to achieve diversified functions and precise control, and obtain a wider application range.

[0038] The preferred specific embodiments of the present invention have been described in detail above. It should be understood that those of ordinary skill in the art can make many modifications and variations based on the concept of the present invention without creative labor. Therefore, all technical solutions that can be obtained by those skilled in the art in the technical field of the present invention through logical analysis, reasoning or limited experiments based on the concept of the present invention on the basis of the prior art should be within the protection scope determined by the claims.

Claims

1. A drug-eluting balloon catheter system with vibration, characterized in that, The system includes an elongated member and an inflatable balloon; The interior of the balloon is hollow and is provided with a vibration structure unit. The outer surface of the balloon is covered with a drug. When the balloon is filled and inflated, the drug on the surface contacts the blood vessel wall, and the balloon enters a vibration state; The elongated member has a lumen therein, and the lumen communicates with the interior of the balloon and is filled with gas or liquid; the vibration structure unit is a liquid-electric effect vibration structure. Electrodes are arranged inside the balloon. The elongated member is used to conduct the voltage pulse generated by an external power source to the electrodes, and the balloon is filled with liquid, so that a discharge channel is formed between the electrodes, and the generated discharge current vaporizes and expands the liquid, thereby generating vibration; The electrodes are attached to the surface of the elongated member and arranged along the extending direction of the elongated member. A temperature sensor is arranged on the surface or inside of the balloon. The shape of the balloon is designed to have a concave structure.

2. The drug-eluting balloon catheter system with vibration according to claim 1, characterized in that, The balloon is filled with one or both of a contrast agent or physiological saline to fill and inflate the balloon.

3. The drug-eluting balloon catheter system with vibration according to claim 1, characterized in that, During the vibration state process, the balloon continuously maintains a filled and inflated state.

4. The drug-eluting balloon catheter system with vibration according to claim 3, characterized in that, The duration of the filled and inflated state of the balloon is 10 to 180 seconds.

5. The drug-eluting balloon catheter system with vibration according to claim 1, wherein The drug includes paclitaxel or rapamycin.

6. The drug-eluting balloon catheter system with vibration according to claim 5, wherein The drug is arranged to be sprayed on the surface of the balloon to form a drug coating, and the concentration of the drug coating is 0.1 to 6 μg / mm 2 .

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