WO2024066203A1 - 一种冲击波球囊导管装置 - Google Patents

一种冲击波球囊导管装置 Download PDF

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Publication number
WO2024066203A1
WO2024066203A1 PCT/CN2023/079488 CN2023079488W WO2024066203A1 WO 2024066203 A1 WO2024066203 A1 WO 2024066203A1 CN 2023079488 W CN2023079488 W CN 2023079488W WO 2024066203 A1 WO2024066203 A1 WO 2024066203A1
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WIPO (PCT)
Prior art keywords
electrode
inner electrode
sheath
electrode assembly
power supply
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PCT/CN2023/079488
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English (en)
French (fr)
Inventor
刘广志
江挺益
朱备备
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苏州润迈德医疗科技有限公司
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Publication of WO2024066203A1 publication Critical patent/WO2024066203A1/zh

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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
    • 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
    • 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
    • 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
    • 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
    • A61B2017/22051—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
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a shock wave balloon catheter device.
  • a shock wave balloon catheter device for vascular calcification lesions; during treatment, the balloon on the catheter is pushed into the vascular calcification area; the balloon is then inflated and pressurized with liquid; high-voltage pulses are applied to the electrode pairs in the balloon, causing the electrode pairs to discharge and generate shock waves in the liquid; the shock waves hit the balloon wall, causing the calcified plaque to rupture; after the calcified plaque ruptures, the balloon can be further inflated to open the blood vessel.
  • the electrode pair includes a first electrode and a second electrode; the first electrode and the second electrode are radially stacked from the inside to the outside on the catheter; an insulating layer is provided between the first electrode and the second electrode to prevent the second electrode from communicating with the second electrode; discharge holes are provided on the second electrode and the insulating layer respectively, so that part of the second electrode can contact the liquid in the balloon; when a voltage is applied between the first electrode and the second electrode, the first electrode and the second electrode generate a discharge arc at the discharge hole.
  • a discharge hole needs to be provided on the second electrode, resulting in high processing costs for the second electrode.
  • the embodiments of the present application provide a shock wave balloon catheter device, which avoids the need to open discharge holes on electrodes.
  • a shock wave balloon catheter device comprising a catheter, a balloon sealed around the outer circumference of the catheter, and an electrode assembly disposed in the balloon, wherein the balloon can be filled with liquid; the electrode assembly comprises an inner electrode, an insulating layer, and an outer electrode sheath;
  • the inner electrode is laid on the outer wall of the catheter;
  • the insulating layer is located on the outer periphery of the inner electrode and is used to insulate and separate the inner electrode from the outer electrode sheath;
  • the outer electrode sheath surrounds the outer periphery of the insulating layer;
  • the inner electrode comprises a discharge portion; the discharge portion is located outside the axial coverage interval of the outer electrode sheath, and the discharge portion can contact with the liquid in the balloon;
  • a discharge arc may be generated in the liquid between the discharge portion and the outer electrode sheath.
  • a shock wave balloon catheter device comprising a catheter, a sealing device surrounding A balloon on the periphery of the catheter and an electrode assembly arranged in the balloon, wherein the balloon can be filled with liquid;
  • the electrode assembly comprises an inner electrode, an insulating layer and an outer electrode sheath;
  • the inner electrode is laid on the outer wall of the catheter;
  • the insulating layer is located on the outer periphery of the inner electrode and is used to insulate and separate the inner electrode from the outer electrode sheath;
  • the outer electrode sheath surrounds the outer periphery of the insulating layer;
  • the proximal end surface of the inner electrode, the proximal end surface of the insulating layer and the proximal end surface of the outer electrode sheath are flush; the proximal end surface of the inner electrode constitutes a discharge portion;
  • the distal end surface of the inner electrode, the distal end surface of the insulating layer and the distal end surface of the outer electrode sheath are flush; the distal end surface of the inner electrode constitutes a discharge portion;
  • a discharge arc may be generated in the liquid between the discharge portion and the outer electrode sheath.
  • FIG1 is a longitudinal cross-sectional view of an electrode assembly provided in one embodiment of the present application.
  • FIG2 is a schematic diagram of the axial structure of an electrode assembly provided in one embodiment of the present application.
  • FIG3 is a radial view of an electrode assembly provided by one embodiment of the present application.
  • FIG4 is a schematic structural diagram of a shock wave balloon catheter device provided by one embodiment of the present application.
  • FIG5 is a schematic diagram of the assembly of a catheter and an electrode assembly provided by one embodiment of the present application.
  • FIG6 is a schematic diagram of the assembly of a catheter and an electrode assembly provided by another embodiment of the present application.
  • FIG7 is a radial view of an electrode assembly provided in another embodiment of the present application.
  • FIG8 is a schematic diagram of the assembly of a catheter and an electrode assembly provided by another embodiment of the present application.
  • FIG9 is a schematic diagram of an inner electrode structure provided by another embodiment of the present application.
  • FIG10 is a schematic diagram of an inner electrode structure provided by another embodiment of the present application.
  • FIG11 is a schematic diagram of an inner electrode structure provided by another embodiment of the present application.
  • FIG12 is a radial view of an electrode assembly having two inner electrodes provided in one embodiment of the present application.
  • Fig. 13 is a cross-sectional view of the A-A section of Fig. 12;
  • Fig. 14 is a cross-sectional view of the B-B section of Fig. 13;
  • FIG15 is an exploded view of a circuit connection between a first electrical component and a second electrode component provided by one embodiment of the present application;
  • FIG16 is an exploded view of the circuit connection between the first electrical component and the second electrode component provided in another embodiment of the present application.
  • proximal end in this application refers to the side close to the operator, and the distal end refers to the side away from the operator.
  • shock wave balloon catheter device of the embodiment of the present specification will be explained and described below in conjunction with Figures 1 to 16. It should be noted that in the embodiments of the present invention, the same reference numerals represent the same components. For the sake of brevity, detailed descriptions of the same components are omitted in different embodiments, and the descriptions of the same components can be referenced and quoted to each other.
  • the shock wave balloon catheter device is indicated for interventional treatment of vascular calcification.
  • the shock wave balloon catheter device comprises a catheter, a balloon sealed around the outer circumference of the catheter, and at least one electrode pair arranged in the balloon; the balloon can be filled with liquid;
  • Each of the electrode pairs includes a first electrode and a second electrode; when a voltage is applied between the first electrode and the second electrode, a plasma arc is formed in the liquid in the balloon between the first electrode and the second electrode, thereby generating bubbles in the liquid, which expand and collapse, and then form a mechanical shock wave in the balloon, which is mechanically transmitted through the liquid and the balloon to apply mechanical force or pressure to break apart any calcified plaque on or in the wall of the vascular system.
  • the balloon in a decompressed state should first be delivered to the site of the calcified lesion, and the balloon should be pressurized to ensure that it fits tightly against the blood vessel wall; then a voltage is applied between the first electrode and the second electrode, and the liquid in the balloon between the first electrode and the second electrode forms a discharge shock wave.
  • the shock wave impacts and destroys the calcified lesion, causing the calcification of the intima and the media to break.
  • the modification effect of the calcified lesion can be judged by evaluating the symmetrical expansion of the balloon.
  • the shock wave balloon catheter device efficiently and safely destroys superficial and deep calcifications, thereby significantly improving vascular compliance.
  • the device is effective not only for superficial and deep calcifications, but also for eccentric and non-eccentric lesions, reducing the risk of complications such as dissection and perforation.
  • the first electrode and the second electrode are stacked and installed on the catheter from the inside to the outside along the radial direction of the catheter; an insulating layer is provided between the first electrode and the second electrode to prevent the second electrode from communicating with the second electrode; discharge holes are provided on the second electrode and the insulating layer respectively, so that part of the first electrode can contact the liquid in the balloon; when a voltage is applied between the first electrode and the second electrode, the first electrode and the second electrode generate a discharge arc at the discharge hole.
  • an optional embodiment of the shock wave balloon catheter device includes a catheter 1, a balloon 2 sealed around the outer circumference of the catheter 1, and an electrode assembly disposed in the balloon 2; the balloon 2 may be filled with a liquid, wherein the liquid includes but is not limited to water, saline, contrast agent, and a mixture thereof;
  • the electrode assembly comprises an inner electrode 301, an insulating layer 302 and an outer electrode sheath 303; the inner electrode 301, the insulating layer 302 and the outer electrode sheath 303 are stacked and installed on the catheter 1 from the inside to the outside along the radial direction of the catheter 1; the inner electrode 301 is laid on the outer wall of the catheter 1; the insulating layer 302 is located at the outer periphery of the inner electrode 301, and is used to insulate and separate the inner electrode 301 and the outer electrode sheath 303; the outer electrode sheath 303 surrounds the outer periphery of the insulating layer 302, wherein the outer electrode sheath 303 is preferably in the shape of a hoop, which can firmly clamp the inner electrode 301 and the insulating layer 302 on the catheter 1 to prevent the inner electrode 301, the insulating layer 302 and the outer electrode sheath 303 from being displaced relative to the catheter 1; the outer periphery in this embodiment is based on
  • the inner electrode 301 includes a discharge portion 3011; the discharge portion 3011 is located in the axial direction of the outer electrode sheath 303.
  • the axial coverage interval of the outer electrode sheath 303 in this embodiment refers to the area between the proximal end face and the distal end face of the outer electrode sheath 303; therefore, the outer electrode sheath 303 does not prevent the discharge portion 3011 from contacting the liquid in the balloon 2, and the discharge portion 3011 can contact the liquid in the balloon 2 without opening a hole in the outer electrode sheath 303;
  • the outer electrode sheath 303 when a voltage is applied between the inner electrode 301 and the outer electrode sheath 303, a discharge arc is generated between the discharge portion 3011 located outside the axial coverage area of the outer electrode sheath 303 and the outer electrode sheath 303; therefore, there is no need to drill a hole in the outer electrode sheath 303, thereby reducing the processing cost; in addition, compared with the outer electrode sheath 303 with a hole, the outer electrode sheath 303 without a hole has better integrity, better mechanical properties, and a longer service life.
  • the number of the inner electrodes 301 of one of the electrode assemblies may be one or more than one, and the present application does not impose any limitation on this.
  • the inner electrode 301 is sleeve-shaped or the cross section of the inner electrode 301 is arc-shaped, surrounding the outer circumference of the conduit 1; the corresponding insulating layer 302 is sleeve-shaped, surrounding the outer circumference of the inner electrode 301.
  • the inner electrode 301 is sleeve-shaped.
  • a portion of the inner electrode 301 is covered by the insulating layer 302 and isolated from the liquid in the balloon 2; the proximal end and/or the distal end of the inner electrode 301 extends outside the axial coverage interval of the insulating layer 302. Part of the outer peripheral wall of the inner electrode 301 is located outside the axial coverage interval of the insulating layer 302, constituting the discharge portion 3011.
  • the discharge portion 3011 is annular, so the surface area of the discharge portion 3011 is large, and the position where the discharge arc occurs has a certain randomness, which avoids the electrode damage caused by too many discharges at the same or similar positions, and improves the service life of the inner electrode 301 and the outer electrode sheath 303.
  • part of the outer peripheral wall of the proximal end of the inner electrode 301 is located outside the axial coverage interval of the insulating layer 302, constituting the discharge portion 3011; the outer peripheral wall and the distal end face of the distal end of the inner electrode 301 are covered by the insulating layer 302 and cannot contact the liquid.
  • the proximal end surface of the inner electrode 301 is flush with the proximal end surface of the insulating layer 302; the proximal end surface of the inner electrode 301 constitutes the discharge portion 3011; in this optional scheme, the outer electrode sheath 303 is located within the axial section of the insulating layer 302, or the proximal end surface of the outer electrode sheath 303 is flush with the proximal end surface of the inner electrode 301; in this application, the proximal end surface of the outer electrode sheath 303 is flush with the proximal end surface of the inner electrode 301. When the proximal end surfaces are flush, the proximal end surface of the inner electrode 301 is defined as being outside the axial coverage interval of the outer electrode sheath 303 .
  • the distal end face of the inner electrode 301 is flush with the distal end face of the insulating layer 302; the distal end face of the inner electrode 301 constitutes the discharge portion 3011; in this optional scheme, the outer electrode sheath 303 is located within the axial interval of the insulating layer 302, or the distal end face of the outer electrode sheath 303 is flush with the distal end face of the inner electrode 301; in the present application, when the distal end face of the outer electrode sheath 303 is flush with the distal end face of the inner electrode 301, the distal end face of the inner electrode 301 is defined as being located outside the axial coverage interval of the outer electrode sheath 303.
  • the outer electrode sheath 303 is located within the axial section of the insulating layer 302; the insulating layer 302 is provided with a discharge hole 3021; the discharge hole 3021 is located outside the axial coverage section of the outer electrode sheath 303; the discharge hole 3021 is configured to expose part of the inner electrode 301; the exposed part of the inner electrode 301 constitutes the discharge portion 3011.
  • the inner electrode 301 includes a main body 3012 and a discharge portion 3011; the main body 3012 is sleeve-shaped and surrounds the outer periphery of the catheter 1; the discharge portion 3011 includes at least one boss; the boss is connected to the end face of the main body 3012 along the axial end of the catheter 1 and extends in the axial direction; the insulating layer 302 is sleeve-shaped and surrounds the outer periphery of the main body 3012.
  • the discharge portion 3011 is formed by the boss, so that the number and position of the boss can be configured as needed to adjust the position where the discharge arc occurs.
  • two bosses are provided on both the proximal end face and the distal end face of the main body 3012.
  • the boss is only provided on the proximal end face, and the number can be two as shown in FIG10 or four as shown in FIG11, and the present application does not limit this.
  • the electrode assembly when the number of the electrode assemblies is at least two, including but not limited to the first electrode assembly 3a and the second electrode assembly 3b; the electrode assembly is supplied with a pulse voltage through a pulse voltage generator; the power supply method of the electrode assembly includes the following embodiments:
  • the pulse voltage generator is configured with two groups of power supply circuits; the first electrode assembly 3a and the second electrode assembly 3b are respectively connected to one group of power supply circuits, so that the first electrode assembly 3a and the second electrode assembly 3b can be independently controlled for power supply.
  • the pulse voltage generator includes a first power supply terminal, a second power supply terminal and a third power supply terminal; the voltage polarity of the first power supply terminal is the same as that of the second power supply terminal; the voltage polarity of the third power supply terminal is opposite to that of the first power supply terminal; the inner electrode 301 of the first electrode assembly 3a
  • the third power supply terminal is electrically connected to the inner electrode 301 of the second electrode assembly 3b, the outer electrode sheath 303 of the first electrode assembly 3a is electrically connected to the first power supply terminal, and the outer electrode sheath 303 of the second electrode assembly 3b is electrically connected to the second power supply terminal.
  • the pulse voltage generator includes a first power supply terminal and a second power supply terminal; the voltage polarity of the first power supply terminal is opposite to that of the second power supply terminal; the inner electrode 301 of the first electrode assembly 3a is electrically connected to the first power supply terminal, the outer electrode sheath 303 of the first electrode assembly 3a is electrically connected to the second power supply terminal, the inner electrode 301 of the second electrode assembly 3b is electrically connected to the first power supply terminal, and the outer electrode sheath 303 of the second electrode assembly 3b is electrically connected to the second power supply terminal.
  • the outer electrode sheath 303 of the first electrode assembly 3a is electrically connected to the inner electrode 301 of the second electrode assembly 3b; when a voltage is applied between the inner electrode 301 of the first electrode assembly 3a and the outer electrode sheath 303 of the second electrode assembly 3b, a discharge arc is generated between the discharge portion 3011 of the inner electrode 301 of the first electrode assembly 3a and the outer electrode sheath 303 of the first electrode assembly 3a, and a discharge arc is generated between the discharge portion 3011 of the inner electrode 301 of the second electrode assembly 3b and the outer electrode sheath 303 of the second electrode assembly 3b; so as to allow current to pass through the inner electrode 301 of the first electrode assembly 3a, the outer electrode sheath 303 of the first electrode assembly 3a, the inner electrode 301 of the second electrode assembly 3b, and the outer electrode sheath 303 of the second electrode assembly 3b in sequence.
  • the outer electrode sheath 303 of the first electrode assembly 3a is not directly connected to a power source through a wire, but when a voltage is applied between the inner electrode 301 of the first electrode assembly 3a and the outer electrode sheath 303 of the second electrode assembly 3b, there is a potential difference between the outer electrode sheath 303 of the first electrode assembly 3a and the inner electrode 301 of the first electrode assembly 3a, and therefore, a voltage is deemed to be applied between the outer electrode sheath 303 of the first electrode assembly 3a and the inner electrode 301 of the first electrode assembly 3a.
  • the inner electrode 301 includes a first inner electrode 301a and a second inner electrode 301b arranged at intervals; when the first inner electrode 301a or the second inner electrode 301b is in the shape of a sleeve, the first inner electrode 301a and the second inner electrode 301b can be arranged at intervals along the axial direction, and the discharge portion 3011 of the first inner electrode 301a and the discharge portion 3011 of the second inner electrode 301b, one is located at the distal end of the outer electrode sheath 303, and the other is located at the proximal end of the outer electrode sheath 303; or as shown in Figures 12 to 14, the cross-section of the inner electrode 301 is an arc shape, and the first inner electrode 301a and the second inner electrode 301b can also be arranged at intervals along the circumferential direction.
  • the gap size between the first inner electrode 301a and the second inner electrode 301b is configured such that when a voltage is applied between the first inner electrode 301a and the second inner electrode 301b, the gap between the first inner electrode 301a and the second inner electrode 301b is No discharge arc is formed between the two inner electrodes 301b in the liquid.
  • an insulating shielding medium is arranged between the first inner electrode 301a and the second inner electrode 301b so that when a voltage is applied between the first inner electrode 301a and the second inner electrode 301b, no discharge arc is formed in the liquid between the first inner electrode 301a and the second inner electrode 301b.
  • the insulating layer 302 includes a first insulating layer 302a and a second insulating layer 302b arranged at intervals; the first insulating layer 302a covers the outer periphery of the first inner electrode 301a, and the second insulating layer 302b covers the outer periphery of the second inner electrode 301b; another optional scheme, as shown in Figures 12 to 14, the insulating layer 302 is sleeve-shaped, surrounding the outer periphery of the first inner electrode 301a and the second inner electrode 301b.
  • the first inner electrode 301 a includes a discharge portion 3011 .
  • the discharge portion 3011 of the first inner electrode 301 a is located outside the axial coverage interval of the outer electrode sheath 303 , and the discharge portion 3011 can contact the liquid in the balloon 2 .
  • a part of the first inner electrode 301a is covered by the insulating layer 302 and isolated from the liquid in the balloon 2; the proximal end and/or the distal end of the first inner electrode 301a extends outside the axial coverage interval of the insulating layer 302.
  • the discharge portion 3011 of the first inner electrode 301a includes a part of the outer peripheral wall of the first inner electrode 301a; the part of the outer peripheral wall of the first inner electrode 301a is located outside the axial coverage interval of the insulating layer 302.
  • the discharge portion 3011 of the first inner electrode 301a is annular, so the surface area of the discharge portion 3011 of the first inner electrode 301a is large, and the position where the discharge arc occurs has a certain randomness, which avoids the electrode damage caused by too many discharges at the same or similar positions, and improves the service life of the first inner electrode 301a and the outer electrode sheath 303;
  • the cross section of the other part of the inner electrode 301 located within the axial coverage interval of the insulating layer 302 can be annular, or can also be arc-shaped.
  • the proximal end face of the first inner electrode 301a is flush with the proximal end face of the insulating layer 302; the proximal end face of the first inner electrode 301a constitutes the discharge portion 3011 of the first inner electrode 301a; in this optional scheme, the outer electrode sheath 303 is located within the axial interval of the insulating layer 302, or the proximal end face of the outer electrode sheath 303 is flush with the proximal end face of the first inner electrode 301a; in the present application, when the proximal end face of the outer electrode sheath 303 is flush with the proximal end face of the first inner electrode 301a, the proximal end face of the first inner electrode 301a is defined as being located outside the axial coverage interval of the outer electrode sheath 303.
  • the distal end surface of the first inner electrode 301a is flush with the distal end surface of the insulating layer 302; the distal end surface of the first inner electrode 301a constitutes the discharge portion 3011 of the first inner electrode 301a; in this optional solution, the outer electrode sheath 303 is located within the axial section of the insulating layer 302, or the distal end surface of the outer electrode sheath 303 is flush with the distal end surface of the first inner electrode 301a; in this application, the outer When the distal end surface of the electrode sheath 303 is flush with the distal end surface of the first inner electrode 301 a , the distal end surface of the first inner electrode 301 a is defined as being outside the axial coverage interval of the outer electrode sheath 303 .
  • the outer electrode sheath 303 is located within the axial section of the insulating layer 302; the insulating layer 302 is provided with a discharge hole 3021; the discharge hole 3021 is located outside the axial coverage section of the outer electrode sheath 303; the discharge hole 3021 is configured to expose part of the first inner electrode 301a; the exposed part of the first inner electrode 301a constitutes the discharge portion 3011 of the first inner electrode 301a.
  • the discharge hole 3021 provided on the insulating layer 302 can adjust the size of the discharge gap between the discharge portion 3011 of the first inner electrode 301a and the outer electrode sheath 303, and can configure the position where the discharge arc occurs as required.
  • the first inner electrode 301a includes a main body 3012 and a discharge portion 3011; the main body 3012 is sleeve-shaped and surrounds the outer periphery of the catheter 1; the discharge portion 3011 of the first inner electrode 301a includes at least one boss; the boss is connected to the end surface of the main body 3012 along the axial end of the catheter 1 and extends in the axial direction; the insulating layer 302 is sleeve-shaped and surrounds the outer periphery of the main body 3012.
  • the discharge portion 3011 of the first inner electrode 301a is formed by the boss, so that the number and position of the boss can be configured as needed to adjust the position where the discharge arc occurs.
  • the second inner electrode 301b includes a discharge portion 3011, and the discharge portion 3011 of the second inner electrode 301b is located outside the axial coverage area of the outer electrode sheath 303, and the discharge portion 3011 can contact the liquid in the balloon 2; the relative position connection relationship between the discharge portion 3011 of the second inner electrode 301b, the axial end face of the insulating layer 302 and the axial end face of the outer electrode sheath 303 can refer to the embodiment of the first inner electrode 301a, and will not be repeated here.
  • a voltage is applied between the first inner electrode 301a and the second inner electrode 301b, so that a discharge arc is generated between the discharge portion 3011 of the first inner electrode 301a and the outer electrode sheath 303, and a discharge arc is generated between the outer electrode sheath 303 and the discharge portion 3011 of the second inner electrode 301b, so that current flows through the first inner electrode 301a, the outer electrode sheath 303, and the second inner electrode 301b in sequence.
  • the discharge position corresponding to the first inner electrode 301a and the discharge position corresponding to the second inner electrode 301b are distributed along the circumferential direction; when the first inner electrode 301a and the second inner electrode 301b are arranged at intervals along the axial direction, one of the discharge positions corresponding to the first inner electrode 301a and the discharge position corresponding to the second inner electrode 301b is located at the proximal end of the electrode assembly, and the other discharge position is located at the distal end of the electrode assembly.
  • the pulse voltage generator includes a first power supply terminal, a second power supply terminal and a third power supply terminal; the voltage polarity of the first power supply terminal is the same as that of the second power supply terminal; the voltage polarity of the third power supply terminal is opposite to that of the first power supply terminal; the first inner electrode 301a is electrically connected to the first power supply terminal; The second inner electrode 301b is electrically connected to the second power supply terminal; the outer electrode sheath 303 is electrically connected to the third power supply terminal.
  • a discharge arc can be generated in the liquid between the discharge portion 3011 of the first inner electrode 301a and the outer electrode sheath 303; when a voltage is applied between the second inner electrode 301b and the outer electrode sheath 303, a discharge arc can be generated in the liquid between the discharge portion 3011 of the second inner electrode 301b and the outer electrode sheath 303.
  • the power supply mode of at least two of the electrode assemblies includes the following embodiments:
  • the number of the electrode assemblies is at least two, including but not limited to a first electrode assembly 3a and a second electrode assembly 3b; the second inner electrode 301b of the first electrode assembly 3a is electrically connected to the first inner electrode 301a of the second electrode assembly 3b through a third wire 403; when a voltage is applied between the first inner electrode 301a of the first electrode assembly 3a and the second inner electrode 301b of the second electrode assembly 3b, a discharge arc is generated between the discharge portion 3011 of the first inner electrode 301a of the first electrode assembly 3a and the outer electrode sheath 303 of the first electrode assembly 3a and the discharge portion 3011 of the second inner electrode 301b of the first electrode assembly 3a.
  • a discharge arc is generated between the discharge part 3011 of the first inner electrode 301a of the second electrode assembly 3b and the outer electrode sheath 303 of the second electrode assembly 3b, and a discharge arc is generated between the outer electrode sheath 303 of the second electrode assembly 3b and the discharge part 3011 of the second inner electrode 301b of the second electrode assembly 3b; so as to allow current to pass through the first inner electrode 301a of the first electrode assembly 3a, the outer electrode sheath 303 of the first electrode assembly 3a, the second inner electrode 301b of the first electrode assembly 3a, the first inner electrode 301a of the second electrode assembly 3b, the outer electrode sheath 303 of the second electrode assembly 3b, and the second inner electrode 301b of the second electrode assembly 3b in sequence.
  • the first inner electrode 301a of the first electrode assembly 3a is electrically connected to the first power supply terminal of the pulse generator through the first wire 401
  • the second inner electrode 301b of the second electrode assembly 3b is electrically connected to the second power supply terminal of the pulse generator through the second wire 402; the voltage polarities of the first power supply terminal and the second power supply terminal are opposite.
  • the pulse voltage generator includes a plurality of power supply units, each power supply unit corresponds to one of the electrode assemblies, forming an independent current loop.
  • the number of the electrode assemblies is at least two, including but not limited to a first electrode assembly 3a and a second electrode assembly 3b; the first inner electrode 301a of the first electrode assembly 3a and the first inner electrode 301a of the second electrode assembly 3b are electrically connected to a first power supply terminal of the pulse voltage generator; the second inner electrode 301b of the first electrode assembly 3a and the second inner electrode 301b of the second electrode assembly 3b are electrically connected to a second power supply terminal of the pulse voltage generator; the outer electrode sheath 303 of the first electrode assembly 3a is electrically connected to a first power supply terminal of the pulse voltage generator; Connected to the third power supply terminal of the pulse voltage generator; the outer electrode sheath 303 of the second electrode assembly 3b is electrically connected to the fourth power supply terminal of the pulse voltage generator; the voltage polarity of the first power supply terminal is the same as that of the second power supply terminal; the voltage polarity of the third power supply terminal is the same as that of the fourth power supply terminal; the voltage polarity of
  • a discharge arc may be generated in the liquid between the discharge portion 3011 of the first inner electrode 301a of the first electrode assembly 3a and the outer electrode sheath 303 of the first electrode assembly 3a;
  • a discharge arc may be generated in the liquid between the discharge portion 3011 of the first inner electrode 301a of the second electrode assembly 3b and the outer electrode sheath 303 of the second electrode assembly 3b;
  • a discharge arc may be generated in the liquid between the discharge portion 3011 of the second inner electrode 301b of the first electrode assembly 3a and the outer electrode sheath 303 of the first electrode assembly 3a;
  • a discharge arc may be generated in the liquid between the discharge portion 3011 of the second inner electrode 301b of the first electrode assembly 3a and the outer electrode sheath 303 of the first electrode assembly 3a;
  • a discharge arc may be generated in the liquid between the discharge portion 3011 of the second inner electrode 301b of the second electrode assembly 3b
  • the number of electrode assemblies is at least two, including but not limited to a first electrode assembly 3a and a second electrode assembly 3b; the first inner electrode 301a of the first electrode assembly 3a is electrically connected to the first inner electrode 301a of the second electrode assembly 3b through a fourth wire 404, and the first inner electrode 301a of the first electrode assembly 3a is electrically connected to the first power supply terminal of the pulse voltage generator through a fifth wire 405; the second inner electrode 301b of the first electrode assembly 3a is electrically connected to the second inner electrode 301b of the second electrode assembly 3b through a sixth wire 406, and the second inner electrode 301b of the first electrode assembly 3a is electrically connected to the second power supply terminal of the pulse voltage generator through a seventh wire 407; the voltage polarity of the first power supply terminal and the second power supply terminal On the contrary; when the pulse voltage generator is supplying power, in the first electrode assembly 3a, a discharge arc is generated between the discharge portion 3011 of the first inner electrode 301
  • the number of the inner electrodes 301 of one electrode assembly may also be more than two, that is, the inner electrodes 301 include but are not limited to the first inner electrode 301a and the second inner electrode 301b.
  • Each of the inner electrodes 301 includes a discharge portion 3011; each of the discharge portions 3011 is located outside the axial coverage interval of the outer electrode sheath 303, and each of the discharge portions 3011 A voltage is applied between each of the inner electrodes 301 and the outer electrode sheath 303 , and a discharge arc is generated between the discharge portion 3011 of each of the inner electrodes 301 and the outer electrode sheath 303 .

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Abstract

本申请实施例提供一种冲击波球囊导管装置，包括导管、密封围绕在导管外周的球囊和设置在球囊内的电极组件，球囊内可填充液体；电极组件包括内电极、绝缘层和外电极护套；内电极铺设在导管外壁；绝缘层位于内电极外周，用于绝缘分隔内电极与外电极护套；外电极护套围绕在绝缘层的外周；内电极包括放电部；放电部位于外电极护套的轴向覆盖区间之外，并且放电部能与球囊内的液体接触；当在内电极与外电极护套之间施加电压时，放电部与外电极护套之间产生放电电弧。本申请提供的实施例，当在内电极与外电极护套之间施加电压时，位于外电极护套的轴向覆盖区间之外的放电部与外电极护套之间产生放电电弧，避免在外电极护套上开孔，降低了加工成本。

Description

一种冲击波球囊导管装置 技术领域
本申请涉及医疗器械技术领域，具体涉及一种冲击波球囊导管装置。
背景技术
随着心脏病患者年龄的增长和疾病的进展，外周血管及冠状动脉中的斑块会逐渐钙化。这种骨状结构类似物会造成脉管狭窄，降低脉管血流量，最终可能导致脉管完全闭塞。
针对脉管钙化病灶，提供了一种冲击波球囊导管装置；在治疗时，导管上的球囊被推进至脉管钙化区域；然后用液体对球囊膨胀加压；向球囊中的电极对施加高压脉冲，使电极对放电在液体中产生冲击波；冲击波撞击球囊壁，使钙化斑块破裂；钙化斑块破裂后，球囊可以进一步膨胀以打通脉管。
在冲击波球囊导管装置的一个可选实施例中，所述电极对包括第一电极和第二电极；所述第一电极与所述第二电极沿径向由内向外层叠安装在导管上；所述第一电极与所述第二电极之间设置有一层绝缘层，以阻止所述第二电极与所述第二电极连通；所述第二电极及所述绝缘层上分别设置有放电孔，以使得所述第二电极的部分可接触球囊内的液体；当在所述第一电极与所述第二电极之间施加电压时，所述第一电极与所述第二电极在放电孔处产生放电电弧。该实施例中，需要在第二电极上开设放电孔，导致第二电极的加工成本高。
发明内容
本申请的实施例提供了一种冲击波球囊导管装置，避免在了电极上开设放电孔。
在本申请的一个实施例中，提供了一种冲击波球囊导管装置，包括导管、密封围绕在导管外周的球囊和设置在球囊内的电极组件，所述球囊内可填充液体；所述电极组件包括内电极、绝缘层和外电极护套；
所述内电极铺设在所述导管外壁；所述绝缘层位于所述内电极外周，用于绝缘分隔所述内电极与所述外电极护套；所述外电极护套围绕在所述绝缘层的外周；
所述内电极包括放电部；所述放电部位于所述外电极护套的轴向覆盖区间之外，并且所述放电部能与球囊内的液体接触；
当在所述内电极与所述外电极护套之间施加电压时，所述放电部与所述外电极护套之间可在液体中产生放电电弧。
在本申请的另一个实施例中，提供了一种冲击波球囊导管装置，包括导管、密封围绕在 导管外周的球囊和设置在球囊内的电极组件，所述球囊内可填充液体；所述电极组件包括内电极、绝缘层和外电极护套；
所述内电极铺设在所述导管外壁；所述绝缘层位于所述内电极外周，用于绝缘分隔所述内电极与所述外电极护套；所述外电极护套围绕在所述绝缘层的外周；
所述内电极的近端端面、所述绝缘层的近端端面与所述外电极护套的近端端面齐平；所述内电极的近端端面构成放电部；
和/或，
所述内电极的远端端面、所述绝缘层的远端端面与所述外电极护套的远端端面齐平；所述内电极的远端端面构成放电部；
当在所述内电极与所述外电极护套之间施加电压时，所述放电部与所述外电极护套之间可在液体中产生放电电弧。
本申请提供的实施例，当在所述内电极与所述外电极护套之间施加电压时，位于所述外电极护套的轴向覆盖区间之外的所述放电部与所述外电极护套之间产生放电电弧，避免在外电极护套上开孔，降低了加工成本。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域技术人员来讲，在不付出创造性劳动力的前提下，还可以根据这些附图获得其他的附图。
图1为本申请一个实施例提供的电极组件的纵截面剖面图；
图2为本申请一个实施例提供的电极组件的轴向结构示意图；
图3为本申请一个实施例提供的电极组件的径向视图；
图4为本申请一个实施例提供的冲击波球囊导管装置的结构示意图；
图5为本申请一个实施例提供的导管与电极组件的装配示意图；
图6为本申请另一个实施例提供的导管与电极组件的装配示意图；
图7为本申请另一个实施例提供的电极组件的径向视图；
图8为本申请另一个实施例提供的导管与电极组件的装配示意图；
图9为本申请另一个实施例提供的内电极结构示意图；
图10为本申请另一个实施例提供的内电极结构示意图；
图11为本申请另一个实施例提供的内电极结构示意图；
图12为本申请一个实施例提供的具有两个内电极的电极组件的径向视图；
图13为图12的A-A截面的剖面图；
图14为图13的B-B截面的剖面图；
图15为本申请一个实施例提供的第一电组件与第二电极组件的电路连接爆炸图；
图16为本申请另一个实施例提供的第一电组件与第二电极组件的电路连接爆炸图。
附图标记说明：
1、导管；
2、球囊；
3a、第一电极组件；3b、第二电极组件；301、内电极；302、绝缘层；303、外电极护
套；3011、放电部；3012、主体；3021、放电孔；301a、第一内电极；301b、第二内电极；302a、第一绝缘层；302b、第二绝缘层；
401、第一导线；402、第二导线；403、第三导线；404、第四导线；405、第五导线；
406、第六导线；407、第七导线。
具体实施方式
下面将结合附图和具体实施方式，对本发明的技术方案作详细说明，应理解这些实施方式仅用于说明本发明而不用于限制范围，在阅读了本发明之后，本领域技术人员对本发明的各种等价形式的修改均落入本申请所限定的范围内。
需要说明的是，当元件被称为“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本申请中的“近端”指的是靠近操作者的一侧，“远端”指的是远离操作者的一侧。
下面将结合图1至图16对本说明书实施例的冲击波球囊导管装置进行解释和说明。需要说明的是，在本发明的实施例中，相同的附图标记表示相同的部件。而为了简洁，在不同的实施例中，省略对相同部件的详细说明，且相同部件的说明可互相参照和引用。
随着心脏病患者年龄的增长和疾病的进展，外周血管及冠状动脉中的斑块会逐渐钙化。这种骨状结构类似物会造成脉管狭窄，降低脉管血流量，最终可能导致脉管完全闭塞。
冲击波球囊导管装置适应症包括介入治疗血管钙化病变。冲击波球囊导管装置包括导管、密封围绕在导管外周的球囊和设置在球囊内的至少一个电极对；所述球囊内能填充液体； 每个所述电极对包括第一电极和第二电极；当在所述第一电极与所述第二电极之间施加电压时，所述第一电极与所述第二电极之间在球囊内的液体形成等离子体电弧，从而在液体内生成气泡，该气泡会膨胀和崩塌，继而在气囊中形成机械冲击波，该机械冲击波通过液体及球囊机械地传导以施加机械力或压力以使脉管系统壁上或脉管系统壁中的任何钙化斑块分裂开。
在该装置临床工作时，应首先将泄压状态的球囊递送至钙化病变部位，将球囊加压以确保与血管壁紧密贴合；然后向所述第一电极与所述第二电极之间施加电压，所述第一电极与所述第二电极之间在球囊内的液体形成放电冲击波。冲击波冲击并破坏钙化病变，导致内膜和中膜钙化断裂。可通过评估球囊对称膨胀情况来判断钙化病变的修饰效果。
冲击波球囊导管装置以高效和安全地破坏浅表与深层钙化，从而明显地改善血管顺应性。该器械不仅对浅层钙化和深层钙化均有效，同时对于偏心性病变和非偏心病变亦具有治疗作用，降低夹层和穿孔等并发症的风险。
在一个可选实施例中，所述第一电极与所述第二电极沿导管径向由内向外层叠安装在导管上；所述第一电极与所述第二电极之间设置有一层绝缘层，以阻止所述第二电极与所述第二电极连通；所述第二电极及所述绝缘层上分别设置有放电孔，以使得所述第一电极的部分可接触球囊内的液体；当在所述第一电极与所述第二电极之间施加电压时，所述第一电极与所述第二电极在放电孔处产生放电电弧。该实施例中，需要在第二电极上开孔，导致第二电极的加工成本高；另外在第二电极上开孔，也会破坏第二电极的整体性，导致第二电极的机械性能下降，影响使用寿命。
如图1至图5所示，本申请提供的冲击波球囊导管装置的一个可选实施例，包括导管1、密封围绕在导管1外周的球囊2和设置在球囊2内的电极组件；所述球囊2内可填充液体，其中所述液体包括但不限于水,盐水,造影剂及其混合物；
所述电极组件包括内电极301、绝缘层302和外电极护套303；所述内电极301、所述绝缘层302和所述外电极护套303沿导管1径向由内向外的层叠安装在导管1上；所述内电极301铺设在所述导管1外壁；所述绝缘层302位于所述内电极301外周，用于绝缘分隔所述内电极301与所述外电极护套303；所述外电极护套303围绕在所述绝缘层302的外周，其中所述外电极护套303优选为套箍状，可以将所述内电极301及所述绝缘层302牢牢箍在导管1上，防止所述内电极301、所述绝缘层302和所述外电极护套303相对导管1产生位移；本实施例中的外周，以所述导管1轴心为基准；
所述内电极301包括放电部3011；所述放电部3011位于所述外电极护套303的轴向覆 盖区间之外，并且所述放电部3011能与球囊2内的液体接触；本实施例中的所述外电极护套303的轴向覆盖区间，指的是所述外电极护套303的近端端面与远端端面之间的区域；因此所述外电极护套303并不会阻碍所述放电部3011与球囊2内的液体接触，无需在上述外电极护套303上开孔，即可实现所述放电部3011与球囊2内的液体接触；
当在所述内电极301与所述外电极护套303之间施加电压时，所述放电部3011与所述外电极护套303之间产生放电电弧。
本申请提供的实施例，当在所述内电极301与所述外电极护套303之间施加电压时，位于所述外电极护套303的轴向覆盖区间之外的所述放电部3011与所述外电极护套303之间产生放电电弧；因此不需要在外电极护套303上开孔，降低了加工成本；另外不开孔的外电极护套303相比于开孔的外电极护套303，具有更好的整体性，机械性能更优，使用寿命得到了提高。
本申请中一个所述电极组件的所述内电极301的数量，可以是一个，也可以是一个以上，本申请对此不做限制。
在一个所述电极组件的所述内电极301的数量为一个的实施例中，所述内电极301为套筒状或者所述内电极301横截面为圆弧状，围绕在所述导管1的外周；相应的所述绝缘层302是套筒状，围绕在所述内电极301的外周。图1至图3所示的实施例中，所述内电极301为套筒状。
如图1，本实施例的一个可选方案中，所述内电极301的一部分被所述绝缘层302覆盖，与球囊2内的液体隔离；所述内电极301的近端和/或远端延伸至所述绝缘层302的轴向覆盖区间之外。所述内电极301的部分外周壁位于所述绝缘层302的轴向覆盖区间之外，构成所述放电部3011。在本可选方案中，所述放电部3011为圆环状，因此放电部3011表面积较大，且发生放电电弧的位置具有一定随机性，避免了电极在相同或相近位置的放电次数过多而造成电极损伤，提高了内电极301和外电极护套303的使用寿命。由图1和图3可知，所述内电极301近端的部分外周壁位于所述绝缘层302的轴向覆盖区间之外，构成所述放电部3011；所述内电极301远端端的外周壁及远端端面均被所述绝缘层302覆盖，不能接触液体。
本实施例的另一个可选方案中，所述内电极301的近端端面与所述绝缘层302的近端端面齐平；所述内电极301的近端端面构成所述放电部3011；在该可选方案中，所述外电极护套303位于所述绝缘层302的轴向区间之内，或者所述外电极护套303的近端端面与所述内电极301的近端端面齐平；本申请中，所述外电极护套303的近端端面与所述内电极301的 近端端面齐平时，将所述内电极301的近端端面定义为位于所述外电极护套303的轴向覆盖区间之外。
本实施例的另一个可选方案中，所述内电极301的远端端面与所述绝缘层302的远端端面齐平；所述内电极301的远端端面构成所述放电部3011；在该可选方案中，所述外电极护套303位于所述绝缘层302的轴向区间之内，或者所述外电极护套303的远端端面与所述内电极301的远端端面齐平；本申请中，所述外电极护套303的远端端面与所述内电极301的远端端面齐平时，将所述内电极301的远端端面定义为位于所述外电极护套303的轴向覆盖区间之外。
如图6和图7，本实施例的又一个可选方案中，所述外电极护套303位于所述绝缘层302的轴向区间之内；所述绝缘层302上设置有放电孔3021；所述放电孔3021位于所述外电极护套303的轴向覆盖区间之外；所述放电孔3021被配置为使得所述内电极301的部分露出；所述内电极301的露出部分构成所述放电部3011。通过设置在绝缘层302上的放电孔3021，一方面能够调整所述放电部3011与所述外电极护套303之间的放电间隙的大小，另一方面能够根据需要配置发生放电电弧的位置。
如图8和图9，在一个所述电极组件的所述内电极301的数量为一个的另一实施例中，所述内电极301包括主体3012和放电部3011；所述主体3012为套筒状，并围绕在所述导管1的外周；所述放电部3011包括至少一个凸台；所述凸台连接在所述主体3012沿所述导管1轴向一端的端面上，且沿轴向延伸；所述绝缘层302为套筒状，围绕在所述主体3012的外周。本实施例通过凸台构成放电部3011，从而能够根据需要配置凸台的数量及位置，调整发生放电电弧的位置。图8和图9的实施例中，所述主体3012的近端端面和远端端面均设置有两个所述凸台。图10和图11的实施例中，所述凸台仅设置在近端端面，数量可以是图10所示的两个，也可以是图11所示的四个，本申请对此不作限制。
上述实施例中，当所述电极组件的数量为至少两个，包括但不限于第一电极组件3a和第二电极组件3b；所述电极组件通过脉冲电压发生器供应脉冲电压；所述电极组件的供电方式包括以下实施例：
在一个可选实施例中，所述脉冲电压发生器配置了两组供电回路；所述第一电极组件3a和所述第二电极组件3b分别连接一组供电回路，可实现所述第一电极组件3a和所述第二电极组件3b独立控制供电。在一个可选方案中，所述脉冲电压发生器包括第一供电端子、第二供电端子和第三供电端子；所述第一供电端子与所述第二供电端子的电压极性相同；所述第三供电端子与所述第一供电端子的电压极性相反；所述第一电极组件3a的所述内电极301 与所述第二电极组件3b的所述内电极301共同电连接所述第三供电端子，所述第一电极组件3a的所述外电极护套303电连接所述第一供电端子，所述第二电极组件3b的所述外电极护套303电连接所述第二供电端子。
在另一个可选实施例中，所述脉冲电压发生器包括第一供电端子和第二供电端子；所述第一供电端子与所述第二供电端子的电压极性相反；所述第一电极组件3a的所述内电极301电连接所述第一供电端子，所述第一电极组件3a的所述外电极护套303电连接所述第二供电端子，所述第二电极组件3b的所述内电极301电连接所述第一供电端子，所述第二电极组件3b的所述外电极护套303电连接所述第二供电端子。
在又一个可选实施例中，所述第一电极组件3a的所述外电极护套303电连接至所述第二电极组件3b的所述内电极301；在所述第一电极组件3a的所述内电极301与所述第二电极组件3b的所述外电极护套303之间施加电压时，使得所述第一电极组件3a的所述内电极301的所述放电部3011与所述第一电极组件3a的所述外电极护套303之间产生放电电弧，所述第二电极组件3b的所述内电极301的所述放电部3011与所述第二电极组件3b的所述外电极护套303之间产生放电电弧；以允许电流依次通过所述第一电极组件3a的所述内电极301、所述第一电极组件3a的所述外电极护套303、所述第二电极组件3b的所述内电极301、所述第二电极组件3b的所述外电极护套303。在该实施例中，所述第一电极组件3a的所述外电极护套303并未通过导线直接连接电源，但是当在所述第一电极组件3a的所述内电极301与所述第二电极组件3b的所述外电极护套303之间施加电压时，所述第一电极组件3a的所述外电极护套303与所述第一电极组件3a的所述内电极301之间具有电势差，因此视为在所述第一电极组件3a的所述外电极护套303与所述第一电极组件3a的所述内电极301之间施加了电压。
在一个所述电极组件的所述内电极301的数量为两个的实施例中，所述内电极301包括间隔布置的第一内电极301a和第二内电极301b；所述第一内电极301a或所述第二内电极301b为套筒状时，所述第一内电极301a与所述第二内电极301b可以沿轴向间隔布置，则所述第一内电极301a的放电部3011与所述第二内电极301b的放电部3011，一者位于所述外电极护套303的远端，另一者位于所述外电极护套303的近端；或者如图12至图14所示，所述内电极301横截面为圆弧状，所述第一内电极301a与所述第二内电极301b也可以沿周向间隔布置。
可选的，所述第一内电极301a与所述第二内电极301b之间的间隙大小被配置为当在所述第一内电极301a与所述第二内电极301b之间施加电压时，所述第一内电极301a与所述第 二内电极301b之间在液体中不形成放电电弧。
可选的，所述第一内电极301a与所述第二内电极301b之间设置有绝缘屏蔽介质，以使得当在所述第一内电极301a与所述第二内电极301b之间施加电压时，所述第一内电极301a与所述第二内电极301b之间在液体中不形成放电电弧。
本实施例中，可选的，所述绝缘层302包括间隔布置的第一绝缘层302a和第二绝缘层302b；所述第一绝缘层302a覆盖在所述第一内电极301a外周，所述第二绝缘层302b覆盖在所述第二内电极301b外周；另一可选方案，如图12至图14所示，所述绝缘层302为套筒状，围绕在所述第一内电极301a及所述第二内电极301b的外周。
所述第一内电极301a包括放电部3011，所述第一内电极301a的所述放电部3011位于所述外电极护套303的轴向覆盖区间之外，并且所述放电部3011能与球囊2内的液体接触。
本实施例的一个可选方案中，所述第一内电极301a的一部分被所述绝缘层302覆盖，与球囊2内的液体隔离；所述第一内电极301a的近端和/或远端延伸至所述绝缘层302的轴向覆盖区间之外。所述第一内电极301a的所述放电部3011包括所述第一内电极301a的部分外周壁；所述第一内电极301a的部分外周壁位于所述绝缘层302的轴向覆盖区间之外。在本可选方案中，所述第一内电极301a的所述放电部3011为圆环状，因此所述第一内电极301a的所述放电部3011表面积较大，且发生放电电弧的位置具有一定随机性，避免了电极在相同或相近位置的放电次数过多而造成电极损伤，提高了第一内电极301a和外电极护套303的使用寿命；位于所述绝缘层302的轴向覆盖区间之内的另一部分所述内电极301的横截面可以是圆环状，或者也可以是圆弧状。
本实施例的另一个可选方案中，所述第一内电极301a的近端端面与所述绝缘层302的近端端面齐平；所述第一内电极301a的近端端面构成所述第一内电极301a的所述放电部3011；在该可选方案中，所述外电极护套303位于所述绝缘层302的轴向区间之内，或者所述外电极护套303的近端端面与所述第一内电极301a的近端端面齐平；本申请中，所述外电极护套303的近端端面与所述第一内电极301a的近端端面齐平时，将所述第一内电极301a的近端端面定义为位于所述外电极护套303的轴向覆盖区间之外。
本实施例的另一个可选方案中，所述第一内电极301a的远端端面与所述绝缘层302的远端端面齐平；所述第一内电极301a的远端端面构成所述第一内电极301a的所述放电部3011；在该可选方案中，所述外电极护套303位于所述绝缘层302的轴向区间之内，或者所述外电极护套303的远端端面与所述第一内电极301a的远端端面齐平；本申请中，所述外 电极护套303的远端端面与所述第一内电极301a的远端端面齐平时，将所述第一内电极301a的远端端面定义为位于所述外电极护套303的轴向覆盖区间之外。
本实施例的又一个可选方案中，所述外电极护套303位于所述绝缘层302的轴向区间之内；所述绝缘层302上设置有放电孔3021；所述放电孔3021位于所述外电极护套303的轴向覆盖区间之外；所述放电孔3021被配置为使得所述第一内电极301a的部分露出；所述第一内电极301a的露出部分构成所述第一内电极301a的所述放电部3011。通过设置在绝缘层302上的放电孔3021，一方面能够调整所述第一内电极301a的所述放电部3011与所述外电极护套303之间的放电间隙的大小，另一方面能够根据需要配置发生放电电弧的位置。
在一个所述电极组件的所述内电极301的数量为两个的另一实施例中，所述第一内电极301a包括主体3012和放电部3011；所述主体3012为套筒状，并围绕在所述导管1的外周；所述第一内电极301a的所述放电部3011包括至少一个凸台；所述凸台连接在所述主体3012沿所述导管1轴向一端的端面上，且沿轴向延伸；所述绝缘层302为套筒状，围绕在所述主体3012的外周。本实施例通过凸台构成所述第一内电极301a的所述放电部3011，从而能够根据需要配置凸台的数量及位置，调整发生放电电弧的位置。
所述第二内电极301b包括放电部3011，所述第二内电极301b的所述放电部3011位于所述外电极护套303的轴向覆盖区间之外，并且所述放电部3011能与球囊2内的液体接触；所述第二内电极301b的所述放电部3011、所述绝缘层302的轴向端面与所述外电极护套303的轴向端面之间的相对位置连接关系可参考所述第一内电极301a的实施例，在此不做赘述。
单个所述电极组件的供电方式包括以下实施例：
在一个可选实施例中，在所述第一内电极301a与所述第二内电极301b之间施加电压，使得所述第一内电极301a的所述放电部3011与所述外电极护套303之间产生放电电弧，所述外电极护套303与所述第二内电极301b的所述放电部3011之间产生放电电弧，以使得电流依次流经所述第一内电极301a、所述外电极护套303、所述第二内电极301b。所述第一内电极301a与所述第二内电极301b沿周向间隔布置时，所述第一内电极301a对应的放电位置与所述第二内电极301b对应的放电位置沿周向分布；所述第一内电极301a与所述第二内电沿轴向间隔布置时，所述第一内电极301a对应的放电位置与所述第二内电极301b对应的放电位置中，一个放电位置位于所述电极组件近端，另一个放电位置位于所述电极组件远端。
在另一个可选实施例中，所述脉冲电压发生器包括第一供电端子、第二供电端子和第三供电端子；所述第一供电端子与所述第二供电端子的电压极性相同；所述第三供电端子与所述第一供电端子的电压极性相反；所述第一内电极301a电连接在所述第一供电端子上；所 述第二内电极301b电连接在所述第二供电端子上；所述外电极护套303电连接在所述第三供电端子上。当在所述第一内电极301a与所述外电极护套303之间施加电压时，所述第一内电极301a的所述放电部3011与所述外电极护套303之间可在液体中产生放电电弧；当在所述第二内电极301b与所述外电极护套303之间施加电压时，所述第二内电极301b的所述放电部3011与所述外电极护套303之间可在液体中产生放电电弧。
上述实施例中，当所述电极组件的数量为至少两个，至少两个所述电极组件的供电方式包括以下实施例：
在如图15的可选实施例中，所述电极组件的数量为至少两个，包括但不限于第一电极组件3a和第二电极组件3b；所述第一电极组件3a的所述第二内电极301b通过第三导线403电连接至所述第二电极组件3b的所述第一内电极301a；当在所述第一电极组件3a的所述第一内电极301a与所述第二电极组件3b的所述第二内电极301b之间施加电压时，所述第一电极组件3a的所述第一内电极301a的所述放电部3011与所述第一电极组件3a的所述外电极护套303之间产生放电电弧，所述第一电极组件3a的所述外电极护套303与所述第一电极组件3a的所述第二内电极301b的所述放电部3011之间产生放电电弧，所述第二电极组件3b的所述第一内电极301a的所述放电部3011与所述第二电极组件3b的所述外电极护套303之间产生放电电弧，所述第二电极组件3b的所述外电极护套303与所述第二电极组件3b的所述第二内电极301b的所述放电部3011之间产生放电电弧；以允许电流依次通过所述第一电极组件3a的所述第一内电极301a、所述第一电极组件3a的所述外电极护套303、所述第一电极组件3a的所述第二内电极301b、所述第二电极组件3b的所述第一内电极301a、所述第二电极组件3b的所述外电极护套303、所述第二电极组件3b的所述第二内电极301b。图15中，所述第一电极组件3a的所述第一内电极301a通过第一导线401电连接脉冲发生器的第一供电端子，所述第二电极组件3b的所述第二内电极301b通过第二导线402电连接脉冲发生器的第二供电端子；所述第一供电端子与所述第二供电端子的电压极性相反。
在另一个可选实施例中，所述脉冲电压发生器包括多个供电单元，每个供电单元对应一个所述电极组件，形成独立的电流回路。
在又一个可选实施例中，所述电极组件的数量为至少两个，包括但不限于第一电极组件3a和第二电极组件3b；所述第一电极组件3a的所述第一内电极301a与所述第二电极组件3b的所述第一内电极301a共同电连接至所述脉冲电压发生器的第一供电端子；所述第一电极组件3a的所述第二内电极301b与所述第二电极组件3b的所述第二内电极301b共同电连接至所述脉冲电压发生器的第二供电端子；所述第一电极组件3a的所述外电极护套303电 连接至所述脉冲电压发生器的第三供电端子；所述第二电极组件3b的所述外电极护套303电连接至所述脉冲电压发生器的第四供电端子；所述第一供电端子与所述第二供电端子的电压极性相同；所述第三供电端子与所述第四供电端子的电压极性相同；所述第三供电端子与所述第一供电端子的电压极性相反。当在所述第一供电端子与所述第三供电端子之间施加电压时，所述第一电极组件3a的所述第一内电极301a的所述放电部3011与所述第一电极组件3a的所述外电极护套303之间可在液体中产生放电电弧；当在所述第一供电端子与所述第四供电端子之间施加电压时，所述第二电极组件3b的所述第一内电极301a的所述放电部3011与所述第二电极组件3b的所述外电极护套303之间可在液体中产生放电电弧；当在所述第二供电端子与所述第三供电端子之间施加电压时，所述第一电极组件3a的所述第二内电极301b的所述放电部3011与所述第一电极组件3a的所述外电极护套303之间可在液体中产生放电电弧；当在所述第二供电端子与所述第四供电端子之间施加电压时，所述第二电极组件3b的所述第二内电极301b的所述放电部3011与所述第二电极组件3b的所述外电极护套303之间可在液体中产生放电电弧。
在图16所示的可选实施例中，所述电极组件的数量为至少两个，包括但不限于第一电极组件3a和第二电极组件3b；所述第一电极组件3a的所述第一内电极301a通过第四导线404电连接所述第二电极组件3b的所述第一内电极301a，所述第一电极组件3a的所述第一内电极301a通过第五导线405电连接至所述脉冲电压发生器的第一供电端子；所述第一电极组件3a的所述第二内电极301b通过第六导线406电连接所述第二电极组件3b的所述第二内电极301b，所述第一电极组件3a的所述第二内电极301b通过第七导线407电连接至所述脉冲电压发生器的第二供电端子；所述第一供电端子与所述第二供电端子的电压极性相反；当所述脉冲电压发生器供电时，所述第一电极组件3a中，所述第一内电极301a的所述放电部3011与所述外电极护套303之间产生放电电弧，所述外电极护套303与所述第二内电极301b的所述放电部3011之间产生放电电弧，以使得电流依次流经所述第一内电极301a、所述外电极护套303、所述第二内电极301b；所述第二电极组件3b中，所述第一内电极301a的所述放电部3011与所述外电极护套303之间产生放电电弧，所述外电极护套303与所述第二内电极301b的所述放电部3011之间产生放电电弧，以使得电流依次流经所述第一内电极301a、所述外电极护套303、所述第二内电极301b。
一个所述电极组件的所述内电极301的数量也可以为两个以上，即所述内电极301包括但不限于第一内电极301a和第二内电极301b。每个所述内电极301均包括放电部3011；每个所述放电部3011位于所述外电极护套303的轴向覆盖区间之外，并且每个所述放电部3011 能与球囊2内的液体接触；在每个所述内电极301与所述外电极护套303之间施加电压，每个所述内电极301的所述放电部3011与所述外电极护套303之间分别产生放电电弧。
需要说明的是，在本说明书的描述中，术语“第一”、“第二”等仅用于描述目的和区别类似的对象，两者之间并不存在先后顺序，也不能理解为指示或暗示相对重要性。此外，在本说明书的描述中，除非另有说明，“多个”的含义是两个或两个以上。
上述实施例只为说明本申请的技术构思及特点，其目的在于让熟悉此项技术的人士能够了解本申请的内容并据以实施，并不能以此限制本申请的保护范围。凡根据本申请精神实质所作的等效变化或修饰，都应涵盖在本申请的保护范围之内。
应该理解，以上描述是为了进行图示说明而不是为了进行限制。通过阅读上述描述，在所提供的示例之外的许多实施方式和许多应用对本领域技术人员来说都将是显而易见的。出于全面之目的，所有文章和参考包括专利申请和公告的公开都通过参考结合在本文中。

Claims (14)

  1. 一种冲击波球囊导管装置，包括导管、密封围绕在导管外周的球囊和设置在球囊内的电极组件，所述球囊内可填充液体；其特征在于：所述电极组件包括内电极、绝缘层和外电极护套；
    所述内电极铺设在所述导管外壁；所述绝缘层位于所述内电极外周，用于绝缘分隔所述内电极与所述外电极护套；所述外电极护套围绕在所述绝缘层的外周；
    所述内电极包括放电部；所述放电部位于所述外电极护套的轴向覆盖区间之外，并且所述放电部能与球囊内的液体接触；
    当在所述内电极与所述外电极护套之间施加电压时，所述放电部与所述外电极护套之间可在液体中产生放电电弧。
  2. 如权利要求1所述的装置，其特征在于：所述放电部包括所述内电极的部分外周壁；所述内电极的部分外周壁位于所述绝缘层的轴向覆盖区间之外。
  3. 如权利要求1所述的装置，其特征在于：所述内电极的近端端面与所述绝缘层的近端端面齐平；所述内电极的近端端面构成所述放电部；
    和/或，
    所述内电极的远端端面与所述绝缘层的远端端面齐平；所述内电极的远端端面构成所述放电部。
  4. 如权利要求1所述的装置，其特征在于：所述绝缘层上设置有放电孔；所述放电孔位于所述外电极护套的轴向覆盖区间之外；所述放电孔被配置为使得所述内电极的部分露出；所述内电极的露出部分构成所述放电部。
  5. 如权利要求1所述的装置，其特征在于：所述内电极包括主体和放电部；所述主体为套筒状，并围绕在所述导管的外周；所述放电部包括至少一个凸台；所述凸台连接在所述主体沿所述导管轴向一端的端面上，且沿轴向延伸；所述绝缘层为套筒状，围绕在所述主体的外周。
  6. 如权利要求1所述的装置，其特征在于：所述内电极包括间隔布置的第一内电极和第二内电极；当在所述第一内电极与所述第二内电极之间施加电压时，所述第一内电极的 所述放电部与所述外电极护套之间可在液体中产生放电电弧，所述外电极护套与所述第二内电极的所述放电部之间可在液体中产生放电电弧，以使得电流依次流经所述第一内电极、所述外电极护套、所述第二内电极。
  7. 如权利要求1所述的装置，其特征在于：所述内电极包括间隔布置的第一内电极和第二内电极；所述电极组件通过脉冲电压发生器供应脉冲电压；所述脉冲电压发生器包括第一供电端子、第二供电端子和第三供电端子；所述第一供电端子与所述第二供电端子的电压极性相同；所述第三供电端子与所述第一供电端子的电压极性相反；所述第一内电极电连接在所述第一供电端子上；所述第二内电极电连接在所述第二供电端子上；所述外电极护套电连接在所述第三供电端子上；当在所述第一内电极与所述外电极护套之间施加电压时，所述第一内电极的所述放电部与所述外电极护套之间可在液体中产生放电电弧；当在所述第二内电极与所述外电极护套之间施加电压时，所述第二内电极的所述放电部与所述外电极护套之间可在液体中产生放电电弧。
  8. 如权利要求6或7所述的装置，其特征在于：所述第一内电极与所述第二内电极之间的间隙大小被配置为当在所述第一内电极与所述第二内电极之间施加电压时，所述第一内电极与所述第二内电极之间在液体中不形成放电电弧。
  9. 如权利要求6或7所述的装置，其特征在于：所述绝缘层包括间隔布置的第一绝缘层和第二绝缘层；所述第一绝缘层覆盖在所述第一内电极外周，所述第二绝缘层覆盖在所述第二内电极外周。
  10. 如权利要求1所述的装置，其特征在于：所述外电极护套位于所述绝缘层的轴向区间之内；
    或，
    所述外电极护套的近端端面与所述绝缘层的近端端面齐平，所述外电极护套的远端端面与所述绝缘层的远端端面齐平。
  11. 如权利要求6所述的装置，其特征在于：所述电极组件的数量为至少两个，包括第一电极组件和第二电极组件；所述第一电极组件的所述第二内电极电连接至所述第二电极组件的所述第一内电极；当在所述第一电极组件的所述第一内电极与所述第二电极组件的 所述第二内电极之间施加电压时，所述第一电极组件的所述第一内电极的所述放电部与所述第一电极组件的所述外电极护套之间可在液体中产生放电电弧，所述第一电极组件的所述外电极护套与所述第一电极组件的所述第二内电极的所述放电部之间可在液体中产生放电电弧，所述第二电极组件的所述第一内电极的所述放电部与所述第二电极组件的所述外电极护套之间可在液体中产生放电电弧，所述第二电极组件的所述外电极护套与所述第二电极组件的所述第二内电极的所述放电部之间可在液体中产生放电电弧；以允许电流依次通过所述第一电极组件的所述第一内电极、所述第一电极组件的所述外电极护套、所述第一电极组件的所述第二内电极、所述第二电极组件的所述第一内电极、所述第二电极组件的所述外电极护套、所述第二电极组件的所述第二内电极。
  12. 如权利要求7所述的装置，其特征在于：所述脉冲电压发生器还包括第四供电端子；所述第三供电端子与所述第四供电端子的电压极性相同；所述电极组件的数量为至少两个，包括第一电极组件和第二电极组件；所述第一电极组件的所述第一内电极与所述第二电极组件的所述第一内电极共同电连接至所述脉冲电压发生器的第一供电端子；所述第一电极组件的所述第二内电极与所述第二电极组件的所述第二内电极共同电连接至所述脉冲电压发生器的第二供电端子；所述第一电极组件的所述外电极护套电连接至所述脉冲电压发生器的第三供电端子；所述第二电极组件的所述外电极护套电连接至所述脉冲电压发生器的第四供电端子；
    当在所述第一供电端子与所述第三供电端子之间施加电压时，所述第一电极组件的所述第一内电极的所述放电部与所述第一电极组件的所述外电极护套之间可在液体中产生放电电弧；当在所述第一供电端子与所述第四供电端子之间施加电压时，所述第二电极组件的所述第一内电极的所述放电部与所述第二电极组件的所述外电极护套之间可在液体中产生放电电弧；当在所述第二供电端子与所述第三供电端子之间施加电压时，所述第一电极组件的所述第二内电极的所述放电部与所述第一电极组件的所述外电极护套之间可在液体中产生放电电弧；当在所述第二供电端子与所述第四供电端子之间施加电压时，所述第二电极组件的所述第二内电极的所述放电部与所述第二电极组件的所述外电极护套之间可在液体中产生放电电弧。
  13. 如权利要求1所述的装置，其特征在于：所述电极组件的数量为至少两个，包括第一电极组件和第二电极组件；所述第一电极组件的所述外电极电连接至所述第二电极组件的所述内电极；当在所述第一电极组件的所述内电极与所述第二电极组件的所述外电极护 套之间施加电压时，所述第一电极组件的所述内电极的所述放电部与所述第一电极组件的所述外电极护套之间可在液体中产生放电电弧，所述第二电极组件的所述内电极的所述放电部与所述第二电极组件的所述外电极护套之间可在液体中产生放电电弧；以允许电流依次通过所述第一电极组件的所述内电极、所述第一电极组件的所述外电极护套、所述第二电极组件的所述内电极、所述第二电极组件的所述外电极护套。
  14. 一种冲击波球囊导管装置，包括导管、密封围绕在导管外周的球囊和设置在球囊内的电极组件，所述球囊内可填充液体；其特征在于：所述电极组件包括内电极、绝缘层和外电极护套；
    所述内电极铺设在所述导管外壁；所述绝缘层位于所述内电极外周，用于绝缘分隔所述内电极与所述外电极护套；所述外电极护套围绕在所述绝缘层的外周；
    所述内电极的近端端面、所述绝缘层的近端端面与所述外电极护套的近端端面齐平；所述内电极的近端端面构成放电部；
    和/或，
    所述内电极的远端端面、所述绝缘层的远端端面与所述外电极护套的远端端面齐平；所述内电极的远端端面构成放电部；
    当在所述内电极与所述外电极护套之间施加电压时，所述放电部与所述外电极护套之间可在液体中产生放电电弧。
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