Ultrasonic detection auxiliary system for catheter and method therefor

Abstract

An ultrasonic detection auxiliary system for a catheter and a method therefor, which are applicable to an ultrasonic detection auxiliary system for a catheter, which system is imported into a cardiovascular system, so as to improve the blockage of the cardiovascular system or tissues surrounding the cardiovascular system. The ultrasonic detection auxiliary system for a catheter comprises: an ultrasonic balloon catheter, which has an ultrasonic probe to continuously emit ultrasonic waves and obtain a calcified blood vessel reflection signal; and a control host. The ultrasonic detection auxiliary system for a catheter further comprises: a signal receiving unit, which is electrically connected to the ultrasonic probe to receive a calcification reflection analog signal; a digital-to-analog conversion circuit, which is configured to receive the calcified blood vessel reflection signal and generate a calcification feature signal; a duplex circuit, which is coupled to the signal receiving unit and the digital-to-analog conversion circuit; a processing unit, which is electrically connected to the digital-to-analog conversion circuit and is configured to perform analysis operation on the calcification feature signal to generate a control signal, so as to enhance or reduce ultrasonic output energy; and an amplification circuit, which is electrically connected to the processing unit and is configured to amplify a resonant signal on the basis of the control signal, such that the ultrasonic probe emits ultrasonic waves.

Description

Ultrasonic detection auxiliary system and method for catheter Technical Field

[0001] The present application is a catheter-based ultrasonic detection-assisted system and method, and in particular, relates to a catheter-based ultrasonic detection-assisted system and method used in vascular treatment that can use an ultrasonic probe to receive the degree of vascular calcification and fragmentation to adjust the intensity and direction of the ultrasonic wave. Background Art

[0002] Cardiovascular disease has long been among the top ten causes of death worldwide. With an aging population and a shift toward a more Westernized diet, the prevalence and mortality rates of cardiovascular disease are increasing annually, with the incidence trending toward younger patients. Coronary artery disease (CAD) and peripheral artery disease (PAD) are the most common cardiovascular diseases. Both are primarily caused by the accumulation of fat or other substances in the arteries, which harden and form plaques or calcifications, leading to arteriosclerosis and obstruction of blood flow. As you can imagine, insufficient or no blood flow in the coronary arteries can lead to heart disease or even heart failure, resulting in sudden death. Furthermore, PAD can cause pain when walking and impaired wound healing in the limbs. In severe cases, it can lead to critical limb ischemia (CLI) and amputation.

[0003] When vascular calcification causes the vessel walls to harden and lose their elasticity, the contraction and relaxation functions of the vessels deteriorate. Furthermore, excessive calcium deposition occurs on the vessel walls, a condition known as vascular calcification. Calcification can lead to vascular stenosis, which in turn causes blood flow obstruction. Generally, there are many ways to treat vascular stenosis, such as laser or atherectomy. Currently, the most common and cheapest method is percutaneous transluminal angioplasty (PTA), commonly known as balloon catheter dilation. This procedure uses water pressure to inflate a balloon, thereby restoring the narrowed blood vessels. However, when the symptoms of sclerosis are too severe, the balloon often fails to expand and ruptures, posing surgical risks.

[0004] Summary of the Invention

[0005] The purpose of this application is to provide a catheter-based ultrasonic detection-assisted system and method. This system uses an ultrasonic probe that emits ultrasonic waves to induce a cavitation effect, and uses ultrasonic wave reflection or scattering to determine the fragmentation of vascular calcification. This system is used to adjust the intensity and direction of the ultrasonic waves in a timely manner, effectively improving arterial blockage or stubborn vascular calcification.

[0006] To achieve the above objectives, the present application provides a catheter-based ultrasound detection assistance system suitable for introduction into the cardiovascular system to improve blockage in the cardiovascular system or surrounding tissues. The catheter-based ultrasound detection assistance system comprises: an ultrasonic balloon catheter having at least two ultrasonic probes for continuously emitting an ultrasonic wave and obtaining a calcified blood vessel reflection signal; and a control host further comprising: a signal receiving unit electrically connected to the at least two ultrasonic probes for receiving the calcified blood vessel reflection analog signal; a digital-to-analog conversion circuit for receiving the calcified blood vessel reflection signal and generating a calcification characteristic signal; a duplex circuit coupling the signal receiving unit and the digital-to-analog conversion circuit; and a processing unit electrically connected to the digital-to-analog conversion circuit for analyzing and calculating the calcification characteristic signal to generate a correlation value, a sample entropy value, a Shannon entropy value, an approximate entropy value, and an envelope signal-to-noise ratio (ENR). The processing unit includes a processor, a processor, and a processor. The processor generates a calcification data value based on the correlation value, and generates a control signal based on the calcification data value, the sample entropy value, the Shannon entropy value, the approximate entropy value, and the packet signal-to-noise ratio to increase or decrease the ultrasonic output energy. The processor also includes an amplifier circuit, electrically connected to the processing unit, and configured to amplify a resonance signal based on the control signal to enable the ultrasonic probe to transmit the ultrasonic wave.

[0007] In one embodiment of the present application, the ultrasonic balloon catheter comprises a multi-lumen catheter, a flexible hose having at least one opening, and a balloon made of a polymer material, having an expansion portion for expansion and contraction, and a neck portion disposed at each end of the expansion portion. The balloon is fixed to the outside of the multi-lumen catheter by each of the neck portions, and the expansion portion and each of the neck portions form an expansion space outside the multi-lumen catheter for injecting a fluid composition containing microbubbles through each of the openings.

[0008] In one embodiment of the present application, the at least two ultrasonic probes are disposed in the expansion portion of the balloon and are sleeved on the multi-lumen catheter to emit an ultrasonic wave and induce the microbubbles in the fluid composition located in the expansion space to produce an inertial cavitation effect.

[0009] In one embodiment of the present application, the multi-lumen catheter comprises an inner tube and an outer tube, which are arranged in a concentric circle structure. The inner tube forms a guidewire lumen, in which a guidewire is located. The guidewire lumen allows the ultrasonic balloon catheter to slide between blood vessels and allows the expanded portion of the balloon to be placed at a calcified site in the blood vessel. The outer tube has at least one chamber, including a microbubble chamber for injecting the fluid composition and a power chamber for providing an electric wire for supplying power to each of the ultrasonic probes.

[0010] In one embodiment of the present application, the inner tube of the multi-lumen catheter has an outer diameter of 1 to 0.5 mm and an inner diameter of 0.8 to 0.3 mm, and the outer tube has an outer diameter of 2 mm and an inner diameter of 1 to 0.5 mm.

[0011] In one embodiment of the present application, the ultrasonic balloon catheter further includes a catheter assembly, one end of which is connected to the multi-lumen catheter, and the other end of which has a guide wire channel and a fluid composition channel. The guide wire channel allows the guide wire to pass through the guide wire lumen, and the fluid composition channel allows the fluid composition to be injected into the microbubble lumen.

[0012] In one embodiment of the present application, the at least two ultrasound probes can be divided into a transmitting probe for transmitting the ultrasound and a receiving probe for obtaining the reflected signal of the calcified blood vessel, and the transmitting probe and the receiving probe are spaced apart and arranged on the ultrasound balloon catheter.

[0013] In one embodiment of the present application, the at least two ultrasonic probes are tubular ultrasonic probes having an inner diameter of 0.5 to 1 mm, an outer diameter of 1.5 to 2.5 mm, and a height of 2 to 6 mm, and a resonant frequency of 100 k to 2 MHz and 2 M to 10 MHz.

[0014] In one embodiment of the present application, the ground electrodes on the outer surfaces of the at least two ultrasonic probes are divided into electrodes with gaps of 0.01 to 0.2 mm cut every 90 to 180 degrees.

[0015] The present application also includes a catheter-assisted ultrasound detection method suitable for use in a cardiovascular system to improve blockage in the cardiovascular system or surrounding tissues. The catheter-assisted ultrasound detection method comprises the following steps: transmitting an ultrasound wave through an ultrasound probe in an ultrasound balloon catheter and obtaining a calcified blood vessel reflection signal through another ultrasound probe; receiving the calcification reflection analog signal through a signal receiving unit of a control host; converting the calcified blood vessel reflection signal into a calcification characteristic signal through a digital-to-analog conversion circuit; analyzing the calcification characteristic signal through a processing unit to generate a correlation value, which is cross-correlated with samples in a database to determine the type of calcification and generate a calcification data value; and calculating a sample entropy value, a Shannon entropy value, an approximate entropy value, and an envelope signal-to-noise ratio (ENV) based on the calcification characteristic signal through the processing unit. SNR) and compares it with a sample entropy threshold, a Shannon entropy threshold, an approximate entropy threshold, and a packet signal-to-noise ratio threshold in the database to determine a calcification fragmentation level. The processing unit determines whether the vascular calcification has been completely fragmented based on the calcification data value and the calcification fragmentation level. When the vascular calcification has been completely fragmented, a control signal is generated to stop transmitting the ultrasound wave. When the vascular calcification has not been completely fragmented, the control signal is generated and the ultrasound wave is adjusted in size through the amplification circuit. After a preset time, the signal receiving unit reacquires the reflected signal from the calcified blood vessel and performs analysis and calculation.

[0016] The catheter-use ultrasonic detection-assisted system and method of the present application have at least the following characteristics: ultrasonic waves are emitted by a transmitting probe in a plurality of ultrasonic probes to induce a cavitation effect, and the reflected ultrasonic waves are received by a receiving probe to understand the status of vascular calcification and fragmentation, thereby adjusting the intensity and direction of the ultrasonic waves in a timely manner. The catheter-use ultrasonic detection-assisted system and method can effectively improve arterial blockage or stubborn vascular calcification. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG1 is a block diagram of an ultrasonic detection auxiliary system for a catheter according to the present application;

[0018] FIG2 is a schematic structural diagram of an ultrasonic detection auxiliary system for a catheter according to the present application;

[0019] FIG3 is a schematic diagram of an ultrasonic balloon catheter of an ultrasonic detection auxiliary system for a catheter according to the present application;

[0020] 4A to 4D are schematic diagrams of a multi-lumen catheter of a catheter ultrasonic detection auxiliary system according to the present application;

[0021] FIG5 is a schematic diagram of an ultrasonic probe of an ultrasonic detection auxiliary system for a catheter according to the present application;

[0022] FIG6 is a schematic diagram of an ultrasonic balloon catheter according to the first embodiment of the present application;

[0023] 7 is a flowchart of the operation of the catheter ultrasound detection auxiliary system according to the first embodiment of the present application;

[0024] FIG8 is a schematic diagram of an ultrasonic balloon catheter according to a second embodiment of the present application;

[0025] FIG9 is an operation flow chart of a catheter-use ultrasound detection auxiliary system according to a second embodiment of the present application;

[0026] FIG10 is a flowchart of a method for assisting catheter ultrasound detection according to the present application;

[0027] FIG. 11 is a schematic diagram illustrating the cavitation effect.

[0028] In the figure: 11 ultrasonic balloon catheter; 111 ultrasonic probe; 1111 transmitting probe; 1112 receiving probe; 1113 slit; 1114 live wire; 1115 ground pole; 112 multi-lumen catheter; 1121 opening; 113 balloon; 1131 dilator; 1132 neck; 12 control host; 121 signal receiving unit; 122 digital-to-analog conversion circuit; 123 duplex circuit; 124 processing unit; 125 amplification circuit; 13 catheter assembly; 131 guide wire channel; 132 fluid composition channel; 2 multi-lumen catheter; 21 inner tube; 211 guide wire cavity; 22 outer tube; 221 microbubble cavity; 222 power cavity; 2221 electric wire; step S101 to S107B process flow. DETAILED DESCRIPTION

[0029] In order to make the above features and advantages of the present application more obvious and easy to understand, the following embodiments are specifically given in conjunction with the accompanying drawings. In addition to these detailed descriptions, the present application can also be widely implemented in other embodiments. Any easy replacement, modification, and equivalent changes of the described embodiments are included in the scope of this application and are subject to the scope of the patent application.

[0030] In the description of the specification, many specific details are provided to provide the reader with a more complete understanding of the present application; however, the present application may still be implemented if some or all of the specific details are omitted. In addition, well-known steps or components are not described in detail to avoid unnecessary limitations on the present application. Identical or similar components in the drawings are represented by identical or similar symbols. It is important to note that the drawings are for illustrative purposes only and do not represent the actual size or number of components. Some details may not be fully drawn to maintain the simplicity of the drawings. A detailed description is provided below.

[0031] The following descriptions of the various embodiments are made with reference to the accompanying drawings to illustrate specific embodiments in which the present application may be implemented. Directional terms mentioned in this application, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the accompanying drawings. Therefore, the directional terms used are used to illustrate and understand the present application, rather than to limit the present application. In addition, in the specification, unless explicitly described to the contrary, the word "comprising" will be understood to mean including the stated elements but not excluding any other elements.

[0032] FIG1 is a block diagram of an ultrasonic detection auxiliary system for a catheter according to the present application. 1 , a catheter-based ultrasound detection auxiliary system is shown. The catheter-based ultrasound detection auxiliary system is suitable for being introduced into the cardiovascular system to improve blockage in the cardiovascular system or its surrounding tissues. The catheter-based ultrasound detection auxiliary system comprises: an ultrasound balloon catheter 11 having at least two ultrasound probes 111 for continuously transmitting an ultrasound wave and obtaining a calcified blood vessel reflection signal; and a control host 12 further comprising: a signal receiving unit 121 electrically connected to the at least two ultrasound probes 111 for receiving the calcification reflection analog signal; a digital-to-analog conversion circuit 122 for receiving the calcified blood vessel reflection signal and generating a calcification characteristic signal; a duplex circuit 123 coupling the signal receiving unit 121 and the digital-to-analog conversion circuit 122; and a processing unit 124 electrically connected to the digital-to-analog conversion circuit 122 for analyzing and calculating the calcification characteristic signal to generate a correlation value, a sample entropy value, and a Shannon entropy value. Entropy), an approximate entropy, and an envelope signal-to-noise ratio (Envelope SNR), and generates a calcification data value based on the correlation value, and generates a control signal based on the calcification data value, the sample entropy, the Shannon entropy, the approximate entropy, and the envelope signal-to-noise ratio to enhance or reduce the ultrasonic output energy; and an amplifier circuit 125 is electrically connected to the processing unit 124, and is used to amplify a resonance signal based on the control signal to enable the ultrasonic probe 111 to transmit the ultrasonic wave.

[0033] Among them, the cavitation effect is also known as cavitation phenomenon, cavitation phenomenon or hollow phenomenon, which refers to the cavitation effect induced by microbubbles when ultrasonic waves of a certain energy and frequency are applied to microbubbles.

[0034] Inertial cavitation occurs when microbubbles are extremely compressed and expanded under the strong energy of ultrasound waves, eventually collapsing and generating pulse waves and liquid ejection. These forces can increase drug absorption at the target site.

[0035] In this embodiment, the ultrasonic balloon catheter 11 includes a multi-lumen catheter, a flexible hose having at least one opening, and a balloon made of a polymer material, having an expansion portion that expands and contracts, and a neck portion disposed at each end of the expansion portion. The balloon is fixed to the outside of the multi-lumen catheter by each of the neck portions, and the expansion portion and each of the neck portions form an expansion space outside the multi-lumen catheter to allow a fluid composition containing microbubbles to be injected through each of the openings.

[0036] In this embodiment, the at least two ultrasonic probes 111 are disposed in the expansion portion of the balloon and are sleeved on the multi-lumen catheter to emit an ultrasonic wave and induce microbubbles in the fluid composition located in the expansion space to produce an inertial cavitation effect.

[0037] In this embodiment, the multi-lumen catheter includes an inner tube and an outer tube, which are arranged in a concentric circle structure. The inner tube forms a guide wire lumen, which contains a guide wire. The guide wire allows the ultrasonic balloon catheter 11 to slide between blood vessels and place the expanded portion of the balloon at a calcified area of ​​the blood vessel. The outer tube has at least one chamber, including a microbubble chamber for injecting the fluid composition and a power chamber for providing an electric wire for supplying power to each of the ultrasonic probes 111.

[0038] When the multi-lumen catheter passes through the vascular network of the cardiovascular system, the multi-lumen catheter is matched with the guide wire path and slides along the guide wire.

[0039] The multi-lumen catheter is circular, and the balloon can be smoothly guided to the affected area for treatment through the guide wire.

[0040] The circular structure of the multi-lumen catheter allows each component to reach the affected area through the blood vessels without being damaged and to operate smoothly.

[0041] In this embodiment, the inner tube of the multi-lumen catheter has an outer diameter of 1 to 0.5 mm and an inner diameter of 0.8 to 0.3 mm, and the outer tube has an outer diameter of 2 mm and an inner diameter of 1 to 0.5 mm.

[0042] The outer tube is made of a soft material, and the soft material includes but is not limited to metal, epoxy resin, acrylic resin, polyurethane (PU) resin, polyimide (PI) resin, rubber, silicone, plastic nylon, or at least one of other polymer materials.

[0043] In this embodiment, the ultrasonic balloon catheter 11 further includes a catheter assembly, one end of which is connected to the multi-lumen catheter, and the other end of which has a guide wire channel and a fluid composition channel. The guide wire channel allows the guide wire to pass through the guide wire lumen, and the fluid composition channel allows the fluid composition to be injected into the microbubble lumen.

[0044] The catheter assembly may be, but is not limited to, a Luer connector.

[0045] The method further includes injecting the fluid composition containing microbubbles through the catheter assembly according to the control signal when it is determined that the microbubbles are insufficient.

[0046] When it is determined that the microbubbles are insufficient, a prompt message is displayed on the catheter ultrasonic detection auxiliary system according to the control signal to prompt the user to inject the fluid composition containing microbubbles.

[0047] In this embodiment, the at least two ultrasonic probes 111 can be divided into a transmitting probe for transmitting the ultrasonic wave and a receiving probe for obtaining the reflected signal of the calcified blood vessel, and the transmitting probe and the receiving probe are spaced apart and arranged on the ultrasonic balloon catheter 11 .

[0048] Taking two ultrasonic probes 111 as an example, the one close to the front end of the balloon is the transmitting probe, and the one close to the rear end of the balloon is the receiving probe.

[0049] Taking three ultrasonic probes 111 as an example, the two at the front and rear of the ultrasonic balloon catheter 11 are the transmitting probes, and the middle one is the receiving probe.

[0050] Taking five ultrasonic probes 111 as an example, the three at the front, middle and back of the ultrasonic balloon catheter 11 are transmitting probes, and the receiving probes are arranged between the transmitting probes.

[0051] The transmitting probes may be connected in parallel or independently wired.

[0052] In this embodiment, the end of the ultrasonic balloon catheter 11 is connected to the control host 12, the receiving probe is connected to the signal receiving unit 121, the duplex circuit 123 and the digital-to-analog conversion circuit 122, and the transmitting probe is connected to the amplifying circuit 125 and finally connected to the control host 12.

[0053] The duplex circuit 123 is implemented by a coupler or a duplexer.

[0054] The wire used to supply power to the ultrasonic probe 111 may be, but is not limited to, an enameled wire, a central conductive metal tube, a copper sticker, or other connection methods with high conductive efficiency.

[0055] In this embodiment, the at least two ultrasonic probes 111 are tubular ultrasonic probes with an inner diameter of 0.5 to 1 mm, an outer diameter of 1.5 to 2.5 mm, and a height of 2 to 6 mm. The resonant frequencies of the ultrasonic probes 111 are 100 k to 2 MHz and 2 MHz to 10 MHz.

[0056] The at least two ultrasonic probes 111 may be made of, but not limited to, a piezoelectric material.

[0057] The electrode coating on the surface of the at least two ultrasonic probes 111 may be, but is not limited to, nickel-plated gold (NiAu), silver (Ag) or other materials with high conductive efficiency.

[0058] The at least two ultrasonic probes 111 are made of piezoelectric material with a metal coating on the surface.

[0059] In this embodiment, the ground electrodes on the outer surfaces of the at least two ultrasonic probes 111 are separated by gaps of 0.01 to 0.2 mm cut every 90 to 180 degrees.

[0060] The split electrodes are enabled to collect the calcified blood vessel reflection signals at different angles through the slits, so as to clearly determine the reflection angle of the calcified blood vessel reflection signals.

[0061] At least one wire is connected to the fire electrode of each of the ultrasonic probes 111 .

[0062] At least one wire is connected to the ground of each ultrasonic probe 111 .

[0063] FIG2 is a schematic structural diagram of an ultrasonic detection auxiliary system for a catheter according to the present application. 2 , a catheter-based ultrasound detection auxiliary system is shown. The catheter-based ultrasound detection auxiliary system is suitable for being introduced into the cardiovascular system to improve blockage in the cardiovascular system or its surrounding tissues. The catheter-based ultrasound detection auxiliary system includes: an ultrasound balloon catheter 11 having at least two ultrasound probes 111 for continuously transmitting an ultrasound wave and obtaining a calcified blood vessel reflection signal; and a control host 12 further including: a signal receiving unit 121 electrically connected to the at least two ultrasound probes 111 for receiving the calcification reflection analog signal; a digital-to-analog conversion circuit 122 for receiving the calcified blood vessel reflection signal and generating a calcification characteristic signal; a duplex circuit 123 coupling the signal receiving unit 121 and the digital-to-analog conversion circuit 122; and a processing unit 124 electrically connected to the digital-to-analog conversion circuit 122 for analyzing and calculating the calcification characteristic signal to generate a correlation value, a sample entropy value, and a Shannon entropy value. Entropy), an approximate entropy, and an envelope signal-to-noise ratio (Envelope SNR), and generates a calcification data value based on the correlation value, and generates a control signal based on the calcification data value, the sample entropy, the Shannon entropy, the approximate entropy, and the envelope signal-to-noise ratio to enhance or reduce the ultrasonic output energy; and an amplifier circuit 125 is electrically connected to the processing unit 124, and is used to amplify a resonance signal based on the control signal to enable the ultrasonic probe 111 to transmit the ultrasonic wave.

[0064] In this embodiment, the ultrasonic balloon catheter 11 includes a multi-lumen catheter 112, a flexible hose having at least one opening, and a balloon 113, which is made of a polymer material and has an expansion portion that can expand and contract, and a neck portion disposed at each end of the expansion portion. The balloon 113 is fixed to the outside of the multi-lumen catheter 112 by each of the neck portions, and the expansion portion and each of the neck portions form an expansion space outside the multi-lumen catheter 112 to allow a fluid composition containing microbubbles to be injected through each of the openings.

[0065] In this embodiment, the at least two ultrasonic probes 111 are disposed in the expansion portion of the balloon 113 and are sleeved on the multi-lumen catheter 112 to emit an ultrasonic wave and induce microbubbles in the fluid composition located in the expansion space to produce an inertial cavitation effect.

[0066] In this embodiment, the multi-lumen catheter 112 includes an inner tube and an outer tube, which are arranged in a concentric circle structure. The inner tube forms a guide wire lumen, which contains a guide wire. The guide wire allows the ultrasonic balloon catheter 11 to slide between blood vessels and place the expanded portion of the balloon 113 at a vascular calcification. The outer tube has at least one chamber, including a microbubble chamber for injecting the fluid composition and a power chamber for providing an electric wire for supplying the power required by each of the ultrasonic probes 111.

[0067] In this embodiment, the inner tube of the multi-lumen catheter 112 has an outer diameter of 1 to 0.5 mm and an inner diameter of 0.8 to 0.3 mm, and the outer tube has an outer diameter of 2 mm and an inner diameter of 1 to 0.5 mm.

[0068] In this embodiment, the ultrasonic balloon catheter 11 further includes a catheter assembly 13, one end of which is connected to the multi-lumen catheter 112, and the other end of which has a guide wire channel 131 and a fluid composition channel 132. The guide wire channel 131 allows the guide wire to pass through the guide wire lumen, and the fluid composition channel 132 allows the fluid composition to be injected into the microbubble lumen.

[0069] In this embodiment, the at least two ultrasonic probes 111 can be divided into a transmitting probe 1111 for transmitting the ultrasonic wave, and a receiving probe 1112 for obtaining the reflection signal of the calcified blood vessel, and the transmitting probe 1111 and the receiving probe 1112 are spaced apart and arranged on the ultrasonic balloon catheter 11.

[0070] In this embodiment, three ultrasonic probes 111 are taken as an example. The two at the front and rear of the ultrasonic balloon catheter 11 are the transmitting probes 1111 , and the middle one is the receiving probe 1112 .

[0071] In this embodiment, the end of the ultrasonic balloon catheter 11 is connected to the control host 12, the receiving probe 1112 is connected to the signal receiving unit 121, the duplex circuit 123 and the digital-to-analog conversion circuit 122, and the transmitting probe 1111 is connected to the amplifying circuit 125 and finally connected to the control host 12.

[0072] In this embodiment, the at least two ultrasonic probes 111 are tubular ultrasonic probes with an inner diameter of 0.5 to 1 mm, an outer diameter of 1.5 to 2.5 mm, and a height of 2 to 6 mm. The resonant frequencies of the ultrasonic probes 111 are 100 k to 2 MHz and 2 MHz to 10 MHz.

[0073] The at least two ultrasonic probes 111 may be made of, but not limited to, a piezoelectric material.

[0074] The electrode coating on the surface of the at least two ultrasonic probes 111 may be, but is not limited to, nickel-plated gold (NiAu), silver (Ag) or other materials with high conductive efficiency.

[0075] The at least two ultrasonic probes 111 are made of piezoelectric material with a metal coating on the surface.

[0076] In this embodiment, the ground electrodes on the outer surfaces of the at least two ultrasonic probes 111 are separated by gaps of 0.01 to 0.2 mm cut every 90 to 180 degrees.

[0077] FIG3 is a schematic diagram of an ultrasonic balloon catheter 11 of a catheter-use ultrasonic detection-assisted system according to the present application. Referring to FIG3 , the ultrasonic balloon catheter 11 comprises a multi-lumen catheter 112, a flexible hose having at least one opening, and a balloon 113 made of a polymer material. The balloon 113 comprises an expansion portion 1131 capable of expansion and contraction, and necks 1132 disposed at either end of the expansion portion 1131. The balloon 113 is secured to the exterior of the multi-lumen catheter 112 by the necks 1132. The expansion portion 1131 and the necks 1132 form an expansion space outside the multi-lumen catheter 112, allowing a fluid composition containing microbubbles to be injected through the openings 1121.

[0078] In this embodiment, the at least two ultrasonic probes 111 are disposed in the expansion portion 1131 of the balloon 113 and are sleeved on the multi-lumen catheter 112 to emit an ultrasonic wave and induce microbubbles in the fluid composition located in the expansion space to produce an inertial cavitation effect.

[0079] In this embodiment, the multi-lumen catheter 112 includes an inner tube and an outer tube, which are arranged in a concentric circle structure. The inner tube forms a guide wire lumen, which contains a guide wire. The guide wire allows the ultrasonic balloon catheter 11 to slide between blood vessels and allows the expanded portion 1131 of the balloon 113 to be placed at a vascular calcification. The outer tube has at least one chamber, including a microbubble chamber for injecting the fluid composition and a power chamber for providing an electric wire for supplying the power required by each of the ultrasonic probes 111.

[0080] In this embodiment, the inner tube of the multi-lumen catheter 112 has an outer diameter of 1 to 0.5 mm and an inner diameter of 0.8 to 0.3 mm, and the outer tube has an outer diameter of 2 mm and an inner diameter of 1 to 0.5 mm.

[0081] In this embodiment, the ultrasonic balloon catheter 11 further includes a catheter assembly, one end of which is connected to the multi-lumen catheter 112, and the other end of which has a guide wire channel and a fluid composition channel. The guide wire channel allows the guide wire to pass through the guide wire lumen, and the fluid composition channel allows the fluid composition to be injected into the microbubble lumen.

[0082] Please refer to FIG. 4A to FIG. 4D at the same time. FIG. 4A to FIG. 4D are schematic diagrams of a multi-lumen catheter of a catheter ultrasonic detection auxiliary system according to the present application.

[0083] As shown in FIG4A , the multi-lumen catheter 2 includes an inner tube 21 and an outer tube 22 arranged in a concentric circle structure. The inner tube 21 forms a guide wire lumen 211 containing a guide wire; and the outer tube 22 has two chambers, including a microbubble chamber 221 for injecting the fluid composition, and an electric power chamber 222 for providing an electric wire 2221 for supplying power required by each of the ultrasonic probes.

[0084] As shown in FIG4B , the multi-lumen catheter 2 includes an inner tube 21 and an outer tube 22 arranged in a concentric circle structure. The inner tube 21 forms a guide wire lumen 211 containing a guide wire; and the outer tube 22 has four chambers, including a microbubble chamber 221 for injecting the fluid composition, and three power chambers 222 through which an electric wire 2221 passes to provide power required by each of the ultrasonic probes.

[0085] As shown in FIG4C , the multi-lumen catheter 2 includes an inner tube 21 and an outer tube 22 arranged in a concentric circle structure. The inner tube 21 forms a guide wire lumen 211 containing a guide wire; and the outer tube 22 has two chambers arranged in a concentric circle structure, including a microbubble chamber 221 for injecting the fluid composition, and an electric power chamber 222 for providing an electric wire 2221 for supplying the power required by each of the ultrasonic probes.

[0086] As shown in FIG4D , the multi-lumen catheter 2 includes an inner tube 21 and an outer tube 22 arranged in a concentric circle structure. The inner tube 21 forms a guide wire lumen 211 containing a guide wire; and the outer tube 22 has a chamber, which is a microbubble chamber 221 for injecting the fluid composition and a wire 2221 for providing power to each of the ultrasonic probes.

[0087] FIG5 is a schematic diagram of an ultrasonic probe for a catheter ultrasound detection assistance system according to the present application. The ultrasonic probe 111 shown in FIG5 is tubular, having an inner diameter of 0.5 to 1 mm, an outer diameter of 1.5 to 2.5 mm, and a height of 2 to 6 mm. The resonant frequencies of the ultrasonic probe 111 are 100 kΩ to 2 MHz and 2 MHz to 10 MHz, respectively.

[0088] The at least two ultrasonic probes 111 may be made of, but not limited to, a piezoelectric material.

[0089] The electrode coating on the surface of the at least two ultrasonic probes 111 may be, but is not limited to, nickel-plated gold (NiAu), silver (Ag) or other materials with high conductive efficiency.

[0090] The at least two ultrasonic probes 111 are made of piezoelectric material with a metal coating on the surface.

[0091] In this embodiment, the ground electrodes on the outer surfaces of the at least two ultrasonic probes are divided into electrodes by cutting slits 1113 of 0.01 to 0.2 mm every 90 to 180 degrees.

[0092] The reflection angle of the calcified blood vessel reflection signal can be clearly determined through the slits 1113 .

[0093] At least one wire is connected to each of the ultrasonic probe fire electrodes 1114 (fire).

[0094] At least one wire is connected to the ground of each ultrasound probe 1115 .

[0095] Please refer to Figures 6 and 7 simultaneously. Figure 6 is a schematic diagram of an ultrasonic balloon catheter according to the first embodiment of the present application; Figure 7 is an operational flow chart of an ultrasonic detection assistance system for a catheter according to the first embodiment of the present application. As shown in Figure 6, the ultrasonic detection assistance system for a catheter comprises five ultrasonic probes, with the front, middle, and rear three of the ultrasonic balloon catheter being transmitting probes 1111, and receiving probes 1112 being provided between each of the transmitting probes 1111.

[0096] In this embodiment, the transmitting probe 1111 transmits the ultrasonic wave, and the receiving probe 1112 receives the reflected signal of the calcified blood vessel.

[0097] The processing unit analyzes and calculates the calcification characteristic signal to generate a correlation value, which is then compared with samples in a database through cross correlation to determine the type of calcification and generate the calcification data value.

[0098] The calcification data value includes a calcification hardness, a calcification angle, and a calcification position.

[0099] The calcification position is a position relative to the receiving probe 1112 .

[0100] The processing unit then calculates a sample entropy, a Shannon entropy, an approximate entropy, and an envelope signal-to-noise ratio (SNR) based on the calcification characteristic signal. These values ​​are then compared with a sample entropy threshold, a Shannon entropy threshold, an approximate entropy threshold, and an envelope signal-to-noise ratio threshold in the database to determine a calcification fragmentation level.

[0101] The processing unit enables the transmitting probe 1111 to continuously transmit ultrasonic waves for 10 to 20 minutes, and simultaneously enables the receiving probe 1112 to receive the calcification reflection analog signal.

[0102] When the vascular calcification has been completely broken up, a control signal is generated to stop transmitting the ultrasonic wave.

[0103] Or when the vascular calcification is not completely fragmented, the control signal is generated and the size of the ultrasonic wave is adjusted through the amplifying circuit.

[0104] Please refer to Figures 8 and 9 simultaneously. Figure 8 is a schematic diagram of an ultrasonic balloon catheter according to the second embodiment of the present application; Figure 9 is an operational flow chart of an ultrasonic detection assistance system for a catheter according to the second embodiment of the present application. As shown in Figure 8, the ultrasonic detection assistance system for a catheter comprises five ultrasonic probes, with the front, middle, and rear three of the ultrasonic balloon catheter being transmitting probes 1111, and receiving probes 1112 being provided between each of the transmitting probes 1111.

[0105] The receiving probe 1112 can simultaneously transmit ultrasonic waves.

[0106] In this embodiment, the transmitting probe 1111 only transmits the ultrasonic wave to induce microbubbles to produce an inertial cavitation effect, and the receiving probe 1112 transmits the ultrasonic wave and receives the reflected signal of the calcified blood vessel.

[0107] The processing unit analyzes and calculates the calcification characteristic signal to generate a correlation value, which is then compared with samples in a database through cross correlation to determine the type of calcification and generate the calcification data value.

[0108] The calcification data value includes a calcification hardness, a calcification angle, and a calcification position.

[0109] The calcification position is a position relative to the receiving probe 1112 .

[0110] The processing unit then calculates a sample entropy, a Shannon entropy, an approximate entropy, and an envelope signal-to-noise ratio (SNR) based on the calcification characteristic signal. These values ​​are then compared with a sample entropy threshold, a Shannon entropy threshold, an approximate entropy threshold, and an envelope signal-to-noise ratio threshold in the database to determine a calcification fragmentation level.

[0111] The processing unit is used to make the transmitting probe 1111 continuously transmit ultrasound for 10 to 20 minutes, and sequence control is used to change the receiving probe 1112 to transmit ultrasound and receive the calcification reflection analog signal after the transmitting probe 1111 transmits ultrasound.

[0112] When the vascular calcification has been completely broken up, a control signal is generated to stop transmitting the ultrasonic wave.

[0113] Or when the vascular calcification is not completely fragmented, the control signal is generated and the size of the ultrasonic wave is adjusted through the amplifying circuit.

[0114] FIG10 is a flowchart of a catheter-assisted ultrasound detection method according to the present application. The catheter-assisted ultrasound detection method in FIG10 is suitable for use in the cardiovascular system to improve blockage in the cardiovascular system or surrounding tissues, and includes the following steps:

[0115] Step S101: transmitting ultrasound waves through an ultrasound probe in an ultrasound balloon catheter, and obtaining reflection signals from calcified blood vessels through another ultrasound probe;

[0116] Step S102: receiving the calcification reflection simulation signal through a signal receiving unit;

[0117] Step S103: converting the calcified blood vessel reflection signal into a calcification characteristic signal through a digital-to-analog conversion circuit;

[0118] Step S104: The processing unit analyzes and calculates the calcification characteristic signal to generate a correlation value, which is then cross-correlated with samples in the database to determine the type of calcification and generate a calcification data value.

[0119] The processing unit performs a cross-correlation comparison on the calcification characteristic signal and the sample signals in the database, classifies the calcification characteristic signal to determine the type of calcification, and performs a weighted adjustment on the calcification characteristic signal.

[0120] Step S105: The processing unit calculates the sample entropy, Shannon entropy, approximate entropy, and envelope signal-to-noise ratio (ENR) based on the calcification characteristic signal, and compares the calculated values ​​with the sample entropy threshold, Shannon entropy threshold, approximate entropy threshold, and envelope signal-to-noise ratio threshold in the database to determine the calcification fragmentation level.

[0121] The calcification characteristic signal is subjected to the above four types of disorder calculations and compared with the corresponding disorder thresholds.

[0122] When two or more of the four levels of disorder are greater than the disorder threshold, it is determined to be the calcification fragmentation level.

[0123] Among them, the calcification fragmentation grade is divided into:

[0124] 1. Not broken;

[0125] 2. Slight cracks: such as single or two cracks;

[0126] 3. About to break: such as multiple cracks;

[0127] 4. Complete fragmentation: multiple large cracks and dilated blood vessels;

[0128] Step S106: The processing unit determines whether the vascular calcification is completely fragmented based on the calcification data value and the calcification fragmentation level. If the vascular calcification is completely fragmented, step S107A is executed.

[0129] Step S107A: When the vascular calcification has been completely fragmented, a control signal is generated to stop transmitting the ultrasonic wave;

[0130] Step S107B: When the vascular calcification is not completely fragmented, the control signal is generated, and the ultrasound amplitude is adjusted through the amplification circuit, and step S101 is executed after a preset time.

[0131] Figure 11 is a schematic diagram illustrating the cavitation effect. Cavitation, also known as cavitation, cavitation, or hollowing, refers to the cavitation effect induced by microbubbles when ultrasound of a certain energy and frequency is applied to them.

[0132] In this embodiment, the cavitation effect is inertial cavitation. When microbubbles are delivered into the blood vessels and adsorbed at the target location, ultrasound waves are activated. Under the strong energy of ultrasound waves, the microbubbles are extremely compressed and expanded, generating shock waves that shatter the microbubbles, ultimately leading to their collapse and the resulting pulse waves. These forces can modify the accumulated tissue, fat, or calcified structures at the obstruction site.

[0133] In summary, the catheter-use ultrasonic detection-assisted system and method of the present application have at least the following features: The system uses a transmitting probe within a plurality of ultrasonic probes to emit ultrasonic waves to induce cavitation, and a receiving probe receives the reflected ultrasonic signals to understand the extent of vascular calcification and fragmentation, thereby enabling timely adjustment of the ultrasonic wave intensity and direction. This system and method can effectively improve arterial blockage or stubborn vascular calcification.

[0134] The above-described embodiments are merely preferred embodiments for the purpose of fully illustrating the present application, and the scope of protection of the present application is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art based on the present application are within the scope of protection of the present application. The scope of protection of the present application shall be subject to the claims.

Claims

1. A catheter-use ultrasonic detection auxiliary system, which is suitable for being introduced into the cardiovascular system to improve blockage of the cardiovascular system or the tissues surrounding it, and the catheter-use ultrasonic detection auxiliary system comprises: An ultrasonic balloon catheter having at least two ultrasonic probes for continuously emitting an ultrasonic wave and obtaining a reflection signal of a calcified blood vessel; as well as A control host further comprising: a signal receiving unit, electrically connected to the at least two ultrasonic probes, for receiving the calcification reflection simulation signal; a digital-to-analog conversion circuit, used for receiving the calcified blood vessel reflection signal and generating a calcification characteristic signal; a duplex circuit, coupling the signal receiving unit and the digital-to-analog conversion circuit; a processing unit, electrically connected to the digital-to-analog conversion circuit, for analyzing and calculating the calcification characteristic signal to generate a correlation value, a sample entropy value, a Shannon entropy value, an approximate entropy value, and a packet signal-to-noise ratio, and generating a calcification data value according to the correlation value, and generating a control signal according to the calcification data value, the sample entropy value, the Shannon entropy value, the approximate entropy value, and the packet signal-to-noise ratio, for enhancing or reducing the ultrasonic output energy; and An amplifier circuit is electrically connected to the processing unit and is used to amplify a resonance signal according to the control signal so that the ultrasonic probe emits the ultrasonic wave.

2. An ultrasonic detection auxiliary system for a catheter as described in claim 1, wherein the ultrasonic balloon catheter includes a multi-lumen catheter, which is a flexible hose with at least one opening, and a balloon, which is made of a high molecular polymer material, has an expansion portion for expansion and contraction, and a neck respectively arranged at both ends of the expansion portion, and the balloon is fixed to the outside of the multi-lumen catheter by each of the necks, and the expansion portion and each of the necks form an expansion space outside the multi-lumen catheter to inject a fluid composition containing microbubbles through each of the openings.

3. An ultrasonic detection auxiliary system for a catheter as described in claim 2, wherein the at least two ultrasonic probes are arranged in the expansion portion of the balloon and are sleeved on the multi-lumen catheter to emit an ultrasonic wave and induce the microbubbles in the fluid composition located in the expansion space to produce an inertial cavitation effect.

4. The catheter-assisted ultrasound detection system as described in claim 2, wherein the multi-lumen catheter comprises an inner tube and an outer tube, and is arranged in a concentric circle structure, the inner tube forms a guide wire cavity, and a guide wire is arranged in the guide wire cavity, through which the ultrasonic balloon catheter slides between blood vessels and the expansion portion of the balloon is placed at a calcified blood vessel, and the outer tube has at least one chamber, including a microbubble cavity for injecting the fluid composition, and a power cavity for providing an electric wire for passing the power required by each of the ultrasonic probes.

5. The ultrasound detection auxiliary system for a catheter as described in claim 4, wherein the inner tube of the multi-lumen catheter has an outer diameter of 1 to 0.5 mm and an inner diameter of 0.8 to 0.3 mm, and the outer tube has an outer diameter of 2 mm and an inner diameter of 1 to 0.5 mm.

6. The ultrasound detection auxiliary system for a catheter as described in claim 2, wherein the ultrasound balloon catheter further comprises a catheter assembly, one end of the catheter assembly is connected to the multi-lumen catheter, and the other end has a guide wire channel and a fluid composition channel, the guide wire channel allows the guide wire to pass through the guide wire cavity, and the fluid composition channel allows the fluid composition to be injected into the microbubble cavity.

7. The catheter-use ultrasonic detection auxiliary system as described in claim 1, wherein the at least two ultrasonic probes can be divided into a transmitting probe for transmitting the ultrasonic wave, and a receiving probe for obtaining the reflection signal of the calcified blood vessel, and the transmitting probe and the receiving probe are arranged on the ultrasonic balloon catheter at intervals.

8. An ultrasonic detection auxiliary system for a catheter as described in claim 1, wherein the at least two ultrasonic probes are tubular ultrasonic probes, the inner diameter of the ultrasonic probe is 0.5 to 1 mm, the outer diameter is 1.5 to 2.5 mm, and the height is 2 to 6 mm, and the resonant frequency of the ultrasonic probe is 100k to 2 MHz and 2M to 10 MHz.

9. The catheter ultrasonic detection auxiliary system as claimed in claim 1, wherein the ground electrodes on the outer surfaces of the at least two ultrasonic probes are divided into electrodes with gaps of 0.01 to 0.2 mm cut every 90 to 180 degrees.

10. A catheter-assisted ultrasound detection method, suitable for being introduced into the cardiovascular system to improve blockage of the cardiovascular system or its surrounding tissues, comprising the following steps: An ultrasonic probe in an ultrasonic balloon catheter emits an ultrasonic wave, and another ultrasonic probe obtains a reflected signal from a calcified blood vessel; Receiving the calcification reflection simulation signal through a signal receiving unit of a control host; The calcified blood vessel reflection signal is converted into a calcification characteristic signal through a digital-to-analog conversion circuit; The calcification characteristic signal is analyzed and calculated by a processing unit to generate a correlation value, which is cross-correlatedly compared with samples in a database to determine the type of calcification and generate a calcification data value; By means of the processing unit, a sample entropy value, a Shannon entropy value, an approximate entropy value, and a packet signal-to-noise ratio are respectively calculated according to the calcification characteristic signal, and compared with a sample entropy threshold value, a Shannon entropy threshold value, an approximate entropy threshold value, and a packet signal-to-noise ratio threshold value in the database, respectively, to determine a calcification fragmentation level; The processing unit determines whether the vascular calcification is completely fragmented according to the calcification data value and the calcification fragmentation level; When the vascular calcification has been completely broken up, a control signal is generated to stop transmitting the ultrasonic wave; When the calcified blood vessel is not completely fragmented, the control signal is generated, and the size of the ultrasonic wave is adjusted through the amplifying circuit. After a preset time, the reflected signal of the calcified blood vessel is obtained again through the signal receiving unit and analyzed and calculated.

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