WO2022127509A1 - Cathéter à ballonnet à ondes de pression - Google Patents

Cathéter à ballonnet à ondes de pression Download PDF

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Publication number
WO2022127509A1
WO2022127509A1 PCT/CN2021/131540 CN2021131540W WO2022127509A1 WO 2022127509 A1 WO2022127509 A1 WO 2022127509A1 CN 2021131540 W CN2021131540 W CN 2021131540W WO 2022127509 A1 WO2022127509 A1 WO 2022127509A1
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WO
WIPO (PCT)
Prior art keywords
conductor
balloon
catheter
pressure wave
insulating layer
Prior art date
Application number
PCT/CN2021/131540
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 WO2022127509A1 publication Critical patent/WO2022127509A1/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 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. damage to blood vessels.
  • the present application provides a pressure wave balloon catheter to solve the problem in the related art that the cross-sectional size of the balloon is large, resulting in poor passage of the balloon at the lesion position in the blood vessel.
  • a pressure wave balloon catheter comprising: a catheter, a balloon, a first conductor, a second conductor and a lead wire;
  • 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 catheter is located on the inner peripheral wall of the balloon and is recessed inward to form an installation groove; the first conductor and the second conductor are connected in series on the pulse circuit, and the first conductor is wrapped on the bottom of the installation groove on the wall, or the first conductor is covered on the peripheral wall of the conduit, the second conductor is located on one side of the first conductor, and there is a connection between the first conductor and the second conductor a channel, the communication channel is used for connecting the first conductor and the second conductor and forming an electrode; the electrode is used for generating a pressure wave in the balloon under the pulse voltage.
  • the first conductor and the second conductor are embedded in the installation groove, the second conductor is arranged on one side of the first conductor, and the first conductor and the second conductor are arranged in the installation groove.
  • a communication channel is opened between the second conductors, so that an electrode is formed between the first conductor and the second conductor through the communication channel. Therefore, the stacking of the electrode, the first conductor and the second conductor on the peripheral wall of the catheter can be effectively reduced, the cross-sectional size of the catheter and the balloon can be reduced, and the passability of the balloon in the vascular tissue can be effectively improved.
  • the second conductor is located on the inner side of the first conductor, an insulating layer is provided between the first conductor and the second conductor, and the communication channel starts from the first conductor.
  • the peripheral wall of the conductor penetrates the insulating layer inward;
  • the communication channel includes a first hole segment and a second hole segment, the first hole segment penetrates the first conductor, and the second hole segment penetrates the insulating layer , the diameter of the first hole segment is larger than the diameter of the second hole segment.
  • the diameter of the first hole segment is 0.25-0.6 mm
  • the diameter of the second hole segment is 0.1-0.4 mm.
  • the second conductor includes at least two wires, the wires are embedded in the conduit, and the front ends of the two wires communicate with the first conductor respectively through the communication channel.
  • the wires can be prevented from being stacked on the peripheral wall of the conduit, and the cross-sectional size of the conduit can be reduced.
  • the conduit is a solid structure or a hollow structure
  • the insulating layer includes a conduit between the first conductor and the second conductor.
  • the conduit is directly used as the insulating layer without increasing the cross-sectional size of the conduit.
  • the thickness of the insulating layer is 0.02-0.2 mm.
  • the insulating layer will not be stacked with a large thickness in the radial direction of the conduit, which can effectively reduce the cross-sectional size of the conduit.
  • the second conductor includes at least two metal sheets, and the metal sheets are attached to the bottom wall of the installation slot; the insulating layer is an annular structure, and the insulating layer wraps on the periphery of the second conductor.
  • each of the metal sheets corresponds to one of the communication channels, one of the two metal sheets is connected to the positive pole of the pulse power supply, and the other is connected to the negative pole of the pulse power supply.
  • a uniform pressure wave or shock wave can be generated on the outer periphery of the catheter, and the lesions on the peripheral wall of the blood vessel can be uniformly treated.
  • the first conductor includes a plurality of first conductors, and the plurality of first conductors are arranged at intervals along the axial direction of the conduit; each of the first conductors is provided with two
  • the metal sheet is serially connected to the pulse circuit through a plurality of the first conductors in sequence.
  • a uniform pressure wave or shock wave can be generated in the axial direction of the catheter, and the lesions on the peripheral wall of the blood vessel can be uniformly treated.
  • the first conductor and the second conductor are arranged at intervals along the axial direction of the conduit, and are connected in series on the pulse circuit; the edge of the first conductor has protrusions
  • the second conductor has a concave portion at a position opposite to the protruding portion, and the protruding portion and the concave portion form the electrode.
  • the stacking of the second conductor and the insulating layer on the peripheral wall of the catheter can be reduced, so that the cross-sectional size of the catheter can be effectively reduced, and the passability of the balloon in the vascular tissue can be improved.
  • 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 schematic structural diagram of the catheter in the pressure wave balloon catheter provided in the embodiment of the present application located inside the balloon;
  • Fig. 3 is the front view of Fig. 2;
  • Fig. 4 is a sectional view along line A-A in Fig. 3;
  • FIG. 5 is a schematic diagram of an assembly structure of a first conductor, a second conductor and an insulating layer in an embodiment of the present application;
  • Fig. 6 is the front view of Fig. 5;
  • FIG. 7 is a schematic diagram of another assembly structure of the first conductor, the second conductor and the insulating layer in the embodiment of the present application;
  • FIG. 8 is a first cross-sectional view of the balloon and the catheter in the pressure wave balloon catheter provided by the embodiment of the present application;
  • Fig. 9 is the sectional view along B-B line in Fig. 8.
  • FIG. 10 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. 11 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. 12 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 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. 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 a high high-voltage pulse in the human body, and the generated high-voltage pulse can cause the liquid filled in the balloon to generate air bubbles. The purpose of the lesion.
  • the pulsed power supply provides pulsed voltage to the electrodes, so that arc breakdown occurs between the electrodes.
  • a pressure wave or shock wave is generated within the balloon; this increases the cross-sectional size of the balloon catheter.
  • 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, and to open a mounting groove inward on the peripheral wall of the catheter to connect the two conductors in series.
  • An insulating layer is arranged between the conductors; in this way, the stacking is embedded in the mounting groove, and through holes are opened from the outside of the outer conductors inwards. After the through holes penetrate the insulating layer, the two conductors are connected to form an electrode for arc discharge. .
  • the electrodes will not be stacked on the peripheral wall of the catheter; the cross-sectional size of the catheter can be effectively reduced, so that the cross-sectional size of the balloon catheter can be reduced, and the passability of the balloon catheter in the vascular tissue can be improved.
  • FIG. 1 is a schematic diagram of the overall structure of a pressure wave balloon catheter provided by an embodiment of the present application
  • FIG. 2 is a schematic structural diagram of a catheter in the pressure wave balloon catheter provided by an embodiment of the present application located inside the balloon
  • FIG. 3 is a schematic diagram of FIG. 2 Front view
  • FIG. 4 is a cross-sectional view taken along the line A-A in FIG. 3 .
  • an embodiment of the present application provides a pressure wave balloon catheter, which is characterized in that it includes: a catheter 10 , a balloon 20 , a first conductor 30 , a second conductor 40 and a lead wire 50;
  • a guide wire may be provided in the catheter 10, and the main function of the guide wire is to guide the front end of the pressure wave balloon catheter into the vascular tissue, and guide it to the lesion location along the blood vessel. (such as calcification lesions), so that targeted treatment can be carried out for lesions in the vascular tissue.
  • a guide wire may be disposed within the catheter 10 .
  • the inside of the catheter 10 is made into a hollow structure, so that a guide wire can be passed through the catheter 10 .
  • a cavity structure may also be provided at the front end of the catheter 10, and the cavity structure is used to pass a guide wire.
  • the catheter 10 is of solid construction.
  • 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, and the conductive liquid can be physiological saline or a mixture of physiological saline and contrast agent.
  • the peripheral wall of the catheter 10 located inside the balloon 20 is recessed inward to form a mounting groove 11 .
  • the installation groove 11 may be formed together with the conduit 10 when the conduit 10 is formed. For example, at the time of molding, it is obtained by molding with a mold. It can be understood that the installation groove 11 may also be obtained by secondary processing after the conduit 10 is formed.
  • the first conductor 30 and the second conductor 40 are connected in series on the pulse circuit through the wire 50 .
  • the peripheral wall of the conduit 10 may not be provided with the installation groove 11 , in this case, the first conductor 30 is wrapped on the peripheral wall of the conduit 10 , and the second conductor 40 is located inside the first conductor 30 or the second conductor 40 is arranged on the peripheral wall of the conduit 10 side by side with the first conductor 30 .
  • the first conductor 30 and the second conductor 40 may be made of metal materials such as stainless steel, copper, silver, or tungsten.
  • the first conductor 30 is a ring-shaped structure
  • the second conductor 40 may be a metal piece with a sheet-like structure or the second conductor 40 may also be a wire.
  • the pulse circuit may be a circuit connected between the positive and negative electrodes of the pulse power supply 80 . Therefore, in the embodiment of the present application, a communication channel 31 is opened between the first conductor 30 and the second conductor 40, and the communication channel 31 is used to connect the first conductor 30 and the second conductor 40 and form the electrode 70; the electrode 70 is used to connect the Under the pulsed voltage, pressure waves are generated within the balloon 20 .
  • the pulse power supply 80 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 80 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 80 through the catheter seat and wires.
  • the first conductor 30 and the second conductor 40 pass through the opened communication channel 31 to generate an arc discharge phenomenon, that is, a breakdown phenomenon, thereby making the first conductor 30 and the second conductor 40 conduct. , and a pressure wave or shock wave is generated in the balloon 20 , so that the lesions in the vascular tissue are treated by the balloon 20 .
  • the first conductor 30 and the second conductor 40 are embedded in the installation groove 11 by opening the installation groove 11 on the peripheral wall of the conduit 10, and the second conductor 40 is arranged on one side of the first conductor 30, Furthermore, by opening the communication channel 31 between the first conductor 30 and the second conductor 40 , the electrode 70 is formed between the first conductor 30 and the second conductor 40 through the communication channel 31 . Therefore, the stacking of the electrode 70, the first conductor 30 and the second conductor 40 on the peripheral wall of the catheter 10 can be effectively reduced, the cross-sectional size of the catheter 10 can be reduced, and the passability of the balloon catheter in the vascular tissue can be effectively improved.
  • FIG. 5 is an embodiment of the present application.
  • a schematic diagram of an assembly structure of the first conductor, the second conductor and the insulating layer, FIG. 6 is a front view of FIG. 5 , and FIG.
  • FIG. 7 is another assembly structure of the first conductor, the second conductor and the insulating layer in the embodiment of the present application.
  • the second conductor 40 is located inside the first conductor 30
  • an insulating layer 60 is provided between the first conductor 30 and the second conductor 40
  • the communication channel 31 penetrates the insulating layer from the peripheral wall of the first conductor 30 inward. 60.
  • the material of the insulating layer 60 may be one or more of polyamide, polyimide, polyether block polyamide and other materials.
  • the communication channel 31 includes a first hole segment 311 and a second hole segment 312 , the first hole segment 311 penetrates the first conductor 30 , the second hole segment 312 penetrates the insulating layer 60 , and the diameter of the first hole segment 311 is larger than that of the second hole segment 312 aperture.
  • the diameter of the first hole section 311 is 0.25-0.6 mm
  • the diameter of the second hole section 312 is 0.1-0.4 mm.
  • the hole diameters of the first hole segment 311 and the second hole segment 312 are only different between 0.15-0.5mm, that is, the radius is only different between 0.075-0.25mm.
  • the difference between the first conductor 30 and the second conductor 40 is There is a gap between them, which will not be directly conductive; and the gap is small, which can effectively reduce the breakdown voltage required by the electrode 70 formed by the first conductor 30 and the second conductor 40, and can reduce the electrode loss.
  • the first hole segment 311 may be a special-shaped hole.
  • the cross section of the first hole segment 311 may be other shapes than circular, for example, oval, polygonal, or racetrack.
  • radial protrusions such as planar protrusions shown in FIGS. 5-7 , or sharp protrusions may be provided on the hole wall of the circular hole.
  • the included angle of the convex portion can be 30°, 45°, 90° or 150°; of course, it can also be any angle between 0 and 180°.
  • the convex portion may be provided at one end of the cross-sectional diameter of the first hole segment 311 , that is, only one convex portion may be provided in the first hole segment 311 .
  • the convex parts can also be provided at both ends of the cross-sectional diameter of the first hole segment 311 , that is, two convex parts that are symmetrical to each other are provided.
  • a tip discharge can be formed between the first conductor 30 and the second conductor 40 , and the arc discharge intensity of the electrode 70 can be improved.
  • FIG. 8 is a first cross-sectional view of the balloon and the catheter in the pressure wave balloon catheter provided by the embodiment of the present application, and FIG. Sectional view of line B-B.
  • the second conductor 40 includes at least two wires, the wires are embedded in the conduit 10 , and the front ends of the two wires communicate with the first conductor 30 through the communication channel 31 respectively.
  • the conduit 10 is a solid structure or a hollow structure
  • the insulating layer 60 includes the conduit 10 between the first conductor 30 and the second conductor 40 .
  • the second conductor 40 may be embedded inside the conduit 10 .
  • the insulating layer 60 may be a part of the conduit between the first conductor 30 and the second conductor 40 .
  • the rear end of one of the wires may be connected to the positive pole of the pulse power supply, and the rear end of the other wire may be connected to the negative pole of the pulse power supply. Since the front ends of the two wires are embedded in the catheter 10, the front ends of the two wires are insulated and disconnected from each other. Then, the first conductor 30 is covered on the peripheral wall of the catheter 10 , and a communication channel 31 is opened inward from the peripheral wall of the first conductor 30 , and the communication channel 31 penetrates to the wire.
  • the communication channel 31 will be filled with the conductive liquid stored in the balloon 20, so that when the pulsed power source 80 sends out a pulse voltage, the positive electrode of the current passes through one of the wires, and an arc discharge occurs with the first conductor 30 at the communication channel 31 (ie The electrode 70 is broken down), thereby forming a pressure wave; further, the current on the first conductor 30 passes through another communication channel 31 to generate arc discharge with the wire connected to the negative electrode, and flows into the negative electrode of the pulse voltage. Thereby forming a loop of the entire pulse circuit.
  • a plurality of first conductors 30 may be provided in the axial direction of the catheter 10 , and the plurality of first conductors 30 are arranged at intervals. At this time, the number of wires used as the second conductors 40 may be increased accordingly. For example, as shown in FIG. 3 , when there are two first conductors 30 , the number of wires may be three. One of them may be disposed between the two first conductors 30 and form an electrode 70 with both of the first conductors 30 .
  • a plurality of electrodes 70 can be formed in the axial direction of the catheter 10. After the plurality of electrodes 70 are connected in series, arc power generation can be generated, that is, pressure waves or shock waves can be generated. After the pressure waves or shock waves generated by the plurality of electrodes 70 are superimposed on each other, the diffusion and propagation range of the pressure waves or shock waves can be increased, and the treatment of large blood vessels or eccentric lesions can be effectively performed.
  • the thickness of the insulating layer 60 is 0.02-0.2 mm. In this way, the insulating layer 60 will not be stacked with a large thickness in the radial direction of the conduit 10 , which can effectively reduce the cross-sectional size of the conduit 10 .
  • FIG. 10 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. 11 is the pressure wave ball provided by the embodiment of the present application.
  • the second conductor 40 includes at least two metal sheets, and the metal sheets are attached to the bottom wall of the installation slot 11 ;
  • each metal piece corresponds to a communication channel 31 , one of the two metal pieces is connected to the positive pole of the pulse power supply, and the other is connected to the negative pole of the pulse power supply.
  • the second conductor 40 is configured as two metal sheets. In this way, the second conductors 40 and the first conductors 10 can form electrodes 70 on both sides of the catheter 10 . That is, arcing can occur on both sides of the conduit 10, thereby generating pressure waves or shock waves. In this way, a uniform pressure wave or shock wave can be generated on the outer periphery of the catheter 10, and the lesions on the peripheral wall of the blood vessel can be uniformly treated.
  • first conductors 30 include a plurality of first conductors 30, and the plurality of first conductors 30 are arranged at intervals along the axial direction of the catheter 10; two metal sheets are provided on the inner side of each first conductor 30, and the metal sheets pass through the plurality of first conductors in sequence.
  • a conductor 30 is connected in series with the pulse circuit.
  • the current starts from the positive pole of the pulse power supply 80 and first flows through a metal sheet at the front end of the catheter 10 (shown on the left in FIG. 10 )
  • the second conductor 40), the metal sheet and the first conductor 30 at the front end of the conduit 10 have arc discharge, the current flows through the first conductor 30, the first conductor 30 and another metal sheet have arc discharge, the metal sheet is connected to the wire 50 through the wire 50.
  • the metal sheet in the other first conductor 30 (the second conductor 40 shown on the right side in FIG. 10 ) is electrically connected.
  • an arc discharge occurs with the first conductor 30 , and the first conductor 30 is re-connected.
  • An arc discharge occurs with another metal sheet, and then flows back to the negative electrode of the pulse power supply 80 .
  • the positive and negative electrodes of the pulse power supply 80 can also be reversed, so that the current is conducted in the reverse direction in the above-mentioned flow direction.
  • connection manner of the metal sheet serving as the second conductor 40 in FIG. 11 may be the same as or similar to the foregoing manner, which will not be repeated in this embodiment of the present application.
  • the difference from Fig. 10 is that the four electrode holes are more uniformly distributed in the circumferential direction of the inner tube.
  • FIG. 12 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.
  • the first conductor 30 and the second conductor 40 are arranged at intervals along the axial direction of the catheter 10 and are connected in series on the pulse circuit; the edge of the first conductor 30 has a protruding part 32, and the second conductor 40 is at a position opposite to the protruding part 32 There is a concave portion 41 , and the protruding portion 32 and the concave portion 41 form an electrode 70 .
  • the stacking of the second conductor 40 and the insulating layer 60 on the peripheral wall of the catheter 10 can be reduced, so that the cross-sectional size of the catheter 10 can be effectively reduced, and the passability of the balloon catheter in the vascular tissue can be improved.
  • an insulating layer 60 may also be provided between the first conductor 30 and the second conductor 40, and the communication channel 31 penetrates the insulating layer 60 at the protruding portion 32 and the recessed portion 41, so as to realize An electrode 70 is formed between the protruding portion 32 and the recessed portion 41 .
  • the insulating layer 60 may not be provided between the first conductor 30 and the second conductor 40 . Due to the existence of the protruding portion 32 and the recessed portion 41 , the tip discharge will occur between the first conductor 30 and the second conductor 40 through the protruding portion 32 and the recessed portion 41 , and will not discharge from other parts.

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Abstract

Cathéter à ballonnet à ondes de pression, comprenant : un cathéter (10), un ballonnet (20), un premier conducteur (30), un second conducteur (40) et un fil (50). Le ballonnet (20) est disposé à l'extrémité avant du cathéter (10). Le ballonnet (20) et la paroi périphérique du cathéter (10) forment un espace fermé. Entraîné par le cathéter (10), le ballonnet (20) s'étend dans le tissu vasculaire. La paroi périphérique, à l'intérieur du ballonnet (20), du cathéter (10) est enfoncée vers l'intérieur pour former un évidement de montage (11). Le premier conducteur (30) et le second conducteur (40) sont connectés en série dans un circuit d'impulsions au moyen du fil (50). Le premier conducteur (30) recouvre la paroi inférieure de l'évidement de montage (11), ou le premier conducteur (30) recouvre la paroi périphérique du cathéter (10). Le second conducteur (40) est situé sur un côté du premier conducteur (30). Un canal de communication (31) est disposé entre le premier conducteur (30) et le second conducteur (40). Le canal de communication (31) est utilisé pour communiquer avec le premier conducteur (30) et le second conducteur (40) et former une électrode (70). L'électrode (70) est utilisée pour générer une onde de pression dans le ballonnet (20) sous une tension d'impulsion. Le cathéter à ballonnet à ondes de pression selon l'invention peut réduire la taille de section transversale du cathéter à ballonnet, et améliorer l'aptitude au passage du ballonnet dans le tissu vasculaire.
PCT/CN2021/131540 2020-12-16 2021-11-18 Cathéter à ballonnet à ondes de pression WO2022127509A1 (fr)

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