WO2022217917A1 - Drug balloon catheter, and drug balloon catheter system and control method therefor - Google Patents

Abstract

A drug balloon catheter, and a drug balloon catheter system and a control method therefor. The drug balloon catheter comprises a balloon (20) having an outer surface coated with a drug coating (21), a catheter (1) passing through the balloon (20), and shock wave components (3) connected to the catheter (1); each shock wave component (3) is used for emitting shock waves to the drug coating (21) after the catheter (1) is conveyed to a predetermined position, so that the drug coating (21) falls off from the outer surface of the balloon (20); the drug coating (21) comprises a protective layer (212) and a drug carrying layer (211), and the drug carrying layer (211) is located between the outer surface of the balloon (20) and the protective layer (212); or the drug coating (21) comprises an active drug and a polymer carrier; or the drug coating (21) comprises the active drug and a liposome used for wrapping the active drug. The drug balloon catheter system comprises a control assembly and the drug balloon catheter, and the shock wave components (3) are connected to the control assembly by means of a wire (6). The drug balloon catheter, and the drug balloon catheter system and the control method therefor provided by the present application have the characteristics of being high in drug utilization rate, simple in structure, and convenient to operate.

Description

A kind of drug balloon catheter, drug balloon catheter system and control method thereof

This application claims the priority of the Chinese Patent Application No. 202110410650.3 filed with the China Patent Office on April 14, 2021, the entire contents of which are incorporated herein by reference.

technical field

The present application belongs to the field of medical devices, and more particularly, relates to a drug balloon catheter, a drug balloon catheter system and a control method thereof.

Background technique

Percutaneous Transluminal Angiography ( PTA ) has gone through the stages of bare balloon, bare metal stent, drug-eluting stent, and drug-coated balloon since the 1970s. Among them, the Drug Coated Balloon ( DCB ), on the one hand, the drug can effectively inhibit the excessive proliferation of smooth muscle cells to reduce the incidence of restenosis, on the other hand, it does not require stent placement, thereby reducing the inflammatory response of the vascular intima and reducing the risk of restenosis. It reduces the risk of stent thrombosis, shortens the time of dual antiplatelet, and reduces the risk of bleeding.

Existing drug balloons usually use the contrast agent iopromide as a carrier and paclitaxel as a drug coating to coat the balloon catheter to treat coronary restenosis. Due to the hydrophilic properties of iopromide, it can improve the lipid-soluble drugs. The transfer rate of paclitaxel to vascular tissue ensures the effectiveness of the product in clinical use. However, there are still some deficiencies in the clinical use of the drug balloon product with this coating structure, mainly as follows: First, the existing drug balloon has a certain complication rate, especially iopromide belongs to the larger The single use of this carrier will cause serious transport loss during clinical use, and the coating will generate more particles, and the particles will be larger, causing the risk of downstream blood vessel blockage.

Secondly, due to the scouring effect of blood during the delivery of the drug balloon, part of the drug coating falls off, so that the active drug is washed away before the balloon reaches the target diseased blood vessel, and the coating on the balloon after the drug balloon is withdrawn Not all of them fall off, so some active drugs remain on the balloon, causing waste of drugs, and some of the washed-out drugs will also poison downstream tissues and cause downstream tissue necrosis. In addition, the drug attached to the inner wall of the blood vessel is also easily lost under the flushing of blood flow, and the effective drug concentration in the tissue is maintained for a short time, resulting in poor therapeutic effect.

Finally, for severe calcified lesions, the existing drug balloons cannot dilate the diseased blood vessels, and the drug transfer rate is low. The current clinical strategy is to pre-treat calcified blood vessels before drug balloon intervention, such as rotational atherectomy, cutting balloon treatment, etc. However, such operations will increase the complexity of the operation, prolong the operation time, and increase the operation cost.

technical problem

The purpose of the embodiments of the present application is to provide a drug balloon catheter to solve the technical problems of low drug utilization rate, poor drug absorption effect and inconvenient clinical use in the prior art.

technical solutions

To achieve the above purpose, the technical scheme adopted in the application is:

The first aspect: the embodiment of the present application provides a drug balloon catheter, which includes a balloon whose outer surface is coated with a drug coating, a catheter penetrating the balloon, a shock wave component connected to the catheter, a wire, and a connected catheter. a catheter joint, the shock wave component is used to emit shock waves to the drug coating after the catheter is delivered to a predetermined position, so that the drug coating is peeled off from the outer surface of the balloon;

The drug coating includes a protective layer and a drug-loading layer, and the drug-loading layer is located between the outer surface of the balloon and the protective layer; or,

The drug coating includes an active drug and a macromolecular carrier; or,

The drug coating includes an active drug and liposomes for encapsulating the active drug.

Optionally, the drug-loading layer includes a low-molecular-weight carrier and an active drug, and the protective layer is made of a high-molecular-weight carrier.

Optionally, the liposome adopts at least one of cholesterol, lecithin, soybean lecithin, cephalin, polyvinyl alcohol, and polylactic acid-glycolic acid copolymer.

Optionally, the active drug is at least one of rapamycin, zotarolimus, tacrolimus, paclitaxel, dexamethasone and derivatives thereof, and the active drug is on the outer surface of the balloon The unit drug loading is 0.1 μg/mm ² -2 μg/mm ² .

Optionally, the macromolecular carrier adopts at least one selected from polyols, polyesters, poloxamers, iopromide, polyvinylpyrrolidone, and Tween, and/or, the low-molecular carrier adopts At least one of polyols, organic acid salts, and urea.

Optionally, the polyol is at least one of polyethylene glycol, xylitol, mannitol, sorbitol, and amino alcohol.

Optionally, the esters are polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polybutylene succinate, polyhydroxyalkanoate, polycaprolactone, polyethylene adipate. At least one of glycol ester or polyhydroxybutyrate valerate copolymer.

Optionally, the shock wave component is a shock wave electrode connected with a wire, and the shock wave electrode includes a first electrode, a second electrode, and an insulating portion located between the first electrode and the second electrode.

Optionally, the first electrode has an annular structure and is provided with an electrode hole, and the second electrode is located inside the first electrode and faces the electrode hole; A wire break inside the balloon, and the wire forms the first electrode and the second electrode at both ends of the wire break, respectively.

Optionally, the shock wave components are provided in multiple groups and face in different directions, and each shock wave component is independently controlled so that each shock wave component emits shock waves independently; Each of the shock wave components emits shock waves simultaneously.

Optionally, the catheter includes a catheter body, a catheter base and a catheter joint, one end of the catheter body penetrates the balloon, the other end of the catheter body is connected to the catheter base, and the lead wire of the shock wave component extends. Out of the catheter adapter and connected to the catheter connector.

The beneficial effect of the drug balloon catheter provided by the embodiments of the present application is that compared with the prior art, the drug balloon catheter provided by the present application utilizes a protective layer/polymer carrier/liposome to reduce blood flushing during the delivery process The impact on the active drug can effectively prevent the falling off of the active drug and reduce waste, and when the drug balloon catheter is delivered to the predetermined position, the shock wave generated by the shock wave component can destroy the drug coating, so that the drug coating can fall off in time. At the same time, under the action of the shock wave, it can promote the absorption of the drug-loaded layer by the vascular tissue, improve the utilization rate of the drug, and will not affect the downstream vascular tissue. Fragmentation is performed without causing blockage in the blood vessel. In addition, for lesions with severe vascular calcification, the shock wave can selectively break the calcified lesions in the blood vessel wall, resulting in the fragmentation of the calcified plaque and accelerating the transfer of drugs to the blood vessel wall.

A second aspect: the embodiments of the present application further provide a drug balloon catheter system, including a control assembly and the above-mentioned drug balloon catheter, and the shock wave component is connected to the control assembly through a wire.

Optionally, the control assembly includes an operating handle connected to the shock wave component, a pulse power host connected to the operating handle, and a perfusion pump connected to the catheter and used to control the expansion and contraction of the balloon.

The beneficial effect of the drug balloon catheter system provided by the embodiments of the present application is that compared with the prior art, the drug balloon catheter system provided by the present application controls the drug balloon catheter through a control component, which can effectively prevent intraoperative The waste of drugs improves the utilization rate of drugs, and accelerates the absorption of anti-proliferative drugs by the blood vessel wall while breaking the vascular calcification lesions, thereby shortening the surgical treatment time for vascular calcification lesions.

A third aspect: the embodiments of the present application also provide a method for controlling a drug balloon catheter system, which is used to control the above-mentioned drug balloon catheter system, including the following steps:

the balloon is expanded and close to the vessel wall;

The pulse power supply host emits a first electrical signal to cause the shock wave component to generate shock waves to destroy the drug coating and/or calcified lesions;

The balloon continues to expand to a set pressure to expand the blood vessel, and the pulse power host emits a second electrical signal, so that the shock wave component generates shock waves to promote the absorption of active drugs;

The discharge period of the shock wave component under the first electrical signal and the discharge period under the second electrical signal may be the same or different, and the discharge frequencies of the two may be the same or different.

Optionally, the balloon is delivered to the calcified lesion treatment point through a guide wire, and is positioned by a developing ring, and a perfusion pump delivers a liquid medium to the balloon, so that the balloon is expanded, and at the same time, the liquid medium is controlled at the location. circulation between the balloon and the perfusion pump; the perfusion pump removes the gas generated by the hydroelectric effect in the liquid medium.

Optionally, the working voltage of the shock wave component under the first electrical signal and the second electrical signal is 500V-3500V, the working frequency is 0.1Hz-50Hz, and the discharge period lasts 10s-120s; and/or, The working voltage, working frequency and discharge period of the shock wave component under the first electrical signal are greater than or equal to the working voltage, working frequency and discharge period under the second electrical signal.

The beneficial effect of the control method for the drug balloon catheter system provided by the embodiment of the present application is that compared with the prior art, the control method for the drug balloon catheter system provided by the present application utilizes the first pulse emitted by the pulse power host. An electrical signal and a second electrical signal are used to control the working frequency and discharge cycle of the shock wave component, so that the shock wave component can achieve different uses under a specific operating frequency. At the same time, the operation time is shortened, and on the other hand, downstream blood vessel blockage can be avoided and postoperative complications can be reduced.

Description of drawings

In order to illustrate the technical solutions in the embodiments of the present application more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only for the present application. In some embodiments, for those of ordinary skill in the art, other drawings can also be obtained according to these drawings without any creative effort.

1 is a schematic structural diagram of a drug balloon catheter system provided in Embodiment 1 of the application;

2 is a schematic diagram of a balloon and a drug coating of a drug balloon catheter provided in Embodiment 1 of the application;

3 is a schematic three-dimensional structural diagram of a shock wave electrode of a drug balloon catheter provided in Embodiment 1 of the present application;

FIG. 4 is a schematic diagram of another optional embodiment of a shock wave electrode of a drug balloon catheter provided in Example 1 of the present application;

5 is a schematic flowchart of a control method for a drug balloon catheter system provided in Embodiment 1 of the present application;

6 is a schematic diagram of a balloon and a drug coating of a drug balloon catheter provided in Embodiment 2 of the application;

FIG. 7 is a schematic diagram of a balloon and a drug coating of a drug balloon catheter according to Embodiment 3 of the present application.

Among them, each reference sign in the figure:

1—Catheter 10—Catheter body 11—Catheter hub

111—Port 12—conduit connector 13—Development ring

20—Balloon 21—Drug coating 211—Drug-loaded layer

212—protective layer 213—liposome

3—Shock wave parts 30—Shock wave electrodes

31—the first electrode 32—the second electrode 33—Insulation

34—electrode hole 4—operating handle 5—pulse power host

6—wire 60—Conductor fracture 7—Irrigation pump.

Embodiments of the present invention

In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application clearer, the present application will be described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application.

It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

It is to be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top" , "bottom", "inside", "outside", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, only for the convenience of describing the application and simplifying the description, rather than indicating or implying the indicated A device or element must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as a limitation of the present application. In addition, the terms "first" and "second" are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature defined as "first" or "second" may expressly or implicitly include one or more of that feature. In the description of the present application, "plurality" means two or more, unless otherwise expressly and specifically defined.

Each specific technical feature and each embodiment described in the specific implementation manner can be combined in any suitable manner if there is no contradiction, for example, a combination of different specific technical features/embodiments/implementations can form For different implementations, in order to avoid unnecessary repetition, various possible combinations of specific technical features/embodiments/implementations in this application will not be described separately.

Example 1:

Referring to FIG. 1 , the present application provides a drug balloon catheter, including a balloon 20 , a catheter 1 and a shock wave component 3 , wherein the catheter 1 penetrates the balloon 20 , and the shock wave component 3 is located inside the balloon 20 and connected to the catheter 1 2, the outer surface of the balloon 20 is coated with a drug coating 21, the drug coating 21 includes a protective layer 212 and a drug-loading layer 211, and the drug-loading layer 211 is located on the outer surface of the balloon 20 and the protective layer 212, that is, the outer surface of the balloon 20, the drug-carrying layer 211 and the protective layer 212 are arranged adjacent to each other in sequence. In specific applications, the drug on the drug balloon catheter can be divided into three parts according to the flow direction of the drug: the first part is that during the delivery and withdrawal of the drug balloon catheter, due to the flushing effect of blood, the drug part falls off and accumulates downstream. In the vascular tissue; the second part is transferred to the diseased blood vessel by tissue adsorption; the third part is part of the drug left on the surface of the balloon 20 after the drug balloon catheter is withdrawn. When the existing drug balloon catheter is applied, the second part of the drug (that is, the drug that is effectively utilized) only accounts for about 10% of the total amount of the drug, but when the drug balloon catheter of the present embodiment is applied clinically, In the process of moving the part of the catheter 1 connected with the balloon 20 to the lesion, since the protective layer 212 covers the outer surface of the drug-carrying layer 211, even if the drug coating 21 is washed by blood, under the action of the protective layer 212, The drug-loading layer 211 is also not easy to fall off the outer surface of the balloon 20, which effectively reduces the waste of drugs in the first part. When the shock wave component 3 is used to generate a shock wave and act on the balloon 20, the protective layer 212 and the drug-loading layer 211 on the outer surface of the balloon 20 can be broken and fall off. The absorption of the drug, thereby increasing the transfer speed of the drug to the tissue, is beneficial to improve the utilization rate of the second part of the drug, and reduce the residue of the drug on the balloon 20, further reducing the waste of the first part and the third part of the drug. At the same time, the protective layer 212 that falls off together can be fragmented to a smaller size under the action of the shock wave, so as to avoid blockage of downstream blood vessels and reduce postoperative complications. In addition, for lesions with severe vascular calcification, the shock wave can selectively break the calcified lesions in the blood vessel wall, causing the fragmentation of the calcified plaque and accelerating the transfer of drugs to the blood vessel wall, simplifying the operation and reducing the treatment time.

As an optional implementation of this embodiment, the drug-carrying layer 211 includes a low-molecular-weight carrier (ie, a low-molecular-weight excipient) and an active drug, and the protective layer 212 includes a macromolecular carrier (ie, a high-molecular-weight excipient). The drug layer 211 can be a low-molecular carrier and an active drug uniformly mixed and then sprayed on the outer surface of the balloon 20 , and the protective layer 212 can be a polymer carrier directly sprayed on the outer surface of the drug-loading layer to form a double-layer structure. In specific applications, the polymer carrier has stability and can be stably attached to the surface of the drug-loading layer without falling off under the scouring of blood. The polymer carrier has shock wave sensitivity. Under the action of the shock wave, the protective layer can be It is crushed and peeled off to expose the drug-loading layer. Because the adhesion of the low-molecular-weight carrier is not as good as that of the polymer carrier, the low-molecular-weight carrier is easier to fall off under the action of the shock wave than the polymer carrier, so that the drug-loading layer 211 is removed from the balloon. The outer surface of 20 is sloughed off, allowing the active drug to be absorbed by the vascular tissue. In this way, by reasonably selecting the type of carrier, the drug coating 21 does not fall off at will before reaching the diseased blood vessel, and at the same time, after reaching the diseased blood vessel, the drug coating 21 can be broken and peeled off in time under the action of the shock wave.

Optionally, as one of the optional implementations of this embodiment, the active drug can be at least one of rapamycin, zotarolimus, tacrolimus, paclitaxel, dexamethasone and derivatives thereof , the unit drug loading amount of the active drug on the outer surface of the balloon 20 is 0.1 μg/mm ² -2 μg/mm ² , such as 0.5 μg/mm ² , 1 μg/mm ² or 1.5 μg/mm ² . In specific applications, active drugs can effectively inhibit the excessive proliferation of smooth muscle cells and reduce the incidence of vascular restenosis, thereby achieving the purpose of effectively dilating vascular calcification lesions and reducing the incidence of long-term restenosis.

Optionally, as one of the optional implementations of this embodiment, the polymer carrier can be at least one of polyols, polyesters, poloxamers, iopromide, polyvinylpyrrolidone, and Tween. , the low molecular carrier can be at least one of polyols, organic acid salts and urea. In a specific application, the protective layer 212 can protect the inner drug-loading layer 211 from falling off under the scouring of blood, and the protective layer 212 can be sensitive to shock waves, that is, the protective layer 212 can be easily broken and fall off under the action of shock waves , which is beneficial to the diffusion and absorption of the drug in the drug-loading layer 211 , and at the same time, the protective layer 212 will be crushed to a smaller size under the action of the shock wave, so as to prevent the fragments of the protective layer 212 from accumulating and blocking downstream of the blood vessel.

Optionally, as one of the optional implementations of this embodiment, the ester substances can be polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polybutylene succinate, polyhydroxy fatty acid At least one of ester, polycaprolactone, polyethylene adipate or polyhydroxybutyrate valerate copolymer. In specific applications, the drug-carrying layer 211 and the protective layer 212 may also be composed of other suitable components and structures, which are not limited in this embodiment.

As an optional implementation of this embodiment, please refer to FIG. 1 and FIG. 3 together, the shock wave component 3 is a shock wave electrode 30 connected with a wire 6 , and the shock wave electrode 30 includes a first electrode 31 , a second electrode 32 and The insulating portion 33 is located between the first electrode 31 and the second electrode 32 . In a specific application, the first electrode 31 and the second electrode 32 can be connected to the positive and negative electrodes of the pulse power host 5 respectively. After the first electrode 31 and the second electrode 32 receive the electrical signal, the first electrode 31 and the second electrode 32 A hydroelectric effect can occur in between to generate shock waves and act on the balloon 20 and/or calcified lesions.

Specifically, after the first electrode 31 and the second electrode 32 receive electrical signals, electrons in the liquid between the electrodes are accelerated, and ionize liquid molecules near the electrodes. The ionized electrons in the liquid are accelerated by the strong electric field between the electrodes to ionize more electrons, forming an electron avalanche. A plasma channel is formed in the area where the liquid molecules are ionized. With the expansion of the ionized area, a discharge channel is formed between the electrodes, and the liquid is broken down. After the discharge channel is generated, due to the small discharge resistance, a discharge current will be generated and the liquid around the channel will be heated, causing the liquid to vaporize and rapidly expand outward. The rapidly expanding outer edge of the air cavity generates a shock wave in the liquid medium, and the shock wave acts on the surrounding medium in the form of impulse or shock pressure with the difference of discharge current and discharge time.

In specific applications, the shock wave components 3 can be provided in multiple groups and can be oriented in different directions, and each shock wave component 3 can be controlled independently, so that the shock wave components 3 can selectively emit shock waves in various directions, so as to achieve directional treatment and improve the accuracy and effect of surgery. .

Specifically, as one of the optional implementations of this embodiment, please refer to FIG. 3 , the first electrode 31 may have an annular structure and be connected to the catheter 1 , and the first electrode 31 may be provided with electrode holes 34 , and the second electrode 31 may be provided with an electrode hole 34 . The electrode 32 may be located inside the first electrode 31 and face the electrode hole 34 , and the insulating portion 33 is located in the electrode hole 34 to separate the first electrode 31 and the second electrode 32 . Preferably, in this embodiment, the diameter of the first electrode 31 can be the same as the diameter of the catheter 1, and the two can be coaxially arranged. In specific applications, the numbers and positions of the first electrodes 31 , the second electrodes 32 and the electrode holes 34 may be reasonably set according to actual conditions, which are not limited in this embodiment.

Or, as an optional alternative to the above-mentioned embodiment, please refer to FIG. 1 and FIG. 4 together, the insulating portion 33 may be a wire break 60 of the wire 6 located inside the balloon 20 , and the wire 6 is located at both ends of the wire break 60 respectively. The first electrode and the second electrode are formed, in this way, the first electrode and the second electrode can also generate a hydroelectric effect and generate a shock wave after receiving the electrical signal. Of course, in other embodiments, the first electrode, the second electrode and the insulating portion may be other suitable specific structures, or the shock wave component 3 may also be an ultrasonic device, and the ultrasonic device can generate ultrasonic waves. The layer 211 and the protective layer 212 are sensitive to shock waves (especially ultrasonic waves). The ultrasonic waves can further improve the shedding of the drug coating 21 and the absorption efficiency of the active drugs. At the same time, the ultrasonic waves, as an additional driving force, can also enable the drugs to quickly diffuse into the medium. The membrane can reduce the loss of drugs caused by blood scouring the inner wall of the blood vessel in the short term, and the drug persistence time will be prolonged, so that the effective drug concentration in the tissue will be maintained for a longer time and further reduce the incidence of long-term restenosis.

As an optional implementation of this embodiment, please refer to FIG. 1 , the catheter 1 includes a catheter body 10 , a catheter hub 11 and a catheter joint 12 , one end of the catheter body 10 penetrates the balloon 20 , and the other end of the catheter body 10 is connected to In the catheter hub 11 , the lead wire 6 of the shock wave component 3 extends out of the catheter hub 11 and is connected to the catheter connector 12 . Specifically, the catheter hub 11 may have a plurality of ports 111, and the ports 111 may be used for the passage of the wire 6 and the liquid medium. The body 10 may be provided with a developing ring 13 inside the balloon 20 to facilitate the advancement of the catheter 1 in the blood vessel.

The beneficial effect of the drug balloon catheter provided by the present application is that compared with the prior art, the drug balloon catheter provided by the present application utilizes the protective layer 212 to reduce the influence of blood scouring on the drug-loading layer 211 during the delivery process, effectively The drug-loading layer 211 is prevented from falling off, waste is reduced, and when the drug balloon catheter is delivered to a predetermined position, the drug coating 21 can be destroyed by the shock wave generated by the shock wave component 3, so that the drug coating 21 can be peeled off in time. Under the action of the shock wave, the absorption of the drug-loading layer 211 by the tissue can be promoted, and the utilization rate of the drug can be improved (tested by the applicant, the results of the simulation test of the in vitro animal blood vessel model in this embodiment show that the active drug is transferred from the balloon 20 to the tissue. The transfer rate is 30%-60%), which will not affect the downstream tissue, and the shock wave can also crush the falling off protective layer 212 without causing blockage in the blood vessel. In addition, for lesions with severe vascular calcification, the shock wave can selectively break the calcified lesions in the blood vessel wall, resulting in the fragmentation of the calcified plaque and accelerating the transfer of drugs to the blood vessel wall.

The embodiment of the present application also provides a drug balloon catheter system, please refer to FIG. In specific applications, the operator can control the drug balloon catheter through the control component, and thereby control the operating frequency and discharge period of the shock wave component 3, and can adjust the operating frequency and discharge period of the shock wave according to different situations, further improving the surgical effect.

As an optional implementation of this embodiment, the control assembly includes an operating handle 4 connected to the shock wave component 3 , a pulse power host 5 connected to the operating handle 4 , and a perfusion pump 7 for controlling the expansion or contraction of the balloon 20 . In a specific application, the wire 6 of the shock wave part 3 can be connected to the operating handle 4 through the catheter joint 12 , the pulse power host 5 can transmit an electrical signal to the shock wave part 3 to drive the shock wave part 3 to generate shock waves, and the perfusion pump 7 can pass the catheter 1 to the The balloon 20 is filled with a liquid medium (such as a contrast agent and physiological saline, etc.), so that the balloon 20 is inflated or contracted, and at the same time, the gas generated by the hydroelectric effect in the liquid medium can be removed.

The beneficial effect of the drug balloon catheter system provided by the present application is that compared with the prior art, the drug balloon catheter system provided by the present application controls the drug balloon catheter by controlling components, which can effectively prevent intraoperative drug leakage. waste, improve the utilization rate of drugs, and accelerate the absorption of anti-proliferative drugs by the blood vessel wall while breaking the vascular calcification lesions, thereby shortening the surgical treatment time for vascular calcification lesions.

The embodiment of the present application also provides a control method for a drug balloon catheter system, which is used to control the above-mentioned drug balloon catheter system. Please refer to FIG. 5. The control method includes the following steps:

The balloon 20 is expanded and close to the blood vessel wall, and the pulse power source host 5 emits a first electrical signal, so that the shock wave component 3 generates shock waves to destroy the drug coating 21 and/or calcified lesions;

The balloon 20 continues to expand to the set pressure, and the pulse power host 5 emits a second electrical signal, so that the shock wave component 3 generates shock waves to promote the absorption of the active drug;

The working power of the shock wave component 3 under the first electrical signal is higher than that under the second electrical signal.

Optionally, as an optional implementation manner of this embodiment, the working voltage of the shock wave component 3 under the first electrical signal may be 500V-3500V, the working frequency may be 0.1Hz-50Hz, and the discharge period may be 10s-120s For example, the working voltage can be 1000V, 2000V or 3000V, the working frequency can be 1Hz, 5Hz or 10Hz, and the discharge period can be 30s, 45s, 90s or 100s. The working voltage of the shock wave component 3 under the second electrical signal can be 500V-3500V, the working frequency can be 0.1Hz-50Hz, and the discharge cycle can last for 10s-120s. For example, the working voltage can be 500V, 1000V, or 1500V, and the working frequency can be It can be 1Hz, 5Hz or 10Hz, and the discharge period can last for 30s, 45s, 90s or 100s.

Specifically, the operating voltage range, operating frequency range and discharge period range of the shock wave component 3 under the first electrical signal and the second electrical signal may be the same, but different parameters may be selected under the first electrical signal and the second electrical signal Further, the working voltage, working frequency and discharge period selected by the shock wave component 3 under the first electrical signal may be greater than or equal to the working voltage, working frequency and discharge period selected under the second electrical signal.

In a specific application, the drug balloon catheter can be delivered to the lesion through the guide wire and positioned by the imaging ring 13, and then the liquid medium can be delivered through the perfusion pump 7 to expand the balloon 20, so that the outer surface of the balloon 20 is close to The blood vessel wall, while controlling the liquid medium to circulate between the balloon 20 and the perfusion pump 7, and then through the operation handle 4, the pulse power host 5 emits a first electrical signal, and the shock wave component 3 will generate shock waves to destroy the drug coating 21 and / or calcified lesions, after the discharge cycle ends, continue to expand the balloon 20 to the set pressure, so that the outer surface of the balloon 20 further fits the blood vessel wall, at this time, the pulse power host 5 transmits a second electrical signal to the shock wave component 3 At the same time, the shock wave component 3 generates a shock wave to promote the penetration of the active drug into the tissue from the blood vessel wall, and at the same time, the protective layer 212 and other excipients can be crushed to a smaller size, so as to avoid downstream and distal blood vessel embolism and reduce surgery. Post complications. After the discharge period of the second electrical signal ends, the pulse power supply host 5 stops working, and the perfusion pump 7 contracts the balloon 20 to restore the original size of the balloon 20 .

The beneficial effect of the control method for the drug balloon catheter system provided by the embodiment of the present application is that compared with the prior art, the control method for the drug balloon catheter system provided by the present application uses the pulse power host 5 to transmit The first electrical signal and the second electrical signal are used to control the working frequency and discharge cycle of the shock wave component 3, so that the shock wave component 3 can achieve different purposes under a specific working frequency and discharge cycle. On the one hand, it can break calcified lesions and accelerate drug absorption, It can effectively improve the utilization rate of drugs and shorten the operation time. On the other hand, it can avoid the blockage of downstream blood vessels and reduce postoperative complications.

Embodiment 2:

This embodiment provides a drug balloon catheter. The difference between this embodiment and the first embodiment is that, please refer to FIG. 6 , the drug coating 21 includes an active drug and a polymer carrier, and the active drug can be uniformly mixed with the polymer carrier agent After spraying on the outer surface of the balloon 20, a layer of stable drug coating 21 is formed on the outer surface of the balloon 20. The polymer carrier in the drug coating 21 can make the active drug adhere to the balloon 20 stably. It can effectively avoid the drug coating 21 falling off due to blood scouring, and prevent the waste of active drugs. At the same time, the drug coating 21 of this embodiment can fall off the outer surface of the balloon 20 under the action of the shock wave, so as to promote the absorption of the active drug by the vascular tissue, and the shock wave can also crush the excipient to a smaller size to avoid its The downstream blood vessels accumulate and cause blockage, which improves the therapeutic effect of surgery.

As one of the optional implementations of this embodiment, the polymer carrier can be at least one of polyols, polyesters, poloxamers, iopromide, polyvinylpyrrolidone, and Tween. In specific applications , the drug coating 21 that the polymer carrier can protect will not fall off under the scouring of blood, and the polymer carrier can be sensitive to shock waves, that is, the polymer carrier can easily break and fall off under the action of the shock wave, which is beneficial to the drug The active drug in the coating 21 is diffused and absorbed, and at the same time, the polymer carrier will be crushed to a smaller size under the action of the shock wave, so as to avoid the accumulation and blockage of the fragments in the downstream of the blood vessel.

Optionally, as one of the optional implementations of this embodiment, the ester substances can be polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polybutylene succinate, polyhydroxy fatty acid At least one of ester, polycaprolactone, polyethylene adipate or polyhydroxybutyrate valerate copolymer. In specific applications, the polymer carrier may also be composed of other suitable components and structures, which are not limited in this embodiment.

The beneficial effect of the drug balloon catheter provided by the present application is that compared with the prior art, the drug balloon catheter provided by the present application utilizes a polymer carrier to improve the stability of the drug coating layer 21, so as to reduce blood flow during the delivery process. The influence of scouring on the drug coating 21 can effectively prevent the drug coating 21 from falling off and reduce waste, and when the drug balloon catheter is delivered to a predetermined position, the shock wave generated by the shock wave component 3 can be used to destroy the drug coating 21, so that The drug coating 21 falls off in time, and at the same time, under the action of the shock wave, it can promote the absorption of the active drug by the tissue and improve the utilization rate of the drug (tested by the applicant, the results of the simulation test of the in vitro animal blood vessel model in this example show that the active drug The transfer rate from the balloon 20 to the tissue is up to 25%-55%), which will not affect the downstream tissue, and the shock wave can also break the detached polymer carrier without causing blockage in the blood vessel. In addition, for lesions with severe vascular calcification, the shock wave can selectively break the calcified lesions in the blood vessel wall, resulting in the fragmentation of the calcified plaque and accelerating the transfer of drugs to the blood vessel wall.

Embodiment three:

This embodiment provides a drug balloon catheter. The difference between this embodiment and Embodiment 1 and Embodiment 2 is that, please refer to FIG. 7 , the drug coating 21 includes an active drug and a liposome 213 for encapsulating the active drug. , specifically, the liposome 213 can be in the shape of a hollow sphere, the active drug can be located inside the liposome 213, the liposome 213 has targeting, sustained release and cell affinity, and the liposome 213 has a shock wave With a certain sensitivity, under the action of the shock wave, the liposome 213 will be dispersed and transferred to the tissue, and then ruptured, releasing the active drug inside, the effective tissue absorption rate of the active drug, and improving the surgical effect.

Optionally, as one of the optional implementations of this embodiment, the liposome 213 may adopt at least one of cholesterol, lecithin, soybean phospholipid, cephalin, polyvinyl alcohol, and polylactic acid-glycolic acid copolymer , the size of liposome 213 can be between 0.1um-10um, such as 0.5um, 1um and 5um, etc. Smaller particles are conducive to tissue absorption, and can further avoid the accumulation of liposomes 213 to block blood vessels .

The beneficial effect of the drug balloon catheter provided by the present application is that compared with the prior art, the drug balloon catheter provided by the present application uses the liposome 213 to improve the stability of the drug coating layer 21, so as to reduce the number of times during the delivery process. The influence of blood scouring on the drug coating 21 can effectively prevent the drug coating 21 from falling off and reduce waste, and when the drug balloon catheter is delivered to a predetermined position, the shock wave generated by the shock wave component 3 can destroy the drug coating 21, Make the drug coating 21 fall off in time and smash the liposome 213, so that the active drug inside the liposome is released, and at the same time, under the action of the shock wave, it can promote the absorption of the active drug by the tissue and improve the utilization rate of the drug (applied for). Human test, the results of the simulation test in the in vitro animal vascular model in this example show that the transfer rate of the active drug from the balloon 20 to the tissue is 15%-40%), and it will not affect the downstream tissue. In addition, for lesions with severe vascular calcification, the shock wave can selectively break the calcified lesions in the blood vessel wall, resulting in the fragmentation of the calcified plaque and accelerating the transfer of drugs to the blood vessel wall.

The above descriptions are only preferred embodiments of the present application and are not intended to limit the present application. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present application shall be included in the protection of the present application. within the range.

Claims (16)

1. A drug balloon catheter, characterized in that it comprises a balloon whose outer surface is coated with a drug coating, a catheter penetrating the balloon, and a shock wave component connected to the catheter, and the shock wave component is used in the After the catheter is delivered to the predetermined position, a shock wave is emitted to the drug coating, so that the drug coating is peeled off from the outer surface of the balloon;

   The drug coating includes a protective layer and a drug-loading layer, and the drug-loading layer is located between the outer surface of the balloon and the protective layer; or,

   The drug coating includes an active drug and a macromolecular carrier; or,

   The drug coating includes an active drug and liposomes for encapsulating the active drug.
2. The drug balloon catheter according to claim 1, wherein the drug-carrying layer comprises a low-molecular-weight carrier and an active drug, and the protective layer is made of a high-molecular-weight carrier.
3. The drug balloon catheter according to claim 1, wherein the liposome adopts at least one of cholesterol, lecithin, soybean lecithin, cephalin, polyvinyl alcohol, and polylactic acid-glycolic acid copolymer. kind.
4. A drug balloon catheter according to claim 1 or 2, wherein the active drug is rapamycin, zotarolimus, tacrolimus, paclitaxel, dexamethasone and derivatives thereof At least one of the above, the unit drug loading of the active drug on the outer surface of the balloon is 0.1 μg/mm ² -2 μg/mm ² .
5. A drug balloon catheter according to claim 1 or 2, wherein the polymer carrier is a polyol, polyester, poloxamer, iopromide, polyvinylpyrrolidone or Tween At least one of, and/or, the low molecular carrier adopts at least one of polyol, organic acid salt, and urea.
6. The drug balloon catheter according to claim 5, wherein the polyol is at least one of polyethylene glycol, xylitol, mannitol, sorbitol, and amino alcohol.
7. The drug balloon catheter according to claim 5, wherein the esters are polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polybutylene succinate, polyhydroxy At least one of fatty acid ester, polycaprolactone, polyethylene adipate or polyhydroxybutyrate valerate copolymer.
8. The drug balloon catheter according to claim 1, wherein the shock wave component is a shock wave electrode connected with a wire, and the shock wave electrode comprises a first electrode, a second electrode, and a shock wave electrode located at the first electrode and the second electrode. Insulation between electrodes.
9. The drug balloon catheter according to claim 8, wherein the first electrode has an annular structure and is provided with an electrode hole, and the second electrode is located inside the first electrode and faces the an electrode hole; or, the insulating portion is a wire break of the wire inside the balloon, and the wire forms the first electrode and the second electrode at both ends of the wire break, respectively.
10. The drug balloon catheter according to claim 1, wherein the shock wave components are provided in multiple groups and face in different directions, and each shock wave component is independently controlled so that each shock wave component emits independently shock wave; or, each of the shock wave components is controlled in a unified manner, so that each of the shock wave components emits shock waves at the same time.
11. The drug balloon catheter according to claim 1, wherein the catheter comprises a catheter body, a catheter base and a catheter joint, one end of the catheter body penetrates the balloon, and the other end of the catheter body Connected to the catheter hub, the wire of the shock wave component extends out of the catheter hub and is connected to the catheter connector.
12. A drug balloon catheter system, characterized by comprising a control assembly and a drug balloon catheter according to any one of claims 1 to 11, wherein the shock wave component is connected to the control assembly through a wire.
13. The drug balloon catheter system according to claim 12, wherein the control assembly comprises an operating handle connected to the shock wave component, a pulse power host connected to the operating handle, and a main body connected to the catheter. And a perfusion pump for controlling the inflation or deflation of the balloon.
14. A control method of a drug balloon catheter system, characterized in that, for controlling a drug balloon catheter system as claimed in claim 12 or 13, comprising the steps of:

    the balloon is expanded and close to the vessel wall;

    The pulse power supply host emits a first electrical signal to cause the shock wave component to generate shock waves to destroy the drug coating and/or calcified lesions;

    The balloon continues to expand to a set pressure to expand the diseased blood vessel, and the pulse power host emits a second electrical signal to cause the shock wave component to generate shock waves to promote active drug absorption;

    The working power of the shock wave component under the first electrical signal is higher than or equal to the working power under the second electrical signal.
15. The method for controlling a drug balloon catheter system according to claim 14, wherein the balloon is delivered to the calcified lesion treatment point through a guide wire, and is positioned by a developing ring, and a perfusion pump delivers a liquid medium to the calcified lesion. The balloon is used to inflate the balloon, while controlling the liquid medium to circulate between the balloon and the perfusion pump; the perfusion pump removes the gas generated by the hydroelectric effect in the liquid medium.
16. The control method for a drug balloon catheter system according to claim 14 or 15, wherein the working voltage of the shock wave component under the first electrical signal and the second electrical signal is 500V-3500V , the operating frequency is 0.1Hz-50Hz, and the discharge period lasts 10s-120s; and/or, the shock wave component is under the condition that the operating voltage, operating frequency and discharge period of the first electrical signal are greater than or equal to the second electrical signal operating voltage, operating frequency and discharge cycle.