Shockwave catheter system

Abstract

This invention relates to the field of medical device technology, and in particular to a shockwave guidewire system, comprising a guidewire, an axial vibration generating device, and a shockwave generating device. The axial vibration generating device is driven and connected to the guidewire to induce axial vibration in the guidewire. The guidewire includes a first end, a second end, and a guidewire body connecting the two. The first end is used to enter the lesion tissue, and its outer diameter decreases continuously along the length of the guidewire away from the guidewire body. The second end is driven and connected to the axial vibration generating device. The shockwave generating device is disposed on the guidewire body and is capable of generating shock waves that propagate circumferentially along the guidewire. This invention's shockwave guidewire system organically integrates the axial vibration generating device, the shockwave generating device, and the guidewire into a single device. This allows for the establishment of an intraluminal channel for the complete occlusion of lesions using a single instrument, significantly reducing surgical time and the burden on both the patient and the surgeon.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an shock waveguide wire system. Background Technology

[0002] Chronic total coronary artery occlusion (CTO) refers to 100% blockage of the coronary artery lumen. Percutaneous coronary intervention (PCI) for this condition has a low success rate and a high complication rate. Currently, the main clinical treatment for this disease is to open the CTO lesion. Successful opening of the CTO lesion can relieve angina symptoms, improve left ventricular function, stabilize myocardial electrical activity, and thus enhance the patient's tolerance to future coronary events.

[0003] In traditional techniques, CTO recanalization typically involves a surgeon, with image guidance, inserting a thin guidewire near the lesion. The guidewire then penetrates the CTO tissue under pressure to open the recanalization. However, CTO recanalization heavily relies on the surgeon's experience. This is because selecting the appropriate guidewire type and controlling its penetration force are difficult. Furthermore, the presence of calcified and fibrotic tissue, combined with the complexity of vessel size and curvature, makes improper operation during CTO recanalization highly susceptible to complications such as coronary perforation or cardiac tamponade, leading to recanalization failure. In addition, the complexity and length of the CTO recanalization procedure, along with the large amount of contrast agent used and the high X-ray exposure, pose significant negative impacts on both the patient and the surgeon.

[0004] To address this issue, some existing methods involve adding sensors or optimizing the guidewire structure to improve the effectiveness and safety of CTO penetration, thereby increasing the success rate and shortening the operation time. However, these methods do not significantly improve the success rate when encountering lesions with severe calcification or large CTO lengths. Summary of the Invention

[0005] Based on this, the present invention proposes an shock waveguide wire system that effectively integrates axial mechanical vibration with circumferential impact, which can improve the effectiveness and recanalization efficiency of treating lesions with severe calcification and long CTO.

[0006] This invention discloses a shock wave guide wire system, which includes a guide wire, an axial vibration generating device, and a shock wave generating device, wherein...

[0007] The axial vibration generating device is connected to the guide wire drive and is used to cause the guide wire to vibrate axially.

[0008] The guidewire includes a first end, a second end, and a guidewire body connecting the two. The first end is used to enter the lesion tissue, and the outer diameter of the first end decreases continuously along the length of the guidewire away from the guidewire body. The second end is driven and connected to the axial vibration generating device.

[0009] The shock wave generating device is disposed on the guide wire body, and the shock wave generating device is capable of generating shock waves that propagate circumferentially along the guide wire.

[0010] In some embodiments, the shock wave guidewire system further includes a cavity disposed on the guidewire body, the cavity being expandable to at least partially conform its wall to the lesion tissue, and the cavity being capable of conducting the shock wave generated by the shock wave generating device to the lesion tissue.

[0011] In some embodiments, the cavity is provided with a medium that expands the cavity, and the medium is able to communicate with the shock wave generating device and conduct the shock wave.

[0012] In some embodiments, the shock wave generating device includes at least one electrode assembly, the medium being an electrolyte, and the electrode assembly receives an external electrical signal and, in conjunction with the electrolyte, generates a shock wave.

[0013] In some embodiments, the electrode assembly is multiple.

[0014] In some embodiments, a plurality of the electrode assemblies are spaced apart along the length and / or circumferential direction of the guidewire body.

[0015] In some embodiments, the electrode assembly is coaxially sleeved outside the guidewire body.

[0016] In some embodiments, the shock wave generating device includes an inductor coil and a diaphragm, the diaphragm being in communication with the medium, and the inductor coil receiving an external electrical signal to cause the diaphragm to vibrate.

[0017] In some embodiments, the medium further includes a contrast agent.

[0018] In some embodiments, the shock wave generating device is connected to the cavity wall of the cavity, so that the cavity wall conducts the shock wave to the diseased tissue.

[0019] In some embodiments, the shock wave generating device includes a piezoelectric crystal disposed on the cavity wall of the cavity, and the piezoelectric crystal receives external electrical signals to generate shock waves.

[0020] In some embodiments, when the cavity is not expanded, the outer diameter of the cavity is less than or equal to the maximum outer diameter of the first end.

[0021] In some embodiments, when the cavity expands, the outer diameter of the cavity is greater than or equal to the maximum outer diameter of the first end.

[0022] In some embodiments, the axial vibration generating device is a piezoelectric generator.

[0023] In some embodiments, the resonant frequency of the mechanical vibration generated by the piezoelectric generator is 10kHz-10MHz, the amplitude is 20μm-100μm, the pulse effective time is 1μs-20μs, and the pulse repetition frequency is 10Hz-100Hz.

[0024] In some embodiments, the shock waveguide wire system further includes a cavity disposed on the wire body, and the shock waveguide wire system further includes a conduit through which the wire passes.

[0025] In some embodiments, the catheter is provided with a fluid conduit extending its length, and the fluid conduit is in communication with the cavity.

[0026] In some embodiments, the shock wave guide wire system further includes a control host, which is electrically connected to the axial vibration generating device and the shock wave generating device.

[0027] Beneficial effects

[0028] The shockwave guidewire system of this invention organically integrates an axial vibration generating device, a shockwave generating device, and a guidewire into one unit. The first end of the guidewire is specially designed; its small tip, combined with the axial vibration of the axial vibration generating device, can effectively penetrate calcified areas in chronic total coronary artery occlusion (CTO). As the shockwave generating device moves with the guidewire body to the lesion, it generates a shockwave that propagates circumferentially along the guidewire. This shockwave can fracture and soften the lesion, increasing vascular compliance to facilitate the expansion of the CTO lesion. Therefore, using this shockwave guidewire system, a single device can establish the necessary endovascular access for stent implantation in a completely occluded lesion, significantly reducing surgical time and the burden on both the patient and the surgeon.

[0029] Furthermore, by setting the outer diameter of the first end of the guidewire to decrease continuously along its length away from the second end, the larger portion of the outer diameter of the first end after insertion into the blood vessel is significantly constrained by the vessel wall, preventing excessive bending of the guidewire within the vessel. When the guidewire vibrates axially under the action of the axial vibration generating device, this setting reduces the torsional (radial) vibration caused by the mechanical wave transmission component resulting from the angularity of the guidewire within the curved blood vessel. This allows the axial vibration, which can effectively penetrate occluded lesions, to be transmitted more effectively to the first end of the guidewire, increasing penetration efficiency. At the same time, reducing torsional (radial) vibration also lowers the risk of vessel wall damage caused by guidewire flare. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the shock waveguide wire system of the present invention in some embodiments;

[0031] Figure 2 This is a schematic diagram of the guide wire and shock wave generating device of the shock wave guide wire system of the present invention in some embodiments;

[0032] Figure 3 This is a schematic diagram of the shock waveguide wire system of the present invention without expansion in some embodiments;

[0033] Figure 4 This is a schematic diagram of the cavity expansion of the shock waveguide wire system of the present invention in some embodiments;

[0034] Figure 5 for Figure 1 A cross-sectional view of the conduit of the shock waveguide wire system of the present invention at point AA;

[0035] Figure 6 This is a connection diagram of the control host of the shock waveguide wire system of the present invention in some embodiments;

[0036] Figure 7 This is a schematic diagram of the shock wave generating device of the shock wave guide wire system of the present invention in another embodiment;

[0037] Figure 8 This is a schematic diagram of the shock wave generating device of the shock wave guide wire system of the present invention in another embodiment;

[0038] Figure 9 for Figure 8 A radial cross-sectional view of the shock wave generating device in the illustrated embodiment;

[0039] Among them, 1 is the axial vibration generating device, 2 is the guide wire, 3 is the cavity, 5 is the catheter, 6 is the control host, 7 is the handle, 8 is the lesion tissue, 21 is the first end, 22 is the guide wire body, 41 is the shock wave generating device, 42 is the conductive connecting wire, 51 is the fluid pipeline, 61 is the high-pressure drive module, and 62 is the piezoelectric drive module. Detailed Implementation

[0040] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0041] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0042] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0043] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0044] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0045] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0046] See Figure 1 , Figure 1 A schematic diagram of a shock wave guide wire system according to an embodiment of the present invention is shown. The shock wave guide wire system provided in an embodiment of the present invention includes an axial vibration generating device 1, a guide wire 2, and a shock wave generating device.

[0047] Specifically, guidewire 2 is inserted into the patient's blood vessel so that the operator can use the shockwave guidewire system of the present invention to open chronic total occlusion (CTO) of the coronary artery in the patient. For example... Figure 2 The diagram shown is a schematic of the guidewire 2 in a partial embodiment. The guidewire 2 has a first end 21, a second end, and a guidewire body 22 connecting the first end 21 and the second end. An axial vibration generating device 1 is driven to the second end of the guidewire 2. The axial vibration generating device 1 can drive the guidewire 2 to vibrate axially, allowing the first end 21 to more smoothly enter the lesion tissue 8. To ensure that the guidewire 2 can smoothly transmit the axial vibration generated by the axial vibration generating device 1 from the second end to the first end 21, for example, the guidewire 2 can be made of materials such as stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, or nickel-titanium shape memory alloy. This type of guidewire 2 can effectively withstand and transmit the axial stress and strain generated by the axial vibration generating device 1, enabling the first end 21 of the guidewire 2 to output axial vibration to the lesion tissue 8, accelerating its passage through the lesion tissue 8, so as to further utilize the shockwave guidewire system of the present invention for treatment.

[0048] Specifically, the first end 21 of guidewire 2 is configured to decrease in length along the direction away from the second end, such as... Figure 2As shown, in some embodiments, the axial cross-sectional view of the first end 21 is an isosceles trapezoid. The small tip of the first end 21 allows it to amplify the axial vibration transmitted from the axial vibration generating device 1, improving the ability of the first end 21 of the guidewire 2 to penetrate the lesion tissue. As the outer diameter of the portion of the first end 21 away from the tip increases, the first end 21 also expands the channel through the lesion tissue when penetrating it, in order to facilitate further treatment.

[0049] Continue reading Figure 2 The shock wave guide wire system of the present invention has a shock wave generating device 41 provided on the guide wire body 22. The shock wave generating device 41 is capable of generating shock waves that propagate circumferentially along the guide wire 2.

[0050] The shockwave guidewire system of this invention organically integrates the axial vibration generating device 1, the shockwave generating device, and the guidewire 2 into one unit. The first end 21 of the guidewire 2 is specially designed; its small tip, combined with the axial vibration of the axial vibration generating device 1, can effectively penetrate the lesion tissue 8 in chronic total coronary artery occlusion (CTO). The guidewire body 22 follows the first end 21 as it extends into the patient's body. When the shockwave generating device 41 moves with the guidewire body 22 to the lesion tissue 8, the shockwave generating device 41 generates a shockwave that propagates circumferentially along the guidewire 2. This shockwave can fracture and soften the lesion tissue 8, increasing vascular compliance to facilitate the expansion of the CTO lesion. Therefore, using the shockwave guidewire system of this invention, the necessary endovascular access for stent implantation can be established for completely occluded lesions, significantly saving surgical time and reducing the burden on both the patient and the surgeon.

[0051] It is particularly important to emphasize that by setting the outer diameter of the first end 21 of guidewire 2 to continuously decrease along the length of guidewire away from the second end, the larger portion of the outer diameter of the first end 21 after guidewire 2 is inserted into the blood vessel will be significantly constrained by the blood vessel wall, preventing guidewire 2 from bending excessively within the blood vessel. When guidewire 2 vibrates axially under the action of axial vibration generating device 1, this setting can reduce the torsional (radial) vibration caused by the mechanical wave transmission component due to the angle formed by guidewire 2 in the curved blood vessel, allowing the axial vibration that can effectively penetrate the occluded lesion to be transmitted more effectively to the first end 21 of guidewire 2, increasing penetration efficiency. At the same time, reducing torsional (radial) vibration also reduces the risk of blood vessel wall damage caused by guidewire 2 swinging.

[0052] In some preferred embodiments, the shockwave guidewire system of the present invention further includes a cavity 3 on the guidewire body 22. The cavity 3 is expandable so that its wall at least partially adheres to the lesion tissue 8, and the cavity 3 can conduct the shock wave generated by the shock wave generating device 41 to the lesion tissue 8. Since the cavity 3 partially adheres to the lesion tissue 8 when it expands, the shock wave can directly act on the lesion tissue 8, thereby improving the opening effect for CTO.

[0053] Understandably, there are multiple ways to implement how the shock wave generating device 41 conducts the shock wave through the cavity 3. In some embodiments, the shock wave generating device 41 can be directly connected to the cavity wall of the cavity 3, allowing the shock wave to be directly transmitted to the cavity 3. For example, as... Figure 8 , Figure 9 As shown, in this embodiment, the shock wave generating device 41 can be a piezoelectric crystal, which is disposed on the cavity wall of the cavity 3 and connected to an external high-frequency voltage device. When the cavity 3 is attached to the lesion tissue 8, the high-frequency voltage device generates a high-frequency voltage that is transmitted to the piezoelectric crystal. The piezoelectric crystal generates an inverse piezoelectric effect, expands and contracts, and vibrates. This vibration is then directly transmitted to the lesion tissue 8 through the cavity 3.

[0054] In other embodiments, the cavity 3 is provided with a medium capable of expanding the cavity 3, and the medium is in communication with the shock wave generating device and conducts the shock wave. For example, in some embodiments, such as Figure 7 As shown, a medium and a shock wave generating device 41 are installed inside the cavity 3. The shock wave generating device 41 includes an inductor coil 411, which is covered by a diaphragm 412. The inductor coil 411 is connected to an external high-voltage capacitor, and the diaphragm 412 is in communication with the medium. The high-voltage capacitor discharges to the inductor coil 411, and the pulse current generated by the inductor coil 411 forms a strong pulsed magnetic field, which induces a diaphragm magnetic field in the diaphragm 412. The interaction between the diaphragm magnetic field and the pulsed magnetic field generates a repulsive force, causing vibration and forming a shock wave. The shock wave is transmitted to the cavity 3 by the medium, which cracks and loosens the diseased tissue 8.

[0055] As another achievable instance, such as Figure 2 , Figure 4 As shown, the shock wave generating device 41 may include an electrode assembly and a conductive connecting line 42. The electrode assembly is disposed in the cavity 3. One end of the conductive connecting line 42 is connected to the electrode assembly, and the other end of the conductive connecting line 42 extends out of the cavity 3 and is connected to an external pulse signal transmitting device. An electrolyte is also disposed in the cavity 3 as a medium. The electrode assembly receives the pulse signal and cooperates with the electrolyte to generate a shock wave.

[0056] Specifically, such as Figure 6As shown, the electrode assembly receives a high-voltage pulse signal from the external control host 6. Under the action of the high-voltage strong electric field, electrons in the medium near the electrode assembly in the cavity 3 are accelerated and ionize the liquid molecules near the electrode assembly. The ionized electrons in the medium are accelerated by the high-voltage strong electric field to ionize more electrons, forming an electron avalanche. A plasma channel is formed in the region where the medium molecules are ionized. As the ionization region expands, the electrode assembly forms a discharge channel, and the liquid is broken down. After the discharge channel is generated, due to the very small discharge resistance, a discharge current of tens of kiloamperes will be generated. The discharge current heats the liquid around the channel, causing the liquid to vaporize and expand rapidly outward. The rapidly expanding outer edge of the gas cavity generates a powerful shock wave in the water medium. In this embodiment, the shock wave guide wire system of the present invention utilizes the hydroelectric effect between the electrode assembly and the medium to generate a high-intensity ultrasonic shock wave, which, together with the axial mechanical vibration described above, acts on the diseased tissue, significantly improving the effectiveness and recanalization efficiency of treating lesions with severe calcification and large CTO length.

[0057] Specifically, the conductive connecting wire 42 and the electrode assembly can be made of gold, silver, aluminum, copper, copper-clad steel wire, etc. Of course, in some embodiments, the conductive connecting wire 42 can also be surrounded by an insulating layer, providing insulation while also offering some support for the electrode assembly. In some embodiments, the conductive connecting wire 42 can be a multi-core cable that branches into multiple connecting wires near the cavity 3 to connect to multiple electrode assemblies, or it can be multiple coaxial cables connecting multiple electrode assemblies.

[0058] Specifically, multiple electrode assemblies can be configured. For example, there can be two, or as follows: Figure 2-4 The example shown has 3, but you can also set more, such as 4 or more. For example... Figure 6 The diagram shows the circuit connection between the control host 6 and the shock wave generating device and the axial vibration generating device. Multiple electrode assemblies are preferably connected in parallel, so that even if some of the electrode assemblies fail, the shock wave guidewire system of this invention will still function normally, avoiding any impact on the surgical procedure.

[0059] by Figure 2 In the illustrated embodiment, preferably, multiple electrode assemblies are spaced apart along the length of the guidewire body 22. This spaced arrangement allows the shockwave guidewire system of the present invention to uniformly soften and open the calcified portions of the lesion tissue 8 along the length of the blood vessel. Similarly, in other embodiments, multiple electrode assemblies can also be uniformly spaced around the guidewire body 22 in the circumferential direction. This arrangement allows for uniform softening and opening of the calcified portions of the circumferential lesion tissue 8 within the blood vessel. When both of these arrangements are used together, the shockwave guidewire system of the present invention achieves better CTO recanalization treatment results.

[0060] Specifically, when the electrode assembly is configured to run along the length of the guidewire body 22, the electrode assembly is preferably annular, coaxially sleeved on the guidewire body 22 and insulated from it. This configuration allows the electrode assembly to be securely fixed in a relatively simple manner, ensuring that after the shockwave guidewire system of the present invention is inserted into the patient's blood vessel and reaches the location of the lesion tissue 8, the electrode assembly is in optimal working condition to provide the best recanalization treatment effect.

[0061] It is understood that the shock wave guide wire system of the present invention does not strictly limit the specific form of the axial vibration generating device 1. As one specific achievable example, the axial vibration generating device 1 can be a piezoelectric generator. In some embodiments, the piezoelectric generator has a stack of multiple piezoelectric ceramics inside, one end of which is drivenly connected to the guide wire 2, and the other end is fixedly connected to, for example, Figure 1 The piezoelectric generator is located on the handle 7 shown. More specifically, the piezoelectric generator is connected to an external control host 6 and receives piezoelectric drive signals from the control host 6. This causes the stack to generate mechanical vibration, which is then transmitted to the guide wire 2. The piezoelectric ceramic material is PZT-4, but it can also be PZT-8, PZT-4D, etc. The overall shape of the piezoelectric generator is cylindrical, with a diameter of approximately 20mm-30mm, but it can also be annular or other highly centrally symmetrical shapes. The piezoelectric generator and the guide wire 2 can be connected by internal or external threads, direct welding, or other rigid connection methods.

[0062] Obviously, the piezoelectric generator is not limited to a stack of piezoelectric ceramics. In other embodiments, it can be replaced by other piezoelectric devices, such as a piezoelectric stack combined with a mechanical amplifier or a sandwich transducer. However, regardless of the specific form of the piezoelectric generator, preferably, the resonant frequency of the mechanical vibration generated by the piezoelectric generator is about 10 kHz to 10 MHz, the amplitude is about 20 μm to 100 μm, the effective pulse time (referring to the portion of the pulse amplitude above -6 dB) is about 1 μs to 20 μs, and the pulse repetition frequency is about 10 Hz to 100 Hz. With this configuration, the first end 21 of the guidewire 2 will be able to generate a penetrating force of not less than 10 N on the lesion tissue. Combined with a higher vibration frequency and a shorter amplitude, it can efficiently open the lesion tissue.

[0063] like Figure 2As shown in some embodiments, the shock wave guide wire system of the present invention optimizes the fit between the cavity 3 and the guide wire 2. Specifically, when the cavity 3 is in an unfilled state, the outer diameter of the cavity 3 is set to be less than or equal to the maximum outer diameter of the first end 21. With this setting, since the outer diameter of the cavity 3 is smaller than the maximum outer diameter of the first end 21 when unfilled, after the first end 21 of the guide wire 2 smoothly penetrates the lesion tissue 8 with the help of the axial vibration generating device 1, the cavity 3 can follow the first end 21 smoothly into the lesion tissue 8 without being blocked by the lesion tissue, so that the cavity 3 can subsequently fill and expand to soften and open the lesion tissue.

[0064] In addition, such as Figure 4 As shown, in the preferred embodiment of the shockwave guidewire system of the present invention, when the cavity 3 is in a filled state, the outer diameter of the cavity 3 is greater than or equal to the maximum outer diameter of the first end 21. As can be seen from the foregoing analysis, the shockwave guidewire system of the present invention first enters the lesion tissue 8 through the first end 21 of the guidewire 2; therefore, the maximum size of the lesion tissue 8 is determined by the maximum outer diameter of the first end 21. By setting the outer diameter of the cavity 3 in the filled state to be greater than or equal to the maximum outer diameter of the first end 21, the filled cavity 3 can fit well against the lesion tissue 8, and the shock wave from the shockwave generating device can be well transmitted to the lesion tissue 8 through the medium to perform open-circuit treatment. When the calcified portion in the lesion tissue 8 is fractured and loosened, the inner diameter of the lesion tissue 8 increases. Because the outer diameter of the cavity 3 is greater than the maximum outer diameter of the first end 21, the cavity 3 can continue to maintain a tight fit with the lesion tissue 8, thereby better achieving the opening of the CTO.

[0065] like Figure 1 As shown, in some embodiments, the shock wave guidewire system of the present invention further includes a conduit 5, in which a guidewire 2 passes through the conduit 5, and the first end 21 of the guidewire 2 extends out of the conduit 5. The shock wave generating device is connected to the cavity 3 through the conduit 5. The conduit 5 provides a base for mounting and fixing the cavity 3, the guidewire 2, and the shock wave generating device. Specifically, the conductive connection wire 42 of the shock wave generating device passes out of the cavity 3 through the conduit 5 and connects to an external pulse signal transmitting device.

[0066] like Figure 5 The image shows catheter 5 in one of the embodiments. Figure 1 The cross-sectional view at point AA shows that a fluid conduit 51, running the length of the conduit 5, is provided on its wall. The fluid conduit 51 allows the medium to be introduced from the outside into the cavity 3. Preferably, the fluid conduit 51, guide wire 2, and conductive connecting wire 42 are all independently and separately arranged. The guide wire 2 is located at the center of the conduit 5, while the fluid conduit 51 and conductive connecting wire 42 are located on either side of the guide wire 2. This arrangement allows for full and rational utilization of the space in the conduit 5, reducing production difficulty and improving production efficiency.

[0067] Since the catheter 5 needs to be inserted into a blood vessel in the patient's body, in some embodiments, the catheter 5 is preferably made of a biocompatible material, or its surface is coated with a biocompatible coating, such as a polytetrafluoroethylene coating. Similarly, since the first end 21 of the guidewire 2 is used to penetrate the lesion tissue 8, the first end 21 can also be similarly provided with an insulating material layer. This insulating material layer prevents the guidewire 2 from conducting electricity and causing damage to the human body, and also makes the surface of the first end 21 smooth, avoiding scratching the blood vessel.

[0068] Specifically, in order to drive the shock wave generating device and the axial vibration generating device 1 of the shock wave guide wire system of the present invention, in some embodiments, such as Figure 6 As shown, the control host 6 of the shock wave guide wire system of the present invention integrates a high-voltage drive module 61 and a piezoelectric drive module 62. The high-voltage drive module 61 is electrically connected to the shock wave generating device, while the piezoelectric drive module 62 is electrically connected to the axial vibration generating device 1. The integrated control host 6 can simultaneously drive the shock wave generating device and the axial vibration generating device 1, thereby simplifying the composition structure of the shock wave guide wire system of the present invention.

[0069] In some embodiments, the medium in the shock wave guidewire system of the present invention, in addition to filling the cavity 3 and conducting shock waves, can also be used for imaging. Specifically, the medium includes a contrast agent. With this configuration, the shock wave guidewire system of the present invention no longer needs a separate imaging structure to determine the specific location of the cavity 3. Furthermore, when the cavity 3 is filled with a medium containing the contrast agent, the imaging device can monitor the amount of medium within the cavity 3 using the contrast agent. When the cavity 3 expands under the influence of the medium and closely adheres to the vessel wall of the lesion tissue 8, the input of the medium into the cavity 3 is stopped. In this way, on the one hand, the cavity 3 can be made as close as possible to the vessel wall; on the other hand, excessive medium in the cavity 3 can be avoided, which could damage the vessel wall.

[0070] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0071] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An impact waveguide wire system, characterized in that, The shock wave guide wire system includes a guide wire, an axial vibration generating device, and a shock wave generating device, wherein... The axial vibration generating device is connected to the guide wire drive and is used to cause the guide wire to vibrate axially. The guidewire includes a first end, a second end, and a guidewire body connecting the two. The first end is used to enter the lesion tissue, and the outer diameter of the first end decreases continuously along the length of the guidewire away from the guidewire body. The second end is driven and connected to the axial vibration generating device. The shock wave generating device is disposed on the guide wire body, and the shock wave generating device is capable of generating shock waves that propagate along the circumference of the guide wire. The shock wave guidewire system further includes a cavity disposed on the guidewire body. The cavity is capable of expanding so that its wall at least partially adheres to the lesion tissue. The cavity is capable of conducting the shock wave generated by the shock wave generating device to the lesion tissue. When the cavity is not expanded, the outer diameter of the cavity is less than or equal to the maximum outer diameter of the first end.

2. The shock waveguide wire system according to claim 1, characterized in that, The cavity is provided with a medium that expands the cavity, and the medium can communicate with the shock wave generating device and conduct the shock wave.

3. The shock waveguide wire system according to claim 2, characterized in that, The shock wave generating device includes at least one electrode assembly, the medium being an electrolyte, and the electrode assembly receives an external electrical signal and, in conjunction with the electrolyte, generates a shock wave.

4. The shock waveguide wire system according to claim 3, characterized in that, The electrode assembly comprises multiple components.

5. The shock waveguide wire system according to claim 4, characterized in that, The plurality of electrode assemblies are arranged at intervals along the length and / or circumferential direction of the guidewire body.

6. The shock waveguide wire system according to claim 5, characterized in that, The electrode assembly is coaxially sleeved outside the guide wire body.

7. The shock waveguide wire system according to claim 2, characterized in that, The shock wave generating device includes an inductor coil and a diaphragm. The diaphragm is in communication with the medium, and the inductor coil receives external electrical signals to cause the diaphragm to vibrate.

8. The shock waveguide wire system according to any one of claims 2-7, characterized in that, The medium also includes a contrast agent.

9. The shock waveguide wire system according to claim 1, characterized in that, The shock wave generating device is connected to the cavity wall of the cavity, so that the cavity wall conducts the shock wave to the diseased tissue.

10. The shock waveguide wire system according to claim 9, characterized in that, The shock wave generating device includes a piezoelectric crystal, which is disposed on the cavity wall of the cavity. The piezoelectric crystal receives external electrical signals to generate shock waves.

11. The shock waveguide wire system according to claim 1, characterized in that, When the cavity expands, the outer diameter of the cavity is greater than or equal to the maximum outer diameter of the first end.

12. The shock waveguide wire system according to claim 1, characterized in that, The axial vibration generating device is a piezoelectric generator.

13. The shock waveguide wire system according to claim 12, characterized in that, The piezoelectric generator produces mechanical vibrations with a resonant frequency of 10kHz-10MHz, an amplitude of 20μm-100μm, an effective pulse duration of 1μs-20μs, and a pulse repetition frequency of 10Hz-100Hz.

14. The shock waveguide wire system according to claim 1, characterized in that, The shock wave guidewire system also includes a conduit through which the guidewire passes.

15. The shock waveguide wire system according to claim 14, characterized in that, The catheter is provided with a fluid conduit that extends its length, and the fluid conduit is connected to the cavity.

16. The shock waveguide wire system according to claim 1, characterized in that, The shock wave guide wire system also includes a control host, which is electrically connected to the axial vibration generating device and the shock wave generating device.

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