WO2022127508A1 - Cathéter à ballonnet à ondes de pression - Google Patents

Cathéter à ballonnet à ondes de pression Download PDF

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Publication number
WO2022127508A1
WO2022127508A1 PCT/CN2021/131538 CN2021131538W WO2022127508A1 WO 2022127508 A1 WO2022127508 A1 WO 2022127508A1 CN 2021131538 W CN2021131538 W CN 2021131538W WO 2022127508 A1 WO2022127508 A1 WO 2022127508A1
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WO
WIPO (PCT)
Prior art keywords
conductor
catheter
balloon
pressure wave
conduit
Prior art date
Application number
PCT/CN2021/131538
Other languages
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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Application filed by 深圳市赛禾医疗技术有限公司 filed Critical 深圳市赛禾医疗技术有限公司
Publication of WO2022127508A1 publication Critical patent/WO2022127508A1/fr

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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
    • A61B17/22004—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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • 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
    • 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
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Definitions

  • the present application relates to the technical field of medical equipment, and in particular, to a pressure wave balloon catheter.
  • Cardiovascular disease has always been one of the important causes of death in the world. In the past half century, with the development of medical knowledge and medical technology, the mortality of cardiovascular disease has been greatly reduced. Among them, balloon angioplasty has played an important role in reducing the morbidity and mortality of obstructive tubular artery disease.
  • Traditional catheter interventional techniques usually use percutaneous transluminal angioplasty (PTA) to open calcified lesions in arterial and venous vessels.
  • PTA percutaneous transluminal angioplasty
  • the balloon When the balloon is inflated to dilate the calcified lesion in the vessel wall, the balloon will gradually release pressure until the calcified lesion ruptures; but at the same time, the pressure accumulated in the balloon will be released instantaneously, causing the balloon to rapidly expand to its maximum size , may cause some damage to the blood vessel wall.
  • the hydroelectric lithotripsy technology based on high-voltage underwater discharge is clinically applied to destroy calcified deposits or stones in the urethra or bile duct; therefore, the high-voltage underwater discharge technology can also be applied to destroy calcified lesions in blood vessels.
  • One or several pairs of discharge electrodes are placed in the angioplasty balloon to form a set of pressure wave generators, and then the electrodes are connected to the high-voltage pulse power host at the other end of the balloon dilation catheter through wires.
  • the host applies a high-voltage pulse voltage to release the pressure from the pressure wave generator in the balloon, and the pressure wave can selectively destroy the calcified lesion in the blood vessel. At the same time, it can avoid damage to blood vessels.
  • wires and electrodes need to be installed on the inner tube of the balloon catheter to generate pressure waves in the balloon, so that the cross-sectional size of the balloon catheter is large, resulting in the location of the balloon in the blood vessel. Passability is poor.
  • the present application provides a pressure wave balloon catheter to solve the need to install wires and electrodes on the balloon catheter to generate pressure waves in the balloon in the related art, so that the cross-sectional size of the balloon is larger, resulting in the balloon being trapped in the blood vessel.
  • a pressure wave balloon catheter comprising: a catheter, a balloon, a first conductor and a second conductor;
  • the balloon is arranged at the front end of the catheter, the balloon and the peripheral wall of the catheter form a closed space, and the balloon is extended to the inside of the vascular tissue under the driving of the catheter;
  • the first conductor is arranged inside the conduit, the second conductor is adjacent to the peripheral wall of the conduit, and the first conductor and the second conductor are connected in series in a pulse circuit;
  • a notch is provided on the peripheral wall of the catheter inside the balloon, and the notch is used to cut off the second conductor to form an electrode; the electrode is used for discharging under a pulse voltage to generate a pulse in the balloon. pressure wave.
  • the first conductor and the second conductor are connected in series on the pulse circuit, the first conductor is embedded in the conduit, and the second conductor is arranged at a position adjacent to the peripheral wall of the conduit; a slot is formed inward from the peripheral wall of the conduit , to cut off the second conductor to form an electrode.
  • the first conductor, the second conductor or the electrode will not be superimposed or stacked on the peripheral wall of the catheter, therefore, the diameter of the catheter will not be additionally increased; the diameter of the catheter can be reduced, that is, the cross-sectional size of the balloon catheter can be reduced, Thereby, the passability of the pressure wave balloon catheter in the vascular tissue is improved.
  • the bottom wall of the slot is insulated from the first conductor.
  • the discharge between the first conductor and the electrode can be avoided, the arc discharge of the electrode can be accurately guided, so that the pressure wave or the shock wave can be accurately guided.
  • the conduit is made of insulating material, and the bottom wall of the slot and the first conductor are insulated and isolated by the conduit.
  • the second conductor is embedded in the conduit, and the notch is a concave hole recessed inward from a peripheral wall of the conduit or a groove surrounding the peripheral wall of the conduit.
  • the second conductors By burying the second conductors in the conduits, the second conductors are not stacked on the peripheral wall of the conduits, and the cross-sectional size of the conduits can be further reduced.
  • the front end of the second conductor is electrically connected to the front end of the first conductor through a wire.
  • the second conductor can be connected in series in the circuit to form an effective discharge electrode, thereby generating pressure waves.
  • the second conductor extends along the axis of the conduit.
  • the second conductor includes a plurality of second conductors, and the plurality of second conductors are arranged at intervals in the circumferential direction of the conduit.
  • the number of electrodes can be increased, and the intensity of the pressure wave or shock wave can be increased.
  • the second conductor extends helically along the circumference of the conduit.
  • the electrodes can be uniformly arranged in the circumferential direction of the catheter, thereby improving the uniformity of the generated pressure wave or shock wave, which is beneficial to uniformly treat the calcified lesions distributed along the axial direction of the vascular tissue.
  • the conduit is a solid structure.
  • the conduit can provide sufficient burying space for the first conductor and the second conductor, and can insulate and isolate the first conductor and the second conductor.
  • the width of the notch along the axial direction of the conduit is 0.05-1 mm.
  • the gap between the electrodes can be made smaller, the breakdown voltage of the electrodes can be reduced, and the electrodes can be effectively protected from damage.
  • FIG. 1 is a schematic diagram of the overall structure of a pressure wave balloon catheter system provided by an embodiment of the present application
  • FIG. 2 is a first cross-sectional view of a balloon and a catheter in a pressure wave balloon catheter provided by an embodiment of the present application;
  • FIG. 3 is a second cross-sectional view of the balloon and the catheter in the pressure wave balloon catheter provided by the embodiment of the present application;
  • FIG. 4 is a third cross-sectional view of the balloon and the catheter in the pressure wave balloon catheter provided by the embodiment of the present application;
  • FIG. 5 is a fourth cross-sectional view of the balloon and the catheter in the pressure wave balloon catheter provided by the 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.
  • Cardiovascular disease has always been one of the important causes of death in the world. In the past half century, with the development of medical knowledge and medical technology, the mortality of cardiovascular disease has been greatly reduced. Among them, balloon angioplasty has played an important role in reducing the morbidity and mortality of obstructive tubular artery disease.
  • Traditional catheter interventional techniques usually use percutaneous transluminal angioplasty (PTA) to open calcified lesions in arterial and venous vessels.
  • PTA percutaneous transluminal angioplasty
  • the balloon When the balloon is inflated to dilate the calcified lesion in the vessel wall, the balloon will gradually release pressure until the calcified lesion ruptures; but at the same time, the pressure accumulated in the balloon will be released instantaneously, causing the balloon to rapidly expand to its maximum size , may cause some damage to the blood vessel wall.
  • Hydroelectric technology is a technology that uses "hydroelectric effect” to form shock waves or pressure waves in liquid to treat calcified lesions.
  • 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.
  • One or several pairs of discharge electrodes are placed in the angioplasty balloon to form a set of pressure wave generators, and then the electrodes are connected to the high-voltage pulse power host at the other end of the balloon dilation catheter through wires.
  • the host applies a high-voltage pulse voltage to release the pressure from the pressure wave generator in the balloon, and the pressure wave can selectively destroy the calcified lesion in the blood vessel. At the same time, it can avoid damage to blood vessels.
  • SHOCKWAVE MEDICAL uses shock waves or pressure waves to remove calcified lesions in blood vessels. It is usually necessary to generate high-voltage pulses in the human body, and the generated high-voltage pulses can cause the liquid filled in the balloon to generate bubbles. When the bubbles burst, they act on the balloon wall, and then act on the calcified lesions, so as to break the calcification. The purpose of the lesion.
  • the pulse power supply provides pulse voltage to the electrodes, causing arc breakdown between the electrodes. This results in a pressure wave or shock wave inside the balloon; this increases the cross-sectional size of the balloon.
  • lesions such as calcified lesions
  • the cross-sectional size of the blood vessels will become smaller, that is, the vascular channels will become narrow. Larger balloon cross-sectional dimensions make it difficult to pass through narrow passages in the vascular tissue at the site of the lesion; that is, the balloon has poorer passage in the blood vessel.
  • the embodiment of the present application provides a pressure wave balloon catheter, the main idea of which is to connect two conductors in series between the positive and negative electrodes of the pulse power supply; at least one of the two conductors is embedded inside the catheter of the balloon catheter , the other is set adjacent to the peripheral wall of the conduit; then, a slot is opened inward from the peripheral wall of the conduit, and the slot cuts off one of the conductors to form an electrode, or the slot connects the two conductors to form an electrode between the two conductors;
  • multiple electrode rings, electrode sheets, wires and insulating rings do not overlap each other on the peripheral wall of the catheter; thus, the cross-sectional area of the catheter can be effectively reduced, that is, the cross-sectional size of the balloon catheter can be reduced, and the Passability of the balloon at the site of vascular lesions.
  • FIG. 1 is a schematic diagram of the overall structure of a pressure wave balloon catheter system provided by an embodiment of the present application
  • FIG. 2 is a first cross-sectional view of a balloon and a catheter in the pressure wave balloon catheter provided by an embodiment of the present application
  • FIG. 3 is a schematic diagram of the present application
  • FIG. 4 is the third cross-sectional view of the balloon and the catheter in the pressure wave balloon catheter provided by the embodiment of the application
  • FIG. 5 is the application Embodiments provide a fourth cross-sectional view of the balloon and the catheter in the pressure wave balloon catheter.
  • a pressure wave balloon catheter provided by an embodiment of the present application includes: a catheter 10 , a balloon 20 , a first conductor 30 and a second conductor 40 .
  • the front end of the catheter 10 has a cavity, and the cavity can be used to pass the guide wire 60 .
  • the main function of the guide wire 60 is to guide the pressure wave balloon catheter.
  • the leading end of the vascular tissue is guided into the vascular tissue, and guided along the blood vessel to the lesion location (such as the calcified lesion), so that targeted treatment can be performed for the lesions in the vascular tissue.
  • the balloon 20 since the balloon 20 enters the vascular tissue together with the front end of the catheter 10 , the balloon 20 is arranged at the front end of the catheter 10 , and the balloon 20 and the peripheral wall of the catheter 10 form a closed space.
  • the closed space is connected to the filling port of the catheter base, and the conductive liquid is injected into the balloon from the filling port, and the balloon is expanded.
  • the conductive liquid can be physiological saline or a mixture of physiological saline and contrast agent.
  • the first conductor 30 is disposed inside the catheter 10, the second conductor 40 is adjacent to the peripheral wall of the catheter 10, and the first conductor 30 and the second conductor 40 are connected in series in the pulse circuit.
  • the first conductor 30 may be directly embedded inside the conduit 10 .
  • the first conductor 30 may be molded into the interior of the catheter 10 while the catheter 10 is being molded.
  • the first conductor 30 is integrally molded into the interior.
  • the conduit 10 may be an insulating layer wrapped around the periphery of the first conductor 30 .
  • the material of the catheter 10 may be one or more of polyamide, polyimide, polyether block polyamide and other materials.
  • the second conductor 40 may also be embedded inside the conduit 10 and adjacent to the peripheral wall of the conduit 10 .
  • the first conductor 30 and the second conductor 40 may be connected in series between the positive and negative electrodes of the pulse power supply 50 , that is, the pulse circuit in the embodiment of the present application is a circuit connected between the positive and negative electrodes of the pulse power supply 50 .
  • the front ends of the first conductors 30 and the second conductors 40 ie, the ends away from the pulse power supply 50 ) may be electrically connected. Specifically, it can be connected by wires or connected by other conductive media.
  • the pulse power supply 50 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 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 may also be a double-pulse power supply or a multi-pulse power supply.
  • the pulse power supply 50 may provide a pulse voltage of 500-5000V, and the pulse width may be 0.1-5 ⁇ s.
  • a catheter seat is further provided at the rear end of the catheter 10 , and the rear end of the catheter 10 is connected to the pulse power source 50 through the catheter seat and wires.
  • a notch 11 is formed on the peripheral wall of the catheter 10 inside the balloon 20 , and the notch 11 is used to cut off the second conductor 40 .
  • the second conductor 40 forms an electrode 41 at a position interrupted by the notch 11 .
  • the second conductor 40 may be made of materials such as stainless steel, copper, silver, or tungsten. Wherein, the second conductor 40 may be a wire or a metal piece connected to the wire.
  • the second conductor 40 can be embedded on the peripheral wall of the conduit 10, for example, a recessed slot or mounting portion is provided on the peripheral wall of the conduit 10, the second conductor 40 is installed in the slot or the mounting portion, and then Holes or grooves are dug inward to isolate the second conductor 40 .
  • the balloon 20 will be injected with the conductive liquid before discharging. Therefore, the conductive liquid will be filled into the notch 11, so that the gap of the electrode 41 is filled with the conductive liquid, which can reduce the impact required by the electrode 41.
  • the breakdown voltage can effectively protect the electrode 41 .
  • the first conductor 30 and the second conductor 40 are connected in series on the pulse circuit, and the first conductor 30 is embedded in the conduit 10, and the second conductor 40 is arranged at a position adjacent to the peripheral wall of the conduit 10;
  • the peripheral wall of 10 is provided with a notch inward to cut off the second conductor 40 to form the electrode 41 .
  • the first conductor 30, the second conductor 40 or the electrode 41 will not be superimposed or stacked on the peripheral wall of the catheter 10, therefore, the diameter of the catheter 10 will not be additionally increased; the diameter of the catheter 10 can be reduced, that is, the ball can be reduced
  • the cross-sectional size of the balloon 20 can improve the passability of the pressure wave balloon catheter in the vascular tissue.
  • the bottom wall of the slot 11 is insulated from the first conductor 30 .
  • the discharge between the first conductor 30 and the electrode 41 can be avoided, the arc discharge of the electrode 41 can be accurately guided, and the pressure wave or shock wave can be accurately guided.
  • the conduit 10 is made of insulating material, the bottom wall of the slot 11 and the first conductor 30 can be insulated and isolated directly through the conduit 10 .
  • the second conductor 40 is embedded in the conduit 10
  • the notch 11 is a concave hole recessed inward from the peripheral wall of the conduit 10 or surrounds the peripheral wall of the conduit 10 . groove.
  • the second conductor 40 may be a wire, and the wire may be a copper-core wire, an aluminum-core wire, or a silver-core wire, or the like.
  • the notch 11 may be formed by secondary processing.
  • a hole is dug inward from the peripheral wall of the conduit 10 (eg, by drilling or laser drilling).
  • the second conductor 40 embedded in the conduit 10 is cut off.
  • a groove can also be used, an annular groove is formed along the peripheral wall of the conduit 10 , and the annular groove cuts off the second conductor 40 embedded in the conduit 10 .
  • the notches 11 may include a plurality of notches 11 , and the plurality of notches 11 are along the axial direction of the catheter 10 . spaced arrangement.
  • each electrode 41 can be formed at each slot 11.
  • each electrode 41 can generate arc discharge, thereby generating a pressure wave or shock wave.
  • the pressure waves or shock waves are superimposed on each other, they spread outward, which can effectively enhance the scope of action of the pressure waves or shock waves.
  • each electrode 41 is equivalent to a capacitor, the required breakdown voltage will also increase with each additional electrode 41 .
  • the number of the notches 11 is set to 4-10. In this way, the pressure wave or shock wave is guaranteed to have a sufficient diffusion and propagation range, and an excessively high breakdown voltage will not be required.
  • the breakdown voltage of the electrode 41 is also related to the width or diameter of the slot 11 , that is, the size of the slot 11 separating the second conductor 40 .
  • the width of the notch 11 along the axial direction of the conduit 10 is set to 0.05-1 mm.
  • the gap between the electrodes 41 can be made smaller, the breakdown voltage of the electrodes 41 can be reduced, and the electrodes 41 can be effectively protected from being damaged.
  • the front end of the second conductor 40 and the front end of the first conductor 30 are electrically connected by wires.
  • the wires may be copper-cored wires, aluminum-cored wires, or silver-cored wires.
  • the first conductor 30, the second conductor 40 and the electrode 41 can be connected in series between the positive and negative electrodes of the pulse power supply.
  • the first conductor 30 and the second conductor 40 may be the same wire, one end of the wire is connected to the positive pole of the pulse power supply, and the other end of the wire extends along the catheter 10 to the front end of the catheter 10, and then runs along the The catheter 10 is looped back and connected to the negative terminal of the pulsed power supply.
  • the notch 11 cuts the lead wire to form the electrode 41 .
  • the first conductor 30 may be arranged coaxially with the conduit 10 , and the second conductor 40 may be embedded in a position of the conduit 10 close to the peripheral wall.
  • the opening depth of the notch 11 can be reduced, the strength of the catheter 10 can be ensured, and the pressure wave or shock wave can be effectively propagated and diffused to the outside of the balloon 20 .
  • both the first conductor 30 and the second conductor 40 may also be disposed at positions close to the peripheral wall of the catheter 10 .
  • the first conductor 30 and the second conductor 40 may be disposed at both ends of the diameter of the catheter 10 , that is, the first conductor 30 and the second conductor 40 are disposed opposite to each other at both ends of the diameter of the catheter 10 .
  • the notch 11 can separate the first conductor 30 and the second conductor 40 respectively. In this way, a plurality of electrodes 41 can be formed through the fracture of the first conductor 30 and the second conductor 40, which can increase the intensity and effective range of the pressure wave or shock wave.
  • first conductor 30 and the second conductor 40 may also be provided at the ends of the cross section of the conduit 10 with different diameters. That is, the included angle between the first conductor 30 and the second conductor 40 and the axis of the conduit 40 is greater than 0° and less than 180°. In this way, the generated pressure wave or shock wave can be propagated and diffused toward one side of the catheter 10 . Therefore, the eccentric lesions in the vascular tissue can be effectively treated, the normal vascular tissue is not affected, and the normal vascular tissue can be effectively protected.
  • the conduit 10 is a solid structure.
  • the conduit 10 can provide sufficient burying space for the first conductor 30 and the second conductor 40 , and can insulate and isolate the first conductor 30 and the second conductor 40 .
  • the discharge between the first conductor 30 and the electrode 41 can be avoided, the arc discharge of the electrode 41 can be accurately guided, and the pressure wave or shock wave can be accurately guided.
  • the second conductor 40 extends along the axis of the catheter 10 .
  • a plurality of second conductors 40 may be provided, and the plurality of second conductors 40 are arranged at intervals in the circumferential direction of the catheter 10 .
  • the number of electrodes 41 can be increased, and the intensity and effective range of the pressure wave or shock wave can be improved.
  • the front ends of multiple second conductors 40 may be connected to the front end of the same first conductor 30 .
  • the first conductor 30 may be connected to the positive pole of the pulse power supply 50
  • any one of the plurality of second conductors 40 may be connected to the negative pole of the pulse power supply 50 .
  • the electrode 41 formed by one of the second conductors 40 can be broken down, thereby generating a pressure wave or a shock wave.
  • the second conductor 40 may be made of a material that can be seen under an imaging device, for example, stainless steel, copper, silver or tungsten and other materials that can be developed under X-rays.
  • the second conductor 40 that is closer to the lesion is determined by the imaging device, and the second conductor 40 is connected to the negative pole of the pulse power supply 50, so that the Effective treatment of eccentric lesions in vascular tissue, especially for eccentric lesions in large blood vessels, the pressure wave formed by the discharge of the electrode 41 is closer to the lesion, which can make the lesion within the effective range of the pressure wave or shock wave, so that the Precise treatment of eccentric calcified lesions.
  • the first conductor 30 may also be connected to the positive electrode of the pulse power supply 50, and the plurality of second conductors 40 may be connected simultaneously on the negative terminal of the pulse power supply 50 .
  • the electrodes 41 formed by different second conductors 40 are connected in parallel on the circuit, the breakdown voltage will not be increased, and a more uniform pressure wave or shock wave can be generated.
  • the first conductor 30 may also be connected to the negative pole of the pulse power supply 50
  • the second conductor 40 may be connected to the positive pole of the pulse power supply 50 .
  • the second conductor 40 may also be extended in a spiral shape along the circumferential direction of the catheter 10 .
  • the electrodes 41 can be uniformly arranged in the circumferential direction of the catheter 10, thereby improving the uniformity of the generated pressure wave or shock wave, which is conducive to uniform treatment along the axial direction of the vascular tissue Distribution of calcified lesions.

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Abstract

Cathéter à ballonnet à ondes de pression, comprenant : un cathéter (10), un ballonnet (20), un premier conducteur (30) et un second conducteur (40). Le ballonnet (20) est disposé à l'extrémité avant du cathéter (10). Le ballonnet (20) forme un espace fermé avec la paroi périphérique du cathéter (10). Entraîné par le cathéter (10), le ballonnet (20) s'étend dans le tissu vasculaire. Le premier conducteur (30) est disposé à l'intérieur du cathéter (10). Le second conducteur (40) est adjacent à la paroi périphérique du cathéter (10). Le premier conducteur (30) et le second conducteur (40) sont connectés en série dans un circuit d'impulsion. La paroi périphérique, à l'intérieur du ballonnet (20), du cathéter (10) est pourvue d'ouvertures (11), et les ouvertures (11) sont utilisées pour séparer le second conducteur (40) et former des électrodes (41). Les électrodes (41) sont utilisées pour se décharger sous une tension d'impulsion et générer une onde de pression dans le ballonnet (20). Le cathéter à ballonnet à ondes de pression selon l'invention peut réduire la dimension de section transversale du cathéter à ballonnet, et améliorer l'aptitude au passage du cathéter à ballonnet à ondes de pression dans le tissu vasculaire.
PCT/CN2021/131538 2020-12-16 2021-11-18 Cathéter à ballonnet à ondes de pression WO2022127508A1 (fr)

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CN202011488822.0A CN113951973A (zh) 2020-12-16 2020-12-16 一种压力波球囊导管

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US11660427B2 (en) 2019-06-24 2023-05-30 Boston Scientific Scimed, Inc. Superheating system for inertial impulse generation to disrupt vascular lesions
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CN114903558B (zh) * 2022-05-19 2023-11-10 杭州天路医疗器械有限公司 一种用于体内腔道塑形的冲击波发生装置
CN114831697B (zh) * 2022-05-19 2024-03-19 杭州天路医疗器械有限公司 一种用于体内腔道塑形的冲击波发生装置
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CN115463317B (zh) * 2022-08-23 2023-08-29 深圳市赛禾医疗技术有限公司 一种冲击波球囊导管
CN115245373B (zh) * 2022-09-26 2023-06-23 上海百心安生物技术股份有限公司 一种均匀碎化的脉冲球囊扩张导管
CN116492011B (zh) * 2023-03-30 2024-04-26 广东博迈医疗科技股份有限公司 冲击波球囊导管

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