A lithotripsy catheter and lithotripsy device

Abstract

The application discloses a kind of gravel catheter and gravel equipment, gravel catheter includes body, at least one shock wave generator, at least one ultrasonic wave generator and control piece, shock wave generator and ultrasonic wave generator are set on body, control piece is electrically connected with shock wave generator and ultrasonic wave generator, control piece has the first state of control shock wave generator power-off while controlling ultrasonic wave generator power-on to generate vibration to body, or the second state of control shock wave generator and ultrasonic wave generator power-on simultaneously.Gravel catheter generates ultrasonic wave when working, and cavitation reaction occurs on blood vessel calcified plaque and constantly produces microbubble, and the microbubble generated by ultrasonic wave cavitation reaction has periodic expansion and contraction and high-frequency vibration, and expansion and contraction and high-frequency vibration will cause mechanical fatigue and damage to plaque, thereby improving treatment efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a lithotripsy catheter and lithotripsy device. Background Technology

[0002] Vascular calcification is the abnormal deposition of calcium phosphate salts, primarily in the form of hydroxyapatite, in the walls of arteries and veins, leading to calcified plaques on the inner wall of the vessel. Currently, the main clinical treatment strategy for vascular calcification is mechanical therapy, with percutaneous coronary artery intervention (PCI) used for more severe coronary artery calcification. Common procedures include rotational atherectomy (RA) combined with a cutting balloon (CB) for pre-dilation, or RA combined with a conventional semi-compliant balloon (SB) for pre-dilation. However, because both methods involve mechanical contact with the calcified plaques, they can easily cause damage to the vessel wall, leading to intimal tears, perforation, dissection, vasospasm, acute occlusion, etc., posing a high surgical risk.

[0003] Shockwave lithotripsy is safer, faster, and more thorough than traditional treatments. Because the excitation source is small and placed inside the blood vessel, the resulting shockwave has a small amplitude and fast propagation speed, minimizing its impact on soft tissues and thus greatly reducing damage to the blood vessel wall. However, current technology often suffers from a decrease in treatment efficiency as treatment time increases. This results in patients with large areas or severe vascular calcification failing to achieve good treatment outcomes with prolonged treatment, leading to low treatment efficiency. Summary of the Invention

[0004] Therefore, the technical problem to be solved by the present invention is the deficiency of low treatment efficiency in existing technologies during prolonged treatment. To this end, the present invention provides a lithotripsy catheter, comprising:

[0005] ontology;

[0006] At least one shock wave generator is disposed on the body and is adapted to be electrically connected to an external power source;

[0007] At least one ultrasonic generator is disposed on the body and is adapted to be electrically connected to an external power source.

[0008] A control unit is electrically connected to the shock wave generator and the ultrasonic wave generator. The control unit has a first state of controlling the shock wave generator to be de-energized while controlling the ultrasonic wave generator to be energized to generate vibration in the body, or a second state of controlling the shock wave generator and the ultrasonic wave generator to be energized simultaneously.

[0009] Optionally, in the above-mentioned lithotripsy guide tube, the control element has a third state in which it controls the shock wave generator to be energized while simultaneously controlling the ultrasonic wave generator to be de-energized to generate a shock wave in the shock wave generator.

[0010] Optionally, the aforementioned lithotripsy guide tube further includes an installation channel adapted to contain a conductive liquid. The installation channel has a clearance portion, and the shock wave generator is disposed within the installation channel, adapted to send a shock wave to the outside at the clearance portion in a third state or a second state.

[0011] Optionally, in the above-mentioned lithotripsy guide tube, the shock wave generator is a wire.

[0012] Optionally, the above-mentioned lithotripsy catheter further includes an ultrasonic wave generating chamber in its main body, and the ultrasonic wave generating element is disposed within the ultrasonic wave generating chamber.

[0013] Optionally, in the above-mentioned lithotripsy conduit, the ultrasonic generating cavity has a clearance cavity after the ultrasonic generating element is installed, and the clearance cavity is adapted to be filled with a cooling medium.

[0014] Optionally, in the above-mentioned lithotripsy catheter, the ultrasonic generator is an ultrasonic transducer.

[0015] Optionally, in the above-mentioned lithotripsy conduit, the center frequency of the ultrasonic generator is greater than or equal to 500 kHz and less than or equal to 5 MHz.

[0016] Optionally, the above-mentioned lithotripsy catheter also includes

[0017] A guide cavity is provided on the body along the axial direction;

[0018] A guide element, which passes through the guide cavity, is adapted to guide the body to perform displacement and rotation.

[0019] Optionally, the above-mentioned lithotripsy catheter includes:

[0020] A pair of shock wave generators are disposed on the body. The shock wave generators include a first shock wave generator and a second shock wave generator. The body includes a first mounting channel and a second mounting channel. The first mounting channel and the second mounting channel have a first opening and a second opening, respectively. The first opening and the second opening are disposed on the same radial plane of the body.

[0021] and / or

[0022] A pair of ultrasonic generators are disposed on the body. The ultrasonic generators include a first ultrasonic generator and a second ultrasonic generator, which are disposed on the same radial plane of the body.

[0023] Optionally, in the above-mentioned lithotripsy guide tube, on any plane along the radial direction of the body, the lines connecting the two mounting channel axes to the axis of the body respectively form a first angle, and the ultrasonic generator is disposed on the angle bisector of the first angle.

[0024] Optionally, in the above-mentioned lithotripsy conduit, the mechanical index of the ultrasonic wave generated by the ultrasonic wave generator is greater than 0 and less than 3.

[0025] Optionally, in the above-mentioned lithotripsy conduit, the mechanical index of the ultrasonic wave generated by the ultrasonic wave generator is greater than 0.4 and less than 0.8.

[0026] Optionally, in the above-mentioned lithotripsy catheter, the third state is maintained for a first maintenance time, which is more than 1 ms and less than 500 ms.

[0027] Optionally, in the above-mentioned lithotripsy catheter, the first state or the second state is maintained for a second maintenance time, wherein the second maintenance time is more than 1 ms and less than 500 ms.

[0028] A lithotripsy device includes an external power supply and at least one lithotripsy conduit.

[0029] Optionally, in the above-mentioned stone crushing equipment, the external power supply includes a bipolar power supply, and the bipolar power supply is electrically connected to the wire.

[0030] The technical solution provided by this invention has the following advantages:

[0031] 1. The lithotripsy catheter provided by the present invention includes a body, at least one shock wave generator, at least one ultrasonic wave generator, and a control unit. The shock wave generator and the ultrasonic wave generator are disposed on the body. The control unit is electrically connected to the shock wave generator and the ultrasonic wave generator. The control unit has a first state of controlling the shock wave generator to be de-energized while controlling the ultrasonic wave generator to be energized to generate vibration of the body, or a second state of controlling the shock wave generator and the ultrasonic wave generator to be energized simultaneously. The ultrasonic waves generated by the lithotripsy catheter in the first and second states will cause cavitation reactions on the calcified plaques in the blood vessels and continuously generate microbubbles. Since the plaque itself is not dense and has gaps, the microbubbles can penetrate into the plaque through the gaps and continuously expand and contract, thereby destroying the plaque from the inside. At the same time, the vibration of the microbubbles continuously agitates the surrounding liquid, accelerating the fragmentation of the plaque. Furthermore, the periodic expansion and contraction generated by cavitation exerts a force on the plaque surface, leading to surface fatigue failure. Thus, under the combined action of these principles, the plaque ruptures and fragments. In addition, in the first state, by setting up an ultrasonic generator and a control unit, the ultrasonic waves generated cause the microbubble clouds generated by the shock wave to interact with each other. The microbubble clouds are stimulated and aggregate into large microbubbles and move towards the trough of the sound field, reducing the microbubble shielding area, thereby alleviating the microbubble shielding phenomenon and improving the efficiency of treatment.

[0032] 2. The lithotripsy conduit provided by this invention uses a wire as the ultrasonic generator. By setting the wire as the shock wave generator, it can directly contact the liquid in the working environment through the wire on the installation channel when energized, thereby generating a hydroelectric effect and thus generating a shock wave. The lithotripsy conduit with the above structure is simple in structure and does not require an additional shock wave generating device, which is beneficial for the lithotripsy conduit to move in a confined working environment and reduces mechanical damage to the inner wall of the working environment.

[0033] 3. The lithotripsy conduit provided by this invention has an ultrasonic generating cavity with a clearance cavity after the ultrasonic generator is installed. The clearance cavity is suitable for filling with a cooling medium. The ultrasonic generator will generate high temperatures after prolonged operation. By providing a clearance cavity that can be filled with a cooling medium, various cooling media can be filled into the cavity to reduce the temperature of the ultrasonic generator and the lithotripsy conduit, thereby reducing the risk of the ultrasonic generator burning out.

[0034] 4. In the lithotripsy guide tube provided by this invention, on any plane along the radial direction of the body, the lines connecting the axes of the two mounting channels to the axis of the body respectively form a first angle, and the ultrasonic generator is disposed on the angle bisector of the first angle. By disposing the ultrasonic generator on the angle bisector of the first angle, the ultrasonic waves generated by the ultrasonic generator can have the same effect on the shock waves generated by the two shock wave generators. Therefore, when the lithotripsy guide tube with the above structure releases shock waves to paired target areas, the microbubble clouds generated can interact with each other, further reducing the microbubble shielding area, further mitigating the microbubble shielding phenomenon, and further improving working efficiency. Attached Figure Description

[0035] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0036] Figure 1 This is a schematic diagram of the lithotripsy conduit structure provided in an embodiment of the present invention;

[0037] Figure 2 This is a schematic cross-sectional view of the lithotripsy conduit provided in Embodiment 1 of the present invention;

[0038] Explanation of reference numerals in the attached figures:

[0039] 1-Shock wave generator;

[0040] 2-Ultrasonic generator;

[0041] 3-Installation channel;

[0042] 4-Ultrasonic generating cavity; 41-Relief cavity;

[0043] 5-Guiding cavity. Detailed Implementation

[0044] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., 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 the invention and for 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 the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0046] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0047] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0048] Example 1

[0049] This embodiment provides a lithotripsy catheter, such as Figure 1 and Figure 2 As shown, the device includes a body, a shock wave generator 1, an ultrasonic generator 2, and a control unit. The shock wave generator 1 is disposed on the body, the ultrasonic generator 2 is disposed on the body, and the control unit is electrically connected to the shock wave generator 1 and the ultrasonic generator 2. The control unit has a first state of controlling the shock wave generator 1 to be de-energized while controlling the ultrasonic generator 2 to be energized to generate vibration in the body, or a second state of controlling the shock wave generator 1 and the ultrasonic generator 2 to be energized simultaneously, and a third state of controlling the shock wave generator 1 to be energized while controlling the ultrasonic generator 2 to be de-energized to form a shock wave at the shock wave generator 1.

[0050] The lithotripsy catheter described above generates ultrasound waves that induce cavitation reactions on calcified plaques in blood vessels, continuously producing microbubbles. Because the plaque structure is not dense and contains gaps, microbubbles can penetrate the plaque through these gaps and continuously expand and contract, thus breaking down the plaque from within. Simultaneously, the vibrations of the microbubbles continuously agitate the surrounding fluid, accelerating plaque fragmentation. Furthermore, the periodic expansion and contraction caused by cavitation exert forces on the plaque surface, leading to surface fatigue failure. Under the combined effect of these principles, the plaque ruptures and fragments. In addition, by incorporating the ultrasound generator 2 and control components, the generated ultrasound waves cause interactions between the microbubble clouds produced by the shock waves. These microbubble clouds are stimulated and aggregate into larger microbubbles, reducing the microbubble shielding area and thus mitigating the microbubble shielding phenomenon, thereby improving treatment efficiency.

[0051] Furthermore, existing lithotripsy catheters, due to the thermal effect of the electric current, generate numerous bubbles when heating the liquid. Simultaneously, the shock waves excited by the electrohydraulic effect are characterized by low intensity and high energy density, significantly disturbing the liquid and generating bubbles during shock wave propagation. The abrupt changes in the shock wave's characteristics alter the properties of the liquid before and after the wavefront, changing the solubility of gases and causing significant gas leakage. Simultaneously, upon breakdown, large bubbles are ruptured, forming numerous microbubble clouds. These microbubble clouds, due to their small size, can exist stably in the liquid. Additionally, the collapse of the larger microbubbles induced by initial cavitation generates numerous nanoscale microbubbles, forming microbubble clouds that persist for far longer than one second. Therefore, during treatment, these microbubble clouds remain until the next shock wave arrives, significantly affecting the therapeutic effect of subsequent shock waves. Current solutions involve extending the time interval between two treatment shock waves to allow the microbubble clouds to dissipate or dissipate naturally. If we rely solely on the natural dissipation of microbubbles, the treatment interval will be very long, greatly increasing the treatment time. If we use the currently common frequency of triggering treatment once per second, most of the shock wave will be dissipated by the microbubbles, reducing the treatment efficiency.

[0052] By configuring the ultrasonic wave generator 2 and the control unit, the generated ultrasonic waves cause the microbubble clouds produced by the shock wave to interact. The microbubble clouds are stimulated and aggregate into larger microbubbles, reducing the microbubble shielding area and thus mitigating the microbubble shielding phenomenon, thereby improving treatment efficiency. Specifically, this embodiment does not limit the number of shock wave generator 1 and ultrasonic wave generator 2; they can be two, three, or even more. Different numbers of shock wave generator 1 and ultrasonic wave generator 2 only differ in the degree of optimization of the treatment effect of the lithotripsy catheter with the above structure. The lithotripsy catheter with the above structure only needs to have both shock wave generator 1 and ultrasonic wave generator 2. Similarly, this embodiment does not limit the type of control unit; it can be a PLC (Programmable Logic Controller), a DCS (Distributed Control System), or an FCS (Fieldbus Control System), as long as it can control the shock wave generator 1 and ultrasonic wave generator 2.

[0053] In this embodiment, the mechanical index of the ultrasound generated by the ultrasonic wave generator is greater than 0 and less than 3. The mechanical index of the ultrasound is a direct factor affecting treatment efficiency. When the mechanical index of the ultrasound is increased, the cavitation effect of the ultrasound generated by the lithotripsy catheter of the above-mentioned structure at the calcified plaque is more intense. The stronger the cavitation reaction, the more microbubbles are generated at the plaque. Therefore, the calcified plaque experiences greater forces from the vibration and expansion / contraction of the microbubbles themselves, both internally and on the surface, resulting in better treatment efficacy. Conversely, the treatment efficacy is weaker. By setting the mechanical index of the ultrasound generated by the ultrasonic wave generator within this range, the lithotripsy catheter of the above-mentioned structure can have a controllable treatment effect. During treatment, an appropriate mechanical index can be set according to the size of the plaque at the lesion site, making the process convenient and quick.

[0054] As one possible implementation method of this embodiment, the mechanical index of the ultrasound generated by the ultrasonic generator is greater than 0 and less than 0.8. By setting the mechanical index within the above range, the lithotripsy catheter of the above structure can adjust the mechanical index within a certain range and obtain a better therapeutic effect within this range. At the same time, when the mechanical index is set within this range, as the mechanical index increases, the force of the ultrasound on the microbubble cloud generated by the shock wave generator increases, and the aggregation rate of the microbubbles after stimulation increases, further improving the treatment efficiency of the lithotripsy catheter of the above structure.

[0055] As another possible implementation of this embodiment, the mechanical index of the ultrasound generated by the ultrasonic generator is greater than 0.8 and less than 3. By setting the mechanical index within the above range, when the mechanical index increases, the cavitation effect generated by the ultrasound generated by the lithotripsy catheter of the above structure on the surface of the calcified plaque is stronger. Furthermore, since the occurrence rate of the cavitation effect is linearly related to the mechanical index, its rate is better than that of setting the mechanical index to be greater than 0 and less than 0.8 in this embodiment, resulting in better treatment efficiency. In addition, when the mechanical index of the ultrasound generated by the lithotripsy catheter of the above structure is within the above range, the stimulation of the microbubble cloud generated by the ultrasound on the shock wave generator is actually lower than that of setting the mechanical index to be greater than 0 and less than 0.8 in this embodiment. Although the therapeutic effect of the lithotripsy catheter of the above structure is reduced due to the elimination of microbubble clouds by the ultrasound, thereby increasing the force of the alternating positive and negative pressure generated by the shock wave on the calcified plaque, the lithotripsy catheter of the above structure still has good therapeutic effect due to the improved treatment efficiency brought about by the cavitation effect.

[0056] In one possible implementation of this embodiment, the ultrasonic mechanical index generated by the ultrasonic generator is equal to 0.8. By setting the mechanical index to this value, the ultrasonic waves generated by the lithotripsy catheter of the above structure exhibit a better cavitation effect at the calcified plaque. At the same time, the ultrasonic waves exert a peak force on the microbubble cloud generated by the shock wave generator. At this point, the lithotripsy catheter of the above structure has a better treatment efficiency due to the better cavitation effect and the best treatment efficiency due to the ultrasonic defoaming. The overall treatment effect of the lithotripsy catheter also reaches its peak. Therefore, this value can be used as the preferred value for the lithotripsy catheter of the above structure in conventional use.

[0057] The lithotripsy guide tube provided in this embodiment also includes an installation channel 3, which is suitable for containing conductive liquid. The installation channel 3 has a clearance portion, and a shock wave generator 1 is disposed in the installation channel 3. In the third state or the second state, the shock wave generator 1 sends a shock wave to the outside at the clearance portion.

[0058] In one possible implementation of this embodiment, the shock wave generator 1 is a wire. The wire contacts the conductive liquid in the relief portion. When the lithotripsy catheter of the above structure is in the third or second state, the wire is energized, causing the energized wire to contact the conductive liquid at the relief portion and break down the liquid, thereby triggering a hydroelectric effect and generating a shock wave. The shock wave directed towards the vascular plaque causes the plaque to generate alternating positive and negative pressures. The mechanical stress generated by the alternating positive and negative pressures causes the plaque to break up. Simultaneously, the lithotripsy catheter of the above structure has a simple structure and requires no additional shock wave generating device, which facilitates the movement of the lithotripsy catheter in narrow blood vessels and reduces mechanical damage to the inner wall of the working environment. In this embodiment, the conductive liquid is physiological saline, but it can also be other conductive liquids, as long as a hydroelectric effect occurs after energizing the wire.

[0059] Of course, the shock wave generator 1 can also be other externally purchased shock wave generators, as long as they can achieve the effect of releasing shock waves.

[0060] The lithotripsy catheter provided in this embodiment also includes an ultrasonic wave generating chamber 4, with an ultrasonic wave generator 2 disposed within the ultrasonic wave generating chamber 4. By placing the ultrasonic wave generator 2 within the ultrasonic wave generating chamber 4, direct contact between the ultrasonic wave generator 2 and the lead fluid can be avoided, reducing corrosion of the ultrasonic wave generator 2 by the lead fluid and preventing the formation of unnecessary circuits. Simultaneously, during operation, the ultrasonic wave generator 2 generates a certain amount of heat. By providing the ultrasonic wave generating chamber 4, some of the heat conducted from the ultrasonic wave generator 2 to the blood and blood vessels can be blocked, reducing the impact of the heat generated by the lithotripsy catheter on the patient's blood and blood vessel temperature.

[0061] The lithotripsy catheter provided in this embodiment has an ultrasonic generating cavity 41 after the ultrasonic generator 2 is installed. This cavity 41 is suitable for filling with a cooling medium and also acts as a coupling agent. The cooling medium is a flowing, degassed liquid with an acoustic impedance similar to that of human tissue to reduce the impact of sound attenuation. Specifically, in this embodiment, the cooling medium is degassed saline solution, but it can also be other media that meet the above conditions; this embodiment does not impose specific limitations. The ultrasonic generator 2 will generate high temperatures after prolonged operation. By providing the cavity 41, which can be filled with a cooling medium, various cooling media can be filled into the cavity to reduce the temperature of the ultrasonic generator 2 and the lithotripsy catheter, thereby reducing the risk of the ultrasonic generator 2 burning out.

[0062] Specifically, in this embodiment, the ultrasonic generator 2 is an ultrasonic transducer. The ultrasonic transducer can monitor the operating frequency and power of the high-power ultrasonic system, and can adjust various parameters such as power, amplitude, and running time in real time according to different user requirements. By setting the ultrasonic generator 2 as an ultrasonic transducer, the operation of the lithotripsy catheter in the above structure can be monitored and adjusted, reducing the difficulty of control during the treatment process.

[0063] The lithotripsy catheter provided in this embodiment has an ultrasonic generator 2 with a center frequency greater than or equal to 500 kHz and less than or equal to 5 MHz. By setting the ultrasonic generator 2 with a center frequency greater than or equal to 500 kHz and less than or equal to 5 MHz, the center frequency of the ultrasonic generator 2 can be adjusted within the above range when different sizes of calcified plaques require different treatment times during treatment. This allows for the selection of a specific and suitable frequency for the affected area, achieving better treatment results while saving energy and reducing heat generation. The output power can also be adjusted with the frequency to obtain a better MI (Mechanical Index) value for treatment. In this embodiment, MI is the mechanical index, which is a reference indicator used to reflect the mechanical effect of the ultrasonic beam. The mechanical effect of the ultrasonic beam is directly proportional to the peak negative pressure (or peak rarefaction pressure) of the ultrasonic beam and inversely proportional to the square root of the ultrasonic frequency, i.e., MI = sound pressure / (frequency^1 / 2).

[0064] The lithotripsy catheter provided in this embodiment also includes a guide cavity and a guide element. The guide cavity is axially disposed on the main body, and the guide element passes through the guide cavity. The guide element is adapted to guide the main body to move and turn. By providing the guide cavity and the matching guide element, the lithotripsy catheter with the above structure can pass through blood vessels narrowed by calcification under the guidance of the guide element. At the same time, if the lithotripsy catheter is stuck in the blood vessel, the lithotripsy catheter can be pulled out by traction guide element. Specifically, this embodiment does not limit the material of the guide element, which can be made of steel or titanium, as long as it can achieve a certain strength and can guide or traction the lithotripsy catheter. Similarly, this embodiment does not limit the shape of the guide element, and its cross-section can be circular, rectangular, triangular, etc.

[0065] The lithotripsy catheter provided in this embodiment includes a pair of shock wave generators 1, each disposed on the main body. Each shock wave generator 1 includes a first shock wave generator 1 and a second shock wave generator 1. The main body includes a first mounting channel 3 and a second mounting channel 3, each having a first opening and a second opening, both located on the same radial plane of the main body. By placing a pair of shock wave generators 1 and a pair of matching mounting channels 3 on the same radial plane of the main body, the lithotripsy catheter with the above structure can simultaneously treat calcified plaques at two different angles in the same blood vessel, reducing the risk of scratching the blood vessel due to frequent rotation during treatment of calcified plaques at different angles. In specific operation, the relative positions of the two mounting channels 3 can be adjusted according to the location of the vascular lesion, or a matching lithotripsy catheter can be selected. The adjusted or directly selected lithotripsy catheter is then guided to the lesion through a guide to treat the calcified plaque.

[0066] As one possible implementation method of this embodiment, the lithotripsy catheter includes a pair of ultrasonic generators 2, which are disposed on the body. The ultrasonic generators 2 include a first ultrasonic generator 2 and a second ultrasonic generator 2, which are disposed on the same radial plane of the body. By disposing of a pair of ultrasonic generators 2 on the same radial plane of the body, after the shock wave generator 1 of the above-mentioned lithotripsy catheter has worked on the calcified plaque, this radial plane can be moved to the area where the shock wave generator 1 works by a guide, sending ultrasonic waves to the microbubble cloud generated when the shock wave generator 1 works, exciting it to interact with itself, and gradually forming a larger microbubble. At the same time, the microbubble cloud often moves from the gap between the calcified plaque and the shock wave generator 1 to other adjacent areas. That is to say, by setting ultrasonic generators 2 at different angles, a larger area of ​​microbubble cloud can be covered, thereby increasing the speed at which the microbubble cloud at the lesion gathers and merges, and thus improving the treatment efficiency.

[0067] As another possible implementation of this embodiment, the lithotripsy catheter includes a pair of shock wave generators 1 and a pair of ultrasound generators 2. The shock wave generators 1 and the ultrasound generators 2 are disposed on the same radial plane of the main body, and the remaining installation methods are consistent with the above embodiment, and will not be described in detail. The lithotripsy catheter with the above structure, by simultaneously disposing of a pair of shock wave generators 1 and a pair of ultrasound generators 2 on the same radial plane of the main body, can treat calcified plaques at different angles in the same blood vessel, and can stimulate and aggregate microbubble clouds generated during or after treatment, thus meeting the treatment needs in various situations.

[0068] In the lithotripsy guide tube provided in this embodiment, on any plane along the radial direction of the body, the lines connecting the axes of the two mounting channels 3 to the axis of the body respectively form a first angle, and the ultrasonic generator 2 is disposed on the angle bisector of the first angle. By placing the ultrasonic generator 2 on the angle bisector of the first angle, the ultrasonic waves generated by the ultrasonic generator 2 can produce the same effect on the shock waves generated by the two shock wave generators 1. Thus, when the lithotripsy guide tube with the above structure releases shock waves to paired target areas, the microbubble clouds generated can interact with each other, further reducing the microbubble shielding area, further mitigating the microbubble shielding phenomenon, and further improving working efficiency.

[0069] The lithotripsy catheter provided in this embodiment maintains the third state for a first duration, which is greater than 1 ms and less than 500 ms. It also maintains either the first state or the second state for a second duration, which is greater than 1 ms and less than 500 ms. During continuous operation, the ultrasonic generator 2 of the lithotripsy catheter with the above structure generates a large amount of heat, resulting in a high temperature for both the working environment and the lithotripsy catheter itself. If the continuous operating time of the lithotripsy catheter is insufficient, it will lead to incomplete removal of calcified plaques. Therefore, it is necessary to set a suitable treatment method based on the actual condition of the patient at the lesion site.

[0070] As one possible implementation method of this embodiment, the first maintenance time is 100ms and the second maintenance time is 100ms. Setting both the first and second maintenance times to 100ms is applicable to cases where the calcified plaque area is small. Here, "small area" should be understood as meaning that the overlapping area of ​​the shock wave generated by the lithotripsy catheter of the above structure and the ultrasound can completely cover the calcified plaque. At the same time, when both the first and second maintenance times are 100ms, the shock wave generated by the lithotripsy catheter of the above structure can minimize mechanical damage to the patient's blood vessel wall and reduce the heat generated by prolonged operation, thus reducing discomfort to the patient.

[0071] As another possible implementation of this embodiment, the first maintenance time is 400ms and the second maintenance time is 400ms. Setting both the first and second maintenance times to 400ms can be applied to cases where the calcified plaque area is large and the plaque is thick. The longer working duration can make the lithotripsy catheter of the above structure remove the calcified plaque more thoroughly, effectively break up more stubborn plaques, and reduce the number of times the lithotripsy catheter of the above structure is used.

[0072] Specifically, in this embodiment, setting the first and second maintenance times to be the same length is a more preferred approach. This ensures that the ultrasonic generator 2 can effectively excite and gather the microbubble cloud generated by the shock wave generator 1 after the working time ends. Of course, the lengths of the first and second maintenance times do not necessarily have to be equal. For example, the first maintenance time can be 100ms and the second maintenance time can be 200ms, or the first maintenance time can be 200ms and the second maintenance time can be 100ms, or the first maintenance time can be 450ms and the second maintenance time can be 480ms, etc. As long as the ultrasonic waves generated by the ultrasonic generator 2 can remove at least a portion of the microbubble cloud generated by the shock wave generator 1 within the second maintenance time, it can optimize the treatment effect.

[0073] Example 2

[0074] This embodiment provides a stone crushing device, including an external power supply and the stone crushing conduit provided in Embodiment 1. The external power supply includes a bipolar power supply, which is electrically connected to a wire. The stone crushing device with the above structure can provide current in two directions when the wire is energized, thereby reducing the erosion caused by unidirectional current in one direction within the same working time, thus improving the service life of the wire and consequently increasing the service life of the stone crushing device.

[0075] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A lithotripsy catheter, characterized in that, include: The body includes a first mounting channel (3) and a second mounting channel (3), the first mounting channel (3) and the second mounting channel (3) respectively have a first opening and a second opening, the first opening and the second opening are disposed on the same radial plane of the body; A pair of shock wave generators (1) are disposed on the body. The shock wave generators (1) are adapted to be electrically connected to an external power supply. The shock wave generators (1) include a first shock wave generator (1) and a second shock wave generator (1). The two shock wave generators (1) are respectively disposed in an installation channel (3). A pair of ultrasonic generators (2) are disposed on the body. The ultrasonic generators (2) are adapted to be electrically connected to an external power supply. The ultrasonic generators (2) include a first ultrasonic generator (2) and a second ultrasonic generator (2). On any plane along the radial direction of the body, the axes of the two mounting channels (3) form a first angle with the line connecting the axes of the body. The ultrasonic generators (2) are disposed on the angle bisector of the first angle. A control unit adapted to be electrically connected to an external power supply, the shock wave generator (1), and the ultrasonic generator (2), the control unit having a first state of controlling the shock wave generator (1) to be de-energized while controlling the ultrasonic generator (2) to be energized to generate vibration on the body, a second state of controlling the shock wave generator (1) and the ultrasonic generator (2) to be energized simultaneously, and a third state of controlling the shock wave generator (1) to be energized while controlling the ultrasonic generator (2) to be de-energized to form a shock wave at the shock wave generator (1).

2. The lithotripsy catheter according to claim 1, characterized in that, Both of the mounting channels (3) are adapted to contain conductive liquid, and the mounting channels (3) have a clearance portion. The shock wave generator (1) sends a shock wave to the outside at the clearance portion in the third state or the second state.

3. The lithotripsy catheter according to claim 2, characterized in that, The shock wave generator (1) is a conductor.

4. The lithotripsy catheter according to claim 1, characterized in that, The body also includes an ultrasonic generating cavity (4), and the ultrasonic generating element (2) is disposed in the ultrasonic generating cavity (4).

5. The lithotripsy catheter according to claim 4, characterized in that, The ultrasonic generating cavity (4) has a clearance cavity (41) after the ultrasonic generating element (2) is installed, and the clearance cavity (41) is adapted to be filled with a cooling medium.

6. The lithotripsy catheter according to claim 5, characterized in that, The ultrasonic generator (2) is an ultrasonic transducer.

7. The lithotripsy catheter according to claim 6, characterized in that, The center frequency of the ultrasonic generator (2) is greater than or equal to 500KHz and less than or equal to 5 MHz.

8. The lithotripsy catheter according to claim 1, characterized in that, Also includes A guide cavity is provided on the body along the axial direction; A guide element, which passes through the guide cavity, is adapted to guide the body to perform displacement and rotation.

9. The lithotripsy catheter according to claim 1, characterized in that, The ultrasonic generator (2) generates ultrasonic waves with a mechanical index greater than 0 and less than 3.

10. The lithotripsy catheter according to claim 9, characterized in that, The ultrasonic generator (2) generates ultrasonic waves with a mechanical index greater than 0.4 and less than 0.

8.

11. The lithotripsy catheter according to claim 1, characterized in that, The third state is maintained for a first maintenance time, which is more than 1 ms and less than 500 ms.

12. The lithotripsy catheter according to claim 1, characterized in that, The first state or the second state is maintained for a second duration, wherein the second duration is greater than 1 ms and less than 500 ms.

13. A stone crushing device, characterized in that, Includes an external power supply and the lithotripsy catheter as described in any one of claims 1-12.

14. The stone crushing equipment according to claim 13, wherein the external power supply includes a bipolar power supply, and the bipolar power supply is electrically connected to a wire.

Images