WO2022127506A1 - Appareil de génération d'ondes de pression et dispositif médical - Google Patents

Appareil de génération d'ondes de pression et dispositif médical Download PDF

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Publication number
WO2022127506A1
WO2022127506A1 PCT/CN2021/131536 CN2021131536W WO2022127506A1 WO 2022127506 A1 WO2022127506 A1 WO 2022127506A1 CN 2021131536 W CN2021131536 W CN 2021131536W WO 2022127506 A1 WO2022127506 A1 WO 2022127506A1
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WO
WIPO (PCT)
Prior art keywords
electrode
pressure wave
positive electrode
power supply
pulse power
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PCT/CN2021/131536
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English (en)
Chinese (zh)
Inventor
胡军
刘斌
李斌
Original Assignee
深圳市赛禾医疗技术有限公司
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Publication of WO2022127506A1 publication Critical patent/WO2022127506A1/fr

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    • 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

Definitions

  • the present application relates to the technical field of medical equipment, and in particular, to a pressure wave generating device and a medical instrument.
  • Hydroelectric effect is a phenomenon in which a rapid high-voltage arc discharge occurs at the electrode in the liquid, and the arc breaks down the liquid to form an arc channel; the arc channel expands rapidly and the liquid is electrolyzed, vaporized and expanded to radiate strong pressure waves outward.
  • the "hydroelectric effect” is widely used in the field of medical technology, such as the treatment of cardiovascular diseases.
  • a high-voltage pulse power supply is usually used to discharge two oppositely arranged electrode plates to generate hydroelectric pulse pressure waves to impact vascular lesions (such as calcified lesions) to dredge the vascular calcified lesions; plate-to-plate electrodes are usually used to generate arc, thereby forming a pressure wave.
  • the arc position generated by the plate-plate electrode is uncertain, and it is difficult to accurately guide the pressure wave; and the plate-plate electrode has certain constraints on the pressure wave generated by the plate-plate electrode; it is difficult to obtain a high-intensity pressure wave.
  • the needle-plate electrode requires a high breakdown voltage, and the needle electrode is easy to wear out; this leads to a large change in the breakdown voltage of the needle-plate electrode, which affects the service life of the pressure wave generating device.
  • the present application provides a pressure wave generating device and a medical device, so as to solve the problem that the needle electrode of the needle-plate electrode in the related art is easily worn, resulting in a large change in the breakdown voltage of the needle-plate electrode.
  • a pressure wave generating device comprising: a pulse power source, an electrode and a liquid storage mechanism;
  • the pulse power source is electrically connected to the electrode, and the pulse power source is used to provide a pulse voltage for the electrode;
  • the electrode is located in the liquid storage mechanism, and a liquid conductive medium is stored in the liquid storage mechanism, and the liquid conductive medium is stored in the liquid storage mechanism. a liquid conductive medium immerses the electrodes;
  • the electrode comprises a positive electrode and a negative electrode arranged oppositely, the positive electrode is electrically connected to the positive electrode of the pulse power supply, the negative electrode is electrically connected to the negative electrode of the pulse power supply; the positive electrode is electrically connected to the negative electrode The opposite end of at least one of them is point-shaped or line-shaped; the liquid conductive medium is an aqueous solution of salt; the liquid conductive medium is used to form a conductive path between the positive electrode and the negative electrode, so as to The breakdown voltage between the positive electrode and the negative electrode is reduced.
  • the liquid conductive medium made of an aqueous solution of salt is stored in the liquid storage mechanism, and the opposite end of at least one of the positive electrode or the negative electrode of the electrode is set in a point shape or a line shape; in this way,
  • the liquid conductive medium made of an aqueous salt solution can improve the conductivity of the liquid and reduce the breakdown voltage between the positive electrode and the negative electrode; that is, the calorific value of the electrode is reduced, and the service life of the electrode can be increased.
  • the position of the point-shaped or linear electrode to generate the breakdown arc is fixed, which can accurately guide the generated shock wave or pressure wave; at the same time, the propagation and diffusion resistance of the generated shock wave or pressure wave is small, which is conducive to improving the shock wave or pressure wave. the strength of the wave.
  • the electrodes include any one of the following: wire-plate electrodes, point-plate electrodes, wire-wire electrodes, point-wire electrodes or point-point electrodes.
  • the pressure wave will propagate and diffuse in the liquid bypassing the wire electrode or the point electrode, and will not be blocked by the electrode, which can effectively improve the intensity of the pressure wave.
  • both the positive electrode and the negative electrode are annular structures to form the wire-wire electrode.
  • the wire-wire electrodes are formed by two annular-structured electrodes, which can facilitate the positioning between the wire electrodes and reduce the gap between the wire electrodes. Thus, the breakdown voltage of the electrode gap can be reduced.
  • one of the positive electrode and the negative electrode is a dot-shaped structure, and the other is a ring-shaped structure, so as to form the dot-line electrode.
  • a point-line electrode is formed by a point electrode and an electrode with a ring structure, which can facilitate the positioning between the line electrodes and reduce the gap between the line electrodes. Thus, the breakdown voltage of the electrode gap can be reduced.
  • the multiple electrodes are connected in series between the positive electrode and the negative electrode of the pulse power supply.
  • a plurality of electrodes are arranged, and after the plurality of electrodes are connected in series, the generated pressure waves can be superimposed on each other and propagate in the liquid conductive medium, which can enhance the intensity of the pressure waves.
  • the gap between the positive electrode and the negative electrode is 0.01-1 mm.
  • the gap between the electrodes is kept small, the breakdown voltage between the electrodes can be reduced, and the wear of the electrodes can be reduced.
  • the output voltage of the pulse power supply is 500-5000V.
  • the pulse width of the pulse power supply is 0.5-2 ⁇ s.
  • the liquid conductive medium includes any one of the following solutions: sodium chloride solution, potassium chloride solution, sodium phosphate solution, and potassium phosphate solution.
  • a medical device including the pressure wave generating device provided in any possible design manner of the first aspect of the present application.
  • FIG. 1 is a perspective structural schematic diagram of a first implementation manner of a pressure wave generating device provided in an embodiment of the present application
  • FIG. 2 is a perspective structural schematic diagram of a pressure wave generating device provided by an embodiment of the present application from another perspective;
  • FIG. 3 is a perspective structural schematic diagram of a second implementation manner of a pressure wave generating device provided in an embodiment of the present application.
  • FIG. 4 is a perspective structural schematic diagram of a third implementation manner of a pressure wave generating device provided by an embodiment of the present application.
  • FIG. 5 is a perspective structural schematic diagram of a fourth implementation manner of a pressure wave generating device provided by an embodiment of the present application.
  • first and second are only used for description purposes, and cannot be understood as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature delimited with “first”, “second” may expressly or implicitly include at least one of that feature.
  • plurality means at least two, such as two, three, etc., unless expressly and specifically defined otherwise.
  • the terms “installed”, “connected”, “connected”, “fixed” and other terms should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection , or integrated; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal communication between two elements or the interaction relationship between the two elements, unless otherwise clearly defined.
  • installed e.g., it may be a fixed connection or a detachable connection , or integrated; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal communication between two elements or the interaction relationship between the two elements, unless otherwise clearly defined.
  • the specific meanings of the above terms in this application can be understood according to specific situations.
  • a first feature "on” or “under” a second feature may be in direct contact with the first and second features, or the first and second features indirectly through an intermediary touch.
  • the first feature being “above”, “over” and “above” the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
  • the first feature being “below”, “below” and “below” the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.
  • orientation or positional relationship (if any) indicated by the terms “inside”, “outside”, “upper”, “bottom”, “front”, “rear”, etc. is
  • the orientation or positional relationship shown in FIG. 1 is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot It is construed as a limitation of this application.
  • the main principle of the "hydroelectric effect" is that under the action of a high-voltage and strong electric field, the electrons in the liquid between the electrodes are accelerated, and the liquid molecules near the electrodes are ionized.
  • the ionized electrons in the liquid will be accelerated by the strong electric field between the electrodes to ionize more electrons, forming an electron avalanche.
  • Plasma channels are formed in the regions where the liquid molecules are ionized. As the ionization region expands, discharge channels are formed between the electrodes, and the liquid is broken down.
  • Shock waves are also called pressure waves. Because they diffuse in the surrounding medium in the form of shock pressure, shock waves or pressure waves can produce energy gradient differences and torsional tension between tissues of different densities, resulting in biological effects and acting on the local area. tissue to achieve therapeutic effect. It is more and more widely used in modern medical technology.
  • a shock wave or pressure wave is applied for tissue destruction, and the shock wave or pressure wave has a pressure phase and a tension phase. Squeeze in the pressure phase and stretch in the tension phase.
  • the damage mechanics effect produced by the shock wave or pressure wave itself is a direct effect, and in the tension phase of the shock wave or pressure wave, the cavitation effect produced by the tension wave is an indirect effect of tissue damage.
  • shock wave or the pressure wave can also be applied in some other scenarios.
  • osteogenesis for example, osteogenesis, analgesia, metabolic activation, and inhibition or killing of tumor cells.
  • shock waves are generated by placing two electrode plates facing each other in a liquid (for example, water), and the two electrode plates are connected to the positive and negative poles of the pulse power supply;
  • the high-voltage pulse voltage causes the liquid between the plates to be broken down to form an arc; thereby forming a pressure wave.
  • the flat plate of the plate-plate electrode cannot be absolutely flat and smooth. In actual production, there will always be uneven bumps or pits. This will lead to the location where the electrical breakdown of the plate-to-plate electrode is not fixed, and it is more likely to cause the breakdown to form arcs at the bumps, while it is difficult to cause the breakdown to form arcs at the pits.
  • the unfixed position of the arc makes it difficult to determine the position of the shock wave or pressure wave, so that the shock wave or pressure wave cannot be accurately guided and act on the lesion.
  • the shock wave or pressure wave generated also needs to spread and propagate in the liquid. It is difficult to obtain high-intensity shock waves or pressure waves, and the effect on the lesion site is limited.
  • the needle-plate electrode can improve the energy injection efficiency of the arc channel or the discharge channel, thereby increasing the intensity of the pressure wave.
  • the needle electrode is easily worn out; the gap between the needle and the plate electrode changes, so that the breakdown voltage of the gap changes greatly; the service life of the electrode is affected.
  • the embodiment of the present application provides a pressure wave generating device, the main idea is to set at least one of the positive electrode or the negative electrode of the electrode into a point electrode or a line electrode;
  • the conductive medium is set to be an aqueous solution of salt.
  • higher energy can be injected into the arc channel or discharge channel, which is beneficial to improve the intensity of the pressure wave;
  • the breakdown voltage of the electrode gap is reduced, so that the service life of the electrode can be effectively improved.
  • the discharge position of the point electrode or the wire electrode is fixed, which is conducive to the precise guidance of the shock wave or the pressure wave, and the treatment of the lesion.
  • the point-shaped electrode or the wire-shaped electrode has less resistance to the propagation and diffusion of the shock wave or the pressure wave in the liquid medium, and can further improve the intensity of the shock wave or the pressure wave.
  • FIG. 1 is a perspective structural schematic diagram of a first implementation manner of a pressure wave generating device provided by an embodiment of the present application.
  • a pressure wave generating device 1 provided in an embodiment of the present application includes: a pulse power source 10 , an electrode 20 and a liquid storage mechanism 30 .
  • the pulse power supply 10 may be a single positive pulse power supply, or may be a double positive and negative pulse power supply.
  • the positive pulse turn-on time width (ie the positive pulse width) and the negative turn-on time width (ie the negative pulse width) of the positive and negative pulse power supplies can be adjusted in the full cycle respectively.
  • the pulse mode of the pulse power supply 10 in the embodiment of the present application may be a square wave pulse, which is also called a single pulse.
  • the single-pulse power supply generally outputs a one-way pulse current with fixed parameters.
  • the pulse power supply 10 may also be a double-pulse power supply or a multi-pulse power supply.
  • the electrode 20 may be made of materials such as stainless steel, copper, silver, and tungsten.
  • the electrodes 20 may be of a material that is visible under imaging equipment, eg, visible under X-rays.
  • the pulse power supply 10 is electrically connected to the electrode 20 .
  • the pulse power supply 10 is electrically connected to the electrodes 20 through wires.
  • the wire may be an aluminum core wire, a copper core wire or a silver core wire.
  • the pulse power supply 10 is used to supply pulse voltage to the electrodes 20 .
  • the liquid storage mechanism 30 of the present application may be made of insulating material, and the liquid storage mechanism 30 has a liquid storage cavity inside.
  • the liquid storage mechanism 30 may be made of a material with certain plasticity (eg elastic deformation), so that after shock waves or pressure waves are generated in the liquid storage cavity of the liquid storage mechanism 30, the shock wave Alternatively, the pressure wave can exert pressure on the wall of the fluid storage mechanism 30 to deform, so as to treat the lesion.
  • certain plasticity eg elastic deformation
  • the electrode 20 is disposed in the liquid storage cavity in the liquid storage mechanism 30 , the liquid conductive medium is stored in the liquid storage cavity in the liquid storage mechanism 30 , and the liquid conductive medium immerses the electrode 20 .
  • the liquid conductive medium may be physiological saline.
  • the liquid conductive medium may also be an aqueous solution of other electrolytes, and the concentration of which may be greater than or equal to that of physiological saline.
  • the electrode 20 usually includes a positive electrode 21 and a negative electrode 22 disposed opposite to each other, the positive electrode 21 is electrically connected to the positive electrode of the pulse power supply 10 (for example, electrically connected through a wire), and the negative electrode 22 is electrically connected to the negative electrode of the pulse power supply 10 .
  • the positive electrode 21 and the negative electrode 22 are not fixed.
  • the electrode connected to the positive electrode of the pulse power supply 10 is the positive electrode 21, and the electrode connected to the pulse power supply 10 is the positive electrode 21.
  • the electrode connected to the negative electrode of 10 is the negative electrode 22; that is, in different connection methods, the positive electrode 21 and the negative electrode 22 may change.
  • the opposite end of at least one of the positive electrode 21 and the negative electrode 22 to the other has a dot shape or a line shape.
  • one of the positive electrode 21 and the negative electrode 22 may be a needle electrode or a wire electrode.
  • both the positive electrode 21 and the negative electrode 22 may be needle electrodes or both may be wire electrodes.
  • the liquid conductive medium is used to form a conductive path between the positive electrode 21 and the negative electrode 22 , so as to reduce the breakdown voltage between the positive electrode 21 and the negative electrode 22 .
  • the opposite end of at least one of the positive electrode 21 or the negative electrode 22 of the electrode 20 is set as a dot or line
  • the liquid conductive medium made of the aqueous salt solution can improve the conductivity of the liquid and reduce the breakdown voltage between the positive electrode 21 and the negative electrode 22; that is, the calorific value of the electrode is reduced, which can improve the service life.
  • the position of the point-shaped or linear electrode to generate the breakdown arc is fixed, which can accurately guide the generated shock wave or pressure wave; at the same time, the propagation and diffusion resistance of the generated shock wave or pressure wave is small, which is conducive to improving the shock wave or pressure wave. the strength of the wave.
  • FIG. 2 is a schematic perspective view of a pressure wave generator provided by an embodiment of the present application from another perspective
  • FIG. 3 is a pressure wave generator provided by an embodiment of the present application.
  • a schematic perspective structure diagram of a second implementation of the device FIG. 4 is a perspective structure schematic diagram of a third implementation of a pressure wave generating device provided by an embodiment of the present application
  • FIG. 5 is a pressure wave generator provided by an embodiment of the present application.
  • the perspective structure diagram of the fourth implementation manner of the device is shown in FIGS. 1-5 .
  • the electrodes 20 include any one of the following: wire-plate electrodes, point-plate electrodes, wire-wire electrodes, point-wire electrodes, or point-point electrodes.
  • the wire-plate electrode may be one of the positive electrode 21 or the negative electrode 22 is a wire electrode, and the other is a plate electrode; wherein the wire electrode may be a wire, a conductive rod, or a conductive ring.
  • the shock wave or pressure wave generated in this way will propagate around the wire electrode and will not be blocked by the wire electrode; thus, a uniform and effective shock wave or pressure wave can be generated around the electrode 20 .
  • the point-plate electrode may be the electrode shown in FIG. 3 and FIG. 4 , one of the positive electrode 21 and the negative electrode 22 may be a point electrode, and the point electrode may be a needle electrode. Needle tip. The other can be a plate electrode. It can be understood that, in the embodiment of the present application, the pressure wave direction of the point-plate electrode may be emitted in the direction from the point electrode to the plate electrode. In this way, the shock wave or pressure wave is not blocked by the electrode, and a uniform shock wave or pressure wave can be generated around the electrode.
  • the line-line electrode may be that both the positive electrode 21 and the negative electrode 22 are conductive rods, and the two conductive rods are arranged parallel to each other.
  • both the positive electrode 21 and the negative electrode 22 are annular structures to form wire-wire electrodes.
  • the positive electrode 21 and the negative electrode 22 of the annular structure can be circular, elliptical, or polygonal annular structures.
  • the wire-wire electrode can also be that one of the positive electrode 21 and the negative electrode 22 is a conductive rod, and the other is a conductive ring of annular structure.
  • the point-point electrodes may be two opposing needle electrodes, and the point-line electrodes may be electrodes formed by a needle electrode and a conductive rod.
  • the point-line electrode may also be that one of the positive electrode 21 and the negative electrode 22 is a point-shaped structure, and the other is a ring-shaped structure.
  • the emission direction of the shock wave or the pressure wave may be emitted in the direction from the point electrode to the ring electrode.
  • the point electrode may be disposed at the center of the ring electrode, or may be offset from the center of the ring electrode by a certain distance.
  • the range of pressure waves or shock waves that can be generated by a single electrode 20 in the liquid conductive medium is limited, in order to enhance the strength of the pressure waves or shock waves and the propagation in the liquid conductive medium range for effective treatment of the lesion site.
  • a plurality of electrodes 20 are arranged in the liquid conductive medium, and the plurality of electrodes 20 are connected in series between the positive electrode and the negative electrode of the pulse power supply 10 .
  • multiple electrodes 20 jointly generate shock waves or pressure waves, and the shock waves or pressure waves are superimposed on each other and spread outward with the multiple electrodes 20 as the center, which can effectively enhance the intensity and diffusion range of the shock waves or pressure waves.
  • the pressure wave generating device provided in the embodiment of the present application can generate a shock wave or pressure wave with a pressure of 0.5-10 MPa, and the diffusion range of the shock wave or pressure wave can reach the range of 0-10 mm from the electrode 20 .
  • the number of electrodes 20 is set to be no more than 10 (four electrodes 20 are shown as an example in the figure).
  • the heat generation of the electrode 20 is reduced, thereby increasing the service life of the electrode.
  • the gap between the positive electrode 21 and the negative electrode 22 of the electrode 20 is kept at 0.01-1 mm. In some possible examples, the gap between the positive electrode 21 and the negative electrode 22 is 0.1-0.9 mm.
  • the output voltage of the pulse power supply 10 is 500-5000V.
  • the pulse width of the pulse power supply 10 is 0.5 to 2 ⁇ s.
  • the liquid conductive medium includes any one of the following solutions: sodium chloride solution, potassium chloride solution, sodium phosphate solution, and potassium phosphate solution.
  • concentration of the liquid conductive medium may be greater than or equal to the concentration of physiological saline (mass fraction 0.9%).
  • an embodiment of the present application provides a medical device, including the pressure wave generating device 1 provided by any optional embodiment of the first aspect of the present application.

Abstract

L'invention concerne un appareil de génération d'ondes de pression (1), comprenant : une alimentation en courant pulsé (10), des électrodes (20), et un mécanisme de stockage de liquide (30). L'alimentation en courant pulsé (10) est connectée électriquement à l'électrode (20). L'alimentation en courant pulsé (10) est utilisée pour fournir une tension pulsée aux électrodes (20). Les électrodes (20) sont situées dans le mécanisme de stockage de liquide (30). Un milieu conducteur liquide est stocké dans le mécanisme de stockage de liquide (30). Les électrodes (20) sont immergées dans le milieu conducteur liquide. Chaque électrode (20) comprend une électrode positive (21) et une électrode négative (22) qui sont disposées à l'opposé l'une de l'autre. L'électrode positive (21) est connectée électriquement à l'électrode positive de l'alimentation en courant pulsé (10), et l'électrode négative (22) est connectée électriquement à l'électrode négative de l'alimentation en courant pulsé (10). L'électrode positive (21) et/ou l'électrode négative (22) présentent au moins une extrémité opposée à l'autre en forme de pointe ou linéaire. Le milieu conducteur liquide est une solution aqueuse d'un sel. Le milieu conducteur liquide est utilisé pour former un chemin conducteur entre l'électrode positive (21) et l'électrode négative (22), de manière à réduire la tension de claquage entre l'électrode positive (21) et l'électrode négative (22). L'appareil de génération d'ondes de pression (1) améliore la durée de vie des électrodes (20), et améliore la force des ondes de choc ou des ondes de pression.
PCT/CN2021/131536 2020-12-16 2021-11-18 Appareil de génération d'ondes de pression et dispositif médical WO2022127506A1 (fr)

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CN202011488754 2020-12-16
CN202011488754.8 2020-12-16

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992012513A1 (fr) * 1990-12-26 1992-07-23 Technomed International Procede et dispositif interposant un liquide entre des electrodes dans un appareil d'ondes de choc
US6383152B1 (en) * 1997-01-24 2002-05-07 Siemens Aktiengesellschaft Apparatus for producing shock waves for technical, preferably medical applications
US20160184570A1 (en) * 2014-12-30 2016-06-30 The Spectranetics Corporation Electrically-induced fluid filled balloon catheter
US20170056035A1 (en) * 2012-09-13 2017-03-02 Shockwave Medical, Inc. Shock wave catheter system with energy control
CN108452426A (zh) * 2018-03-16 2018-08-28 上海心至医疗科技有限公司 一种基于液电效应的球囊导管
CN109069167A (zh) * 2016-04-25 2018-12-21 冲击波医疗公司 具有极性切换的冲击波装置
US20200129742A1 (en) * 2018-10-25 2020-04-30 Medtronic Vascular, Inc. Cavitation catheter
CN214907696U (zh) * 2020-12-16 2021-11-30 深圳市赛禾医疗技术有限公司 一种压力波发生装置及医疗器械

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992012513A1 (fr) * 1990-12-26 1992-07-23 Technomed International Procede et dispositif interposant un liquide entre des electrodes dans un appareil d'ondes de choc
US6383152B1 (en) * 1997-01-24 2002-05-07 Siemens Aktiengesellschaft Apparatus for producing shock waves for technical, preferably medical applications
US20170056035A1 (en) * 2012-09-13 2017-03-02 Shockwave Medical, Inc. Shock wave catheter system with energy control
US20160184570A1 (en) * 2014-12-30 2016-06-30 The Spectranetics Corporation Electrically-induced fluid filled balloon catheter
CN109069167A (zh) * 2016-04-25 2018-12-21 冲击波医疗公司 具有极性切换的冲击波装置
CN108452426A (zh) * 2018-03-16 2018-08-28 上海心至医疗科技有限公司 一种基于液电效应的球囊导管
US20200129742A1 (en) * 2018-10-25 2020-04-30 Medtronic Vascular, Inc. Cavitation catheter
CN214907696U (zh) * 2020-12-16 2021-11-30 深圳市赛禾医疗技术有限公司 一种压力波发生装置及医疗器械

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