CN116058922B

CN116058922B - Ultrasonic-assisted thrombolysis device and system

Info

Publication number: CN116058922B
Application number: CN202211677503.3A
Authority: CN
Inventors: 吴常生; 杨涛; 马云鹏
Original assignee: Shanghai Xinhong Life Science Co ltd
Current assignee: Shanghai Xinhong Life Science Co ltd
Priority date: 2022-12-26
Filing date: 2022-12-26
Publication date: 2024-04-30
Anticipated expiration: 2042-12-26
Also published as: CN116058922A

Abstract

The invention relates to an ultrasonic auxiliary thrombolysis device and system, wherein the thrombolysis device comprises a drug delivery catheter, an ultrasonic guide core and an interception basket; the drug delivery catheter comprises an inner tube and an outer tube; an ultrasonic cavity is arranged at the inner side of the inner tube; a medicine injection cavity is arranged between the inner pipe and the outer pipe; the far end of the outer tube is provided with a medicine injection section, and the medicine injection section is provided with a plurality of medicine injection holes; the ultrasonic waveguide core is arranged in the ultrasonic cavity in a penetrating way, and is provided with an ultrasonic transmitting section which corresponds to the medicine injection section in position; the distal end of the ultrasonic waveguide core penetrates out of the distal end of the drug delivery catheter, and the interception basket is arranged between the distal end of the ultrasonic waveguide core and the distal end of the drug delivery catheter; the interception net basket comprises a self-expansion structure and is in a shape of a fusiform net tube or a net disc; the mesh density of the intercepting basket increases progressively from the proximal end to the distal end. The invention can realize more excellent thrombus removing effect through high-frequency ultrasonic, and meanwhile, the interception basket is arranged at the far end of the device, so that broken emboli can be intercepted, and thrombus escape is avoided.

Description

Ultrasonic-assisted thrombolysis device and system

Technical Field

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

Background

Thrombus is a small block of blood flow formed on the surface of the inside surface of a cardiovascular system vessel where it is exfoliated or repaired. In the variable fluid dependency (var iable flow DEPENDENT PATTERNS), the thrombus consists of insoluble fibrin, deposited platelets, accumulated white blood cells and entrapped red blood cells. If thrombus forms a blockage in the blood vessel of a human body, the blood flow is interrupted, myocardial infarction can occur when the thrombus is blocked in coronary arteries, cerebral infarction can occur when the thrombus is blocked in cerebral arteries, pulmonary embolism can occur when the thrombus is blocked in pulmonary arteries, limb infarction can occur when the thrombus is blocked in limb artery and vein, and the coronary artery are serious diseases and even endanger lives.

For thrombus treatment, the traditional treatment method mainly comprises a vascular cutting and thrombus removing operation, a vascular intima stripping operation, a venous thrombolysis operation and the like, wherein the vascular cutting and thrombus removing operation is required to be carried out by dissecting and cutting, and the vascular intima stripping operation is carried out after the cutting, so that the operation wound is very large; intravenous thrombolysis requires thrombolysis medicine to enter the whole body through the venous system, and has long thrombolysis time, high bleeding risk and low effect. With the development of intracavitary intervention technology and innovation of materials, the open operation mode is gradually replaced by minimally invasive intervention intracavitary treatment, including catheter thrombolysis, thrombus aspiration and the like, wherein the catheter thrombolysis can effectively dissolve thrombus, the method has been widely accepted and enters clinical guidelines, and thrombolytic catheters are placed in thrombus areas to directly perfuse thrombolytic drugs to achieve thrombolysis effect.

In order to reduce the dosage of thrombolytic drugs, improve the thrombolysis efficiency and effect, reduce the bleeding risk, the intravascular ultrasound thrombolysis technique increasingly attracts attention to treatment, and has good thrombolysis effect by utilizing the cavitation effect and the mechanical vibration effect of ultrasound, the thrombolysis effect can be achieved by adopting high-frequency ultrasound at present, but undissolved thrombus can be fallen off and flows to the far end due to the vibration and the movement of an ultrasound catheter in the thrombolysis process.

Based on the above, how to design a novel ultrasonic thrombolysis device, so as to realize efficient thrombolysis and avoid emboli escaping to the far end, and the novel ultrasonic thrombolysis device becomes a technical problem to be solved in the prior art.

Disclosure of Invention

The invention discloses an ultrasonic-assisted thrombolysis device and system, which are used for solving the technical problems in the prior art.

In a first aspect, the invention provides an ultrasonic-assisted thrombolysis device comprising a drug delivery catheter, an ultrasonic guide core and an interception basket;

The drug delivery catheter comprises an inner tube and an outer tube; an ultrasonic cavity is arranged at the inner side of the inner tube; the inner tube and the outer tube are fixedly and hermetically connected at the far end, and an annular cavity between the inner tube and the outer tube is a medicine injection cavity; the far end of the outer tube is provided with a medicine injection section, and the medicine injection section is provided with a plurality of medicine injection holes;

The ultrasonic waveguide core is arranged in the ultrasonic cavity in a penetrating way, and is provided with an ultrasonic transmitting section which corresponds to the medicine injection section in position;

The distal end of the ultrasonic waveguide core penetrates out of the distal end of the drug delivery catheter, and the interception basket is arranged between the distal end of the ultrasonic waveguide core and the distal end of the drug delivery catheter;

The interception net basket comprises a self-expansion structure and is in a shape of a fusiform net tube or a net disc; the mesh density of the intercepting basket increases progressively from the proximal end to the distal end.

As a preferable technical scheme, the distal end of the interception basket is fixed on the ultrasonic waveguide core, the proximal end of the interception basket is provided with an actuating piece, and the actuating piece penetrates through the proximal end of the drug delivery catheter; the intercepting basket is able to collapse radially under the control of the actuator.

As a preferable technical scheme, the actuating piece comprises an actuating wire, and the actuating wire is arranged along the axial direction of the ultrasonic guide core;

At least one locating piece is arranged between the actuating wire and the ultrasonic guide core, two through holes are formed in the locating piece, the actuating wire and the ultrasonic guide core are respectively arranged in the two through holes in a penetrating mode, and at least the actuating wire can slide in the through holes.

As a preferred solution, the positioning member is configured as a tube or ring for preventing the actuation wire and the ultrasound catheter core from being entangled and/or knotted in the drug delivery catheter.

As a preferred technical scheme, the interception basket is provided with at least two sections with different grid densities; the distal section of the intercepting basket has a greater braid density than the proximal section;

And/or the distal section of the intercepting basket has a smaller mesh size than the proximal section;

and/or the distal section of the intercepting basket has a larger braided wire diameter than the proximal section.

As the preferable technical scheme, the far end of the ultrasonic guide core is provided with at least two interception baskets which are in the shape of a net disk.

As the preferable technical scheme, the far end of the interception basket arranged at the far end is fixed on the ultrasonic waveguide core, the adjacent interception baskets are connected end to end, and the interception basket arranged at the near end is fixedly connected with the actuating piece.

As a preferable technical scheme, adjacent interception baskets are directly fixedly connected end to end, or are connected through an actuating piece.

As a preferred technical solution, the intercepting basket provided at the distal end has a greater knitting density than the intercepting basket provided at the proximal end;

and/or the intercepting basket disposed at the distal end has a smaller mesh size than the intercepting basket disposed at the proximal end;

and/or the intercepting basket disposed at the distal end has a larger braid wire diameter than the intercepting basket disposed at the proximal end;

and/or the intercepting basket disposed distally has a larger size than the intercepting basket disposed proximally.

As a preferred technical scheme, the grid density of each interception basket gradually increases from the respective proximal end to the distal end.

As a preferred technical scheme, the interception net basket comprises a shape memory alloy material; the intercepting basket is manufactured through a laser cutting or braiding process.

As the preferable technical scheme, the medicine injection holes are arranged at the periphery of the medicine injection section in a lattice mode.

As a preferred technical scheme, the ultrasonic transmitting section is provided with a plurality of ultrasonic transducers.

As a preferable technical scheme, the medical device also comprises a proximal handle, wherein the proximal ends of the drug delivery catheter and the ultrasonic guide core are arranged in the proximal handle;

the proximal handle is connected with an ultrasonic generator, and the ultrasonic generator is connected with the proximal end of the ultrasonic guide core.

In a second aspect, the invention also provides an ultrasound-assisted thrombolysis system comprising an ultrasound-assisted thrombolysis device according to any of the above.

Compared with the prior art, the technical scheme adopted by the invention can achieve the following beneficial effects:

The invention mainly provides an ultrasonic auxiliary thrombolysis device, which structurally comprises an ultrasonic waveguide core, a drug delivery catheter and an interception basket; the far end of the ultrasonic waveguide core is provided with an ultrasonic emission section, the far end of the drug delivery catheter is provided with a drug injection section, the positions of the ultrasonic emission section and the drug injection section are matched, the structure can realize drug thrombolysis while ultrasonic thrombolysis, the drug injection section is distributed over the drug injection hole, can be clung to the inner side of the vessel wall and is contacted with thrombus, and the efficiency of thrombolysis is obviously improved by matching with the cavitation effect and the mechanical vibration effect of ultrasonic waves.

Further, the far end of the ultrasonic emission section is further provided with one or more interception baskets, the far end of each interception basket is provided with grid density larger than that of the near end, thrombus falling off in the thrombolysis process can enter the interception basket and is intercepted, after thrombolysis is finished, the interception basket is controlled to shrink radially through the actuating piece so as to cover the falling-off thrombus, and the thrombus leaves the human body together with the ultrasonic guide core and the interception basket, so that the thrombus is prevented from escaping to the far end.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments are briefly described below to form a part of the present invention, and the exemplary embodiments of the present invention and the description thereof illustrate the present invention and do not constitute undue limitations of the present invention. In the drawings:

FIG. 1 is a perspective view of an ultrasound-assisted thrombolysis device according to a preferred embodiment of the disclosure as example 1;

FIG. 2 is a schematic view of an ultrasound-assisted thrombolysis device according to a preferred embodiment of the present invention as disclosed in example 1;

FIG. 3 is a perspective view of an ultrasonic waveguide core and an intercepting basket according to a preferred embodiment of the invention disclosed in example 1;

FIG. 4 is a schematic view of the structure of an ultrasonic waveguide core and an intercepting basket according to a preferred embodiment of the invention disclosed in example 1;

FIG. 5 is a schematic view of the structure of an ultrasonic emission section in a preferred embodiment disclosed in example 1 of the present invention;

fig. 6 is a schematic structural view of an ultrasonic-assisted thrombolysis device according to a preferred embodiment of the invention as disclosed in example 2.

Reference numerals illustrate:

A drug delivery catheter 100, a drug infusion section 110, a drug infusion orifice 111; an ultrasonic waveguide core 200, an ultrasonic transmitting section 210, an ultrasonic transducer 211, an electrode lead 220, a metal guide wire 230 and a coating layer 240; intercepting basket 300, mesh 310, first section 311, second section 312, third section 313, actuation wire 320, positioning member 330; a proximal handle 400, an ultrasonic switch 410, and an ultrasonic adjustment knob 420.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

In the description of the present invention, those skilled in the art will understand that the terms "proximal" and "distal" are relative to the operator unless explicitly specified and defined otherwise; the "proximal" is the one-dimensional direction defined by the body vessel that is closer to the user after the ultrasound catheter or drug delivery catheter enters the body vessel, and the "distal" is the one-dimensional direction defined by the body vessel that is further from the user. And those skilled in the art will appreciate that the distance and near are not meant to be a straight line distance from the user's three-dimensional space.

It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

The application provides an ultrasonic auxiliary thrombolysis device, which comprises a drug delivery catheter 100, an ultrasonic waveguide core 200 and an interception basket 300; the drug delivery catheter 100 comprises an inner tube and an outer tube; an ultrasonic cavity is arranged at the inner side of the inner tube; the inner tube and the outer tube are fixedly and hermetically connected at the far end, and an annular cavity between the inner tube and the outer tube is a medicine injection cavity; the far end of the outer tube is provided with a medicine injection section 110, and the medicine injection section 110 is provided with a plurality of medicine injection holes 111; the ultrasonic waveguide core 200 is arranged in the ultrasonic cavity in a penetrating way, the ultrasonic waveguide core 200 is provided with an ultrasonic transmitting section 210, and the ultrasonic transmitting section 210 corresponds to the medicine injecting section 110 in position; the distal end of the ultrasonic waveguide core 200 extends out of the distal end of the drug delivery catheter 100, and the intercepting basket 300 is disposed between the distal end of the ultrasonic waveguide core 200 and the distal end of the drug delivery catheter 100; the intercepting basket 300 comprises a self-expanding structure, and is in the shape of a fusiform net tube or net disc; the density of the mesh 310 of the intercepting basket 300 increases progressively from the proximal end to the distal end.

Example 1

This embodiment 1 will be described with reference to fig. 1 to 5. The present embodiment provides an ultrasound-assisted thrombolysis device, which at least includes a drug delivery catheter 100, an ultrasound catheter core 200, an interception basket 300 and a proximal handle 400, and is shown in fig. 2, wherein the left end corresponds to the distal end of the device, and the right end corresponds to the proximal end of the device. Since the inside diameters of blood vessels are not the same for different patients or for different diseased sites of the same patient, it is contemplated by those skilled in the art that the dimensions and specifications of the drug delivery catheter 100, ultrasound waveguide 200 and interception basket 300 can be adapted according to the patient's situation.

In a preferred embodiment, the drug delivery catheter 100 comprises an inner tube and an outer tube, both of which are flexible catheters and are fixedly connected at a distal end in a sealed manner, an annular cavity therebetween is a drug injection cavity, and a drug injection port is provided at a proximal end of the drug injection cavity; the two ends of the inner tube are communicated, the inner side of the inner tube is provided with an ultrasonic cavity, and the ultrasonic guide core 200 can be arranged in the ultrasonic cavity in a penetrating way.

In a preferred embodiment, the proximal end of the drug delivery catheter 100 is a multi-way tube, the opening in the side of the multi-way tube being configured as a drug injection port, the axial opening of the multi-way tube being provided with a luer fitting by which the drug delivery catheter 100 can be connected to the proximal handle 400.

In a preferred embodiment, the inner and outer tubes of the drug delivery catheter 100 may be fabricated using the same material, such as PEBAX or PTFE polymer materials.

As shown in fig. 1 and 2, preferably, a medicine injection section 110 is disposed at the distal end of the outer tube, and the medicine injection section 110 is provided with a plurality of medicine injection holes 111, so that when the thrombolytic medicine is injected into the medicine injection cavity, the medicine can flow out of the medicine injection holes 111 and act on the thrombus to achieve the thrombolytic effect.

It will be appreciated by those skilled in the art that the most preferred drugs are not the same for different sites of occurrence or different forms of thrombus, and are not limited herein and are not intended to be illustrative.

In a preferred embodiment, the drug delivery segment 110 is provided with a visualization ring at both axial ends, which is embedded in the inner or outer tube to facilitate the physician in locating the drug delivery segment 110 in the imaging system.

Preferably, the injection holes 111 are uniformly distributed on the outer peripheral surface of the injection section 110 in a lattice shape, the injection holes 111 are in a regular round shape, an oval shape or a square shape, or the injection holes 111 are in an irregular curved shape which is adapted to the outline of thrombus; because the texture of part of the thrombus is compact in the middle and sparse at the two ends, in a preferred embodiment, the drug injection hole 111 presents a trend of large density and small density at the two ends of the middle drug injection hole 111 in the axial direction, or presents a trend of large size and small size at the two ends of the middle drug injection hole 111 in the axial direction so as to adapt to the shape of a blood vessel; in another preferred embodiment, the drug injection well 111 is configured to: the dimension and density are large in the middle of the injection section 110, and small at the two ends of the injection section 110.

Because thrombus of different shapes and sizes may occur in different patients or in different disease sites of the same patient, in a preferred embodiment, a doctor can determine the shape and size of thrombus in an imaging system first, and then specifically configure the size and distribution mode of the injection holes 111 according to the actual situation of the patient. The size of the drug injection hole 111 is not particularly limited here.

In a preferred embodiment, the ultrasound catheter 200 is disposed through the ultrasound lumen with its distal end extending out of the ultrasound lumen and its proximal end disposed in the proximal handle 400. Preferably, the ultrasonic guide core 200 is provided with an ultrasonic transmitting section 210, at least one ultrasonic transducer 211 is arranged in the ultrasonic transmitting section 210, and the position of the ultrasonic transmitting section 210 is matched with the position of the medicine injecting section 110.

In a preferred embodiment, as shown in fig. 4, the ultrasound transmission section 210 is only positioned to match the drug delivery section 110, and the length may be greater or less than the length of the drug delivery section 110; in another preferred embodiment, the ultrasound transmitting section 210 is positioned and axially elongated in the same manner as the drug delivery section 110 to ensure that the ultrasound thrombolysis and drug thrombolysis positions are completely matched during operation of the ultrasound transducer 211, so that thrombolysis effect is maximized.

Referring to fig. 5, the ultrasonic waveguide core 200 preferably includes a metal wire 230, an electrode lead 220, an ultrasonic transducer 211, and a cladding 240.

In a preferred embodiment, the ultrasonic transducer 211 is made of piezoelectric ceramics, in particular, may be axially stacked of several piezoelectric ceramics, and is connected to the electrode wire 220; preferably, 3 to 30 ultrasonic transducers 211 capable of converting an electric signal into a mechanical vibration signal to generate a sound field accelerating thrombolysis dispersion are uniformly arranged in the ultrasonic emission section 210.

In a preferred embodiment, the cladding layer 240 is made of a metal or a polymeric material; specifically, the polymer material may be selected from one or more of polyolefin such as ethylene, polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone resin, fluoropolymer (PTFE, ETFE, PFA, etc.), or a composite material of these materials, latex rubber, silicone rubber, or nylon elastomer. Specifically, the metal material may be a stainless steel material.

Preferably, the metal wire 230 disposed in the ultrasonic waveguide core 200 is also made of a stainless steel material, such as one of SUS304, SUS303, SUS316L, SUS J1, SUS316J 1L, SUS, SUS430, SUS434, SUS444, SUS429, SUS430F, or SUS302, for providing the ultrasonic waveguide core 200 with higher axial structural strength.

In a preferred embodiment, the distal end of the ultrasonic waveguide 200 is also provided with a contact probe, preferably configured as a spring, for providing contact feedback.

In a preferred embodiment, the ultrasonic waveguide 200 is energized by an ultrasonic generator, which may be disposed in the proximal handle 400 and connected to the proximal end of the electrode wire 220; the frequency of the ultrasonic generator is 20-50 KHz, and the energy is 0-1W.

In a preferred embodiment, the ultrasonic generator is disposed in the proximal handle 400, and preferably, an ultrasonic switch 410 and an ultrasonic adjusting knob 420 are further disposed in the proximal handle 400; the ultrasonic switch 410 is connected with the ultrasonic generator and is used for controlling the on and off of the ultrasonic generator; the ultrasonic adjusting knob 420 is disposed between the ultrasonic generator and the ultrasonic guide core 200 for adjusting the ultrasonic frequency.

In another preferred embodiment, the ultrasonic generator is not disposed in the proximal handle 400, but is disposed outside the ultrasonic generator host, and the proximal end of the ultrasonic guide core 200 is connected to the ultrasonic generator host through the proximal handle 400; preferably, an ultrasonic switch 410 and an ultrasonic adjusting knob 420 are arranged in the ultrasonic generator main machine, and are used for controlling the start and stop of ultrasonic waves and the adjustment of frequency.

Preferably, an interception basket 300 is further provided at the distal end of the ultrasonic waveguide core 200, and the interception basket 300 is positioned more distally than the ultrasonic emission section 210, more specifically, the interception basket 300 is provided between the distal end of the ultrasonic waveguide core 200 and the distal end of the drug delivery catheter 100 for intercepting thrombus detached during ultrasonic and drug thrombolysis.

In a preferred embodiment, the intercepting basket 300 is a self-expanding structure, in the form of a fusiform net tube or net disc; preferably, the interception basket 300 is distributed over the hollow grid 310, and the density of the grid 310 gradually increases from the proximal end to the distal end, and the grid 310 with the larger proximal end can allow thrombus to penetrate into the interception basket 300, wherein the grid 310 with the smaller distal end can prevent thrombus from penetrating therethrough, so as to achieve the effect of preventing thrombus from escaping distally.

Preferably, the interception basket 300 is made of a shape memory alloy, such as a nickel titanium alloy memory material or other memory polymer material or alloy, and in this embodiment, a plurality of interconnected grids 310 are formed by processing the nickel titanium alloy memory material or the like; optionally, the above-mentioned processing means include, but are not limited to, braiding, laser cutting, welding, rivet connection, screw connection, and the like.

It will be appreciated by those skilled in the art that shape memory alloy materials have a memory effect and are capable of collapsing radially at low temperatures after being formed into a mesh tubular or disc-like structure in vitro, and undergo radial self-expansion with increasing temperature after entering the body and release, with some elasticity.

In a preferred embodiment, the distal end of the interception basket 300 is fixed to the ultrasonic waveguide core 200, and the proximal end is in a ring shape slidably connected to the ultrasonic waveguide core 200; preferably, the proximal end of the intercepting basket 300 is provided with an actuator that protrudes through the proximal end of the drug delivery catheter 100 and is capable of controlling the radial collapse of the intercepting basket 300.

Preferably, as the interception basket 300 is wrapped in the outer sheath tube or the delivery catheter or the drug delivery catheter 100 during in-vivo delivery, the interception basket 300 can maintain a radially contracted state when being limited by the circumferential limit, and can convert axial pressure into radial expansion force when being removed from the limit of the outer periphery of the interception basket 300, thereby realizing self-expansion and gradually expanding to a size matched with the inner diameter of a blood vessel so as to intercept falling emboli and avoid the emboli from escaping from a gap between the interception basket 300 and the blood vessel wall; when thrombolysis is completed, the actuating member is retracted proximally, the distance between the proximal end and the distal end of the interception basket 300 is stretched to realize radial retraction of the interception basket, and the size of the grid 310 is reduced due to radial contraction of the interception basket 300, so that the density of the grid 310 is increased to completely cover thrombus therein. It will be appreciated by those skilled in the art that the distance between the proximal and distal ends of the intercepting basket 300 is generally inversely related to the diameter of the intercepting basket 300.

Preferably, since the diseased site of the same patient or different patients is different, the vessel inner diameter and thrombus volume are different, and it can be understood that the size of the interception basket 300 can be freely decided according to the actual physiological state of the patient, which is not described herein.

In a preferred embodiment, as shown in fig. 3 and 4, the actuator is an actuator wire 320, and the actuator wire 320 is disposed axially of the ultrasound catheter 200 and extends through the drug delivery catheter 100. The proximal end of actuation wire 320 extends through drug delivery catheter 100 and further out proximal handle 400, enabling radial retraction of the intercepting basket 300 when actuation wire 320 is retracted proximally.

It will be appreciated by those skilled in the art that due to the complex anatomy of veins and arteries in the human body, even a single guidewire is prone to kinking and twisting during interventional procedures, and is more prone to kinking when multiple guidewire structures are desired. Based on the above, in a more preferred embodiment, at least one positioning member 330 is provided between the actuation wire 320 and the ultrasonic waveguide 200, the positioning member 330 being tubular, cylindrical or adapted to the shape of the actuation wire 320 and the ultrasonic waveguide 200; the positioning member 330 is provided with two through holes, the actuation wire 320 and the ultrasound catheter 200 are respectively arranged in the two through holes in a penetrating way, at least the actuation wire 320 can slide in the through holes, and the positioning member 330 can prevent the actuation wire 320 and the ultrasound catheter 200 from being wound and/or knotted in the drug delivery catheter 100.

Preferably, the length of the positioning member 330 is 100-500mm.

On the one hand, configuring the actuation member as an actuation wire 320 can ensure that the volume of the drug delivery catheter 100 is not significantly increased; in the second aspect, after the positioning piece 330 is added, the usability and the safety of the actuation wire 320 are obviously improved, so that the situation that the actuation wire 320 is folded and wound with the ultrasonic guide core 200 and the operation fails is avoided; in the third aspect, the actuating member is arranged in a linear shape instead of being sleeved outside the ultrasonic waveguide core 200, so that the actuating member itself can be prevented from shielding ultrasonic waves, and thus the thrombus removing failure is avoided.

As shown in fig. 4, preferably, the intercepting basket 300 is provided with at least two sections having different densities of the meshes 310; preferably, the intercepting basket 300 comprises a first section 311, a second section 312 and a third section 313, the first section 311 is disposed at the proximal end of the intercepting basket 300, the third section 313 is disposed at the distal end of the intercepting basket 300, and the second section 312 is disposed between the first section 311 and the third section 313.

In a preferred embodiment, the distal section of the intercepting basket 300 has a greater braid density than the proximal section; preferably, the first section 311 has a relatively sparse weave density, the third section 313 has a maximum weave density, and the second section 312 has a weave density intermediate the two.

Preferably, the knitting density of the third section 313 satisfies: the thrombus is prevented from escaping and the blood flow is not blocked. So as to ensure that excessive blood loss is not caused while the thrombus is taken.

In another preferred embodiment, the distal section of the intercepting basket 300 has a smaller mesh 310 size than the proximal section; preferably, the mesh 310 of the first section 311 is larger in size to accommodate thrombus inflow, the mesh 310 of the third section 313 is smallest in size to avoid thrombus outflow, and the mesh 310 of the second section 312 is intermediate in size.

Preferably, the mesh 310 size of the third section 313 satisfies: the thrombus is prevented from escaping and the blood flow is not blocked.

In another preferred embodiment, the distal section of the intercepting basket 300 has a thicker braided wire diameter than the proximal section; preferably, the braided filaments of the first section 311 are thinner, so that the mesh 310 is larger in size and the mesh 310 is sparse, and the braided filaments of the third section 313 are thicker, so that the mesh 310 is smaller in size and the mesh 310 is denser, and the braided filaments of the second section 312 have a diameter intermediate therebetween.

It should be noted that, although the intercepting basket 300 is divided into a plurality of sections, there is no connection structure between adjacent sections, and it should be understood by those skilled in the art that the division of different sections may be achieved by gradually adjusting the density/size/knitting wire diameter of the mesh 310 of the intercepting basket 300, or the transition between adjacent sections may be gradually performed to achieve structural integrity.

In this embodiment, the use process of the above ultrasound-assisted thrombolysis device is as follows:

The above-mentioned ultrasonic auxiliary thrombolysis device reaches the thrombus through the guide catheter, at this time, the interception basket 300 is released and self-expands at the distal end of the thrombus, the injection section 110 of the drug delivery catheter 100 is in direct contact with the thrombus, the thrombolytic drug is injected inwards through the injection port of the proximal handle 400, the drug flows out from the injection hole 111 of the injection section 110 and acts on the thrombus, at this time, the inner ultrasonic injection section simultaneously starts working to produce cavitation effect and mechanical vibration effect, and the structure can enable simultaneous thrombolysis at the ultrasonic and drug thrombolysis, thereby improving thrombolysis efficiency.

Further, the thrombus falling off in the thrombolysis process can enter the interception basket 300 and be intercepted, after thrombolysis is finished, the interception basket 300 is controlled to radially shrink by the actuation wire 320 so as to cover the falling-off thrombus, and the thrombus leaves the human body together with the ultrasonic guide core 200 and the drug delivery catheter 100, so that the thrombus is prevented from escaping to the distal end.

Example 2

In this embodiment, an ultrasound-assisted thrombolysis device is provided, which includes the drug delivery catheter 100, the ultrasound waveguide core 200, the interception basket 300 and the proximal handle 400, wherein the features of the drug delivery catheter 100, the ultrasound waveguide core 200 and the proximal handle 400 described in embodiment 1 are naturally inherited in this embodiment.

In a preferred embodiment, as shown in fig. 6, at least two intercepting baskets 300 are provided at the distal end of the ultrasonic waveguide 200, and preferably, the intercepting baskets 300 are disc-shaped and are sequentially provided in the axial direction of the ultrasonic waveguide 200, and by providing the intercepting baskets 300 in a disc shape, the total length of the axial arrangement of the plurality of intercepting baskets 300 can be controlled.

In a preferred embodiment, the distal end of the interception basket 300 disposed at the distal end is fixed on the ultrasonic waveguide core 200, the adjacent interception baskets 300 are connected end to end, and the interception basket 300 disposed at the proximal end is slidably connected with the ultrasonic waveguide core 200 and fixedly connected with the actuating member, and by retracting the actuating member, a plurality of interception baskets 300 can be radially collapsed at the same time.

In a preferred embodiment, the actuating member is an actuating wire 320, and adjacent intercepting baskets 300 are fixedly connected end to end, or adjacent intercepting baskets 300 are connected by actuating wire 320.

Preferably, at least one positioning member 330 is provided between the actuation wire 320 and the ultrasound catheter 200, two perforations are provided in the positioning member 330, the actuation wire 320 and the ultrasound catheter 200 are respectively provided in the two perforations, at least the actuation wire 320 is capable of sliding in the perforations, and the positioning member 330 is provided to prevent the actuation wire 320 and the ultrasound catheter 200 from being entangled and/or knotted in the drug delivery catheter 100.

In this embodiment, the arrangement of the actuation wire 320 is the same as that of embodiment 1 described above, and will not be described again.

In a preferred embodiment, the mesh 310 density of each intercepting basket 300 increases progressively from the respective proximal end to the distal end; specifically, each intercepting basket 300 may adopt any of the schemes described in embodiment 1, and will not be described herein. At this point, the thrombus dislodged during thrombolysis may penetrate into and be captured by the first intercepting basket 300 and, if dislodged, continue to penetrate into the second intercepting basket 300 to intercept it there, and so on, until the dislodged emboli are intercepted by the most distal intercepting basket 300.

In one embodiment, distally disposed intercepting basket 300 has a greater braid density than proximally disposed intercepting basket 300; preferably, the interception basket 300 disposed at the proximal end has a sparse knitting density, and can intercept the dropped emboli preliminarily; the interception basket 300 disposed at the distal end has the greatest weaving density for further capturing the detached thrombus not captured by the interception basket 300 at the proximal end, thereby playing a double-securing role. More preferably, the knitted density of the intercepting basket 300 disposed at the most distal end should be such that: the thrombus is prevented from escaping and the blood flow is not blocked. So as to ensure that excessive blood loss is not caused while the thrombus is taken.

In a preferred embodiment, the distally disposed intercepting basket 300 has a smaller mesh 310 size than the proximally disposed intercepting basket 300.

In a preferred embodiment, the distally disposed intercepting basket 300 has a larger braided wire diameter than the proximally disposed intercepting basket 300.

More preferably, whichever of the above embodiments is employed, the density of the mesh 310 of the first intercepting basket 300 disposed at the proximal end increases progressively from the proximal end to the distal end; that is, the first intercepting basket 300 may independently accomplish a part of the intercepting effect, and if not all the intercepting baskets 300 disposed at a more remote end may intercept again.

More preferably, regardless of the embodiment described above, the distally disposed intercepting basket 300 has a larger size or diameter than the proximally disposed intercepting basket 300 and has a smaller mesh 310 size than the proximally disposed intercepting basket 300, at least to ensure complete apposition to the inner wall of the vessel after complete expansion and complete capture of emboli not captured by the proximally disposed intercepting basket 300 for superior thrombus escape prevention.

Example 3

In this embodiment, an ultrasound-assisted thrombolysis system is provided, which at least includes the ultrasound-assisted thrombolysis device described in embodiment 1 or embodiment 2, and the technical features already included in the above embodiment are naturally inherited in this embodiment and are not described again.

In a preferred embodiment, the ultrasound-assisted thrombolysis system comprises an ultrasound-assisted thrombolysis device and an ultrasound generator host, wherein at least one ultrasound emission interface is arranged in the ultrasound generator host, the ultrasound emission interface is connected with a proximal handle 400 of the ultrasound-assisted thrombolysis device, an ultrasound guide core 200 in the proximal handle 400 is connected into the ultrasound emission interface, the start and stop of ultrasound and the adjustment of ultrasound frequency are controlled by the ultrasound generator host, and at this time, an ultrasound generator and an ultrasound adjusting knob 420 are not arranged in the proximal handle 400.

The embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present invention and the scope of the claims, which are to be protected by the present invention.

Claims

1. An ultrasonic auxiliary thrombolysis device is characterized by comprising a drug delivery catheter, an ultrasonic guide core and an interception basket;

The drug delivery catheter comprises an inner tube and an outer tube; an ultrasonic cavity is arranged on the inner side of the inner tube; the inner tube and the outer tube are fixedly and hermetically connected at the far end, and an annular cavity between the inner tube and the outer tube is a medicine injection cavity; the far end of the outer tube is provided with a medicine injection section, the medicine injection section is provided with a plurality of medicine injection holes, the medicine injection holes are uniformly distributed on the peripheral surface of the medicine injection section in a lattice mode, and the medicine injection holes are in a regular round shape, an oval shape or a square shape or in an irregular curved shape which is matched with the outline of thrombus;

the ultrasonic guide core is arranged in the ultrasonic cavity in a penetrating way, an ultrasonic transmitting section is arranged on the ultrasonic guide core, and the ultrasonic transmitting section corresponds to the medicine injection section in position;

The distal end of the ultrasonic guide core penetrates through the distal end of the drug delivery catheter, and the interception basket is arranged between the distal end of the ultrasonic guide core and the distal end of the drug delivery catheter;

The interception basket comprises a self-expansion structure and is in a fusiform net tubular shape or a net disc shape; the grid density of the interception net basket is gradually increased from the near end to the far end, the grid with the larger near end can enable thrombus which falls off in the ultrasonic and drug thrombolysis processes to penetrate into the interception net basket, and the grid with the smaller far end can prevent thrombus from penetrating;

The distal end of the interception basket is fixed on the ultrasonic guide core, the proximal end of the interception basket is provided with an actuating piece, the actuating piece comprises an actuating wire, the actuating wire is arranged along the axial direction of the ultrasonic guide core, and the actuating wire penetrates through the proximal end of the drug delivery catheter; the intercepting basket is radially collapsible under the control of the actuation wire;

At least one locating piece is arranged between the actuating wire and the ultrasonic guide core, two through holes are formed in the locating piece, the actuating wire and the ultrasonic guide core are respectively arranged in the two through holes in a penetrating mode, at least the actuating wire can slide in the through holes, and the locating piece is used for preventing the actuating wire and the ultrasonic guide core from being wound and/or knotted in the drug delivery catheter.

2. The ultrasound assisted thrombolysis device according to claim 1 wherein said positioning member is configured in a tubular or annular shape.

3. The ultrasonic-assisted thrombolytic device according to claim 1, wherein said interception basket is provided with at least two sections having different mesh densities; the distal section of the intercepting basket has a greater braid density than the proximal section;

4. The ultrasonic-assisted thrombolysis device according to claim 2, wherein the distal end of the ultrasonic guide core is provided with at least two interception baskets, and the interception baskets are in a net disk shape.

5. The ultrasonic-assisted thrombolysis device according to claim 4 wherein the distal end of the interception basket disposed at the distal end is fixed on the ultrasonic guide core, adjacent interception baskets are connected end to end, and the interception basket disposed at the proximal end is fixedly connected with the actuator.

6. The ultrasonic-assisted thrombolytic device according to claim 5 wherein adjacent said intercepting baskets are fixedly connected end to end or connected by said actuating member.

7. The ultrasonic assisted thrombolysis device according to claim 5 wherein said interception basket disposed at the distal end has a greater braid density than said interception basket disposed at the proximal end;

And/or the intercepting basket disposed at the distal end has a larger size than the intercepting basket disposed at the proximal end.

8. The ultrasonic-assisted thrombolytic device according to claim 5, wherein the mesh density of each of said interception baskets increases progressively from the respective proximal end to the distal end.

9. The ultrasonic assisted thrombolytic device of claim 1, wherein said interception basket comprises a shape memory alloy material; the intercepting basket is manufactured through a laser cutting or braiding process.

10. The ultrasonic-assisted thrombolytic device of claim 1, wherein the drug injection holes are arranged on the periphery of the drug injection section in a lattice.

11. The ultrasound-assisted thrombolysis device according to claim 1 wherein said ultrasound emitting section is provided with a plurality of ultrasound transducers.

12. The ultrasound assisted thrombolysis device according to any of claims 1-11 further comprising a proximal handle, wherein the proximal ends of said drug delivery catheter and said ultrasound catheter core are disposed within said proximal handle;

13. An ultrasound-assisted thrombolysis system comprising an ultrasound-assisted thrombolysis device according to any of claims 1-12.