WO2019174625A1 - 一种基于液电效应的球囊导管 - Google Patents

一种基于液电效应的球囊导管 Download PDF

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Publication number
WO2019174625A1
WO2019174625A1 PCT/CN2019/078214 CN2019078214W WO2019174625A1 WO 2019174625 A1 WO2019174625 A1 WO 2019174625A1 CN 2019078214 W CN2019078214 W CN 2019078214W WO 2019174625 A1 WO2019174625 A1 WO 2019174625A1
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Prior art keywords
balloon
balloon catheter
electrode
electrode pairs
electrode pair
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PCT/CN2019/078214
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English (en)
French (fr)
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 WO2019174625A1 publication Critical patent/WO2019174625A1/zh

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    • 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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/22022—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement using electric discharge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B2017/22005—Effects, e.g. on tissue
    • A61B2017/22011—Combined types of vibration, e.g. ultrasonic and electrohydraulic
    • A—HUMAN NECESSITIES
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    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22098—Decalcification of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00369—Heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00714—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • 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
    • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • 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
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
    • 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
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • A—HUMAN NECESSITIES
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    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature

Definitions

  • the present invention relates to the field of angioplasty surgical devices, and more particularly to a balloon catheter based on a liquid electrical effect.
  • Aortic calcification is the accumulation of calcium deposits on the cardiovascular aortic valve. In severe cases, thickening of calcium deposits can narrow the aortic opening, reduce blood flow, and cause chest pain or heart disease. Currently, there is no effective treatment for aortic calcification. Existing clinical treatments include monitoring the further development of arterial calcification, or drug intervention to lower cholesterol levels; the valve is severely narrowed and treated by angioplasty.
  • angioplasty In angioplasty, an expandable balloon is built into the blood vessel, and the mechanical stress caused by the rapid expansion of the balloon acts on the calcification stove to break it.
  • angioplasty is only suitable for concentrated large calcified sediments. It cannot treat calcifications that are scattered or penetrated into the ventricle. The calcium removal efficiency is low and incomplete.
  • the rapid expansion of the balloon causes a sudden change in the pressure of the blood vessel wall. It is easy to damage blood vessels and even cause thrombosis, so the therapeutic effect is risky.
  • the technical problem to be solved by the present invention is how to study a fluid-electric effect-based balloon catheter device with small vascular damage and high calcium removal efficiency and small volume while being rationally designed. .
  • the present invention provides a balloon catheter based on a liquid electric effect, comprising an inner lumen tube, a balloon, a conductive liquid, and an electrode pair; wherein the lumen tube is configured to penetrate the interior of the balloon
  • the balloon is internally filled with the conductive liquid; the electrode pair is configured to be fixed to an outer surface of the lumen inside the balloon.
  • the electrode pair includes one or more tip type electrode pairs.
  • the positive electrode and the negative electrode of the electrode pair are of a needle tip type, and the tips are opposite; a discharge gap between the positive electrode and the negative electrode is configured to be in the direction of the lumen tube or perpendicular to the lumen tube.
  • the balloon catheter further includes a pulse power source that supplies a pulse voltage required for discharge of the electrode pair and is connected to the electrode pair through a wire.
  • the pulse power supply voltage ranges from 400V to 5000V, and the duration of the control discharge is 1 ⁇ 3us.
  • a plurality of the electrode pairs are uniformly distributed along a length direction of the inner cavity tube, the discharge gap length ranges from 50 ⁇ m to 2 mm, and the positive and negative electrodes of the plurality of electrode pairs are configured to be connected in parallel.
  • the inner lumen tube is a hollow cylinder.
  • the balloon catheter is further configured with a sensor fixed to a surface of the lumen tube, the wave sensor being connected to the pulse power source; according to a signal of the sensor, the pulse power source adjusts a tip discharge duration and Output energy.
  • the conductive liquid includes one or more of physiological saline and contrast liquid.
  • the balloon catheter is further provided with two radiopaque development markers arranged to mark the length of the cylindrical portion of the balloon.
  • the invention generates a shock wave by the electrode discharge based on the liquid electric effect, can effectively remove the calcification spots of various strengths by adjusting the duration of the shock wave and releasing the energy; at the same time, the sensor and the like are arranged, and the discharge can be adjusted according to the real-time situation in the human body. Time and pulse size, especially for the treatment of non-concentrated calcification of blood vessels.
  • FIG. 1 is a schematic view of a balloon catheter based on a liquid electric effect according to a specific preferred embodiment of the present invention
  • FIG. 2 is a schematic view of a balloon catheter based on a liquid electric effect according to another specific preferred embodiment of the present invention.
  • FIG. 3 is a schematic view of a balloon catheter based on a liquid electric effect according to another specific preferred embodiment of the present invention.
  • FIG. 4 is a perspective view of a partial lumen tube of a balloon catheter based on a liquid electric effect according to another specific preferred embodiment of the present invention.
  • a particularly preferred embodiment of the present invention includes an inner lumen 1, a balloon 2, a conductive liquid 3, an electrode pair, and a pulsed power source 6.
  • the lumen tube 1 is configured to penetrate the interior of the balloon 2 and is coaxial with the balloon 2 in the longitudinal direction; the balloon 2 is configured to be sealed to the outer surface of the lumen tube 1; the conductive liquid 3 is configured to fill the interior of the balloon 2
  • the electrode pair is composed of the first electrode pair 4 and the second electrode pair 5; the first electrode pair 4 and the second electrode pair 5 are fixed to the inner tube 1 inside the balloon 2 in the direction of the lumen 1
  • the outer surface, the positive electrode of the first electrode pair 4 and the positive electrode of the second electrode pair 5 are connected by a wire, the negative electrode of the first electrode pair 4 and the negative electrode of the second electrode pair 5 are connected by a wire; the pulse power source 6 provides a tip discharge required
  • the pulse voltage is connected to the first electrode pair 4 and the second electrode pair 5 by wires.
  • the lumen tube 1 is a hollow cylinder.
  • a wire connecting the pulse power source 6 to the first electrode pair 4 and the second electrode pair 5 is placed in the lumen of the lumen tube 1 and passes through the lumen tube 1
  • the through opening of the side wall is connected to the first electrode pair 4 and the second electrode pair 5.
  • the lumen tube 1 is made of an insulating soft material.
  • the filling amount of the conductive liquid 3 should be the natural lumen volume of the balloon 2 in an undeformed state.
  • the positive and negative electrodes of the first electrode pair 4 and the second electrode pair 5 are discharged or arc-discharged, and the conductive liquid 3 at the discharge gap is broken.
  • the conductive liquid 3 generates a large number of bubbles, and the bubble expands and disappears.
  • the stress will generate a shock wave, and the shock wave will be transmitted to the lesion site, which will soften and break the calcification plaque, thereby achieving the purpose of eliminating the calcification and smoothing the blood vessel.
  • the conductive liquid 3 is selected from one or more of a 3% to 5% sodium hydrogencarbonate solution, a physiological saline solution, and a contrast medium.
  • a physiological saline solution e.g., a physiological saline solution
  • a contrast medium e.g., a sodium bicarbonate solution, physiological saline and contrast medium.
  • sodium bicarbonate solution, physiological saline and contrast medium can rapidly generate carbon dioxide or vaporized gas through its own reversible reaction; the tip discharge pulse disappears, gas or bubbles are no longer generated, and the balloon is restored. Initial state.
  • the positive electrode of the first electrode pair 4 and the second electrode pair 5 is a platinum electrode having a diameter of 0.1 to 0.2 mm
  • the negative electrode is a copper electrode having a diameter of 0.1 to 0.2 mm.
  • the discontinuity formed by the platinum-plated electrode on the outer surface along the direction of the lumen tube 1 is the discharge gap of the first electrode pair 4 and the second electrode pair 5.
  • the electrode discharge employs a tip discharge.
  • the outer surface of the balloon 2 is not in contact with the blood vessel wall, and the first electrode 4 and the second electrode are 5
  • the linear distance from the calcification zone is 1 ⁇ 3mm, and the discharge gap length ranges from 50 ⁇ m to 2mm.
  • Figure 2 shows another preferred embodiment of the present invention.
  • the gap between the positive and negative electrodes of the first electrode pair 4 and the second electrode pair 5 formed on the outer surface in the vertical direction of the inner tube 1 is the discharge gap of the first electrode pair 4 and the second electrode pair 5.
  • the outer surface of the lumen tube 1 of the discharge gap has a circular cross-sectional arc length of 50 ⁇ m 2 mm.
  • the balloon 2 is a gourd shape.
  • the outer surface of the inner tube 1 on which the first electrode pair 4 and the second electrode pair 5 are located is provided with an electrode pair sliding groove of 5 mm length; the device is further provided with an automatic adjustment system, which mainly comprises fixing to the inner tube 1 Surface sensor 7; sensor 7 may be a temperature sensor or an amplitude sensor or the like, which can feed back the temperature of the balloon catheter and the signal strength of the shock wave, and the sensor 7 is connected to the pulse power source 6.
  • the pulse power source 6 can reduce the amplitude of the discharge pulse or shorten the discharge time; when the temperature sensed by the sensor 7 is insufficient or the amplitude of the vibration is too small, the pulse power source 6 can be raised.
  • the energy of the external electric pulse can be adjusted at any time to achieve precise control.
  • the pulse power source 6 has a pulse duration of 1 to 3 us, a pulse energy of 30 to 100 mJ, and a pulse voltage of 400 V to 5000 V.
  • the balloon catheter is also provided with two radiopaque development markers arranged to mark the length of the cylindrical portion of the balloon to reveal the effective length of the balloon.
  • the inner tube adopts metal or PE, PVC, PU and coating materials, and the metal can improve the rigidity of the inner tube; and the PE, PVC, PU and coating materials can improve the flexibility without causing damage to the blood vessel. .

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Abstract

本发明公开了一种基于液电效应的球囊导管，包括内腔管、球囊、导电液体、电极对和脉冲电源；内腔管被配置为贯通球囊内部，且与球囊沿长度方向同轴；球囊被配置为密闭于内腔管外表面；导电液体被配置为填充球囊内部；电极对被配置为固定于球囊内部的内腔管外表面，数量为一个或多个；脉冲电源提供电极对放电所需的脉冲电压，并通过导线与电极对相连；电极对得电后击穿正负极放电间隙处的导电液体，产生冲击波。本发明体积小巧，通过基于液电效应的电极放电产生可控的冲击波，微创高效地清除血管钙化灶，尤其适用于血管的非集中式钙化灶治疗。

Description

一种基于液电效应的球囊导管
技术领域
本发明涉及血管成形手术装置领域，尤其涉及一种基于液电效应的球囊导管。
背景技术
主动脉钙化，是钙沉积物在心血管的主动脉瓣膜上的累积。严重时，钙沉积物的变厚会使得主动脉开口变窄，血流减少，引起胸痛或心脏病。当前，对主动脉钙化尚无有效的治疗方案。现有临床治疗手段包括监测动脉钙化进一步发展，或药物介入降低胆固醇水平；待瓣膜严重变窄，通过血管成型手术进行治疗。
血管成形手术，是在血管中内置可扩张球囊，通过球囊快速扩张的机械应力作用于钙化灶，使之破碎。但血管成型手术只适用于集中式的大块钙化沉积物，无法处理分散或者深入到心室的钙化灶，除钙效率较低且不彻底；另外，球囊快速扩张会导致血管壁的压力突变，容易损伤血管甚至引起血栓，因而治疗效果有一定的风险性。考虑到疾病的“早发现、早治疗”以及碎石术现在已经成熟地用于泌尿系统结石或胆囊结石的治疗，因此使用碎石方法产生冲击波对轻微钙化的血管介入治疗，是一种对血管创伤较小且可行的替代治疗手段。
因此，本领域的技术人员致力开发一种体积小巧、对血管损伤小并且除钙效率较高的基于液电效应的球囊导管。
发明内容
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通过合理的设计，研究一种对血管损伤小并且除钙效率较高，同时体积小巧的基于液电效应的球囊导管装置。
为实现上述目的，本发明提供了一种基于液电效应的球囊导管，包括内腔管、球囊、导电液体和电极对；其中，所述内腔管被配置为贯通所述球囊内部；所述球囊内部填充有所述导电液体；所述电极对被配置为固定于所述球囊内部的所述内腔管外表面。
进一步地，所述电极对包括一个或多个尖端型电极对。
进一步地，所述电极对的正极和负极为针尖型，且尖端相对；所述正极与所述负极之间的放电间隙被配置为沿所述内腔管方向或垂直所述内腔管方向。
进一步地，所述球囊导管还包括脉冲电源，所述脉冲电源提供所述电极对放电所需的脉冲电压，并通过导线与所述电极对相连。
进一步地，所述脉冲电源电压范围为400V~5000V，控制放电的持续时间为1~3us。
进一步地，多个所述电极对沿所述内腔管的长度方向均匀分布，所述放电间隙长度范围为50μm~2mm，且多个所述电极对的正负极被配置为并联连接。
进一步地，所述内腔管为中空圆柱体。
进一步地，所述球囊导管还配置有固定于所述内腔管表面的传感器，所述波传感器与所述脉冲电源相连；根据所述传感器的信号，所述脉冲电源调整尖端放电持续时间和输出能量。
进一步地，所述导电液体包括生理盐水和造影液中的一种或多种。
进一步地，所述球囊导管还配置有两个不透射线的显影标记，被设置为标记所述球囊的圆柱形部分的长度。
本发明通过基于液电效应的电极放电产生冲击波，通过调节冲击波的持续时间和释放能量，可以高效地清除各类强度的钙化斑；同时设置了传感器等配置，可根据人体内实时情况，调整放电时间和脉冲大小，尤其适用于血管的非集中式钙化灶治疗。
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。
附图说明
图1是本发明一个具体较佳实施例的基于液电效应的球囊导管示意图；
图2是本发明另一个具体较佳实施例的基于液电效应的球囊导管示意图；
图3是本发明另一个具体较佳实施例的基于液电效应的球囊导管示意图；
图4是本发明另一个具体较佳实施例的基于液电效应的球囊导管的局部内腔管透视图；
附图标记说明：1-内腔管；2-球囊；3-导电液体；4-第一电极对；5-第二电极对；6-脉冲电源；7-传感器。
具体实施方式
以下结合说明书附图对本发明的实施例作详细说明，使其技术内容更加清楚和便于理解。本发明可以通过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。
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。
如图1所示，是本发明的一个具体较佳应用实施例，包括内腔管1、球囊2、导电液体3、电极对和脉冲电源6。内腔管1被配置为贯通球囊2内部，且与球囊2沿长度方向同轴；球囊2被配置为密闭于内腔管1外表面；导电液体3被配置为填充球囊2内部；电极对由第一电极对4和第二电极对5组成；第一电极对4和第二电极对5沿内腔管1方向被固定于球囊2内部的内腔管1 外表面，第一电极对4的正极与第二电极对5的正极通过导线相连，第一电极对4的负极与第二电极对5的负极通过导线相连；脉冲电源6提供尖端放电所需的脉冲电压，并通过导线与第一电极对4和第二电极对5相连。
本实施例中，内腔管1为中空圆柱体。脉冲电源6与第一电极对4和第二电极对5相连的导线放置于内腔管1的内腔，并通过内腔管1 侧壁的贯通口与第一电极对4和第二电极对5相连。为更好地应用于弯曲的血管，优选地，内腔管1选用绝缘软性材料。
本实施例中，导电液体3填充量应为球囊2在无形变状态下的自然内腔体积。在脉冲电源6的作用下，第一电极对4和第二电极对5的正负极尖端放电或弧光放电，击穿放电间隙处的导电液体3，导电液体3产生大量气泡，气泡膨胀与消失的应力会产生冲击波，冲击波传递到病灶部位，会软化和破裂钙化斑，从而达到消除钙化灶、畅通血管的目的。优选地，导电液体3选用3%~5%的碳酸氢钠溶液、生理盐水和造影液中的一种或多种。尖端放电下，碳酸氢钠溶液、生理盐水和造影液中的一种或者混合液，通过自身的可逆反应可以快速产生二氧化碳或者汽化气体；尖端放电脉冲消失，气体或气泡不再产生，恢复球囊初始状态。
本实施例中，第一电极对4和第二电极对5的正极采用直径0.1~0.2mm的铂电极，负极采用直径0.1~0.2mm的铜电极。铂铜电极沿内腔管1方向在外表面形成的间断口，为第一电极对4和第二电极对5的放电间隙。考虑到尖端放电相对于电弧放电有更低的击穿电压和更小的电极对和放电间隙，为进一步优化装置体积，优选地，电极放电采用尖端放电。
本实施例中，为更好地发挥液电冲击波的效果，且尽量降低对血管的损伤，优选地，所述球囊2外表面不与血管壁接触，所述第一电极4与第二电极5与钙化灶区域直线距离为1~3mm，且放电间隙长度范围为50μm~2mm。
图2所示为本发明的另一较佳具体实施例。本实施例中，第一电极对4和第二电极对5的正负极沿内腔管1垂直方向在外表面形成的间断口，为第一电极对4和第二电极对5的放电间隙。为更好地保证尖端放电效果，优选地，放电间隙的内腔管1外表面圆形横截面圆弧长度为50μm~2mm。
图3和图4所示为本发明的另一较佳具体实施例，在本实施例中，球囊2为葫芦形。
本实施例中，第一电极对4和第二电极对5所在的内腔管1外表面设置有5mm长度的电极对滑动凹槽；装置还配有自动调节系统，主要包括固定于内腔管1表面的传感器7；传感器7可以为温度传感器或者幅度传感器等，可以反馈球囊导管处的温度和冲击波的信号强度，且传感器7与脉冲电源6相连。当传感器7感受到的温度超高或者振动幅度过大时，脉冲电源6可以降低放电脉冲幅值或者缩短放电时间；当传感器7感受到的温度不够或者振动幅度过小时，脉冲电源6可以升高放电脉冲幅值或者加长放电时间。此外通过传感器7反馈的信号强度，可以随时调整外部电脉冲的能量大小，达到精准控制的目的。优选地，脉冲电源6的脉冲持续时间为1~3us，脉冲能量为30~100mJ，脉冲电压为400V~5000V。
球囊导管还配置有两个不透射线的显影标记，被设置为标记所述球囊的圆柱形部分的长度，可以显现球囊的有效长度。优选地，内腔管选用金属或者PE、PVC、PU及涂层材料，采用金属可以提高内腔管的刚度；而采用PE、PVC、PU及涂层材料，可以提高柔性度，不对血管造成损伤。
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。

Claims (10)

  1. 一种基于液电效应的球囊导管，其特征在于，包括内腔管、球囊、导电液体和电极对；其中，所述内腔管被配置为贯通所述球囊内部；所述球囊内部填充有所述导电液体；所述电极对被配置为固定于所述球囊内部的所述内腔管外表面。
  2. 如权利要求1所述的基于液电效应的球囊导管，其特征在于，所述电极对包括一个或多个尖端型电极对。
  3. 如权利要求2所述的基于液电效应的球囊导管，其特征在于，所述电极对的正极和负极为针尖型，且尖端相对；所述正极与所述负极之间的放电间隙被配置为沿所述内腔管方向或垂直所述内腔管方向。
  4. 如权利要求1所述的基于液电效应的球囊导管，其特征在于，所述球囊导管还包括脉冲电源，所述脉冲电源提供所述电极对放电所需的脉冲电压，并通过导线与所述电极对相连。
  5. 如权利要求4所述的基于液电效应的球囊导管，其特征在于，所述脉冲电源电压范围为400V~5000V，控制放电的持续时间为1~3us。
  6. 如权利要求1所述的基于液电效应的球囊导管，其特征在于，多个所述电极对沿所述内腔管的长度方向均匀分布，所述放电间隙长度范围为50μm~2mm，且多个所述电极对的正负极被配置为并联连接。
  7. 如权利要求1所述的基于液电效应的球囊导管，其特征在于，所述内腔管为中空圆柱体。
  8. 如权利要求4所述的基于液电效应的球囊导管，其特征在于，所述球囊导管还配置有固定于所述内腔管表面的传感器，所述波传感器与所述脉冲电源相连；根据所述传感器的信号，所述脉冲电源调整尖端放电持续时间和输出能量。
  9. 如权利要求1所述的基于液电效应的球囊导管，其特征在于，所述导电液体包括生理盐水和造影液中的一种或多种。
  10. 如权利要求1所述的基于液电效应的球囊导管，其特征在于，所述球囊导管还配置有两个不透射线的显影标记，被设置为标记所述球囊的圆柱形部分的长度。
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