WO2015062306A1 - 体外冲击波碎石机及用于体外冲击波碎石机的充放电电路 - Google Patents

体外冲击波碎石机及用于体外冲击波碎石机的充放电电路 Download PDF

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Publication number
WO2015062306A1
WO2015062306A1 PCT/CN2014/081702 CN2014081702W WO2015062306A1 WO 2015062306 A1 WO2015062306 A1 WO 2015062306A1 CN 2014081702 W CN2014081702 W CN 2014081702W WO 2015062306 A1 WO2015062306 A1 WO 2015062306A1
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WO
WIPO (PCT)
Prior art keywords
shock wave
capacitor
lithotripter
coil
extracorporeal
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Application number
PCT/CN2014/081702
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English (en)
French (fr)
Inventor
杜锡鑫
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苏州市锡鑫医疗器械有限公司
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Application filed by 苏州市锡鑫医疗器械有限公司 filed Critical 苏州市锡鑫医疗器械有限公司
Priority to US15/033,360 priority Critical patent/US10194930B2/en
Priority to EP14858171.3A priority patent/EP3064157A4/en
Publication of WO2015062306A1 publication Critical patent/WO2015062306A1/zh

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Classifications

    • 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
    • A61B17/225—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 for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/008—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms using shock waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00137—Details of operation mode
    • A61B2017/00154—Details of operation mode pulsed
    • A61B2017/00159—Pulse shapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00137—Details of operation mode
    • A61B2017/00154—Details of operation mode pulsed
    • A61B2017/00181—Means for setting or varying the pulse energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/12—Driving means
    • A61H2201/1207—Driving means with electric or magnetic drive
    • G—PHYSICS
    • G10—MUSICAL INSTRUMENTS; ACOUSTICS
    • G10K—SOUND-PRODUCING DEVICES; METHODS OR DEVICES FOR PROTECTING AGAINST, OR FOR DAMPING, NOISE OR OTHER ACOUSTIC WAVES IN GENERAL; ACOUSTICS NOT OTHERWISE PROVIDED FOR
    • G10K15/00—Acoustics not otherwise provided for
    • G10K15/04—Sound-producing devices
    • G10K15/06—Sound-producing devices using electric discharge

Definitions

  • the invention relates to the field of medical instruments, in particular to an extracorporeal shock wave lithotripter and a charging and discharging circuit for an extracorporeal shock wave lithotripter.
  • the object of the present invention is to provide an extracorporeal shock wave lithotripter which reduces or avoids damage to human soft tissues while pulverizing human stones.
  • an aspect of the present invention provides an extracorporeal shock wave lithotripter including a shock wave generating device having a charging circuit and a discharging circuit.
  • the charging circuit is composed of a resistor and a capacitor
  • the discharging circuit is composed of the capacitor, a high voltage switch and a shock wave source device in series, and the capacitance value of the capacitor is 1.5 ⁇ F to 2.5 ⁇ F.
  • the capacitor is discharged to the shock wave source device to generate a shock wave with a peak pressure peak of 6 MPa to 20 MPa, and the bottom pulse width of the shock wave is 3 ⁇ s to 5 Ss.
  • the bottom pulse width of the shock wave is specifically preferably 3 ⁇ s in the positive pressure section and 5 ⁇ s in the negative pressure section.
  • the charging circuit has a charging voltage of 5000V to 11000V.
  • the capacitance of the capacitor is between 1.6 ⁇ F and 2.4 ⁇ F.
  • the shock wave source device may be any one of an electromagnetic wave source, a liquid electric wave source, and a piezoelectric wave source.
  • the shock wave source device is preferably an electromagnetic wave source
  • the electromagnetic wave source includes a coil connected to the capacitor at one end and connected to the high voltage switch at the other end, a metal diaphragm disposed opposite the coil, and a coil disposed on the coil and the metal diaphragm.
  • An insulating layer is interposed between the coil and the metal diaphragm as a unitary seal in the inner cavity of the water-filled bladder.
  • the coil is a single-layer spiral spherical coil with a number of turns of 15 to 30 and a diameter of 65 mm to 130 mm.
  • the coil can be wound from a copper wire with a cross section of 0.5 mm to 2.5 mm in diameter or a length of 0.5 mm to 2.5 mm and a width of 0.5 mm to 1.5 mm.
  • the metal diaphragm may be a pure copper film having a thickness of 0.1 mm to 0.3 mm.
  • the pure copper film referred to herein and elsewhere refers to a copper content of preferably 99.99% or more.
  • the shock wave has a positive pressure section and a negative pressure section, and the fracture direction of the stone caused by the positive pressure section and the fracture direction of the stone caused by the negative pressure section are perpendicular.
  • Another aspect of the present invention also provides a charge and discharge circuit for use in the above-described extracorporeal shock wave lithotripter, comprising a charging circuit and a discharging circuit.
  • the charging circuit is composed of a resistor and a capacitor
  • the discharging circuit is composed of the capacitor, a high voltage switch and a shock wave source device, and the capacitance value of the capacitor as a constituent component of the charging circuit and a constituent component of the discharging circuit. 1.5 ⁇ F to 2.5 ⁇ F.
  • the capacitance value is from 1.6 ⁇ F to 2.4 ⁇ F.
  • the invention selects a capacitor of 1.5 ⁇ F to 2.5 ⁇ F, and the peak pressure of the shock wave generated is 6 MPa ⁇ 30MPa, bottom pulse width is 3 ⁇ s ⁇ 5 ⁇ s . Because the pressure of the shock wave is small, the curve head is gentle, most of it penetrates into the stone, and the stress concentration is caused by the impurity, and the pulse width length (that is, the duration of the shock wave) is long, which causes the stone model to be irreversible and cumulative. The center is broken. Moreover, the pressure of the shock wave is low, and most of the penetration into the stone, so the reflection pressure generated on the outer surface of the stone model is also small, thereby greatly reducing the damage to the soft tissue of the human body. At the same time, the pressure and pressure difference of the shock wave is very low, and the cavitation effect can be small, which is not enough to cause damage to the organism.
  • FIG. 1 is a schematic structural view of a shock wave generating device in the present invention
  • FIG. 2 is a schematic structural view of a self-focusing electromagnetic shock wave generating device in the present invention
  • FIG. 3 is an equivalent diagram of a structure of a charge and discharge circuit in the present invention.
  • FIG. 4 is a waveform diagram of a shock wave generated by an extracorporeal shock wave lithotripter according to the present invention.
  • Figure 5 is a schematic view of the shock wave generated by the extracorporeal shock wave lithotripter in the present invention and the stone continuously meet at the focus;
  • Figure 6 is a picture of the relationship between the shock wave pressure and the fragmentation of the stone.
  • the shock wave generating device includes a charge and discharge circuit.
  • figure 1 This charge and discharge circuit is shown.
  • the specific structure includes a charging circuit 1 and a discharging circuit 2, wherein the charging circuit 1 is composed of a resistor 11 and a capacitor 12, and the discharging circuit is composed of a capacitor 12 and a high voltage switch 13 And the shock wave source device 14 is formed in series in series.
  • the capacitor 12 is charged.
  • the high voltage switch 13 is turned on, and the capacitor 12 is turned to the shock wave source device.
  • Instantaneous discharge produces shock waves.
  • there are two modes of discharge one is manual discharge, that is, one switch is pressed 13 Put it once.
  • the other is continuous discharge, which discharges at a given frequency.
  • the frequency of this discharge can be set as needed. Such as 30 times per minute.
  • shock wave source device 14 There are three types of electromagnetic wave sources, liquid electric wave sources and piezoelectric wave sources. In order to clarify the present invention, the present invention will be described in detail below by taking a self-focusing electromagnetic shock wave generating device as an example.
  • FIG. 2 shows the treatment of stones in the human kidney 36 using a self-focusing electromagnetic shock wave generating device.
  • the self-focusing electromagnetic shock wave generating device specifically includes a charging circuit and a discharging circuit, wherein the charging circuit is composed of a resistor 31 and a capacitor 32; the discharging circuit is composed of a capacitor 32 and a high voltage switch 33.
  • the electromagnetic shock wave source device 34 is formed in series in series.
  • the electromagnetic shock wave source device 34 includes a coil 341 connected to the capacitor 32 at one end and connected to the high voltage switch 33 at the other end, and a coil 341 The oppositely disposed metal diaphragm 342, the inner skin filled with water 343 and the substrate 344 connected to the skin 343.
  • the coil 341 and the metal diaphragm 342 are disposed in the skin capsule In the inner cavity of the 343, an insulating layer (not shown) is provided between the coil 341 and the metal diaphragm 342, which are known to those skilled in the art, and therefore will not be described again with reference to the drawings.
  • Capacitor 32 The wire 343 is attached to the coil 341 by a wire, and the skin 343 is in close contact with the skin of the human body 35 .
  • the coil 341 is preferably a single-layer spiral spherical coil, which can be wound by a copper wire, and the metal diaphragm 342 A copper film can be used.
  • the working principle of the self-focusing electromagnetic wave source is to charge the capacitor C to a given voltage, through the high voltage switch G, the capacitor C When a discharge is completed, a strong pulse current is generated in the coil.
  • the strong pulse current flows through the coil 341, an induced current is generated in the metal diaphragm 342, and the magnetic fields formed by the two currents repel each other to make the metal diaphragm 342 A short and rapid motion is generated, which drives a strong pressure pulse in the water and propagates to form a shock wave.
  • the existing extracorporeal shock wave lithotripter has a greater damage to the human body. This damage is mainly caused by the excessive peak pressure of the shock wave generated by the existing crusher and the high frequency. In order to reduce the damage to the human body, it is necessary to reduce the pressure and frequency of the shock wave.
  • the focus pressure peak of the shock wave is determined by the capacitance value, the charging voltage value, and the conversion capability of the shock wave source device to the electric energy, and the frequency of the shock wave is mainly determined by the capacitance value.
  • the capacitance of the extracorporeal shock wave lithotripter The capacitance value of C is 1.5 ⁇ F to 2.5 ⁇ F. Most preferably, the capacitance is 1.6 ⁇ F to 2.4 ⁇ F. .
  • the shock wave generated by the crusher of the present invention has a peak pressure peak of 6 MPa to 20 MPa, and the bottom pulse width is, for example, a positive pressure section of 3 ⁇ s and a negative pressure section of 5 ⁇ s. .
  • the waveform is shown in Figure 4.
  • the energy of the capacitor discharge is determined by the capacitance value and the charging voltage, and the final conversion of the electrical energy into mechanical energy depends on the conversion capability of the shock wave generating device to the electrical energy. Therefore, those skilled in the art can select a suitable charging voltage according to the conversion capability of the different shock wave generating devices to electric energy.
  • the charging voltage may be in the range of 5000V ⁇ 11000V.
  • the number of turns of the coil 341 is preferably 15 to 30, considering the service life and effect, and the diameter is 65mm ⁇ 130mm
  • the coil 341 is made of copper wire, and a copper wire with a circular or rectangular cross section can be selected.
  • a copper wire with a circular cross section is selected, its diameter ranges from 0.5 mm to ⁇ 2.5mm.
  • the length of the rectangle is 0.5 mm to 2.5 mm, the width is 0.5 mm to 1.5 mm, and the length is preferably 2 mm.
  • the metal diaphragm 342 is a pure copper film having a thickness of 0.1 mm to 0.3 mm.
  • the shock wave of the extracorporeal shock wave lithotripter according to the present invention has a peak pressure peak of 6 MPa to 20 MPa. Although it is much smaller than the peak pressure peak of the shock wave generated by the existing extracorporeal shock wave lithotripter, it has been found through experiments that the same experimental stone can also achieve the desired crushing effect. With a capacitance between 1.5 ⁇ F and 2.5 For example, an extracorporeal shock wave lithotripter with a peak pressure of 16 MPa between ⁇ F passes through 644. After a few discharges, the gravel can be completed.
  • the mechanism and effect of the extracorporeal shock wave lithotripter according to the present invention relying on low pressure crushed stone are explained below.
  • Figure 4 shows a specific waveform of a shock wave generated by the extracorporeal shock wave lithotripter of the present invention, with a peak pressure peak of about 16 MPa.
  • the bottom pulse width of the positive pressure section is 3 ⁇ s, and the bottom pulse width of the negative pressure section is 5 ⁇ s.
  • Figure 5 shows the situation when the shock wave and the stone shown in Figure 4 meet.
  • Figure 4 The vertical axis represents the pressure value of the shock wave in MPa and the horizontal axis as time in ⁇ s.
  • the shock wave shown has a small peak of the focus pressure, a wide bottom pulse width, and a milder head, that is, a low frequency, so when it encounters a stone, most of the energy penetrates into the stone (Fig. 4). Shown), encountering impurities, small defects or micro-cracks originally existing inside the stone, causing a high degree of stress concentration, which is the amplified induced stress, causing the original impurities or micro-cracks under the action of the stress Constantly expanding, becoming an irreversible cumulative fragmentation, repeated in this way, the stone being beaten suddenly collapses due to its fatigue limit equal to or less than the pressure (negative pressure).
  • the bottom pulse width of the shock wave in the present invention is wider, that is, the time span is increased, the cumulative chipping is made more conspicuous.
  • the micro-cracks gradually expand and accumulate to a certain extent, and the stones break and collapse. This is a different mechanism of crushing stone, which we call the central fragmentation effect.
  • the stress here is always tensile stress, perpendicular or parallel to the direction of shock wave motion.
  • the shock wave shown in Figure 4 consists of a positive pressure section I and a negative pressure section II.
  • Figure 5 shows the positive pressure section I and the negative pressure section II, respectively.
  • the direction of the shock wave of the positive pressure section I is parallel to the direction of the fragmentation of the caused stone, and the direction of the shock wave of the negative pressure section II is perpendicular to the direction of the fracture of the caused stone.
  • Positive pressure section I The fragmentation direction and negative pressure section of the stone caused by the shock wave II
  • the direction of the fracture of the stones caused by the shock wave is perpendicular to each other.
  • the fracture surface of the stone must be generated on the section where the induced stress of the stone is first fully achieved, which is greater than the failure stress of the stone, thereby causing the fracture of the stone.

Abstract

一种体外冲击波碎石机以及用于该体外冲击波碎石机的充放电电路。其中体外冲击波碎石机的冲击波发生装置包括充电电路（1）和放电电路（2），充电电路（1）由电阻（11，31）和电容（12，32）组成，放电电路由该电容（12，32）、高压开关（13，33）以及冲击波波源装置（14，34）组成。其中电容（12，32）的电容值为1.5μF〜2.5μF，经该电容向冲击波波源装置（14，34）放电产生的冲击波的焦点压力峰值为6MPa〜20Mpa，底部脉宽正压段为3μs，负压段为5μs。通过该体外冲击波碎石机，产生的冲击波底部脉宽较宽，压力较平缓，且冲击波的焦点压力峰值小，通过应力集中使结石碎裂，同时降低了对人体的副作用。

Description

体外冲击波碎石机及用于体外冲击波碎石机的充放电电路
技术领域
本发明涉及医疗器械领域，尤其涉及一种体外冲击波碎石机及用于体外冲击波碎石机的充放电电路。
背景技术
随着医疗技术的发展，体外冲击波碎石机越来越多的被应用。为了将体内的结石击碎的更加彻底，冲击波的焦点压力被设计得越来越高。然而，于此带来的是冲击波的压力超过了人体软组织的承受极限，造成了人体软组织的损伤。因此，如何提供一种对人体损伤较小或无损伤的体外冲击波碎石机是目前急需解决的问题。
发明内容
本发明的目的在于提供一种体外冲击波碎石机，在粉碎人体结石的同时，降低或避免对人体软组织的伤害。
基于上述目的，本发明一方面提供一种体外冲击波碎石机，包括冲击波发生装置，该冲击波发生装置具有充电电路和放电电路。充电电路由一电阻和一电容组成，放电电路由所述电容、一高压开关以及一冲击波波源装置依次串联组成，电容的电容值为 1.5 μF ～ 2.5 μF 。经电容向冲击波波源装置放电产生焦点压力峰值为 6MPa ～ 20MPa 的冲击波，该冲击波的底部脉宽为 3 μs ～ 5 μs 。冲击波的底部脉宽具体优选为正压段 3 μs ， 负压段 5 μs 。
优选的，充电电路的充电电压为 5000V ～ 11000V 。
优选的，电容的电容值为 1.6 μF ～ 2.4 μF 。
优选的，冲击波波源装置可以为电磁式波源、液电式波源和压电式波源中的任一种。
在一具体实施例中，冲击波波源装置优选为电磁式波源，电磁式波源包括一端与电容相连且另一端与高压开关相连的线圈、与线圈相对设置的金属膜片及设置在线圈与金属膜片之间的绝缘层，其中，线圈和金属膜片作为一整体密封地设置在充满水的皮囊的内腔体中。
更具体地，线圈为单层螺旋球形线圈，匝数为 15 ～ 30 ，直径为 65mm ～ 130mm 。线圈可以由铜线绕制而成，铜线的横截面为直径 0.5mm ～ 2.5mm 的圆形或长度 0.5 mm ～ 2.5 mm 、宽度 0.5 mm ～ 1.5 mm 的矩形。金属膜片可以采用纯铜膜，该纯铜膜的厚度为 0.1mm ～ 0.3mm 。本文此处及其它各处提及的纯铜膜指其铜含量最好达到 99.99% 以上。
优选的，冲击波具有正压段和负压段，且正压段引起的结石的碎裂方向和负压段引起的结石的碎裂方向垂直。
本发明另一方面还提供一种充放电电路，应用在上述的体外冲击波碎石机中，包括充电电路和放电电路。其中，充电电路由一电阻和一电容组成，放电电路由所述电容、一高压开关以及一冲击波波源装置组成，既作为充电电路的构成元件又作为放电电路的构成元件的电容的电容值为 1.5 μF ～ 2.5 μF 。
在一优选实例中，电容值为 1.6 μF ～ 2.4 μF 。
基于上述技术方案，本发明的有益效果是：
本发明选用 1.5 μF ～ 2.5 μF 的电容，并使产生的冲击波的焦点压力峰值在 6 MPa ～ 30MPa ，底部脉宽在 3 μ s ～ 5 μ s 。因为冲击波的压力小，曲线头部较缓和，大部分穿透进入结石中，遇到杂质引起应力集中，且脉宽长度（即冲击波的持续时间）较长，造成了结石模型不可逆转和累积的中心碎裂。而且冲击波的压力低，大部分透进了结石，所以在结石模型的外表面产生的反射压力也很小，因此大大降低了对人体软组织的损伤。同时，冲击波的压力和压力差很低，能产生的空化效应很小，不足以引起有机体的损伤。
附图说明
图 1 为本发明中的冲击波发生装置结构示意图；
图 2 为本发明中的自聚焦电磁式冲击波发生装置结构示意图；
图 3 为本发明中的充放电电路结构等效图；
图 4 为本发明中的体外冲击波碎石机产生的焦区冲击波波形图；
图 5 为本发明中的体外冲击波碎石机产生的冲击波与结石在焦点处连续相遇的示意图；
图 6 为反应冲击波压力与结石碎裂关系的图片。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
体外冲击波碎石机都需要一个冲击波发生装置。该冲击波发生装置包括一个充放电电路。图 1 示出了该充放电电路。其具体包括充电电路 1 和放电电路 2 ，其中充电电路 1 由电阻 11 和电容 12 组成，放电电路由电容 12 、高压开关 13 和冲击波波源装置 14 依次串联组成。首先对电容 12 进行充电，充电完成后导通高压开关 13 ，电容 12 便向冲击波波源装置 14 瞬时放电而产生冲击波。其中，放电有两种模式，一种为手动放电，就是按一次开关 13 ，放一次电。另一种就是连续放电，即按给定的频率放电。该放电的频率可根据需要设定。如每分钟 30 次。
目前常用的冲击波波源装置 14 有电磁式波源、液电式波源和压电式波源三种。为使本发明更加清楚，以下以自聚焦电磁式冲击波发生装置为例，对本发明进行详细的介绍。
图 2 为采用自聚焦电磁式冲击波发生装置治疗人体肾脏 36 内的结石 37 的示意图。自聚焦电磁式冲击波发生装置具体包括充电电路和放电电路，其中充电电路由电阻 31 和电容 32 组成；放电电路由电容 32 、高压开关 33 和电磁式冲击波波源装置 34 依次串联组成。其中电磁式冲击波波源装置 34 包括一端与电容 32 相连且另一端与高压开关 33 相连的线圈 341 、与线圈 341 相对设置的金属膜片 342 、内部充填有水的皮囊 343 以及与皮囊 343 相连的衬底 344 。其中线圈 341 和金属膜片 342 设置在皮囊 343 的内腔体中，线圈 341 和金属膜片 342 之间设有绝缘层（图中未示出），这些已为本领域技术人员所知晓，因此不再采用附图赘述。电容 32 通过导线连接至线圈 341 ，皮囊 343 紧贴 人体的皮肤 35 。其中线圈 341 优选为单层螺旋球形线圈，可由铜线绕制而成，金属膜片 342 可以选用铜膜。
在图 3 中，以电容 C 、电阻 R 、高压开关 G 和电感 L 组成的电路的等效电路图的方式示出自聚焦电磁式波源的充放电电路。其中电感 L 本质上由金属膜片 342 从线圈 341 感应得到。本发明中的充电电压可由交流电压经高压变压器变压继而经整流器整流后获的。
该自聚焦电磁式波源的工作原理为给电容 C 充电到给定电压，通过高压开关 G ，电容 C 完成一次放电，在线圈中产生强脉冲电流，该强脉冲电流流过线圈 341 时，在金属膜片 342 中产生感应电流，两个电流形成的磁场相互排斥，使金属膜片 342 产生一短促而快速的运动，从而在水中驱动出一强压力脉冲并传播，形成冲击波。
现有的体外冲击波碎石机对人体的伤害较大 , 这一伤害主要源于现有碎石机产生的冲击波的焦点压力峰值过大，且频率高。为减小对人体的伤害，需要降低该冲击波的压力和频率。在体外冲击波碎石机中，冲击波的焦点压力峰值由电容值、充电电压值以及冲击波波源装置对电能的转换能力决定，而冲击波的频率主要由电容值决定。基于此，申请人进行了多次试验，最终得到并证明了一种既能降低碎石所需要的电压，又能很好的完成碎石，同时副作用又特别小的体外冲击波碎石机，这是利用增加电容的方法来达到的，具体如下：该体外冲击波碎石机采用的电容 C 的电容值为 1.5 μF ～ 2.5 μF 。最为优选的，该电容值为 1.6 μF ～ 2.4 μF 。经由上述电容放电产生一冲击波，本发明的碎石机产生的冲击波的焦点压力峰值为 6MPa ～ 20MPa ，底部脉宽例如为正压段 3 μ s ，负压段 5 μ s 。其波形具体如图 4 所示。
根据公式 W=½CU² 可知，电容放电的能量由电容值和充电电压共同决定，而最终电能转换成机械能还取决于冲击波产生装置对电能的转换能力。因此，本领域的技术人员可以根据不同冲击波产生装置对电能的转换能力来选取合适的充电电压。本发明的具体实施例中，充电电压的范围可为 5000V ～ 11000V 。
当采用上述自聚焦电磁式波源时，考虑到使用寿命和效果，其线圈 341 的匝数优选为 15 ～ 30 ，直径为 65mm ～ 130mm ，线圈 341 由铜线绕制而成，可以选用横截面为圆形或矩形的铜线。当选用横截面为圆形的铜线时，其直径范围为 0.5mm ～ 2.5mm 。当选用横截面为矩形的铜线时，该矩形的长度为 0.5 mm ～ 2.5 mm ，宽度为 0.5 mm ～ 1.5 mm ，优选长度 2mm 左右、宽度 1mm 左右的矩形。金属膜片 342 为纯铜膜，其厚度为 0.1mm ～ 0.3mm 。
我们知道，现有的体外冲击波碎石机都是依靠高压力瞬时击碎人体内的结石。而本发明中的体外冲击波碎石机产生的冲击波的焦点压力峰值在 6 MPa ～ 20MPa ，虽远小于现有的体外冲击波碎石机所产生的冲击波的焦点压力峰值，但经过实验发现对同一实验用结石，其同样能够实现理想的碎石效果。以电容在 1.5 μF ～ 2.5 μF 之间，焦点压力峰值为 16MPa 的体外冲击波碎石机为例，其经过 644 次左右的放电即可完成碎石。本发明中的体外冲击波碎石机依靠低压力碎石的机理及效果说明如下。
图 4 示出了本发明中的体外冲击波碎石机产生的冲击波的一个具体波形，焦点压力峰值约为 16MPa ，正压段底部脉宽为 3 μ s ，负压段底脉宽为 5 μ s 。图 5 示出了图 4 中所示冲击波和结石相遇时的情形。图 4 的纵轴表示的是冲击波的压力值，单位为 MPa ，横轴为时间，单位为 μ s 。
对于图 4 所示的冲击波，由于它的焦点压力峰值小，底部脉宽较宽，头部比较缓和，即频率低，所以当它遇到结石时，大部分能量透进了结石（如图 4 所示），遇到了原先存在于结石内部的杂质、小缺陷或微裂缝，就引起了高度应力集中，这就是放大了的诱导应力，造成了原有的杂质或微裂缝在该应力的作用下不断扩大，成为不可逆转的累积碎裂，按照这种方式重复多次，被打的结石因其疲劳极限等于或小于承受的压力（负压）时就突然碎裂崩溃。而且由于本发明中的冲击波的底部脉宽较宽即增加了时间跨度，因此使得累积碎裂更加明显。随着放电一次次的重复，微裂缝逐步扩大，积累到一定程度，结石便碎裂崩溃。这是一种不同的碎石机理，我们称之为中心碎裂效应。此处的应力始终为张应力，垂直或平行于冲击波运动方向。
图 4 中所示的冲击波由正压段 I 和负压段 II 组成，图 5 分别示出了正压段 I 和负压段 II 结石的碎裂情况。其中正压段 I 的冲击波运动方向与所引起的结石的碎裂方向平行，负压段 II 的冲击波方向与所引起的结石的碎裂方向垂直。即正压段 I 的冲击波所引起的结石的碎裂方向与负压段 II 的冲击波所引起的结石的碎裂方向相互垂直。结石的断裂面必然产生在最先全面达到结石的诱导应力大于结石的破坏应力的剖面上，从而引起结石的断裂。
实验时，可以根据压力的大小，很稳定的得到在不同的压力下，不同的碎裂式样。实验证明，当压力由低到高，如 6 MPa 到 30 MPa ，结石的碎裂形式发生不断的变化。当焦点压力等于 7 MPa ，出现双瓣裂。在压力增加到 9.5 MPa ，就出现三瓣碎裂。当压力增加到 17 MPa 时，就出现多瓣裂。增加到 23 MPa 时，就出现混合碎裂。增加到 29.5 MPa ，就出现纯冲击碎裂。图 6 示出的几个图片反映了压力与碎裂关系，不同的焦点压力，结石碎裂形式也不同，示于图 6 中。
图 4 所示的冲击波的压力本身较小，且在遇到结石时，大部分透进了结石，因反射而增加的压力微乎其微，所以此时结石的周边压力很小，而且产生的空化效应也很小，因而对附近的软组织几乎没有任何的副作用。
以上的具体实施例，对本发明的目的、技术方案和有益效果进行了进一步详细说明，所应注意的是，以上仅为本发明的具体实施例，本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (9)

1 、一种体外冲击波碎石机，包括一冲击波发生装置，所述冲击波发生装置具有充电电路和放电电路，所述充电电路由一电阻和一电容组成，所述放电电路由所述电容、一高压开关以及一冲击波波源装置依次串联组成，所述电容的电容值为 1.5 μF ～ 2.5 μF , 所述电容经高压开关向所述冲击波波源装置放电产生焦点压力峰值为 6MPa ～ 20MPa 的冲击波，所述冲击波的底部脉宽为 3 μs ～ 5 μs 。
2 、如权利要求 1 所述的体外冲击波碎石机，其中，充电电路的充电电压为 5000V ～ 11000V 。
3 、如权利要求 1 所述的体外冲击波碎石机，其中，电容的电容值为 1.6 μF ～ 2.4 μF 。
4 、如权利要求 1 或 3 所述的体外冲击波碎石机，其中，电容的电容值为 2.0 μF ～ 2.3 μF.
5 、如权利要求 1 所述的体外冲击波碎石机，其中，冲击波波源装置为电磁式波源、液电式波源和压电式波源中的任一种。
6 、如权利要求 1 所述的体外冲击波碎石机，其中，冲击波波源装置为电磁式波源，所述电磁式波源包括一端与电容相连且另一端与高压开关相连的线圈、与所述线圈相对设置的金属膜片 , 线圈与金属膜片之间设置一绝缘层，线圈和金属膜片作为一整体密封后置于充满水的皮囊的内腔体中。
7 、如权利要求 6 所述的体外冲击波碎石机，其中，线圈为单层螺旋球形线圈，线圈的匝数为 15 ～ 30 圈，线圈的直径为 65mm ～ 130mm ，线圈由铜线绕制而成，金属膜片是厚度为 0.1mm ～ 0.3mm 的铜膜，其中，铜线的横截面为直径 0.5mm ～ 2.5mm 的圆形或长度 0.5 mm ～ 2.5 mm 、宽度 0.5 mm ～ 1.5 mm 的矩形。
8 、如权利要求 1 所述的体外冲击波碎石机，其中，冲击波具有正压段和负压段，所述正压段引起的结石的碎裂方向和所述负压段引起的结石的碎裂方向相垂直。
9 、一种充放电电路，用于如权利要求 1-8 中的任一项所述的体外冲击波碎石机，包括充电电路和放电电路，充电电路由一电阻和一电容组成，放电电路由所述电容、一高压开关以及一冲击波波源装置组成，所述电容的电容值为 1.5 μF ～ 2.5 μF 。
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