Ultrasonic catheter

Abstract

The ultrasonic catheter comprises a catheter body and an ultrasonic transducer, the ultrasonic transducer is used for converting electric energy into mechanical energy, an early warning device is arranged at the far end of the ultrasonic transducer, and the early warning device can give out corresponding early warning according to the position of the catheter body. According to the ultrasonic catheter provided by the invention, higher image resolution and definition are provided in a relatively close detection distance range. Meanwhile, the ultrasonic sensor can provide dimensional and dimensional visual imaging, and direct physical contact between the catheter and the tissue structure in the heart cavity can be avoided.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an ultrasonic catheter. Background Art

[0002] In recent years, percutaneous catheter-based interventional diagnostic and treatment techniques have continued to advance, becoming a fundamental strategy for the diagnosis and treatment of many structural heart diseases and arrhythmias. With the increasing popularity and complexity of cardiac interventional procedures, the demand for intraoperative imaging is growing. Intracardiac echocardiography (ICE), with its advantages such as real-time imaging, real-time monitoring of intraoperative complications, and good tolerability, is highly suitable for these procedures. In particular, ICE catheters are increasingly used in various cardiac interventional procedures due to their lack of X-rays, repeatability, full visualization, and precise display of local anatomical structures, cardiac blood flow signals, and blood velocity.

[0003] The ICE catheter is an emerging imaging technology that uses a miniature transducer mounted on the catheter tip to transmit and receive high-frequency sound waves, enabling real-time, high-quality imaging and hemodynamic analysis of the heart and adjacent tissues. Based on different technical principles, intracardiac ultrasound catheters are categorized as mechanical rotary ultrasound catheters and electronic phased array ultrasound catheters. Currently, electronic phased array ultrasound catheters are primarily used clinically. Utility Model Content

[0004] In order to solve the problems existing in the prior art, the present application provides an ultrasonic catheter.

[0005] The ICE catheter has a high barrier to use and a long learning curve, requiring the operator to rotate the catheter and operate the two knobs on the catheter handle to complete imaging within the cardiac cavity. Installing a magnetic sensor at the tip of the ICE catheter allows real-time monitoring of the catheter's position within the cardiac cavity using a three-dimensional mapping system. However, this still cannot prevent the distal tip of the catheter from contacting the intracardiac tissue, leading to perforation and rupture. Therefore, applying a function that issues a warning when the distal tip of the catheter contacts the intracardiac tissue or that knows in advance the distance between the distal tip of the catheter and the intracardiac tissue structure can increase the safety of the operation while reducing the operator's training cycle.

[0006] Commonly used imaging technologies in cardiovascular medicine include optical coherence tomography (OCT) and ultrasound. OCT is limited by its own detection depth and blood flow, so ultrasound can better achieve early warning functions.

[0007] The specific technical solutions of this application are as follows:

[0008] 1. An ultrasonic catheter, wherein the ultrasonic catheter comprises a catheter and an ultrasonic transducer, wherein the ultrasonic transducer is used to convert electrical energy into mechanical energy.

[0009] An early warning device is provided at the distal end of the ultrasonic transducer, and the early warning device can issue a corresponding alarm according to the position of the catheter.

[0010] 2. According to the ultrasonic catheter of item 1, the warning device is capable of issuing an alarm based on the position of the catheter before contact with human tissue.

[0011] 3. The ultrasound catheter according to item 1 or 2, wherein the warning device comprises an ultrasound sensor.

[0012] 4. According to the ultrasound catheter of item 3, the ultrasound sensor and the ultrasound transducer are integrally formed.

[0013] 5. The ultrasound catheter according to item 4, wherein the ultrasound sensor has a square structure.

[0014] 6. The ultrasound catheter according to item 5, wherein the side length of the ultrasound sensor is 0.5 to 2.5 mm; the thickness of the ultrasound sensor is 0.5 to 2.5 mm;

[0015] Preferably, the side length of the ultrasonic sensor is 1 to 1.5 mm; the thickness of the ultrasonic sensor is 1 to 1.5 mm.

[0016] 7. According to the ultrasonic catheter of item 4, the distance between the ultrasonic sensor and the ultrasonic transducer in the axial direction is 0.1 to 2 mm, preferably 0.5 to 1 mm.

[0017] 8. The ultrasound catheter according to item 4, wherein an acoustic attenuation layer is provided between the ultrasound sensor and the ultrasound transducer.

[0018] 9. The ultrasonic catheter according to item 8, wherein the sound attenuation layer comprises rubber particles, epoxy resin, tungsten powder, and glass beads.

[0019] 10. The ultrasonic catheter according to item 8, wherein the attenuation coefficient of the acoustic attenuation layer is -10 to -45 dB, preferably -20 to -35 dB.

[0020] 11. The ultrasound catheter according to item 1 or 2, wherein the warning device is capable of sounding an alarm when in contact with human tissue.

[0021] 12. According to the ultrasonic catheter described in item 11, a mounting groove for mounting an early warning device is provided on the distal end of the catheter; the early warning device is fixedly connected through the mounting groove.

[0022] 13. The ultrasound catheter according to item 11, wherein the warning device comprises an electrode.

[0023] 14. The ultrasound catheter according to item 13, wherein the electrode is columnar, preferably cylindrical.

[0024] 15. According to the ultrasound catheter of item 14, the distal end of the electrode is hemispherical, and a groove begins to be formed near the middle of the electrode along the axis, and the groove is annular.

[0025] 16. The ultrasound catheter according to item 15, wherein a connecting portion is provided at the proximal end of the electrode, and an outer diameter of the connecting portion is smaller than an outer diameter of the electrode.

[0026] 17. According to the ultrasound catheter of item 11, the warning device includes a pressure sensor; preferably, the pressure sensor is a fiber optic sensor, and more preferably, it is a highly sensitive fiber optic sensor.

[0027] 18. The ultrasonic catheter according to item 17, wherein an electromagnetic shielding wire is provided on the periphery of the pressure sensor.

[0028] 19. The ultrasound catheter according to item 17, wherein the pressure sensor is columnar, preferably cylindrical.

[0029] 20. According to the ultrasonic catheter described in item 19, the outer diameter of the pressure sensor is 1 to 3 mm; the thickness is 1 to 3 mm; preferably, the outer diameter of the pressure sensor is 2-2.5 mm; the thickness is 1.5 to 2 mm.

[0030] 21. The ultrasound catheter according to item 1 or 2, wherein the ultrasound transducer comprises an ultrasonic crystal and a cable; the cable is arranged at the proximal end of the ultrasonic crystal.

[0031] 22. According to the ultrasonic catheter of item 21, the ultrasonic transducer further comprises a driving element capable of driving the ultrasonic crystal to vibrate, and preferably the driving element is a piezoelectric ceramic.

[0032] 23. According to the ultrasonic catheter described in item 21, the length of the ultrasonic crystal is 6 to 12 mm; the width is 1 to 3.5 mm; and the thickness is 0.5 to 3 mm; preferably, the length of the ultrasonic crystal is 8 to 10 mm, the width is 2 to 2.7 mm, and the thickness is 1 to 2 mm.

[0033] 24. The ultrasound catheter according to item 21, wherein the length of the cable is 900 to 1500 mm, preferably 1000 to 1200 mm.

[0034] 25. According to the ultrasonic catheter of item 21, two passive piezoelectric ceramics are respectively provided on both sides of the effective radiation surface of the ultrasonic crystal.

[0035] 26. According to the ultrasound catheter of item 1, the ultrasound catheter also includes a magnetic sensor for positioning; the magnetic sensor is a columnar structure, preferably a cylindrical structure.

[0036] 27. The ultrasound catheter according to item 26, wherein the magnetic sensor is located at the proximal end of the ultrasound transducer and is electrically connected to the ultrasound transducer.

[0037] 28. The ultrasound catheter according to item 26 or 27, wherein the distance between the magnetic sensor and the ultrasound transducer is less than 1 mm; preferably less than 0.5 mm.

[0038] 29. The ultrasonic catheter according to item 1 or 2 further comprises a sound-transmitting window, wherein the sound-transmitting window is arranged at the distal end of the catheter, a rectangular through groove is opened in the sound-transmitting window, the early warning device is arranged at the distal end of the rectangular through groove, and the ultrasonic transducer is arranged at the proximal end of the rectangular groove.

[0039] 30. The ultrasonic catheter according to item 1 or 2, wherein a plurality of drawing wires are arranged inside the catheter, the drawing wires are coaxially arranged with the catheter, and the drawing wires are located inside the tube skin of the catheter.

[0040] 31. The ultrasonic catheter according to item 30, wherein the number of the drawing wires is four and the four drawing wires are evenly arranged along the circumference of the catheter.

[0041] 32. The ultrasound catheter of item 1 or 2, comprising an inner plastic layer, a metal braided mesh, and an outer plastic layer.

[0042] 32. According to the ultrasonic catheter described in item 1 or 2, the inner plastic layer is made of polytetrafluoroethylene, the outer plastic layer is made of polyether block polyamide, and the metal braided mesh is a mesh structure made of stainless steel or nickel-titanium alloy.

[0043] 33. A method for manufacturing an ultrasonic catheter, wherein:

[0044] Select an integrated ultrasonic sensor with suitable piezoelectric ceramics;

[0045] Cutting the piezoelectric ceramic into two parts using a cutting tool to form two separation layers;

[0046] Filling the space between the two separated layers after cutting with sound attenuation material to form a sound attenuation layer;

[0047] Fixing the separation layer after filling the sound attenuation material;

[0048] The two fixed separation layers are encapsulated inside the ultrasound catheter.

[0049] 34. The method according to item 33, wherein the blade thickness of the cutting tool is 10 μm.

[0050] 35. According to the method described in item 33, the accuracy of the tool when cutting piezoelectric ceramics is controlled within 1%.

[0051] 36. The method according to item 33, wherein the interval between the two separated layers after division is 0.2 to 2 mm; preferably 0.5 to 1 mm.

[0052] 37. According to the method of item 33, the two separated layers after segmentation are used for diagnostic imaging and for ranging, respectively.

[0053] 38. According to the method of item 33, the sound attenuation material includes colloidal particles, epoxy resin, tungsten powder, and glass beads.

[0054] 39. The method according to item 33, wherein the attenuation coefficient of the sound attenuation layer is -10 to -45 dB, preferably -20 to -35 dB.

[0055] 40. The method according to item 33, wherein when fixing the two separation layers, the separation layers forming the sound attenuation layer are placed together in a high-precision mold, and heated in an oven at 60-90°C for 6-8 hours, and then cooled to room temperature.

[0056] 41. According to the method described in item 33, when installing the two fixed separation layers, the ultrasonic catheter needs to be pre-formed, the material of the ultrasonic catheter needs to be modified, and then hot-melt encapsulated.

[0057] Beneficial effects

[0058] The ultrasonic catheter of the present application has the following beneficial effects:

[0059] 1. The ultrasonic transducer provided in this application utilizes high-performance piezoelectric ceramics as its driving element, which can improve the transducer's detection depth and imaging resolution. The passive piezoelectric ceramics left on either side of the active radiating element can reduce the transducer's edge effects during acoustic radiation, minimizing acoustic energy loss, improving acoustic detection efficiency, and enhancing the imaging quality of intracardiac catheters.

[0060] 2. The magnetic sensor provided in this application can provide a positioning function for the front end of the catheter in the magnetic positioning system, and the magnetic sensor is in close contact with the ultrasonic transducer, which improves the positioning and navigation accuracy of the distal end of the catheter in the cardiac cavity, and at the same time facilitates the operator to determine the imaging base point of the ultrasonic transducer.

[0061] 3. When the distal tip placement warning device for an intracardiac ultrasound catheter provided in this application utilizes an electrode or pressure sensor, when the tip electrode or pressure sensor contacts intracardiac tissue, impedance data is displayed on the 3D mapping system. The system automatically zooms in on the warning device model image, allowing the operator to make minor adjustments to the catheter. If the impedance data exceeds the rated value, the system issues an alarm indicating that the catheter poses a risk of damaging intracardiac tissue. This feature significantly improves surgical safety and reduces operator training time.

[0062] 4. The intracardiac ultrasound catheter distal tip placement warning device provided in this application employs an ultrasonic sensor using an electronic phased array, which operates at a higher frequency than an ultrasonic transducer. This provides higher image resolution and clarity within a shorter detection range. Furthermore, the ultrasonic sensor provides visual imaging, preventing direct physical contact between the catheter and intracardiac tissue structures.

[0063] 5. The preformed notches in the acoustic window provided by this application can improve the success rate of packaging ultrasound transducers and early warning devices. The use of a multi-component blend of flexible materials also increases acoustic transmission efficiency, thereby improving the imaging quality of intracardiac catheters. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 It is a schematic diagram of the ultrasound catheter of this application.

[0065] In the figure, 1. Ultrasonic transducer; 2. Magnetic sensor; 3. Early warning device; 4. Sound-transmitting window; 5. Catheter. DETAILED DESCRIPTION

[0066] The present application is described in detail below. Although specific embodiments of the present application are shown, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0067] It should be noted that certain words are used in the specification and claims to refer to specific components. Those skilled in the art should understand that technicians may use different nouns to refer to the same component. This specification and claims do not use the difference in nouns as a way to distinguish components, but use the difference in the functions of the components as the criterion for distinction. As mentioned throughout the specification and claims, "including" or "comprising" are open-ended terms and should be interpreted as "including but not limited to". The subsequent description of the specification is a preferred embodiment of the present application, but the description is based on the general principles of the specification and is not intended to limit the scope of the present application. The scope of protection of this application shall be as defined by the attached claims.

[0068] refer to Figure 1 The present application provides an ultrasonic catheter, wherein the ultrasonic catheter includes a catheter 5 and an ultrasonic transducer 1, and the ultrasonic transducer 1 is used to convert electrical energy into mechanical energy.

[0069] An early warning device 3 is provided at the distal end of the ultrasonic transducer 1 , and the early warning device 3 can issue a corresponding alarm according to the position of the catheter 5 .

[0070] In the field of interventional medicine, the end closest to the operator is defined as the "proximal end," and the end away from the operator is defined as the "distal end." For elongated objects, the direction parallel to their length is defined as the "axial direction." For objects with a circular cross-section, the direction surrounding their axis is defined as the "circumferential direction." For cylindrical objects, the direction of their extension is defined as the "axial direction," and the direction of the circular cross-section's radius is defined as the "radial direction."

[0071] The ultrasonic transducer 1 used in this application converts input electrical energy into mechanical vibration energy, i.e., ultrasonic waves, and transmits the generated ultrasonic waves. Ultrasonic transducer 1 is used to generate ultrasonic waves, which are then used to detect human body conditions.

[0072] The catheter 5 used in this application is a strip-shaped tubular structure, and the ultrasonic transducer 1 is arranged at the distal end of the tube. When the ultrasonic transducer 1 detects the human body, the catheter 5 will transport the ultrasonic transducer 1 into the human body.

[0073] When the ultrasonic transducer 1 is transported into the human body, in order to improve the detection accuracy of the ultrasonic transducer 1 on the human body, the ultrasonic transducer 1 is placed as close to the tissue as possible. However, since it is difficult to accurately position the ultrasonic transducer 1 inside the human body, it is easy for the ultrasonic transducer 1 to collide with the human tissue when moving inside the human body, causing damage to the human tissue. Furthermore, when inside the human heart, there is a risk of premature beats.

[0074] The warning device 3 is located distally from the ultrasonic transducer 1. When the ultrasonic transducer 1 approaches human tissue, the warning device 3 sounds an alarm, warning that the ultrasonic transducer 1 is too close to or in contact with the tissue. This allows the user to control the ultrasonic transducer 1 to move away from the tissue during the warning, reducing the possibility of the ultrasonic catheter puncturing or scratching the tissue, and reducing contact between the ultrasonic catheter or ultrasonic transducer 1 and the tissue, thereby reducing the possibility of the ultrasonic transducer 1 causing damage to the tissue.

[0075] In a specific embodiment, the warning device 3 can issue an alarm based on the position of the catheter 5 before contacting the human tissue.

[0076] The warning device 3 is used to issue a warning based on the distance between the ultrasonic transducer 1 or the catheter 5 and the human tissue, thereby reducing the risk of damage to the tissue caused by the ultrasonic transducer 1 or the catheter 5, or preventing the ultrasonic transducer 1 or the catheter 5 from contacting the tissue for a long time, thereby causing significant damage.

[0077] In order to further reduce the possibility of the ultrasonic transducer 1 causing damage to the tissue when in contact with the tissue, the early warning device 3 can warn that the ultrasonic transducer 1 is too close to the human body before contacting the human tissue, thereby enabling the user to react accordingly when the ultrasonic transducer 1 approaches the human tissue, thereby further reducing the possibility of the ultrasonic transducer 1 causing damage to the human tissue.

[0078] The early warning device 3 includes an ultrasonic sensor.

[0079] An ultrasonic sensor is a sensor that converts ultrasonic signals into other energy signals (usually electrical signals). The ultrasonic transducer 1 is capable of generating ultrasonic waves. When the ultrasonic waves emitted from the ultrasonic transducer 1 come into contact with human tissue, part of the ultrasonic waves will be reflected by the human tissue, and the reflected ultrasonic waves will be captured by the ultrasonic sensor. The time difference between the ultrasonic sensor and the ultrasonic transducer 1 and the time of capturing the ultrasonic waves is then used to calculate the distance between the ultrasonic sensor and the human tissue. The early warning device 3 then issues an alarm based on the calculation results of the ultrasonic sensor. The user can then know that the distance between the ultrasonic transducer 1 and the human tissue is too close. The user can then evacuate the ultrasonic transducer 1 to reduce damage to the human tissue.

[0080] In a specific embodiment, when the ultrasonic sensor detects that the distance between it and human tissue is less than 5 mm, the early warning device 3 will sound an alarm.

[0081] The ultrasound catheter provided in this application is equipped with an ultrasonic sensor at the distal end for early warning. Using an electronic phased array, the ultrasonic sensor operates at a higher frequency than an ultrasonic transducer, providing higher image resolution and clarity within a shorter detection range. Furthermore, the ultrasonic sensor provides visual imaging, avoiding direct physical contact between the catheter and intracardiac tissue structures.

[0082] The ultrasonic sensor and the ultrasonic transducer 1 are integrally formed.

[0083] Specifically, the main components of the ultrasonic sensor and the main components of the ultrasonic transducer 1 are both made of piezoelectric ceramics. Therefore, the main piezoelectric components of the ultrasonic sensor and the ultrasonic transducer 1 are integrally formed during their manufacture.

[0084] The integrally formed ultrasonic sensor and ultrasonic transducer 1 can significantly reduce the space occupied by them, and thus reduce the space occupied by the early warning device 3 , thereby enabling the early warning device 3 to be installed in a limited space.

[0085] The ultrasonic sensor has a square structure.

[0086] The ultrasonic sensor may be circular, sector-shaped, crescent-shaped, elliptical, rectangular, square, trapezoidal, rhombus-shaped, pentagonal, polygonal, or irregular in shape. Preferably, the ultrasonic sensor is a square or rectangular structure.

[0087] The shape of the ultrasonic sensor refers to its cross-sectional shape along the axial direction.

[0088] The square ultrasonic sensor of a regular shape can more easily capture ultrasonic waves located in the distal direction thereof, thereby improving the detection accuracy of the ultrasonic sensor.

[0089] The side length of the ultrasonic sensor is 0.5 to 2.5 mm; the thickness of the ultrasonic sensor is 0.5 to 2.5 mm;

[0090] Preferably, the side length of the ultrasonic sensor is 1 to 1.5 mm; the thickness of the ultrasonic sensor is 1 to 1.5 mm.

[0091] Specifically, the side lengths of the ultrasonic sensor are: 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, and 2.5mm.

[0092] Specifically, the thickness of the ultrasonic sensor is: 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, and 1.5 mm.

[0093] The distance between the ultrasonic sensor and the ultrasonic transducer 1 in the axial direction is 0.1 to 2 mm, preferably 0.5 to 1 mm.

[0094] Specifically, the distance between the ultrasonic sensor and the ultrasonic transducer 1 on the axis is: 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, and 2mm.

[0095] A sound attenuation layer is provided between the ultrasonic sensor and the ultrasonic transducer 1 .

[0096] The acoustic attenuation layer serves to separate the ultrasonic sensor from the ultrasonic transducer 1, thereby reducing the impact of the ultrasonic waves generated by the ultrasonic transducer 1 on the ultrasonic sensor. This allows the ultrasonic sensor to accurately capture ultrasonic waves reflected by human tissue, improving the accuracy of the ultrasonic sensor's warning of the distance to human tissue.

[0097] The sound attenuation layer includes rubber particles, epoxy resin, tungsten powder and glass beads.

[0098] The sound attenuation layer is obtained by mixing rubber particles, epoxy resin, tungsten powder, glass beads, etc. in a certain proportion.

[0099] The sound attenuation layer is prepared by the following method: rubber particles, epoxy resin, tungsten powder, glass beads and other materials are mixed in proportion, and then heated at a certain temperature to form the mixture.

[0100] The attenuation coefficient of the sound attenuation layer is -10 to -45 dB, preferably -20 to -35 dB.

[0101] Specifically, the attenuation coefficient of the sound attenuation layer is: -45dB, -44dB, -43dB, -42dB, -41dB, -40dB, -39dB, -38dB, -37dB, -36dB, -35dB, -34dB, -33dB, -32dB, -31dB, -30dB, -29dB, -28dB, -27dB, -26dB, -25dB, -24dB, -23dB, -22dB, -21dB, -20dB, -19dB, -18dB, -17dB, -16dB, -15dB, -14dB, -13dB, -12dB, -11dB, and -10dB.

[0102] In a specific embodiment, the warning device 3 can sound an alarm when it comes into contact with human tissue.

[0103] In this embodiment, the warning device 3 is a contact warning device, that is, the alarm will be issued only when the warning device 3 contacts or contacts human tissue, and no alarm will be issued when the distance between the warning device 3 and human tissue is too close but not in contact.

[0104] Because the warning device 3 is trigger-activated and located distally from the ultrasonic transducer, it issues a corresponding alarm by detecting contact with human tissue. Therefore, upon seeing the alarm from the warning device 3, the user will know that the warning device or ultrasonic transducer 1 has come into contact with human tissue. The user should then remove the ultrasonic transducer 1 or move it with minimal force. This reduces the risk of tissue damage caused by misdirection after the ultrasonic catheter contacts the tissue.

[0105] A mounting groove for mounting the early warning device 3 is provided on the distal end of the catheter 5 ; the early warning device 3 is fixedly connected via the mounting groove.

[0106] The mounting slot is defined in the catheter 5, so the warning device 3 is fixedly connected to the catheter 5, and the warning device 3 is located at the distal end of the ultrasonic transducer 1. Therefore, the ultrasonic transducer 1 is mounted between the catheter 5 and the warning device 3; and since both the ultrasonic transducer 1 and the warning device 3 are connected to the catheter 5, there is no direct connection between the ultrasonic transducer 1 and the warning device 3.

[0107] Directly connecting the warning device 3 to the catheter 5 firstly reduces the connection structure between the warning device 3 and the ultrasonic transducer 1, thereby reducing the need for modification and impact on the ultrasonic transducer 1. Secondly, when the warning device 3 contacts human tissue to generate an alarm, the force acting on the warning device 3 will directly act on the catheter 5, reducing the possibility of this force affecting the ultrasonic transducer 1.

[0108] When the ultrasound catheter is performing in-vivo detection, the warning device 3, directly connected to the catheter 5, is located at the distal end. When the warning device 3 comes into contact with human tissue, it detects the contact or reacts to the tissue, triggering an alarm. The force exerted by the tissue on the warning device 3 acts directly on the catheter 5, minimizing its impact on the ultrasonic transducer 1.

[0109] The early warning device 3 includes electrodes.

[0110] An electrode is positioned distally from the ultrasonic transducer 1 and fixedly connected to the catheter 5. Two electrodes are provided. When the electrodes come into contact with human tissue, due to the electrophysiological properties of tissue, the tissue creates a connection between the two electrodes. This connection allows the electrodes to determine whether they are in contact with human tissue.

[0111] Use the electrode pair to determine whether the catheter 5 or the ultrasonic transducer 1 is in contact with human tissue.

[0112] When the ultrasonic transducer 1 and catheter 5 are moved inside the human body, when the distal electrode contacts the body, communication between the two electrodes occurs, and the warning device 3 sounds an alarm. This alerts the user that the distal end of the catheter 5 has come into contact with human tissue. This instructs the user to pay attention to the direction and position of movement of the catheter 5, thus reducing damage to human tissue caused by the ultrasonic transducer 1 and catheter 5.

[0113] The electrode is columnar, preferably cylindrical.

[0114] The electrode is located at the distal end of the ultrasonic transducer 1 , so when the ultrasonic transducer 1 moves inside the human body under the action of the catheter 5 , the electrode is used to trigger an alarm when the ultrasonic transducer 1 contacts human tissue.

[0115] In order to enable the electrode to respond quickly when it contacts tissue as the ultrasonic transducer 1 moves, and to reduce the risk of the electrode puncturing human tissue, the cylindrical electrode can significantly reduce the number of sharp edges on the electrode's periphery, thereby reducing the possibility of scratches or lacerations caused by the electrode. Furthermore, when the ultrasonic transducer 1 and the electrode are moving, or even when the electrode slides along human tissue under the action of the ultrasonic transducer 1, the possibility of scratches or lacerations caused by the electrode is reduced.

[0116] The distal end of the electrode is hemispherical, and a groove is provided near the middle of the electrode along the axial direction, and the groove is annular.

[0117] The distal tip of the electrode is designed to be hemispherical and conform to the cylinder, further transforming the edge of the distal end of the electrode into a smooth curved surface, reducing the possibility of scratches on human tissue caused by the electrode tip. Furthermore, the smooth spherical tip further reduces sharp corners, thereby reducing the possibility of punctures caused by the electrode.

[0118] A connecting portion is provided at the proximal end of the electrode, and an outer diameter of the connecting portion is smaller than an outer diameter of the electrode.

[0119] The connecting portion is used to connect the electrode to the ultrasonic transducer 1. Since the electrode and the ultrasonic transducer 1 are made of different materials, welding is difficult to achieve. Therefore, the electrode and the ultrasonic transducer 1 are connected by a clip-on method. The groove provided on the proximal end of the electrode enables the electrode to be clipped onto the ultrasonic transducer 1. In order to reduce the size of the proximal end of the electrode and to facilitate the clipping of the electrode to the ultrasonic transducer, the outer diameter of the connecting portion is smaller, so that the connection structure between the electrode and the ultrasonic transducer 1 is more easily adapted to the outer diameter of the electrode, further reducing the possibility of sharp corners or edges on the outer peripheral surface of the electrode; reducing the possibility of the electrode causing damage to human tissue.

[0120] In another specific embodiment, the early warning device 3 is a pressure sensor;

[0121] A pressure sensor is used for early warning. The pressure sensor can detect the pressure at the distal end of the ultrasonic transducer 1, thereby further reducing the possibility of the ultrasonic transducer 1 causing harm to the human body due to the uncertain position when performing mapping in the human body. On the other hand, the pressure sensor can detect the force applied by the ultrasonic transducer 1 during movement, and can also detect the pressure generated when the ultrasonic transducer 1 presses on human tissue. Therefore, at this time, for a specific tissue structure, when contact mapping is required, the pressure detected by the pressure sensor can be used to achieve mapping of the human tissue within a range that causes less damage to the tissue. In other words, the use of a pressure sensor can control the pressure of the ultrasonic transducer 1 on the human tissue within a reasonable range, thereby achieving mapping of specific tissues.

[0122] Specifically, when the pressure detected by the pressure sensor is greater than 0, the early warning device 3 will trigger an alarm.

[0123] The pressure sensor is preferably an optical fiber sensor, and more preferably a highly sensitive optical fiber sensor.

[0124] Fiber optic sensors are fabricated by utilizing the relationship between the propagation characteristics of light in optical fiber materials and the pressure acting on photoelastic elements. Using fiber optic sensors here can firstly increase the transmission of pressure sensor signals. Optical fiber data transmission speeds are fast, and low latency allows users to immediately know the intensity of force applied. Secondly, fiber optic sensors offer higher detection accuracy. At the same time, fiber optic sensors are more sensitive. When the ultrasonic transducer 1 comes into contact with human tissue, it is immediately detected by the fiber optic sensor, allowing the user to immediately understand the relationship between the fiber optic sensor and the human tissue. This, in turn, reduces the possibility of ultrasonic transducer 1 causing damage to human tissue.

[0125] An electromagnetic shielding wire is provided on the outer periphery of the pressure sensor.

[0126] The electromagnetic shielding wire is arranged on the periphery of the pressure sensor, and the electromagnetic shielding wire wraps the pressure sensor. The electromagnetic shielding wire is used to shield the electromagnetic signal. When the pressure sensor detects pressure or transmits the detected pressure signal, the pressure sensor may generate an electrical signal. The electromagnetic shielding wire can restrain the electrical signal generated by the pressure sensor, reduce the overflow of the electrical signal generated by the pressure sensor, and thereby prevent the electrical signal from interfering with the ultrasonic transducer 1 in mapping human tissue. This improves the accuracy of mapping human tissue.

[0127] The pressure sensor is in a columnar shape, preferably a cylindrical shape.

[0128] The shape of the pressure sensor refers to its cross-sectional shape along the axial direction of the catheter.

[0129] The pressure sensor is used to detect pressure, so it only detects pressure when in contact with human tissue. To reduce the possibility of sharp corners at the distal end of the pressure sensor causing punctures or scratches to the tissue, the pressure sensor is designed to be cylindrical to minimize tissue damage. Furthermore, because the pressure sensor can detect the pressure exerted by the ultrasonic transducer 1 on tissue, the distal end of the pressure sensor can be non-spherical to control manufacturing costs and enable the pressure sensor to more accurately detect pressure when in contact with human tissue.

[0130] When the distal tip placement warning device for an intracardiac ultrasound catheter provided in this application utilizes an electrode or pressure sensor, when the electrode or pressure sensor contacts intracardiac tissue, impedance data or pressure data is displayed on a three-dimensional mapping system. The system automatically amplifies the warning device model image, allowing the operator to make minor adjustments to the catheter, thereby reducing the possibility of tissue damage caused by the ultrasound transducer or catheter.

[0131] When impedance data or pressure data exceeds the rated value, the system alarm indicates that the catheter has the risk of damaging the tissue in the cardiac cavity. This function greatly improves the safety of the operation and reduces the training period of the operator.

[0132] The outer diameter of the pressure sensor is 1-3 mm, and the thickness is 1-3 mm. Preferably, the outer diameter of the pressure sensor is 2-2.5 mm, and the thickness is 1.5-2 mm.

[0133] Specifically, the outer diameter of the pressure sensor is: 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, and 3mm.

[0134] Specifically, the thickness of the pressure sensor is: 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, and 3mm.

[0135] The ultrasonic transducer 1 includes an ultrasonic crystal and a cable; the cable is arranged at the proximal end of the ultrasonic crystal.

[0136] Ultrasonic crystals are used to emit or receive ultrasonic waves.

[0137] After the ultrasonic transducer 1 generates ultrasonic waves, they are emitted to human tissues. Then, according to the different reflections of ultrasonic waves by different human tissues, the human tissues are mapped by detecting the ultrasonic waves reflected by the tissues.

[0138] The ultrasonic transducer 1 emits ultrasonic waves, which are irradiated on human tissue and reflected by the human tissue. The ultrasonic crystal can then capture the ultrasonic waves reflected by the human tissue and convert the received ultrasonic signals into electrical signals, which are then transmitted through the cable.

[0139] The distal end of the cable is connected to an ultrasonic crystal, while the proximal end is connected to a 3D mapping system. This system converts the electrical signals transmitted by the cable into a 3D model of human tissue, allowing the user to diagnose the tissue.

[0140] The ultrasonic transducer 1 further includes a driving element capable of driving the ultrasonic crystal to vibrate, and the driving element is preferably a piezoelectric ceramic.

[0141] The driver is bonded to the ultrasonic crystal and is a device that converts electrical signals into ultrasonic signals. It can also drive the ultrasonic crystal to vibrate.

[0142] In this application, both the ultrasonic crystal and the driver element are capable of converting ultrasonic signals into electrical signals. The ultrasonic crystal is highly sensitive to ultrasonic signals, so it is used to receive ultrasonic signals reflected by human tissue. The driver element is used to transmit ultrasonic signals. The three-dimensional mapping system transmits the electrical signals to the driver element. The driver element is then able to emit a strong ultrasonic signal, enabling the ultrasonic signal emitted by the driver element to map the human body.

[0143] This application uses a driver element and an ultrasonic crystal to transmit and receive ultrasonic signals, respectively, allowing the ultrasound catheter to emit sufficiently strong ultrasonic waves for mapping. At the same time, the high-precision ultrasonic crystal can accurately capture ultrasonic signals reflected by the human body, further improving the accuracy of the ultrasound catheter's mapping of the human body.

[0144] Preferably, the driving element in this application is a piezoelectric ceramic.

[0145] The length of the ultrasonic crystal is 6 to 12 mm, the width is 1 to 3.5 mm, and the thickness is 0.5 to 3 mm. Preferably, the length of the ultrasonic crystal is 8 to 10 mm, the width is 2 to 2.7 mm, and the thickness is 1 to 2 mm.

[0146] Specifically, the lengths of the ultrasonic crystals are: 6mm, 6.3mm, 6.5mm, 6.7mm, 7mm, 7.3mm, 7.5mm, 7.7mm, 8mm, 8.3mm, 8.5mm, 8.7mm, 9mm, 9.3mm, 9.5mm, 9.7mm, 10mm, 10.3mm, 10.5mm, 10.7mm, 11mm, 11.3mm, 11.5mm, 11.7mm, and 12mm.

[0147] The width of the ultrasonic crystal is: 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm.

[0148] The thickness of the ultrasonic crystal is: 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, and 3mm.

[0149] The length of the cable is 900-1500 mm, preferably 1000-1200 mm.

[0150] Specifically, the cable lengths are: 900mm, 930mm, 950mm, 970mm, 1000mm, 1030mm, 1050mm, 1070mm, 1100mm, 1130mm, 1150mm, 1170mm, 1200mm, 1230mm, 1250mm, 1270mm, 1300mm, 1330mm, 1350mm, 1370mm, 1400mm, 1430mm, 1450mm, 1470mm, and 1500mm.

[0151] Two passive piezoelectric ceramics are respectively arranged on both sides of the effective radiation surface of the ultrasonic crystal.

[0152] The passive piezoelectric ceramics left on either side of the effective radiating element are used to mitigate the edge effects of ultrasonic transducer 1, reducing energy loss during use and increasing the strength of the ultrasonic signal emitted by ultrasonic transducer 2. This also enhances the ultrasonic signal reflected from human tissue, making tissue mapping more accurate. This further improves the efficiency of acoustic detection, enhances the imaging quality of intracardiac catheters, and improves the detection depth and imaging resolution of the ultrasonic transducer.

[0153] The ultrasonic catheter further includes a magnetic sensor 2 for positioning; the magnetic sensor 2 is a columnar structure, preferably a cylindrical structure.

[0154] Here, the shape of the magnetic sensor 2 refers to its cross-sectional shape along the axial direction of the catheter.

[0155] The magnetic sensor 2 is arranged on the ultrasound catheter. Preferably, the magnetic sensor 2 is arranged on the ultrasound transducer 1 .

[0156] The magnetic sensor 2 is fixedly connected to the ultrasonic transducer 1. The magnetic sensor provided in this application can provide a positioning function for the front end of the catheter in the magnetic positioning system, so that the operator can know the precise position of the ultrasonic transducer 1 inside the human body. At the same time, the magnetic sensor 2 uses magnetic induction for positioning, which has strong penetrating power while causing less harm to the human body. It is convenient to obtain the position of the ultrasonic transducer 1. So that the ultrasonic transducer 1 can be delivered to the target area, and it is convenient for the operator to determine the imaging base point of the ultrasonic transducer. The positioning and navigation accuracy of the distal end of the intracardiac catheter is improved, thereby improving the accuracy of the ultrasonic catheter in detecting human tissue.

[0157] The magnetic sensor 2 is located at the proximal end of the ultrasonic transducer 1 and is electrically connected to the ultrasonic transducer 1 .

[0158] The magnetic sensor 2 is positioned opposite the early warning device 3. The early warning device 3 is used to warn of contact between the distal end of the ultrasonic transducer 1 and human tissue. The magnetic sensor 2 is used to position the ultrasonic transducer 1, allowing it to accurately move to the target location along a preset route. Through the interaction between the early warning device 3 and the magnetic sensor 2, the ultrasonic transducer 1 can be accurately transported to the target location in the human body for mapping, while also reducing damage to human tissue caused by the ultrasonic transducer 1 during the mapping process.

[0159] When the ultrasound catheter enters the human body, the user can use magnetic sensor 2 to locate it, allowing the ultrasound catheter to advance along the preset route. Furthermore, magnetic sensor 2 can promptly detect when the ultrasound catheter deviates from its path. Furthermore, magnetic sensor 2 can precisely locate the point where the ultrasound catheter deviates from its path. This allows the user to quickly determine if the ultrasound catheter has deviated and provides guidance for the next step. This reduces the risk of accidental damage to the ultrasound catheter.

[0160] The distance between the magnetic sensor 2 and the ultrasonic transducer 1 is less than 1 mm; preferably less than 0.5 mm.

[0161] Specifically, the distance between the secondary sensor and the ultrasonic transducer 1 is less than: 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, or 0.1 mm.

[0162] The ultrasonic catheter also includes a sound-transmitting window 4, which is arranged at the distal end of the catheter 5. A rectangular through groove is opened in the sound-transmitting window 4, the early warning device 3 is arranged at the distal end of the rectangular through groove, and the ultrasonic transducer 1 is arranged at the proximal end of the rectangular groove.

[0163] The rectangular through-slot is used to house the ultrasonic transducer 1, and the acoustic window 4 is sleeved on the outside of the ultrasonic transducer 1. The acoustic window 4 corresponds to the part of the ultrasonic transducer 1 that emits ultrasonic waves. The ultrasonic waves emitted by the ultrasonic transducer 1 can pass through the acoustic window 4. At the same time, the acoustic window can also protect the ultrasonic transducer 1, reducing the possibility of damage to the ultrasonic transducer 1 inside human tissue.

[0164] Because the ultrasonic transducer 1 is an electrical device, liquids can easily cause internal damage and malfunction. Therefore, when used inside the human body, a protective structure is placed around the transducer 1. To minimize the impact of the protective structure on the ultrasonic signal emitted by the transducer 1, the portion of the transducer 1 used to emit the ultrasonic signal for mapping is located within the acoustic window 4. This allows the ultrasonic wave to accurately pass through the acoustic window 4.

[0165] The acoustically transparent window 4 is made of a material that has minimal impact on ultrasonic signals. This allows the ultrasonic signal to pass through the acoustically transparent window 4 and irradiate human tissue. Simultaneously, the ultrasonic signal reflected by the tissue can also pass through the acoustically transparent window 4 and enter the ultrasonic transducer 1, where it can be captured. This allows for mapping of human tissue.

[0166] Specifically, the sound-transmitting window 4 is made of PEBAX material.

[0167] The preformed notch of the acoustic window 4 provided in this application can improve the packaging success rate of the ultrasonic transducer 1 and the early warning device 3. At the same time, the use of a multi-component mixed flexible material improves the acoustic transmission efficiency, thereby improving the imaging quality of the intracardiac catheter.

[0168] A plurality of drawing wires are arranged inside the catheter 5 , and the drawing wires are arranged coaxially with the catheter 5 , and are located inside the tube skin of the catheter 5 .

[0169] The drawing wire is slidably connected to the catheter 5 and can slide inside the catheter 5 .

[0170] The drawing wire is used to control the bending of the distal end of the catheter 5 , and the distal end of the drawing wire is fixedly connected to the distal end of the catheter 5 .

[0171] As the opposing wires slide, they cause the catheter 5 to bend. For example, if one of the two opposing wires extends while the other contracts, the catheter 5 will bend from the extending wire toward the contracting wire. By controlling the expansion and contraction of the wires, the catheter 5 is bent, allowing it to follow a pre-set path and precisely reach the target location.

[0172] Hiding the wire inside the catheter 5 reduces the possibility of abrasion between the wire and human tissue as it moves within the body, thus improving the safety of catheter 5. Furthermore, catheter 5 protects the wire and reduces the possibility of damage. In the art, catheter 5 is relatively long and flexible. Therefore, the wire is subjected to less force during use. Therefore, under normal circumstances, the service life of the wire is longer than that of catheter 5. Furthermore, in certain specific use cases, ultrasonic catheters are disposable. If damaged, the wire has low repair value, so simply placing the wire inside catheter 5 is sufficient.

[0173] There are four drawing wires, which are evenly arranged along the circumference of the catheter 5 .

[0174] The circumferentially arranged drawing wires are grouped into two opposite groups, each corresponding to a bending direction of the control tube 5. The four drawing wires work together to control the tube 5 to bend in multiple directions, thereby improving the flexibility of the tube 5.

[0175] The catheter 5 comprises an inner plastic layer, a metal braided mesh and an outer plastic layer.

[0176] The inner plastic layer is made of polytetrafluoroethylene, the outer plastic layer is made of polyether block polyamide, and the metal woven mesh is a mesh structure made of stainless steel and nickel-titanium alloy.

[0177] The metal braided mesh is used to support the catheter 5. It also increases the strength of the catheter 5, providing sufficient support for the catheter 5 as it moves through the body. It also provides sufficient strength for the catheter 5, reducing the likelihood of it breaking.

[0178] The inner plastic layer and the outer plastic layer are respectively arranged on the inner and outer sides of the metal braided mesh. The inner plastic layer and the outer plastic layer wrap the metal braided mesh. On the one hand, they protect the metal braided mesh and reduce the possibility of corrosion of the metal braided mesh. On the other hand, the inner plastic layer and the outer plastic layer are relatively soft, which can reduce the possibility of the metal braided mesh causing scratches or punctures to human tissue when inside the human body. It is worth mentioning that after the inner plastic layer and the outer plastic layer wrap the metal braided mesh, they will also fill the gaps inside the metal braided mesh and fill the pores between the metal braided meshes. This reduces the mutual friction between the metal inside the metal braided mesh when it is bent, thereby reducing the loss of the metal braided mesh itself and improving the safety of the catheter 5.

[0179] In summary, the present application provides an ultrasound catheter. When the ultrasound catheter is in use, the warning device 3 at the distal end thereof can issue a warning when the ultrasound catheter contacts or is about to contact the human body.

[0180] When an ultrasonic sensor is used in the early warning device 3 for detection, the ultrasonic sensor will determine the distance between the early warning device 3 and the ultrasonic transducer 1 and the human tissue by detecting the reflection of the ultrasonic wave after it is emitted. Then, when the distance is too close, the early warning device 3 will issue an early warning.

[0181] When the early warning device 3 uses electrodes, the electrodes located at the distal end of the ultrasonic transducer 1 detect human tissue upon contact, triggering an alarm. The manufacturing and processing costs of the electrodes are significantly lower than those of pressure sensors and ultrasonic sensors. Furthermore, the electrodes are more stable.

[0182] When the early warning device 3 uses a pressure sensor for detection, the pressure sensor detects the pressure exerted by the ultrasonic transducer 1 on the human tissue after contact with the human tissue. If the pressure exerted by the ultrasonic transducer 1 on the human tissue is excessive, an alarm is sounded. Using a pressure sensor can detect situations where the ultrasonic transducer 1 is in contact with the human body but does not cause damage to the human tissue. This helps address extreme situations that are difficult to measure. It can meet the need for detecting human tissue while minimizing damage to the tissue.

[0183] A method for manufacturing an ultrasonic catheter, wherein:

[0184] Select an integrated ultrasonic sensor with suitable piezoelectric ceramics;

[0185] Cutting the piezoelectric ceramic into two parts using a cutting tool to form two separation layers;

[0186] Filling the space between the two separated layers after cutting with sound attenuation material to form a sound attenuation layer;

[0187] Fixing the separation layer after filling the sound attenuation material;

[0188] The two fixed separation layers are encapsulated inside the ultrasound catheter.

[0189] In the present application, the piezoelectric ceramic inside the ultrasonic catheter is cut and processed so as to separate the piezoelectric ceramic into two parts.

[0190] The two separated layers are then used for diagnostic imaging and distance measurement respectively.

[0191] Therefore, in this application, this segmentation method enables the ultrasound catheter to perform distance measurement at the distal end. Furthermore, the ultrasound catheter manufactured using the above method can not only perform ultrasound mapping but also perform distance detection, thereby reducing the possibility of the catheter 5 penetrating human tissue.

[0192] The present application creatively uses a segmentation method to separate the piezoelectric ceramic having only a mapping function into an independent distance measuring unit, so that the mapping unit and the distance measuring unit in the present application only need to use the same power supply.

[0193] In this application, an acoustic attenuation layer is placed between the two separated layers to reduce the impact of the ultrasonic waves generated by the mapping layer on the distance measurement layer, allowing the distance measurement layer to accurately detect the distance between the ultrasound catheter and human tissue.

[0194] The thickness of the blade of the cutting tool was 10 μm.

[0195] Specifically, the blade thickness of the tool is 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, and 10 μm.

[0196] The precision of the tool when cutting piezoelectric ceramics is controlled within 1%.

[0197] Specifically, the accuracy of the tool when cutting ceramics is controlled at 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, and 1%.

[0198] The interval between the two separated layers after division is 0.2 to 2 mm, preferably 0.5 to 1 mm.

[0199] Specifically, the interval between the two separation layers after segmentation is 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, and 2mm.

[0200] The two separated layers after segmentation are used for diagnostic imaging and distance measurement respectively.

[0201] Sound attenuation materials include colloidal particles, epoxy resin, tungsten powder, and glass beads.

[0202] The preparation method of the sound attenuation layer is as follows: rubber particles, epoxy resin, tungsten powder, glass beads and other materials are mixed in proportion, and then heated at a certain temperature to form the mixture.

[0203] The attenuation coefficient of the sound attenuation layer is -10 to -45 dB, preferably -20 to -35 dB.

[0204] The attenuation coefficient of the sound attenuation layer is: -45dB, -44dB, -43dB, -42dB, -41dB, -40dB, -39dB, -38dB, -37dB, -36dB, -35dB, -34dB, -33dB, -32dB, -31dB, -30dB, -29dB, -28dB, -27dB, -26dB, -25dB, -24dB, -23dB, -22dB, -21dB, -20dB, -19dB, -18dB, -17dB, -16dB, -15dB, -14dB, -13dB, -12dB, -11dB, -10dB.

[0205] When the two separation layers are fixed, the separation layers forming the sound attenuation layer are placed together in a high-precision mold, and are heated in an oven at 60 to 90° C. for 6 to 8 hours, and then cooled to room temperature.

[0206] The viscosity of the sound attenuation layer is increased by heating, and then the separation layers on both sides of the sound attenuation layer are bonded by cooling, thereby solidifying and fixing the two separation layers and the sound attenuation layer.

[0207] When installing the two fixed separation layers, the ultrasonic catheter needs to be preformed, the material of the ultrasonic catheter needs to be modified, and then hot-melt encapsulated.

[0208] Example

[0209] The present application provides an ultrasonic catheter, which includes a catheter and an ultrasonic transducer. The catheter includes an inner plastic layer, a metal braided mesh, and an outer plastic layer. Specifically, the inner plastic layer is made of polytetrafluoroethylene, which has a lower coefficient of friction and allows for smoother forward movement. The outer plastic layer is made of polyether block polyamide, which has good flexibility and bending resistance. The metal braided mesh uses metals such as stainless steel and nickel-titanium alloy as a supporting skeleton, and is woven into a mesh structure to give the catheter greater toughness and strength.

[0210] The diameter of the catheter is 3.33 mm.

[0211] The ultrasonic transducer consists of a rectangular ultrasonic crystal and a cable. The ultrasonic crystal is 9 mm long, 2 mm wide, and 1.5 mm thick. The cable is a flexible printed circuit board and is 1000 mm long.

[0212] The overall structure of the ultrasonic transducer has a length of 1100 mm, a width of 2 mm, and a thickness of 1.5 mm.

[0213] The magnetic sensor is a cylindrical structure with a diameter of 1.6 mm and a thickness of 7 mm. The distance between the magnetic sensor and the ultrasonic transducer is 0.5 mm.

[0214] The acoustic window is a cylindrical structure with an outer diameter of 3.33mm and a length of 21mm. It is made of PEBAX.

[0215] When the early warning device is an ultrasonic sensor, the ultrasonic sensor has a square structure, a side length of 2 mm, and a thickness of 1.5 mm.

[0216] When the early warning device is an electrode, the electrode has a cylindrical structure with a diameter of 3.33 mm and a height of 2 mm.

[0217] When the early warning device is a pressure sensor, the pressure sensor has a cylindrical structure, an outer diameter of the pressure sensor is 2 mm, and a height of 2 mm.

[0218] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed, but as long as they are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. An ultrasonic catheter, characterized in that: The ultrasonic catheter comprises a catheter and an ultrasonic transducer, wherein the ultrasonic transducer is used to convert electrical energy into mechanical energy. An early warning device is provided at the distal end of the ultrasonic transducer, and the early warning device can issue a corresponding alarm according to the position of the catheter.

2. The ultrasonic catheter according to claim 1, wherein The early warning device includes an ultrasonic sensor.

3. The ultrasonic catheter according to claim 2, characterized in that The ultrasonic sensor has a square structure.

4. The ultrasonic catheter according to claim 3, characterized in that The side length of the ultrasonic sensor is 0.5-2.5 mm; the thickness of the ultrasonic sensor is 0.5-2.5 mm.

5. The ultrasonic catheter according to claim 3, characterized in that The side length of the ultrasonic sensor is 1 to 1.5 mm; the thickness of the ultrasonic sensor is 1 to 1.5 mm.

6. The ultrasonic catheter according to claim 2, characterized in that The distance between the ultrasonic sensor and the ultrasonic transducer in the axial direction is 0.1 to 2 mm.

7. The ultrasonic catheter according to claim 2, characterized in that The distance between the ultrasonic sensor and the ultrasonic transducer in the axial direction is 0.5-1 mm.

8. The ultrasonic catheter according to claim 2, characterized in that A sound attenuation layer is provided between the ultrasonic sensor and the ultrasonic transducer.

9. The ultrasonic catheter according to claim 8, characterized in that The sound attenuation layer comprises rubber particles, epoxy resin, tungsten powder and glass beads.

10. The ultrasonic catheter according to claim 8, characterized in that The attenuation coefficient of the sound attenuation layer is -10 to -45 dB.

11. The ultrasonic catheter according to claim 8, characterized in that The attenuation coefficient of the sound attenuation layer is -20 to -35 dB.

12. The ultrasonic catheter according to claim 1, wherein A mounting groove for mounting an early warning device is provided on the distal end of the catheter; the early warning device is fixedly connected via the mounting groove.

13. The ultrasonic catheter according to claim 1, characterized in that The early warning device includes electrodes.

14. The ultrasonic catheter according to claim 13, characterized in that The distal end of the electrode is hemispherical, and a groove is formed near the middle of the electrode along the axis, and the groove is annular.

15. The ultrasonic catheter according to claim 14, characterized in that A connecting portion is provided at the proximal end of the electrode, and an outer diameter of the connecting portion is smaller than an outer diameter of the electrode.

16. The ultrasonic catheter according to claim 1, characterized in that The early warning device includes a pressure sensor.

17. The ultrasonic catheter according to claim 16, characterized in that The pressure sensor is a fiber optic sensor.

18. The ultrasonic catheter according to claim 16, characterized in that The pressure sensor is a highly sensitive optical fiber sensor.

19. The ultrasonic catheter according to claim 16, wherein An electromagnetic shielding wire is provided on the outer periphery of the pressure sensor.

20. The ultrasonic catheter according to claim 16, wherein The pressure sensor is cylindrical.

21. The ultrasonic catheter according to claim 16, wherein The pressure sensor is cylindrical.

22. The ultrasonic catheter according to claim 16, wherein The outer diameter of the pressure sensor is 1 to 3 mm, and the thickness is 1 to 3 mm.

23. The ultrasonic catheter according to claim 16, wherein The outer diameter of the pressure sensor is 2-2.5 mm, and the thickness is 1.5-2 mm.

24. The ultrasonic catheter according to claim 1, wherein The ultrasonic transducer includes an ultrasonic crystal and a cable; the cable is arranged at the proximal end of the ultrasonic crystal.

25. The ultrasonic catheter according to claim 24, characterized in that The ultrasonic transducer further includes a driving element capable of driving the ultrasonic crystal to vibrate.

26. The ultrasonic catheter according to claim 25, characterized in that The driving element is piezoelectric ceramic.

27. The ultrasonic catheter according to claim 24, characterized in that The ultrasonic crystal has a length of 6 to 12 mm, a width of 1 to 3.5 mm, and a thickness of 0.5 to 3 mm.

28. The ultrasonic catheter according to claim 24, wherein The ultrasonic crystal has a length of 8 to 10 mm, a width of 2 to 2.7 mm, and a thickness of 1 to 2 mm.

29. The ultrasonic catheter according to claim 24, wherein The length of the cable is 900-1500 mm.

30. The ultrasonic catheter according to claim 24, wherein The length of the cable is 1000-1200 mm.

31. The ultrasonic catheter according to claim 24, wherein Two passive piezoelectric ceramics are respectively arranged on both sides of the effective radiation surface of the ultrasonic crystal.

32. The ultrasonic catheter according to claim 1, wherein The ultrasonic catheter further includes a magnetic sensor for positioning; the magnetic sensor is a columnar structure.

33. The ultrasonic catheter according to claim 32, characterized in that The magnetic sensor is a cylindrical structure.

34. The ultrasonic catheter according to claim 32, wherein The magnetic sensor is located at the proximal end of the ultrasonic transducer and is electrically connected to the ultrasonic transducer.

35. The ultrasonic catheter according to claim 32, wherein The distance between the magnetic sensor and the ultrasonic transducer is less than 1 mm.

36. The ultrasonic catheter according to claim 32, wherein The distance between the magnetic sensor and the ultrasonic transducer is less than 0.5 mm.

37. The ultrasonic catheter according to claim 1, wherein The ultrasonic catheter also includes a sound-transmitting window, which is arranged at the distal end of the catheter. A rectangular through groove is opened in the sound-transmitting window, the early warning device is arranged at the distal end of the rectangular through groove, and the ultrasonic transducer is arranged at the proximal end of the rectangular groove.

38. The ultrasonic catheter according to claim 1, wherein A plurality of drawing wires are arranged inside the catheter, the drawing wires are coaxially arranged with the catheter, and the drawing wires are located inside the tube skin of the catheter.

39. The ultrasonic catheter according to claim 38, characterized in that There are four drawing wires, and the four drawing wires are evenly arranged along the circumference of the catheter.

40. The ultrasonic catheter according to claim 1, wherein The catheter includes an inner plastic layer, a metal braided mesh, and an outer plastic layer.

41. The ultrasonic catheter according to claim 40, characterized in that The inner plastic layer is made of polytetrafluoroethylene, the outer plastic layer is made of polyether block polyamide, and the metal woven mesh is a mesh structure made of stainless steel and nickel-titanium alloy.

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