WO2023160505A1 - Dispositif de cathéter à ballonnet à ondes de choc et appareil médical - Google Patents

Dispositif de cathéter à ballonnet à ondes de choc et appareil médical Download PDF

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Publication number
WO2023160505A1
WO2023160505A1 PCT/CN2023/077276 CN2023077276W WO2023160505A1 WO 2023160505 A1 WO2023160505 A1 WO 2023160505A1 CN 2023077276 W CN2023077276 W CN 2023077276W WO 2023160505 A1 WO2023160505 A1 WO 2023160505A1
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WIPO (PCT)
Prior art keywords
shock wave
balloon
electrode
catheter device
balloon catheter
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PCT/CN2023/077276
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English (en)
Chinese (zh)
Inventor
徐鹏飞
阙志文
王成
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上海蓝帆博元医疗科技有限公司
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Publication of WO2023160505A1 publication Critical patent/WO2023160505A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • 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

Definitions

  • the present disclosure relates to a shock wave balloon catheter device, in particular to a shock wave catheter device including a double-layer structure balloon and medical equipment.
  • Atherosclerosis is a narrowing and hardening of the arteries caused by plaque buildup.
  • the plaque is composed of fibrous tissue, fat, and calcium.
  • Accumulated calcified plaque blocks the normal flow of blood, reducing the supply of oxygen and nutrients to the body. This results in disease related to the arteries that supply blood to key parts of the body, including the brain, heart and extremities.
  • the method of electrohydraulic effect has been used to destroy the structure of calcified lesions attached to the wall of diseased blood vessels, that is, intravascular shock wave lithotripsy is an effective means of destroying highly calcified lesions.
  • the present disclosure provides a shock wave balloon catheter device.
  • the device emits high-intensity shock waves that rupture calcified plaque.
  • the device can also provide high dilation pressure to fully complete the dilation of the lesion, thereby opening up the blood vessel.
  • a shock wave balloon catheter device includes a balloon, an inner tube, at least one shock wave electrode assembly and an outer tube.
  • the balloon includes an inner layer and an outer layer, the hardness of the inner layer being different from that of the outer layer.
  • the inner tube runs through the balloon, and the distal end of the inner tube is connected with the distal end of the balloon.
  • the shock wave electrode assembly is arranged outside the inner tube.
  • the outer tube is sheathed on the outside of the inner tube and connected with the proximal end of the balloon.
  • the hardness of the outer layer is greater than the hardness of the inner layer.
  • the outer layer is made of a combination of one or more of nylon, polyethylene terephthalate and polyethylene; the inner layer is made of polyether block polyamide copolymer, polyvinyl chloride , Polyurethane and silicone rubber in one or more combinations.
  • the hardness of the outer layer is 71D-90D, and the hardness of the inner layer is 35D-70D.
  • the mass ratio of the outer layer to the inner layer ranges from 1:3 to 3:1.
  • the outer layer is made of nylon 12
  • the inner layer is made of polyether block polyamide copolymer
  • the mass ratio of nylon 12 to polyether block polyamide copolymer is 1:1.
  • the shock wave electrode assembly includes an inner electrode and an outer electrode, and is configured to generate a high voltage pulse between the inner electrode and the outer electrode under a high voltage power source, thereby generating a mechanical shock wave in the balloon;
  • the shock wave balloon catheter device also It includes a connecting wire, the connecting wire includes a first electrode wire and a second electrode wire extending along its axial direction, the inner electrode is connected to the first electrode wire, the outer electrode is connected to the second electrode wire, and the first electrode wire and the second electrode wire The wires are configured to be respectively connected to two poles of the high voltage power supply.
  • the shock wave electrode assembly further includes an insulating layer located between the inner electrode and the outer electrode, protruding pins are arranged on the surface of the inner electrode, a first hole is arranged on the insulating layer, and a second hole is arranged on the outer electrode. Two holes, the diameter of the second hole is greater than the diameter of the first hole, the protruding pin, the first hole and the second hole are configured so that the protruding pin extends through the first hole and extends into the second hole, thereby externally A ring-shaped discharge channel is formed between the electrodes and the inner electrodes.
  • the shock wave balloon catheter device includes a plurality of shock wave electrode assemblies arranged at intervals along the axial direction of the inner tube.
  • multiple shockwave electrode assemblies are arranged in series.
  • multiple shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube, or arranged at an angle in the circumferential direction.
  • the present disclosure also proposes a medical device, which includes the shock wave balloon catheter device and the high voltage generator of the above embodiment, the shock wave balloon catheter device also includes a connecting wire, the distal end of the connecting wire is connected to the shock wave electrode assembly, the connecting wire The proximal end is connected to a high-voltage generator; the pulse voltage of the high-voltage generator is 500V-10kV, the pulse voltage width is 200ns-20 ⁇ s, the pulse current of the high-voltage generator is 50A-400A, and the pulse current width is 10ns-2 ⁇ s.
  • each shock wave electrode assembly generates a shock wave with a sound pressure intensity of 2Mpa-20Mpa, and a discharge frequency of 0.1Hz-10Hz.
  • the shock wave action can effectively crush the calcified plaque, and the balloon adopts a double-layer structure design with different hardness of the inner layer and the outer layer, which can effectively increase the burst pressure of the balloon at the same time , so that the balloon has better compliance and adherence; firstly, the calcified plaque is crushed by the shock wave, and then the balloon is further expanded by using a higher filling pressure.
  • the increase of the balloon inflation pressure weakens the attenuation of the shock wave to a certain extent, which promotes the transmission of the shock wave.
  • the high inflation pressure of the balloon and the shock wave work together to make the shock wave balloon catheter device generate a higher sound pressure. strength to more effectively crush calcified plaque.
  • Fig. 1 is a schematic structural diagram of a shock wave balloon catheter device according to an embodiment of the present disclosure.
  • Fig. 2 is a schematic structural diagram of a balloon according to an embodiment of the present disclosure.
  • FIG. 3 is a cross-sectional view of the balloon of FIG. 2 .
  • FIG. 4 is a schematic cross-sectional view of a shock wave electrode assembly according to one embodiment of the present disclosure.
  • FIG. 5 is a graph of sound pressure intensity curves of a shock wave electrode assembly and a common shock wave electrode assembly under different pulse voltages according to an embodiment of the present disclosure.
  • Fig. 6 is a schematic cross-sectional view of a shock wave balloon catheter device provided with a shock wave two-electrode assembly.
  • Figure 7 shows a schematic diagram of a shockwave balloon catheter device with two shockwave two-electrode assemblies.
  • FIG. 8A is a schematic cross-sectional view of a shock wave two-electrode assembly in FIG. 7 , showing the orientation of the first hole.
  • FIG. 8B is a schematic cross-sectional view of another shock wave two-electrode assembly in FIG. 7 , showing the arrangement of its first hole orientation.
  • FIG. 9 is a graph of sound pressure intensity of a shock wave electrode assembly under different filling pressures according to an embodiment of the present disclosure.
  • Figure 10 shows the dilation effect of different shock wave balloon catheter devices.
  • Fig. 11 is a schematic structural diagram of a medical device according to an embodiment of the present disclosure.
  • the intravascular shock wave technology in the prior art is a more effective means to solve vascular calcification, specifically through the action of electrodes and high voltage generators together to destroy calcified lesions in the arterial wall.
  • a high-flexibility ball made of a less rigid material such as polyether block polyamide copolymer is usually used bladder, its inflation pressure is usually below 16 atmospheres.
  • the high-flexibility balloon When in use, the high-flexibility balloon is filled with a low-pressure medium to make the balloon adhere to the blood vessel wall, and a series of high-voltage pulses are applied to the electrodes in the balloon through a high-voltage generator, thereby generating shock waves in the conductive fluid, and the shock waves pass through the ball
  • the cyst wall reaches the blocked area, rupturing the calcified plaque.
  • the inventors of the present disclosure have found that calcified lesions may not be completely fragmented due to large fluctuations in the intensity of shock waves generated by the electrodes. Electrodes may generate unpredictable electrical sparks and shock waves with potential damage to high-flexibility balloons.
  • the burst pressure of the balloon is increased by increasing the wall thickness of the high-flexibility balloon, thereby providing sufficient expansion pressure.
  • a larger wall thickness will increase the loss of the shock wave during propagation, reduce the energy acting on the lesion, and also reduce the adherence and passability of the balloon. Therefore, the current technology is difficult to simultaneously meet the requirements of the balloon for high inflation pressure and high shock wave sound pressure intensity.
  • shock wave balloon catheter device provided by the embodiments of the present disclosure solves some of the above-mentioned technical problems.
  • the embodiments of the present disclosure and examples thereof will be described in detail below with reference to the accompanying drawings.
  • FIG. 1 is a schematic diagram of a shock wave balloon catheter device according to one embodiment of the present disclosure.
  • Fig. 2 is a schematic structural diagram of a balloon according to an embodiment of the present disclosure.
  • FIG. 3 is a cross-sectional view of the balloon of FIG. 2 .
  • the shock wave balloon catheter device 100 includes an inner tube 110 , a balloon 120 , an outer tube 130 and a shock wave electrode assembly 200 .
  • the shock wave electrode assembly 200 is disposed on the inner tube 110, and its specific content will be described in detail later. In one embodiment, according to actual needs, there are multiple shock wave electrode assemblies.
  • the inner tube 110 runs through the balloon 120 , and the distal end of the inner tube 110 is connected with the distal end of the balloon 120 .
  • the distal end of the balloon 120 is welded to the inner tube 110 .
  • the outer tube 130 is sleeved on the outside of the inner tube 110 and connected to the proximal end of the balloon 120 .
  • the proximal portion of the balloon 120 is welded to the outer tube 130 .
  • the gap between the inner tube 110 and the outer tube 130 forms a channel for receiving the conductive fluid.
  • Inside the balloon 120 is a filling cavity 140 .
  • the balloon 120 has a double layer structure of an inner layer 122 and an outer layer 124 .
  • the inner layer 122 and the outer layer 124 are made of materials with different hardness, for example, Shore hardness is used as the basis for hardness.
  • a material with high hardness is called “hard material”
  • a material with low hardness is called “soft material”.
  • the hard material includes one or more combinations of nylon, polyethylene terephthalate and polyethylene.
  • the soft material includes one or more combinations of polyether block polyamide copolymer, polyvinyl chloride, polyurethane and silicone rubber.
  • its outer layer can be made of soft material (that is, the inner layer is made of hard material, at this time, the double-layer structure is hard on the inside and soft on the outside), or it can be made of hard material ( That is, the inner layer is made of soft material, at this time the double-layer structure is soft inside and hard outside).
  • the double-layer structure balloon with soft inside and hard outside can withstand higher pressure.
  • the double-layer structure balloon with hard inside and soft outside has higher compliance and less damage to blood vessels.
  • the inner layer 122 is made of soft material
  • the outer layer 124 is made of hard material, that is, the hardness of the inner layer 122 is smaller than that of the outer layer 124 .
  • the soft material makes the balloon 120 have a certain flexibility, which is beneficial for the balloon 120 to pass through the tortuous lesion.
  • the balloon 120 has a certain degree of adherence to the wall.
  • the hard material increases the anti-burst capability of the balloon 120, so that the balloon 120 can provide high expansion pressure, thereby fully completing the expansion of the lesion and opening the blood vessel.
  • the balloon 120 of the embodiment of the present disclosure adopts a double-layer structure feature, on the one hand, it exhibits better adhesion to the wall, that is, when the balloon 120 is filled with a low-pressure medium, the balloon 120 can better adhere to the blood vessel wall.
  • the wall thickness of the balloon using the double layer structure is smaller, thereby reducing the shock wave energy losses during transmission. This allows more energy to be delivered to the lesion to better break down calcified plaque.
  • the balloon 120 of the embodiment of the present disclosure is made of soft material and hard material, and the burst pressure, compliance and wall adhesion of the balloon are related to the hardness of the material itself and the mass ratio of the soft material to the hard material.
  • the hardness of the soft material is 35D-70D, and the hardness of the hard material is 71D-90D; the hardness of the soft material is preferably 69D, and the hardness of the hard material is preferably 81D.
  • the mass of the soft material accounts for 25%-75% of the total mass of the balloon 120, and the mass of the hard material accounts for 25%-75% of the total mass of the balloon 120. That is, the mass ratio of the soft material to the hard material in the balloon 120 of the embodiment of the present disclosure ranges from 1:3 to 3:1. By adjusting the mass ratio, the burst pressure, compliance and wall-adherence of the balloon 120 will be significantly changed.
  • the existing intravascular shock wave lithotripsy technology usually uses a highly flexible balloon made of polyether block polyamide copolymer to ensure the shock wave sound pressure intensity and energy transmission.
  • a highly flexible balloon made of polyether block polyamide copolymer to ensure the shock wave sound pressure intensity and energy transmission.
  • the test results show that the compliance of the balloon with the same wall thickness is 5.0%-8%, the balloon 120 has semi-compliance and good adherence, and the balloon 120 Burst pressure is 10atm ⁇ 16atm, but the burst pressure can not meet the demand for effective expansion of calcified lesions; and in order to improve the inflation pressure of the balloon, the polyether block polyamide copolymer material in the prior art is replaced with a higher hardness
  • the test results show that the compliance of the balloon with the same wall thickness is 0%-0.5%.
  • the burst pressure of the balloon 120 is 24atm to 30atm, but the balloon 120 is a non-compliant balloon and has poor wall adhesion, and the balloon made of hard material will affect the shock wave sound pressure intensity and energy transmission effect;
  • High balloon inflation pressure when the burst pressure of the balloon is increased by increasing the wall thickness of the high-flexibility balloon, the larger wall thickness will increase the loss of the shock wave during propagation, reduce the energy acting on the lesion, and also reduce the Adherence and passability of the balloon. Therefore, the inventors of the present application found that the current technology is difficult to simultaneously satisfy the requirements of balloon compliance, wall adhesion, high dilation pressure and high shock wave sound pressure intensity.
  • the balloon 120 of the embodiment of the present disclosure adopts a double-layer structure design with different hardness of the inner layer and the outer layer, which can meet the requirements of high burst pressure and high shock wave sound pressure intensity of the balloon while ensuring the compliance and wall adhesion of the balloon .
  • the compliance of the balloon 120 is 0.5%-3.0%
  • the balloon 120 is semi-compliant. Therefore, by adjusting the mass ratio of the hard material to the soft material, the double-layer structure balloon has better compliance and wall-adherence of the soft material balloon on the one hand, and has a higher flexibility of the hard material balloon on the other hand.
  • the burst pressure of the balloon 120 is 30 atm.
  • the inner layer 122 is made of soft material polyether block polyamide copolymer (Pebax), and the outer layer 124 is made of hard material nylon 12, tightly bonded between the two layers of capsules, as shown in Figure 2 and Figure 3 shows.
  • the Pebax material of the inner layer 122 can endow the balloon 120 with a certain degree of flexibility, which is conducive to passing tortuous lesions, and the nylon 12 of the outer layer 124 can increase the anti-burst ability of the balloon 120, so that the balloon 120 can provide high inflation pressure.
  • it is considered that excessive expansion pressure will cause trauma to the vessel wall, resulting in vessel rebound, dissection, and thrombus formation.
  • the mass ratio of Pebax to Nylon 12 is 1:1, the hardness of Pebax is 69D, and the hardness of Nylon 12 is 81D. At this time, the burst pressure of the balloon 120 is 20 atm, and the compliance is 1.5%. In another embodiment, the mass ratio of Pebax to nylon 12 is 1:1, the hardness of Pebax is 63D, and the hardness of nylon 12 is 81D.
  • the "compliance" herein refers to the change rate of the diameter of the balloon 120 caused by the increase of the filling pressure within the working pressure range.
  • balloon 120 has a nominal diameter at nominal pressure, and its compliance is equal to the increase in diameter of balloon 120 divided by the nominal diameter for each one atmosphere increase in inflation pressure.
  • there is no strict and uniform division of the scope of compliance and it is only defined by experience in a small number of groups.
  • the inflation pressure is increased, the diameter of the balloon 120 remains substantially unchanged, and the balloon can be considered to be non-compliant.
  • “Adherence” refers to the tightness of the balloon 120 when it is filled with a certain pressure medium and adheres to the blood vessel wall, which is mainly related to the deformation of the balloon 120 . In other words, a balloon 120 that is prone to deformation will fit the lesion more easily. In addition, the adherence is related to the compliance, specifically, the adherence of the compliant balloon 120 is the best, and the adherence of the non-compliant balloon 120 is the worst. “Burst pressure” refers to the maximum inflation pressure reached by the balloon 120 during expansion.
  • Calcified plaque is a heterogeneous and anisotropic substance with randomly distributed particles of various sizes inside. Degree-level pores and cracks. For severe calcified lesions, relying solely on balloon dilation has limited effect on opening up. Therefore, endovascular shock wave lithotripsy is currently used to destroy highly calcified lesions. However, calcified lesions may not be completely fragmented due to large fluctuations in the intensity of the shock wave generated by the existing electrode structure. Therefore, the present disclosure adopts a shock wave electrode assembly 200 , the cross-sectional schematic diagram of which is shown in FIG. 4 .
  • the shock wave electrode assembly 200 includes an inner electrode 210 , an outer electrode 230 and an insulating layer 220 between the inner electrode 210 and the outer electrode 230 .
  • Protruding pins 212 are disposed on the surface of the internal electrode 210 , and first holes 222 are disposed on the insulating layer 220 .
  • a second hole 232 is disposed on the external electrode 230 , and the diameter of the second hole 232 is larger than that of the first hole 222 .
  • the protruding pin 212 extends through the first hole 222 and extends into the second hole 232, so that an annular gap is formed between the external electrode 230 and the protruding pin 212, and the gap makes the gap between the external electrode 230 and the internal electrode 210 constitutes a discharge circuit.
  • the shock wave balloon catheter device 100 also includes connecting wires (see connecting wire 320 in FIG.
  • the connecting wires include a first electrode wire and a second electrode wire (not shown) extending along its axial direction, and the inner electrode
  • the outer electrode is connected to the first electrode lead, and the outer electrode is connected to the second electrode lead, and the first electrode lead and the second electrode lead are configured to be respectively connected to two poles of the high-voltage power supply.
  • a high-voltage pulse is generated between the inner electrode 210 and the outer electrode 230 , thereby generating a mechanical shock wave in the balloon 120 .
  • the shock wave electrode assembly 200 is put into the liquid and given an appropriate pulse voltage, the electrode assembly can break down the filled liquid.
  • a stable electric spark is emitted between the protruding pin 212 and the external electrode 230 to generate a shock wave.
  • the shock wave electrode assembly is arranged outside the inner tube, and the shock wave propagates through the liquid inside the balloon 120 to impact the balloon wall and the calcification area. Repeated pulses can destroy the structure of calcified foci and dilate narrow blood vessels without damaging the surrounding soft tissue.
  • a stable electric spark can also reduce the potential for damage to the balloon, thereby ensuring the feasibility of improving the pressure resistance of the balloon.
  • the inventors of the present disclosure experimentally studied the sound pressure intensity of a common shock wave electrode assembly without protruding pins and the shock wave electrode assembly 200 of the present disclosure under different pulse voltages, as shown in FIG. 5 .
  • the shock wave electrode assembly 200 can generate high-intensity sound pressure more efficiently, that is, exhibit higher sound pressure intensity. This is more conducive to effectively destroying calcified lesions and improving the therapeutic effect of the shock wave balloon catheter device 100 .
  • the internal electrode 210 is a sheet-like structure.
  • the insulating layer 220 and the external electrode 230 are ring structures.
  • a shock wave electrode assembly 200 includes a plurality of inner electrodes 210 , the insulating layer 220 includes a plurality of first holes 222 , and the outer electrode 230 includes a plurality of second holes 232 .
  • the numbers of the internal electrodes 210 , the first holes 222 and the second holes 232 are equal.
  • there may be multiple calcified lesions that need to be treated so the shock wave electrode assembly 200 with multiple internal electrodes 210 can be used, thereby Multiple discharge regions are constructed on the shock wave balloon catheter device 100 .
  • the shock wave electrode assembly 200 having a structure of multiple inner electrodes 210 is referred to as a "shock wave multi-electrode assembly".
  • a shockwave multi-electrode assembly is one example of a shockwave electrode assembly 200 according to the present disclosure.
  • FIG. 6 shows a schematic cross-sectional view of a shock wave balloon catheter device 100 provided with a shock wave two-electrode assembly.
  • the two inner electrodes 210-1 and 210-2 of the shock wave two-electrode assembly are arranged outside the inner tube, and the orientation of the two inner electrodes 210-1 and 210-2 is 180 degrees.
  • the distribution of the multiple internal electrodes 210 of the shock wave multi-electrode assembly in the circumferential direction of the inner tube 110 can be adjusted accordingly according to the actual distribution of calcified lesions to be treated, which is not limited in the present disclosure.
  • a plurality of shock wave multi-electrode assemblies are arranged at intervals along the axial direction of the inner tube 110 . If there are multiple calcified lesions to be treated, and they are separated by a certain distance. If the shock wave balloon catheter device 100 uses a single shock wave multi-electrode assembly, it is necessary to transport the shock wave balloon catheter device 100 to different calcified lesions for treatment one by one, which is inconvenient to operate. Therefore, for the above situation, the shock wave balloon catheter device 100 having a plurality of shock wave multi-electrode assemblies 200 arranged at intervals along the axial direction of the inner tube 110 may be used.
  • FIG. 7 shows a schematic diagram of a shockwave balloon catheter device 100 with two shockwave two-electrode assemblies 200 .
  • the distribution of different shock wave electrode assemblies 200 in the axial direction of the inner tube 110 is adjusted accordingly, which is not limited in the present disclosure.
  • the first shock wave two-electrode assembly 200A is fixed on the inner tube 110
  • the second shock wave two-electrode assembly 200B is separated from the first shock wave two-electrode assembly 200A along the circumference of the inner tube 110 .
  • the orientations of the first holes 222 of adjacent shock wave two-electrode assemblies can be arranged at any angle. No limit.
  • the orientations of the first holes 222 of the three shock wave two-electrode assemblies are sequentially distributed at intervals of 60 degrees
  • the orientations of the first holes 222 of the four shock wave two-electrode assemblies are sequentially distributed at intervals of 45 degrees.
  • arrangements similar to the above-mentioned method can also be performed, which will not be repeated here.
  • the double-layer balloon 120 according to the embodiment of the present invention has a beneficial effect on improving the sound pressure intensity of the shock wave emitted by the shock wave electrode assembly 200 .
  • FIG. 9 shows the sound pressure intensity of the shock wave emitted by the shock wave electrode assembly 200 under different inflation pressures of the balloon.
  • water is selected as the filling liquid medium
  • the filling pressure in the double-layer balloon 120 increases from 0 atm to 20 atm
  • the sound pressure intensity of the shock wave presents a trend of first increasing and then decreasing. This is mainly due to the joint effect of the following two aspects.
  • the continuous increase of the filling pressure increases the hindrance effect of the water medium on the formation of the shock wave breakdown channel, which leads to an increase in the energy loss of the shock wave breakdown discharge and a decrease in the sound pressure intensity generated by the shock wave.
  • the increase of filling pressure weakens the shock wave attenuation to a certain extent, which promotes the shock wave transmission.
  • the filling pressure is low (0atm-6atm)
  • the effect of filling pressure on promoting shock wave transmission is stronger than its inhibiting effect on shock wave breakdown. Therefore, the sound pressure intensity of the shock wave increases with the increase of the filling pressure.
  • the filling pressure is 6atm
  • the sound pressure intensity of the shock wave is the largest and reaches the peak value.
  • each set of discharge parameters corresponds to an optimal filling pressure value, so that the effect of lesion fracturing is the best.
  • the double-layer balloon 120 ensures that the shock wave can generate the optimal sound pressure intensity, and at the same time, it also has a relatively high filling pressure.
  • the double-layer balloon 120 and the shock wave assembly 200 work together to effectively treat calcified lesions .
  • Pulsed shock waves act on calcified lesions driven by high-energy plasma. Due to the good energy transfer characteristics of the filled water medium, a vibration effect is generated at the calcified fracture. This causes the expansion and development of the original hydraulic fractures and the initial fractures, and finally the fractures interpenetrate with each other to form macroscopic through fractures. High-voltage pulse discharge is repeated in a short period of time.
  • the shock wave balloon catheter device 100 of the embodiment of the present disclosure has the combined design of the above-mentioned double-layer balloon 120 and the shock wave electrode assembly 200, which can not only meet the requirements of the device for emitting shock waves under high filling pressure, but also ensure that the balloon wall-attachment effect.
  • the inventors of the present disclosure used a plaster ring as a calcification model to study the expansion effect of the same shock wave balloon catheter device 100 under the following three conditions, and recorded the fragmentation of the plaster ring under different conditions.
  • the shockwave electrode assembly 200 delivered shockwaves at 0 atm filling pressure.
  • the shock wave balloon catheter device 100 was only used with an inflation pressure of 6 atm.
  • the shock wave electrode assembly 200 delivered shock waves at a filling pressure of 6 atm. turn out, The shock wave balloon catheter device 100 in both the first and second experiments was unable to fracture the plaster circle.
  • the shock wave electrode assembly 200 can emit several shock waves to break the gypsum circle.
  • the inventors of the present disclosure also studied the expansion effect of the shock wave balloon catheter device 100 with different configurations, as shown in FIG. 10 .
  • the expansion effect test was carried out under the same pulse voltage and filling pressure.
  • the test results show that using the shock wave balloon catheter device 100 of the present disclosure, compared with the soft balloon, the double-layer balloon can crush the calcified model with fewer discharge times;
  • the shock wave electrode assembly, under the same pulse voltage condition, the shock wave electrode assembly 200 of the embodiment of the present disclosure can crush the calcification model with fewer discharge times.
  • the wall thickness of the double-layered balloon is smaller, and the smaller wall thickness reduces the loss of shock wave energy during the transmission process, so that more energy can be transmitted to the lesion , so as to better crush the calcified plaque.
  • the shock wave balloon catheter device 100 arranged with the shock wave electrode assembly 200 and the double-layer balloon 120 can effectively crush calcified plaques and has an excellent expansion effect, and can be applied in angioplasty.
  • the shock wave balloon catheter device 100 has a high burst pressure, up to 20 standard atmospheres, due to its unique double-layer balloon design.
  • the balloon 120 can be further expanded directly after the emitted shock wave causes cracks in the lesion.
  • the higher expansion pressure avoids the situation that the traditional shock wave balloon catheter device is under-expanded and needs to be re-inserted with a high-pressure balloon for use.
  • the efficient and stable shock wave electrode assembly 200 provides high sound pressure intensity for the entire shock wave guide device 100 , and the double-layer structure of the balloon 120 provides sufficient expansion pressure.
  • the synergistic effect of the two can fully expand the lesion and open up the blood vessels. Thereby reducing surgical steps, shortening operating time, and reducing the risk of surgical complications.
  • the inventor also proposes a medical device.
  • the medical device includes the above-mentioned shock wave balloon catheter device 100 , a high pressure generator 310 and a catheter adapter 330 .
  • the above-mentioned shock wave balloon catheter device 100 further includes a connecting wire 320 , the distal end of which is connected to the shock wave electrode assembly 200 through the catheter adapter 330 .
  • the proximal end of the connecting wire 320 is connected to the high voltage generator 310 .
  • each shock wave electrode assembly 200 generates a shock wave with a sound pressure intensity of 2Mpa-20Mpa, and a discharge frequency of 0.1Hz-10Hz.
  • the connecting wire 320 includes a first electrode wire and a second electrode wire, the first electrode wire is connected to the inner electrode 210 , and the second electrode wire is connected to the outer electrode 230 .
  • the current is transmitted to the inner electrode 210 through the first electrode wire, and the inner electrode 210 forms a loop with the outer electrode 230 through the filled conductive fluid.
  • the high-voltage pulse breaks down the conductive fluid, generating shock waves in the axial direction of the first hole 222 .
  • the current is transmitted to the outer electrode 230, and returns to the high voltage generator along the second electrode lead.
  • the shock wave generated by the shock wave electrode assembly 200 propagates through the liquid inside the balloon 120 and impacts the balloon wall and the calcification area. Repeated pulses can destroy the structure of calcified foci and dilate narrow blood vessels without damaging the surrounding soft tissue.
  • the balloon adopts a double-layer structure design, which makes the balloon have better compliance and wall adhesion while effectively increasing the burst pressure of the balloon.
  • shockwave balloon catheter devices can also generate higher acoustic pressure intensities. Through the synergistic effect of high acoustic pressure intensity and high filling pressure, calcified plaque can be more easily comminuted. Therefore, the medical device of the embodiment of the present disclosure can more effectively destroy the calcified lesion structure attached to the wall of the diseased blood vessel, and improve the therapeutic effect on the blocked lesion.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
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Abstract

L'invention concerne un dispositif de cathéter à ballonnet à onde de choc (100) et un appareil médical, qui comprend le dispositif de cathéter à ballonnet à onde de choc (100). Le dispositif de cathéter à ballonnet à onde de choc (100) comprend un ballonnet (120), un tube interne (110) et un tube externe (130). Le ballonnet (120) comprend une couche interne (122) et une couche externe (124), la dureté de la couche interne (122) étant différente de celle de la couche externe (124). Le ballonnet (120) entoure le tube interne (110), et une extrémité distale du tube interne (110) est reliée à une extrémité distale du ballonnet (120). Le tube externe (130) est emmanché à l'extérieur du tube interne (110) et est relié à une extrémité proximale du ballonnet (120). Le dispositif de cathéter à ballonnet à onde de choc (100) peut émettre des ondes de choc à haute résistance pour rompre des plaques calcifiées, et peut également fournir une pression de dilatation élevée pour achever complètement la dilatation d'une lésion et ainsi ouvrir un vaisseau sanguin.
PCT/CN2023/077276 2022-02-24 2023-02-21 Dispositif de cathéter à ballonnet à ondes de choc et appareil médical WO2023160505A1 (fr)

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CN202210172787.4 2022-02-24

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CN114533198A (zh) * 2022-02-24 2022-05-27 上海蓝帆博元医疗科技有限公司 一种冲击波球囊导管装置以及医疗设备
CN115569292A (zh) * 2022-07-11 2023-01-06 上海百心安生物技术股份有限公司 一种具有光学干涉断层扫描能力的脉冲球囊扩张导管
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CN115192872B (zh) * 2022-07-18 2023-09-26 深圳市赛禾医疗技术有限公司 球囊导管及冲击波装置
CN115154858A (zh) * 2022-07-26 2022-10-11 深圳高性能医疗器械国家研究院有限公司 爆裂波球囊导管
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
CN115644983A (zh) * 2022-10-17 2023-01-31 翌铭科技(广州)有限公司 一种血管超声扩张集成装置
WO2024088366A1 (fr) * 2022-10-27 2024-05-02 上海蓝帆博奥医疗科技有限公司 Dispositif à ballonnet pour dispositif médical à ondes de choc, et dispositif médical à ondes de choc
CN115644989B (zh) * 2022-12-29 2023-09-15 南京沃福曼医疗科技有限公司 一种多通道脉冲高压参数可控的冲击波碎石球囊成像系统及其导管

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