Ultrasonic medicine perfusion balloon catheter and application thereof

Abstract

The invention discloses an ultrasonic medicine perfusion balloon catheter which comprises a catheter body, a medicine conveying pipe and a balloon arranged on the catheter body. The catheter comprises an inner tube for conveying a guide wire and an outer tube for conveying a filling medium to the balloon; the balloon comprises a near-end balloon and a far-end balloon, and the near-end balloon and the far-end balloon are sequentially arranged on the catheter in a sleeving mode from the near end to the far end in the axial direction of the catheter at intervals. An ultrasonic part used for emitting ultrasonic waves is arranged in a spacing area between the near-end balloon and the far-end balloon and comprises a base arranged outside the catheter in a sleeving mode and a plurality of ultrasonic transducers arranged on the outer side surface of the base and distributed around the center axis of the base; the drug delivery tube and the catheter are arranged in parallel, and the far end of the drug delivery tube intervenes between the near-end balloon and the far-end balloon. According to the ultrasonic medicine perfusion balloon catheter, in the using process, the ultrasonic action energy and the focus position are dynamically distributed, blood vessel circumferential full coverage can be achieved, the medicine absorption rate is effectively increased, and the penetration depth is increased.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an ultrasonic drug perfusion balloon catheter and its application. Background Art

[0002] In the field of vascular interventional therapy, drug inhibition of excessive proliferation of smooth muscle cells is an important means to prevent restenosis. Traditional drug balloons inhibit intimal hyperplasia by locally releasing anti-proliferative drugs (such as paclitaxel), but there are risks of low drug loading, uncontrollable release, and distal embolization. Although porous perfusion balloons can improve the uniformity of drug distribution and reduce the risk of distal obstruction, the unabsorbed drugs will also enter the systemic circulation, resulting in systemic side effects. Chinese Patent Application CN110548212A discloses a double-balloon catheter with self-perfusion function, which designs two balloons to block the target blood vessel site, blocks blood flow for a short time to facilitate the entry of liquid medicine into the target blood vessel site, realizes continuous perfusion of liquid medicine, and sets a liquid return channel. During the perfusion of liquid medicine, the liquid medicine outside the balloon catheter is aspirated through the liquid return channel to ensure that the blocked target area always maintains a high drug concentration, thereby reducing the loss of drugs during transportation and perfusion, improving the efficiency of drug transfer to the target tissue, and reducing the risk of thrombus formation. However, the existing occlusive perfusion balloons are prone to displacement due to blood scouring, resulting in deviation of the drug action site. Moreover, the liquid medicine is in a static state after being perfused into the occluded area, and the drug penetration depth is limited, making it difficult to effectively act on deep vascular wall cells and difficult to achieve the effect of long-term inhibition of vascular restenosis. By combining the drug balloon with ultrasonic technology, the absorption of drugs can be promoted more safely and controllably by using the micro-jet effect and cavitation effect of ultrasound. However, most existing ultrasonic catheters use single-element transducers with a single frequency. On the one hand, single-point ultrasound is difficult to achieve circumferential coverage of blood vessels, and long-term irradiation of a fixed area may cause tissue overheating; on the other hand, the focal position and energy distribution cannot be dynamically adjusted, and the utilization of ultrasound is limited. Summary of the Invention

[0003] In view of this, the purpose of the present invention is to provide an ultrasonic drug perfusion balloon catheter, in which the ultrasonic action energy and focal position are dynamically distributed during use, which can achieve circumferential coverage of blood vessels, effectively improve the drug absorption rate and increase the penetration depth.

[0004] The present invention is realized by the following technical solutions:

[0005] An ultrasonic drug perfusion balloon catheter, comprising a catheter, a drug delivery tube, and a balloon provided on the catheter;

[0006] The catheter includes an inner tube for delivering a guide wire and an outer tube for delivering a filling medium to the balloon. The outer tube is sleeved on the inner tube, and the gap between the outer tube and the inner tube forms a channel communicating with the balloon; ?

[0007] The balloon includes a proximal balloon and a distal balloon. The proximal balloon and the distal balloon are sequentially and spacedly sleeved on the catheter from the proximal end to the distal end along the axial direction of the catheter; an ultrasonic component for emitting ultrasonic waves is arranged in the interval area between the proximal balloon and the distal balloon; the ultrasonic component includes a base sleeved outside the catheter and a plurality of ultrasonic transducers arranged on the outer surface of the base; the ultrasonic transducers are distributed around the central axis of the hollow cavity of the base;

[0008] The drug delivery tube is arranged in parallel with the catheter, and the distal end of the drug delivery tube intervenes between the proximal balloon and the distal balloon.

[0009] As a preferred embodiment, the perpendicular distance from each ultrasonic transducer to the central axis of the hollow cavity of the base changes in a stepped manner.

[0010] As another preferred embodiment, the perpendicular distance from each ultrasonic transducer to the central axis of the hollow cavity of the base is the same, and each ultrasonic transducer is separately provided with a power amplifier for adjusting the ultrasonic wave emission time, so that the ultrasonic wave emission time of each ultrasonic transducer changes in a stepped manner.

[0011] Furthermore, the ultrasonic transducers are sequentially offset in the axial position, and the axial spacing and the circumferential spacing angle between adjacent ultrasonic transducers are both kept constant, forming a spiral arrangement configuration surrounding the base.

[0012] Furthermore, the catheter further includes a blood flow tube; the blood flow tube penetrates through the proximal balloon and the distal balloon, and the lumen of the blood flow tube is not communicated with the cavity of the balloon.

[0013] As a preferred embodiment, the drug delivery tube and the blood flow tube are respectively closely attached to both sides of the outer tube, and the lumens of the inner tube, the outer tube, the drug delivery tube and the blood flow tube are not communicated with each other.

[0014] Furthermore, a drug delivery needle seat is arranged at the proximal nozzle of the drug delivery catheter; a drug storage pump is arranged on the drug delivery needle seat; the cavity of the drug storage pump is divided into upper and lower layers, which are a drug powder cavity and a drug dispersion medium cavity respectively, and an ultrasonic element is arranged inside the cavity; the ultrasonic element is an ultrasonic transducer.

[0015] Furthermore, after being filled with a filling medium, both the proximal balloon and the distal balloon are double-concave disc-shaped balloons; the double-concave disc-shaped balloon includes opposite first concave surface and second concave surface; the first concave surface and the second concave surface are recessed into the balloon relative to each other along the central axis of the catheter.

[0016] Preferably, the ratio of the length at the outer edge position to the length at the central position of the double-concave disc-shaped balloon is greater than 2:1, and more preferably (2-5):1.

[0017] Preferably, an anti-slip layer is provided on the outer edge surface of the double-concave disc-shaped balloon; further, the silica gel layer includes a number of anti-slip bumps with a size in the micron range.

[0018] The present invention also provides an application of the above-mentioned drug perfusion balloon catheter in a vascular intervention treatment device.

[0019] The present invention has the following beneficial effects:

[0020] For the ultrasonic drug perfusion balloon catheter of the present invention, by designing ultrasonic components in the liquid medicine perfusion area between the proximal balloon and the distal balloon, and further finely regulating the arrangement mode of the ultrasonic transducers, the deflection of the sound beam and the control of the energy distribution are realized, the shearing force of the ultrasonic wave can be enhanced, the ultrasonic action energy and the focal position are dynamically distributed, the circumferential coverage of the blood vessel is realized, and the flow of the liquid medicine in the perfusion area is driven by mechanical force, the shearing force on the blood vessel is increased, the drug absorption rate is effectively improved, and the penetration depth is increased.

[0021] The present invention further adopts a balloon with a double-concave disc structure, which can minimize the volume of the balloon, reserve a larger liquid medicine perfusion space, effectively increase the contact area between the balloon and the blood vessel wall at the same time, and can change the direction of the blood flow shearing force, reduce the direct impact area of the blood on the contact area between the blood vessel wall and the balloon, and reduce the risk of balloon displacement. Description of the Drawings

[0022] Figure 1 is a schematic structural diagram of an ultrasonic drug perfusion balloon catheter provided by the present invention;

[0023] Figure 2 is a schematic cross-sectional structure diagram of a metal base provided by the present invention;

[0024] Figure 3 is a schematic diagram of an arrangement mode of transducers provided by the present invention;

[0025] Figure 4 is a schematic cross-sectional structure diagram of the catheter at the distal balloon (left) and a schematic cross-sectional structure diagram of the catheter at the proximal balloon (right) provided by the present invention;

[0026] Figure 5 is a schematic structural diagram of a drug storage pump provided by the present invention;

[0027] Figure 6 is a three-dimensional structural diagram of a double-concave disc-shaped balloon (left) and an axial sectional structure diagram through the central axis of the balloon (right) provided by the present invention;

[0028] Reference Signs:

[0029] 1 - catheter, 14 - blood delivery tube, 242 - second concave surface

[0030] 11 - Drug delivery tube 2 - Balloon 25 - Balloon pin

[0031] 12 - Inner tube 21 - Proximal balloon 3 - Drug delivery needle seat

[0032] 13 - Outer tube 22 - Distal balloon 31 - Drug storage pump

[0033] 131 - First balloon inflation hole 23 - Silicone layer 311 - Drug powder chamber

[0034] 132 - Second balloon inflation hole 241 - First concave surface 312 - Drug dispersion medium chamber

[0035] 313 - Ultrasonic element 5 - Ultrasonic component 52 - Ultrasonic transducer

[0036] 4 - Inflation needle seat 51 - Base 6 - Lead wire Detailed implementation mode

[0037] To elaborate in detail the technical content, achieved objectives and effects of the present invention, the technical solution of the present invention will be clearly and completely described below in conjunction with the implementation modes and with reference to the accompanying drawings. However, the described embodiments are only a part of the embodiments of the present invention, and the implementation and protection of the present invention are not limited thereto. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall within the scope of protection of the present invention. It should be noted that for the processes not specifically described in detail below, those skilled in the art can implement or understand them with reference to the existing technology.

[0038] Embodiment 1

[0039] Combined with Figure 1 As shown, this embodiment provides an ultrasonic drug perfusion balloon catheter, including a catheter 1, a drug delivery tube 11 and a balloon 2 provided on the catheter; the catheter 1 includes an inner tube 12 for delivering a guide wire and an outer tube 13 for delivering a filling medium to the balloon, the outer tube 13 is sleeved on the inner tube 12, and the gap between the outer tube 13 and the inner tube 12 forms a channel communicating with the balloon; the balloon 2 includes a proximal balloon 21 and a distal balloon 22, and the proximal balloon 21 and the distal balloon 22 are sequentially and spacedly sleeved on the catheter along the axial direction of the catheter 1 from the proximal end to the distal end; an ultrasonic component 5 for emitting ultrasonic waves is arranged in the interval region between the proximal balloon 21 and the distal balloon 22; the ultrasonic component 5 includes a base 51 sleeved outside the catheter and a plurality of ultrasonic transducers 52 arranged on the outer surface of the base; the ultrasonic transducers 52 are distributed around the central axis of the base;; the drug delivery tube 11 is arranged in parallel with the catheter 1, and the distal end of the drug delivery tube 11 intervenes between the proximal balloon 21 and the distal balloon 22.

[0040] In a specific application, during operation, the balloon part of the drug perfusion balloon catheter is advanced along the guide wire to the target blood vessel site. A pressurizing pump is used to deliver a filling medium to the balloon to fill the balloon to the rated pressure, so that the balloon expands and the outer edge of the balloon closely adheres to the blood vessel wall, making the blood flow at the target blood vessel site in a closed state. At this time, the liquid medicine is delivered to the closed position of the target blood vessel between the proximal balloon and the distal balloon through the drug delivery tube. The ultrasonic component emits ultrasonic waves according to the set power, frequency, treatment duration, and duty cycle. The cavitation and micro-jet effects of the ultrasonic waves are utilized to promote the absorption of the drug by the blood vessel wall. The settable range of the duty cycle is relatively large, from 5% to 80%, which greatly increases the ultrasonic working efficiency and improves the drug loading rate. However, preferably, the range of the duty cycle should be lower than 30%, which will reduce the heat generated during the operation of the ultrasonic component and improve the overall safety (the ultrasonic duty cycle refers to the ratio of the time when the high-level signal exists in a cycle of the ultrasonic wave signal to the entire cycle, usually expressed as a percentage. For example, a duty cycle of 50% means that the time when the high-level signal exists accounts for half of the entire cycle). After the blood vessel wall absorbs the drug and the treatment is completed, the excess liquid medicine can be withdrawn from the drug delivery tube to prevent it from flowing into the systemic blood circulation. Immediately afterwards, a withdrawal procedure is performed on the balloon, and the balloon shrinks, facilitating the subsequent withdrawal of the balloon.

[0041] As an alternative implementation manner of this embodiment, the base can be cylindrical or prismatic with multiple sides (such as 3, 4, 5, 6, 7, 8 sides, etc.), and the base can be a metal base. According to actual needs, the ultrasonic transducer can be selected as a sheet ultrasonic transducer (such as a piezoelectric ceramic sheet) or an arc-shaped ultrasonic transducer.

[0042] As a preferred implementation manner, the perpendicular distance from each ultrasonic transducer to the central axis of the hollow cavity of the base changes in a stepped manner, so that the ultrasonic waves emitted by each ultrasonic transducer generate a phase difference. The time / space delay is used to form acoustic interference, generating a directional energy deflection and generating a circumferential shear force for cutting the blood vessel, enabling the dynamic distribution of the ultrasonic action energy and the focal position, and achieving full circumferential coverage of the blood vessel. Further, combined with Figure 2As shown, sheet-like ultrasonic transducers are mounted on six side surfaces of a hexagonal metal base, namely 52a, 52b, 52c, 52d, 52e, and 52f in sequence. The perpendicular distances from the ultrasonic transducers on the six side surfaces of the metal base to the central axis of the hollow cavity of the base change in a stepped manner. Among them, the perpendicular distance from the surface 52a of the ultrasonic transducer to the central axis of the base is the farthest, and the perpendicular distance from the surface 52f to the central axis of the base is the closest, causing phase differences to occur between the ultrasonic transducers 52a and 52b, 52c, 52d, 52e, and 52f respectively. The ultrasonic phase difference in this design method is also related to factors such as the material of the metal base and the frequency of the transducer. In a specific implementation case, a hexagonal base made of aluminum metal is selected, and the frequency of the transducer is 10 MHz. Then, the perpendicular distances from the six side surfaces of the base to the central axis of the base decrease linearly in steps from 52a to 52f. The perpendicular distance from each adjacent transducer to the central axis of the base decreases by 0.1053 mm, and the cumulative reduction is 0.5265 mm, causing phase differences of 60°, 120°, 180°, 240°, and 300° to exist between the ultrasonic transducers 52a and 52b, 52c, 52d, 52e, and 52f respectively. In sequence, the ultrasonic waves reach the blood vessel wall, forming acoustic interference by using time / space delay, generating directional energy deflection, generating a circumferential cutting shear force for the blood vessel, making the ultrasonic action energy and the focal position dynamically distributed, and achieving circumferential full coverage of the blood vessel. There are no special restrictions on the material of the base and the frequency of the ultrasonic transducer in the present invention. The base made of other metal materials and ultrasonic transducers with other frequencies can be selected according to actual needs. Preferably, the frequency of the ultrasonic transducer is 0.5 - 25 MHz. The metal base can be designed into prisms with different numbers of side surfaces (such as 3, 4, 5, 6, 7, 8 sides, etc.) or cylinders according to actual needs, and phase differences are designed according to requirements, which can also produce similar effects.

[0043] As another preferred implementation manner, when the perpendicular distances from each ultrasonic transducer to the central axis of the hollow cavity of the base are the same, a power amplifier for adjusting the ultrasonic emission time is separately provided for each ultrasonic transducer, making the ultrasonic emission times of each ultrasonic transducer change in a stepped manner. By delaying the ultrasonic emission times, phase differences are generated, which can also produce effects similar to those of the previous scheme.

[0044] Furthermore, the ultrasonic transducers are misaligned in the axial position in sequence, and the axial spacing and circumferential interval angle between adjacent ultrasonic transducers are both kept constant, forming a spiral arrangement configuration surrounding the base, such as Figure 3As shown, six sheet-shaped ultrasonic transducers are mounted on the six side surfaces of a hexagonal metal base, which are 52a, 52b, 52c, 52d, 52e, and 52f in sequence. The axial positions of the six sheet-shaped ultrasonic transducers are staggered in sequence, and the distances from the ends of the hexagonal metal base increase in sequence, forming a spiral arrangement configuration surrounding the base. This special arrangement can generate an oblique spiral shear force, which can maximize the promotion of the flow of the liquid medicine in the treatment space, enhance the micro-jet effect and cavitation effect, and at the same time increase the shear force on the blood vessel wall and improve the vascular permeability, thereby promoting the absorption of the drug.

[0045] In the present invention, the interval between the two balloons can be designed into different specifications according to the length and diameter of the lesion. The specifications of the ultrasonic transducer and the metal base can be selected according to the length of the balloon interval. According to the actual application requirements, the single metal base does not exceed 15 mm, and the length of a single transducer does not exceed 5 mm, which can make the balloon catheter have better passability when in use and avoid being blocked when passing through tortuous blood vessels. In a preferred specific embodiment, the distance between the two balloons is 25 mm. Then, 2 metal bases with a length of 12 mm are installed outside the catheter, and a 4-mm-long transducer is attached to each side surface. The top ends of each transducer in the axial direction are spaced 1.5 mm apart, and they are pasted clockwise or counterclockwise in combination with the thickness of the metal base. It can make the balloon catheter have better passability when in use, and can realize the deflection of the sound beam and the control of the energy distribution, enhance the shear force of the ultrasound, make the energy of the ultrasound action and the focal position be dynamically distributed, achieve circumferential full coverage of the blood vessels, and drive the flow of the liquid medicine in the perfusion area through mechanical force, increase the shear force on the blood vessels, effectively improve the absorption rate of the drug, and increase the penetration depth.

[0046] As an optional implementation manner of this embodiment, the catheter of the present invention further includes a blood circulation tube 14; the blood circulation tube penetrates through the proximal balloon and the distal balloon. During the treatment process, the target blood vessel site is blocked into a closed space, and the blood can still pass through the target blood vessel site through the blood circulation tube, keeping the blood of the whole body unobstructed, avoiding local ischemia and tissue damage that may be caused by long-term dilation, so the drug action time (5 minutes or even dozens of minutes) can be increased, making the treatment effect better.

[0047] As a preferred implementation manner, in combination with Figure 4 As shown, the outer tube is sleeved on the inner tube, and the gap between the outer tube and the inner tube forms a channel communicating with the balloon; the drug delivery tube and the blood circulation tube are respectively attached to both sides of the outer tube, and the lumens of the inner tube, the outer tube, the drug delivery tube, and the blood circulation tube do not communicate with each other. The outer tube is provided with balloon filling holes, and the balloon filling holes are set within the range of the balloon (the first balloon filling hole 131 and the second balloon filling hole 132 are respectively arranged on the outer tube walls at the positions within the proximal balloon and the distal balloon), and the balloon pin 25 is arranged at the connection of the balloon and the catheter to block the gap at the connection (such asFigure 6 as shown in the figure) to avoid the problem of extravasation of the balloon filling medium.

[0048] As an optional implementation mode of this embodiment, the drug delivery catheter can be a single-hole or multi-hole catheter. The proximal port of the drug delivery catheter is provided with a drug delivery needle seat 3, which can be delivered by a simple external syringe or designed as a self-contained drug storage pump 31. In a specific implementation case (combined with Figure 5 as shown in the figure), the cavity of the drug storage pump is divided into upper and lower layers, namely a drug powder cavity 311 and a drug dispersion medium cavity 312, which are respectively filled with drug powder and drug dispersion medium. An ultrasonic element 313 is arranged inside the cavity. Before use, the drug powder and the drug dispersion medium are mixed, and the built-in ultrasonic element (which can be a low-frequency ultrasonic transducer, preferably with a frequency of 50KHz-1MHz) is used to fully mix them and then inject and deliver the drug. The drugs for treatment are not limited, and can be paclitaxel, sirolimus and its derivatives, etc. However, drug preparations with ultrasonic response characteristics are preferably used, such as liposomes, porous microspheres, drug-loaded microbubbles, combinations of blank microbubbles and drugs, etc., which have a synergistic effect with ultrasound and can further improve the curative effect. The ultrasonic response characteristic drug preparation refers to a drug preparation formed by wrapping a drug in a carrier material with ultrasonic responsiveness, which can produce a specific response to ultrasonic stimulation. This kind of preparation can usually utilize the physical action of ultrasound to cause structural changes or other effects in the carrier, so as to realize drug release or enhance the therapeutic effect of the drug; for example, due to the structure of its internal cavity, liposomes will reduce the cavitation threshold under ultrasound, produce a greater cavitation effect, thereby increasing the permeability of the blood vessel wall and increasing the absorption of the drug. Among them, sustained-release preparations such as microspheres can also achieve long-term sustained release after entering the blood vessel wall, continuously inhibit intimal hyperplasia and avoid restenosis.

[0049] As an optional implementation mode of this embodiment, the proximal port of the outer tube is provided with a filling needle seat 4 for pumping a filling medium (which can be a liquid, such as normal saline) into the outer tube and delivering it to the balloon to expand the balloon.

[0050] As an optional implementation mode of this embodiment, after being filled with the filling medium, both the proximal balloon and the distal balloon are double-concave disc-shaped balloons. The double-concave disc-shaped balloon imitates the shape of human blood red blood cells (the thickness gradually decreases from the edge to the center, forming a double-sided concave shape), and its structure includes opposite first concave surface 241 and second concave surface 242; the first concave surface and the second concave surface are recessed into the balloon relative to each other along the central axis of the catheter (combined with Figure 6This structure minimizes balloon volume, leaving more room for drug infusion, while effectively increasing the contact area between the balloon and the vessel wall. It also redirects blood flow shear forces, reducing the direct impact of blood on the contact area between the vessel wall and the balloon, and minimizing the risk of balloon displacement. The ratio of the outer edge length L1 to the center length L2 of the biconcave disc-shaped balloon is greater than 2:1, ensuring a larger contact area between the balloon's outer edge and the vessel wall and redirecting blood flow shear forces. The preferred ratio is (2-5):1.

[0051] As one of the optional implementation methods of this embodiment, combined with Figure 6 As shown, the outer edge surface of the biconcave disc-shaped balloon is provided with an anti-skid layer 23; further, the silicone layer is a plurality of anti-skid bumps of micron size. This design can further enhance the friction between the balloon and the blood vessel wall, effectively reducing the situation of balloon displacement. The anti-skid layer of the present invention can be made of at least one of silicone materials with a high friction coefficient (such as MED-6020, etc.), butadiene rubber, styrene-butadiene rubber, thermoplastic polyurethane elastomer, polyamide, etc. The balloon material of the present invention can be selected from common balloon materials such as nylon. Regarding the connection method of the ultrasonic transducer wire 6, in a preferred specific implementation case, after the positive wire is connected to the transducer and the negative wire is connected to the metal base, the wire passes through the hole opened on the outer tube, and the wire is pulled out from the outer tube lumen to connect to the ultrasonic control system, while blocking the hole to avoid air leakage or saline extravasation. In other implementation cases, a new wire channel can also be compounded outside the catheter to prevent blood from directly contacting the catheter. In a preferred specific implementation case, a temperature measuring line is added to the treatment cavity and pasted on the outer tube (next to the transducer), which can detect the temperature of the ultrasonic component in real time. When the operating temperature reaches a predetermined threshold, the temperature sensor sends a signal to the control system, which can then stop the operation of the ultrasonic transducer, thereby allowing the ultrasonic energy to be used as effectively as possible while reducing the damage to blood vessels and tissues caused by temperature rise. In a preferred specific implementation case, the catheter can be additionally provided with a water outlet pipe, which is designed as a circulating water system, which can take away the heat generated by the ultrasonic transducer during operation and increase the safety of the catheter operation. In a specific implementation case, an additional water outlet pipe is provided to pass through the two balloons and extend to the left area of the filling needle seat, and a water outlet needle seat is provided at this position. The first balloon water outlet hole and the second balloon water outlet hole are provided on the tube wall at the inner position of the proximal balloon and the distal balloon, respectively, to achieve the circulating water function.

[0052] In the specific application of the above solution, during operation, the balloon part of the drug infusion balloon catheter is advanced along the guide wire to the target blood vessel site. A pressurizing pump is used to deliver normal saline to the balloon to fill the balloon to the rated pressure, causing the balloon to expand into a double concave disc shape. The outer edge of the balloon closely adheres to the blood vessel wall, making the blood flow at the target blood vessel site in a closed state. When the blood flow passes through the balloon occlusion area, due to the double concave disc shape of the balloon, the direction of the blood flow shear force is changed, reducing the direct impact area of the blood on the contact area between the blood vessel wall and the balloon, reducing the risk of balloon displacement, and making the blood more inclined to flow through the middle part of the balloon and then smoothly flow out from the blood circulation pipeline. During the treatment process, the blood throughout the body remains unobstructed, avoiding local ischemia and tissue damage that may be caused by long-term dilation. The drug storage pump injects the liquid medicine into the drug delivery tube and transports it to the closed position of the target blood vessel between the proximal balloon and the distal balloon. The ultrasonic component emits ultrasonic waves according to the set power, frequency, treatment duration, and duty cycle. The cavitation and micro-jet effects of the ultrasonic waves are used to promote the absorption of the drug by the blood vessel wall. Due to the special arrangement method of the ultrasonic transducers, there is a phase difference in the ultrasonic waves emitted by each ultrasonic transducer. The time / space delay is used to form acoustic interference, generating a directional energy deflection and generating a circumferential cutting shear force on the blood vessel, making the ultrasonic action energy and the focal position dynamically distributed, achieving full circumferential coverage of the blood vessel. At the same time, the helical arrangement configuration can generate an oblique helical shear force, maximizing the promotion of the flow of the liquid medicine in the treatment space, enhancing the micro-jet effect and cavitation, while increasing the shear force on the blood vessel wall and improving the blood vessel permeability, thereby promoting the absorption of the drug. After the treatment work is completed, the excess liquid medicine can be withdrawn from the drug delivery tube to avoid its flow into the systemic blood circulation. Immediately afterwards, a withdrawal procedure is performed on the balloon, and the balloon shrinks, facilitating the subsequent withdrawal of the balloon.

[0053] For those skilled in the art, the present invention is not limited to the details of the above exemplary embodiments, and the present invention can be implemented in other specific forms without departing from the spirit or basic characteristics of the present invention. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be encompassed by the present invention. Any reference signs in the claims should not be regarded as limiting the claimed rights.

[0054] All of the above embodiments are preferred embodiments of the present invention, but the embodiments of the present invention are not limited by the described embodiments. Any other changes, modifications, substitutions, combinations, and simplifications made without departing from the spirit and principle of the present invention should be equivalent replacement methods and are all included in the protection scope of the present invention.

Claims

1. An ultrasonic drug perfusion balloon catheter, characterized in that, It includes a catheter, a drug delivery tube and a balloon arranged on the catheter; The catheter comprises an inner tube for conveying a guide wire and an outer tube for conveying a filling medium to the balloon, wherein the outer tube is sleeved on the inner tube, and a gap between the outer tube and the inner tube forms a channel communicating with the balloon; The balloon comprises a proximal balloon and a distal balloon, which are sequentially spaced apart and sleeved on the catheter from the proximal end to the distal end along the axial direction of the catheter; an ultrasonic component for emitting ultrasonic waves is provided in the spaced area between the proximal balloon and the distal balloon; the ultrasonic component comprises a base sleeved on the outside of the catheter and a plurality of ultrasonic transducers provided on the outer surface of the base; the ultrasonic transducers are distributed around the central axis of the hollow cavity in the base; The drug delivery tube is arranged in parallel with the catheter, and the distal end of the drug delivery tube is inserted between the proximal balloon and the distal balloon.

2. The ultrasonic drug perfusion balloon catheter according to claim 1, wherein The vertical distance between each ultrasonic transducer and the central axis of the cavity in the base changes in a step-like manner.

3. The ultrasound drug perfusion balloon catheter according to claim 1, wherein The vertical distance from each ultrasonic transducer to the central axis of the cavity in the base is the same, and each ultrasonic transducer is individually provided with a power amplifier for adjusting the ultrasonic emission time, so that the ultrasonic emission time of each ultrasonic transducer changes in a step-by-step manner.

4. The ultrasonic drug perfusion balloon catheter according to claim 1, characterized in that, The ultrasonic transducers are staggered in sequence in axial position, and the axial spacing and circumferential spacing angles of adjacent ultrasonic transducers are kept constant, forming a spiral arrangement configuration surrounding the base.

5. The ultrasound drug perfusion balloon catheter according to claim 1, wherein The catheter further comprises a blood circulation tube; the blood circulation tube passes through the proximal balloon and the distal balloon, and the lumen of the blood circulation tube is not connected to the cavity of the balloon.

6. The ultrasound drug perfusion balloon catheter according to claim 5, characterized in that, The drug delivery tube and the blood circulation tube are respectively closely attached to the two sides of the outer tube, and the lumens of the inner tube, the outer tube, the drug delivery tube and the blood circulation tube are not connected to each other.

7. The ultrasound drug perfusion balloon catheter according to claim 1, wherein The proximal tube mouth of the drug delivery catheter is provided with a drug delivery needle seat; a drug storage pump is provided on the drug delivery needle seat; the cavity of the drug storage pump is divided into two layers, namely the drug powder cavity and the drug dispersion medium cavity, and an ultrasonic element is provided inside the cavity; the ultrasonic element is an ultrasonic transducer.

8. The ultrasound drug perfusion balloon catheter according to claim 1, wherein The proximal balloon and the distal balloon are both biconcave disc-shaped balloons after being filled with the filling medium; the biconcave disc-shaped balloon includes a first concave surface and a second concave surface relative to each other; the first concave surface and the second concave surface are relatively concave inwardly of the balloon along the central axis of the catheter; the ratio of the outer edge length to the center length of the biconcave disc-shaped balloon is greater than 2:

1.

9. The ultrasound drug perfusion balloon catheter according to claim 8, wherein The outer edge surface of the biconcave disc-shaped balloon is provided with an anti-skid layer; the anti-skid layer includes a plurality of anti-skid convex points with a size of micron level.

10. Use of the ultrasonic drug infusion balloon catheter according to any one of claims 1 to 9 in vascular interventional treatment equipment.

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