CN114939984B

CN114939984B - Manufacturing process of ultrasonic transduction device

Info

Publication number: CN114939984B
Application number: CN202210485133.7A
Authority: CN
Inventors: 请求不公布姓名
Original assignee: Suzhou Puluo Medical Technology Co ltd
Current assignee: Suzhou Puluo Medical Technology Co ltd
Priority date: 2022-05-06
Filing date: 2022-05-06
Publication date: 2024-07-26
Anticipated expiration: 2042-05-06
Also published as: CN114939984A

Abstract

The invention provides a manufacturing process of an ultrasonic transduction device, which comprises the following steps: dividing the substrate into a first area and a second area surrounding the first area, and coating an insulating coating on the second area to prepare a interlayer structure; the first areas on two sides of the interlayer structure are respectively provided with a first transducer and/or a second transducer, and an ultrasonic transduction component is formed; and (3) loading the assembled ultrasonic transduction assembly into a heat shrinkage tube containing pouring sealant, and performing heat shrinkage curing to obtain the ultrasonic transduction device. The ultrasonic transduction device is prepared by the manufacturing process, and in the thermal shrinkage process, bubbles in the first area can be extruded in the second area, so that the performance of the ultrasonic transduction device is improved; the ultrasonic catheter is provided with two transducers with different functions, the isolation of ultrasonic waves of the two transducers is realized through the interlayer structure, and the mutual interference between the ultrasonic waves emitted by the two transducers is avoided, so that the ultrasonic catheter manufactured by the ultrasonic transducer has higher anti-interference capability and higher treatment precision.

Description

Manufacturing process of ultrasonic transduction device

Technical Field

The invention relates to the technical field of ultrasound, in particular to a manufacturing process of an ultrasonic transduction device.

Background

In several medical applications, there are situations where ultrasound energy is used to enhance the effect on various therapeutic compounds, for example, ultrasound catheters are used to deliver ultrasound energy and therapeutic compounds to a treatment site within a patient. Such ultrasound catheters typically include an ultrasound transducer assembly configured to generate ultrasound energy and a fluid delivery lumen for delivering a therapeutic compound to a treatment site.

In particular, ultrasound catheters may be used to treat human blood vessels that have been partially or completely occluded by plaque, thrombus, emboli, or other substances that reduce the blood carrying capacity of the vessel. To remove or reduce the occlusion, an ultrasound catheter is used to deliver a solution containing the therapeutic compound directly to the occlusion site. The ultrasonic energy generated by the ultrasonic transducer assembly enhances the effect of the therapeutic compound. Such devices may be used to treat diseases such as peripheral arterial occlusion, deep vein thrombosis, or acute ischemic stroke. In such applications, ultrasound energy enhances the treatment of the obstruction by therapeutic compounds (such as urokinase, tissue plasminogen activator, recombinant tissue plasminogen activator, etc.).

Existing ultrasound transducer assemblies are configured with therapeutic ultrasound transducers for converting electrical energy into ultrasound energy. For example, the therapeutic ultrasound transducer may be a lead zirconate titanate (PZT) ultrasound transducer, or other materials capable of producing the same piezoelectric effect. However, the existing ultrasonic transduction component is only provided with an ultrasonic therapeutic transducer, but not provided with an ultrasonic imaging transducer, and cannot monitor the therapeutic process in real time. The reason is that the ultrasonic therapy transducer is configured to cause signal interference to the ultrasonic imaging transducer, so that the imaging quality is poor, and meanwhile, the ultrasonic imaging transducer also causes signal interference to the ultrasonic therapy transducer, so that no method for effectively solving the signal interference problem exists in the prior art.

In addition, for the preparation of ultrasonic transduction components, pouring sealant is generally injected into a heat shrinkage tube, then the ultrasonic transduction components are fixed in the heat shrinkage tube, and then the packaging is formed after the ultrasonic transduction components are heated, heat-shrunk and solidified. Air bubbles may be introduced during the process of packaging and preparing the ultrasonic transduction assembly, and if the air bubbles appear at the emitting surface position corresponding to the ultrasonic therapeutic transducer, the emitting energy of the ultrasonic therapeutic transducer may be affected.

In view of this, there is a need for improvements in the manufacturing process of ultrasonic assemblies in the prior art to solve the above-described problems.

Disclosure of Invention

The invention provides a manufacturing process of an ultrasonic transduction device, which not only avoids the generation of bubbles on the emitting surface of an ultrasonic transduction component in the packaging process, but also solves the problem of signal interference between two ultrasonic transducers.

The invention provides a manufacturing process of an ultrasonic transduction device, which comprises the following steps:

dividing the substrate into a first area and a second area surrounding the first area, and coating an insulating coating on the second area to prepare a interlayer structure;

The first areas on two sides of the interlayer structure are respectively provided with a first transducer and/or a second transducer, and an ultrasonic transduction component is formed;

And (3) loading the assembled ultrasonic transduction assembly into a heat shrinkage tube containing pouring sealant, and performing heat shrinkage curing to obtain the ultrasonic transduction device.

As a further development of the invention, the second region is coated with an insulating coating having a thickness of 0.1-0.5 mm.

As a further improvement of the present invention, the insulating coating is provided as a porous structure, and the porosity is configured to be 30% -80%.

As a further development of the invention, the sandwich structure is a solid plate-like structure or a plate-like structure with a cavity arranged in the middle, which cavity is filled with gas or with tungsten-containing epoxy resin or is arranged in vacuum.

As a further improvement of the 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.

As a further development of the invention, a first transducer and a second transducer are respectively arranged in a first region on both sides of the sandwich structure, a first electrical connection plate being arranged between the first transducer and the sandwich structure, and a second electrical connection plate being arranged between the second transducer and the sandwich structure.

As a further development of the invention, first transducers are respectively arranged in first regions on both sides of the sandwich structure, a first electrical connection plate being arranged between the first transducers and the sandwich structure; or respectively assembling second energy transducers in the first areas on two sides of the interlayer structure, and arranging a second electric connection plate between the second energy transducers and the interlayer structure.

As a further improvement of the present invention, a plurality of ultrasonic transduction assemblies are connected in series in the longitudinal direction, and the center distance between adjacent ultrasonic transduction assemblies is configured to be 0.7cm to 2cm.

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

As a further improvement of the invention, the first transducer and the second transducer are each provided with a matching layer, the thickness of the matching layer is 0.3nm-0.6nm, and the acoustic impedance of the matching layer is 2MRayls-10MRayls.

Compared with the prior art, the invention has the beneficial effects that:

According to the manufacturing process of the ultrasonic transduction device, the substrate is divided into the first area for configuring the ultrasonic transducer and the second area surrounding the periphery of the first area, and in the thermal shrinkage process, bubbles at the first area are extruded in the second area, so that the performance of the ultrasonic transduction device is improved; and the first areas on two sides of the interlayer structure are respectively provided with two transducers with different functions, the isolation of the ultrasonic waves of the two transducers is realized through the interlayer structure, and the mutual interference between the ultrasonic waves emitted by the two transducers is avoided, so that the ultrasonic catheter manufactured by the ultrasonic transduction device has higher anti-interference capability and higher treatment precision.

Drawings

FIG. 1 is a schematic illustration of the components of a tubular body portion of an ultrasound catheter provided by the present invention;

FIG. 2 is a schematic illustration of the components of the proximal end of an ultrasound catheter provided by the present invention;

FIG. 3 is a process flow diagram of an ultrasonic transducer provided by the present invention;

FIG. 4 is a schematic plan view of a spacer structure according to the present invention;

FIG. 5 is a schematic perspective view of an embodiment of an ultrasonic transducer according to the present invention;

FIG. 6 is a schematic cross-sectional view of one embodiment of an ultrasonic transducer apparatus according to the present invention;

FIG. 7 is a schematic cross-sectional view of another embodiment of an ultrasonic transducer apparatus according to the present invention;

fig. 8 is a schematic cross-sectional view of an ultrasonic transducer according to the present invention.

Detailed Description

The present invention will be described in detail below with reference to the embodiments shown in the drawings, but it should be understood that the embodiments are not limited to the present invention, and functional, method, or structural equivalents and alternatives according to the embodiments are within the scope of protection of the present invention by those skilled in the art.

It should be understood that the terms "center," "vertical," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," "positive," "negative," etc. indicate orientations or positional relationships based on the orientations or positional relationships illustrated in the drawings, are merely for convenience in describing the present technology and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be configured and operated in a particular orientation, and therefore should not be construed as limiting the technology. If, throughout, reference is made to "first," "second," etc., the description of "first," "second," etc., is used merely for distinguishing between similar objects and not for understanding as indicating or implying a relative importance, order, or implicitly indicating the number of technical features indicated, it being understood that the number of "first," "second," etc., descriptions may be interchanged where appropriate.

The present invention seeks to provide for an ultrasound catheter having various features and advantages, examples of such 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 a treatment site. Embodiments of ultrasound catheters having certain of these features and advantages are described herein. Methods of using such ultrasound catheters are also described herein.

Ultrasound catheters described herein may be used to enhance the therapeutic effect of therapeutic compounds at a treatment site within a patient. As used herein, the term "therapeutic compound" is broadly, but not limited to, a drug, a medicament, a lytic compound, genetic material, an anticancer drug, or any other substance capable of affecting physiological function. For use in treating partially or completely occluded human blood vessels that have been occluded by plaque, thrombus, emboli, or other substances that reduce the blood carrying capacity of the vessel, suitable therapeutic compounds include, but are not limited to, aqueous solutions containing heparin, urinary hormones, streptokinase.

Certain features and aspects of the ultrasound catheters disclosed herein may also be used in applications in which the ultrasound energy itself provides the therapeutic effect. Examples of such therapeutic effects include preventing or reducing stenosis and/or restenosis; tissue ablation, abrasion or disruption; promoting a temporary or permanent physiological change in an intracellular or intercellular structure; and cleaving the microspheres or microbubbles for therapeutic compound delivery.

The ultrasound catheters described herein may be configured for applying ultrasound energy over a substantial length of a body lumen, such as, for example, in a lower extremity artery. In other embodiments, the catheter may be configured for treating pulmonary embolism ("PE") that may occur when a large blood clot blocks a large blood vessel leading from the heart to the lung. However, it should be appreciated that certain features and aspects of the present disclosure may be applied to catheters configured for insertion in other vessels or lumens, such as small brain vessels, solid tissues, ductwork, and body cavities.

Fig. 1 schematically illustrates an ultrasound catheter 10 configured for use in a large vessel of a patient's body structure. For example, the ultrasound catheter 10 shown in fig. 1 may be used to treat long segment peripheral arterial obstructions, such as those in the vasculature of lower extremity arteries. Or in other examples, the ultrasound catheter 10 shown in fig. 1 may be used to treat pulmonary embolism, the ultrasound catheter 10 being configured to be introduced into a large blood vessel (e.g., a pulmonary artery) of a patient leading from the heart to the lung. In one embodiment of use, femoral vein access may be used to place the ultrasound catheter 10 into such vessels. In such embodiments, the ultrasound catheter 10 may 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 particular application for which the ultrasound catheter 10 will be used.

As shown in fig. 1, the ultrasound catheter 10 may include a multi-component, elongated, flexible guide catheter 11, the guide catheter 11 having a distal end 12 and a proximal end 13. The guide catheter 11 may include an ultrasound transducer tube 14 located in the distal end 12 of the ultrasound catheter 10, with the distal end 12 of the guide catheter 11 extending out of the ultrasound transducer tube 14 as illustrated in fig. 1 for purposes of more clearly illustrating the structure of the ultrasound transducer tube 14. The guide catheter 11 and other components of the ultrasound catheter 10 may be manufactured according to any of a variety of techniques well known in the catheter manufacturing arts. Suitable materials and dimensions can be readily selected based on the natural and anatomical dimensions of the treatment site and based on the desired percutaneous access site.

For example, in some embodiments, the distal end 12 of the guide catheter 11 may comprise a material having flexibility, kink resistance, rigidity, and structural support sufficient to push the ultrasound transduction tube 14 through the vasculature of a patient to reach a treatment site. Examples of such materials include, but are not limited to, extruded polytetrafluoroethylene, polyethylene, polyamide, and other similar materials. In certain example aspects, the proximal end 13 of the guide catheter 11 is reinforced by braiding, mesh, or other construction to provide increased kink resistance and pushability. For example, nickel titanium wire or stainless steel wire may be placed along the guide catheter 11 or incorporated into the guide catheter 11 to reduce kinking.

The cross-sectional shape of the guide catheter 11 may be circular, square or other irregular shape. In some embodiments configured for treating thrombus in a lower extremity artery, the guide catheter 11 has an outer diameter of between about 0.15cm and about 0.19 cm. In another embodiment, the guide catheter 11 has an outer diameter of about 0.18 cm. In certain embodiments, the guide catheter 11 has a length of 10cm-200cm, for example, an axial length of preferably 106cm to 135cm, with the particular length being determined according to the length required for treatment.

The ultrasound transducer tube 14 may comprise a thinner material or a material with greater acoustic transmissivity than the material of the proximal end 13 of the guide catheter 11. Thinner materials generally have greater acoustic transmissivity than thicker materials. Suitable materials for the ultrasound transducer tube 14 may include, but are not limited to, high or low density polyethylene, urethane, nylon, and the like. In certain modified embodiments, the ultrasound transducer tube 14 may be formed of the same material or the same thickness of material as the proximal end 13.

As shown in connection with fig. 1 and 2, to provide access to the interior of the guide catheter 11, fluid may be injected into the proximal end 13 of the ultrasound catheter 10 through a plurality of injection ports 15. In some embodiments, the proximal end 13 of the ultrasound catheter 10 is configured with a plurality of fill ports 15, and the fill ports 15 may include a drug inlet, a saline inlet, and the like. In some embodiments, to provide electrical connection to the ultrasound transducer tube 14, the ultrasound catheter 10 may further include a cable (not shown), which may include a connector (not shown) to a control system (not shown). In some embodiments, the cable may be connected to the ultrasound catheter 10 at the proximal end 13 through a proximal access port (not labeled).

As shown in fig. 1, 2 to 5, an ultrasonic transducer 200 is disposed in the ultrasonic transducer tube 14. The ultrasound transducer device 200 comprises a sandwich structure 24 extending in a longitudinal direction a, and ultrasound transducer assemblies 20, 20' connected in series to the sandwich structure 24 in the longitudinal direction a, the ultrasound transducer assemblies 20, 20' comprising a therapeutic ultrasound transducer 21 and/or an imaging ultrasound transducer 22, the therapeutic ultrasound transducer 21 and/or the imaging ultrasound transducer 22 within each set of ultrasound transducer assemblies 20, 20' being arranged circumferentially about the sandwich structure 24. The transducer assemblies may be 1, 2 or more, preferably more than 3 groups, depending on the size of the lesion to be actually treated.

Referring to fig. 3, the invention provides a manufacturing process of an ultrasonic transducer, which comprises the following steps:

S01, preparing interlayer structure

Referring to fig. 4, the substrate is divided into a first region 241 and a second region 242 surrounding the first region 241, and an insulating coating is applied to the second region 242 to prepare the interlayer structure 24.

The first region 241 is used for assembling an ultrasonic transducer, and when a rectangular ultrasonic transducer is applied, the first region 241 is configured as a rectangle. The second region 242 encloses the first region 241, and the second region 242 extends toward both ends of the longitudinal direction a to serially connect a plurality of ultrasonic transducers along the longitudinal direction a.

In one embodiment, referring to fig. 6, the interlayer structure 24 is a plate-like structure with a cavity 240 disposed in the middle, and the cavity 240 is filled with gas or the cavity 240 is filled with tungsten-containing epoxy resin or the cavity 240 is disposed in a vacuum. In another embodiment, the interlayer structure 24 is a solid plate structure, and the material of the interlayer structure 24 may be a metal such as copper, silver, or the like.

In one embodiment, the second region 242 is coated with an insulating coating having a thickness of 0.1-0.5mm, preferably 0.1-0.3 mm. An excessively low thickness of the insulating coating layer does not function as insulation, and an excessively large thickness increases the volume, so that the thickness of the insulating coating layer is more preferably 0.2mm. The material of the insulating coating is not limited, and any insulating material may be used, such as polyimide, polyurethane, etc. For the choice of properties of the insulating coating, a dielectric strength of 900-7000V/m is preferred.

Because the working time of the whole ultrasonic thrombolytic therapy system machine is longer and is at least 2 hours, the working time is 6 hours. The ultrasonic transducer is in a continuous working state, more heat can be generated, the performance of the ultrasonic transducer is easily affected by the accumulation of more heat, meanwhile, the temperature of the assembly is too high, certain influence is also generated on human tissues, for example, human tissues can be scalded, in the scheme of the application, the higher the heat conductivity is not required, the better the heat conductivity is, because the too high heat conduction capability can take away excessive heat, and the promotion of thrombolysis is not facilitated. Through multiple experimental verification, the inventor finds that the temperature of the ultrasonic transducer is controlled to be 45 ℃ more appropriately.

According to the scheme, the heat dissipation effect of the interlayer structure 24 is achieved through the technical scheme that the porous structure is arranged on the insulating coating. Due to the arrangement of the porous structure, the porous structure can support the electrode wires on the one hand, isolate the electrode wires from the electric connection plate assembled on the backing layer of the ultrasonic transducer, and on the other hand, facilitate heat dissipation of the interlayer structure 24.

Further preferably, for example, insulating materials such as rayleigh, nylon, teflon, ceramic, etc. are used for the insulating coating, and the thermal conductivity is higher than that of air, for example, insulating coating having a thermal conductivity of 1.0 to 5.0x104 Cal/cm.s. The heat dissipation performance of the insulating coating is adjusted by setting the porosity. The porosity of the insulating coating is limited by certain requirements, and the technical scheme provided by the invention is as follows: the porosity of the insulating coating is configured to be 20% -80%. Preferably, the insulating coating has a porosity of 25% to 55%; further preferably 20% -45%, which is advantageous for maintaining the temperature of the ultrasonic transducer assembly at 35-45 ℃.

S02, assembling an ultrasonic transduction assembly

As shown in connection with fig. 4 to 7, the first and/or second transducers are assembled in the first region 241 on both sides of the sandwich structure 24, respectively, to form the ultrasound transducer assembly 20, 20'.

In an embodiment, the first transducer is configured as an ultrasound therapy transducer 21 and the second transducer is configured as an ultrasound imaging transducer 22. In a specific assembly mode, as shown in fig. 4 to 6, first, the first electric connection plate 231 is welded to the first region 241 on one side of the interlayer structure 24, and then the therapeutic ultrasound transducer 21 is welded to the first electric connection plate 231; then, welding a second electric connection plate 232 to the first region 241 on the other side of the interlayer structure 24, and welding the ultrasonic imaging transducer 22 to the second electric connection plate 232; finally, the piezoelectric layer (not shown) of the therapeutic ultrasound transducer 21 and the piezoelectric layer (not shown) of the imaging ultrasound transducer 22 are connected to the respective corresponding positive electrode lines, and the first electrical connection plate 231 and the second electrical connection plate 232 are connected to the respective corresponding negative electrode lines (not shown).

In one embodiment, the center frequency of the therapeutic ultrasound transducer 21 is configured to be 1MHz to 10MHz, preferably, the center frequency of the therapeutic ultrasound transducer 21 is controlled to be 2.5MHz; the center frequency of the ultrasonic imaging transducer 22 is configured to be 10MHz to 30MHz, and preferably, the center frequency of the ultrasonic imaging transducer 22 is controlled to be 18MHz.

The first positive lines led out from the adjacent ultrasonic therapy transducers 21 along the longitudinal direction a are sequentially electrically connected, extend to the proximal end 13, and are connected to a control system; the first negative wires led out from the first electric connection plates 231 adjacent to each other in the longitudinal direction a are electrically connected in sequence, extend to the proximal end 13, and are connected to the control system; the second positive electrode wires led out from the adjacent ultrasonic imaging transducers 22 are electrically connected in sequence, extend to the proximal end 13 and are connected to a control system; the second negative wires from adjacent second electrical connection plates 232 are in turn electrically connected, extend to the proximal end 13, and are connected to the control system.

The assembled ultrasound transducer assembly 20, with the therapeutic ultrasound transducer 21 and the imaging ultrasound transducer 22 therein, is disposed back-to-back in the thickness direction b. In other alternative embodiments, the therapeutic ultrasound transducer 21 and the imaging ultrasound transducer 22 may be rectangular, the 1-set ultrasound transducer assembly may include 3 rectangular therapeutic ultrasound transducers 21 and/or imaging ultrasound transducers 22, the 3 rectangular transducers may be 120 ° included between the transducers and the center point of the transducers; the 1-set transducer assembly may also include 4 rectangular therapeutic ultrasound transducers 21 and/or ultrasound imaging transducers 22, and the 4 rectangular transducers may be 90 ° from the center point of the transducers.

Referring to fig. 7, in one embodiment, the first and second ultrasonic transducer assemblies are spaced apart along the longitudinal direction a, assembled into an ultrasonic transducer assembly 20'. Wherein the first transducer assembly is configured as an ultrasound therapy transducer assembly 21 'and the second transducer assembly is configured as an ultrasound imaging transducer assembly 22'.

The therapeutic ultrasound transducer assembly 21' includes a first therapeutic ultrasound transducer 21a ' and a second therapeutic ultrasound transducer 21b ', the first therapeutic ultrasound transducer 21a ' and the second therapeutic ultrasound transducer 21b ' being configured back-to-back along the thickness direction b. The first electrical connection plate 231 'is arranged between the first therapeutic ultrasound transducer 21a' and the spacer structure 24', while the first electrical connection plate 231' is arranged between the second therapeutic ultrasound transducer 21b 'and the spacer structure 24'.

The ultrasonic imaging transducer assembly 22' includes a first ultrasonic imaging transducer 22a ' and a second ultrasonic imaging transducer 22b ', the first ultrasonic imaging transducer 22a ' and the second ultrasonic imaging transducer 22b ' being configured back-to-back along the thickness direction b. The second electrical connection plate 232 'is arranged between the first ultrasound imaging transducer 22a' and the spacer structure 24', while the second electrical connection plate 232' is arranged between the second ultrasound imaging transducer 22b 'and the spacer structure 24'.

The first therapeutic ultrasound transducer 21a 'and the second therapeutic ultrasound transducer 21b' are arranged back to back in the thickness direction, and the center-to-center distances of the adjacent therapeutic ultrasound transducer assembly 21 'and the ultrasonic imaging transducer assembly 22' are arranged to be 0.7cm to 2cm, i.e., the center-to-center distances of the adjacent first therapeutic ultrasound transducer 21a 'and the first ultrasonic imaging transducer 22a' are arranged to be 0.7cm to 2cm, and the center-to-center distances of the adjacent second therapeutic ultrasound transducer 21b 'and the second ultrasonic imaging transducer 22b' are arranged to be 0.7cm to 2cm. As the distance between two transducers in the same longitudinal direction a is too large, the energy of ultrasonic emission is not uniform; therefore, through multiple experimental analysis, the center-to-center spacing of the adjacent ultrasonic therapy transducer assemblies 21 'and the ultrasonic imaging transducer assemblies 22' is configured to be 0.7cm-2cm, so that the problems caused by overlarge or overlarge spacing of the two transducers can be effectively avoided.

Further investigation, configuring the center-to-center spacing of adjacent ultrasound transducer assemblies (e.g., adjacent ultrasound therapy transducer assembly 21 'and ultrasound imaging transducer assembly 22' as in fig. 7) to be 1.2cm may avoid signal interference between the individual transducers while advantageously maintaining the stiffness of distal end 12 of ultrasound catheter 10. It should be noted that the distal end 12 of the ultrasound catheter 10 requires a suitable stiffness to facilitate advancement of the ultrasound catheter 10 within the body, but is too stiff to facilitate passage of the ultrasound catheter 10 through the bend region within the body. The inventors have found that when the center-to-center spacing of adjacent ultrasound transducer assemblies is set to 1.2cm, the stiffness of the optimal ultrasound catheter can be maintained while the co-operating spacer structure 24 can address electromagnetic signal interference between transducers.

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' may all be rectangular, for example, the first ultrasound therapy transducer 21a ', and the second ultrasound therapy transducer 21b' are configured to be 2mm by 0.4mm by 0.3mm in size; the first ultrasound imaging transducer 22a ', the second ultrasound imaging transducer 22b' are configured to be 1mm by 0.2mm by 0.1mm in size. The ultrasonic transducer assembly 20' provided in this embodiment is added with the ultrasonic imaging transducer assembly 22' on the basis of configuring the ultrasonic therapeutic transducer assembly 21', so as to realize real-time monitoring of the therapeutic process, and facilitate guiding the next action of the doctor. When the ultrasonic imaging transducer assembly 22 'is applied, the ultrasonic imaging transducer assembly 22' is arranged at a distance in front of the ultrasonic therapy transducer assembly 21', when the guide catheter 11 enters a blood vessel, imaging information of thrombus can be firstly observed by the ultrasonic imaging transducer assembly 22', then the position and the size of the thrombus are judged according to the imaging information, and then the ultrasonic therapy transducer assembly 21 'and the thrombus are precisely coordinated, so that the situation that the ultrasonic therapy transducer assembly 21' cannot be arranged at a thrombus position is avoided, and the treatment effect is reduced.

For the specific structure of the therapeutic ultrasound transducer and the imaging ultrasound transducer, taking the ultrasonic transducer device 20 as an example, the therapeutic ultrasound transducer may be configured with only a piezoelectric layer, i.e., a piezoelectric ceramic layer, or as shown in fig. 6 and 8, the imaging ultrasound transducer 22 may include a backing layer 211, a piezoelectric layer 212, and a matching layer 213 that are stacked.

Among them, the piezoelectric layer 212 is made of a piezoelectric material such as Barium Titanate (BTO), lead zirconate titanate (PZT), potassium sodium niobate (KNN), lead magnesium niobate-lead titanate (PMN-PT), lead magnesium niobate-lead hafnium titanate (PMN-PH-PT), preferably lead zirconate titanate having a porous structure, and the porosity of the piezoelectric layer 212 is configured to be 35% -60%. When the porosity of the piezoelectric layer 212 is 35% -60%, the impedance of the ultrasonic imaging transducer can be kept below 10 MRaays, if the range of the porosity is exceeded, the impedance is beyond 10 MRaays, and the impedance of normal tissues of a human body is below 10 MRaays, so that the porosity of the piezoelectric layer 212 is controlled to be 35% -60%, attenuation of ultrasonic energy can be reduced, and resolution of an imaging image can be improved. In particular, the porosity of the piezoelectric layer 212 is controlled to be 48%, the impedance can be controlled to be maintained at 8.3MRayls, and the piezoelectric layer can be well matched with human tissues under the condition that the ultrasonic imaging transducer 22 and the ultrasonic therapy transducer 21 are not added with the matching layer 213, so that the energy attenuation loss is reduced to the maximum extent.

The thickness of the matching layer 213 is configured to be 0.3nm to 0.6nm, for example, the thickness of the matching layer 213 is 0.5nm, or the thickness of the matching layer 213 is between 0.3nm to 0.49nm, or the thickness of the matching layer 213 is between 0.51nm to 0.6 nm. The acoustic impedance of the matching layer 213 is preferably 2MRayls-10MRayls because attenuation of ultrasonic energy is increased when the acoustic impedance of the matching layer 213 exceeds 10 MRayls.

S03, glue filling and thermal shrinkage fixing

Referring to fig. 1 and 5, the assembled ultrasonic transducer assembly is put into a heat shrink tube containing pouring sealant, and after heat shrink curing, an ultrasonic transducer 200 is obtained.

Taking the case of packaging the ultrasound transducer assembly 20, during the heat shrinkage of the ultrasound transducer assembly 20, air bubbles may occur at the opposite portions of the emitting surfaces of the ultrasound therapy transducer 21 and the ultrasound imaging transducer 22 (i.e., at the matching layer 213), and since the width of the first region 241 in the thickness direction b is greater than the width of the second region 242 in the thickness direction b, the air bubbles at the first region 241 may be compressed at the second region 242. With further thermal compression, the bubbles will enter the porous structure of the insulating coating, avoiding the influence of the bubbles on the ultrasonic energy of the therapeutic ultrasound transducer 21 and the imaging ultrasound transducer 22, and further improving the performance of the ultrasound transducer device 200, i.e. the performance of the ultrasound catheter 10.

Meanwhile, in the ultrasonic transduction device 200 manufactured by the manufacturing process provided by the invention, two transducers with different functions are respectively configured in the first areas 241 on the two sides of the interlayer structure 24, specifically, the ultrasonic imaging transducer 22 is added on the basis of configuring the ultrasonic therapeutic transducer 21, so that the real-time monitoring of the therapeutic process is realized. Meanwhile, a interlayer structure 24 is arranged between the ultrasonic therapeutic transducer 21 and the ultrasonic imaging transducer 22, isolation of two groups of ultrasonic waves is realized through the interlayer structure 24, and mutual interference between ultrasonic waves emitted by the two ultrasonic transducers is avoided, so that the ultrasonic catheter 10 manufactured by the ultrasonic transducer device 200 has higher anti-interference capability and higher therapeutic precision.

The above list of detailed descriptions is only specific to practical embodiments of the present invention, and they are not intended to limit the scope of the present invention, and all equivalent embodiments or modifications that do not depart from the spirit of the present invention should be included in the scope of the present invention.

Furthermore, it should be understood that although the present disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is provided for clarity only, and that the disclosure is not limited to the embodiments described in detail below, and that the embodiments described in the examples may be combined as appropriate to form other embodiments that will be apparent to those skilled in the art.

Claims

1. A process for manufacturing an ultrasonic transducer, comprising:

the first energy converter and/or the second energy converter are/is assembled in the first area on two sides of the interlayer structure respectively to form an ultrasonic energy conversion assembly, wherein the width of the first area in the thickness direction is larger than that of the second area in the thickness direction;

2. The process for manufacturing an ultrasonic transducer of claim 1, wherein the second region is coated with an insulating coating having a thickness of 0.1-0.5 mm.

3. The process of manufacturing an ultrasonic transducer according to claim 1 or 2, wherein the insulating coating is provided in a porous structure with a porosity of 30% -80%.

4. The process of claim 1, wherein the interlayer structure is a solid plate structure or a plate structure with a cavity in the middle, and the cavity is filled with gas or filled with tungsten-containing epoxy resin or vacuum.

5. The process of claim 1, wherein the first transducer has a center frequency of 1MHz to 10MHz and the second transducer has a center frequency of 10MHz to 30MHz.

6. The process for manufacturing an ultrasonic transducer according to claim 1, wherein a first transducer and a second transducer are respectively mounted in a first area on both sides of the sandwich structure, a first electrical connection plate is arranged between the first transducer and the sandwich structure, and a second electrical connection plate is arranged between the second transducer and the sandwich structure.

7. The process for manufacturing an ultrasonic transducer according to claim 1, wherein first transducers are respectively mounted in first areas on both sides of a sandwich structure, and a first electrical connection plate is arranged between the first transducers and the sandwich structure; or respectively assembling second energy transducers in the first areas on two sides of the interlayer structure, and arranging a second electric connection plate between the second energy transducers and the interlayer structure.

8. The process of manufacturing an ultrasonic transducer of claim 1, wherein a plurality of ultrasonic transducer assemblies are connected in series in the longitudinal direction, and the center distance between adjacent ultrasonic transducer assemblies is set to 0.7cm to 2cm.

9. The process of claim 1, wherein the first transducer and the second transducer are each provided with a piezoelectric layer made of one or more piezoelectric materials selected from barium titanate, lead zirconate titanate, potassium sodium niobate, lead magnesium niobate-lead titanate, lead magnesium niobate-lead hafnium titanate, and the piezoelectric layer has a porosity of 35% to 60%.

10. The process of claim 1, wherein the first transducer and the second transducer are each provided with a matching layer having a thickness of 0.3nm to 0.6nm, and the matching layer has an acoustic impedance of 2MRayls to 10MRayls.