Ultrasound balloon catheter

Abstract

An ultrasound balloon catheter (1), which is used to be introduced into the cardiovascular system for the treatment of stenosis or obstruction of the cardiac or peripheral blood vessels. The ultrasound balloon catheter (1) comprises: a catheter tube (11), which is a flexible tube; a balloon (12), which is made of an elastic material, has an expansion portion (121) for expansion and contraction and neck portions (122) respectively arranged at two ends of the expansion portion (121), and is fixedly arranged on the outer side of the catheter tube (11) by means of the neck portions (122), the expansion portion (121) and the neck portions (122) forming an expansion space on the outer tube wall of the catheter tube (11), and a fluid composition being introduced into the expansion space through an opening in the outer tube wall; and an ultrasound probe (13), which is arranged in the expansion portion (121) of the balloon (12) and sleeved on an inner tube (111) and at the opening in the outer tube wall, and is used to emit ultrasound and induce cavitation formed by microbubbles in the fluid composition in the expansion space.

Description

Ultrasonic balloon catheter Technical Field

[0001] The present application is an ultrasonic balloon catheter, and more particularly relates to an ultrasonic balloon catheter that uses an ultrasonic probe capable of emitting ultrasonic waves to induce a cavitation effect to assist balloon expansion and improve blood vessel obstruction. Background Art

[0002] Cardiovascular disease has long been one of the top five causes of death in Taiwan. With an aging population and a shift toward a more Westernized diet, the prevalence and mortality rates of cardiovascular disease are increasing annually, with a younger population onset. 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] Vascular calcification occurs when the vessel walls become hard and lose their elasticity, impairing their contraction and relaxation functions. Furthermore, excessive calcium deposition occurs on the vessel walls, a condition known as vascular calcification. Generally, there are many treatments for vascular stenosis, vascular sclerosis, and atherosclerosis, such as laser or rotational atherectomy. Currently, the most common and least expensive 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 the present application is to provide an ultrasonic balloon catheter that uses an ultrasonic probe that can emit ultrasonic waves to induce a cavitation effect to assist balloon expansion, thereby improving arterial blockage or stubborn vascular calcification.

[0006] To achieve the above-mentioned objectives, the present application provides an ultrasonic balloon catheter, which is an ultrasonic balloon catheter for being introduced into the cardiovascular system to treat stenosis or obstruction of the heart or peripheral blood vessels. The ultrasonic balloon catheter comprises: a catheter hose, which is a flexible hose, further comprising: an inner tube having an inner tube wall that can define a first accommodating space, the first accommodating space being used to allow a guide wire to pass through; an outer tube, which is sleeved on the outside of the inner tube wall and has an outer tube wall that can define a second accommodating space, the second accommodating space being used to flow in a fluid composition containing microbubbles, the outer tube wall having at least one opening for allowing the fluid composition to flow out; and an electrode tube, which is arranged in the outer tube and has a third accommodating space that can define a third accommodating space. An electrode tube wall of the accommodating space, the third accommodating space is used to allow at least one electrode wire to pass through; a balloon, made of an elastic material, having an expansion part for expansion and contraction, and a neck respectively arranged at both ends of the expansion part, and the balloon is fixed to the outside of the catheter hose by each of the necks, and the expansion part and each of the necks form an expansion space on the outer wall of the catheter hose, so that the fluid composition can be injected into the expansion space through each of the openings on the outer tube wall; and at least one ultrasonic probe is arranged in the expansion part of the balloon, and is sleeved on the outside of the inner tube and each of the openings on the outer tube wall, for emitting an ultrasonic wave and inducing microbubbles in the fluid composition located in the expansion space to produce a cavitation effect.

[0007] In one embodiment of the present application, when the catheter hose passes through the vascular network of the cardiovascular system, the catheter hose is adapted to fit the guide wire path and slides along the guide wire.

[0008] In one embodiment of the present application, in the above-mentioned catheter hose, the inner tube and the outer tube are arranged in concentric circles, and the outer diameter of the inner tube is smaller than the inner diameter of the outer tube.

[0009] In one embodiment of the present application, the inner tube is made of polyether polyamide block copolymer (PEBAX), polyamide (NYLON), thermoplastic polyurethane (TPU) or other polymer materials with high sound transmission properties.

[0010] In one embodiment of the present application, the balloon is made of polyether polyamide block copolymer (PEBAX), polyamide (NYLON), thermoplastic polyurethane (TPU) or other polymer materials with high sound transmission properties.

[0011] In one embodiment of the present application, the effective length of the balloon is 20 to 80 mm, and the diameter is 2 to 7 mm.

[0012] In one embodiment of the present application, the maximum pressure resistance of the balloon is 10 to 15 atm, and the fully expanded pressure is 3 to 7 atm.

[0013] In one embodiment of the present application, the at least one ultrasonic probe is a tubular ultrasonic probe 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 5 MHz and 1 MHz to 10 MHz.

[0014] Among them, the ultrasonic probe is made of PZT piezoelectric material, and the surface electrode coating is gold, silver, platinum or other high conductivity materials.

[0015] In one embodiment of the present application, the at least one ultrasonic probe mentioned above is an ultrasonic probe composed of a sheet combination, and the sheet combination can be two or more sheets. The ultrasonic probe has a length of 0.2 to 1.5 mm, a width of 1 to 6 mm, and a height of 0.5 to 6 mm, and a resonant frequency of the ultrasonic probe is 1M to 20 MHz.

[0016] Among them, the ultrasonic probe is made of PZT piezoelectric material, and the surface electrode coating is gold, silver, platinum or other high conductivity materials.

[0017] The ultrasonic balloon catheter of the present application has at least the following characteristics: through the concentrically arranged catheter hose structure, the guide wire is effectively used to select the correct path through the vascular network of the cardiovascular system under the user's push, and once the correct path is established, the catheter hose slides along the guide wire to the site of blood vessel obstruction, so that the balloon is in the correct position. By injecting a fluid composition containing microbubbles, and then cooperating with the ultrasonic probe inside the balloon to generate ultrasonic waves, the balloon is assisted in expansion and induces a cavitation effect. The energy released in the process of bubble formation to rupture is used to quickly and efficiently improve blood vessel obstruction and stubborn vascular calcification. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG1 is a schematic structural diagram of an ultrasonic balloon catheter according to the present application;

[0019] FIG2 is a schematic structural diagram of a catheter hose according to a first embodiment of the present application;

[0020] FIG3 is a schematic structural diagram of a catheter hose according to a second embodiment of the present application;

[0021] FIG4 is a schematic structural diagram of a catheter hose according to a third embodiment of the present application;

[0022] FIG5 is a schematic structural diagram of a catheter hose according to a fourth embodiment of the present application;

[0023] FIG6 is a schematic structural diagram of an ultrasonic probe according to a fifth embodiment of the present application;

[0024] FIG7 is a graph showing an input voltage-output sound pressure curve generated by an ultrasonic probe according to a fifth embodiment of the present application;

[0025] FIG8 is a schematic structural diagram of an ultrasonic probe according to a sixth embodiment of the present application;

[0026] FIG9 is a graph showing an input voltage-output sound pressure curve generated by an ultrasonic probe according to a sixth embodiment of the present application;

[0027] FIG10 is a schematic diagram of an ultrasonic balloon catheter operation according to the present application;

[0028] FIG. 11 is a schematic diagram illustrating the cavitation effect.

[0029] Explanation of the symbols in the figure: 1 ultrasonic balloon catheter; 11 catheter hose; 111 inner tube; 1111 first accommodating space; 112 outer tube; 1121 second accommodating space; 113 electrode tube; 1131 third accommodating space; 1132 electrode wire; 12 balloon; 121 dilation part; 122 neck; 13 ultrasonic probe; 14 blood vessel. DETAILED DESCRIPTION

[0030] The present application will be further described below in conjunction with the accompanying drawings and specific embodiments so that those skilled in the art can better understand the present application and implement it, but the embodiments are not intended to limit the present application.

[0031] 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.

[0032] 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.

[0033] FIG1 is a schematic diagram of the structure of an ultrasonic balloon catheter according to the present application. Please refer to the ultrasonic balloon catheter 1 shown in FIG1 , which is an ultrasonic balloon catheter 1 for being introduced into the cardiovascular system to treat stenosis or obstruction of the heart or peripheral blood vessels. The ultrasonic balloon catheter 1 comprises: a catheter hose 11, which is a flexible hose, further comprising: an inner tube having an inner tube wall defining a first accommodation space, the first accommodation space being used for a guide wire to pass through; an outer tube, which is sleeved on the outside of the inner tube wall and has an outer tube wall defining a second accommodation space, the second accommodation space being used for a fluid composition containing microbubbles to flow in, the outer tube wall having at least one opening for the fluid composition to flow out; and an electrode tube, which is arranged in the outer tube and has an electrode tube wall defining a third accommodation space, the third accommodation space being used for a fluid composition containing microbubbles to flow out. a balloon 12 formed of an elastic material, having an expansion portion 121 for expansion and contraction, and a neck portion 122 respectively arranged at both ends of the expansion portion 121, and the balloon 12 is fixed to the outside of the catheter hose 11 by means of each of the neck portions 122, and the expansion portion 121 and each of the neck portions 122 form an expansion space on the outer wall of the catheter hose 11, so that the fluid composition can be injected into the expansion space through each of the openings on the outer tube wall; and at least one ultrasonic probe 13 is arranged in the expansion portion 121 of the balloon 12, and is sleeved on the outside of the inner tube and at each of the openings on the outer tube wall, for emitting an ultrasonic wave and inducing microbubbles in the fluid composition in the expansion space to produce a cavitation effect.

[0034] In this embodiment, when the catheter tube 11 passes through the vascular network of the cardiovascular system, the catheter tube 11 is adapted to the guide wire path and slides along the guide wire.

[0035] The catheter tube 11 is circular, and the balloon 12 can be smoothly guided to the affected area for treatment through the guide wire.

[0036] Preferably, the circular structure of the catheter hose 11 allows each component to reach the affected area through the blood vessels without being damaged and to operate smoothly.

[0037] The caliber of the guide wire may be, but is not limited to, 0.014", 0.018", 0.021" or 0.025".

[0038] In this embodiment, the inner tube and the outer tube in the conduit hose 11 are arranged in concentric circles, and the outer diameter of the inner tube is smaller than the inner diameter of the outer tube.

[0039] Wherein, the first accommodating space of the inner tube forms a guide wire cavity.

[0040] The guide wire cavity is used to allow the guide wire to pass through.

[0041] Wherein, the second accommodating space of the outer tube forms a water cavity.

[0042] Preferably, the water cavity is used for flowing the fluid composition containing microbubbles.

[0043] The third accommodation space of the electrode tube wall is a wire cavity for accommodating at least two electrode wires for providing power to the ultrasonic probe 13 .

[0044] Preferably, the electrode wires include at least one electrode wire connected to the fire electrode of the ultrasonic probe 13 .

[0045] Preferably, the electrode wires include at least one electrode wire connected to a ground electrode of the ultrasonic probe 13 .

[0046] Preferably, the wire cavity is used to insulate and cover each of the electrode wires.

[0047] The catheter hose 11 has one or three to five ultrasonic probes 13 .

[0048] In this embodiment, the inner tube comprises polyether polyamide block copolymer (PEBAX), polyamide (NYLON), thermoplastic polyurethane (TPU) or other polymer materials with high sound transmission properties.

[0049] In this embodiment, the balloon 12 is made of polyether polyamide block copolymer (PEBAX), polyamide (NYLON), thermoplastic polyurethane (TPU) or other polymer materials with high sound transmission properties.

[0050] In this embodiment, the effective length of the balloon 12 is 20 to 80 mm, and the diameter is 2 to 7 mm.

[0051] In this embodiment, the maximum pressure resistance of the balloon 12 is 10 to 15 atm, and the fully expanded pressure is 3 to 7 atm.

[0052] Preferably, the organic polymer material is ultraviolet curing glue (UV glue) adhered to the conduit hose 11 .

[0053] In this embodiment, the at least one ultrasonic probe 13 may be a tubular or sheet-shaped ultrasonic probe.

[0054] In this embodiment, the at least one ultrasonic probe 13 is a tubular ultrasonic probe 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 frequency of the ultrasonic probe 13 is 100 k to 5 MHz and 1 MHz to 10 MHz.

[0055] The catheter hose 11 has one or three to five ultrasonic probes 13 .

[0056] The distance between each two ultrasonic probes 13 is 1 to 10 mm.

[0057] The ultrasonic probes 13 may be connected in series or in parallel.

[0058] Each of the ultrasonic probes 13 may be made of, but not limited to, a hard piezoelectric material made of lead zirconate titanate (PTZ).

[0059] The electrode coating on the surface of each ultrasonic probe 13 may be, but is not limited to, nickel-plated gold, silver, or platinum coating.

[0060] At least one electrode wire is connected to the fire electrode of the ultrasonic probe 13 .

[0061] At least one electrode wire is connected to the ground of the ultrasonic probe 13 .

[0062] The sound penetration rate of the inner pipe wall can reach 70% to 99% at a frequency (100k to 1MHz) and a distance (0.1 to 1mm).

[0063] The sound penetration rate of the inner pipe wall can reach 70% to 99% at a frequency (2 to 6 MHz) and a distance (0.1 to 1 mm).

[0064] In this embodiment, the at least one ultrasonic probe 13 is a sheet-shaped combination ultrasonic probe, and the sheet-shaped combination can be two or more sheets. The ultrasonic probe 13 has a length of 0.2 to 1.5 mm, a width of 1 to 6 mm, and a height of 0.5 to 6 mm, and a resonant frequency of the ultrasonic probe 13 is 1M to 20 MHz.

[0065] The ultrasonic probe 13 is a combination of two, three or more sheets of hard piezoelectric materials.

[0066] The catheter hose 11 has one or three to five ultrasonic probes 13 .

[0067] The two adjacent ultrasonic probes 13 are rotated along the axial direction of the catheter hose 11 at an angle of 135 to 225 degrees.

[0068] The distance between each two ultrasonic probes 13 is 1 to 10 mm.

[0069] The ultrasonic probes 13 may be connected in series or in parallel.

[0070] Each of the ultrasonic probes 13 may be made of, but not limited to, a hard piezoelectric material made of lead zirconate titanate (PTZ).

[0071] The electrode coating on the surface of each ultrasonic probe 13 may be, but is not limited to, nickel-plated gold, platinum or silver coating.

[0072] At least one electrode wire is connected to the fire electrode of the ultrasonic probe 13 .

[0073] At least one electrode wire is connected to the ground of the ultrasonic probe 13 .

[0074] In this embodiment, the cavitation effect is an inertial cavitation effect.

[0075] 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.

[0076] Inertial cavitation is the pulse wave generated when microbubbles are extremely compressed and expanded under the strong sound energy of ultrasound, and finally collapse. These forces can modify the accumulated tissue, fat or calcification structure at the obstruction site.

[0077] FIG2 is a schematic diagram of the structure of a catheter hose 11 according to the first embodiment of the present application. Referring to FIG2 , the catheter hose 11 is a flexible hose that further comprises: an inner tube 111 having an inner tube wall defining a first accommodating space 1111 for passing a guide wire; an outer tube 112 sleeved over the inner tube wall and having an outer tube wall defining a second accommodating space 1121 for admitting a fluid composition containing microbubbles, the outer tube wall having at least one opening for allowing the fluid composition to flow out; and an electrode tube 113 disposed within the outer tube 112 and having an electrode tube wall defining a third accommodating space 1131 for passing an electrode wire 1132.

[0078] In this embodiment, when the catheter tube 11 passes through the vascular network of the cardiovascular system, the catheter tube 11 is adapted to the guide wire path and slides along the guide wire.

[0079] The catheter tube 11 is circular, and the balloon 12 can be smoothly guided to the affected area for treatment through the guide wire.

[0080] Preferably, the circular structure of the catheter hose 11 allows each component to reach the affected area through the blood vessels without being damaged and to operate smoothly.

[0081] In this embodiment, the outer tube wall is interrupted at each of the ultrasonic probes 13 , so that each of the ultrasonic probes 13 directly contacts the fluid composition in the expansion space of the balloon 12 .

[0082] In this embodiment, the catheter hose 11 has three cavities, namely the guide wire cavity of the first accommodating space 1111 , the water cavity of the second accommodating space 1121 , and the wire cavity of the third accommodating space 1131 .

[0083] The water cavity and the guide wire cavity are arranged in concentric circles.

[0084] From the inside to the outside, they are: the guide wire cavity and the water cavity.

[0085] In this embodiment, the electrical wire cavity is disposed outside the guide wire cavity.

[0086] The wire cavity is used for allowing at least two electrode wires 1132 to pass through, and is used to insulate and cover each of the electrode wires 1132 .

[0087] The wire cavity is bonded to the guide wire cavity with ultraviolet curing glue (UV glue) and covers the guide wire cavity.

[0088] Preferably, the covering angle of the electric wire cavity covering the guide wire cavity is 0 to 180 degrees.

[0089] FIG3 is a schematic structural diagram of a catheter hose 11 according to a second embodiment of the present application. Referring to FIG3 , the catheter hose 11 is a flexible hose that further comprises: an inner tube 111 having an inner tube wall defining a first accommodating space 1111 for passing a guide wire; an outer tube 112 sleeved over the inner tube wall and having an outer tube wall defining a second accommodating space 1121 for admitting a fluid composition containing microbubbles, the outer tube wall having at least one opening for allowing the fluid composition to flow out; and an electrode tube 113 disposed within the outer tube 112 and having an electrode tube wall defining a third accommodating space 1131 for passing an electrode wire 1132.

[0090] In this embodiment, when the catheter tube 11 passes through the vascular network of the cardiovascular system, the catheter tube 11 is adapted to the guide wire path and slides along the guide wire.

[0091] The catheter tube 11 is circular, and the balloon 12 can be smoothly guided to the affected area for treatment through the guide wire.

[0092] Preferably, the circular structure of the catheter hose 11 allows each component to reach the affected area through the blood vessels without being damaged and to operate smoothly.

[0093] In this embodiment, the outer tube wall is interrupted at each of the ultrasonic probes 13 , so that each of the ultrasonic probes 13 directly contacts the fluid composition in the expansion space of the balloon 12 .

[0094] In this embodiment, the catheter hose 11 has three cavities, namely the guide wire cavity of the first accommodating space 1111 , the water cavity of the second accommodating space 1121 , and the wire cavity of the third accommodating space 1131 .

[0095] In this embodiment, the water cavity is disposed outside the guide wire cavity.

[0096] Preferably, the angle at which the water cavity covers the guide wire cavity is 0 to 180 degrees.

[0097] In this embodiment, the electrical wire cavity is disposed outside the guide wire cavity.

[0098] Preferably, the angle at which the wire cavity covers the guide wire cavity is 0 to 180 degrees.

[0099] The water cavity and the wire cavity are not arranged to overlap.

[0100] The wire cavity is used for allowing at least two electrode wires 1132 to pass through, and is used to insulate and cover each of the electrode wires 1132 .

[0101] FIG4 is a schematic diagram of the structure of a catheter hose 11 according to a third embodiment of the present application. Referring to FIG4 , the catheter hose 11 is a flexible hose that further comprises: an inner tube 111 having an inner tube wall defining a first accommodating space 1111 for passing a guide wire; an outer tube 112 sleeved onto the outer portion of the inner tube wall and having an outer tube wall defining a second accommodating space 1121 for admitting a fluid composition containing microbubbles; and an outer tube wall having at least one opening for allowing the fluid composition to flow out and for allowing an electrode wire 1132 to pass through.

[0102] In this embodiment, when the catheter tube 11 passes through the vascular network of the cardiovascular system, the catheter tube 11 is adapted to the guide wire path and slides along the guide wire.

[0103] The catheter tube 11 is circular, and the balloon 12 can be smoothly guided to the affected area for treatment through the guide wire.

[0104] Preferably, the circular structure of the catheter hose 11 allows each component to reach the affected area through the blood vessels without being damaged and to operate smoothly.

[0105] In this embodiment, the outer tube wall is interrupted at each of the ultrasonic probes 13 , so that each of the ultrasonic probes 13 directly contacts the fluid composition in the expansion space of the balloon 12 .

[0106] In this embodiment, the catheter hose 11 has two lumens, namely the guide wire lumen of the first accommodating space 1111 and the water lumen of the second accommodating space 1121 .

[0107] The water cavity and the guide wire cavity are arranged in concentric circles.

[0108] From the inside to the outside, they are: the guide wire cavity and the water cavity.

[0109] In this embodiment, each of the electrode wires 1132 is disposed outside the guide wire cavity.

[0110] FIG5 is a schematic structural diagram of a catheter hose 11 according to a fourth embodiment of the present application. Referring to FIG5 , the catheter hose 11 is a flexible hose that further comprises: an inner tube 111 having an inner tube wall defining a first accommodating space 1111 for passing a guide wire; an outer tube 112 sleeved over the inner tube wall and having an outer tube wall defining a second accommodating space 1121 for admitting a fluid composition containing microbubbles, the outer tube wall having at least one opening for allowing the fluid composition to flow out; and an electrode tube 113 disposed within the outer tube 112 and having an electrode tube wall defining a third accommodating space 1131 for passing an electrode wire 1132.

[0111] In this embodiment, when the catheter tube 11 passes through the vascular network of the cardiovascular system, the catheter tube 11 is adapted to the guide wire path and slides along the guide wire.

[0112] The catheter tube 11 is circular, and the balloon 12 can be smoothly guided to the affected area for treatment through the guide wire.

[0113] Preferably, the circular structure of the catheter hose 11 allows each component to reach the affected area through the blood vessels without being damaged and to operate smoothly.

[0114] In this embodiment, the catheter hose 11 has three cavities, namely the guide wire cavity of the first accommodating space 1111 , the water cavity of the second accommodating space 1121 , and the wire cavity of the third accommodating space 1131 .

[0115] The water cavity, the wire cavity and the guide wire cavity are arranged in concentric circles.

[0116] From the inside to the outside, they are: the guide wire cavity, the wire cavity and the water cavity.

[0117] In this embodiment, the electric wire cavity is sleeved on the outside of the guide wire cavity.

[0118] The wire cavity is used for allowing at least two electrode wires 1132 to pass through, and is used to insulate and cover each of the electrode wires 1132 .

[0119] In this embodiment, each of the ultrasonic probes 13 is disposed in the gap between the guide wire cavity and the electrical wire cavity.

[0120] In this embodiment, the interior of the wire cavity is filled with colloid, wherein the acoustic impedance value of the colloid is 1.2 to 1.6×10 6 kg / m 2 s.

[0121] Please refer to Figures 6 and 7 simultaneously. Figure 6 is a schematic diagram of the structure of an ultrasonic probe 13 according to the fifth embodiment of the present application, and Figure 7 is a graph of the input voltage-output sound pressure curve generated by the ultrasonic probe 13 according to the fifth embodiment of the present application. As shown in Figure 6, at least one ultrasonic probe 13 is disposed within the expansion portion of the balloon and is sheathed over the outer portion of the inner tube 111 and the openings on the outer tube wall to emit an ultrasonic wave and induce cavitation effects in the microbubbles in the fluid composition within the expansion space.

[0122] In this embodiment, the at least one ultrasonic probe 13 is a tubular ultrasonic probe 131 , the inner diameter of the ultrasonic probe 13 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 13 is 100 k to 5 MHz and 1 MHz to 10 MHz.

[0123] The catheter hose 11 has one or three to five ultrasonic probes 13 .

[0124] The distance between each two ultrasonic probes 13 is 1 to 10 mm.

[0125] The ultrasonic probes 13 may be connected in series or in parallel.

[0126] Each of the ultrasonic probes 13 may be made of, but not limited to, a hard piezoelectric material made of lead zirconate titanate (PTZ).

[0127] The electrode coating on the surface of each ultrasonic probe 13 may be, but is not limited to, nickel-plated gold, platinum or silver coating.

[0128] At least one electrode wire 1132 is connected to the fire electrode of the ultrasonic probe 13 .

[0129] At least one electrode wire 1132 is connected to the ground of the ultrasonic probe 13 .

[0130] The sound transmission rate of the inner tube 111 through the tube wall can reach 70% to 99% at a frequency (100k to 1MHz) and a distance (0.1 to 1mm).

[0131] The sound transmission rate of the inner tube 111 through the tube wall can reach 70% to 99% at a frequency (2 to 6 MHz) and a distance (0.1 to 1 mm).

[0132] In this embodiment, as shown in FIG. 7 , the acoustic properties of the tubular ultrasonic probe 131 are measured using a waterphone. It can be found that the greater the input voltage, the greater the output sound pressure, indicating that the ultrasonic probe 13 has a high transducer efficiency.

[0133] Please refer to Figures 8 and 9 simultaneously. Figure 8 is a schematic diagram of the structure of an ultrasonic probe 13 according to the sixth embodiment of the present application, and Figure 9 is a graph of the input voltage-output sound pressure curve generated by the ultrasonic probe 13 according to the sixth embodiment of the present application. As shown in Figure 8, at least one ultrasonic probe 13 is disposed within the expansion portion of the balloon and is sheathed over the outer portion of the inner tube 111 and the openings on the outer tube wall to emit an ultrasonic wave and induce cavitation effects in the microbubbles in the fluid composition within the expansion space.

[0134] In this embodiment, the at least one ultrasonic probe 13 is a sheet-shaped combined ultrasonic probe 132. The sheet-shaped combined ultrasonic probe 132 can be two or more sheets. The length of the ultrasonic probe 13 is 0.2 to 1.5 mm, the width is 1 to 6 mm, and the height is 0.5 to 6 mm. The resonant frequency of the ultrasonic probe 13 is 1M to 20 MHz.

[0135] The ultrasonic probe 13 is a combination of two, three or more sheets of hard piezoelectric materials.

[0136] The catheter hose 11 has one or three to five ultrasonic probes 13 .

[0137] The two adjacent ultrasonic probes 13 are rotated along the axial direction of the catheter hose 11 at an angle of 135 to 225 degrees.

[0138] The distance between each two ultrasonic probes 13 is 1 to 10 mm.

[0139] The ultrasonic probes 13 may be connected in series or in parallel.

[0140] Each of the ultrasonic probes 13 may be made of, but not limited to, a hard piezoelectric material made of lead zirconate titanate (PTZ).

[0141] The electrode coating on the surface of each ultrasonic probe 13 may be, but is not limited to, platinum, nickel-coated gold or silver coating.

[0142] At least one electrode wire 1132 is connected to the fire electrode of the ultrasonic probe 13 .

[0143] At least one electrode wire 1132 is connected to the ground of the ultrasonic probe 13 .

[0144] In this embodiment, as shown in FIG. 9 , the acoustic properties of the sheet-shaped combined ultrasonic probe 132 are measured using a water phone. It can be found that the greater the input voltage, the greater the output sound pressure, indicating that the ultrasonic probe 13 has a high transducer efficiency.

[0145] FIG10 is a schematic diagram illustrating the operation of an ultrasonic balloon catheter 1 according to the present application. Referring to FIG10 , after the ultrasonic balloon catheter 1 is introduced into the cardiovascular system and enters a blood vessel 14, with the balloon 12 positioned at the site of blood vessel obstruction, a fluid composition containing microbubbles flows through the outer tube 112 of the catheter tube 11 into the expansion space within the balloon 12. Simultaneously, each ultrasonic probe 13 emits ultrasonic waves 130. The energy of the ultrasonic waves 130 induces an inertial cavitation effect, causing the microbubbles to be extremely compressed and expanded under the strong acoustic energy of the ultrasonic waves 130, ultimately collapsing and generating a pulse wave. Simultaneously, the expansion of the balloon 12 and the energy of the ultrasonic waves 130 assist in dilating the obstructed blood vessel, thereby restoring blood flow.

[0146] 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.

[0147] 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.

[0148] In summary, the ultrasonic balloon catheter of the present application has at least the following characteristics: through the concentrically arranged catheter hose structure, the guide wire is effectively used to select the correct path through the vascular network of the cardiovascular system under the push of the user, and once the correct path is established, the catheter hose slides along the guide wire to the site of blood vessel obstruction, so that the balloon is in the correct position by injecting a fluid composition containing microbubbles, and then cooperating with the ultrasonic probe in the balloon to generate ultrasonic waves to assist the balloon expansion and induce cavitation effect, and utilize the energy released in the process of bubble formation to rupture to quickly and effectively improve peripheral blood vessel obstruction and stubborn vascular calcification.

[0149] 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. An ultrasonic balloon catheter is used to be introduced into the cardiovascular system to treat stenosis or obstruction of the heart or peripheral blood vessels, and the ultrasonic balloon catheter comprises: The catheter hose is each of the above-mentioned hoses having flexibility, further comprising: An inner tube member having inner tube walls defining the first accommodating spaces, wherein the first accommodating spaces are used for the guide wires to pass through; an outer tube member, sleeved on the outer side of the inner tube wall, and having outer tube walls defining the second accommodating spaces, the second accommodating spaces being used for the fluid compositions containing microbubbles to flow in, and the outer tube wall having at least one opening for the fluid compositions to flow out; and An electrode tube, disposed in the outer tube, having electrode tube walls capable of defining each of the third accommodating spaces, wherein the third accommodating spaces are used for at least one electrode wire to pass through; A balloon, made of the elastic materials, having the expansion parts for expansion and contraction, and the necks respectively arranged at both ends of the expansion parts, and the balloon is fixedly arranged on the outside of the catheter hose by the necks, and the expansion parts and the necks form the expansion spaces on the outer wall of the catheter hose, so that the fluid composition can be injected into the expansion spaces through the openings on the outer tube wall; and At least one ultrasonic probe is disposed in the expansion portion of the balloon and is sleeved on the outside of the inner tube and each of the openings on the outer tube wall to emit each of the ultrasonic waves and induce cavitation effect on microbubbles in the fluid composition located in the expansion space.

2. The ultrasonic balloon catheter as claimed in claim 1, wherein when the catheter hose passes through the vascular network of the cardiovascular system, the catheter hose is adapted to the guide wire path and slides along the guide wire. 3 . The ultrasonic balloon catheter as claimed in claim 1 , wherein the inner tube and the outer tube in the catheter hose are arranged in concentric circles, and the outer diameter of the inner tube is smaller than the inner diameter of the outer tube. 4 . The ultrasonic balloon catheter as claimed in claim 1 , wherein the inner tube is made of polyether polyamide block copolymer, polyamide, thermoplastic polyurethane or other polymer materials with high sound transmission properties. 5 . The ultrasonic balloon catheter as claimed in claim 1 , wherein the balloon is made of polyether polyamide block copolymer, polyamide, thermoplastic polyurethane or other polymer materials with high sound transmission properties.

6. The ultrasonic balloon catheter as claimed in claim 1, wherein the effective length of the balloon is 20 to 80 mm and the diameter is 2 to 7 mm.

7. The ultrasonic balloon catheter as claimed in claim 1, wherein the maximum pressure resistance of the balloon is 10 to 15 atm, and the fully expanded pressure is 3 to 7 atm.

8. The ultrasonic balloon catheter as claimed in claim 1, wherein the neck of the balloon is fixed to the catheter tube by ultraviolet curing glue.

9. The ultrasonic balloon catheter as described in claim 1, wherein the at least one ultrasonic probe is a tubular ultrasonic probe, 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 5 MHz and 1 MHz to 10 MHz.

10. The ultrasonic balloon catheter as described in claim 1, wherein the at least one ultrasonic probe is an ultrasonic probe of each of the sheet combinations, the sheet combination can be two or more sheets, the ultrasonic probe has a length of 0.2 to 1.5 mm, a width of 1 to 6 mm, and a height of 0.5 to 6 mm, and a resonant frequency of the ultrasonic probe is 1M to 20MHz.

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