Interventional medical device and application thereof

Abstract

The invention relates to an interventional medical instrument and application thereof. The medical instrument comprises an inner sleeve, an outer sleeve and an outer sleeve, a special ultrasonic device is arranged at the front end of the inner sleeve and is used for generating a sound beam current in a liquid environment when being driven by a driving device; a wire electrically connected with the special ultrasonic device is arranged in the inner sleeve, and the wire extends to the rear end of the inner sleeve and is used for being electrically connected with the driving device. The interventional instrument can generate a sound beam to ablate thrombus or convey and inject medicine to a focus, and has the characteristics of lower calorific value, higher efficiency and the like.

Description

Technical Field

[0001] This application relates to the fields of microelectromechanical systems (MEMS) and medical device technology, and in particular to an interventional medical device and its application. Background Technology

[0002] Thrombosis can occur in both arteries and veins in the human body. With the development of minimally invasive treatment techniques, especially interventional treatment techniques for blood vessels, interventional treatment of thrombosis has become possible.

[0003] Currently, interventional methods for treating thrombosis include techniques for breaking up thrombi using ultrasound. For example, embodiments in patent applications with publication numbers CN118021393A or CN115429382A both mention ultrasound-based thrombus breaking-up solutions. However, the frequencies of ultrasound-based thrombus breaking-up techniques found so far are mostly between 15kHz and 2MHz. Existing ultrasound-based thrombus breaking-up solutions still have the following drawbacks: On the one hand, ultrasound frequencies range from kHz to MHz. During the thrombus-breaking process, the ultrasound components generate heat, or the vibration of local blood or thrombi caused by ultrasound waves generates heat. Patent application CN118021393A mentions using the thermal effect of ultrasound vibration to promote the reaction between thrombolytic agents and thrombi. However, a potential problem with this thermal effect is that it can cause a burning sensation in patients. For example, patent application CN115429382A mentions that the thermal effect can cause an uncomfortable burning sensation in patients and addresses this by using a temperature sensor to monitor the thrombolytic process of the ultrasound components and introducing cooling saline solution to the ultrasound components to reduce heat generation. However, this solution leads to structural complexity.

[0004] On the other hand, currently disclosed ultrasound-based thrombolysis methods use ultrasound transducers operating in the 15–40 kHz frequency range, with some reaching as high as 2 MHz. Within this frequency range, due to limitations in heat generation, the driving power cannot be too high. Therefore, the energy limitation generally prevents the breaking down of obstructive material into single cells. These small fragments of obstructive material risk reaching distal blood vessels with the bloodstream. Furthermore, the energy limitation makes it difficult to treat soft obstructions.

[0005] Therefore, in this context, how to provide an interventional device for treating thrombosis with lower heat generation and higher thrombus ablation efficiency is a technical problem that needs to be solved. Summary of the Invention

[0006] In view of the above-mentioned problems of the prior art, this application provides an interventional medical device and its application, which can be used for intravascular thrombus ablation, with lower heat generation and higher efficiency, and can also be used for drug delivery or injection at intravascular lesions.

[0007] To achieve the above objectives, the first aspect of this application provides an interventional medical device, comprising: an inner cannula; a special ultrasound device disposed at the front end of the inner cannula, the special ultrasound device being used to generate a sound beam in a liquid environment when driven by a driving device; and a wire electrically connected to the special ultrasound device having a cavity inside the inner cannula, the wire extending to the rear end of the inner cannula for electrically connecting to the driving device.

[0008] As one possible implementation of the first aspect, the inner sleeve is further provided with a guide wire at its front end.

[0009] As one possible implementation of the first aspect, it also includes an umbrella-shaped structure for guiding the acoustic beam to the side, wherein: the umbrella-shaped structure is mounted on the guide wire, or the umbrella-shaped structure is mounted on a support extending from the front end of the inner sleeve.

[0010] As one possible implementation of the first aspect, the inner sleeve front end is provided with a special ultrasonic device, including: the inner sleeve front end is provided with a substrate segment, and the special ultrasonic device is assembled on the front end of the substrate segment.

[0011] As one possible implementation of the first aspect, the ultrasonic device comprises at least two arranged in an array.

[0012] As one possible implementation of the first aspect, the ultrasonic device is configured in one of the following ways: the front end of the substrate segment includes a plane perpendicular to the extension direction of the inner sleeve, and at least one ultrasonic device is disposed on the plane of the front end of the substrate segment with the orientation direction set to the front end extension direction; the front end of the substrate segment includes at least one inclined surface, and at least one ultrasonic device is disposed on the inclined surface of the front end of the substrate segment with the orientation direction forming an acute-obtuse angle with the front end extension direction.

[0013] As one possible implementation of the first aspect, an outer sleeve is also included, which is fitted over the inner sleeve.

[0014] As one possible implementation of the first aspect, there is at least one liquid channel between the outer sleeve and the inner sleeve.

[0015] As one possible implementation of the first aspect, the ultrasonic device is also used to generate one or any combination of the following in the liquid environment when driven by a driving device: eddies, jets, bubbles, thermal effects.

[0016] The second aspect of this application provides an application of the interventional medical device described in the first aspect, which is used for at least one of the following: ablation of intravascular obstruction, delivery of drugs to intravascular lesions, or injection of drugs to intravascular lesions.

[0017] The interventional medical device provided in this application can be used for thrombus ablation. It acts on the thrombus through an acoustic beam, which differs from the vibration principle mentioned in the background art. The acoustic beam generated by this device has a higher conversion rate and lower heat generation. The acoustic beam has a good fragmentation and differentiation effect on obstructive materials, especially soft materials, at a small scale, often differentiating them into single-celled substances. These can directly enter the subsequent systemic circulation through downstream capillaries, naturally dissolving the thrombus. Using this method can reduce the use of stents, thereby reducing the adverse reactions associated with stent use. The medical device of this application is more effective at handling soft, viscous obstructive materials and can be used in scenarios where stents cannot be used. Furthermore, compared to mechanical fragmentation and low-frequency ultrasonic fragmentation (including those using amplitude transformers, resonators, exciters, etc.), the medical device of this application has many advantages, such as adjustable fluid power, high flow rate, good fragmentation effect, ease of handling soft and viscous materials, and less likelihood of generating large fragments.

[0018] The interventional medical device provided in this application can also be used for drug delivery or injection at vascular lesions. It involves injecting a drug-containing liquid into a blood vessel, continuously pushing the drug-containing liquid towards the lesion site using a sound beam or jet, or injecting the drug-containing liquid into the lesion site using a high-pressure sound beam, thereby achieving drug delivery or injection to the lesion. The lesion site can be a thrombus, tumor, or cancer cells, etc. Attached Figure Description

[0019] Figure 1 These are images and diagrams illustrating jet and secondary flow phenomena. Figure 2 This is a diagram of the acoustic beam generated in a liquid environment according to an embodiment of this application; Figure 3 This is a timing diagram of the output signal of the driving device of the ultrasonic device provided in this application embodiment: Figure 4 This is a schematic diagram of the driving device for the ultrasonic device provided in the embodiments of this application; Figure 5 This is a schematic diagram of the interventional medical device provided in the first embodiment of this application; Figure 6 This is a partially enlarged schematic diagram of point A of the interventional medical device provided in the first embodiment of this application; Figure 7 This is a partial schematic diagram of the interventional medical device provided in the second embodiment of this application; Figure 8 This is a partial schematic diagram of the interventional medical device provided in the third embodiment of this application; Figure 9 This is a schematic diagram of thrombolysis provided in one embodiment of this application; Figure 10 This is a schematic diagram of the operation of an interventional medical device with an umbrella-shaped structure performing thrombus ablation according to an embodiment of this application; Figure 11 This is a schematic diagram of the operation of an interventional medical device with an umbrella-shaped structure performing thrombus ablation, provided in another embodiment of this application.

[0020] It should be understood that the dimensions and shapes of the blocks in the above structural diagrams are for reference only and should not constitute an exclusive interpretation of the embodiments of the present invention. The relative positions and inclusion relationships between the blocks presented in the structural diagrams are only schematic representations of the structural relationships between the blocks, and are not intended to limit the physical connection methods of the embodiments of the present invention. Detailed Implementation

[0021] The technical solutions provided in this application will be further described below with reference to the accompanying drawings and embodiments. It should be understood that the device structures and business scenarios provided in the embodiments of this application are mainly for illustrating possible implementations of the technical solutions of this application and should not be construed as the sole limitation on the technical solutions of this application. Those skilled in the art will recognize that, with the evolution of technical structures and the emergence of new business scenarios, the technical solutions provided in this application are equally applicable to similar technical problems.

[0022] It should be understood that since the technical solutions of the various embodiments provided in this application are based on the same or similar principles, some repeated parts may not be described again in the following description of specific embodiments. However, it should be considered that these specific embodiments have referenced each other and can be combined with each other.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. In case of any inconsistency, the meaning set forth in this specification or derived from the content described herein shall prevail. Furthermore, the terminology used herein is for the purpose of describing embodiments of this application only and is not intended to limit this application. To accurately describe the technical content of this application and to accurately understand the invention, the following explanations or definitions of the terms used in this specification are provided before describing specific embodiments: 1) Ultrasonic Device: A high-frequency resonator, which can be a device that generates mechanical vibration by applying voltage based on the piezoelectric effect. In this application, a piezoelectric resonator that generates ultrasonic waves of not less than 0.5 GHz (GHz is equivalent to gigahertz) during operation is used. Preferably, it is a piezoelectric resonator that generates ultrasonic waves of not less than 1 GHz and not more than 30 GHz during operation, for example, it can be 2 GHz to 2.5 GHz. Such piezoelectric resonators can be, for example, surface acoustic wave (SAW) devices, bulk acoustic wave (BAW) devices, etc. For example, when it is BAW, it can be a thin-film bulk acoustic wave resonator (FBAR), a solid-state assembled resonator (SMR), or a Lamb wave resonator (LWR). For ease of description, the piezoelectric resonator that generates ultrasonic waves of not less than 0.5 GHz will be referred to as an ultrasonic device from now on.

[0024] 2) Jet phenomenon: This is a phenomenon that occurs when the sound waves from an ultrasonic device act on a liquid. The regional vibration generated at the working interface of the ultrasonic device can form a traveling wave in the liquid and exert a continuous thrust on the local liquid in the liquid environment, causing at least a portion of the liquid to move in a straight line along the direction of sound wave propagation. This phenomenon of straight-line movement is called jet phenomenon.

[0025] Secondary flow phenomena, including eddies and thermal backflow, are another phenomenon generated when a supersonic device acts on a liquid. They include eddies (or micro vortices) caused by the local circulation of the liquid driven by the jet, and thermal backflow generated by the heating of the supersonic device.

[0026] The jet phenomenon and secondary flow phenomenon can be found in [reference needed]. Figure 1 The images and diagrams shown. Figure 1 The diagram shows a schematic of particle capture using eddies. Secondary flow phenomena are generally associated with jet phenomena.

[0027] 3) Acoustic Beam: Since the acoustic beam in this application is generated based on a supersonic device, it is also referred to as a supersonic acoustic beam. In this application, the acoustic beam is a unique type of jet phenomenon, characterized by the fluid moving at high speed along the direction of sound wave propagation and the jet appearing as a thin cylinder within its path. Before significant attenuation, the acoustic beam and the surrounding liquid are essentially in a laminar flow state, with low mixing. Figure 2 An image of the resulting acoustic beam, captured by a high-speed camera, is shown. Figure 2 It can be seen that the acoustic beam has focusing properties and is no longer like... Figure 1 A cluster of jets, and Figure 2 It is clearly not visible in the middle Figure 1 Secondary flow phenomena in [the context of something].

[0028] The conditions for generating the ultrasonic beam in this embodiment are: driving the ultrasonic device to operate for at least one driving cycle with a first power, each driving cycle including a first stage and a second stage (see...). Figure 3 The drive unit outputs a signal (in the first stage) to drive the ultrasonic device to generate a 0.5-30 GHz ultrasonic effect in the liquid environment, and stops driving the ultrasonic device in the second stage. The first power is sufficient to enable the ultrasonic device to generate a focused columnar acoustic beam perpendicular to the solid-liquid interface during the first stage. The duration of the first stage at the first power is less than a threshold, or the duty cycle of the first stage within one drive cycle is less than a threshold, to keep the temperature of the ultrasonic device within a controllable temperature threshold and to prevent the ultrasonic device from generating secondary flows (including eddies and backflows) in the liquid environment.

[0029] The intensity of the acoustic beam is related to the duration of the first stage (or the duty cycle within a driving cycle) and the intensity of the first power. For example, a shorter first stage duration better suppresses temperature and secondary current, but the acoustic beam intensity is also lower (a shorter first stage duration means a shorter time for energy accumulation). Conversely, a higher first power results in a higher acoustic beam intensity, leading to a higher temperature rise in the ultrasonic device. Therefore, applying a higher first power and a shorter first stage not only yields a higher intensity acoustic beam but also effectively suppresses the temperature and secondary current. Thus, when real-time control of the acoustic beam intensity is required, the preferred approach is to use a shorter, fixed first stage (e.g., the duty cycle of the first stage within the cycle is fixed) and control the intensity of the generated acoustic beam by applying different first power values. A secondary approach is to apply the same first power value and adjust different first stage values ​​(e.g., the duty cycle of the first stage within the cycle) to control the intensity of the generated acoustic beam, or to simultaneously adjust both the first stage value and the first power to control the intensity of the generated acoustic beam.

[0030] Once the liquid environment is determined and the ultrasonic device is selected, the relationship between the acoustic beam intensity and control parameters (first power and / or the periodic signal composed of the first and second stages) can be calibrated. In one scenario, if the periodic signal is a constant (i.e., the first and second stages are constant), calibrating the acoustic beam intensity and the first power can yield the relationship between the first power and the acoustic beam intensity (which corresponds to the distance the acoustic beam can propel particles). This allows for the control of outputting an appropriate first power to propel particles to the desired distance, or along the desired path.

[0031] 4) Regarding the first stage within the drive cycle: In the first stage of the drive cycle, the drive unit continuously outputs several signals. For example, when the signal generator outputs a 1GHz signal, assuming the duration of the first stage is 1 microsecond, the drive unit will output 1000 signals during this first stage. The power applied during the first stage will be applied to these 1000 signals to drive the ultrasonic device. In the second stage of the drive cycle (corresponding to...) Figure 3 (Switch signal low level) No drive signal output.

[0032] In certain cases, such as when the first phase is executed only once and then the process ends, this is equivalent to or considered as executing only one drive cycle in this application, and therefore this situation is also within the scope of protection of this application.

[0033] 5) Driving device for special ultrasonic devices: such as Figure 4 One embodiment is shown, including a control unit and a drive unit, the drive unit comprising a signal generator and a power amplifier. Its signal output principle can be found in [reference needed]. Figure 3 As shown.

[0034] The signal generator is used to generate high-frequency signals. The frequency of the original high-frequency signal it generates is the same as or approximately the operating frequency (or natural frequency) of the ultrasonic device used as a load. The waveform of the signal generator can be a rectangular wave (e.g.,...). Figure 3 The signals shown include square waves, sawtooth waves, sharp pulses (or triangular waves), stepped waves, sine waves, or half-waves. The output signal of the corresponding drive unit is modulated into rectangular waves, sawtooth waves, sharp pulses (or triangular waves), stepped waves, sine waves, or half-waves.

[0035] A power amplifier is used to amplify the signal to be output so that it can drive a high-performance ultrasonic device.

[0036] The control unit can be a switching power supply, which controls the output switching signal. This switching signal can be a periodic signal, with a high level corresponding to the switching on phase (such as the conduction phase of the switching power supply's switching transistor). Figure 3 In the first stage, the switch-off stage corresponds to a low level, which is... Figure 3 The second stage involves controlling the operating voltage or amplification factor input to the power amplifier to achieve different output powers, which is the first power mentioned above. The first power can also be understood as the average energy density input to the ultrasonic device during a driving cycle (which consists of a first stage and a second stage). Since the energy level is related to power and time, the amount of energy input to the ultrasonic device during a driving cycle is related to the level of the first power, the duration of the first stage, or its duty cycle.

[0037] The acoustic beam and related technologies for driving ultrasonic devices to generate acoustic beams, as described above, can also be found in the relevant description in Chinese patent application number CN2024108322079.

[0038] 6) Upstream side and downstream side: In this application, upstream side and downstream side are defined in the same way as the direction of blood flow in blood vessels.

[0039] The interventional medical device provided in this application can be applied to interventional treatment of thrombosis. For example, by guiding a high-speed ultrasound device to the thrombus in a blood vessel, the device generates a high-speed sound beam. This controllable sound beam directly or indirectly generates a controllable high-pressure, strong impact force on the thrombus, achieving ablation and / or fragmentation. This application, based on the direct impact of the sound beam on the thrombus, differs from the ultrasonic vibration technology of the prior art. When the high-speed ultrasound device generates the sound beam, the energy conversion rate is high, and the thermal effect is far lower than that of ultrasound. This method features lower heat generation, higher efficiency, and a simpler structure. The interventional medical device provided in this application can also be used for the direct delivery of drugs to lesions within the body. For example, medication is delivered to the front of the high-speed ultrasound device via a catheter. When the high-speed ultrasound device generates a high-speed sound beam, the drug can be injected into the target location using the sound beam. This target location can be the lesion site, such as a thrombus, tumor, or other diseased tissue. The following will describe this application in detail with reference to the accompanying drawings.

[0040] like Figure 5 This application illustrates an interventional medical device according to a first embodiment. Figure 6 yes Figure 5 The enlarged schematic diagram shows that the interventional medical device provided in this application includes: an inner tube 10, with a special ultrasound device 20 disposed at the front end of the inner tube 10. The special ultrasound device 20 is used to generate a sound beam in a liquid environment when driven by a driving device; the inner tube 10 has a wire 30 electrically connected to the special ultrasound device 20, and the wire 30 extends to the rear end of the inner tube 10 for electrically connecting to the driving device.

[0041] In some embodiments, the aforementioned fluid environment can be an intravascular fluid environment. This fluid environment can be blood within the blood vessels, or a fluid (such as saline solution) or a drug-containing fluid delivered into the blood vessels, or a mixture of blood and the aforementioned fluids.

[0042] In some embodiments, the ultrasonic device 20 generates a sound beam within the blood vessel, which can act on the thrombus within the blood vessel to dissolve or fragment it. In some embodiments, the high-speed, high-pressure sound beam can break down obstructive substances (i.e., thrombi) within the blood vessel into single cells, which can more easily enter the venous circulation through terminal capillaries and eventually be metabolized.

[0043] In some embodiments, the acoustic beam generated by the ultrasound device 20 within a blood vessel can propel or inject drugs into a target location, such as a lesion, a thrombus, a tumor, or other diseased tissue. The acoustic beam can not only propel drugs, but also, due to its focusing properties and controllable high speed and high pressure, can precisely inject drugs into the lesion.

[0044] In some embodiments, the inner sleeve 10 is further provided with a guide wire 40 at its front end, which facilitates guiding the ultrasonic device 20 to the target position. In some embodiments, the ultrasonic device 20 may have a hole in the middle that is slightly larger than the diameter of the guide wire 40, so that the guide wire 40 can pass through it. The position of the guide wire 40 through the hole is not limited to the geometric center or the circumcenter of the ultrasonic device 20, as long as the guide wire 40 passes through to achieve the positioning purpose.

[0045] In some embodiments, such as Figure 10 or Figure 11 As shown, it also includes an umbrella-shaped structure 70 that guides the acoustic beam to the side. The umbrella-shaped structure 70 can guide the axial acoustic beam radially, inducing vortex formation and enhancing the scouring effect on the blood vessel wall. In some embodiments, the side of the umbrella-shaped structure 70 facing the ultrasound device can be a conical structure, an arc-shaped structure, or a sloping structure, etc. In some embodiments, such as... Figure 10 As shown, the umbrella-shaped structure can be mounted on the guidewire, or, as... Figure 11 As shown, the umbrella-shaped structure is mounted on an elastic support extending from the front end of the inner sleeve.

[0046] In some embodiments, the inner sleeve 10 is provided with a substrate 50 segment at its front end ( Figure 6 The substrate segment is shown in perspective to reveal its internal structure. The ultrasonic device 20 is mounted on the front end of the substrate segment 50. The substrate segment 50 contains channels for guide wires 40 and wires 30. The substrate segment 50 is typically made of one of the following: high-resistivity semiconductor materials such as silicon, silicon dioxide, or quartz, or insulating polymer materials such as PP, PF, or PMMA. In some embodiments, the connection between the ultrasonic device 20 and the substrate 50 can be smoothly transitioned.

[0047] In some embodiments, the ultrasonographic devices 20 are at least two arranged in an array. In some embodiments, the arrangement of these ultrasonographic devices 20 can be as follows: Figure 7 The diagram shows an overall ring-shaped arrangement, but it can also be arranged symmetrically along an axis.

[0048] In some embodiments, such as Figure 6 , Figure 7 or Figure 8 As shown, the front end of the substrate 50 segment includes a plane perpendicular to the extension direction of the inner sleeve 10, and at least one special ultrasonic device 20 is disposed on the plane at the front end of the substrate 50 segment, with its orientation set to the front end extension direction.

[0049] In some embodiments, the front end of the substrate 50 segment includes at least one inclined surface, and at least one special ultrasonic device 20 is disposed on the inclined surface of the front end of the substrate 50 segment, with its orientation forming an acute-obtuse angle with the front end extension direction. In some embodiments, the front end of the substrate 50 is an inclined surface, on which one or more special ultrasonic devices 20 are disposed. In other embodiments, the front end of the substrate 50 segment is generally pyramidal (such as a square pyramid), and special ultrasonic devices 20 are disposed on each side of the pyramid (i.e., multiple inclined surfaces), which can generate multiple inclined diverging sound beams.

[0050] In some embodiments, an outer sleeve 60 is further included, which is fitted over the inner sleeve 10. In some embodiments, the outer sleeve 60 may be shorter than the inner sleeve 10. In other embodiments, the length of the outer sleeve 60 may be substantially the same as the length of the inner sleeve 10, and the inner sleeve 10 may rotate or move back and forth within the outer sleeve. The user can control the movement of the inner sleeve 10 by manipulating an external handle connected to it.

[0051] In some embodiments, at least one liquid channel exists between the outer sleeve 60 and the inner sleeve 10. In some embodiments, the liquid channel may be formed by a groove formed on the outer surface of the inner sleeve 10 that mates with the outer sleeve 60. In some embodiments, the liquid channel may be formed by a groove formed on the inner surface of the outer sleeve 60 that mates with the outer surface of the inner sleeve. In some embodiments, the liquid channel may be implemented as a conduit disposed between the inner sleeve 10 and the outer sleeve 60, or as a conduit located within the inner sleeve 10. The outlet at the front end of the conduit may be located on the side or front face of the substrate 50.

[0052] In some embodiments, a liquid channel can be used to deliver liquid, such as saline solution or saline solution containing medication, to the environment where the ultrasound device 20 is located. In some embodiments, a liquid channel can be used to extract liquid from the environment where the ultrasound device 20 is located. Thus, operations such as perfusion and flushing are achieved through the liquid channel.

[0053] The inner sleeve 10 is used to support and connect the special ultrasound device 20 and the substrate 50 segment. It is a sleeve for manual guidance by the surgeon and is generally made of insulating polymer material. The inner sleeve 10 is generally circular in shape.

[0054] The outer cannula 60 is used to protect and guide the inner cannula 10. Depending on the needs of the surgery, it can be as short as just entering the patient's body or it can be designed to be longer to work with the inner cannula 10 to perform other operations, including irrigation and flushing.

[0055] In some embodiments, the inner sheath 10 and the outer sheath 60 move, wherein the movement of the inner sheath 10 can be controlled by manipulating a handle connected to the rear end of the inner sheath 10. This movement may include extending, pulling back, rotating, or moving perpendicular to the axial direction of the outer sheath 60, to adjust the position of the ultrasound device 20 relative to the thrombus. In some embodiments, the handle may be a control handle or the like.

[0056] In some embodiments, the ultrasonic device 20 is further configured to generate one or any combination of the following in the liquid environment when driven by a driving device: eddies, jets, bubbles, and thermal effects. In some embodiments, the generation of one or any combination of acoustic beams, jets, eddies, bubbles, and thermal effects can be achieved through different driving methods of the driving device. Thus, a suitable acoustic fluid effect can be selected to act on lesions, etc.

[0057] In some embodiments, the ultrasonographic device 20 can be connected to the back of the piezoelectric ceramic via an advanced encapsulation method, allowing it to extend from the inner sleeve 10 to the rear end of the inner sleeve 10 together with the bottom electrode 22 via a wire 30 (the wire 30 includes a top electrode lead 31 and a bottom electrode lead 32) for connection to an external drive device. The ultrasonographic device 20 can be made of a piezoelectric material (AlN, etc.), and its shape can be circular, polygonal, etc. (preferably pentagonal or truncated pentagonal, elliptical, willow leaf-shaped, etc.). The outer diameter of the ultrasonographic device 20 is generally 0.5-3 mm. The ultrasonographic device 20 can operate at 0.5-10 GHz, preferably at 1-3 GHz, more preferably at 2.4 GHz, and can form a sound beam perpendicular to the surface of the ultrasonographic device 20 during operation. This sound beam can impact and ablate the obstructing material in the blood vessel. The ultrasonic device 20 features a high operating frequency of 0.5-10 GHz, which attenuates extremely rapidly in a liquid environment, generating a strong acoustic beam phenomenon. This acoustic beam is characterized by high speed (0-20 m / s), small diameter (0-several millimeters), good directionality (divergence angle 0-20 degrees), and ease of modulation (adjustable power, pulse width, and duty cycle). The ultrasonic device 20 can operate continuously or intermittently.

[0058] In some embodiments, the surface of the ultrasonic device 20 may be coated to reduce dirt and particle adhesion, and the guidewire 40 may be coated with a hydrophilic layer to improve the smoothness of the guidewire 40.

[0059] like Figure 9This illustration shows an example of an interventional medical device provided in this application performing ablation of obstructive substances (such as thrombi). One method for ablation of obstructive substances in this embodiment is as follows: Under ultrasound or X-ray guidance, a guidewire 40 is passed through the obstruction area. The interventional medical device, guided by the guidewire 40, reaches the front end of the obstruction area (the end in the direction of blood flow). The ultrasound device 20 is then activated to ablate the obstruction area. The ablated single-cell material moves towards the distal end of the blood vessel through the unblocked portion. Alternatively, under the action of vasodilators, it enters the vein through capillaries and is metabolized by the body. Furthermore, guided by the guidewire 40, the ultrasound device 20 is pushed towards the thrombus area, ablating the thrombus from top to bottom (in the direction of blood flow).

[0060] Another method for ablation of obstructive substances in this embodiment can be as follows: Under ultrasound or X-ray guidance, a guidewire 40 is passed through the obstruction area. The interventional medical device, guided by the guidewire 40, reaches the end of the obstruction area (the end from which blood flow exits). The ultrasound device 20 is then activated to ablate the obstruction area. The ablated single-cell material moves towards the end of the blood vessel through the unblocked portion. Alternatively, under the action of vasodilators, it enters the vein through capillaries and is metabolized by the body. Guided by the guidewire 40, the ultrasound device 20 is pulled towards the thrombus area, ablating the thrombus from bottom to top (in the direction of blood flow).

[0061] like Figure 10 This illustration shows another example of an interventional medical device provided in this application for the ablation of obstructive substances (such as thrombi). The interventional medical device in this example has an umbrella-shaped structure 70. It can ablate thrombi from top to bottom (in the direction of blood flow) or from bottom to top (in the direction of blood flow). Further details are omitted.

[0062] This application also provides the application of the above-mentioned interventional medical device. In some embodiments, it can be applied to the ablation method of obstructive substances (such as thrombi) in blood vessels, as described above, and will not be repeated here.

[0063] In other embodiments, the above-described interventional medical device can be used for drug delivery or injection at intravascular lesions. When... Figure 9 As in embodiment 10, after guiding the ultrasound device 20 to the vicinity of the lesion within the blood vessel, a drug-containing liquid is injected into the blood vessel through a liquid channel. This liquid, or the liquid and blood, form a liquid environment for the ultrasound device 20. The ultrasound device is directed towards the lesion site, continuously pushing the drug-containing liquid towards the lesion site through a sound beam or jet, or injecting the drug-containing liquid into the lesion site through a high-pressure sound beam. The lesion site can be a thrombus, tumor, or cancer cell, etc., and the delivered drug can be a thrombolytic drug, a tumor or cancer treatment drug, such as a targeted drug. The drug can be a liquid-soluble drug or a drug carried by nanoparticles.

[0064] Furthermore, the terms "first, second, third, etc." or similar terms such as module A, module B, and module C used in the specification and claims are only used to distinguish similar objects and do not represent a specific ordering of objects. It is understood that, where permissible, a specific order or sequence may be interchanged so that the embodiments of this application described herein can be implemented in an order other than that illustrated or described herein.

[0065] In the above description, the labels of the steps involved, such as S110, S120, etc., do not mean that the steps will necessarily be executed. The order of the steps can be interchanged or executed simultaneously if permitted.

[0066] The term "comprising" as used in the specification and claims should not be construed as limiting itself to what follows; it does not exclude other elements or steps. Therefore, it should be interpreted as specifying the presence of the mentioned feature, integral, step, or component, but does not exclude the presence or addition of one or more other features, integrals, steps, or components, or groups thereof. Thus, the statement "device comprising means A and B" should not be limited to a device consisting solely of components A and B.

[0067] The terms "an embodiment" or "an embodiment" as used in this specification mean that a particular feature, structure, or characteristic described in conjunction with that embodiment is included in at least one embodiment of this application. Therefore, the terms "in one embodiment" or "in an embodiment" appearing throughout this specification do not necessarily refer to the same embodiment, but may refer to the same embodiment. Furthermore, in one or more embodiments, the particular features, structures, or characteristics can be combined in any suitable manner, as will be apparent to those skilled in the art from this disclosure.

[0068] Note that the above are merely preferred embodiments and the technical principles employed in this application. Those skilled in the art will understand that this application is not limited to the specific embodiments described herein, and various obvious changes, readjustments, and substitutions can be made without departing from the scope of protection of this application. Therefore, although this application has been described in detail through the above embodiments, this application is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of this application, all of which fall within the scope of protection of this application.

Claims

1. An interventional medical instrument, characterized by, Comprising: an inner cannula; said inner cannula is provided with a front end, said front end is provided with a special ultrasound device, said special ultrasound device is used to generate a beam stream in a liquid environment when driven by a driving device; said inner cannula is provided with a wire inside, said wire is electrically connected to said special ultrasound device, said wire extends to a rear end of said inner cannula, and is used to electrically connect said driving device.

2. The medical device of claim 1, wherein, said inner cannula is further provided with a guide wire at the front end.

3. The medical device of claim 2, wherein, further comprising an umbrella-shaped structure for guiding said beam stream to the side, wherein: said umbrella-shaped structure is assembled on said guide wire, or said umbrella-shaped structure is assembled on a support extending from said front end of said inner cannula.

4. The medical device of claim 1, wherein, said inner cannula is provided with a front end, said front end is provided with a special ultrasound device, comprising: said inner cannula is provided with a front end, said front end is provided with a substrate section, and said special ultrasound device is assembled on a front end of said substrate section.

5. The medical device of claim 4, wherein, said special ultrasound device comprises at least two arranged in an array.

6. The medical device of claim 5, wherein, said special ultrasound device is arranged in one of the following ways: said front end of said substrate section comprises a plane perpendicular to the extension direction of said inner cannula, and at least one special ultrasound device is arranged on said plane of said front end of said substrate section, and the direction of said at least one special ultrasound device is arranged as the extension direction of said front end; said front end of said substrate section comprises at least one inclined plane, and at least one special ultrasound device is arranged on said inclined plane of said front end of said substrate section, and the direction of said at least one special ultrasound device is arranged as an acute or obtuse angle with the extension direction of said front end.

7. The medical device of claim 1, wherein, further comprising an outer cannula, which is sleeved outside said inner cannula.

8. The medical device of claim 7, wherein, said outer cannula and said inner cannula are provided with at least one liquid channel therebetween.

9. The medical device of claim 1, wherein, said special ultrasound device is further used to generate one or any combination of the following in said liquid environment when driven by said driving device: vortex, jet, bubble, and thermal effect.

10. Use of an interventional medical instrument according to any one of claims 1 to 9, characterized in that, applied to at least one of the following: ablation of intravascular obstruction, drug delivery to intravascular lesions, or drug infusion to intravascular lesions.

Images