An ultrasonic transducer device and therapeutic system therefor

Abstract

The application provides an ultrasonic transducer device and a treatment system thereof, wherein the ultrasonic transducer device comprises a partition structure extending in a longitudinal direction and transducer assemblies connected in series in the longitudinal direction of the partition structure, the transducer assemblies comprising first transducers and / or second transducers, the first transducers and / or the second transducers in each transducer assembly being arranged in a circle with the partition structure as the center, and the partition structure being a solid plate structure or a plate structure with cavities arranged in the interior. The ultrasonic transducer device uses the first transducers for treatment and the second transducers for imaging, and the purpose of real-time monitoring is achieved simultaneously in the treatment process; the partition structure is used to isolate the ultrasonic waves of the two groups of transducers, so that the mutual interference between the ultrasonic waves emitted by the two transducers is avoided, so that the treatment system made of the ultrasonic transducer device has higher anti-interference ability and higher treatment precision.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to an ultrasonic transducer and its treatment system. Background Technology

[0002] In several medical applications, there are instances where ultrasound energy is used to enhance the effects of various therapeutic compounds. For example, ultrasound catheters are used to deliver ultrasound energy and therapeutic compounds to treatment sites within a patient's body. Such ultrasound catheters typically include an ultrasound component configured to generate ultrasound energy and a fluid delivery cavity for delivering the therapeutic compound to the treatment site.

[0003] Specifically, ultrasound catheters can be used to treat human blood vessels that are partially or completely blocked by plaque, thrombus, embolus, or other substances that reduce the blood-carrying capacity of the vessels. To remove or reduce the blockage, an ultrasound catheter is used to deliver a solution containing a therapeutic compound directly to the blockage site. The effect of the therapeutic compound is enhanced by the ultrasound energy generated by the ultrasound components. Such devices can be used to treat conditions such as peripheral arterial occlusion, deep vein thrombosis, pulmonary embolism, or acute ischemic stroke. In such applications, ultrasound energy enhances the treatment of the blockage with therapeutic compounds (such as urokinase, tissue plasminogen activator, recombinant tissue plasminogen activator, etc.).

[0004] Existing ultrasound modules are equipped with ultrasound therapy transducers to convert electrical energy into ultrasonic energy. For example, an ultrasound therapy transducer can be a lead zirconate titanate (PZT) transducer or other materials capable of producing the same piezoelectric effect. However, existing ultrasound modules only include ultrasound therapy transducers and lack ultrasound imaging transducers, making real-time monitoring of the treatment process impossible. This is because the ultrasound therapy transducer introduces signal interference to the ultrasound imaging transducer, resulting in poor image quality. Conversely, the ultrasound imaging transducer also introduces signal interference to the ultrasound therapy transducer, and current technology lacks an effective solution to this signal interference problem.

[0005] In view of this, it is necessary to improve the ultrasonic components in the existing technology to solve the above problems. Summary of the Invention

[0006] This invention provides an ultrasonic transducer and its treatment system, which solves the problem of signal interference between two ultrasonic transducers.

[0007] This invention provides an ultrasonic transducer, the ultrasonic transducer comprising:

[0008] A longitudinally extending partition structure and a transducer assembly connected in series in the longitudinal direction to the partition structure, the transducer assembly including a first transducer and / or a second transducer, the first transducer and / or the second transducer in each transducer assembly being arranged circumferentially around the partition structure, the partition structure being a solid plate structure or a plate structure with an internal cavity, the cavity being filled with gas or tungsten-containing epoxy resin, or the cavity being configured as a vacuum cavity structure.

[0009] As a further improvement of the present invention, the transducer assembly includes a first transducer disposed back-to-back along the thickness direction, and a first electrical connection plate disposed between the first transducer and the partition structure.

[0010] As a further improvement of the present invention, the transducer assembly includes a second transducer disposed back-to-back along the thickness direction, and a second electrical connection plate disposed between the second transducer and the partition structure.

[0011] As a further improvement of the present invention, the transducer assembly includes a first transducer and a second transducer arranged back-to-back along the thickness direction, a first electrical connection plate disposed between the first transducer and the partition structure, and a second electrical connection plate disposed between the second transducer and the partition structure.

[0012] As a further improvement of the present invention, the center-to-center distance between the longitudinally adjacent first transducers and / or second transducers is 0.7cm-2cm.

[0013] As a further improvement of the present invention, the insulating coating of 0.1 mm to 0.5 mm is coated on the partition structure, and the insulating coating has a porous structure with a porosity of 20% to 80%.

[0014] As a further improvement of the present invention, the first transducer and the second transducer are provided with a piezoelectric layer, the piezoelectric layer being made of one or more piezoelectric materials selected from barium titanate, lead zirconate titanate, potassium sodium niobate, lead magnesium niobate-lead titanate, and lead magnesium niobate-lead hafnium titanate, and the porosity of the piezoelectric layer is 35%-60%.

[0015] As a further improvement of the present invention, the center frequency of the first transducer is configured to be 1MHz-10MHz, and the center frequency of the second transducer is configured to be 10MHz-30MHz.

[0016] The present invention also provides an ultrasound therapy system comprising an ultrasound catheter, a fluid inlet device communicating with the ultrasound catheter, and a control system for controlling the ultrasound catheter, wherein the ultrasound catheter includes an elongated guide tube and the aforementioned ultrasound transducer disposed within the guide tube.

[0017] As a further improvement of the present invention, the ultrasound therapy system further includes a rotating device connected to the ultrasound catheter, for driving the ultrasound transducer to rotate inside the guide catheter.

[0018] Compared with the prior art, the beneficial effects of the present invention are:

[0019] The present invention provides an ultrasonic transducer that uses a first transducer for treatment and adds a second transducer for imaging, achieving real-time monitoring during the treatment process. Furthermore, the ultrasonic waves emitted by the two transducers are isolated by a partition structure, avoiding mutual interference between the ultrasonic waves emitted by the two transducers. This results in a treatment system made from the ultrasonic transducer having high anti-interference capability and high treatment accuracy. Attached Figure Description

[0020] Figure 1 A schematic diagram of a tubular main body component of an ultrasonic catheter provided by the present invention;

[0021] Figure 2 A schematic diagram of a component at the proximal end of an ultrasonic catheter provided by the present invention;

[0022] Figure 3 This is a three-dimensional schematic diagram of an embodiment of an ultrasonic transducer provided by the present invention;

[0023] Figure 4 A cross-sectional schematic diagram of an embodiment of an ultrasonic transducer provided by the present invention;

[0024] Figure 5 A cross-sectional schematic diagram of another embodiment of an ultrasonic transducer provided by the present invention;

[0025] Figure 6 A schematic diagram of yet another embodiment of an ultrasonic transducer provided by the present invention;

[0026] Figure 7 This is a cross-sectional schematic diagram of an ultrasonic transducer provided by the present invention;

[0027] Figure 8 This is a cross-sectional schematic diagram of a guiding catheter provided by the present invention. Detailed Implementation

[0028] The present invention will now be described in detail with reference to the embodiments shown in the accompanying drawings. However, it should be noted that these embodiments are not intended to limit the present invention. Equivalent changes or substitutions in function, method, or structure made by those skilled in the art based on these embodiments are all within the scope of protection of the present invention.

[0029] It should be understood that the terms "center," "vertical," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," "positive direction," and "negative direction," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used solely for the convenience of describing this technical solution and for simplifying the description, and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this technical solution. If the text uses descriptions such as "first" or "second," these descriptions are only used to distinguish similar objects and should not be construed as indicating or implying their relative importance, order of precedence, or implicitly specifying the number of technical features indicated. It should be understood that the number of descriptions such as "first" and "second" can be interchanged where appropriate.

[0030] This invention aims to provide ultrasound catheters with various features and advantages, including the ability to apply ultrasound energy to a treatment site. In other embodiments, the catheter has the ability to deliver a therapeutic compound to the treatment site. Embodiments of ultrasound catheters having some of these features and advantages are described herein. Methods of using such ultrasound catheters are also described herein.

[0031] The ultrasound catheters described herein can be used to enhance the therapeutic effect of therapeutic compounds at the treatment site within the patient. As used herein, the term "therapeutic compound" is broadly, but not limited to, drugs, pharmaceuticals, dissolving compounds, genetic materials, anticancer drugs, or any other substance capable of affecting physiological function. For applications treating human blood vessels partially or completely blocked by plaques, thrombi, emboli, or other substances that reduce the blood-carrying capacity of blood vessels, suitable therapeutic compounds include, but are not limited to, aqueous solutions containing heparin, urea hormones, or streptokinase.

[0032] Certain features and aspects of the ultrasound catheters disclosed herein can also be used in applications where ultrasound energy itself provides therapeutic effects. Examples of such therapeutic effects include preventing or reducing stenosis and / or restenosis; tissue ablation, abrasion, or fragmentation; promoting temporary or permanent physiological changes in intracellular or intercellular structures; and rupturing microballoons or microbubbles for the delivery of therapeutic compounds.

[0033] The ultrasound catheter described herein can be configured to apply ultrasound energy over a long length of a body cavity, such as, for example, an artery in the lower extremities. In other embodiments, the catheter can be configured to treat pulmonary embolism (“PE”), which can occur when a large blood clot blocks a major blood vessel leading from the heart to the lungs. However, it should be understood that certain features and aspects of this disclosure can be applied to catheters configured for insertion into other blood vessels or cavities, such as small cerebral blood vessels, solid tissues, tubular systems, and body cavities.

[0034] Figure 1 An ultrasound catheter 10 configured for use in major blood vessels within a patient's body structure is illustrated schematically. For example, Figure 1 The ultrasound catheter 10 shown can be used to treat long peripheral artery occlusions, such as those in the vascular system of the lower extremity arteries. Alternatively, in other instances, Figure 1 The ultrasound catheter 10 shown can be used to treat pulmonary embolism. The ultrasound catheter 10 is configured to be inserted into a large blood vessel (e.g., the pulmonary artery) leading from the heart to the lungs in a patient. In one embodiment, a femoral vein access can be used to place the ultrasound catheter 10 into such a vessel. In this embodiment, the ultrasound catheter 10 can be advanced through the femoral access site, through the heart, and into the pulmonary artery. The size of the ultrasound catheter 10 is adjusted based on the specific application for which it will be used.

[0035] like Figure 1 As shown, the ultrasound catheter 10 may include a multi-part, elongated, flexible guiding catheter 11, which has a distal end 12 and a proximal end 13. The guiding catheter 11 may include an ultrasound transducer body 14 located in the distal end 12 of the ultrasound catheter 10. To show the structure of the ultrasound transducer body 14 more clearly, Figure 1 The distal end 12 of the guiding catheter 11 extends from the ultrasonic transducer body 14 as an illustration. The guiding catheter 11 and other components of the ultrasonic catheter 10 can be manufactured according to any of the various techniques known in the field of catheter manufacturing. Appropriate materials and sizes can be easily selected based on the natural and anatomical dimensions of the treatment site and the desired percutaneous entry point.

[0036] For example, in some embodiments, the distal end 12 of the guiding catheter 11 may include a material having sufficient flexibility, kink resistance, rigidity, and structural support to propel the ultrasound transducer body 14 through the patient's vascular system to the treatment site. Examples of such materials include, but are not limited to, polytetrafluoroethylene, polyethylene, polyamide, and other similar materials. In some embodiments, the proximal end 13 of the guiding catheter 11 is reinforced by braiding, meshing, or other constructions to provide increased kink resistance and maneuverability. For example, nickel-titanium wire or stainless steel wire may be placed along or incorporated into the guiding catheter 11 to reduce kinking.

[0037] The cross-sectional shape of the guiding catheter 11 can be circular, square, or other irregular shapes. In some embodiments configured for treating thrombosis in the lower extremity arteries, the guiding catheter 11 has an outer diameter of approximately 0.15 cm to approximately 0.19 cm. In another embodiment, the guiding catheter 11 has an outer diameter of approximately 0.18 cm. In some embodiments, the length of the guiding catheter 11 is 10 cm to 200 cm, for example, preferably an axial length of 106 cm to 135 cm, the specific length being determined according to the length required for treatment.

[0038] The ultrasonic transducer body 14 may comprise a material thinner than the material of the proximal end 13 of the guiding conduit 11 or a material with greater acoustic transmittance. Thinner materials generally have greater acoustic transmittance than thicker materials. Suitable materials for the ultrasonic transducer body 14 may include, but are not limited to, high- or low-density polyethylene, urethane, nylon, etc. In some modified embodiments, the ultrasonic transducer body 14 may be formed of the same material or the same thickness as the proximal end 13.

[0039] Combination Figure 1 and Figure 2 As shown, the present invention provides an ultrasound therapy system, including an ultrasound catheter 10, a fluid inlet device 15, and a control system 16. The fluid inlet device 15 includes multiple inlet ports through which fluid is injected into the proximal end 13 of the ultrasound catheter 10. In some embodiments, the fluid inlet device 15 may include a drug inlet, a saline inlet, etc. In some embodiments, to provide electrical connection with the ultrasound transducer body 14, the ultrasound catheter 10 may further include a cable (not shown), which can be electrically connected to the control system 16 at the proximal end 13 through a proximal inlet (not shown).

[0040] Combination Figure 1 , Figures 2 to 5As shown, a partition structure 24 extending longitudinally a is provided inside the ultrasonic transducer tube 14, and multiple ultrasonic transducers 20 are connected in series along longitudinally a on the partition structure 24. A control system 16 connects the main unit and the ultrasonic catheter 10 to control parameters such as the frequency of the ultrasonic transducers 20. Each ultrasonic transducer 20 includes an ultrasonic therapeutic transducer 21 and / or an ultrasonic imaging transducer 22, with the ultrasonic therapeutic transducer 21 and / or ultrasonic imaging transducer 22 arranged circumferentially around the partition structure 24. Depending on the size of the lesion being treated, the ultrasonic transducers 20 can be in one, two, or more groups, preferably three or more groups.

[0041] The ultrasonic transducer 20 provided by this invention, based on the ultrasonic therapeutic transducer 21, adds an ultrasonic imaging transducer 22 to enable real-time monitoring of the treatment process, facilitating guidance for the doctor's next steps. Specifically, when guiding the catheter 11 into the blood vessel, the ultrasonic imaging transducer 22 can first observe the imaging information of the thrombus, then determine the location and size of the thrombus based on the imaging information, and then precisely align the ultrasonic therapeutic transducer 21 with the thrombus, thereby avoiding the situation where the ultrasonic therapeutic transducer 21 is not positioned at the thrombus site, thus preventing a reduction in treatment effectiveness.

[0042] Combination Figure 3 and Figure 4 As shown, in one embodiment, each group of ultrasonic transducers 20 is configured with an ultrasonic therapeutic transducer 21 and an ultrasonic imaging transducer 22 arranged back-to-back, and a partition structure 24 is disposed between the ultrasonic therapeutic transducer 21 and the ultrasonic imaging transducer 22 along the thickness direction b. The ultrasonic transducer 20 also includes a first electrical connection plate 231 and a second electrical connection plate 232. The first electrical connection plate 231 is disposed between the ultrasonic therapeutic transducer 21 and the partition structure 24, and the second electrical connection plate 232 is disposed between the ultrasonic imaging transducer 22 and the partition structure 24. The partition structure 24 can be configured as a plate-like structure with a cavity 240. For example, the cavity 240 can be filled with gas or tungsten-containing epoxy resin, or the cavity 240 can be directly configured as a vacuum cavity structure. In another embodiment, the partition structure 24 is a solid plate-like structure, and the material of the partition structure 24 can be a metal such as copper or silver.

[0043] Combination Figure 3 , Figure 4 and Figure 7The matching layer 213 of the ultrasound therapy transducer 21 and the matching layer 213 of the ultrasound imaging transducer 22 are connected to their respective positive lines 233, and the first electrical connection plate 231 and the second electrical connection plate 232 are connected to their respective negative lines (not shown). Specifically, the ultrasound therapy transducer 21 includes a first positive line led out from its matching layer and a first negative line led out from the first electrical connection plate 231, and the ultrasound imaging transducer 22 includes a second positive line led out from its matching layer and a second negative line led out from the second electrical connection plate 232. The first positive lines from adjacent ultrasound therapy transducers 21 are sequentially connected, extending to the proximal end 13 and connected to the control system; the first negative lines from adjacent first electrical connection plates 231 are sequentially connected, extending to the proximal end 13 and connected to the control system 16; the second positive lines from adjacent ultrasound imaging transducers 22 are sequentially connected, extending to the proximal end 13 and connected to the control system 16; the second negative lines from adjacent second electrical connection plates 232 are sequentially connected, extending to the proximal end 13 and connected to the control system 16.

[0044] Combination Figure 1 , Figure 3 and Figure 4As shown, adjacent ultrasonic transducers 20 are arranged in series along the longitudinal direction a, and ultrasonic therapeutic transducers 21 and ultrasonic imaging transducers 22 are arranged back-to-back along the thickness direction b. In the longitudinal direction a, the center-to-center distance between adjacent ultrasonic transducers 20 is 0.7cm-2cm, that is, the center-to-center distance between adjacent ultrasonic therapeutic transducers 21 is 0.7cm-2cm, and the center-to-center distance between adjacent ultrasonic imaging transducers 22 is 0.7cm-2cm. For ultrasonic therapeutic transducers 21, excessive distance between adjacent transducers 21 will lead to uneven ultrasonic energy emission, resulting in uneven treatment area; insufficient distance between adjacent transducers 21 will cause electromagnetic signal interference between transducers, affecting the energy emission of the transducers 21. For ultrasonic imaging transducers 22, the received signal is interfered with, resulting in higher image noise. Therefore, through multiple experimental analyses, this invention sets the center-to-center distance between adjacent ultrasonic transducers 20 to 0.7cm-2cm, effectively avoiding the aforementioned problems caused by excessively large or small distances between adjacent transducers. Preferably, the center-to-center distance between adjacent ultrasonic therapy transducers 21 is 1.1cm-1.5cm; further research shows that setting the center-to-center distance between adjacent ultrasonic transducers 20 to 1.2cm can avoid signal interference between transducers and simultaneously help maintain the rigidity of the distal end 12 of the ultrasonic catheter 10. It is worth noting that the distal end 12 of the ultrasonic catheter 10 needs appropriate rigidity to facilitate its movement within the body, but excessive rigidity hinders its passage through internal bends. The inventors discovered that setting the center-to-center distance between adjacent ultrasonic transducers 20 to 1.2cm maintains optimal rigidity of the ultrasonic catheter 10, and, combined with the partition structure 24, solves the problem of electromagnetic signal interference between transducers. In this embodiment, the ultrasound therapy transducer 21 and the ultrasound imaging transducer 22 can be rectangular. For example, the size of the ultrasound therapy transducer 21 is 2mm*0.4mm*0.3mm; the size of the ultrasound imaging transducer 22 is 1mm*0.2mm*0.1mm.

[0045] In other alternative embodiments, the ultrasound therapy transducer 21 and the ultrasound imaging transducer 22 may be rectangular, and a transducer assembly may include three rectangular ultrasound therapy transducers 21 and / or ultrasound imaging transducers 22, wherein the angle between the transducers and their center points is 120°; a transducer assembly may also include four rectangular ultrasound therapy transducers 21 and / or ultrasound imaging transducers 22, wherein the angle between the transducers and their center points is 90°.

[0046] Combination Figure 3 and Figure 5As shown, in one embodiment, the ultrasonic transducer 20' includes an ultrasonic therapeutic transducer assembly 21' and an ultrasonic imaging transducer assembly 22' arranged along the longitudinal direction a. The ultrasonic therapeutic transducer assembly 21' includes two back-to-back ultrasonic therapeutic transducers and an isolation structure 24' disposed between the two ultrasonic therapeutic transducers along the thickness direction b. The ultrasonic imaging transducer assembly 22' includes two back-to-back ultrasonic imaging transducers and an isolation structure 24' disposed between the two ultrasonic imaging transducers along the thickness direction b.

[0047] Specifically, the ultrasound therapy transducer assembly 21' includes a first ultrasound therapy transducer 21a' and a second ultrasound therapy transducer 21b', which are arranged back-to-back along the thickness direction b. A first electrical connection plate 231' is disposed on the outer ring of the isolation structure 24', between the first ultrasound therapy transducer 21a' and the isolation structure 24', and also between the second ultrasound therapy transducer 21b' and the isolation structure 24'.

[0048] The ultrasonic imaging transducer assembly 22' includes a first ultrasonic imaging transducer 22a' and a second ultrasonic imaging transducer 22b', which are arranged back-to-back along the thickness direction b. A second electrical connection plate 232' is disposed on the outer ring of the isolation structure 24', and is positioned between the first ultrasonic imaging transducer 22a' and the isolation structure 24'. Simultaneously, the second electrical connection plate 232' is positioned between the second ultrasonic imaging transducer 22b' and the isolation structure 24'.

[0049] The first ultrasonic therapy transducer 21a' and the second ultrasonic therapy transducer 21b' are arranged back-to-back along the thickness direction. The center-to-center distance between adjacent ultrasonic therapy transducer assemblies 21' and ultrasonic imaging transducer assemblies 22' is 0.7cm-2cm, that is, the center-to-center distance between adjacent first ultrasonic therapy transducers 21a' and first ultrasonic imaging transducers 22a' is 0.7cm-2cm, and the center-to-center distance between adjacent second ultrasonic therapy transducers 21b' and second ultrasonic imaging transducers 22b' is 0.7cm-2cm. Since an excessively large distance between two transducers on the same longitudinal direction a can lead to uneven ultrasonic energy emission, this invention, through multiple experimental analyses, sets the center-to-center distance between adjacent ultrasonic therapy transducer assemblies 21' and ultrasonic imaging transducer assemblies 22' to 0.7cm-2cm, effectively avoiding the aforementioned problems caused by excessively large or small distances between the two transducers.

[0050] Further research revealed that adjacent ultrasonic transducer assemblies (e.g., such as...) Figure 5In this design, the center-to-center distance between adjacent ultrasound therapy transducer assemblies 21' and ultrasound imaging transducer assemblies 22' is set to 1.2 cm. This avoids signal interference between the transducers and helps maintain the rigidity of the distal end 12 of the ultrasound catheter 10. It is worth noting that the distal end 12 of the ultrasound catheter 10 requires appropriate rigidity to facilitate its movement within the body; however, excessive rigidity hinders its passage through internal bends. The inventors discovered that setting the center-to-center distance between adjacent ultrasound transducer assemblies to 1.2 cm maintains optimal ultrasound catheter rigidity. Furthermore, the layered structure 24 effectively addresses electromagnetic signal interference between transducers.

[0051] In this embodiment, the first ultrasound therapy transducer 21a', the second ultrasound therapy transducer 21b', the first ultrasound imaging transducer 22a', and the second ultrasound imaging transducer 22b' can all be rectangular. For example, the first ultrasound therapy transducer 21a' and the second ultrasound therapy transducer 21b' have dimensions of 2mm*0.4mm*0.3mm; the first ultrasound imaging transducer 22a' and the second ultrasound imaging transducer 22b' have dimensions of 1mm*0.2mm*0.1mm. The ultrasound transducer device 20' provided in this embodiment, based on the configuration of the ultrasound therapy transducer assembly 21', adds an ultrasound imaging transducer assembly 22' to achieve real-time monitoring of the treatment process, facilitating guidance for the doctor's next steps. In application, the ultrasound imaging transducer assembly 22' is positioned at a distance in front of the ultrasound therapy transducer assembly 21'. When the guide catheter 11 enters the blood vessel, the ultrasound imaging transducer 22' can first observe the imaging information of the thrombus, and then determine the location and size of the thrombus based on the imaging information. Then, the ultrasound therapy transducer 21' is precisely matched with the thrombus, thereby avoiding the situation where the ultrasound therapy transducer assembly 21' fails to be positioned at the thrombus site, which would reduce the treatment effect.

[0052] The ultrasound imaging transducer assembly 22' and the ultrasound therapy transducer assembly 21' can be spaced at a fixed distance, which makes it easier for doctors to observe and judge the catheter area, for example, the fixed distance is 2cm, 5cm, 8cm, 10cm, etc.

[0053] The ultrasound imaging transducer assembly 22' and the ultrasound therapy transducer assembly 21' can be arranged sequentially and at intervals along the longitudinal direction a, or the number can be set according to the treatment needs. For example, the ultrasound therapy transducer assembly 21' can be set to 1-15 groups, preferably 3-12 groups; the ultrasound imaging transducer assembly 22' can be set to 2-4 groups, preferably 2 groups.

[0054] See Figure 6As shown, in one embodiment, the ultrasonic transducer 20” includes an ultrasonic therapeutic transducer assembly and an ultrasonic imaging transducer assembly arranged along the longitudinal direction a. The ultrasonic therapeutic transducer assembly includes an annular ultrasonic therapeutic transducer 21” and an isolation structure 24 that runs through the ultrasonic therapeutic transducer 21” along the longitudinal direction a. The ultrasonic imaging transducer assembly includes an olive-shaped ultrasonic imaging transducer 22” and an isolation structure 24 that runs through the ultrasonic imaging transducer 22” along the longitudinal direction a.

[0055] The ultrasound imaging transducer 22” and the ultrasound therapy transducer 21” can be spaced at a fixed distance, which makes it easier for doctors to observe and judge the catheter area, for example, the fixed distance is 2cm, 5cm, 8cm, 10cm, etc.

[0056] The ultrasound imaging transducer 22” and the ultrasound therapy transducer 21” can be arranged sequentially and at intervals along the longitudinal direction a, or the number can be set according to the treatment needs. For example, the ultrasound therapy transducer assembly 21” can be set to 1-15 groups, preferably 3-12 groups; the ultrasound imaging transducer assembly 22” can be set to 2-4 groups, preferably 2 groups.

[0057] It should be noted that the shape of the therapeutic ultrasound transducer or the imaging ultrasound transducer provided by this invention can be selected from any one of the following: cuboid, cube, cylinder, frustum, olive, or sphere.

[0058] For the ultrasonic transducers 20, 20', 20" provided by the present invention, the internal partition structures 24, 24', 24" are coated with an insulating coating of 0.1mm-0.5mm, preferably 0.1mm-0.3mm. If the insulating coating thickness is too low, it will not provide insulation; if it is too high, it will increase the volume. Therefore, the thickness of the insulating coating is more preferably 0.2mm. The choice of material for the insulating coating is not limited; any material that can provide insulation is acceptable, such as polyimide, polyurethane, etc. Regarding the performance of the insulating coating, a dielectric strength of 900-7000V / m is preferred.

[0059] Because the entire ultrasonic thrombolysis treatment system operates for a considerable period, at least 2 hours and sometimes up to 6 hours, the ultrasonic transducers are in a continuous working state, generating a significant amount of heat. This heat accumulation can easily affect the performance of the ultrasonic therapy transducer 21 or the ultrasonic imaging transducer 22. Furthermore, excessively high component temperatures can also have a negative impact on human tissue, potentially causing burns.

[0060] In existing technologies, thermally conductive materials are typically used to address the problem of poor heat dissipation. However, in this solution, adding a thermally conductive layer would increase the volume of the ultrasound catheter 10, thereby increasing resistance to entry into the blood vessel, especially to the thrombus site. In the solution of this application, higher thermal conductivity is not necessarily better, as excessively high thermal conductivity can remove too much heat, which is detrimental to promoting thrombolysis.

[0061] The thermal conductivity of air at room temperature and pressure is 0.025 W / (mK). In the scheme of this application, the thermal conductivity of the insulating coating only needs to be greater than that of air to achieve a certain heat dissipation performance. For example, the insulating coating can be made of insulating materials such as nylon, Teflon, or ceramics, all of which have higher thermal conductivity than air. For example, an insulating coating with a thermal conductivity of 1.0-5.0 × 10⁴ Cal / cm·s·℃ can be used. Furthermore, the porosity is set to adjust the heat dissipation performance of the insulating coating. After multiple experiments, the inventors found that controlling the temperature of the ultrasonic transducer 20 at 45℃ is more suitable.

[0062] The solution proposed in this application achieves heat dissipation by creating a porous structure on the insulating coating of the partition structure 24. There are certain requirements and limitations on the porosity of the insulating coating. The technical solution provided by this invention is that the porosity of the insulating coating is configured to be 20%-80%. Preferably, the porosity of the insulating coating is 25%-55%; more preferably, it is 20%-45%, which is beneficial for maintaining the temperature of the ultrasonic transducer assembly at 35-45°C.

[0063] Regarding the specific structure of the ultrasound therapy transducer and the ultrasound imaging transducer, taking the ultrasound transducer device 20 as an example, the structure of the ultrasound therapy transducer can be set to have only a piezoelectric layer, i.e., a piezoelectric ceramic layer, or it can be set as follows: Figure 4 and Figure 7 As shown, the ultrasound imaging transducer 22 and the ultrasound therapy transducer 21 have the same specific structure, both including a backing layer 211, a piezoelectric layer 212 and a matching layer 213 stacked together.

[0064] The piezoelectric layer 212 is made of piezoelectric materials such as barium titanate (BTO), lead zirconate titanate (PZT), potassium sodium niobate (KNN), lead magnesium niobate-lead titanate (PMN-PT), and lead magnesium niobate-lead hafnium oxide-lead titanate (PMN-PH-PT), preferably lead zirconate titanate with a porous structure, and the porosity of the piezoelectric layer 212 is 35%-60%. When the porosity of the piezoelectric layer 212 is 35%-60%, the impedance of the ultrasound imaging transducer can be maintained below 10 MRayls. If the porosity exceeds this range, the impedance will exceed 10 MRayls, while the impedance of normal human tissue is below 10 MRayls. Therefore, controlling the porosity of the piezoelectric layer 212 to 35%-60% can reduce the attenuation of ultrasound energy and improve the resolution of the imaging image. In particular, by controlling the porosity of the piezoelectric layer 212 to 48%, the impedance can be controlled to remain at 8.3 MRayls. Without adding a matching layer 213 to the ultrasound imaging transducer 22, it can be well matched with human tissue, minimizing the attenuation loss of ultrasound energy.

[0065] The thickness of the matching layer 213 is 0.3 nm to 0.6 nm. For example, the thickness of the matching layer 213 is 0.5 nm, or the thickness of the matching layer 213 is between 0.3 nm and 0.49 nm, or the thickness of the matching layer 213 is between 0.51 nm and 0.6 nm. The acoustic impedance of the matching layer 213 is preferably 2 MRayls to 15 MRayls, because when the acoustic impedance of the matching layer 213 exceeds 15 MRayls, the attenuation of ultrasonic energy will increase.

[0066] In one embodiment, the structure of the ultrasound therapy transducer 21 is preferably a piezoelectric layer structure only, and the material of the ultrasound therapy transducer 22 is preferably lead magnesium niobate-lead titanate (PMN-PT), lead magnesium niobate-lead hafnium oxide-lead titanate (PMN-PH-PT), lead zirconate titanate (PZT) (e.g., PZT4, PZT5A, PZT5H, PZT8), etc. When the porosity of the piezoelectric layer is controlled at 40%-70%, its impedance can be controlled below 10 MRayls. In particular, when the porosity is controlled at 55%, the attenuation rate of ultrasound can be reduced to below 10%.

[0067] In this application, both the ultrasound therapy transducer 21 and the ultrasound imaging transducer 22 may be without a backing layer. In the absence of a backing layer, the special partition structure can prevent interference between the ultrasound therapy transducer 21 and the ultrasound imaging transducer 22.

[0068] The ultrasound imaging transducer 22 and the ultrasound therapy transducer 21 achieve different imaging and therapeutic functions by using different materials and frequency settings, and by driving and controlling them with different excitation source electrical signals. Depending on the specific condition, another possible implementation is to control the excitation time interval through electrical control, allowing for intermittent control. For example, the ultrasound imaging transducer 22 can be started first, run for a period of time, and then the ultrasound therapy transducer 21 can be turned on. The ultrasound therapy transducer 21 can be activated by intermittently transmitting excitation signals.

[0069] The center frequency of the ultrasound therapy transducer 21 is between 1MHz and 10MHz, preferably controlled at 2.5MHz; the center frequency of the ultrasound imaging transducer 22 is configured to be between 10MHz and 30MHz, preferably controlled at 18MHz.

[0070] Experiments have shown that when the center frequency of the ultrasound therapy transducer 21 is 2.5MHz, the material is lead zirconate titanate, and the porosity is 35%, the refractive index of the ultrasound can reach about 70%.

[0071] In preparing the ultrasonic transducers 20, 20', and 20" provided by the present invention, potting compound is first injected into a pipe containing heat-shrinkable material, and then the assembled ultrasonic transducers 20, 20', and 20" are placed in the pipe and heat-shrinked to obtain the encapsulated ultrasonic transducer tube 14.

[0072] Combination Figure 1 and Figure 8 As shown, the present invention provides an ultrasonic catheter 10, including an elongated guiding catheter 11 and an ultrasonic transducer body 14 disposed within the guiding catheter 11. See also Figure 8 As shown, the guiding catheter 11 has a multi-cavity configuration, including a central cavity 110 extending along the extension direction (i.e., longitudinal a) of the guiding catheter 11 and at least one sub-cavity disposed on the periphery of the central cavity 110. The ultrasonic transducer body 14 is disposed at the distal end 12 of the guiding catheter 11 through the central cavity 110 of the guiding catheter 11.

[0073] For example, in this embodiment, three sub-cavities are arranged around the periphery of the central cavity 110, including a first sub-cavity 112, a second sub-cavity 113, and a third sub-cavity 114. The first sub-cavity 112, the second sub-cavity 113, and the third sub-cavity 114 all extend in the direction of the guiding catheter 11 (i.e., longitudinal a) and are evenly arranged circumferentially around the central cavity 110. During treatment, the central cavity 110 is used to house the ultrasound transducer 14 and inject saline solution, while the first sub-cavities 112, the second sub-cavities 113, and the third sub-cavities 114 are used to house thermocouples, inject saline solution, and administer medications, etc.

[0074] Combination Figure 2 and Figure 8 As shown, in one embodiment, a sub-cavity disposed around the central cavity 110 of the ultrasonic catheter 10 is connected to the inlet channel to allow the flow of drugs and microbubble fluid. The drugs and microbubble fluid flow out through the drug release port at the distal end 12 of the ultrasonic catheter 10. The drug release port can be precisely targeted at the thrombus site, thereby stimulating thrombus dissolution.

[0075] Furthermore, the present invention provides an ultrasound therapy system that, in addition to the ultrasound catheter 10, the fluid inlet device 15, and the control system 16, also includes a rotating device 17. The rotating device 17 is connected to the proximal end 13 of the ultrasound catheter 10 and drives the ultrasound transducer 20 to rotate inside the guide catheter 11. This rotation drives the ultrasound imaging transducer 22 to rotate, enabling the ultrasound imaging transducer 22 to capture 360° imaging information of the surrounding environment, thus making the obtained imaging information more accurate. Simultaneously, the inventors discovered that by introducing the rotating device 17, the drug release rate at the drug release port at the distal end 12 can be increased due to centrifugal force.

[0076] The present invention provides an ultrasonic transducer that, in addition to an ultrasonic therapeutic transducer, adds an ultrasonic imaging transducer to enable real-time monitoring of the treatment process. Furthermore, a partition structure is provided between the ultrasonic therapeutic transducer and the ultrasonic imaging transducer to isolate the two sets of ultrasonic waves, thereby avoiding mutual interference between the ultrasonic waves emitted by the two transducers. As a result, the treatment system made from this ultrasonic transducer has high anti-interference capability and high treatment accuracy.

[0077] The detailed descriptions listed above are merely specific descriptions of feasible embodiments of the present invention, and are not intended to limit the scope of protection of the present invention. All equivalent embodiments or modifications made without departing from the spirit of the present invention should be included within the scope of protection of the present invention.

[0078] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. An ultrasonic transducer, comprising a first transducer and a second transducer, characterized in that, The ultrasonic transducer includes: A longitudinally extending partition structure and a transducer assembly connected in series in the longitudinal direction, the transducer assembly including a first transducer and / or a second transducer arranged back-to-back along the thickness direction, the first transducer and / or the second transducer in each transducer assembly being arranged circumferentially with the partition structure as the center, the first transducer and the second transducer being configured with a piezoelectric layer, the porosity of the piezoelectric layer being 35%-60%, the partition structure being a solid plate structure or a plate structure with an internal cavity, the cavity being filled with gas or tungsten-containing epoxy resin, or the cavity being configured as a vacuum cavity structure.

2. The ultrasonic transducer according to claim 1, characterized in that, The transducer assembly includes a first electrical connection plate disposed between the first transducer and the partition structure.

3. The ultrasonic transducer according to claim 1, characterized in that, The transducer assembly includes a second electrical connection plate disposed between the second transducer and the partition structure.

4. The ultrasonic transducer according to claim 1, characterized in that, The transducer assembly includes a first electrical connection plate disposed between the first transducer and the partition structure, and a second electrical connection plate disposed between the second transducer and the partition structure.

5. The ultrasonic transducer according to claim 1, characterized in that, The center-to-center distance between longitudinally adjacent first and / or second transducers is 0.7cm-2cm.

6. The ultrasonic transducer according to claim 1, characterized in that, The partition structure is coated with an insulating coating of 0.1mm-0.5mm, and the insulating coating has a porous structure with a porosity of 20%-80%.

7. The ultrasonic transducer according to claim 1, characterized in that, The piezoelectric layer is made of one or more piezoelectric materials selected from barium titanate, lead zirconate titanate, potassium sodium niobate, lead magnesium niobate-lead titanate, and lead magnesium niobate-lead hafnium oxide-lead titanate.

8. The ultrasonic transducer according to claim 1, characterized in that, The center frequency of the first transducer is configured to be 1MHz-10MHz, and the center frequency of the second transducer is configured to be 10MHz-30MHz.

9. An ultrasound therapy system, characterized in that, The ultrasonic catheter is configured with an ultrasonic inlet device communicating with the ultrasonic catheter and a control system for controlling the ultrasonic catheter, the ultrasonic catheter including an elongated guide tube and an ultrasonic transducer according to any one of claims 1-8 disposed within the guide tube.

10. The ultrasound therapy system according to claim 9, characterized in that, The ultrasound therapy system also includes a rotating device connected to the ultrasound catheter, which drives the ultrasound transducer to rotate inside the guide catheter.

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