Ultrasound guidewire system

Abstract

The application discloses an ultrasonic guide wire system, which comprises a host computer, an ultrasonic vibration device and an ultrasonic guide wire, wherein the ultrasonic vibration device comprises an ultrasonic transducer, the ultrasonic transducer is electrically connected with the host computer, the ultrasonic guide wire is installed at the distal end of the ultrasonic transducer, the host computer is configured to output an electric signal to the ultrasonic transducer to drive the ultrasonic transducer and the ultrasonic guide wire to vibrate, and to collect voltage data and current data in real time when the ultrasonic transducer works and to adjust the frequency of the electric signal output to the ultrasonic transducer in real time according to the voltage data and the current data. In the application, the ultrasonic guide wire does not need to be provided with a rotary grinding head, a microelectrode or the like structure, has a relatively small radial size, and does not need to be discharged, so that damage to human blood vessels and the like can be effectively avoided.

Description

Technical Field

[0001] This application relates to the field of ultrasonic technology, and in particular to an ultrasonic guidewire system. Background Technology

[0002] Currently, interventional surgery is a common treatment for chronic total occlusion (CTO) lesions. Interventional surgery primarily uses a guidewire to open the treatment channel, inserts a dilating balloon, and then clears the lesion. Guidewire delivery mainly includes manual delivery, rotational atherectomy (ROA) guidewire delivery, and shockwave guidewire delivery. Manual delivery is inefficient, failing to ensure effective penetration through fibrotic or calcified tissue and maintaining sufficient surgical time. ROA guidewires carry a high risk, as the large diameter burr tip cannot effectively prevent damage to blood vessels, severely limiting their application in coronary artery branches. Shockwave guidewires require repeated discharges during operation and are highly dependent on the outer insulation layer for protection; any damage to the insulation layer could easily result in high voltage injury. Summary of the Invention

[0003] The purpose of this application is to provide an ultrasonic guidewire system that can solve at least one of the technical problems mentioned in the background art.

[0004] To achieve the above objectives, this application provides an ultrasonic guidewire system, comprising: Host; An ultrasonic vibration device, comprising an ultrasonic transducer, wherein the ultrasonic transducer is electrically connected to the main unit; An ultrasonic guidewire is mounted at the distal end of the ultrasonic transducer. The host is configured to output an electrical signal to the ultrasonic transducer to drive the ultrasonic transducer and the ultrasonic guidewire to vibrate, and to collect voltage and current data of the ultrasonic transducer in real time and adjust the frequency of the electrical signal output to the ultrasonic transducer in real time according to the voltage and current data.

[0005] Optionally, the host includes: a control circuit module, a DC power supply, a power regulation circuit module, a drive circuit module, and an ultrasonic power amplification circuit module; The control circuit module is electrically connected to the DC power supply, the power regulation circuit module and the drive circuit module respectively, and the control circuit module is configured to output a PWM control signal to the drive circuit module. The power regulation circuit module is electrically connected between the DC power supply and the ultrasonic power amplification circuit module. The drive circuit module is electrically connected to the ultrasonic power amplifier circuit module, and the drive circuit module is configured to output a drive signal to the ultrasonic power amplifier circuit module. The ultrasonic power amplifier circuit module is electrically connected to the ultrasonic transducer, and the ultrasonic power amplifier circuit module is configured to output an electrical signal to the ultrasonic transducer. The control circuit module acquires the voltage and current data of the ultrasonic transducer in real time and adjusts the PWM control signal output to the drive circuit module in real time according to the voltage and current data to adjust the frequency of the electrical signal.

[0006] Optionally, the control circuit module includes a microcontroller, a phase-shift resonant PWM controller, and a signal detection circuit module. The first output terminal of the microcontroller is connected to the frequency control input terminal of the phase-shift resonant PWM controller, and is used to output a frequency signal to the phase-shift resonant PWM controller. The second output terminal of the microcontroller is connected to the phase-shift control input terminal of the phase-shift resonant PWM controller, and is used to output a phase-shift control signal to the phase-shift resonant PWM controller. The output terminal of the phase-shift resonant PWM controller is connected to the input terminal of the drive circuit module, and is used to output the PWM control signal to the drive circuit module. The input terminal of the signal detection circuit module is used to acquire the voltage data and the current data. The signal detection circuit module outputs the phase difference information of the current and voltage to the microcontroller based on the voltage data and the current data. The microcontroller adjusts the frequency signal output to the phase-shift resonant PWM controller in real time based on the phase difference information.

[0007] Optionally, the host is configured to adjust the power of the electrical signal output to the ultrasonic transducer in real time based on the voltage data and the current data.

[0008] Optionally, the ultrasonic transducer includes an amplitude transformer, and the ultrasonic guidewire is mounted at the distal end of the amplitude transformer. The ultrasonic vibration device also includes a handle housing, on which a distance measuring module is provided. The distance measuring module is used to measure the distance data between itself and a set position at the far end of the amplitude transformer. The host is configured to receive the distance data in real time and determine whether to adjust the longitudinal vibration displacement of the amplitude transformer based on the distance data, and adjust the electrical signal input to the ultrasonic transducer in real time when the determination result is yes.

[0009] Optionally, the distal end of the amplitude rod has a working end face located inside the handle housing as the set position, and the ranging module is used to measure the distance data between it and the working end face.

[0010] Optionally, the ultrasonic transducer includes an amplitude transformer, and the distal end of the amplitude transformer is provided with a plurality of clamping arms in the circumferential direction, and the plurality of clamping arms surround to form a clamping hole for insertion of the ultrasonic guidewire; The ultrasonic vibration device also includes a handle housing and a self-tightening element, the self-tightening element being detachably connected to the handle housing; During the process of the self-tightening member moving backward along the handle housing and being installed into the handle housing, the self-tightening member presses the multiple clamping arms inward, causing the multiple clamping arms to close towards the center, so that the clamping hole contracts inward; The plurality of clamping arms are capable of resetting outward after the self-tightening member is disconnected from the handle housing, thereby causing the clamping holes to expand outward.

[0011] Optionally, the host computer obtains the voltage amplitude, current amplitude, and phase difference between voltage and current based on the voltage data and the current data; When the host determines that the voltage amplitude and the current amplitude suddenly drop beyond their respective preset thresholds while the phase difference between the voltage and the current remains within the normal range, it stops outputting electrical signals to the ultrasonic transducer.

[0012] Optionally, the ultrasonic guidewire system further includes a guide sheath and a microcatheter used in conjunction with the ultrasonic guidewire; The guide sheath is directional, allowing it to enter through the interventional surgical port and reach the location of the coronary artery, as well as to allow the insertion of the microcatheter. The microcatheter is directional, and its distal end is configured to extend from the distal end of the guide sheath and reach the location of the coronary lesion. The ultrasound guidewire is configured to be inserted into the microcatheter and reach the location of the coronary lesion.

[0013] Optionally, the ultrasonic guidewire is used in conjunction with a winding wire, the winding wire being sleeved and fixed at the distal end of the ultrasonic guidewire, and a protective coating is formed on the outer surface of the ultrasonic guidewire.

[0014] Optionally, the middle section of the ultrasonic guidewire is formed with a plurality of spaced-apart reducing or increasing diameter sections along the axial direction, and the outer peripheral surface of each reducing or increasing diameter section is transitionally connected to the outer peripheral surface of the ultrasonic guidewire.

[0015] In this embodiment, an ultrasonic guidewire is installed at the distal end of an ultrasonic transducer. The host computer outputs an electrical signal to the ultrasonic transducer to drive it to vibrate at high frequency. The transducer transmits this vibration to the ultrasonic guidewire, enabling automatic high-frequency movement of the guidewire. This high-frequency movement of the guidewire can then be used to directly destroy fibrotic and calcified tissues. Compared to rotary atherectomy guidewires and shock wave guidewires, the ultrasonic guidewire in this embodiment does not require a rotary atherectomy head, microelectrodes, or other structures. Its radial dimension is relatively small, and it does not require discharge, effectively avoiding damage to blood vessels. Furthermore, because the host computer can collect voltage and current data from the ultrasonic transducer in real time and adjust the frequency of the electrical signal output to the transducer accordingly, the ultrasonic guidewire always operates within an optimal frequency range, ensuring its reliability and efficiency. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the ultrasonic guidewire system according to an embodiment of this application.

[0017] Figure 2 This is a schematic block diagram of the host, ultrasonic transducer, and ultrasonic guidewire in an embodiment of this application.

[0018] Figure 3 This is a schematic block diagram of some circuit modules of the host and the super-energy transducer in the embodiment of this application.

[0019] Figure 4 This is a schematic block diagram of the signal detection circuit module, ultrasonic transducer, and microcontroller in an embodiment of this application.

[0020] Figure 5 This is a schematic block diagram of the phase difference direction detection module, ultrasound, energy source, and microcontroller in an embodiment of this application.

[0021] Figure 6 This is a schematic diagram of the main unit and ultrasonic vibration device in an embodiment of this application.

[0022] Figure 7 This is a cross-sectional structural schematic diagram of the ultrasonic vibration device according to an embodiment of this application.

[0023] Figure 8 This is a cross-sectional structural diagram of the ultrasonic vibration device and ultrasonic guide wire according to an embodiment of this application.

[0024] Figure 9 This is a schematic diagram of the structure of the clamping component in an embodiment of this application.

[0025] Figure 10 This is a schematic diagram of the structure of the ultrasonic guidewire, guide sheath, and microcatheter in an embodiment of this application.

[0026] Figure 11This is a schematic diagram of the structure of the ultrasonic guidewire in an embodiment of this application. Detailed Implementation

[0027] To illustrate the technical content, structural features, objectives, and effects of this application in detail, the following description is provided in conjunction with the embodiments and accompanying drawings.

[0028] CTO refers to a complete occlusion of the coronary artery with a TIMI flow grade of 0 for a duration of ≥3 months. It is mainly caused by the rupture of atherosclerotic plaques, leading to thrombus formation and organization. CTO lesions contain hard fibrotic or calcified tissue and are often accompanied by vascular tortuosity. Surgical treatment is time-consuming and has an extremely low success rate, earning it the title of "the last bastion in the field of coronary interventional therapy".

[0029] Compared to other lesions, the difficulty in treating CTO lesions lies primarily in the presence of extensive fibrosis or calcification at the lesion site, resulting in extremely high hardness, making it impossible for conventional drug treatments to reach the internal thrombus. Treatment devices such as dilating balloons require a working guidewire to open the access channel before treatment can proceed. Furthermore, due to the vascular stenosis at the lesion location, large and medium-sized treatment devices cannot be inserted, severely limiting the diameter of the working guidewire that can be used for interventional treatment.

[0030] Traditional treatments for CTO lesions rely on doctors manually inserting a working guidewire, attempting to open a treatment channel through repeated punctures and retrievals, followed by the insertion of dilating balloons and other treatment devices. Due to the lack of visualization within the blood vessel and the extremely low efficiency of manually inserting the working guidewire to destroy fibrotic or calcified tissue, CTO lesion treatment surgeries can take several hours, with no guarantee of success.

[0031] Building upon this foundation, two treatment protocols have been developed: rotational atherectomy with guidewire and shockwave therapy with guidewire. Rotational atherectomy with guidewire involves delivering a specially designed atherectomy head to the CTO lesion site via a working guidewire. An external drive mechanism rotates the atherectomy head at high speed, using numerous diamond particles on its surface to destroy fibrotic or calcified tissue, thus opening a treatment channel for the expansion balloon. Shockwave therapy with guidewire integrates two or more microelectrodes at the guidewire tip. Rapidly delivering a high voltage creates electrical breakdown between the microelectrodes, and the explosive force drives the guidewire tip to destroy fibrotic or calcified tissue.

[0032] Compared to traditional manual treatment methods, rotational atherectomy and shockwave atherectomy offer significant improvements in treatment efficiency and success rate. However, both methods have certain drawbacks. Rotational atherectomy requires ensuring effective transmission of rotational energy from the drive device to the atherectomy head and maintaining effective destruction of fibrotic or calcified tissue. Therefore, the diameter of the rotational atherectomy wire is generally significantly larger than that of a conventional working guidewire, typically reaching 1-1.5 mm. Given that the diameter of the main coronary artery is usually 3-4 mm, and the diameter of branches is usually 2-3 mm, rotational atherectomy carries a high risk and cannot effectively prevent damage to the blood vessels from the atherectomy head, severely limiting its application in coronary artery branches. Shock wave guide wires are smaller than rotary grinding head guide wires, but due to the integrated microelectrodes, their size is still larger than that of conventional working guide wires. Furthermore, shock wave guide wires need to repeatedly discharge during operation and are extremely dependent on the insulation layer of the outer layer for protection. Once an accident such as insulation layer damage occurs, the high voltage can easily cause harm to the human body.

[0033] Based on this, this application proposes an ultrasonic guidewire system that can directly drive the ultrasonic guidewire to move at high frequency to destroy fibrotic or calcified tissue. Compared with rotary atherectomy guidewires and shock wave guidewires, ultrasonic guidewires do not require the setting of rotary atherectomy heads, microelectrodes and other structures, have a relatively small radial dimension, and do not require discharge, which can effectively avoid damage to human blood vessels and other structures.

[0034] Please see Figure 1 The ultrasonic guidewire system includes a main unit 1, an ultrasonic vibration device 5, and an ultrasonic guidewire 9. The ultrasonic vibration device 5 includes an ultrasonic transducer 50, which is electrically connected to the main unit 1. The ultrasonic guidewire 9 is mounted at the distal end of the ultrasonic transducer 50. The main unit 1 is configured to output an electrical signal to the ultrasonic transducer 50, and to acquire, in real time, the voltage and current data of the ultrasonic transducer 50 during operation, and adjust the frequency of the electrical signal output to the ultrasonic transducer 50 in real time based on the voltage and current data.

[0035] In this embodiment, the ultrasonic guidewire 9 is installed at the distal end of the ultrasonic transducer 50. The host 1 outputs an electrical signal to the ultrasonic transducer 50 to drive it to vibrate at high frequency. The ultrasonic transducer 50 transmits the vibration to the ultrasonic guidewire 9, realizing automatic high-frequency movement of the ultrasonic guidewire 9. This high-frequency movement of the ultrasonic guidewire 9 can then be used to directly destroy fibrotic and calcified tissues. Compared to rotary abrasion guidewires and shock wave guidewires, the ultrasonic guidewire 9 in this embodiment does not require a rotary abrasion head, microelectrodes, or other structures. Its radial dimension is relatively small, and it does not require discharge, effectively avoiding damage to blood vessels. Furthermore, since the host 1 can collect voltage and current data of the ultrasonic transducer 50 in real time and adjust the frequency of the electrical signal output to the ultrasonic transducer 50 based on the voltage and current data, the ultrasonic guidewire 9 can always operate within an optimal frequency range, which helps ensure the reliability and efficiency of the ultrasonic guidewire 9.

[0036] In some embodiments, the mechanical effect of the longitudinal movement of the ultrasonic guidewire 9 is used to perform contact puncture, and the lesion plaque is continuously impacted at high frequency. When the pressure or force provided by the distal end of the ultrasonic guidewire 9 exceeds the inherent yield and fatigue strength of the lesion plaque, it eventually penetrates and destroys the hard calcified nodules, fibrous caps, cholesterol crystals, etc. in the lesion plaque, and forms a through hole.

[0037] In some embodiments, non-contact treatment is performed using the cavitation effect of the longitudinal movement of the ultrasound guidewire 9, with a certain distance between the distal end of the ultrasound guidewire 9 and the lesion plaque. When the sound pressure generated at the distal end of the ultrasound guidewire 9 exceeds the critical threshold of the cavitation effect, the cavitation effect occurs, and the cavitation bubbles in the blood undergo rapid deformation and collapse. In the instant before collapse, local high temperature and high pressure are generated near the cavitation nucleus, forming a high-speed microjet with a diameter of tens of micrometers and a speed of hundreds of meters per second that rushes towards the lesion plaque, ultimately tearing and breaking up the soft blood clots, lipids, etc. within the lesion plaque.

[0038] In some embodiments, under the control of the host 1, the ultrasonic transducer 50 can cause the ultrasonic guide wire 9 to generate a cyclic shearing motion, and the shearing motion of the ultrasonic guide wire 9 is used to continuously apply normal impact force and tangential friction force to the wall of the through hole.

[0039] Please see Figure 2 In some embodiments, the host 1 includes: a control circuit module 11, a DC power supply 12, a power regulation circuit module 13, a drive circuit module 14, and an ultrasonic power amplification circuit module 15. The control circuit module 11 is electrically connected to the DC power supply 12, the power regulation circuit module 13 and the drive circuit module 14 respectively. The control circuit module 11 is configured to output a PWM control signal to the drive circuit module 14. The power regulation circuit module 13 is electrically connected between the DC power supply 12 and the ultrasonic power amplifier circuit module 15; The drive circuit module 14 is electrically connected to the ultrasonic power amplifier circuit module 15, and the drive circuit module 14 is configured to output a drive signal to the ultrasonic power amplifier circuit module 15. The ultrasonic power amplifier circuit module 15 is electrically connected to the ultrasonic transducer 50, and the ultrasonic power amplifier circuit module 15 is configured to output an electrical signal to the ultrasonic transducer 50. The control circuit module 11 acquires the voltage and current data of the ultrasonic transducer 50 in real time and adjusts the PWM control signal output to the drive circuit module 14 in real time according to the voltage and current data to adjust the frequency of the electrical signal.

[0040] Please see Figure 3 In some embodiments, the control circuit module 11 includes a microcontroller 20, a phase-shift resonant PWM controller 30, and a signal detection circuit module 40. The first output terminal of the microcontroller 20 is connected to the frequency control input terminal of the phase-shift resonant PWM controller 30, and is used to output a frequency signal to the phase-shift resonant PWM controller 30. The second output terminal of the microcontroller 20 is connected to the phase-shift control input terminal of the phase-shift resonant PWM controller 30, and is used to output a phase-shift control signal to the phase-shift resonant PWM controller 30. The output terminal of the phase-shift resonant PWM controller 30 is connected to the input terminal of the drive circuit module 14, and is used to output a PWM control signal to the drive circuit module 14. The signal detection circuit module 40 is used to acquire voltage data and current data, and outputs the phase difference information of current and voltage to the microcontroller 20 based on the voltage data and current data. The microcontroller 20 adjusts the frequency signal output to the phase-shift resonant PWM controller 30 in real time based on the phase difference information. Through the aforementioned technical means, this embodiment of the application can achieve automatic frequency tracking, enabling timely adjustment of the frequency of the ultrasonic transducer 50 to operate near its resonant frequency. This reduces heat generation in the ultrasonic transducer 50 and improves the working efficiency of the ultrasonic guide wire 9. Furthermore, by using the phase-shift resonant PWM controller 30, when power adjustment is required, the microcontroller 20 can adjust the phase-shift control signal output to the phase-shift resonant PWM controller 30 to regulate the power of the electrical signal output from the ultrasonic power amplifier circuit module 15 to the ultrasonic transducer 50.

[0041] In some embodiments, the phase-shift resonant PWM controller 30 is a phase-shift full-bridge soft-switching PWM controller.

[0042] In some embodiments, the signal detection circuit module 40 is an amplitude and phase detection circuit module, which outputs phase difference information and current and voltage amplitude information (specifically, the current and voltage amplitude information is the ratio of current amplitude to voltage amplitude) to the microcontroller 20 based on voltage data and current data. When the ratio of current amplitude to voltage amplitude exceeds a preset range, the microcontroller 20 gradually adjusts the frequency signal until the ratio falls within the preset range.

[0043] Specifically, when the ratio of the real-time acquired current amplitude to the voltage amplitude is within a preset range, the system directly determines whether to perform frequency tracking based on the phase difference information. When the phase difference exceeds the preset range, the microcontroller 20 adjusts the output frequency signal based on the phase difference information. If it is not within the preset range, for example, in an ideal state, the ratio of the voltage amplitude to the current amplitude is 1:1. When the real-time acquired ratio of the voltage amplitude to the current amplitude deviates significantly from the ideal ratio and exceeds the preset range, the synchronously acquired phase difference information is prone to inaccuracy. In this case, even if the phase difference does not exceed the preset range, frequency adjustment is still performed. The frequency signal can be adjusted gradually and tentatively. After repeated closed-loop adjustments, the acquired ratio of the voltage amplitude to the current amplitude will fall within the preset range.

[0044] In some embodiments, the signal detection circuit module 40 includes an RF / IF amplitude and phase detection chip. The input terminal of the RF / IF amplitude and phase detection chip is used to receive voltage data and current data. The RF / IF amplitude and phase detection chip outputs phase difference information and current and voltage amplitude information to the microcontroller 20. Specifically, the current and voltage amplitude information is the ratio of the current amplitude to the voltage amplitude.

[0045] Please see Figure 4 In some embodiments, the signal detection circuit module 40 includes a phase difference detection module 41 and a phase difference direction detection module 42. The input terminals of the phase difference detection module 41 and the phase difference direction detection module 42 are used to receive voltage data and current data, respectively, and their output terminals are connected to the microcontroller 20. The phase difference detection module 41 outputs the absolute value of the phase difference between the current and voltage to the microcontroller 20 based on the input voltage and current data. The phase difference direction detection module 42 outputs the phase difference direction information (i.e., the lead and lag relationship between the current phase and the voltage phase) to the microcontroller 20 based on the input voltage and current data. The phase difference information includes both absolute phase difference information and phase difference direction information. Since the microcontroller 20 obtains both the absolute phase difference information from the phase difference detection module 41 and the phase difference direction information from the phase difference direction detection module 42, it can perform frequency adjustment based on both the absolute phase difference information and the phase difference direction information.

[0046] Please see Figure 5Specifically, the phase difference direction detection module 42 includes a signal preprocessing module 421 and a phase difference direction latching module 422. The signal preprocessing module 421 is used to receive voltage data and current data and convert them into digital square waves. The phase difference direction latching module 422 is used to determine the phase difference direction by the order of the rising edges of the current and the rising edges of the voltage and output the phase difference direction information to the microcontroller 20.

[0047] In a specific example, the phase difference detection module 41 is an RF / IF amplitude and phase detection chip. The signal preprocessing module 421 of the phase difference direction detection module 42 includes a 74HC14D flip-flop, and the phase difference direction latch module 422 includes a 74HC74 flip-flop.

[0048] In some embodiments, the microcontroller 20 adjusts the frequency signal output to the phase-shift resonant PWM controller 30 based on the phase difference information, so that the phase difference between voltage and current approaches zero. In a specific example, when the absolute value of the phase difference exceeds a preset value, the microcontroller 20 adjusts the frequency signal based on the absolute value and direction of the phase difference.

[0049] Please see Figure 2 In some embodiments, the host 1 further includes a touch screen display 16, which is electrically connected to the control circuit module 11. Parameter adjustment and control operations can be performed via the touch screen display 16. Additionally, the touch screen display 16 can display relevant parameters; for example, the control circuit module 11 can display the obtained optimal frequency point on the touch screen display 16.

[0050] Please see Figure 2 In some embodiments, a switch / fuse 17 and a filter 18 are provided between the mains connector and the DC power supply 12.

[0051] In some embodiments, the host 1 is configured to adjust the power of the electrical signal output to the ultrasonic transducer 50 in real time based on voltage and current data.

[0052] Specifically, host 1 obtains voltage amplitude and current amplitude based on voltage data and current data. When the voltage amplitude and current amplitude deviate from the optimal range during normal operation, the power can be adjusted by adjusting the voltage amplitude.

[0053] Please see Figures 6 to 8In some embodiments, the ultrasonic transducer 50 includes an amplitude transformer 51, and an ultrasonic guidewire 9 is mounted at the distal end of the amplitude transformer 51. The ultrasonic vibration device 5 also includes a handle housing 60, on which a ranging module 63 is provided. The ranging module 63 is used to measure the distance data between itself and a predetermined position at the distal end of the amplitude transformer 51. The host 1 is configured to receive the distance data in real time and determine in real time whether to adjust the longitudinal vibration displacement of the amplitude transformer 51 based on the distance data, and adjust the electrical signal input to the ultrasonic transducer 50 in real time when the determination result is yes. The ultrasonic guidewire system of this application embodiment can realize real-time tracking and adjustment of the longitudinal vibration displacement of the amplitude transformer 51, thereby improving the working efficiency of the ultrasonic guidewire system.

[0054] It should be noted that the distance data measured by the ranging module 63 does not necessarily refer to the actual distance. For example, when the ranging module 63 is a laser probe (excluding signal processing and control unit), the distance data obtained by the ranging module 63 has not actually been converted into distance. At this time, the distance data refers to the data that can be processed to obtain the distance, such as the unprocessed data directly collected by the laser probe.

[0055] It should be noted that this application does not limit the location and specific form of the ranging module 63, as long as the ranging module 63 can collect distance data that can be used to calculate the longitudinal vibration displacement or reflect the change in the longitudinal vibration displacement (the distance data here can be the actual distance or data that can be converted into distance). Of course, it is not necessary to calculate the longitudinal vibration displacement. For example, it is possible to determine whether to adjust the longitudinal vibration displacement based on the directly collected distance.

[0056] Specifically, the longitudinal vibration displacement of the amplitude transformer 51 is adjusted by directly adjusting the voltage value of the electrical signal.

[0057] Please see Figure 7 and Figure 8 Specifically, the distal end of the amplitude rod 51 has a working end face 511 located inside the handle housing 60 as a set position, and the ranging module 63 is used to measure the distance data between it and the working end face 511.

[0058] Specifically, the working end face 511 is the end face of the amplitude transformer 51 (e.g., Figure 7 (as shown) or formed on the stepped surface at the distal end of the amplitude rod 51 (as shown) Figure 8 (As shown).

[0059] It should be noted that the embodiments of this application do not impose special restrictions on the specific location or objective conditions of the set position. As long as the ranging module 63 can measure the distance (for example, the surface of a conventional amplitude transformer can reflect light to enable distance measurement using a laser ranging module), and the measured distance data can reflect the change in longitudinal vibration displacement when the longitudinal vibration displacement of the amplitude transformer 51 changes relatively significantly (requiring adjustment of the vibration displacement), absolute accuracy is not required. Since the amplitude transformer 51 may experience slight lateral vibration during longitudinal vibration, this may affect the ranging accuracy of the set position, but it will not affect the detection of significant longitudinal vibration displacement.

[0060] For laser ranging modules, in order to achieve high ranging accuracy, the preferred setting position is one with high flatness to facilitate the reflection of light back to the laser ranging module.

[0061] Specifically, the ranging module 63 is configured to measure the vertical distance data between itself and the working end face 511.

[0062] Specifically, the ranging module 63 is disposed on the inner wall of the handle housing 60.

[0063] Specifically, a central through hole 621 is formed at the far end of the handle housing 60, and the ranging module 63 is disposed inside or beside the central through hole 621.

[0064] Specifically, the ranging module 63 is a ranging sensor, which is communicatively connected to the host 1.

[0065] Specifically, the ranging module 63 is the probe of the ranging sensor, and the host 1 includes a signal processing and control module for the ranging sensor (which can be independent of the host body or set in the host body). The signal processing and control module is connected to the probe.

[0066] Please see Figure 6 Specifically, the ranging module 63 is a laser probe, including a laser probe emitting end 631 and a laser probe acquiring end 632. The laser probe emitting end 631 is used to emit light to a set position, and the laser probe acquiring end is used to receive the light reflected from the set position. The laser probe emitting end 631 and the laser probe acquiring end 632 are respectively connected to the host 1.

[0067] Please see Figure 8 and Figure 9 In some embodiments, the ultrasonic transducer 50 includes an amplitude transformer 51, and the distal end of the amplitude transformer 51 is provided with a plurality of clamping arms 71 along the circumferential direction. The plurality of clamping arms 71 surround and form a clamping hole 72 for insertion of the ultrasonic guide wire 9. The ultrasonic vibration device 5 also includes a handle housing 60, which includes a housing body 61 and a self-tightening member 62, and the self-tightening member 62 is detachably connected to the handle housing 61. During the process of the self-tightening member 62 moving backward along the outer shell body 61 and being installed into the outer shell body 61, the self-tightening member 62 presses the multiple clamping arms 71 inward, causing the multiple clamping arms 71 to close towards the center, so that the clamping hole 72 shrinks inward. Multiple clamping arms 71 can be reset outward after the self-tightening member 62 is released from the housing body 61, so that the clamping hole 72 expands outward.

[0068] Through the above-mentioned technical means, the embodiments of this application can quickly install and remove the ultrasonic guide wire 9, and can realize the rapid replacement of ultrasonic devices.

[0069] Because the self-tightening element 62 and the clamping arm 71 are located at the distal end of the amplitude transformer 51, and the self-tightening element 62, the clamping arm 71, and the proximal ends of the ultrasonic guide wire 9 are closely fitted together, when the self-tightening element 62 is tightened, the three will be held together tightly, and their contact interfaces will generate large frictional forces, support forces, and clamping forces. In addition, because the acoustic impedance differences of the mechanical coupling structures such as the piezoelectric vibrator 52, the amplitude transformer 51, the self-tightening element 62, the clamping arm 71, and the ultrasonic guide wire 9 are relatively small, the ultrasonic waves generate a high proportion of incident and refracted waves at their contact interfaces. Therefore, the ultrasonic waves, mechanical energy, and vibrations at the distal end of the amplitude transformer 51 can propagate into the interior of the ultrasonic guide wire 9 after passing through the self-tightening element 62 and the clamping arm 71.

[0070] Specifically, the front end of the outer casing 61 forms a mounting head 611, and the self-tightening member 62 is connected to the mounting head 611 via a threaded connection. This threaded connection allows for quick and secure installation and disassembly of the self-tightening member 62. However, the self-tightening member 62 is not limited to a threaded connection; for example, it can also be connected to the mounting head 611 via a snap-fit ​​mechanism, as long as reliable installation of the self-tightening member 62 is achieved.

[0071] Specifically, multiple clamping arms 71 form an outer conical surface 711 that is narrower at the front and wider at the rear. During the process of the self-tightening member 62 moving rearward along the outer shell body 61 and being installed into the outer shell body 61, the self-tightening member 62 presses the outer conical surface 711 inward, causing the multiple clamping arms 71 to close towards the center. In this way, as the self-tightening member 62 moves rearward, the clamping arms 71 can be reliably pressed inward gradually. Specifically, a central through-hole 621 is formed at the middle of the front end of the self-tightening member 62. The limiting hole 621 includes a tapered section 622 that is narrower at the front and wider at the rear. The self-tightening member 62 presses the outer conical surface 711 of each clamping arm 71 inward through the conical surface of the tapered section 622.

[0072] exist Figure 8In the example, the clamping arm 71 is formed on a clamping member 70 independent of the luffing rod 51, and the clamping member 70 is mounted on the front end of the luffing rod 51. It can be considered that the luffing rod includes the luffing rod body 51 and the clamping member 70.

[0073] exist Figure 7 In the example, the clamping arm 71 is integrally formed at the front end of the amplitude rod 51.

[0074] Please see Figure 7 and Figure 8 In some embodiments, the ultrasonic transducer 50 includes, in addition to the amplitude transformer 51, a piezoelectric vibrator 52, an electrode 53, a rear cover 54, and a central screw 55. The piezoelectric vibrator 52 and the electrode 53 are disposed between the rear cover 55 and the amplitude transformer 51 (they can be alternately disposed), and the rear cover 54 and the amplitude transformer 51 are fixedly connected by the central screw 55. The host 1 is electrically connected to the corresponding electrode 53 to send and receive electrical signals. The electrode 53 transmits the received electrical signals from the host 1 to the piezoelectric vibrator 52. Based on the inverse piezoelectric effect, the piezoelectric vibrator 52 converts the electrical energy carried by the electrical signal into mechanical energy that drives the piezoelectric vibrator 52 to vibrate regularly. The vibration of the piezoelectric vibrator 52 is transmitted to the ultrasonic device 5 through the amplitude transformer 51.

[0075] In some embodiments, host 1 obtains voltage amplitude, current amplitude, and phase difference between voltage and current based on voltage data and current data; When the host 1 determines that the voltage amplitude and current amplitude suddenly drop beyond their respective preset thresholds while the phase difference between voltage and current remains within the normal range, it stops outputting electrical signals to the ultrasonic transducer 50.

[0076] Using the above-mentioned technical means, when the working end of the ultrasonic guidewire 9 comes into contact with soft tissues such as blood vessels, the system will automatically stop signal output to avoid damage to soft tissues such as blood vessels caused by the ultrasonic guidewire 9.

[0077] When the above situation occurs repeatedly, DSA image-guided analysis can be used to confirm that the ultrasound guidewire 9 has completed the penetration of fibrotic or calcified tissue, thus confirming the completion of the treatment process.

[0078] Please see Figure 10 In some embodiments, the ultrasound guidewire system further includes a guide sheath 91 and a microcatheter 92 used in conjunction with the ultrasound guidewire 9; the guide sheath 91 is directional for accessing and reaching the location of the coronary artery through the interventional surgical port and for insertion of the microcatheter 92; the microcatheter 92 is directional, with its distal end configured to extend from the distal end of the guide sheath 91 and reach the location of the coronary lesion; the ultrasound guidewire 9 is configured to insert into the microcatheter 92 and reach the location of the coronary lesion.

[0079] Once the proximal end of the ultrasonic guidewire 9 is assembled with the ultrasonic vibration device 5, it can be placed into the microcatheter 92 and slowly pushed to the vicinity of the lesion plaque causing vascular occlusion.

[0080] Specifically, the proximal end of the ultrasonic guidewire 9 is clamped by the clamping member 70 and then placed into the microcatheter 92.

[0081] More specifically, a reduced diameter portion 95 is formed by an inward recess at a position on the proximal end of the ultrasonic guidewire 9. When the ultrasonic guidewire 9 is assembled to the ultrasonic vibration device 5, the clamping member 70 clamps the reduced diameter portion 95.

[0082] Specifically, the proximal end of the guide sheath 91 is formed with an auxiliary inlet 911 with a large radial dimension, which facilitates the insertion of the microcatheter 92.

[0083] Specifically, the proximal end of the microcatheter 92 has an auxiliary inlet 921 with a large radial dimension, which facilitates the insertion of the ultrasonic guidewire 9.

[0084] Please see Figure 11 In some embodiments, the ultrasonic guidewire 9 is used in conjunction with a winding wire 94, which is sleeved and fixed to the distal end of the ultrasonic guidewire 9. A protective coating is formed on the outer surface of the ultrasonic guidewire 9. By using the winding wire 94, the flexibility and support of the ultrasonic guidewire 9 can be balanced, improving maneuverability, tactile feedback, and safety, enabling the ultrasonic guidewire 9 to safely pass through tortuous blood vessels.

[0085] Specifically, the middle section of the ultrasonic guidewire 9 forms multiple spaced-apart diameter reduction sections 93 along the axial direction. The outer peripheral surface of each diameter reduction section 93 is transitionally connected to the outer peripheral surface of the mandrel ultrasonic guidewire 9.

[0086] Alternatively, it can be configured such that the middle section of the ultrasonic guidewire 9 forms multiple spaced-apart diameter-increasing segments along the axial direction, and the outer peripheral surface of each diameter-increasing segment is transitionally connected to the outer peripheral surface of the ultrasonic guidewire 9.

[0087] By setting multiple diameter-reducing sections 93 or diameter-increasing sections, the transmission efficiency of ultrasonic energy can be improved.

[0088] In some embodiments, the ultrasonic guidewire 9 can be an existing guidewire or a specially designed guidewire.

[0089] The above-disclosed embodiments are merely preferred embodiments of this application and should not be construed as limiting the scope of this application. Therefore, any equivalent variations made in accordance with the scope of this application shall still fall within the scope of this application.

Claims

1. An ultrasonic guidewire system, characterized in that, include: Host; An ultrasonic vibration device, comprising an ultrasonic transducer, wherein the ultrasonic transducer is electrically connected to the main unit; An ultrasonic guidewire is mounted at the distal end of the ultrasonic transducer. The host is configured to output an electrical signal to the ultrasonic transducer to drive the ultrasonic transducer and the ultrasonic guidewire to vibrate, and to collect voltage and current data of the ultrasonic transducer in real time and adjust the frequency of the electrical signal output to the ultrasonic transducer in real time according to the voltage and current data.

2. The ultrasonic guidewire system according to claim 1, characterized in that, The host includes: a control circuit module, a DC power supply, a power regulation circuit module, a drive circuit module, and an ultrasonic power amplification circuit module; The control circuit module is electrically connected to the DC power supply, the power regulation circuit module and the drive circuit module respectively, and the control circuit module is configured to output a PWM control signal to the drive circuit module. The power regulation circuit module is electrically connected between the DC power supply and the ultrasonic power amplification circuit module. The drive circuit module is electrically connected to the ultrasonic power amplifier circuit module, and the drive circuit module is configured to output a drive signal to the ultrasonic power amplifier circuit module. The ultrasonic power amplifier circuit module is electrically connected to the ultrasonic transducer, and the ultrasonic power amplifier circuit module is configured to output an electrical signal to the ultrasonic transducer. The control circuit module acquires the voltage and current data of the ultrasonic transducer in real time and adjusts the PWM control signal output to the drive circuit module in real time according to the voltage and current data to adjust the frequency of the electrical signal.

3. The ultrasonic guidewire system according to claim 2, characterized in that, The control circuit module includes a microcontroller, a phase-shift resonant PWM controller, and a signal detection circuit module. The first output terminal of the microcontroller is connected to the frequency control input terminal of the phase-shift resonant PWM controller, and is used to output a frequency signal to the phase-shift resonant PWM controller. The second output terminal of the microcontroller is connected to the phase-shift control input terminal of the phase-shift resonant PWM controller, and is used to output a phase-shift control signal to the phase-shift resonant PWM controller. The output terminal of the phase-shift resonant PWM controller is connected to the input terminal of the drive circuit module, and is used to output the PWM control signal to the drive circuit module. The input terminal of the signal detection circuit module is used to acquire the voltage data and the current data. The signal detection circuit module outputs the phase difference information of the current and voltage to the microcontroller based on the voltage data and the current data. The microcontroller adjusts the frequency signal output to the phase-shift resonant PWM controller in real time based on the phase difference information.

4. The ultrasonic guidewire system according to any one of claims 1 to 3, characterized in that, The host is configured to adjust the power of the electrical signal output to the ultrasonic transducer in real time based on the voltage data and the current data.

5. The ultrasonic guidewire system according to any one of claims 1 to 3, characterized in that, The ultrasonic transducer includes an amplitude transformer, and the ultrasonic guidewire is mounted at the distal end of the amplitude transformer. The ultrasonic vibration device also includes a handle housing, on which a distance measuring module is provided. The distance measuring module is used to measure the distance data between itself and a set position at the far end of the amplitude transformer. The host is configured to receive the distance data in real time and determine whether to adjust the longitudinal vibration displacement of the amplitude transformer based on the distance data, and adjust the electrical signal input to the ultrasonic transducer in real time when the determination result is yes.

6. The ultrasonic guidewire system according to claim 5, characterized in that, The distal end of the amplitude lever has a working end face located inside the handle housing as the set position, and the ranging module is used to measure the distance data between it and the working end face.

7. The ultrasonic guidewire system according to claim 1, characterized in that, The ultrasonic transducer includes an amplitude transformer, and the distal end of the amplitude transformer is provided with a plurality of clamping arms along the circumferential direction. The plurality of clamping arms surround and form a clamping hole for inserting the ultrasonic guidewire. The ultrasonic vibration device also includes a handle housing and a self-tightening element, the self-tightening element being detachably connected to the handle housing; During the process of the self-tightening member moving backward along the handle housing and being installed into the handle housing, the self-tightening member presses the multiple clamping arms inward, causing the multiple clamping arms to close towards the center, so that the clamping hole contracts inward; The plurality of clamping arms are capable of resetting outward after the self-tightening member is disconnected from the handle housing, thereby causing the clamping holes to expand outward.

8. The ultrasonic guidewire system according to claim 1, characterized in that, The host computer obtains the voltage amplitude, current amplitude, and phase difference between voltage and current based on the voltage data and the current data; When the host determines that the voltage amplitude and the current amplitude suddenly drop beyond their respective preset thresholds while the phase difference between the voltage and the current remains within the normal range, it stops outputting electrical signals to the ultrasonic transducer.

9. The ultrasonic guidewire system according to claim 1, characterized in that, The ultrasonic guidewire system also includes a guide sheath and a microcatheter used in conjunction with the ultrasonic guidewire; The guide sheath is directional, allowing it to enter through the interventional surgical port and reach the location of the coronary artery, as well as to allow the insertion of the microcatheter. The microcatheter is directional, and its distal end is configured to extend from the distal end of the guide sheath and reach the location of the coronary lesion. The ultrasound guidewire is configured to be inserted into the microcatheter and reach the location of the coronary lesion.

10. The ultrasonic guidewire system according to claim 1, characterized in that, The ultrasonic guidewire is used in conjunction with a winding wire, which is sleeved and fixed at the distal end of the ultrasonic guidewire. A protective coating is formed on the outer surface of the ultrasonic guidewire.

11. The ultrasonic guidewire system according to claim 10, characterized in that, The middle section of the ultrasonic guidewire has multiple spaced-apart reducing or increasing diameter sections along the axial direction, and the outer peripheral surface of each reducing or increasing diameter section is transitionally connected to the outer peripheral surface of the ultrasonic guidewire.

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