WO2019174100A1 - Vibrating drug-eluting balloon catheter system - Google Patents

Vibrating drug-eluting balloon catheter system Download PDF

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Publication number
WO2019174100A1
WO2019174100A1 PCT/CN2018/083319 CN2018083319W WO2019174100A1 WO 2019174100 A1 WO2019174100 A1 WO 2019174100A1 CN 2018083319 W CN2018083319 W CN 2018083319W WO 2019174100 A1 WO2019174100 A1 WO 2019174100A1
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Prior art keywords
balloon
vibrating
drug
catheter system
balloon catheter
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PCT/CN2018/083319
Other languages
French (fr)
Chinese (zh)
Inventor
盛卫文
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上海心至医疗科技有限公司
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Publication of WO2019174100A1 publication Critical patent/WO2019174100A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10181—Means for forcing inflation fluid into the balloon

Definitions

  • the present invention relates to the field of medical devices, and more particularly to a drug eluting balloon catheter system with vibration.
  • Cardiovascular stenosis is one of the main causes of coronary heart disease, interventional therapy (Percutaneous Coronary Intervention, PCI) is an important means of treating cardiovascular stenosis.
  • PCI can also be used to treat peripheral vascular diseases such as carotid stenosis, Budd-Chiari syndrome, deep vein thrombosis, upper and lower extremity arterial stenosis, hemoptysis, gastrointestinal bleeding.
  • In-stent restenosis in-stent
  • ISR In-stent restenosis
  • 5 to 60% of treated patients will have vascular restenosis in the short and medium term, which severely limits the development of PCI.
  • ISR In-stent restenosis
  • Intravascular interventional diagnosis and treatment as a minimally invasive treatment method has been rapidly developed in recent years with the advancement of imaging equipment and the introduction of new interventional devices. Through vascular interventional therapy, doctors can handle increasingly complex There are more and more cases of lesions and clinical applications, and the types of diseases involved are more and more extensive.
  • the drug acts as an anti-intimal hyperplasia in the local area, thereby preventing restenosis after vascular intervention, and its clinical application research shows that the drug balloon has a good curative effect on the treatment of ISR lesions, and can be used for the treatment of small vessel disease, Bifurcation lesions, primary tubular vascular primary lesions, and patients who are intolerant or unsuitable for long-term oral dual antiplatelet drugs.
  • the drug balloon can block the blood flow when the drug balloon is in an inflated state, how to increase the absorption rate and absorption effect of the drug is very critical and necessary for drug-eluting balloon therapy.
  • 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 surface of the balloon.
  • the present invention provides a vibrating drug eluting balloon catheter system, the system comprising an elongate member and an inflatable balloon;
  • the inside of the balloon is hollow and is provided with a vibrating structural unit, the outer surface of the balloon is covered with a drug, and when the balloon is filled and expanded, the surface-covered drug contacts the blood vessel wall, and the balloon enters a vibrating state. ;
  • the elongated member has a lumen therein that penetrates the interior of the balloon and is filled with a gas or a liquid.
  • the vibration structural unit includes: an ultrasonic vibration or a liquid electric effect vibration structure.
  • the balloon is filled with one or both of a contrast medium or a physiological saline to cause the balloon to expand and expand.
  • the inside of the balloon includes a discharge electrode.
  • the discharge electrode is connected to an external voltage pulse through the elongated member, and a discharge channel may be generated between the discharge electrodes.
  • the balloon continues to remain in a filled and expanded state.
  • the filling and expanding state of the balloon has a duration of 10 to 180 seconds.
  • the inside of the balloon further includes a transducer to convert electrical energy into ultrasonic vibration.
  • the medicament comprises paclitaxel or rapamycin.
  • the drug is configured to be sprayed on the surface of the balloon to form a drug coating having a concentration of 0.1 to 6 ug/mm 2 .
  • the invention can greatly improve the absorption speed and effect of the drug after the drug on the surface of the balloon is closely attached to the blood vessel wall.
  • FIG. 1 is a schematic view showing the structure of a drug eluting balloon catheter system according to a preferred embodiment of the present invention
  • FIG. 2 is a schematic view showing the structure of a drug eluting balloon catheter system according to another preferred embodiment of the present invention.
  • FIG. 1 is a schematic view showing the structure of a drug eluting balloon catheter system according to a preferred embodiment of the present invention, which includes a balloon 1, an elongated member 2, and a vibrating structural unit 4.
  • the balloon 1 is configured as an expansion balloon, in particular an expansion balloon for angioplasty, using a block polyetheramide resin or nylon, wherein the block polyether amide resin (Pebax) is an excellent performance.
  • Nylon elastomer material very suitable for application in the field of medical devices, especially for drug expansion balloons in angioplasty.
  • the surface of the balloon 1 is covered with a drug, and the drug includes paclitaxel, rapamycin, etc., and is mainly used for cardiovascular treatment. Paclitaxel and other drugs are sprayed to form a drug coating on the surface of the balloon.
  • the concentration of the drug coating is 0.1 to 6 ug/mm2, preferably the drug coating concentration is 3. Ug/mm2.
  • the drug on the surface will be in close contact with the blood vessel wall 3 to achieve the effect of releasing the drug to the blood vessel wall.
  • the balloon 1 When the balloon 1 is filled and expanded, it will enter a vibrating state, and the vibration can accelerate the diffusion and absorption of the drug and improve the therapeutic effect.
  • the elongated member 2 is a hollow tubular structure partially disposed inside the balloon 1, and the lumen of the elongated member 2 penetrates the inside of the balloon 1, and can be filled with a gas or a liquid.
  • the vibrating structural unit 4 adopts an ultrasonic vibration structure, and specifically may be an ultrasonic transducer, which can convert ultrasonic waves into high-frequency mechanical vibrations.
  • Other configurations based on the principle of ultrasound or other configurations based on the principle of liquid electrical effects may also be employed without affecting the effect.
  • the function of the elongate member 2 is to wrap and protect the conductive wires, and to conduct external vibration sources into the vibrating structural unit 4, such as conducting external electrical energy to the transducer to generate high frequency mechanical vibrations, such as ultrasonic vibrations and the like.
  • the elongate member 2 may include a lumen tube, a distal tube, a transition tube, a hypotube, a stress support structure and a handle, etc.
  • the lumen tube is mainly placed inside the balloon 1, and the distal tube is used to connect the lumen Tubes and transition tubes, while hypotubes are used to connect transition tubes and stress support structures.
  • the balloon 1 When the balloon 1 enters a designated position of the blood vessel, the balloon 1 can be filled and inflated by injecting a contrast medium or physiological saline or a mixture of the two. Since the drug balloon blocks the blood flow when the drug balloon is in the expanded and filled state, myocardial ischemia may be caused, so the time for the continuous filling of the balloon 1 in the present invention is set to not more than 40 seconds.
  • a schematic view of the structure of a drug eluting balloon catheter system in accordance with another preferred embodiment of the present invention is shown.
  • the vibration can be generated based on the liquid electric effect, in which it is necessary to provide the electrode pair 5 inside the balloon and the liquid in the balloon is filled, the electrode pair 5 includes at least one positive electrode and one negative electrode, and the positive electrode and the negative electrode have gap.
  • the elongated member is used to conduct a voltage pulse generated by an external power source to the electrode pair 5, and under the action of a high voltage strong electric field, electrons in the liquid between the electrodes are accelerated, and ionizes liquid molecules in the vicinity of the electrode, thereby between the electrode pairs 5 A discharge channel is formed and the liquid is broken down.
  • the generation of the discharge current causes the liquid to vaporize and expand, thereby generating vibration.
  • the electrode pair 5 may be attached to the surface of the elongated member, and may be disposed in the extending direction of the elongated member or in the vertical direction.
  • the extending direction of the elongated member is set, the diameter of the elongated member can be well controlled, and the application is expanded. Scenes.
  • the vibration state of the balloon may be that after the balloon is continuously in the state of filling and expanding, the vibration frequency and the vibration time of the balloon are controlled by adjusting the external control source, so that the surface of the balloon vibrates at a small amplitude and high frequency.
  • the shape of the balloon can be designed to have a concave structure. The design with a concave structure can prevent the blood vessels from being continuously blocked, and the blood supply to the organs such as the myocardium can be ensured, but this mode cannot ensure that the surface of the balloon continuously adheres to the blood vessel wall.
  • system of the present invention may also include various control circuits, or ways of adding sensors or the like.
  • a temperature sensor is arranged on the surface or inside the drug balloon, and the upper and lower limits of the temperature are set in conjunction with the external control circuit, the generation of the heat source can be cut off when the temperature is over-temperature to protect the vascular tissue from the heat source generated by the vibration structural unit.
  • the amplitude sensor it is also possible to set the amplitude sensor to realize the monitoring and detection of the vibration amplitude, and the external control circuit to control the amplitude and frequency of the vibration.
  • the input of the vibration source or the vibration structural unit can be reduced.
  • the input of the vibration source or the output of the vibration structural unit can be increased to prevent the absorption of the medicine due to insufficient vibration.
  • the control circuit can be controlled by the system itself by adding a feedback circuit and a CPU or MCU to realize the functions of portability and weight reduction. It is also possible to achieve a wide range of applications by providing a transfer jack in the system, connecting with external devices, and controlling various parameters and commands through external devices to achieve diversification and precise control.

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Abstract

Disclosed is a vibrating drug-eluting balloon catheter system, the system comprising an elongated member (2) and an inflatable balloon (1), wherein the balloon (1) is hollow inside and is provided with a vibration structure unit (4), an outer surface of the balloon (1) is covered by a drug, and when the balloon (1) is inflated, the drug covering the surface is brought into contact with a blood vessel wall (3) and the balloon enters a vibration state; and the elongated member (2) is internally provided with a lumen in communication with the interior of the balloon (1) and which is filled with gas or liquid. Preferably, the drug-eluting balloon catheter system further comprises a vibration source based on an ultrasonic or electrohydraulic effect; after the balloon (1) is in an inflated state, the drug on the surface of the balloon (1) clings to the blood vessel wall (3) and the vibration then faciliates the absorption of the drug. The system enables the drug on the drug-eluting balloon to be better and more quickly absorbed by the blood vessel wall of a human body, and the treatment effect is improved.

Description

一种带振动的药物洗脱球囊导管***  Vibrating drug eluting balloon catheter system
技术领域Technical field
本发明涉及医疗器械领域，尤其涉及一种带振动的药物洗脱球囊导管***。The present invention relates to the field of medical devices, and more particularly to a drug eluting balloon catheter system with vibration.
背景技术Background technique
心血管狭窄是造成冠心病的主要原因之一，介入治疗（Percutaneous Coronary Intervention，PCI）是治疗心血管狭窄的重要手段。此外，PCI还可以用于治疗外周血管疾病，如颈动脉狭窄、布加综合症、深静脉血栓、上下肢动脉狭窄、咯血、消化道出血等。而随着支架使用数量的增加，支架内再狭窄（in-stent restenosis，ISR）问题日益严重，经过治疗的病人5~60%在短、中期会发生血管再狭窄，严重限制了PCI的发展。此外，Cardiovascular stenosis is one of the main causes of coronary heart disease, interventional therapy (Percutaneous Coronary Intervention, PCI) is an important means of treating cardiovascular stenosis. In addition, PCI can also be used to treat peripheral vascular diseases such as carotid stenosis, Budd-Chiari syndrome, deep vein thrombosis, upper and lower extremity arterial stenosis, hemoptysis, gastrointestinal bleeding. In-stent restenosis (in-stent) as the number of stents used increases The problem of restenosis (ISR) is becoming more and more serious. 5 to 60% of treated patients will have vascular restenosis in the short and medium term, which severely limits the development of PCI. In addition,
血管内介入诊断和治疗作为一项微创的治疗方式，近年来随着影像学设备的进步、新型介入器材的引入改进得以快速的发展，通过血管介入治疗，医生已经可以处理越来越复杂的病变，临床应用的病例越来越多，涉及的病种也越来越广泛。Intravascular interventional diagnosis and treatment as a minimally invasive treatment method has been rapidly developed in recent years with the advancement of imaging equipment and the introduction of new interventional devices. Through vascular interventional therapy, doctors can handle increasingly complex There are more and more cases of lesions and clinical applications, and the types of diseases involved are more and more extensive.
特别地，近年来出现了预防介入治疗手术后血管再狭窄的新技术——药物球囊，它是将抗血管内膜增生的药物涂置于球囊表面，当球囊到达病变部位的血管壁时，球囊充盈膨胀并与血管壁内膜接触，再将药物释放至局部血管壁内的技术。药物在局部起到抗血管内膜增生的作用，从而预防血管介入术后再狭窄，而其临床应用方面的研究表明药物球囊处理ISR病变时有着良好的疗效，且可用于治疗小血管病变、分叉病变、部分管状动脉血管原发病变，以及不能耐受或者不适合长期口服双联抗血小板药物的患者。In particular, in recent years, a new technology for preventing vascular restenosis after interventional therapy has been developed, which is a drug balloon that is applied to the surface of the balloon when the balloon reaches the vessel wall of the lesion. At the time, the balloon fills and expands and contacts the intima of the vessel wall, and then releases the drug into the local vessel wall. The drug acts as an anti-intimal hyperplasia in the local area, thereby preventing restenosis after vascular intervention, and its clinical application research shows that the drug balloon has a good curative effect on the treatment of ISR lesions, and can be used for the treatment of small vessel disease, Bifurcation lesions, primary tubular vascular primary lesions, and patients who are intolerant or unsuitable for long-term oral dual antiplatelet drugs.
由于当药物球囊处于膨胀充盈的状态时，药物球囊会阻断血流，如何提高药物的吸收速度和吸收效果，对于药物洗脱球囊治疗术而言是非常关键且必要的。Since the drug balloon can block the blood flow when the drug balloon is in an inflated state, how to increase the absorption rate and absorption effect of the drug is very critical and necessary for drug-eluting balloon therapy.
因此，本领域的技术人员致力于开发一种带振动的药物洗脱球囊导管***，已解决现有技术中球囊药物吸收效果不佳的问题。Accordingly, those skilled in the art are directed to the development of a vibrating drug eluting balloon catheter system that solves the problem of poor absorption of the balloon drug in the prior art.
发明内容Summary of the invention
有鉴于现有技术的上述缺陷，本发明所要解决的技术问题是如何提高球囊表面药物的吸收速度和吸收效果。In view of the above drawbacks 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 surface of the balloon.
为实现上述目的，本发明提供了一种带振动的药物洗脱球囊导管***，所述***包括细长构件和可膨胀的球囊；To achieve the above object, the present invention provides a vibrating drug eluting balloon catheter system, the system comprising an elongate member and an inflatable balloon;
所述球囊内部为中空并设置有振动结构单元，所述球囊的外部表面覆盖有药物，当所述球囊充盈膨胀后，表面覆盖的药物与血管壁接触，所述球囊进入振动状态；The inside of the balloon is hollow and is provided with a vibrating structural unit, the outer surface of the balloon is covered with a drug, and when the balloon is filled and expanded, the surface-covered drug contacts the blood vessel wall, and the balloon enters a vibrating state. ;
所述细长构件内具有管腔，所述管腔与所述球囊的内部相贯通，并填充气体或液体。The elongated member has a lumen therein that penetrates the interior of the balloon and is filled with a gas or a liquid.
进一步地，所述振动结构单元包括：超声波振动或者液电效应振动结构。Further, the vibration structural unit includes: an ultrasonic vibration or a liquid electric effect vibration structure.
进一步地，所述球囊内填充造影液或生理盐水中的一种或两种，使所述球囊充盈膨胀。Further, the balloon is filled with one or both of a contrast medium or a physiological saline to cause the balloon to expand and expand.
进一步地，所述振动结构单元为液电效应振动结构时，所述球囊内部包含有放电电极。Further, when the vibration structural unit is a liquid electric effect vibration structure, the inside of the balloon includes a discharge electrode.
进一步地，所述放电电极通过所述细长构件与外部电压脉冲连接，所述放电电极之间可产生放电通道。Further, the discharge electrode is connected to an external voltage pulse through the elongated member, and a discharge channel may be generated between the discharge electrodes.
进一步地，在所述振动状态过程中，所述球囊持续保持充盈膨胀状态。Further, during the vibration state, the balloon continues to remain in a filled and expanded state.
进一步地，所述球囊的充盈膨胀状态的持续时间为10至180秒。Further, the filling and expanding state of the balloon has a duration of 10 to 180 seconds.
进一步地，所述振动结构单元为超声波振动结构时，所述球囊内部还包含有换能器，将电能转换为超声波振动。Further, when the vibration structural unit is an ultrasonic vibration structure, the inside of the balloon further includes a transducer to convert electrical energy into ultrasonic vibration.
进一步地，所述药物包括紫杉醇或雷帕霉素。Further, the medicament comprises paclitaxel or rapamycin.
进一步地，所述药物被设置为喷涂在所述球囊表面，形成药物涂层，所述药物涂层的浓度为0.1至6ug/mm2。Further, the drug is configured to be sprayed on the surface of the balloon to form a drug coating having a concentration of 0.1 to 6 ug/mm 2 .
本发明通过在药物洗脱球囊的结构中增加振动结构，可以在球囊表面的药物紧贴血管壁后，大大提高药物的吸收速度和效果。By increasing the vibration structure in the structure of the drug eluting balloon, the invention can greatly improve the absorption speed and effect of the drug after the drug on the surface of the balloon is closely attached to the blood vessel wall.
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明，以充分地了解本发明的目的、特征和效果。The concept, the specific structure and the technical effects of the present invention will be further described in conjunction with the accompanying drawings in order to fully understand the objects, features and effects of the invention.
附图说明DRAWINGS
图1是本发明的一个较佳实施例的药物洗脱球囊导管***的结构示意图；1 is a schematic view showing the structure of a drug eluting balloon catheter system according to a preferred embodiment of the present invention;
图2是本发明的另一个较佳实施例的药物洗脱球囊导管***的结构示意图。2 is a schematic view showing the structure of a drug eluting balloon catheter system according to another preferred embodiment of the present invention.
具体实施方式detailed description
以下参考说明书附图介绍本发明的多个优选实施例，使其技术内容更加清楚和便于理解。本发明可以通过许多不同形式的实施例来得以体现，本发明的保护范围并非仅限于文中提到的实施例。The preferred embodiments of the present invention are described in the following description with reference to the accompanying drawings, in which The invention may be embodied in many different forms of embodiments, and the scope of the invention is not limited to the embodiments disclosed herein.
在附图中，结构相同的部件以相同数字标号表示，各处结构或功能相似的组件以相似数字标号表示。附图所示的每一组件的尺寸和厚度是任意示出的，本发明并没有限定每个组件的尺寸和厚度。为了使图示更清晰，附图中有些地方适当夸大了部件的厚度。In the drawings, structurally identical components are denoted by the same reference numerals, and structural or functionally similar components are denoted by like reference numerals. The dimensions and thickness of each component shown in the drawings are arbitrarily shown, and the invention does not limit the size and thickness of each component. In order to make the illustration clearer, some parts of the drawing appropriately exaggerate the thickness of the parts.
如图1所示为本发明的一个较佳实施例的药物洗脱球囊导管***的结构示意图，其中包括球囊1、细长构件2和振动结构单元4。1 is a schematic view showing the structure of a drug eluting balloon catheter system according to a preferred embodiment of the present invention, which includes a balloon 1, an elongated member 2, and a vibrating structural unit 4.
球囊1被设置为扩张球囊，特别是一种用于血管成形术的扩张球囊，采用嵌段聚醚酰胺树脂或者尼龙，其中嵌段聚醚酰胺树脂（Pebax）是一种性能优良的尼龙弹性体材料，非常适合应用在医疗器械领域，特别是血管成形术中的药物膨胀球囊。球囊1的表面覆盖有药物，药物包括自紫杉醇、雷帕霉素等，主要用于心血管的治疗。紫杉醇等药物是采用喷涂技术，在球囊的表面形成药物涂层，药物涂层的浓度为0.1至6ug/mm2，优选地药物涂层浓度为3 ug/mm2。The balloon 1 is configured as an expansion balloon, in particular an expansion balloon for angioplasty, using a block polyetheramide resin or nylon, wherein the block polyether amide resin (Pebax) is an excellent performance. Nylon elastomer material, very suitable for application in the field of medical devices, especially for drug expansion balloons in angioplasty. The surface of the balloon 1 is covered with a drug, and the drug includes paclitaxel, rapamycin, etc., and is mainly used for cardiovascular treatment. Paclitaxel and other drugs are sprayed to form a drug coating on the surface of the balloon. The concentration of the drug coating is 0.1 to 6 ug/mm2, preferably the drug coating concentration is 3. Ug/mm2.
当球囊1充盈膨胀后，表面的药物与血管壁3将紧密接触，达到将药物释放到血管壁的效果。当球囊1充盈膨胀后，将进入振动状态，振动可以加速药物的扩散和吸收，提高治疗效果。When the balloon 1 is filled and expanded, the drug on the surface will be in close contact with the blood vessel wall 3 to achieve the effect of releasing the drug to the blood vessel wall. When the balloon 1 is filled and expanded, it will enter a vibrating state, and the vibration can accelerate the diffusion and absorption of the drug and improve the therapeutic effect.
细长构件2为中空管状结构，部分设置在球囊1的内部，细长构件2的管腔与球囊1的内部相贯通，可以用气体或液体填充。在本具体较佳实施例中，振动结构单元4采用超声波振动结构，具体可以为超声波换能器，可以将超声波转换成高频的机械振动。在不影响效果的情况下，也可以采用基于超声波原理的其他构造或者基于液电效应原理的其他构造。细长构件2的作用是包裹和保护传导线，将外部振动源传导进入振动结构单元4，如将外部的电能传导至换能器以产生高频机械振动，如超声波振动等。The elongated member 2 is a hollow tubular structure partially disposed inside the balloon 1, and the lumen of the elongated member 2 penetrates the inside of the balloon 1, and can be filled with a gas or a liquid. In the specific preferred embodiment, the vibrating structural unit 4 adopts an ultrasonic vibration structure, and specifically may be an ultrasonic transducer, which can convert ultrasonic waves into high-frequency mechanical vibrations. Other configurations based on the principle of ultrasound or other configurations based on the principle of liquid electrical effects may also be employed without affecting the effect. The function of the elongate member 2 is to wrap and protect the conductive wires, and to conduct external vibration sources into the vibrating structural unit 4, such as conducting external electrical energy to the transducer to generate high frequency mechanical vibrations, such as ultrasonic vibrations and the like.
进一步地，细长构件2可包括内腔管、远端管、过渡管、海波管以及应力支撑结构和手柄等，内腔管主要置于球囊1的内部，远端管用于连接内腔管和过渡管，而海波管用于连接过渡管和应力支撑结构。Further, the elongate member 2 may include a lumen tube, a distal tube, a transition tube, a hypotube, a stress support structure and a handle, etc., the lumen tube is mainly placed inside the balloon 1, and the distal tube is used to connect the lumen Tubes and transition tubes, while hypotubes are used to connect transition tubes and stress support structures.
当球囊1进入到血管的指定位置时，可以采用注入造影液或生理盐水或者两者混合物等的方式，使球囊1充盈膨胀。由于当药物球囊处于被撑开、充盈的状态时，药物球囊会阻断血流，否则可能引起心肌缺血，因此本发明中球囊1的持续充盈的时间设置为不超过40秒。When the balloon 1 enters a designated position of the blood vessel, the balloon 1 can be filled and inflated by injecting a contrast medium or physiological saline or a mixture of the two. Since the drug balloon blocks the blood flow when the drug balloon is in the expanded and filled state, myocardial ischemia may be caused, so the time for the continuous filling of the balloon 1 in the present invention is set to not more than 40 seconds.
在图2中，展示了本发明的另一个较佳实施例的药物洗脱球囊导管***的结构示意图。振动可以基于液电效应产生，此时需要在球囊的内部设置有电极对5并且球囊内被液体充盈，电极对5至少包含一个正电极和一个负电极，正电极和负电极之间具有间隙。细长构件被用于将外部电源产生的电压脉冲传导至电极对5，在高压强电场作用下，电极间液体中的电子被加速，并电离电极附近的液体分子，从而在电极对5之间形成放电通道，液体被击穿。放电电流的产生使得液体汽化并膨胀，从而产生振动。In Fig. 2, a schematic view of the structure of a drug eluting balloon catheter system in accordance with another preferred embodiment of the present invention is shown. The vibration can be generated based on the liquid electric effect, in which it is necessary to provide the electrode pair 5 inside the balloon and the liquid in the balloon is filled, the electrode pair 5 includes at least one positive electrode and one negative electrode, and the positive electrode and the negative electrode have gap. The elongated member is used to conduct a voltage pulse generated by an external power source to the electrode pair 5, and under the action of a high voltage strong electric field, electrons in the liquid between the electrodes are accelerated, and ionizes liquid molecules in the vicinity of the electrode, thereby between the electrode pairs 5 A discharge channel is formed and the liquid is broken down. The generation of the discharge current causes the liquid to vaporize and expand, thereby generating vibration.
电极对5可以附着在细长构件的表面，可以延细长构件的延伸方向设置或者垂直方向设置，当延细长构件的延伸方向设置时，可以很好地控制细长构件的直径，扩大应用场景。The electrode pair 5 may be attached to the surface of the elongated member, and may be disposed in the extending direction of the elongated member or in the vertical direction. When the extending direction of the elongated member is set, the diameter of the elongated member can be well controlled, and the application is expanded. Scenes.
球囊的振动状态可以是球囊持续处于充盈膨胀状态后，通过对外部控制源的调节，控制球囊的振动频率和振动时间，使球囊表面小幅度高频率振动。此外，球囊的形状可以设计为具有凹陷结构，采用具有凹陷结构的设计可以使血管不会持续阻断，保证心肌等器官的供血，但此种模式无法保证球囊表面持续紧贴血管壁。The vibration state of the balloon may be that after the balloon is continuously in the state of filling and expanding, the vibration frequency and the vibration time of the balloon are controlled by adjusting the external control source, so that the surface of the balloon vibrates at a small amplitude and high frequency. In addition, the shape of the balloon can be designed to have a concave structure. The design with a concave structure can prevent the blood vessels from being continuously blocked, and the blood supply to the organs such as the myocardium can be ensured, but this mode cannot ensure that the surface of the balloon continuously adheres to the blood vessel wall.
此外，本发明的***还可以包括各种控制电路，或者增加传感器等的方式。如在药物球囊表面或者内部设置温度传感器，配合外部控制电路设置温度的上下限，当过温时可切断热源的产生，以保护血管组织不受振动结构单元产生的热源的损伤。Furthermore, the system of the present invention may also include various control circuits, or ways of adding sensors or the like. For example, if a temperature sensor is arranged on the surface or inside the drug balloon, and the upper and lower limits of the temperature are set in conjunction with the external control circuit, the generation of the heat source can be cut off when the temperature is over-temperature to protect the vascular tissue from the heat source generated by the vibration structural unit.
还可以设置幅度传感器，实现对振动幅度的监控检测，配合外部控制电路控制振动的幅度和频率，当检测到振动幅度过大或者频率过快时，可以减小振动源的输入或者振动结构单元的输出，防止由振动造成心血管壁的损伤。而当检测到振动幅度变小或者频率偏低时，可以增大振动源的输入或者振动结构单元的输出，防止由于振动不够而导致药物吸收不良。It is also possible to set the amplitude sensor to realize the monitoring and detection of the vibration amplitude, and the external control circuit to control the amplitude and frequency of the vibration. When the vibration amplitude is too large or the frequency is too fast, the input of the vibration source or the vibration structural unit can be reduced. Output to prevent damage to the cardiovascular wall caused by vibration. When it is detected that the vibration amplitude becomes small or the frequency is low, the input of the vibration source or the output of the vibration structural unit can be increased to prevent the absorption of the medicine due to insufficient vibration.
控制电路可以由本发明***本身附加反馈电路及CPU或者MCU控制，实现便携化和轻量化的功能。也可以通过在***设置转接插口，通过与外部设备进行连接，通过外部设备进行各种参数和指令的控制，实现功能的多样化及精密控制，获得更为广泛的应用范围。The control circuit can be controlled by the system itself by adding a feedback circuit and a CPU or MCU to realize the functions of portability and weight reduction. It is also possible to achieve a wide range of applications by providing a transfer jack in the system, connecting with external devices, and controlling various parameters and commands through external devices to achieve diversification and precise control.
以上详细描述了本发明的较佳具体实施例。应当理解，本领域的普通技术无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此，凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案，皆应在由权利要求书所确定的保护范围内。The above has described in detail the preferred embodiments of the invention. It should be understood that many modifications and variations can be made in the present invention without departing from the scope of the invention. Therefore, any technical solution that can be obtained by a person skilled in the art based on the prior art based on the prior art by logic analysis, reasoning or limited experimentation should be within the scope of protection determined by the claims.

Claims (10)

  1. 一种带振动的药物洗脱球囊导管***，其特征在于，所述***包括细长构件和可膨胀的球囊； A vibrating drug eluting balloon catheter system, characterized in that the system comprises an elongate member and an inflatable balloon;
    所述球囊内部为中空并设置有振动结构单元，所述球囊的外部表面覆盖有药物，当所述球囊充盈膨胀后，表面覆盖的药物与血管壁接触，所述球囊进入振动状态；The inside of the balloon is hollow and is provided with a vibrating structural unit, the outer surface of the balloon is covered with a drug, and when the balloon is filled and expanded, the surface-covered drug contacts the blood vessel wall, and the balloon enters a vibrating state. ;
    所述细长构件内具有管腔，所述管腔与所述球囊的内部相贯通，并填充气体或液体。The elongated member has a lumen therein that penetrates the interior of the balloon and is filled with a gas or a liquid.
  2. 如权利要求1所述的带振动的药物洗脱球囊导管***，其特征在于，所述振动结构单元包括：超声波振动或者液电效应振动结构。A vibrating drug eluting balloon catheter system according to claim 1, wherein said vibrating structural unit comprises: an ultrasonic vibration or a liquid electric effect vibration structure.
  3. 如权利要求1所述的带振动的药物洗脱球囊导管***，其特征在于，所述球囊内填充造影液或生理盐水中的一种或两种，使所述球囊充盈膨胀。A vibrating drug eluting balloon catheter system according to claim 1 wherein said balloon is filled with one or both of contrast medium or physiological saline to cause said balloon to expand and expand.
  4. 如权利要求2所述的带振动的药物洗脱球囊导管***，其特征在于，所述振动结构单元为液电效应振动结构时，所述球囊内部包含有放电电极。The vibrating drug eluting balloon catheter system according to claim 2, wherein when the vibrating structural unit is a hydroelectric effect vibrating structure, the inside of the balloon contains a discharge electrode.
  5. 如权利要求4所述的带振动的药物洗脱球囊导管***，其特征在于，所述放电电极通过所述细长构件与外部电压脉冲连接，所述放电电极之间可产生放电通道。A vibrating drug eluting balloon catheter system according to claim 4, wherein said discharge electrode is connected to an external voltage pulse by said elongated member, and a discharge channel is formed between said discharge electrodes.
  6. 如权利要求1所述的带振动的药物洗脱球囊导管***，其特征在于，在所述振动状态过程中，所述球囊持续保持充盈膨胀状态。The vibrating drug eluting balloon catheter system of claim 1 wherein said balloon continues to remain in a filled and expanded state during said vibrating state.
  7. 如权利要求6所述的带振动的药物洗脱球囊导管***，其特征在于，所述球囊的充盈膨胀状态的持续时间为10至180秒。The vibrating drug eluting balloon catheter system of claim 6 wherein said balloon is inflated and expanded for a duration of from 10 to 180 seconds.
  8. 如权利要求2所述的带振动的药物洗脱球囊导管***，其特征在于，所述振动结构单元为超声波振动结构时，所述球囊内部还包含有换能器，将电能转换为超声波振动。The vibrating drug eluting balloon catheter system according to claim 2, wherein when the vibrating structural unit is an ultrasonic vibrating structure, the inside of the balloon further comprises a transducer for converting electrical energy into ultrasonic waves. vibration.
  9. 如权利要求1所述的带振动的药物洗脱球囊导管***，其特征在于，所述药物包括紫杉醇或雷帕霉素。The vibrating drug eluting balloon catheter system of claim 1 wherein the medicament comprises paclitaxel or rapamycin.
  10. 如权利要求9所述的带振动的药物洗脱球囊导管***，其特征在于，所述药物被设置为喷涂在所述球囊表面，形成药物涂层，所述药物涂层的浓度为0.1至6ug/mm2。A vibrating drug eluting balloon catheter system according to claim 9 wherein said medicament is configured to be sprayed onto said balloon surface to form a drug coating having a concentration of 0.1 of said drug coating. Up to 6ug/mm2.
PCT/CN2018/083319 2018-03-16 2018-04-17 Vibrating drug-eluting balloon catheter system WO2019174100A1 (en)

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