Ultrasound application method and ultrasound thrombolytic device

Abstract

Embodiments of the present application provide an ultrasonic application method and an ultrasonic thrombolytic device. The method comprises simultaneously and / or sequentially applying ultrasonic waves of multiple different frequencies around one or more ultrasonic transducers so that the positions of the standing points formed by the ultrasonic waves of the multiple different frequencies due to ultrasonic wave interference are different. The device comprises one or more ultrasonic transducers configured to simultaneously and / or sequentially apply ultrasonic waves of multiple different frequencies around the one or more ultrasonic transducers so that the positions of the standing points formed by the ultrasonic waves of the multiple different frequencies due to ultrasonic wave interference are different. The present application can make the ultrasonic field intensity distribution more uniform.

Description

Technical Field

[0001] This application relates to the field of ultrasonic equipment technology, and in particular to an ultrasonic application method and an ultrasonic thrombolysis device. Background Technology

[0002] Interventional therapy has gradually become the future direction of thrombosis treatment. Compared with surgical treatment, it is safer and more efficient. Compared with systemic thrombolysis, it reduces the use of thrombolytic drugs, and can even eliminate the need for thrombolytic drugs altogether, thereby reducing complications such as bleeding. In terms of incision size, treatment time, and treatment effectiveness, interventional therapy significantly reduces the pain experienced by patients during treatment.

[0003] Interventional treatments for thrombosis mainly include catheter-guided thrombolysis, ultrasound-assisted drug thrombolysis, mechanical thrombectomy, and thrombus aspiration. Among these, ultrasound-assisted thrombolysis uses ultrasound waves to promote the diffusion of thrombolytic drugs into the thrombus structure and generates mechanical vibrations to loosen the thrombus structure, thus rapidly dissolving it. It is suitable for treating both fresh and old thrombi, and compared with other treatment methods, it has higher safety and thrombus removal efficiency for treating old thrombi.

[0004] Ultrasound-assisted thrombolysis typically uses single-frequency ultrasound. Single-frequency ultrasound promotes drug diffusion through sound waves, and combined with mechanical vibration, it loosens the thrombus structure. However, when single-frequency ultrasound operates in a confined space (such as within a blood vessel), the presence of interfaces such as the vessel wall causes ultrasound reflection. The reflected ultrasound waves interfere with the incident ultrasound waves, resulting in an uneven distribution of the ultrasound field intensity. In other words, interference occurs during ultrasound propagation due to reflection. The interference (i.e., superposition) of single-frequency ultrasound causes vibrations at certain locations in the sound field to be consistently amplified, while vibrations at other locations are consistently weakened, and vibrations at some locations may even disappear due to ultrasound cancellation, forming stagnation points. When the thrombolytic drug reaches a stagnation point, it will be difficult to diffuse further due to the high surrounding sound pressure. Furthermore, the mechanical effect of ultrasound can only loosen the thrombus in areas of high vibration intensity; its mechanical thrombolytic effect is poor at stagnation points.

[0005] Therefore, it can be seen that the uneven distribution of ultrasonic field strength caused by ultrasonic interference will reduce the diffusion effect of drugs and also reduce the dissolving effect of ultrasonic mechanical action on thrombi. Summary of the Invention

[0006] This application provides an ultrasonic application method and an ultrasonic thrombolysis device to solve the problem of uneven ultrasonic field strength distribution.

[0007] An embodiment of the first aspect of this application provides an ultrasonic application method, comprising: simultaneously and / or sequentially applying multiple ultrasonic waves of different frequencies around one or more ultrasonic transducers, such that the stagnation points formed by the multiple ultrasonic waves of different frequencies due to ultrasonic interference are at different positions.

[0008] In some embodiments, sequentially applying multiple ultrasonic waves of different frequencies includes: sequentially applying multiple ultrasonic waves of different frequencies in a preset order, wherein the preset order is an increasing frequency order, or a decreasing frequency order, or a combination of increasing and decreasing frequency orders.

[0009] In some embodiments, the ratio between any two different frequencies among the plurality of different frequencies is not an integer.

[0010] In some embodiments, the ratio of any larger frequency to any smaller frequency among the plurality of different frequencies is greater than 1.1.

[0011] In some embodiments, the plurality of different frequencies includes at least one frequency less than 1 MHz and at least one frequency greater than 1 MHz.

[0012] An embodiment of the second aspect of this application provides an ultrasonic thrombolysis device, including one or more ultrasonic transducers configured to simultaneously and / or sequentially apply multiple ultrasonic waves of different frequencies around them, such that the locations of the stagnation points formed by the multiple ultrasonic waves of different frequencies due to ultrasonic interference are different.

[0013] In some embodiments, the ultrasonic thrombolysis device includes an ultrasonic transducer configured to sequentially apply multiple ultrasonic waves of different frequencies in a preset order, such that the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are at different positions.

[0014] In some embodiments, the preset order is an increasing frequency order, a decreasing frequency order, or a combination of increasing and decreasing frequency orders.

[0015] In some embodiments, the ultrasonic thrombolysis device includes a plurality of ultrasonic transducers configured to simultaneously apply multiple ultrasonic waves of different frequencies, such that the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are at different locations.

[0016] In some embodiments, each of the ultrasonic transducers is configured to apply ultrasonic waves of the same or different frequencies at different times.

[0017] In some embodiments, the ratio between any two different frequencies among the plurality of different frequencies is not an integer.

[0018] In some embodiments, the ratio of any larger frequency to any smaller frequency among the plurality of different frequencies is greater than 1.1.

[0019] In some embodiments, the plurality of different frequencies includes at least one frequency less than 1 MHz and at least one frequency greater than 1 MHz.

[0020] In some embodiments, the ultrasonic thrombolysis device further includes: an outer catheter; an inner catheter disposed inside the outer catheter, the inner catheter forming an inner cavity, an annular cavity formed between the outer catheter and the inner catheter, and an ultrasonic transducer disposed in the annular cavity; and a side hole extending from the inner catheter to the outer catheter and penetrating the annular cavity to connect the inner cavity with the outside of the outer catheter.

[0021] In some embodiments, the ultrasonic thrombolysis device includes a plurality of ultrasonic transducers, which are arranged at intervals along the length of the external conduit, and at least one side hole is provided between any two adjacent ultrasonic transducers.

[0022] The ultrasonic application method and ultrasonic thrombolysis device of this application apply multiple ultrasonic waves of different frequencies simultaneously and / or sequentially around one or more ultrasonic transducers, so that the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are at different positions, thereby making the ultrasonic field intensity distribution more uniform. Attached Figure Description

[0023] The accompanying drawings, which form part of this specification, are used to provide a further understanding of the embodiments of this disclosure and illustrate implementation methods, and together with the textual description, to explain the principles of this disclosure. Obviously, the drawings described below are merely some embodiments of this disclosure, and those skilled in the art can obtain other drawings based on these drawings without creative effort. In the drawings:

[0024] Figures 1 to 3 This is a schematic diagram of an ultrasonic transducer in an embodiment of this application applying ultrasonic waves of different frequencies at different times through intervention in blood vessels.

[0025] Figures 4 to 6 This is a schematic diagram of an ultrasonic transducer in an embodiment of this application applying ultrasonic waves of different frequencies at different times via a transcutaneous approach;

[0026] Figure 7 This is a schematic diagram illustrating how multiple ultrasound transducers in this application simultaneously apply ultrasound waves of different frequencies at the same time through intervention in blood vessels.

[0027] Figure 8This is a schematic diagram illustrating how multiple ultrasonic transducers in this application simultaneously apply ultrasonic waves of different frequencies via a transcutaneous approach at the same time.

[0028] Figure 9 This is a schematic diagram of an ultrasonic transducer device according to an embodiment of this application. Detailed Implementation

[0029] To enable those skilled in the art to better understand the technical solutions in this specification, the technical solutions in the embodiments of this specification will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this specification, and not all embodiments. Based on the embodiments in this specification, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this specification.

[0030] In the description of this application, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. Unless otherwise stated, "multiple" means two or more. The term "proximal" refers to the position on the device closest to the operator using the device (e.g., a doctor), while the term "distal" refers to the position on the device furthest from the operator.

[0031] An embodiment of the first aspect of this application provides a method for applying ultrasound to solve the problem of uneven distribution of ultrasonic field intensity caused by ultrasonic interference. The method includes:

[0032] Multiple ultrasonic waves of different frequencies are simultaneously and / or sequentially applied (emitted) around one or more ultrasonic transducers, so that the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are at different positions.

[0033] The ultrasonic transducer in this embodiment is a non-focused ultrasonic transducer. The ultrasonic waves generated are divergent rather than converged at a point. The range of the ultrasonic field formed is the space around the ultrasonic transducer, rather than acting on a focal point.

[0034] In the treatment of thrombosis, one or more ultrasound transducers can simultaneously and / or sequentially apply multiple different frequencies of ultrasound waves around the transducer via an interventional or percutaneous approach. This allows the ultrasound field generated by the transducer to act on the thrombus. Because the locations of the stagnation points formed by the multiple ultrasound waves due to ultrasound interference are different, the stagnation points will not always be located at the same site of the thrombus, thus reducing the adverse effects of stagnation points on thrombosis treatment. "Percutaneous approach" should be understood as applying ultrasound waves externally close to the skin without intervening in the blood vessel.

[0035] Because the location of the stagnation point changes over time, a certain part of the thrombus will not always be covered by the stagnation point. In other words, even if a certain part of the thrombus is covered by the stagnation point at a certain moment and cannot be subjected to ultrasonic mechanical action, it will be covered by a greater sound intensity at other times as the stagnation point moves to another location, and thus be subjected to ultrasonic mechanical action. That is to say, the sound field with high ultrasonic vibration intensity will cover different parts of the thrombus in turn, so that different parts of the thrombus are subjected to ultrasonic mechanical action as much as possible, and loosen and decompose due to ultrasonic mechanical vibration, thereby promoting mechanical vibration thrombolysis.

[0036] When multiple ultrasound waves of different frequencies are simultaneously and / or sequentially applied around an ultrasonic transducer to deliver thrombolytic drugs into the blood vessel, the different frequencies of ultrasound can further promote drug delivery. Specifically, as the stagnation point moves, the drug at the stagnation point also moves. Therefore, the movement of the stagnation point not only reduces the restriction on drug diffusion but also provides the impetus for drug diffusion, thereby promoting drug diffusion and facilitating thrombolysis. Furthermore, by controlling the frequency of the ultrasound waves, the direction of the stagnation point's movement can be controlled, which helps in the targeted delivery of drugs. Moreover, by controlling the number of ultrasound frequencies, the application time of each frequency, and the time interval between applying different frequencies, the movement distance, speed, and frequency of the stagnation point can be controlled, thereby controlling the drug's movement distance, speed, and frequency.

[0037] When multiple ultrasound waves of different frequencies are applied simultaneously and / or sequentially around an ultrasonic transducer to deliver microbubbles or low-boiling-point microdroplets into blood vessels, the multiple ultrasound waves of different frequencies can also promote the delivery and cavitation of microbubbles and microdroplets. The mechanism of promoting delivery is basically the same as that of promoting drug delivery. Cavitation is promoted by ultrasound waves of higher frequencies (e.g., greater than 1 MHz) among the multiple different frequencies.

[0038] When multiple ultrasound waves of different frequencies are applied simultaneously and / or sequentially around an ultrasonic transducer to deliver thrombolytic drugs, as well as microbubbles or low-boiling-point microdroplets into the blood vessel, the multiple ultrasound waves of different frequencies can promote the delivery of thrombolytic drugs, microbubbles, and microdroplets, and also promote the cavitation of microbubbles and microdroplets, thereby further improving the thrombolytic effect.

[0039] In the first embodiment, multiple ultrasonic waves of different frequencies are sequentially applied (emitted) around an ultrasonic transducer so that the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are at different positions.

[0040] When an ultrasonic transducer applies ultrasonic waves to its surroundings, an ultrasonic field is formed. Because ultrasonic waves are reflected when they encounter a reflective surface (such as the surface of a blood vessel), the reflected waves interfere with the incident waves (wave superposition), creating stagnation points at one or more locations within the ultrasonic field. The locations of these stagnation points differ depending on the frequency of the ultrasonic waves. Therefore, over a period of time when the ultrasonic transducer sequentially applies multiple ultrasonic waves of different frequencies, the locations of the stagnation points in the ultrasonic field surrounding the transducer change over time, rather than remaining at the same position.

[0041] exist Figures 1 to 3 In the example, the ultrasound transducer 11 sequentially applies multiple ultrasound waves of different frequencies around the interventional blood vessel 10.

[0042] exist Figures 4 to 6 In the example, the ultrasound transducer 11 sequentially applies multiple ultrasound waves of different frequencies around it via a transcutaneous approach, with the ultrasound transducer 11 located outside the blood vessel 10.

[0043] Specifically, such as Figures 1 to 6 As shown, the ultrasonic transducer 11 is configured to apply ultrasonic waves 21 of a first frequency at a first time, ultrasonic waves 22 of a second frequency at a second time, and ultrasonic waves 23 of a third frequency at a third time, wherein the first, second, and third frequencies are all different. In the first time, the stagnation point formed by ultrasonic interference of the ultrasonic wave 21 of the first frequency is located at a first position (not shown); in the second time, the stagnation point formed by ultrasonic interference of the ultrasonic wave 22 of the second frequency is located at a second position (not shown); and in the third time, the stagnation point formed by ultrasonic interference of the ultrasonic wave 23 of the third frequency is located at a third position (not shown). Since the first, second, and third positions are all different, the position of the stagnation point changes over time throughout the entire time period during which the ultrasonic waves of the first, second, and third frequencies are applied. Therefore, although the ultrasonic field intensity distribution may be uneven at a certain point in time due to the presence of a stagnation point at a certain position, the sound field intensity distribution is relatively uniform throughout the entire time period during which the ultrasonic waves are applied.

[0044] This embodiment uses the superposition of ultrasonic fields formed by multiple frequencies of ultrasound over time to make the distribution of ultrasonic field strength more uniform.

[0045] In the second embodiment, multiple ultrasonic transducers simultaneously apply (emit) ultrasonic waves of different frequencies around the transducer, so that the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are at different positions. Therefore, at any given moment when multiple ultrasonic waves of different frequencies are applied simultaneously, the positions of the stagnation points in the ultrasonic field generated by the multiple ultrasonic transducers are different, that is, the stagnation points do not overlap at any given moment.

[0046] exist Figure 7 In the example, ultrasound transducers 11, 12, and 13 sequentially apply ultrasound waves of various frequencies around the interventional blood vessel 10.

[0047] exist Figure 8 In the example, ultrasound transducers 11, 12, and 13 sequentially apply ultrasound waves of different frequencies around the transdermal vessel 10, with ultrasound transducer 11 located outside the vessel 10.

[0048] Specifically, such as Figure 7 , Figure 8 As shown, the first ultrasonic transducer 11 is configured to apply an ultrasonic wave 21 of a first frequency at a first time, the second ultrasonic transducer 12 is configured to apply an ultrasonic wave 22 of a second frequency at a first time, and the third ultrasonic transducer 13 is configured to apply an ultrasonic wave 23 of a third frequency at a first time, wherein the first, second, and third frequencies are all different. During the first time, the stagnation points formed by the ultrasonic waves of the first, second, and third frequencies due to ultrasonic interference are located at the first, second, and third positions, respectively. Since the first, second, and third positions are all different, the stagnation point located at the first position will be covered by a larger sound field formed by ultrasonic waves of other frequencies (such as the second frequency), the stagnation point located at the second position will be covered by a larger sound field formed by ultrasonic waves of other frequencies (such as the third frequency), and the stagnation point located at the third position will be covered by a larger sound field formed by ultrasonic waves of other frequencies (such as the first frequency). Therefore, although each ultrasonic wave of a different frequency forms its own stagnation point, the superimposed ultrasonic field formed by the superposition of multiple ultrasonic waves has no stagnation point.

[0049] Clearly, compared with the ultrasonic field formed by a single frequency ultrasound, the ultrasonic field intensity distribution of a superimposed ultrasonic field is more uniform, thereby reducing the restriction of drug diffusion by the stagnation point and allowing different parts of the thrombus to be subjected to ultrasonic mechanical action, thus promoting thrombolysis.

[0050] In addition, compared with the ultrasound field formed by a single frequency ultrasound, the superimposed ultrasound field has a wider spatial coverage, allowing as many thrombi as possible to be covered by the ultrasound field, thereby improving the thrombolysis efficiency.

[0051] This embodiment uses the superposition of ultrasonic fields formed by multiple frequencies of ultrasound in a spatial domain to make the distribution of ultrasonic field strength more uniform.

[0052] In this embodiment, a single ultrasonic transducer applies ultrasonic waves of the same frequency at different times. Therefore, the field strength distribution of the superimposed ultrasonic fields generated by multiple ultrasonic transducers at different times is basically the same.

[0053] In the third embodiment, multiple ultrasonic transducers simultaneously and sequentially apply (emit) ultrasonic waves of different frequencies around the transducer. That is, multiple ultrasonic transducers simultaneously apply ultrasonic waves of different frequencies at the same time, and a single ultrasonic transducer sequentially applies ultrasonic waves of different frequencies at different times, so that the positions of the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are different at the same time and at different times.

[0054] For example, a first ultrasonic transducer is configured to apply ultrasonic waves of a first frequency at a first time, a second ultrasonic transducer is configured to apply ultrasonic waves of a second frequency at the first time, and a third ultrasonic transducer is configured to apply ultrasonic waves of a third frequency at the first time. Furthermore, the first ultrasonic transducer is also configured to apply ultrasonic waves of a fourth and a fifth frequency at a second and a third time, respectively; the second ultrasonic transducer is also configured to apply ultrasonic waves of a sixth and a seventh frequency at a second and a third time, respectively; and the third ultrasonic transducer is also configured to apply ultrasonic waves of an eighth and a ninth frequency at a second and a third time, respectively. Wherein, the first, second, and third frequencies are all different; the first, fourth, and fifth frequencies are all different; the second, sixth, and seventh frequencies are all different; and the third, eighth, and ninth frequencies are all different. Therefore, the locations of the stagnation points formed by the interference of the ultrasonic waves generated by the first, second, and third ultrasonic transducers at the same time (i.e., the first, second, or third time) are different, and the locations of the stagnation points formed by the interference of the ultrasonic waves generated by the same ultrasonic transducer (i.e., the first, second, or third ultrasonic transducer) at different times (i.e., the first time, the second time, and the third time) are also different.

[0055] This embodiment uses the superposition of ultrasonic fields formed by multiple frequencies of ultrasound in both the time and spatial domains to make the distribution of ultrasonic field strength more uniform.

[0056] In this embodiment, a single ultrasonic transducer applies ultrasonic waves of different frequencies at different times. Therefore, the field strength distribution of the superimposed ultrasonic field generated by multiple ultrasonic transducers at different times is also different.

[0057] This embodiment is a combination of the technical solutions of the first embodiment and the second embodiment, and its mechanism of action and beneficial effects in promoting thrombolysis are also a combination of the first embodiment and the second embodiment.

[0058] In the first and third embodiments, a single ultrasonic transducer sequentially applies (emits) multiple ultrasonic waves of different frequencies in a preset order. The preset order is either an increasing frequency order, a decreasing frequency order, or a combination of increasing and decreasing frequency orders.

[0059] For example, the first frequency, the second frequency, and the third frequency increase sequentially, and the first ultrasonic transducer is configured to apply ultrasonic waves of the first frequency, the second frequency, and the third frequency sequentially at the first time, the second time, and the third time (i.e., in an increasing frequency order), or to apply ultrasonic waves of the third frequency, the second frequency, and the first frequency sequentially at the first time, the second time, and the third time (i.e., in a decreasing frequency order), or to apply ultrasonic waves of the first frequency, the third frequency, and the second frequency sequentially at the first time, the second time, and the third time (i.e., in a combination of increasing and decreasing frequency orders), or to apply ultrasonic waves of the third frequency, the first frequency, and the second frequency sequentially at the first time, the second time, and the third time (i.e., in a combination of increasing and decreasing frequency orders).

[0060] Optionally, the first frequency is 100kHz to 300kHz, the second frequency is 500kHz to 1000kHz, and the third frequency is 1.5MHz to 5MHz.

[0061] Optionally, the durations of the first, second, and third time periods are 0.1 min to 10 min, and the durations of the three time periods can be the same or different. For example, the duration of the first time period is 1 min to 2 min, the duration of the second time period is 2 min to 8 min, and the duration of the third time period is 1 min to 2 min. The application duration of each frequency of ultrasound can be set according to actual needs, and this application does not impose any restrictions on it.

[0062] In some embodiments, the ratio between any two different frequencies is not an integer, so that the superposition of the maximum field strength points generated by the ultrasound of multiple frequencies can cover as many different areas of the thrombus as possible.

[0063] For example, multiple ultrasonic waves of different frequencies are referred to as first frequency, second frequency, and third frequency ultrasonic waves. The ratio of any two of the first frequency, second frequency, and third frequency is not an integer, but a decimal.

[0064] In some embodiments, the ratio of any larger frequency to any smaller frequency among a plurality of different frequencies is greater than 1.1, so that the two frequencies differ significantly rather than being close, so that the field strength distribution of the ultrasonic fields formed by ultrasonic waves of different frequencies is more different and can complement each other, thereby making the field strength distribution of the superimposed ultrasonic fields more uniform.

[0065] For example, the first frequency, the second frequency, and the third frequency increase sequentially, the ratio of the second frequency to the first frequency is greater than 1.1, the ratio of the third frequency to the second frequency is greater than 1.1, and the ratio of the third frequency to the first frequency is also greater than 1.1.

[0066] In some embodiments, the multiple different frequencies include at least one frequency less than 1 MHz and at least one frequency greater than 1 MHz. Frequency less than 1 MHz is considered low frequency, and frequency greater than 1 MHz is considered high frequency; therefore, the multiple different frequencies of ultrasound include at least one low-frequency wave and at least one high-frequency wave. Low-frequency waves have lower frequencies and longer wavelengths, which is beneficial for the full diffusion of the drug flow field and has a better effect on promoting drug delivery. High-frequency waves have higher vibration frequencies and faster changes in vibration direction; objects with less inertia are more likely to follow high-frequency vibrations, thus facilitating the separation of objects with less inertia from objects with greater inertia, and promoting the dissociation of thrombus components from the thrombus.

[0067] The higher the frequency of ultrasound, the greater the area and distribution density of the stagnation points formed by the interference of ultrasound. Therefore, when determining the frequency of ultrasound, the ultrasonic vibration, as well as the area and distribution density of the stagnation points, can be comprehensively considered to determine the ultrasonic frequency that meets the actual needs.

[0068] In some embodiments, the ultrasonic waves of various frequencies are selected from the frequency range of 20 kHz to 10 MHz. For example, the first ultrasonic transducer is configured to apply ultrasonic waves with frequencies of 100 kHz, 500 kHz, 1 MHz, and 5 MHz sequentially at a first time, a second time, a third time, and a fourth time.

[0069] In the embodiments of the first aspect, each ultrasonic transducer is an ultrasonic transmitting transducer for emitting ultrasonic waves, and no ultrasonic transducer is a ultrasonic receiving transducer.

[0070] An embodiment of the second aspect of this application provides an ultrasonic thrombolysis device, including one or more ultrasonic transducers configured to simultaneously and / or sequentially apply (emit) multiple ultrasonic waves of different frequencies around them, such that the locations of the stagnation points formed by the multiple ultrasonic waves of different frequencies are different at the same time and / or at different times.

[0071] The ultrasonic transducer in this embodiment is a non-focused ultrasonic transducer.

[0072] In the first embodiment, see Figures 1 to 6 The ultrasonic thrombolysis device includes an ultrasonic transducer configured to sequentially apply (emit) multiple ultrasonic waves of different frequencies around it, such that the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are at different positions.

[0073] The working mechanism and technical effect of the ultrasonic transducer in this embodiment can be referred to the first embodiment of the ultrasonic application method, so it will not be repeated here.

[0074] In the second embodiment, see Figure 7 and Figure 8 The ultrasonic thrombolysis device includes multiple ultrasonic transducers configured to simultaneously emit ultrasonic waves of various frequencies around them, such that the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are at different times. In this embodiment, a single ultrasonic transducer emits ultrasonic waves of the same frequency at different times.

[0075] The working mechanism and technical effects of the multiple ultrasonic transducers in this embodiment can be referred to the second embodiment of the ultrasonic application method, so they will not be described in detail here.

[0076] In a third embodiment, the ultrasonic thrombolysis device includes multiple ultrasonic transducers configured to simultaneously and sequentially emit multiple ultrasonic waves of different frequencies around them. That is, multiple ultrasonic transducers simultaneously emit multiple ultrasonic waves of different frequencies at the same time, and a single ultrasonic transducer sequentially emits multiple ultrasonic waves of different frequencies at different times, so that the positions of the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference are different at the same time and at different times.

[0077] The working mechanism and technical effects of the multiple ultrasonic transducers in this embodiment can be referred to the third embodiment of the ultrasonic application method, so they will not be described in detail here.

[0078] In the first and third embodiments, a single ultrasonic transducer is configured to sequentially apply (emit) multiple ultrasonic waves of different frequencies in a preset order, wherein the preset order is an increasing frequency order, or a decreasing frequency order, or a combination of increasing and decreasing frequency orders.

[0079] In some embodiments, the ratio between any two different frequencies is not an integer, so that the maximum field strength points generated by the ultrasound of multiple frequencies can be superimposed to cover as much of the thrombus area as possible.

[0080] For example, the ratio of any larger frequency to any smaller frequency among multiple different frequencies is greater than 1.1, so that the two frequencies are significantly different rather than close, so that the field strength distribution of the ultrasonic fields formed by ultrasonic waves of different frequencies is more different and can complement each other, thereby making the field strength distribution of the superimposed ultrasonic fields more uniform.

[0081] In some embodiments, the multiple different frequencies include at least one frequency less than 1 MHz and at least one frequency greater than 1 MHz. The frequency less than 1 MHz is considered low frequency, and the frequency greater than 1 MHz is considered high frequency; therefore, the multiple different frequencies of ultrasound include at least one low-frequency wave and at least one high-frequency wave.

[0082] In some embodiments, the ultrasonic thrombolysis device is an interventional ultrasonic thrombolysis device.

[0083] See Figure 9 In this embodiment, the ultrasonic thrombolysis device further includes an outer conduit 101, an inner conduit 102, and a side hole 103. The inner conduit 102 is disposed inside the outer conduit 101, forming an annular cavity between the outer conduit 101 and the inner conduit 102. The ultrasonic transducer 11 is disposed in the annular cavity. The annular cavity may be filled with a polymer insulating material 104 such as silicone or resin. The insulating material 104 serves both to fix the ultrasonic transducer and as a transmission medium for ultrasonic waves. The outer conduit 101 and the inner conduit 102 may be made of elastic materials such as TPU or silicone, so that the outer conduit 101 and the inner conduit 102 have the ability to deform to accommodate the ultrasonic transducer.

[0084] An inner lumen 105 is formed within the inner catheter 102. The inner lumen 105 serves as a guidewire port during vascular intervention and as a drug delivery channel for thrombolytic drugs during thrombolysis. A side port 103 extends from the inner catheter 102 to the outer catheter 101 and penetrates the annular lumen, connecting the inner lumen 105 to the outside of the outer catheter 101. Therefore, the thrombolytic drugs delivered through the inner lumen 105 can flow out of the outer catheter 101 through the side port 103 to reach the thrombus within the inner catheter. The thrombolytic drugs delivered through the inner lumen 105 not only have a thrombolytic effect but also remove heat generated by the ultrasound transducer, cooling the ultrasound transducer, inner catheter 102, and outer catheter 101.

[0085] In this embodiment, optionally, the ultrasonic thrombolysis device includes a plurality of side holes 103 arranged in an array along the axial direction of the inner catheter 102. The inner catheter 102 has a proximal end and a distal end. In the direction from the distal end to the proximal end, the pressure in the lumen 105 gradually increases. In order to achieve a basically uniform amount of drug released from the side holes 103 at different positions in the axial direction, the plurality of side holes 103 arranged in an array along the axial direction are configured to decrease in diameter in the direction from the distal end to the proximal end.

[0086] In this embodiment, optionally, the ultrasonic thrombolysis device includes multiple ultrasonic transducers. For example, Figure 9 Five ultrasonic transducers are shown: first ultrasonic transducer 11, second ultrasonic transducer 12, third ultrasonic transducer 13, fourth ultrasonic transducer 14, and fifth ultrasonic transducer 15.

[0087] Multiple ultrasonic transducers are arranged at intervals along the length (i.e., axial direction) of the outer conduit 101 within the annular cavity; that is, multiple ultrasonic transducers are arranged at intervals along the length of the outer conduit 101 to form an ultrasonic transducer array. At least one side hole 103 is provided between any two adjacent ultrasonic transducers. That is, along the length of the outer conduit 101, ultrasonic transducers and side holes 103 are arranged alternately to increase the effective range of the thrombolytic drug and the coverage range of the ultrasonic wave field of the ultrasonic transducers, thereby promoting drug-induced thrombolysis and mechanical vibration-induced thrombolysis. Furthermore, it also increases the superposition range of the effective range of the thrombolytic drug and the coverage range of the ultrasonic wave field, allowing the ultrasonic waves to promote drug diffusion and further improve thrombolysis efficiency.

[0088] For example, a plurality of side holes 103 are provided between any two adjacent ultrasonic transducers. The plurality of side holes 103 are arranged at circumferential intervals along the outer conduit 101 and the inner conduit 102 to release drugs in the entire circumferential direction.

[0089] As an example, such as Figure 9 As shown, the ultrasonic transducer is a ring-shaped ultrasonic transducer, which allows it to uniformly emit ultrasonic waves in its surroundings (the entire circumferential direction). The ultrasonic transducer can be made of a piezoelectric material, such as lead zirconate titanate.

[0090] Optionally, the inner and outer cylindrical surfaces of the ultrasonic transducer are connected to positive and negative electrodes, respectively, to provide excitation signals to the ultrasonic transducer. The electrodes can be made of conductive materials, such as silver or copper.

[0091] As another example, an ultrasonic transducer consists of multiple sheet-like piezoelectric elements arranged sequentially along the circumference, thus uniformly releasing ultrasonic waves around it (in the entire circumferential direction). The piezoelectric elements can be made of piezoelectric materials, such as lead zirconate titanate.

[0092] Optionally, positive and negative electrodes are connected to the inner and outer surfaces of multiple piezoelectric elements, respectively, to provide excitation signals to the ultrasonic transducer. The electrodes can be made of conductive materials, such as silver or copper.

[0093] In other embodiments, the ultrasonic thrombolysis device is a percutaneous ultrasonic thrombolysis device, that is, the ultrasonic thrombolysis device does not intervene in the blood vessels, but applies ultrasound close to the skin outside the body.

[0094] In this embodiment, the ultrasonic thrombolysis device may not necessarily include the outer catheter 101, inner catheter 102, and side port 103; instead, ultrasonic waves can be applied directly using an ultrasonic transducer. Alternatively, the ultrasonic thrombolysis device may include components for fixing the ultrasonic transducer, such as mounting multiple ultrasonic transducers on the same carrier for ease of operation.

[0095] In the second aspect of the embodiment, each ultrasonic transducer is a transmitting ultrasonic transducer for emitting ultrasonic waves, and no ultrasonic transducer is a receiving ultrasonic transducer.

[0096] The present disclosure has been described above with reference to specific embodiments. However, those skilled in the art should understand that these descriptions are exemplary and not intended to limit the scope of protection of the present disclosure. Those skilled in the art can make various modifications and variations to the present disclosure based on its spirit and principles, and these modifications and variations are also within the scope of the present disclosure.

Claims

1. An ultrasonic thrombolysis device, characterized in that, include: Multiple ultrasonic transducers are configured to simultaneously apply multiple ultrasonic waves of different frequencies around them, such that the positions of the stagnation points formed by the ultrasonic waves of different frequencies due to ultrasonic interference do not overlap at any time, and the superimposed ultrasonic field formed by the superposition of the ultrasonic waves of different frequencies has no stagnation points. The ratio between any two different frequencies is not an integer, and the ratio of any larger frequency to any smaller frequency is greater than 1.

1.

2. The device according to claim 1, characterized in that, Each of the ultrasonic transducers is configured to apply ultrasonic waves of the same or different frequencies at different times.

3. The device according to claim 1, characterized in that, The various frequencies include at least one frequency less than 1 MHz and at least one frequency greater than 1 MHz.

4. The device according to claim 1, characterized in that, Also includes: External catheter; An inner catheter is disposed inside the outer catheter, forming an inner cavity within the inner catheter, and an annular cavity is formed between the outer catheter and the inner catheter, with the ultrasonic transducer disposed within the annular cavity; A side hole extends from the inner conduit to the outer conduit and passes through the annular cavity to connect the inner cavity with the outside of the outer conduit.

5. The device according to claim 4, characterized in that, It includes a plurality of ultrasonic transducers, which are arranged at intervals along the length of the outer conduit, and at least one side hole is provided between any two adjacent ultrasonic transducers.

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