Ultrasonic catheter device capable of imaging
By using a dual-frequency ultrasonic transducer and filter layer design in the intravascular ultrasonic catheter device, the synchronous progress of ultrasonic imaging and treatment is achieved, solving the complex problems of equipment separation and operation in the prior art, and improving medical efficiency and safety.
Patent Information
- Application Number
- CN202421818083.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-07-30
- Publication Date
- 2025-06-27
- Estimated Expiration
- 2034-07-30
AI Technical Summary
Existing intravascular ultrasound imaging cannot achieve ultrasound imaging and ultrasound treatment at the same time, resulting in different operating frequencies and separation of equipment, increasing patient risks and medical costs.
An imageable ultrasonic catheter device is designed, using a dual-frequency ultrasonic transducer. By providing the first and second piezoelectric layers in the catheter, it is used for high-frequency ultrasonic imaging and low-frequency ultrasonic therapy, and the filter layer is used to isolate the two ultrasonic waves to achieve synchronous imaging and treatment.
The synchronous progress of ultrasound imaging and ultrasound treatment is achieved, reducing multiple insertions and withdrawals of the device, reducing patient risks and medical costs, and improving the safety and accuracy of the surgery.
Smart Images
Figure CN223026080U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical devices, and particularly relates to an imaging ultrasonic catheter device. Background Art
[0002] Vascular calcification is a vascular stenosis and sclerosis disease caused by plaque accumulation in human blood vessels. The so-called plaque is composed of fibrous tissue, fat, and calcium. The accumulated calcified plaque hinders the normal flow of blood, resulting in insufficient supply of oxygen and nutrients to the body. Vascular calcification in peripheral blood vessels causes arteriosclerosis of the lower extremities. In mild cases, it causes coldness, numbness, and intermittent claudication in the lower extremities. In severe cases, it can cause weakening or disappearance of the pulsation of the lower extremity arteries, especially the dorsalis pedis artery, and even requires amputation treatment. Vascular calcification in the coronary artery is clinically manifested as coronary atherosclerotic heart disease, myocardial ischemia, angina pectoris, and myocardial infarction.
[0003] Intravascular ultrasound (IVUS) is a diagnostic method that uses a catheter to introduce a high-frequency micro-ultrasound probe into the blood vessel lumen for detection, and then uses a digital imaging system to display the microstructural information of the cardiovascular tissue structure and geometric morphology. Since the ultrasound probe is directly placed in the blood vessel lumen for detection, intravascular ultrasound can not only accurately measure the size of the lumen, atherosclerotic plaque, or fibrous plaque, but also provide general tissue information of the atherosclerotic plaque, and is significantly superior to digital angiography technology in showing the complex lesion morphology caused by interventional treatment. Therefore, the IVUS method can accurately grasp the wall morphology and stenosis degree of blood vessels, especially in the interventional diagnosis and treatment of coronary heart disease, it has high guiding value.
[0004] However, for the intravascular ultrasound imagers currently sold on the market, whether they use a mechanically rotating probe, such as the iLab intravascular ultrasound imager produced by Boston Scientific, or an electronic phased array probe, such as the S5 series intravascular ultrasound imager produced by Volcano Corporation, they only use ultrasonic reflection imaging to measure the size of the blood vessel lumen, the size of atherosclerotic plaques or fibrous plaques, and some tissue information, etc., and then diagnose the condition and determine the treatment plan, etc., but they lack the ability to directly perform effective treatments, such as thrombus ablation, plaque fragmentation, etc. If treatment is required, generally, according to the condition of the blood vessels obtained by IVUS, treatments such as injecting thrombolytic agents and placing stents are used. This not only makes the workflow complex, but also the medical cost is very expensive.
[0005] This is because, under normal circumstances, the operating frequencies between ultrasonic therapy and ultrasonic imaging are different. Therefore, ultrasonic imaging devices and ultrasonic therapy devices are separate and distinct. This results in the situation where, during intravascular imaging and therapy, the ultrasonic imaging device and the ultrasonic therapy device cannot be used synchronously during the process operation, and both must be inserted into or withdrawn from the patient's blood vessels at least once. That is, in order to evaluate the effectiveness of ultrasonic therapy, the ultrasonic therapy device must be withdrawn from the patient's blood vessels, and the ultrasonic imaging device must be reinserted into the blood vessels. Such multiple insertions and withdrawals of the ultrasonic device not only consume time but also increase the chance of clinical complications such as vascular injury.
[0006] Therefore, there is a need in the industry for an interventional catheter device that can simultaneously achieve stable ultrasonic imaging and stable ultrasonic therapy. Summary of the Utility Model
[0007] The purpose of the present utility model is to provide an ultrasonic imaging catheter device capable of realizing an interventional catheter device that can simultaneously achieve ultrasonic imaging and ultrasonic therapy.
[0008] To achieve the above object, the present utility model provides an ultrasonic imaging catheter device, including a catheter body, a dual-frequency ultrasonic transducer, an ultrasonic horn, an ultrasonic transmission member, and an impact member; the dual-frequency ultrasonic transducer is a tubular structure, the dual-frequency ultrasonic transducer is coaxially arranged with the catheter body and sleeved outside the catheter body; the dual-frequency ultrasonic transducer includes a first piezoelectric layer, a filtering layer, a second piezoelectric layer, and a backing layer arranged in sequence from outside to inside along the radial direction of the tubular structure; the first piezoelectric layer is used to generate or receive a first ultrasonic wave, the second piezoelectric layer is used to generate or receive a second ultrasonic wave, the frequency of the first ultrasonic wave is within a first preset range, the frequency of the second ultrasonic wave is within a second preset range, the minimum value of the first preset range is greater than the maximum value of the second preset range; the filtering layer is used to conduct the second ultrasonic wave and block the first ultrasonic wave; the backing layer is used to support the dual-frequency ultrasonic transducer; the ultrasonic horn is connected to the second piezoelectric layer, and the ultrasonic horn is correspondingly connected to the ultrasonic transmission member; the impact member is arranged at the distal end of the catheter body, and the ultrasonic transmission member is connected to the impact member.
[0009] Optionally, a plurality of the ultrasonic horns and a plurality of ultrasonic transmission members are uniformly arranged along the circumferential direction of the dual-frequency ultrasonic transducer, the impact member is provided with a blind hole, and the ultrasonic transmission member extends into the blind hole to be connected to the impact member.
[0010] Optionally, the cross-section of the impact member is annular, and the impact member is made of a metal material.
[0011] Optionally, the catheter body includes an outer tube and an inner tube, the outer tube is sleeved outside the inner tube to form a liquid passage cavity extending along the axial direction of the catheter body itself; through holes are formed on the surface of the impact member to communicate the liquid passage cavity with the outside.
[0012] Optionally, the catheter body includes an outer tube and an inner tube, the outer tube is sleeved outside the inner tube to form a liquid passage cavity extending along the axial direction of the catheter body itself; through holes are provided on the outer wall of the outer tube to communicate the liquid passage cavity with the outside.
[0013] Optionally, the catheter body includes an outer tube and an inner tube, the outer tube is sleeved outside the inner tube to form a liquid passage cavity extending along the axial direction of the catheter body itself; at least a part of the dual-frequency ultrasonic transducer is embedded in the catheter body and located in the liquid passage cavity, and the dual-frequency ultrasonic transducer is arranged near the distal end of the catheter body.
[0014] Optionally, the first piezoelectric layer is connected to the first control circuit in a controlled manner, and the second piezoelectric layer is connected to the second control circuit in a controlled manner; the first control circuit is used to control the first piezoelectric layer to generate or receive the first ultrasonic wave, and the second control circuit is used to control the second piezoelectric layer to generate or receive the second ultrasonic wave.
[0015] Optionally, it further includes a handle, a switch is provided on the handle, and the switch is used to control the opening and closing of the first control circuit and / or the opening and closing of the second control circuit; when the first piezoelectric layer generates and receives the first ultrasonic wave, the switch can transmit an electrical signal to the second piezoelectric layer.
[0016] Optionally, it further includes a perfusion pipeline, the perfusion pipeline is communicated with the liquid passage cavity, and the perfusion pipeline is used for allowing the heat exchange agent to flow in the liquid passage cavity.
[0017] Optionally, a first matching layer is further provided on the outer periphery of the first piezoelectric layer, and a second matching layer is further provided between the second piezoelectric layer and the backing layer; the first matching layer is used to improve the transmittance of the first ultrasonic wave; the second matching layer is used to improve the reflectivity of the second ultrasonic wave; the filter layer, the first matching layer and the first piezoelectric layer form a first mother matching layer to be used for improving the transmittance of the second ultrasonic wave; the filter layer and the second piezoelectric layer form a second mother matching layer to be used for improving the reflectivity of the first ultrasonic wave.
[0018] The imaging ultrasonic catheter device provided by the present invention has the following beneficial effects:
[0019] The present utility model provides an imaging ultrasonic catheter device, which includes a catheter body, a dual-frequency ultrasonic transducer, an ultrasonic horn, an ultrasonic transmission member, and an impact member; the dual-frequency ultrasonic transducer is of a tubular structure, the dual-frequency ultrasonic transducer is coaxially arranged with the catheter body and sleeved outside the catheter body; the dual-frequency ultrasonic transducer includes a first piezoelectric layer, a filtering layer, a second piezoelectric layer, and a backing layer sequentially arranged from outside to inside along the radial direction of the tubular structure; the first piezoelectric layer is used to generate or receive a first ultrasonic wave, the second piezoelectric layer is used to generate or receive a second ultrasonic wave, the frequency of the first ultrasonic wave is within a first preset range, the frequency of the second ultrasonic wave is within a second preset range, the minimum value of the first preset range is greater than the maximum value of the second preset range; the filtering layer is used to conduct the second ultrasonic wave and block the first ultrasonic wave; the backing layer is used to support the dual-frequency ultrasonic transducer; the ultrasonic horn is connected to the second piezoelectric layer, and the ultrasonic horn is correspondingly connected to the ultrasonic transmission member; the impact member is arranged at the distal end of the catheter body, and the ultrasonic transmission member is connected to the impact member. When using the present utility model, the first ultrasonic wave is a high-frequency ultrasonic wave for imaging, the first ultrasonic wave is generated from the first piezoelectric layer, emitted and received by the first piezoelectric layer during the imaging process. During the imaging process, the filtering layer blocks the first ultrasonic wave, and the first ultrasonic wave does not interfere with the structures inside the filtering layer, reducing the signal overlap with the second ultrasonic wave. The second ultrasonic wave is a low-frequency ultrasonic wave for ultrasonic treatment, the second ultrasonic wave can pass through the filtering layer, and is emitted and received by the second piezoelectric layer, so as not to have signal overlap with the first ultrasonic wave reflected by the filtering layer, realizing the synchronous progress of ultrasonic imaging and ultrasonic treatment. Description of the Drawings
[0020] Figure 1 It is a schematic diagram of the overall structure of the imaging ultrasonic catheter device provided by an embodiment of the present utility model;
[0021] Figure 2 It is a schematic diagram of the connection relationship between the dual-frequency ultrasonic transducer, the inner tube, the outer tube, the ultrasonic horn, the ultrasonic transmission member, and the impact member of the imaging ultrasonic catheter device provided by an embodiment of the present utility model;
[0022] Figure 3 It is a schematic diagram of the connection relationship between the dual-frequency ultrasonic transducer and the ultrasonic horn of the imaging ultrasonic catheter device provided by an embodiment of the present utility model;
[0023] Figure 4 It is a schematic diagram of the layered structure of the dual-frequency ultrasonic transducer of the imaging ultrasonic catheter device provided by an embodiment of the present utility model;
[0024] Wherein the reference numerals are:
[0025] 01 - Impact part; 02 - Ultrasonic transmission part; 03 - Inner tube; 04 - Liquid - passing cavity; 05 - Ultrasonic horn; 06 - Dual - frequency ultrasonic transducer; 07 - Outer tube; 08 - Indicator light; 09 - Main switch; 10 - Handle; 11 - Shift switch; 12 - Perfusion pipeline; 13 - Needle; 14 - Plug; 15 - Wire
[0026] 061 - First matching layer; 062 - First piezoelectric layer; 063 - Filter layer; 064 - Second piezoelectric layer; 065 - Second matching layer; 066 - Backing layer Detailed implementation mode
[0027] To make the objectives, advantages and features of the present utility model clearer, the following further details the present utility model with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in very simplified forms and not drawn to scale, only for facilitating and clearly assisting in explaining the objectives of the embodiments of the present utility model. In addition, the structures shown in the drawings are often part of the actual structures. Specifically, the emphasis to be shown in each drawing is different, and sometimes different scales are used
[0028] It should be understood that when an element or layer is referred to as "on", "connected to" other elements or layers, it can be directly on other elements or layers, connected to other elements or layers, or there may be intervening elements or layers. On the contrary, when an element is referred to as "directly on", "directly connected to" other elements or layers, there are no intervening elements or layers. Although terms such as first, second, third, etc. may be used to describe various elements, components, regions, layers and / or parts, these elements, components, regions, layers and / or parts should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or part from another element, component, region, layer or part. Therefore, without departing from the teachings of the present utility model, the first element, component, region, layer or part discussed below may be represented as the second element, component, region, layer or part. As used herein, the singular forms of "a", "an" and "the" are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term "comprising" is used to determine the presence of features, steps, operations, elements and / or components, but does not exclude the presence or addition of one or more other features, steps, operations, elements, components and / or groups. As used herein, the term "and / or" includes any and all combinations of the related listed items
[0029] In the present utility model, the "distal end" refers to the end of the imagable ultrasonic catheter device that is far from the operator after being delivered into the human body, and the "proximal end" of the present invention refers to the end of the imagable ultrasonic catheter device that is close to the operator after being delivered into the human body
[0030] The purpose of the present utility model is to provide an imaging ultrasonic catheter device, so as to realize an interventional catheter device that can simultaneously perform ultrasonic imaging and ultrasonic treatment and ensure uniform transmission of ultrasonic waves during excitation.
[0031] Please refer to Figures 1 to 4 , Figure 1 which is a schematic diagram of the overall structure of the imaging ultrasonic catheter device provided by an embodiment of the present utility model; Figure 2 which is a schematic diagram of the connection relationship among the dual-frequency ultrasonic transducer 06, the inner tube 03, the outer tube 07, the ultrasonic horn 05, the ultrasonic transmission member 02, and the impact member 01 of the imaging ultrasonic catheter device provided by an embodiment of the present utility model; Figure 3 which is a schematic diagram of the connection relationship between the dual-frequency ultrasonic transducer 06 and the ultrasonic horn 05 of the imaging ultrasonic catheter device provided by an embodiment of the present utility model; Figure 4 which is a schematic diagram of the layered structure of the dual-frequency ultrasonic transducer 06 of the imaging ultrasonic catheter device provided by an embodiment of the present utility model. As Figures 1 to 4 shown, to achieve the above purpose, the present utility model provides an imaging ultrasonic catheter device, including a catheter body, a dual-frequency ultrasonic transducer 06, an ultrasonic horn 05, an ultrasonic transmission member 02, and an impact member 01;
[0032] The catheter body includes an outer tube 07 and an inner tube 03 arranged coaxially. The outer tube 07 is sleeved outside the inner tube 03 to form a liquid passage cavity 04 extending along the axial direction of the catheter body itself. It should be understood that the catheter body can also be in other forms, which will not be elaborated here.
[0033] The dual-frequency ultrasonic transducer 06 is of a tubular structure. The dual-frequency ultrasonic transducer 06 is arranged coaxially with the catheter body and sleeved outside the catheter body. As a preferred embodiment, at least a part of the dual-frequency ultrasonic transducer 06 is embedded in the catheter body and located in the liquid passage cavity 04 to enable the liquid passage cavity 04 to dissipate heat from the dual-frequency ultrasonic transducer 06 by using a heat exchange agent. It should be understood that the dual-frequency ultrasonic transducer 06 may not be embedded in the liquid passage cavity 04 as long as heat exchange with the catheter body can be achieved.
[0034] As a preferred embodiment, the dual-frequency ultrasonic transducer 06 includes a first matching layer 061, a first piezoelectric layer 062, a filtering layer 063, a second piezoelectric layer 064, a second matching layer 065, and a backing layer 066 arranged in sequence from outside to inside along the radial direction of the tubular structure.
[0035] The first piezoelectric layer 062 is used to generate or receive a first ultrasonic wave, the second piezoelectric layer 064 is used to generate or receive a second ultrasonic wave, the frequency of the first ultrasonic wave is within a first preset range, the frequency of the second ultrasonic wave is within a second preset range, and the minimum value of the first preset range is greater than the maximum value of the second preset range.
[0036] The first matching layer 061 is used to improve the transmittance of the first ultrasonic wave.
[0037] The filtering layer 063 is used to conduct the second ultrasonic wave and block the first ultrasonic wave.
[0038] The filtering layer 063, the first matching layer 061 and the first piezoelectric layer 062 form a first mother matching layer to improve the transmittance of the second ultrasonic wave.
[0039] The filtering layer 063 and the second piezoelectric layer 064 form a second mother matching layer to improve the reflectivity of the first ultrasonic wave.
[0040] The second matching layer 065 is used to improve the reflectivity of the second ultrasonic wave.
[0041] It should be noted that the filtering layer 063 may not depend on the first matching layer 061 and the second matching layer 065, and the filtering layer 063 can independently conduct the second ultrasonic wave and block the first ultrasonic wave.
[0042] The backing layer 066 is used to support the dual-frequency ultrasonic transducer 06.
[0043] The ultrasonic horn 05 is connected to the second piezoelectric layer 064. Specifically, the dual-frequency ultrasonic transducer 06 can be connected to the ultrasonic horn 05 in a threaded form at the end of the second piezoelectric layer 064. A plurality of the ultrasonic horns 05 and a plurality of ultrasonic transmission members 02 are uniformly arranged along the circumference of the dual-frequency ultrasonic transducer 06, and the ultrasonic horns 05 are connected to the ultrasonic transmission members 02 in a one-to-one correspondence.
[0044] As a preferred embodiment, the cross-section of the impact member 01 is annular, the impact member 01 is coaxially arranged with the catheter body and is provided at the distal end of the catheter body, and the ultrasonic transmission member 02 is connected to the impact member 01.
[0045] When the present utility model is in use, the first ultrasonic wave is a high-frequency ultrasonic wave for imaging, and is generated from the first piezoelectric layer 062. During the imaging process, it is emitted and received by the first piezoelectric layer 062. During the imaging process, the second mother matching layer including the filtering layer 063 blocks the first ultrasonic wave, and the first ultrasonic wave does not interfere with the structures within the filtering layer 063, reducing the signal overlap with the second ultrasonic wave. The second ultrasonic wave is a low-frequency ultrasonic wave for ultrasonic treatment, and can pass through the first mother matching layer including the filtering layer 063, and is emitted and received by the second piezoelectric layer 064, so as not to have signal overlap with the first ultrasonic wave reflected by the second mother matching layer, realizing the simultaneous progress of ultrasonic imaging and ultrasonic treatment. On this basis, since the dual-frequency ultrasonic transducer 06 is a tubular structure, to ensure the uniform transmission of the second ultrasonic wave during excitation, a plurality of the ultrasonic horn 05 and a plurality of ultrasonic transmission members 02 are uniformly arranged along the circumferential direction of the dual-frequency ultrasonic transducer 06, and the cross-section of the impact member 01 is set to be annular, so as to realize the uniform transmission when the ultrasonic wave excitation is converted into mechanical energy. And after such setting, both the impact member 01 and the dual-frequency ultrasonic transducer 06 have a hollow space in the central region, so that in the state of being coaxially arranged with the catheter body, a guide wire can pass through, realizing the guidance for the interventional operation.
[0046] The present utility model advantageously allows ultrasonic treatment and ultrasonic imaging to be simultaneously completed on a medical device, so that it is not necessary to repeatedly insert and remove the device for imaging and treatment, thereby improving the workflow for patients and physicians. At the same time, the transducers for ultrasonic treatment and imaging are combined together, which not only optimizes the structure and size of the product, but also reduces signal aliasing and weakens artifacts in imaging. And by integrating the functions of ultrasonic treatment and imaging, the safety and accuracy of the operation are improved, and the operation process is simplified, having a wide clinical application prospect.
[0047] During the use of the present utility model, the liquid passage cavity 04 is used for the circulation of a cooling medium (such as normal saline). The present utility model further includes an infusion pipeline 12, which is communicated with the liquid passage cavity 04, and the infusion pipeline 12 is used for allowing a heat exchange agent (such as the cooling medium) to flow in the liquid passage cavity 04. The cooling medium flows in through the needle 13 at the proximal end of the imageable ultrasonic catheter device and flows out from the outflow port of the impact member 01 at the distal end of the imageable ultrasonic catheter device, or openings are provided at a position on the outer tube 07 close to the distal end of the imageable ultrasonic catheter device to allow the cooling medium to flow out. Through the infusion of the cooling medium, on the one hand, a large amount of heat generated during the ultrasonic vibration of the imageable ultrasonic catheter device is carried away, avoiding the failure of the functions of the imageable ultrasonic catheter device due to the increase in temperature, preventing the rigid connection between the catheter body and the impact member 01 from being damaged or even separated from the impact member 01, and avoiding possible irreversible harm to the human body; on the other hand, it is used to cool the dual-frequency ultrasonic transducer 06 to ensure the working effect.
[0048] It should be noted that, in order to achieve the above functions of the dual-frequency ultrasonic transducer 06, in an exemplary embodiment, the materials of the first piezoelectric layer 062 and the second piezoelectric layer 064 are both piezoelectric ceramic PZT4. The first matching layer 061 is a double-layer structure composed of two different materials. The layer far from the first piezoelectric layer 062 is the first high-frequency matching layer, and the layer close to the first piezoelectric layer 062 is the second high-frequency matching layer. The material of the first high-frequency matching layer is epoxy resin with an acoustic impedance of 2.4 MRayl, and the acoustic impedance of the second high-frequency matching layer is 8.9 MRayl. The material of the filtering layer 063 is epoxy resin with an acoustic impedance of 2.4 MRayl. The second matching layer 065 is a double-layer structure composed of two different materials. The layer close to the second piezoelectric layer 064 is the first anti-matching layer, and the layer far from the second piezoelectric layer 064 is the second anti-matching layer. The material of the first anti-matching layer is epoxy resin with an acoustic impedance of 2.4 MRayl, and the material of the second anti-matching layer is iron with an acoustic impedance of 45.4 MRayl. The material of the backing layer 066 is alumina with a particle size of 15 μm and an acoustic impedance of 6.5 MRayl. It should be understood that the present utility model is not limited to the above data and materials.
[0049] Specifically, the impact member 01 is provided with a blind hole, and the ultrasonic transmission member 02 extends into the blind hole to be connected with the impact member 01. The impact member 01 is generally made of metal, and at this time, it can be called a metal cap. Through holes can also be provided on the surface of the impact member 01 to communicate the liquid passage cavity 04 with the outside.
[0050] The impact member 01 has specifically two embodiments. One is for coronary arteries, with a diameter of approximately 0.6 - 1.1 mm and a length of approximately 1 - 2.5 mm; the other is for the periphery, with a diameter of approximately 1.0 - 1.2 mm and a length of approximately 1.5 - 2.5 mm. The front end of the impact member 01 can be flat or bullet-shaped with a taper angle.
[0051] For the impact member 01 of the second embodiment, it may not have through holes, but at least one blind hole. In this case, the liquid for cooling flows out through the opening on the outer tube 07, that is, the outer wall of the outer tube 07 is provided with through holes to communicate the liquid passage cavity 04 with the outside.
[0052] For the impact member 01 of the second embodiment, it has at least one through hole and one blind hole. The blind hole is located inside the impact member 01 and is rigidly connected to an ultrasonic transmission member 02 (made of nitinol). On the front or side wall of the impact member 01, there can be multiple through holes for the cooling medium to be infused from the proximal end of the imaging ultrasonic catheter device to the distal end of the imaging ultrasonic catheter device.
[0053] The large through hole of the impact member 01 is fixed to the inner tube 03 by means such as glue and hot air welding and serves as a guide wire channel; the two small through holes are for the infusion of the cooling medium (such as physiological saline); the blind hole is connected to the ultrasonic transmission member 02 by means such as laser welding and resistance welding. The ultrasonic transducer built into the handle 10 converts electrical energy into mechanical energy, which is transmitted to the impact member 01 through the ultrasonic transmission member 02, causing the impact member 01 to generate mechanical vibration; the impact member 01 is fixed to the outer tube 07 by other means such as glue and hot air welding, and the inner tube 03, ultrasonic transmission member 02, etc. are sleeved inside the outer tube 07. A radiopaque ring can be installed on the outer tube 07, and the material of the radiopaque ring can be any one of metal materials with good imaging properties such as platinum-iridium alloy, tantalum, gold, tungsten, etc.
[0054] The impact member 01 needs to ablate calcified plaques, and the material can be one of titanium, titanium alloy, stainless steel, etc. The inner tube 03 should meet the flexibility and passability of the catheter body. The inner cavity of the inner tube 03 has a smooth characteristic to facilitate the passage of the guide wire. The inner tube 03 can be a three-layer tube, with the outer layer made of a polymer material, which can be Pebax, the middle layer made of a metal material, which can be SUS304, and the inner layer made of a polymer material, which can be HDPE. The ultrasonic transmission member 02 has flexibility, bending resistance, supportability and elasticity, and also needs to consider the influence of the temperature of the imaging ultrasonic catheter device on the material of the ultrasonic transmission member 02. The material can be selected as a shape memory alloy (such as nitinol); the outer tube 07 runs through the entire imaging ultrasonic catheter device and has flexibility and kink resistance. The material can be PFTE or Pebax.
[0055] Please continue to refer toFigure 1 and Figure 2 Preferably, the dual-frequency ultrasonic transducer 06 is disposed near the distal end of the catheter body. With this arrangement, the length of the ultrasonic transmission member 02 can be shortened, thereby reducing its vibration attenuation, controlling its amplitude, and enhancing the vibration effect. In an exemplary embodiment, the distance between the dual-frequency ultrasonic transducer 06 and the distal end of the catheter body is less than 10 mm, but this is not limiting.
[0056] Please continue to refer to Figure 1 , further, the first piezoelectric layer 062 is connected to the first control circuit for control, and the second piezoelectric layer 064 is connected to the second control circuit for control; the first control circuit is used to control the first piezoelectric layer 062 to generate or receive the first ultrasonic wave, and the second control circuit is used to control the second piezoelectric layer 064 to generate or receive the second ultrasonic wave. The present invention further includes a handle 10, and a switch is provided on the handle 10 for controlling the opening and closing of the first control circuit and / or the second control circuit. When the first piezoelectric layer 062 generates and receives the first ultrasonic wave, the switch can transmit an electrical signal to the second piezoelectric layer 062. As Figure 1 shown, the switch may include a main switch 09 and a shift switch 11. During operation, press the main switch 09 on the handle 10, and at this time, the indicator light 08 is on, indicating that the imaging ultrasonic catheter device is in a working state. At this time, the host system provides an electrical signal to the first piezoelectric layer 062 of the dual-frequency ultrasonic transducer 06, and the first piezoelectric layer 062 generates and receives the first ultrasonic wave. The imaging ultrasonic catheter device further includes a display, and the display is communicatively connected to the dual-frequency ultrasonic transducer 06. The first ultrasonic wave is transmitted back to the host system and processed by an ultrasonic processing device in the host system, and finally imaged on the display screen of the host device. At this time, click the shift switch 11 to transmit an electrical signal to the second piezoelectric layer 064 of the dual-frequency ultrasonic transducer 06. The second piezoelectric layer 064 finally converts electrical energy into mechanical energy, and through the action of the ultrasonic horn 05, the amplitude is amplified. The ultrasonic horn 05 and the ultrasonic transmission member 02 are coupled mechanically, and the vibration of the ultrasonic horn 05 is transmitted to the ultrasonic transmission member 02 and finally transmitted to the impact member 01, causing the impact member 01 to generate a large amplitude. During the vibration of the imaging ultrasonic catheter device, the perfused cooling medium (such as normal saline) is ejected from the through holes on the impact member 01 or the outer tube 07. The cooling medium expands and implodes at the front end of the impact member 01, and cooperates with the mechanical vibration at the distal end of the imaging ultrasonic catheter device to ablate the calcified plaque. Finally, the calcified plaque is penetrated to establish a guide wire channel for placing the guide wire, and finally the function of restoring vascular recanalization is realized.
[0057] It should also be noted that although the present invention has been disclosed above with preferred embodiments, the above embodiments are not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, many possible variations and modifications can be made to the technical solution of the present invention by using the technical content disclosed above, or it can be modified into equivalent embodiments with equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still belong to the scope protected by the technical solution of the present invention.
[0058] It should also be understood that unless otherwise specified or indicated, the terms "first", "second", "third", etc. in the specification are only used to distinguish each component, element, step, etc. in the specification, rather than to represent the logical relationship or sequential relationship between each component, element, step, etc.
[0059] In addition, it should also be recognized that the terms described herein are only used to describe specific embodiments and are not used to limit the scope of the present invention. It must be noted that the singular forms "a" and "an" used herein and in the appended claims include plural referents unless the context clearly dictates otherwise. For example, a reference to "a step" or "a device" means a reference to one or more steps or devices and may include sub-steps as well as sub-devices. All conjunctions used should be understood in their broadest sense. Also, the word "or" should be understood to have the definition of logical "or", rather than the definition of logical "exclusive or", unless the context clearly dictates otherwise. In addition, the implementation of the embodiments of the present invention may include performing the selected tasks manually, automatically, or in combination.
Claims
1. An imageable ultrasound catheter device, characterized in that: It includes a catheter body, a dual-frequency ultrasonic transducer, an ultrasonic horn, an ultrasonic transmission component and an impact component; The dual-frequency ultrasonic transducer is a tubular structure, and the dual-frequency ultrasonic transducer is coaxially arranged with the catheter body and sleeved on the outside of the catheter body; The dual-frequency ultrasonic transducer comprises a first piezoelectric layer, a filter layer, a second piezoelectric layer and a backing layer which are sequentially arranged from outside to inside along the radial direction of the tubular structure; The first piezoelectric layer is used to generate or receive a first ultrasonic wave, and the second piezoelectric layer is used to generate or receive a second ultrasonic wave, the frequency of the first ultrasonic wave is within a first preset range, the frequency of the second ultrasonic wave is within a second preset range, and the minimum value of the first preset range is greater than the maximum value of the second preset range; The filter layer is used to conduct the second ultrasonic wave and block the first ultrasonic wave; The backing layer is used to support the dual-frequency ultrasonic transducer; The ultrasonic horn is connected to the second piezoelectric layer, and the ultrasonic horn is correspondingly connected to the ultrasonic transmission element; The impact piece is arranged at the distal end of the catheter body, and the ultrasonic transmission piece is connected to the impact piece.
2. The imageable ultrasound catheter device according to claim 1, characterized in that: The plurality of ultrasonic horn rods and the plurality of ultrasonic transmission members are evenly arranged along the circumference of the dual-frequency ultrasonic transducer, the impact member is provided with a blind hole, and the ultrasonic transmission member extends into the blind hole to be connected with the impact member.
3. The imageable ultrasound catheter device according to claim 1, characterized in that: The cross section of the impact piece is annular and the impact piece is made of metal.
4. The imageable ultrasound catheter device according to claim 1, characterized in that: The catheter body comprises an outer tube and an inner tube, wherein the outer tube is sleeved on the outside of the inner tube to form a liquid passage cavity extending along the axial direction of the catheter body itself; a through hole is opened on the surface of the impact piece to connect the liquid passage cavity with the outside.
5. The imageable ultrasound catheter device according to claim 1, wherein: The catheter body comprises an outer tube and an inner tube, wherein the outer tube is sleeved on the outside of the inner tube to form a liquid passage cavity extending along the axial direction of the catheter body itself; a through hole is provided on the outer wall of the outer tube to connect the liquid passage cavity with the outside.
6. The imageable ultrasound catheter device of claim 1, wherein: The catheter body includes an outer tube and an inner tube, wherein the outer tube is sleeved on the outside of the inner tube to form a liquid-passing cavity extending along the axial direction of the catheter body itself; at least a portion of the dual-frequency ultrasonic transducer is embedded in the catheter body and located in the liquid-passing cavity, and the dual-frequency ultrasonic transducer is arranged near the distal end of the catheter body.
7. The imageable ultrasound catheter device of claim 1, wherein: The first piezoelectric layer is control-connected to a first control circuit, and the second piezoelectric layer is control-connected to a second control circuit; The first control circuit is used to control the first piezoelectric layer to generate or receive the first ultrasonic wave, and the second control circuit is used to control the second piezoelectric layer to generate or receive the second ultrasonic wave.
8. The imageable ultrasound catheter device of claim 7, wherein: It also includes a handle, on which a switch is provided, and the switch is used to control the opening and closing of the first control circuit and / or the opening and closing of the second control circuit; when the first piezoelectric layer generates and receives the first ultrasonic wave, the switch can transmit an electrical signal to the second piezoelectric layer.
9. The imageable ultrasound catheter device according to any one of claims 4 to 6, characterized in that: It also includes a perfusion pipeline, which is communicated with the liquid-passing cavity and is used for allowing a heat exchange agent to flow through the liquid-passing cavity.
10. The imageable ultrasound catheter device of claim 1, wherein: A first matching layer is further provided on the periphery of the first piezoelectric layer, and a second matching layer is further provided between the second piezoelectric layer and the backing layer; The first matching layer is used to improve the transmittance of the first ultrasonic wave; The second matching layer is used to improve the reflectivity of the second ultrasonic wave; The filter layer, the first matching layer and the first piezoelectric layer constitute a first mother matching layer for improving the transmittance of the second ultrasonic wave; the filter layer and the second piezoelectric layer constitute a second mother matching layer for improving the reflectivity of the first ultrasonic wave.