CN115634010A

CN115634010A - Ultrasonic thrombolysis device and ultrasonic thrombolysis system

Info

Publication number: CN115634010A
Application number: CN202211533122.8A
Authority: CN
Inventors: 刘颖; 宋涛; 杜蜀; 董永贺; 朱明哲; 杨峥
Original assignee: Beijing Huatong Jizhi Medical Equipment Co ltd
Current assignee: Beijing Huatong Jizhi Medical Equipment Co ltd
Priority date: 2022-12-02
Filing date: 2022-12-02
Publication date: 2023-01-24
Anticipated expiration: 2042-12-02
Also published as: WO2024114764A1; CN115634010B

Abstract

The invention provides an ultrasonic thrombolysis device and an ultrasonic thrombolysis system, which relate to the field of medical instruments and comprise an inner thrombolysis component and an outer ultrasonic component; the inner layer thrombolysis component comprises an inner pipe; the outer ultrasonic component comprises an outer pipe and an ultrasonic connector; the distal end of the outer tube is connected with at least one expansion part; the inner pipe passes through the expansion part, the outer pipe and the ultrasonic connector; the expanding and contracting portion is configured to have a contracting state of integrally fitting or being close to the outer wall of the inner pipe and an expanding state of expanding toward the outside of the inner pipe along the radial direction of the inner pipe. The ultrasonic enhanced thrombolysis adopts a simpler and easy-to-operate structure, and the ultrasonic and thrombolysis are simultaneously carried out, so that the thrombolysis effect is enhanced, the problems of large dosage and long treatment time of thrombolysis medicines in the treatment of thrombosis and embolism lesion are solved, the bleeding risk is reduced, and the thrombolysis effect is improved.

Description

Ultrasonic thrombolysis device and ultrasonic thrombolysis system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an ultrasonic thrombolysis device and an ultrasonic thrombolysis system.

Background

Thrombosis and embolism are the pathological bases of a large number of cardiovascular and cerebrovascular diseases. Currently, thrombolytic drugs such as tPA administered intravenously are the mainstay of treatment for these diseases. The transvenous thrombolysis has a strict time window, and the transvenous thrombolysis not only has the strict time window, but also has unsatisfactory effect: cerebral thrombosis needs to be administered within 4.5 h of onset of disease, the effective rate of thrombolysis is 30-40%, wherein only 18% can realize complete recanalization of embolized vessels; acute coronary thrombosis is intravenously administered in 12h, the blood vessel recanalization rate is only 50% -83% different, and coronary blood flow can reach TIMI3 level in only 32% -63% of cases, so that safety and effectiveness are greatly improved.

Venous Thromboembolism (VTE) refers to an embolic phenomenon caused by blood flow disorders occurring in the Venous system, and may occur anywhere in the Venous system, and is mainly manifested as deep Venous thrombosis and Pulmonary embolism, and VTE is the third most common cardiovascular disease after ischemic myocardial infarction and stroke, and is mainly manifested as Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE). The most common complication after the occurrence of DVT is Postthrombotic Syndrome (PTS), venous valve damage caused by persistent venous obstruction or venous recanalization is a risk factor for the occurrence of PTS, and the preferred treatment mode for patients with definite venous thromboembolism is anticoagulation. However, although the anticoagulant therapy can prevent recurrent thrombosis, the anticoagulant therapy cannot ablate residual thrombus, the anticoagulant therapy has unsatisfactory effect on preventing PTS (partial pressure of the blood) of acute DVT, and when residual blood clots in a venous system fall off and reach the lung along with blood circulation to block the pulmonary artery, chest pain and dyspnea of a patient are easy to cause, and the patient is seriously threatened.

Transcatheter interventional therapy is another type of treatment currently used in clinical thrombotic disorders. The catheter-oriented thrombolysis method is characterized in that thrombolytic drugs are directly delivered to a thrombus blockage part through a catheter, and compared with a systemic thrombolysis method of intravenous injection, the method has the advantages that the treatment time is shortened, the drug dosage is reduced, and the risk of adverse events such as destructive cerebral hemorrhage is reduced; compared with an anticoagulation method, the catheter directional thrombolysis method can reduce PTS (postthrombotic syndrome) of VTE and improve vein patency rate. However, only by injecting thrombolytic drugs through a catheter, 25-40% of coronary thrombosis and 40-50% of cerebral thrombosis and obstructed blood vessels cannot realize recanalization, the treatment time is long, and the maximum time of catheter directional thrombolysis in the current clinic can reach 7 days.

Ultrasound-enhanced thrombolysis has gained widespread attention due to its great potential in the study make internal disorder or usurp in the treatment of thrombotic disease, where thrombolysis is the destruction of blood cells or the relaxation of the thrombocyte fibrin network structure by cavitation effects, i.e., steady-state cavitation and transient cavitation. Ultrasonic cavitation refers to a dynamic process of forming, growing, contracting and collapsing micro bubble nuclei under the activation of sound waves, generally, stable cavitation occurs under the condition of low sound pressure or sound intensity, micro bubbles undergo stable oscillation along with the periodic change of the ultrasonic sound pressure to cause sound microflow of surrounding liquid, when the sound pressure or the sound intensity reaches a threshold value, the micro bubbles undergo a process of rapid increase and subsequent collapse in a short time, severe micro jet is generated, severe cavitation erosion is suffered around the micro jet, the micro activity of ultrasonic is complex, the micro jet can enhance the inflow of the liquid to fibrin clot, a fibrin network is locally damaged, and thrombolytic drugs under the assistance of ultrasonic can cause remarkable clot quality loss on an animal stroke model, so bleeding symptoms are reduced.

Known ultrasonic energy delivery systems include a generator configured to generate, control, amplify and/or deliver an alternating electronic signal (e.g., a voltage signal) of a desired frequency to a transducer assembly (ultrasonic handle) and a catheter or guidewire; the transducer assembly (ultrasonic handpiece) typically includes one or more piezoelectric ceramics that expand and contract at high frequencies when excited by high frequency electronic signals; these high frequency vibrations are amplified by the horn into ultrasonic energy, which is transmitted to the catheter or guidewire; ultrasound energy is transmitted to the distal end of the catheter or guidewire to ablate and/or otherwise destroy the bodily lesion.

Among the prior art, when adopting supplementary reinforcing thrombolysis effect of supersound, deliver the thrombolysis medicine to the thrombus occlusion position through the pipe earlier, then withdraw from the thrombolysis pipe, reach the pathological change position through ultrasonic energy transmission system alone again to supersound promotes the thrombolysis effect, but, owing to the process and the later stage application supersound reinforcing thrombolysis effect to pathological change position propelling movement thrombolysis medicine are that different instruments of independent control go on, exist: the ultrasonic delay is longer than the thrombolysis, so that the effects of enhancing thrombolysis of thrombolytic drugs and relieving thrombosis by using ultrasonic are not good, and the thrombolysis effect still needs to be further improved; the problems of inconvenient operation and high operation complexity of the operation instruments are solved: and the problems of long treatment time and high bleeding risk.

Disclosure of Invention

The ultrasonic thrombolysis device and the ultrasonic thrombolysis system adopt a simple and easy-to-operate structure, and utilize the simultaneous ultrasonic and thrombolysis to enhance the thrombolysis effect, relieve the problems of large dose of thrombolysis medicine and long treatment time in the treatment of thrombosis and embolic lesion, reduce the bleeding risk and improve the thrombolysis effect.

In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:

in a first aspect, an embodiment of the present invention provides an ultrasonic thrombolysis device, including an inner thrombolysis component and an outer ultrasonic component; the inner thrombolysis assembly comprises an inner tube; the outer ultrasonic component comprises an outer pipe and an ultrasonic connector which are sequentially connected from a far end to a near end; the far end of the outer tube is connected with at least one expansion part; the inner pipe penetrates through the expansion part, the outer pipe and the ultrasonic connector; the expansion and contraction portion is configured to have a contracted state integrally attached to or close to the outer wall of the inner tube and an expanded state expanded toward the outside of the inner tube in the radial direction of the inner tube.

In the operation process, the device can reach the pathological change position along the seal wire that presets, inject the thrombolysis medicine through the inner tube inner chamber, the medicine can be followed inside the inner tube directly gets into the thrombus, meanwhile the removal of the relative inner tube of outer tube can drive the expansion of outer tube dilatation portion, can carry out mechanical cutting to the thrombus of occlusive segment under the dilatation portion expansion state, the supersound drives the whole vibration of the portion that contracts of outer tube, ultrasonic energy can cover whole thrombolysis medicine coverage, the reinforcing thrombolysis medicine is to the inside infiltration of thrombus, be favorable to getting rid of the speed of thrombus with higher speed, shorten the time of putting the pipe, reduce the use amount of the thrombolysis medicine. Specifically, in the operation process, on the first aspect, by means of ultrasonic energy, a combined mechanism of mechanical vibration and cavitation is applied, the far end of the outer tube can be vibrated at high frequency by high-frequency low-amplitude mechanical vibration generated by the ultrasonic energy, the far end of the outer tube can be vibrated at high frequency like a vibration 'hand hammer', the high-frequency vibration generates strong negative pressure and positive pressure circulation in surrounding fluid, gas is dissolved at the negative side of the pressure circulation to form cavitation bubbles, the bubbles are rapidly broken at the positive side of the pressure circulation, and the breakage of the cavitation bubbles can generate strong mechanical shock waves to erode calcified plaques; meanwhile, the ultrasound also has the characteristic of plaque ablation selectivity, tissues with high collagen and elastin contents have extremely strong resistance to ultrasonic damage, however, tissues lacking these components are easily damaged, high-intensity ultrasonic waves damage fibrous or calcified plaques, but normal blood vessels cannot be damaged, in the second aspect, when the distal end of the outer tube is driven by ultrasound to vibrate with the expansion and contraction part, thrombus and calcified plaque in an occlusion section can be mechanically cut under the expansion and contraction state of the expansion and contraction part, although the part is small in length, the ultrasonic energy transmission range is wide, the efficiency is high, the loss is small, the inflow of thrombolytic drugs to fibrin clots can be enhanced, and a fibrin network is locally damaged, so that under the condition that a venous valve is not damaged, the energy reaches the venous valve, the thrombus behind the venous valve is dissolved, the PTS occurrence rate is reduced, the time for placing a tube for thrombolysis is shortened, the effect of thrombolytic drugs is improved, the dosage of the thrombolytic drugs is reduced, and the risk of bleeding is reduced.

In an alternative embodiment of this embodiment, a plurality of side holes are arranged at intervals along the axial direction of the inner tube on the wall of the inner tube near the distal end.

Further optionally and preferably, the distal end of the inner tube is provided with an end blocking member, and the end blocking member is provided with a one-way channel, wherein the one-way channel can allow fluid to pass from the distal end to the proximal end and allow a guide wire to pass through, and can be automatically closed after the fluid or the guide wire passes through; or the distal end of the inner tube is provided with a reducing part with the diameter gradually reduced from the proximal end to the distal end, and the reducing part is configured to be matched with a plugging guide wire to plug the distal end orifice of the inner tube.

In an alternative embodiment of this embodiment, the enlarged and reduced portion has a hollowed-out area communicating the outside of the outer tube and the inside of the outer tube in the expanded state.

Further optionally: the expansion and contraction part comprises a framework, and the framework is in a grid shape or is formed by arranging a plurality of connecting wires extending along the axial direction of the inner tube at intervals.

In an optional implementation manner of this embodiment, the expansion and contraction portion includes a pull wire, and a proximal connection tube, a middle expansion and contraction section, and a distal connection tube, which are connected in sequence, and the proximal connection tube is connected to the distal end of the outer tube; the inner pipe penetrates through the far-end connecting pipe, the middle expanding and contracting section and the near-end connecting pipe; the far end of the pull wire is connected to the far end connecting pipe, and the pull wire penetrates through the middle expansion and contraction section, the near end connecting pipe, the outer pipe and the ultrasonic connector; under the condition that the pull wire is pulled towards the near end side of the ultrasonic connector relative to the ultrasonic connector by external force, the middle expanding and contracting section can be changed from the contracting state to the expanding state.

Further optionally, the ultrasonic thrombolysis device further comprises an ultrasonic handle and a locking wire structure, and the ultrasonic connector is connected to the ultrasonic handle; the locking wire structure is used for locking the pull wire to the ultrasonic handle at least under the condition that the expansion and contraction part is in an expansion state.

Still further optionally, the wire locking structure comprises a wire pulling block, and a proximal end of the wire pulling is fixedly connected to the wire pulling block; when the middle expanding and contracting section is in a contracting state, the far end of the pull wire block is positioned in the ultrasonic handle; the pull wire block is locked at the proximal end side of the ultrasonic handle in the expanded state of the expansion and contraction part to keep the expansion and contraction part in the expanded state.

Still further alternatively, the wire pulling block comprises an elongated connecting portion fixedly or integrally connected to one side surface of the connecting block and a wire pulling ring fixedly or integrally connected to the elongated connecting portion, and the proximal end of the wire pulling is fixedly connected to the wire pulling ring; two crossed straight grooves are arranged on the proximal end face of the ultrasonic handle, wherein the depth of one straight groove in the axial direction of the ultrasonic handle is greater than that of the other straight groove in the axial direction of the ultrasonic handle; the middle expansion and contraction section is in a contraction state, the strip-shaped connecting part is embedded into the straight groove with deeper axial depth, and the near end of the connecting block is exposed out of the near end of the ultrasonic handle; and the middle expansion and contraction section is in an expansion state, and the strip-shaped connecting part is embedded into the straight groove with shallow axial depth after rotating.

In an alternative embodiment of this embodiment, the outer ultrasound assembly further comprises a hose and a one-way valve assembly; the ultrasonic connector is characterized in that a connector liquid injection hole is further formed in the ultrasonic connector, one end of the hose is connected to the connector liquid injection hole, and the part, away from the connector liquid injection hole, of the hose is connected with a one-way valve assembly which only allows liquid to flow into the outer pipe through the connector liquid injection hole.

Further optionally, the inside of supersound connector still is equipped with the sealing member, the sealing member is located the near-end side of liquid hole is annotated to the connector, and seals the outer pipe wall of inner tube with the clearance between the inner wall of supersound connector.

In a second aspect, an embodiment of the present invention provides an ultrasonic thrombolysis system, including an ultrasonic generator and the ultrasonic thrombolysis apparatus described in any one of the foregoing embodiments, where the ultrasonic generator is connected to an ultrasonic handle connected to the ultrasonic connector, and the inner tube passes through the telescopic portion, the outer tube, the ultrasonic connector, and the ultrasonic handle.

Because the thrombolysis system provided by the embodiment of the invention comprises the ultrasonic thrombolysis device provided by the first aspect, the ultrasonic thrombolysis system provided by the embodiment of the invention can achieve all the beneficial effects that the ultrasonic thrombolysis device provided by the first aspect can achieve.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic overall structure diagram of an ultrasonic thrombolysis device according to a first embodiment of the present invention;

FIG. 2 is an enlarged view of a portion of the distal end of the sonothrombolysis device according to an embodiment of the present invention;

fig. 3 is a schematic overall structure diagram of an ultrasonic handle portion in an ultrasonic thrombolysis device provided in an embodiment of the present invention;

FIG. 4 is a cross-sectional view of the whole structure of an ultrasonic handle part in the ultrasonic thrombolysis device provided by the embodiment of the invention;

fig. 5 is an assembly structure view of the ultrasonic thrombolysis device according to an embodiment of the present invention, in which the expansion and contraction portion at the distal end portion is in a contracted state;

fig. 6 is an assembly structure view of the distal expansion and contraction portion of the sonothrombolysis device according to an embodiment of the present invention in an expanded state with the inner tube;

fig. 7 is an assembly structure view of the ultrasonic thrombolysis device according to the second embodiment of the present invention, wherein the expansion and contraction portion is in an expanded state;

fig. 8 is a partial structural sectional view of an ultrasonic connector portion in an ultrasonic thrombolysis device according to an embodiment of the present invention.

Icon: 1-an inner tube; 10-side holes; 2-an end blocking component; 3-an outer tube; 31-a telescopic part; 310-pulling wires; 311-proximal connection tube; 312-middle expansion and contraction section; 313-a distal connection tube; 4-ultrasonic connector; 41-connector liquid injection hole; 5-an ultrasonic handle; 51-a straight slot; 6-a wire pulling block; 61-connecting block; 62-elongated connecting portions; 63-pull wire ring; 71-a hose; 72-a one-way valve assembly; an 8-luer fitting; 9-sealing element.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that the terms "proximal", "distal", "front", "rear", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or the orientations or positional relationships customarily provided for use with products of the present invention, and are used merely for convenience in describing the present invention and to simplify the description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used merely to distinguish one description from another, and are not to be construed as indicating or implying relative importance.

In particular, in the present invention, when an operation is performed, one end of the medical instrument close to an operator is a proximal end of the medical instrument, one end of the medical instrument entering a blood vessel of a patient is a distal end of the medical instrument (the front end of the medical instrument is a distal end, and the rear end of the medical instrument is a proximal end), and the axial direction is a direction parallel to a connection line between the center of the distal end and the center of the proximal end of the medical instrument; radial, means a direction perpendicular to the above-mentioned axial direction.

Furthermore, the terms "horizontal", "vertical" and the like do not imply that the components are required to be absolutely horizontal or pendant, but rather may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," and "connected" are to be construed broadly, e.g., as meaning fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.

Example one example provides an sonothrombolysis device that includes an inner thrombolysis member and an outer ultrasound member, with reference to fig. 1-6. Specifically, the inner layer thrombolysis component comprises an inner tube 1, and the outer layer ultrasonic component comprises an outer tube 3 and an ultrasonic connector 4 which are sequentially connected from a far end to a near end; the distal end of the outer tube 3 is connected with at least one expansion and contraction part 31; the inner tube 1 passes through the expansion and contraction part 31, the outer tube 3 and the ultrasonic connector 4; the expanded/contracted portion 31 is arranged to have a contracted state in which it is entirely attached to or in close proximity to the outer wall of the inner pipe 1 and an expanded state in which it is expanded outward of the inner pipe 1 in the radial direction of the inner pipe 1.

When in use, the ultrasonic connector 4 is connected with the ultrasonic generator through the ultrasonic handle 5, and the distal end of the ultrasonic thrombolysis device extends into the CTO lesion occlusion of a patient when the expansion part 31 is in a contraction state, and then the expansion part 31 is controlled to be changed from the contraction state to an expansion state, and the ultrasonic generator is started.

In the operation process, the device can reach the pathological change position along the seal wire of presetting, inject the thrombolysis medicine through 1 inner chamber of inner tube, the medicine can be followed inside 1 direct entering thrombus of inner tube, meanwhile the removal of 3 relative inner tubes of outer tube 1 can drive the expansion of expanding portion 31 on the outer tube 3, expand and contract and can carry out mechanical cutting to the thrombus of occlusive segment under 31 expansion state of portion, the supersound drives the whole 31 vibrations of expanding portion that contract of outer tube 3, ultrasonic energy can cover whole thrombolysis medicine coverage, the reinforcing thrombolysis medicine is to the inside infiltration of thrombus, be favorable to getting rid of the speed of thrombus with higher speed, shorten the time of putting the pipe, reduce the use amount of the thrombolysis medicine of hindering. Specifically, during operation, in the first aspect, by means of ultrasonic energy, a combined mechanism of mechanical vibration and cavitation is applied, the distal end of the outer tube 3 can vibrate at high frequency like a vibration "hand hammer" with the expansion and contraction part 31 by high-frequency and low-amplitude mechanical vibration generated by the ultrasonic, the high-frequency vibration generates strong negative pressure and positive pressure circulation in surrounding fluid, the dissolved gas can form cavitation bubbles on the negative side of the pressure circulation, the bubbles can burst rapidly on the positive side of the pressure circulation, and the bursting of the cavitation bubbles can generate strong mechanical shock waves to erode calcified plaques; meanwhile, the ultrasound also has the characteristic of plaque ablation selectivity, tissues with high collagen and elastin contents have extremely strong resistance to ultrasonic damage, however, tissues lacking these components are easily damaged, high-intensity ultrasonic waves damage fibrous or calcified plaques, but normal blood vessels cannot be damaged, in the second aspect, when the distal end of the outer tube 3 is driven by ultrasound to vibrate by the expansion and contraction part 31, thrombus and calcified plaques in an occlusion section can be mechanically cut under the expansion state of the expansion and contraction part 31, although the part is small in length, the ultrasonic energy transmission range is wide, the efficiency is high, the loss is small, the inflow of thrombolytic drugs to fibrin clots can be enhanced, a fibrin network is locally damaged, and under the condition that a venous valve is not damaged, the energy reaches the venous valve, the thrombus behind the venous valve is dissolved, the PTS occurrence rate is reduced, the catheter thrombolysis time is shortened, the thrombolytic drug effect is improved, the thrombolytic drug dosage is reduced, and the bleeding risk is reduced.

In addition, in an optional embodiment of this embodiment, it is preferable that a plurality of side holes are arranged on the tube wall of the inner tube 1 near the distal end at intervals along the axial direction of the inner tube 1, when in use, the ultrasonic connector 4 is connected with the ultrasonic generator through the ultrasonic handle 5, and when the expansion and contraction portion 31 is in the contraction state, the distal end of the ultrasonic thrombolysis device is extended into the CTO lesion occlusion of the patient, and then, in no particular order: injecting a thrombolytic agent such as streptokinase or urokinase into the inner tube 1 from the proximal end of the inner tube 1, controlling the change of the expansion and contraction part 31 from the contracted state to the expanded state, and activating the ultrasonic generator; in the operation process, the thrombolysis of the inner tube 1 is matched with the ultrasonic transmission of the outer tube 3, so that the ultrasonic energy is utilized to accelerate the permeation speed of thrombolytic drugs to the interior of thrombus, the dissolving efficiency of the thrombus is greatly improved, the effective volume reduction and the expansion of the lumen are realized, the stent implantation proportion is reduced, the short-term and medium-term treatment effects are improved, the thrombus and calcification are further accelerated to be removed, the larger effective lumen diameter is provided, the opening time is further shortened, and the opening success rate is improved; of course, in the operation process, instead of injecting thrombolytic liquid into the inner tube 1, other medical liquid can be injected to achieve the flushing effect to dissolve thrombus, and at the moment, a medical far-end protector can be arranged at the far end of the inner tube 1 to intercept the broken and fallen plaque.

In this embodiment, it is further preferable that an end blocking member 2 is disposed at the distal end of the inner tube 1, and the end blocking member 2 has a one-way channel, which is capable of allowing fluid to pass from the distal end to the proximal end and allowing a guide wire to pass through, and is capable of being automatically closed after the fluid or the guide wire passes through, for example, but not limited to, the end blocking member 2 employs a blocking valve (commonly used in clinic) as shown in fig. 6 to achieve the above functions, and in particular, the inner tube 1 can be controlled to have positive pressure or negative pressure inside by controlling a device connected to the proximal end (rear end) of the inner tube 1, so that the inner tube 1 can achieve two operation modes of liquid injection and suction; alternatively, in this embodiment, the distal end of the inner tube 1 is provided with a reduced diameter portion having a diameter gradually decreasing from the proximal end to the distal end, and the reduced diameter portion is configured to be capable of fitting with a plugging guide wire to plug the distal orifice of the inner tube 1. In addition, in order to facilitate the injection of liquid into the interior of the inner tube 1, it is preferable, but not limited to, as shown in fig. 1, to provide a luer fitting 8 at the distal end of the inner tube 1.

In an alternative embodiment of this embodiment, it is preferable that the above-mentioned expanding and contracting part 31 has a hollow area communicating the outside of the outer tube 3 and the inside of the outer tube 3 in the expanded state, so that the expanding and contracting part 31 does not obstruct the release of the thrombolytic agent from the side hole 10 on the side wall of the inner tube 1.

It is further preferred, but not limited to, that the expansion and contraction part 31 comprises a skeleton, which can be formed by processing straight, curved, filiform, strip-shaped, net-shaped or spiral or other connecting wires, which can be made of metal material or other high-performance non-metal material or composite material, preferably metal material such as stainless steel, nickel titanium, cobalt base or titanium base, etc., and can be in a grid shape as shown in fig. 1 to 6 or in a spaced arrangement of a plurality of connecting wires extending along the axial direction of the inner tube 1 as shown in fig. 7, and can be respectively bound by the proximal and distal ends of the connecting wires, or can be cut from a single integral tube.

It is further preferable, but not limited to, that the expanding and contracting part 31 further comprises a covering film connected to the skeleton, the covering film is made of a flexible material, openings are arranged on the covering film, and the opening areas constitute the hollow areas. The covering film is made of flexible materials such as PU (polyurethane), nylon, pebax (nylon elastomer), PET (Polyethylene terephthalate), PTFE (polytetrafluoroethylene), PVF (polyvinyl-fluoride), polyvinyl formal, FEP (Fluorinated ethylene propylene copolymer), silicone rubber, PI (polyimide) and the like, is used for coating thrombolytic drugs or anti-endothelial proliferation drugs such as paclitaxel or rapamycin, and in some optional embodiments, is a bare film which is not coated with drugs, and in other optional embodiments, is coated with drugs in advance. Wherein, the covering film can be sewed or connected to the framework by other modes such as coating, bonding, welding, dip coating, spray coating and the like, such as but not limited to: preparing a solution for film forming in advance, wherein the solution can be made of a biocompatible material with high molecular polymer soluble in an organic solvent, immersing a framework into the solution and taking out the framework, a liquid film can be formed by the surface tension of the solution due to small connecting line gaps of the framework, particularly a latticed framework, and suspended at the gaps of the framework, and after the solution is volatilized, a material such as the high molecular polymer is left to form a thin film and then is adhered to the surface of the framework, so that a coating film is formed, the thickness of the coating film can be controlled by the concentration of the solution or the number of times of coating, or two ends of a hollow balloon processed by the high molecular material through an extrusion blow molding process are welded on the framework through laser welding to obtain the coating film and the like. The film coating and drug loading can be realized by attaching the drug on the surface of the film coating by the methods of drug coating, spraying, dipping and the like. The purpose of the film covering is set in the preferred embodiment, mainly for increasing the contact area of the expansion part 31 and the wall of the diseased blood vessel in the expansion state, so that the granular medicine or the medicine layer is adhered to the surface of the film covering, the expansion part 31 expands the skeleton and the film covering in the expansion state, the film surface is attached to the diseased region, the medicine is transmitted through directly attaching the diseased region and mutually matched with ultrasonic vibration, the medicine falls off from the film surface, the medicine dissolution is accelerated under the action of the ultrasonic vibration, and the medicine is absorbed by the diseased tissue to locally treat the diseased region. Especially for rapamycin and paclitaxel anti-endothelial hyperplasia drugs, the drugs have toxicity and are not suitable for being used in large quantities, but if no coating is arranged, the drug layer is only coated on the framework, the contact area of the drug layer and the diseased part is insufficient, and the dosage and the adhesive force of the drug on the surface of the blood vessel wall are insufficient, so compared with the treatment of coating the drug layer on the framework or directly injecting the drug into the blood vessel, the mode of contacting the diseased part after the membrane is expanded is adopted, the utilization rate of the drug is improved, and the toxicity is reduced.

In this embodiment, there are various alternative ways to operate the expansion and contraction portion 31 to change between the contracted state and the expanded state, for example, by sleeving a limiting tube or other limiting structure on the outer wall of the distal end of the inner tube 1 at the distal end of the expansion and contraction portion 31, when the expansion and contraction portion 31 needs to be expanded, the outer tube 3 is pushed forward relative to the inner tube 1 to expand the expansion and contraction portion 31 to the expanded state, or the pre-made expansion and contraction portion 31 is in the expanded state, the expansion and contraction portion 31 is straightened and restrained when in the contracted state, and the expansion and contraction portion 31 returns to the expanded state after being released.

In various alternative embodiments, preferably, as shown in fig. 1 to 6, the enlarged portion 31 includes a pulling wire 310 and a proximal connecting tube 311, a middle enlarged portion 312 and a distal connecting tube 313 connected in sequence, wherein the proximal connecting tube 311 is directly connected or interferingly sleeved or snapped or integrally connected or otherwise connected to the distal end of the outer tube 3; the inner tube 1 passes through the distal connecting tube 313, the middle expanding and contracting section 312 and the proximal connecting tube 311; the distal end of the pulling wire 310 is connected to the distal connecting tube 313, and the pulling wire 310 passes through the middle expanding-contracting section 312, the proximal connecting tube 311, the outer tube 3 and the ultrasonic connector 4; the intermediate flared section 312 is capable of transitioning from the contracted state to the expanded state in the event that an external force pulls the pull wire 310 proximally relative to the ultrasonic connector 4 from the ultrasonic connector 4.

In this embodiment, preferably, the ultrasonic thrombolysis device further includes an ultrasonic handle 5 and a locking wire structure, and the ultrasonic connector 4 is connected to the ultrasonic handle 5; the locking wire structure is used to lock the pulling wire 310 to the ultrasonic handle 5 at least in the case where the telescopic part 31 is in the expanded state. When the pull wire 310 is pulled backwards, the expansion part 31 can be in an expansion state, and the expansion part 31 can be kept in the expansion state by using the locking wire structure, when the pull wire 310 is pulled backwards, the position relation between the expansion state of the expansion part 31 and the inner pipe 1 can be controlled by controlling the position of the outer pipe 3 relative to the inner pipe 1 and the distance of the pull wire 310 pulled backwards, and further the shielding condition of the far-end connecting pipe 313 of the expansion part 31 on the side hole 10 on the inner pipe 1 is adjusted (the side hole 10 is blocked and cannot leak liquid at the position blocked by the far-end connecting pipe 313), so that the ultrasonic waves and the thrombolysis efficiency can be selectively transmitted to the pathological change at any time in the operation process, the regulation is flexible and convenient, the high-speed thrombolysis is favorably aligned, and after the thrombolysis at one pathological change position is transferred to the next adjacent position to continue to thrombolysis, and the opening and expansion efficiency and effect are improved.

The locking wire structure may have various structures, such as, but not limited to, the locking wire structure includes a wire pulling block 6, and the proximal end of the pulling wire 310 is fixedly connected to the wire pulling block 6; in the contracted state of the middle expanding-contracting section 312, the distal end of the pull wire block 6 is located inside the ultrasonic handle 5; with the constricted part 31 in the expanded state, the wire block 6 is locked at the proximal end side of the ultrasonic handle 5 to keep the constricted part 31 in the expanded state.

Further, preferably, the wire pulling block 6 includes a connecting block 61, an elongated connecting portion 62, and a wire pulling ring 63, the elongated connecting portion 62 is fixed or integrally connected to one side surface of the connecting block 61, the wire pulling ring 63 is fixed or integrally connected to the elongated connecting portion 62, and preferably, but not limited to, the connecting block 61 and the wire pulling ring 63 are provided on two side surfaces of the elongated connecting portion 62 facing each other; the proximal end of the pull wire 310 is fixedly connected to the pull wire ring 63; two crossed straight grooves 51 are arranged on the proximal end face of the ultrasonic handle 5, wherein the depth of one straight groove 51 in the axial direction of the ultrasonic handle 5 is greater than that of the other straight groove 51 in the axial direction of the ultrasonic handle 5; when the middle expanding and contracting section 312 is in a contracting state, the strip-shaped connecting part 62 is embedded into the straight groove 51 with deeper axial depth, and the near end of the connecting block 61 is exposed out of the near end of the ultrasonic handle 5; when the middle expanding-contracting section 312 is in an expanded state, the strip-shaped connecting part 62 is inserted into the straight groove 51 with a shallow axial depth after rotating. The two linear grooves 51 may be crossed perpendicularly or at any angle, the elongated connecting portion 62 may be a connecting plate-like structure as shown in fig. 3 or a rib structure, and the connecting block 61 is preferably a spindle-shaped structure as shown in fig. 3 for easy holding. In this embodiment, the connection block 61 is pulled backwards relative to the ultrasonic handle 5 to drive the pull wire 310 to move backwards, so that the expansion and contraction portion 31 becomes an expanded state, and the connection block 61 is rotated to fix the pull wire 310 in a manner that the strip-shaped connection portion 62 is embedded into the shallow linear groove 51, so that the expansion and contraction portion 31 is kept in the expanded state, and when the expansion and contraction portion 31 needs to be returned to the contracted state, the operation is reversed.

In an alternative embodiment of the present embodiment, the connection manner between the distal end of the inner tube 1 and the distal end of the outer tube 3 includes, but is not limited to, sleeving a limiting tube on a portion of the outer sidewall of the distal end of the inner tube 1, which is located at the distal end of the expansion portion 31, and the inner tube 1 and the outer tube 3 are made of rigid or semi-rigid materials, for example, but not limited to, a metal tube or a metal braided composite tube is used for the inner tube 1 and the outer tube 3.

Furthermore, in some alternative embodiments of the present embodiment, it is preferable that the outer ultrasound assembly further comprises a hose 71 and a one-way valve assembly 72, as shown in fig. 1 and 8; the ultrasonic connector 4 is further provided with a connector liquid injection hole 41, one end of the hose 71 is connected to the connector liquid injection hole 41, a part of the hose 71 far away from the connector liquid injection hole 41 is connected with a one-way valve assembly 72 which only allows liquid to flow into the outer tube 3 from the hose 71 through the connector liquid injection hole 41, the hose 71 is used for injecting other diagnosis and treatment liquids such as thrombolytic drugs or contrast agents into the outer tube 3, and the injected liquid also has a cooling effect of cooling an ultrasonic vibration part.

Further preferably, as shown in fig. 8, a sealing member 9 is further provided inside the ultrasonic connector 4, the sealing member 9 is located at the proximal end side of the connector injection hole 41, and seals a gap between the outer tube wall of the inner tube 1 and the inner wall of the ultrasonic connector 4 to prevent the surgical fluid from flowing out of the proximal end (rear end) of the ultrasonic connector 4.

Example two

The present embodiment provides a thrombolysis system, which comprises an ultrasonic generator and the ultrasonic thrombolysis apparatus provided in any one of the alternative embodiments of the first embodiment, wherein the ultrasonic generator is connected to an ultrasonic handle 5 connected to an ultrasonic connector 4, and the inner tube 1 passes through the expansion and contraction part 31, the outer tube 3, the ultrasonic connector 4 and the ultrasonic handle 5.

Since the thrombolysis system provided by this embodiment includes the ultrasound thrombolysis device described in the first embodiment, the thrombolysis system provided by this embodiment can achieve all the beneficial effects that the ultrasound thrombolysis device can achieve in the first embodiment, and the specific structure and the achievable effects thereof can be obtained by referring to each optional or preferred embodiment in the first embodiment.

Finally, it should be noted that: the embodiments in the present description are all described in a progressive manner, each embodiment focuses on the differences from the other embodiments, and the same and similar parts among the embodiments can be referred to each other; the above embodiments in the present specification are only used for illustrating the technical solution of the present invention, and not for limiting the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An ultrasonic thrombolysis device is characterized in that: comprises an inner thrombolysis component and an outer ultrasonic component;

the inner layer thrombolysis component comprises an inner tube (1);

the outer ultrasonic component comprises an outer tube (3) and an ultrasonic connector (4) which are sequentially connected from a far end to a near end; the far end of the outer tube (3) is connected with at least one expansion part (31);

the inner pipe (1) penetrates through the expansion part (31), the outer pipe (3) and the ultrasonic connector (4); the expansion and contraction part (31) is configured to have a contraction state integrally attached to or close to the outer wall of the inner tube (1) and an expansion state expanding toward the outside of the inner tube (1) along the radial direction of the inner tube (1).

2. The sonothrombolysis device of claim 1, wherein: the pipe wall of the inner pipe (1) close to the far end is provided with a plurality of side holes which are arranged along the axial direction of the inner pipe (1) at intervals.

3. The sonothrombolysis device of claim 2, wherein:

the distal end of the inner tube (1) is provided with an end blocking component (2), and the end blocking component (2) is provided with a one-way channel which can allow fluid to pass from the distal end to the proximal end and allow a guide wire to pass through and can be automatically closed after the fluid or the guide wire passes through;

or the distal end of the inner tube (1) is provided with a reducing part with the diameter gradually reduced from the proximal end to the distal end, and the reducing part is configured to be matched with a plugging guide wire to plug the distal end orifice of the inner tube (1).

4. The sonothrombolysis device of claim 1, wherein: the expansion and contraction part (31) has a hollow area communicating the outside of the outer tube (3) and the inside of the outer tube (3) in an expanded state.

5. The sonothrombolysis device of claim 4, wherein: the expansion and contraction part (31) comprises a framework, and the framework is in a grid shape or is formed by arranging a plurality of connecting wires extending along the axial direction of the inner pipe (1) at intervals.

6. The sonothrombolysis device of any one of claims 1-5, wherein:

the expansion and contraction part (31) comprises a pull wire (310), a near-end connecting pipe (311), a middle expansion and contraction section (312) and a far-end connecting pipe (313) which are sequentially connected, and the near-end connecting pipe (311) is connected to the far end of the outer pipe (3);

the inner tube (1) passes through the distal connecting tube (313), the middle expanding and contracting section (312) and the proximal connecting tube (311);

the far end of the pull wire (310) is connected to the far end connecting pipe (313), and the pull wire (310) passes through the middle expanding and contracting section (312), the near end connecting pipe (311), the outer pipe (3) and the ultrasonic connector (4); under the condition that the pull wire (310) is pulled towards the proximal end side of the ultrasonic connector (4) relative to the ultrasonic connector (4) by external force, the middle expansion and contraction section (312) can be changed from the contraction state to the expansion state.

7. The sonothrombolysis device of claim 6, wherein: the ultrasonic thrombolysis device further comprises an ultrasonic handle (5) and a locking wire structure, and the ultrasonic connector (4) is connected to the ultrasonic handle (5); the locking wire structure is used for locking the pull wire (310) to the ultrasonic handle (5) at least under the condition that the expansion part (31) is in an expansion state.

8. The sonothrombolysis device of claim 7, wherein:

the wire locking structure comprises a wire pulling block (6), and the proximal end of the pulling wire (310) is fixedly connected to the wire pulling block (6);

when the middle expanding and contracting section (312) is in a contracting state, the far end of the pull wire block (6) is positioned inside the ultrasonic handle (5); the pull wire block (6) is locked at the proximal end side of the ultrasonic handle (5) in the expanded state of the expanding and contracting portion (31) to keep the expanding and contracting portion (31) in the expanded state.

9. The sonothrombolysis device of claim 8, wherein:

the wire pulling block (6) comprises a connecting block (61), an elongated connecting part (62) fixedly or integrally connected to one side surface of the connecting block (61) and a wire pulling ring (63) fixedly or integrally connected to the elongated connecting part (62), and the near end of the pulling wire (310) is fixedly connected to the wire pulling ring (63);

two crossed straight grooves (51) are formed in the proximal end face of the ultrasonic handle (5), wherein the depth of one straight groove (51) in the axial direction of the ultrasonic handle (5) is larger than that of the other straight groove (51) in the axial direction of the ultrasonic handle (5);

when the middle expanding and contracting section (312) is in a contracting state, the strip-shaped connecting part (62) is embedded into the straight groove (51) with deeper axial depth, and the near end of the connecting block (61) is exposed out of the near end of the ultrasonic handle (5); and the middle expansion and contraction section (312) is in an expansion state, and the long strip-shaped connecting part (62) is embedded into the straight groove (51) with shallow axial depth after rotating.

10. The sonothrombolysis device of claim 2, wherein: the outer ultrasound assembly further comprises a hose (71) and a one-way valve assembly (72);

still seted up connector notes liquid hole (41) on supersound connector (4), the one end of hose (71) connect in hole (41) is annotated to the connector, hose (71) are kept away from the position that hole (41) was annotated to the connector is connected with and only allows liquid certainly hose (71) via hole (41) inflow is annotated to the connector check valve subassembly (72) of outer tube (3).

11. The sonothrombolysis device of claim 10, wherein: the inside of supersound connector (4) still is equipped with sealing member (9), sealing member (9) are located the near-end side of liquid hole (41) is annotated to the connector, and seals the outer pipe wall of inner tube (1) with clearance between the inner wall of supersound connector (4).

12. A thrombolysis system, comprising: comprising an ultrasonic generator and the sonothrombolysis device of any one of claims 1 to 11; the ultrasonic generator with connect in ultrasonic handle (5) of supersound connector (4) are connected, inner tube (1) is passed expand contract portion (31), outer tube (3) supersound connector (4) and ultrasonic handle (5).