CN113796924A

CN113796924A - Thrombus treatment system

Info

Publication number: CN113796924A
Application number: CN202010534509.XA
Authority: CN
Inventors: 冯海全; 张磊; 王晓天; 李晓强; 王永刚; 关丽鹃; 李靖
Original assignee: Suzhou Venmed Technology Co ltd
Current assignee: Suzhou Venmed Technology Co ltd
Priority date: 2020-06-12
Filing date: 2020-06-12
Publication date: 2021-12-17

Abstract

The invention relates to a thrombus treatment system, which is characterized in that: the thrombolytic aspiration device comprises an aspiration tube assembly, a thrombolytic stirring assembly, a filter screen assembly and an aspiration pump, wherein the aspiration tube assembly comprises a guide sheath tube, an aspiration tube main body and an aspiration head, when the aspiration head is opened, a distal end forms an aspiration port, and the caliber of the distal end is larger than that of a proximal end; the thrombolysis stirring component comprises a first guide pipe, a second guide pipe, a stirrer with an opening state and a folding state, a handle and an operating part, wherein when the stirrer is folded, the outer diameter of the stirrer is less than or equal to 6F; the screen assembly includes a filter rod, a first screen having an open state and a collapsed state. The invention can remove thrombus under the condition of ensuring relative safety, is particularly suitable for removing a large amount of thrombus in inferior vena cava, protects venous valves and venous blood vessel walls, has controllable blood loss, higher suction efficiency and simple operation steps, shortens the operation time and lightens the hospitalization cost of patients.

Description

Thrombus treatment system

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a thrombus treatment system.

Background

The existing treatment methods mainly comprise vascular incision embolectomy, catheter contact thrombolysis and percutaneous mechanical puncture embolectomy, wherein the incision embolectomy needs to be performed through dissection separation and blood vessel incision, such as femoral artery, femoral vein or brachial artery incision, and with the development of intracavity intervention technology and the innovation of materials, the open operation mode is gradually replaced by minimally invasive interventional intracavity treatment, namely catheter contact thrombolysis and percutaneous mechanical puncture embolectomy. Catheter contact thrombolysis is not beneficial to many patients because of the high risk of thrombolysis drug bleeding and the extreme severity of the surgical indications, and a large proportion of patients have catheter contact thrombolysis contraindications.

Based on the existing medical cognition, the deep venous thrombosis is often large in capacity, and the acute-phase thrombosis is soft and fragile in texture; arterial thrombosis often has small volume, and thrombus in an acute stage is soft in texture; old thrombi tend to adhere to the vessel wall. For old thrombus, the old thrombus is mainly scraped mechanically by the vessel wall or falls off by thrombolytic drugs at present.

For example, a thrombectomy catheter system, such as an X-sizer thrombectomy catheter system, in which a spiral cutter at the front end of the catheter is used to cut thrombus and blood clots are sucked out of the body, chinese patent CN204092102U discloses a novel peripheral vascular disease thrombus suction connector, which includes: the rotary tail seat comprises a pipe body, a rotary rod, a spiral rotary piece, an arc joint and a connecting tail seat, wherein the pipe body is in a hollow tubular shape, the upper end of the pipe body is movably connected with the arc joint through threads, a rectangular groove is formed in the middle upper portion of the pipe body, the rotary rod is inserted into the pipe body, and the spiral rotary piece is sleeved on the periphery of the rotary rod. However, the thrombus removal device has a complicated structure, high production cost, and cumbersome use, and when the thrombus on the vascular wall is detached by the rotation of the spiral cutter or the spiral rotary blade in the blood vessel, the vascular endothelium is easily damaged, and the thrombus removal sequelae are easily caused.

For another example, the Angiojet thrombus remover can spray a certain amount of thrombolytic agent into the thrombus at high pressure to break up the thrombus, increase the contact area with the thrombus, and perform thrombus suction (called chemical-physical coupling thrombus volume reduction), and is suitable for acute stage thrombus of iliac, femoral and popliteal veins. However, the patient often loses too much blood due to the overlong negative pressure time, and meanwhile, the red blood cell injury may be caused by the high-pressure rapid stirring, so that the hemolysis is caused, and the thrombus extraction sequelae are easy to occur.

Disclosure of Invention

The invention aims to provide a thrombus treatment system to reduce the occurrence of thrombus extraction sequelae.

In order to achieve the purpose, the invention adopts the technical scheme that:

from the viewpoint of product structure: the thrombus treatment system of the present invention comprises: a suction pipe component, a thrombolysis stirring component, a filter screen component and a suction pump,

the suction tube assembly comprises a guide sheath tube with a guide channel, a suction tube main body arranged in the guide channel of the guide sheath tube in a penetrating way, and a suction head which is connected to the far end of the suction tube main body and has an opening state and a folding state, and when the suction head is positioned in the guide sheath tube, the suction head is in the folding state; when the suction head passes through the guide sheath, the suction head is switched from a closed state to an open state; when the suction head is in an open state, the far end of the suction head forms a suction opening, and the caliber of the far end of the suction opening is larger than that of the near end of the suction opening;

the thrombolysis stirring component comprises a first guide pipe, a second guide pipe sleeved outside the first guide pipe in a sliding manner, a stirrer arranged at the far end of the first guide pipe and having an opening state and a folding state, a handle fixedly connected with the near end of one of the first guide pipe and the second guide pipe, and an operating part in sliding connection with the handle, wherein the operating part is fixedly connected with the near end of the other one of the first guide pipe and the second guide pipe; when the operating piece slides relative to the handle, the first guide pipe and the second guide pipe slide relative to each other to enable the stirrer to be switched between an opening state and a folding state; when the stirrer is in a furled state, the outer diameter of the stirrer is less than or equal to 6F;

the filter screen assembly comprises a filter rod and a first filter screen which is fixedly arranged at the far end of the filter rod and has an opening state and a folding state;

the suction pump is communicated with the proximal end of the suction tube main body.

From the use state of the product: the thrombus treatment system comprises a suction pipe component, a thrombolytic stirring component, a filter screen component and a suction pump,

the thrombolysis stirring component comprises a first conduit passing through the suction pipe main body, a second conduit passing through the suction pipe main body and sleeved outside the first conduit in a sliding manner, a stirrer arranged at the far end of the first conduit and having an opening state and a folding state, a handle fixedly connected with the near end of one of the first conduit and the second conduit, and an operating part slidably connected with the handle, wherein the operating part is fixedly connected with the near end of the other one of the first conduit and the second conduit; the handle is positioned at the proximal end of the suction tube main body; when the operating piece slides relative to the handle, the first guide pipe and the second guide pipe slide relative to each other to enable the stirrer to be switched between an opening state and a folding state; when the stirrer is in a furled state, the outer diameter of the stirrer is less than or equal to 6F; said agitator being located at the distal end of said main body when said agitator is in an open position, said agitator moving back and forth in the blood vessel as said first conduit is drawn;

the filter screen assembly comprises a filter rod penetrating through the suction pipe main body, and a first filter screen which is fixedly arranged at the distal end of the filter rod and has an opened state and a folded state; the first filter screen is positioned at the far end of the stirrer;

Preferably, the suction head include a plurality of near-ends connect and be the filter screen backing sheet that the petal form distributes at the suction tube main part distal end and be the second filter screen of at least cover the filter screen backing sheet near-end, when the suction head be in open mode, a plurality of the distal end of filter screen backing sheet enclose to close and be the suction opening, just the distal end of filter screen backing sheet can contact with the blood vessel inner wall. The petaloid head can filter thrombus, and can stir the thrombus by rotating the suction tube main body to enable the far end of the filter screen supporting sheet to improve the thrombus removal efficiency.

Further preferably, the distal end of the filter screen support sheet is rounded. The smooth distal end of the filter screen support sheet can reduce the damage of the filter screen support sheet to the inner wall of the blood vessel.

Preferably, said suction head is formed by a second screen which extends from its proximal end to its distal end for 2-9mm when said suction head is in the deployed state and does not contact the inner wall of the blood vessel. The shorter suction head can be closer to the thrombus, which can improve the efficiency of thrombus suction.

Preferably, said suction head is formed by a second screen which extends from its proximal end to its distal end for 10-18mm and which is adapted to engage the inner wall of a blood vessel when said suction head is in the deployed state. The suction head can be completely attached to the inner wall of the blood vessel, and thrombus drift is effectively prevented.

Preferably, the suction tube assembly further comprises a receiving tube sleeved outside the suction tube main body and limiting the suction head to a folded state, and when the suction head penetrates into the guide channel of the guide sheath tube, the receiving tube relatively moves from the distal end of the suction tube main body to the proximal end thereof. The containment tube both maintains the suction head in a compressed state during production and also facilitates its passage through the guiding sheath during use. In addition, a guiding part which is extended out and is convenient for inserting and guiding the sheath tube is arranged at the far end of the containing tube.

Preferably, the agitator is a wire-formed mesh basket.

Preferably, said agitator is capable of controlling the extent of deployment by said second conduit. Therefore, medical staff can conveniently control the distance between the stirrer and the inner wall of the blood vessel and the fitting degree according to actual needs, and the use is more convenient; and, the agitator adopts the silk thread to weave and forms, and when the state of drawing in, the external diameter is very little to can reduce the size of second pipe, reserve bigger space for the suction channel, improve the efficiency of thrombus extraction.

It is further preferred that the agitator is formed by braiding a plurality of said wires and that the two ends of each of said wires are located at the proximal and distal ends of said first conduit, respectively, i.e. the length of each wire is substantially along the axial direction of the first conduit, rather than along a direction perpendicular to the axial direction of the first conduit.

Further preferably, at least some of said filaments intersect.

It is further preferred that at least part of the wire is rotated around the first conduit by an angle, wherein the angle may be dependent on the length of the wire and the desired maximum outer diameter of the agitator when in the open position.

According to one embodiment, the distal and proximal ends of the plurality of wires are fixedly disposed on the first conduit, and the agitator is disposed within the second conduit when the agitator is in a collapsed state; when said agitator is in an open position, at least a portion of said agitator is disengaged from said second conduit; this embodiment may control the diameter of the agitator after it has been collapsed by controlling the inner diameter of the second conduit.

According to another embodiment, the distal end of the first catheter extends beyond the second catheter; the stirrer comprises a plurality of wires; the far end of each silk thread is fixedly connected with the first catheter, and the near end of each silk thread is fixedly connected with the second catheter; the agitator is opened when the first conduit is moved proximally relative to the second conduit, and the outer diameter of the agitator is larger as the degree of expansion of the agitator is larger as the first conduit is moved a longer distance; when the first catheter is moved distally relative to the second catheter until the wire is straightened, the agitator is in a collapsed state in which the agitator has a minimum outer diameter and substantially conforms to the first catheter.

Preferably, the silk thread is made of one or more of nickel-titanium alloy, stainless steel wire, high molecular polymer and the like. When the silk threads are made of various materials, a single silk thread is not compounded by various materials, but the single silk thread is made of one material, and the materials of all the silk threads can be different, for example, the stirrer can be formed by weaving the silk threads made of nickel-titanium alloy, or can be formed by weaving part of the silk threads made of nickel-titanium alloy, and the other part of the silk threads made of high molecular polymer and the like.

Further preferably, the thrombolysis device further comprises a plurality of ultrasonic generators fixedly arranged on the silk thread, a power line and a signal transmission line connected with the ultrasonic generators, and an ultrasonic joint arranged on the handle and connected with the power line and the signal transmission line.

More preferably, the wire has an internal lumen, the first catheter or the second catheter also has an internal lumen, and the power line and the signal transmission line are located in the internal lumen of the wire and the internal lumen of the first catheter or the second catheter.

Still preferably, the diameter of ultrasonic generator be 0.2~0.4mm, the external diameter of silk thread be 0.2~0.3 mm.

Still preferably, the silk thread internal diameter be 0.1~0.2 mm.

Preferably, the first catheter is sleeved on the filter rod, and the outer diameter of the filter rod is 0.1-1 mm, so that the filter rod can be used as a guide wire, and other components required for removing thrombus can be guided to enter the position required by the blood vessel.

Preferably, the proximal end of the first catheter is provided with an injection hole for injecting thrombolytic drugs, and the distal end of the first catheter and/or the stirrer are/is provided with a plurality of thrombolytic holes for the thrombolytic drugs to enter the blood vessel.

Preferably, the first filter screen is in a basket or a pocket shape with an opening facing to the proximal end, or the first filter screen is in a shuttle shape.

Preferably, the thrombus treatment system further comprises a suction sheath tube capable of passing through the suction tube main body and extending from the distal end to the proximal end of the first filter screen, and a suction pump is connected to the proximal end of the suction sheath tube. Wherein, the suction pump and the suction pump connected with the suction pipe body can be the same or two different pumps.

When the filter screen assembly is used, thrombus can be prevented from flowing into other parts along the blood flow by arranging the filter screen assembly at the downstream of the blood flow; by introducing thrombolytic drugs, dragging the thrombolytic stirring component back and forth to enable the stirrer to move back and forth in the blood vessel, scraping the blood vessel wall back and forth by the stirrer and stirring thrombus in the blood vessel, or by ultrasonic turbulence, so that thrombus falls off from the blood vessel wall, is broken and is captured; and the large-caliber suction head is matched to efficiently suck the thrombus, so that a large amount of deep vein thrombus and old thrombus can be quickly taken out, the vascular wall and vein valves are not damaged, and thrombus taking sequelae are reduced.

On the premise that the suction tube assembly has the thrombus removal function, the suction tube assembly can provide a passage for other thrombus removal equipment, so that a doctor can conveniently select an operation scheme aiming at different thrombus, and the thrombus suction system has wide adaptation diseases.

Of course, for some thrombotic conditions that can be treated by aspiration only through the aspiration tube assembly, the medical professional may use only the aspiration tube assembly of the present invention without the thrombolysis stirring assembly and the screen assembly.

Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:

the invention can remove thrombus under the condition of ensuring relative safety, is particularly suitable for removing a large amount of thrombus in inferior vena cava, protects venous valves and venous blood vessel walls, has controllable blood loss, higher suction efficiency and simple operation steps, shortens the operation time and lightens the hospitalization cost of patients.

Drawings

Fig. 1 is a schematic structural view of a suction tube assembly (a detached state of a guide sheath tube and a suction tube main body);

fig. 2 is a schematic structural view of the suction tube assembly (a connection state of the guide sheath tube and the suction tube main body);

FIGS. 3a, 3b and 3c are schematic structural views of three types of suction heads;

fig. 4 is a schematic structural view of the guide sheath in embodiment 1 and embodiment 2;

FIG. 5 is a schematic partial cross-sectional view of embodiment 1 of the guiding sheath;

FIG. 6 is an enlarged fragmentary view of FIG. 5;

FIG. 7 is a schematic view of the guiding sheath of example 1 at 0 ° and 30 ° bends;

FIG. 8 is a schematic partial cross-sectional view of embodiment 2 of the guiding sheath;

FIG. 9 is an enlarged fragmentary view of FIG. 8;

FIG. 10 is a schematic transverse cross-sectional view of FIG. 8;

FIG. 11 is a schematic view of the guiding sheath of example 2 at a bend of + -30 °;

FIG. 12 is a schematic structural view of embodiment 3 of a guiding sheath;

fig. 13 is a schematic partial cross-sectional view of embodiment 3 of the guiding sheath;

FIG. 14 is an enlarged fragmentary view of FIG. 13;

FIG. 15 is a schematic transverse cross-sectional view of FIG. 13;

fig. 16 is a schematic view of the guiding sheath of example 3 bent within ± 30 ° in the plane;

FIGS. 17-19 are schematic illustrations of three screen assemblies;

FIG. 20 is a schematic view of another embodiment of a thrombolysis stirring assembly in a collapsed state;

FIG. 21 is a schematic view of another embodiment of a thrombolytic stirring module in an open state;

FIG. 22 is an enlarged view at A of FIG. 21;

FIG. 23 is a schematic structural view of yet another embodiment of a thrombolysis stirring assembly in a collapsed state;

FIG. 24 is a schematic view of yet another embodiment of a thrombolytic stirring element in an open state;

FIG. 25 is a schematic transverse cross-sectional view of FIG. 24;

FIG. 26 is an enlarged view at B of FIG. 24;

FIG. 27 is a schematic cross-sectional view of C-C of FIG. 26;

FIG. 28 is a schematic structural view of a sheath;

FIG. 29 is a schematic view showing a state where a sheath tube transports a screen assembly;

FIG. 30 is a schematic view of the dilator;

FIG. 31 is a schematic view of the suction tube assembly and screen assembly in their mated configuration;

FIG. 32 is a schematic view of the suction tube assembly, screen assembly and thrombolysis stirring assembly in their mated condition.

The structure of the drawings in the embodiment is only a schematic diagram, and is not completely equivalent to the actual structure of a product.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present 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.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; 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.

The proximal end is defined herein as the side that is closer to the medical care provider when the thrombectomy system is in use; the distal end is defined on the side away from the medical personnel when the thrombectomy system is in use.

A thrombus treatment system comprises a suction tube component, a thrombolytic stirring component, a filter screen component and a suction pump,

as shown in fig. 1 and 2: the suction tube assembly includes a guide sheath tube 10 having a guide passage, a suction tube main body 60 inserted into the guide passage of the guide sheath tube 10, and a suction head connected to a distal end of the suction tube main body 60 and having an opened state and a closed state. The outer diameter of the evacuation tube body 60 is 10-12F. When the suction tip is in the open position, the distal end of the suction tip forms a suction opening, and the distal end of the suction opening has a larger caliber than the proximal end, giving the suction tube body 60 a suction opening that is much larger than its diameter.

This embodiment shows in particular the structure of three suction heads.

Fig. 3a shows an embodiment of a suction head: the suction head 61 comprises a plurality of petal-shaped screen support plates 610 connected at their proximal ends to the distal end of the suction tube body 60, and a second screen 611 covering at least the proximal ends of the screen support plates 610, the distal ends of the screen support plates 610 being rounded. When the suction head is in an open state, the distal ends of the plurality of filter support sheets 610 enclose a suction opening, and the distal ends of the filter support sheets 610 can contact with the inner wall of the blood vessel. The petaloid head can filter thrombus, and simultaneously can ensure that the distal end of the filter screen supporting sheet 610 can stir the thrombus by rotating the suction pipe main body 60, thereby improving the thrombus removing efficiency without damaging the inner wall of the blood vessel.

Fig. 3b shows another embodiment of the suction head: the suction head 62 is formed by a second sieve which extends 2-9mm from its proximal end to its distal end and does not come into contact with the inner wall of the vessel when the suction head 62 is in the deployed state. The shorter suction head can be closer to the thrombus, which can improve the efficiency of thrombus suction.

Fig. 3c shows another embodiment of the suction head: the suction head 63 is formed by a second sieve which extends 10-18mm from its proximal end to its distal end and which is in abutment with the inner wall of the vessel when the suction head 63 is in the deployed state. The suction head can be completely attached to the inner wall of the blood vessel, and thrombus drift is effectively prevented.

The material of the third filter screen in this embodiment may be nickel titanium alloy or polymer composite material.

The suction tube assembly further includes a receiving tube 64 fitted around the outside of the suction tube body 60 to restrain the suction head in a collapsed state, and a distal end of the receiving tube 64 is provided with a guide portion 640 protruding to facilitate insertion of the guide sheath tube 10. The suction tube main body 60 is inserted into the guide sheath 10 through the guide portion 640, the suction head is kept in a folded state during the transition from the accommodating tube 64 to the guide sheath 10, the suction tube main body 60 is pushed continuously, the accommodating tube 64 moves relatively from the distal end of the suction tube main body 60 to the proximal end thereof until the suction head of the suction tube main body 60 passes through the guide sheath 10, and the suction head is unfolded as shown in fig. 2.

The guide sheath 10 includes a catheter portion having a guide passage extending in an axial direction of the catheter portion and penetrating the catheter portion, and an outer diameter of the catheter portion is 12 to 14F. Fig. 1 and 2 show a guide sheath 10, the guide sheath 10 being a straight tube, and another guide sheath is described below.

Fig. 4-16 are schematic structural views of the guiding sheath 10. The guide sheath 10 includes a catheter portion having a suction channel extending in an axial direction of the catheter portion and penetrating the catheter portion, and the catheter portion has an outer diameter of 12 to 14F.

The catheter section includes a first film layer 11 on the inner side, a second film layer 12 on the outer side, and a support member 13 provided between the first film layer 11 and the second film layer 12, the support member 13 including a plurality of repeating bodies continuously provided in the axial direction of the catheter section, wherein the spacing between the repetitions of the support 13 varies from the proximal end to the distal end, such that the catheter parts are a first tube part 1 at the proximal end, a second tube part 2 at the distal end, a third tube part 3 between the first tube part 1 and the second tube part 2, and the distance between two adjacent repetitions at the position of the first tubular portion 1 and the distance between two adjacent repetitions at the position of the second tubular portion 2 is smaller than the distance between two adjacent repetitions at the position of the third tubular portion 3, thereby make the hardness of third pipe portion 3 be less than the hardness of first pipe portion 1 and second pipe portion 2, and then can be better realize the bending of second pipe portion 2 relative first pipe portion 1.

The supporting member 13 formed by a plurality of repeating bodies can be spiral like a spring, and can also be in an accordion like structure, when the supporting member 13 is in a spiral shape, the pitch of the repeating bodies is the pitch, and when the supporting member 13 is in an accordion structure, the pitch of the repeating bodies is the distance between two adjacent wave crests. In this embodiment, the supporting member 13 preferably has a spiral shape.

As for the bending angle of the second tube 2 relative to the first tube 1, it can be realized by adjusting the distance between the repeating bodies and the material of the conduit tube, in this embodiment, the material of the supporting member 13 is selected from metals, such as 304 stainless steel, nitinol wire, etc.; polytetrafluoroethylene (PTFE), block polyether amide (Pcbax), Polyimide (PI), Polyamide (PA), Polyethylene (PE), metal film etc. are chooseed for use to the material of first rete 11 and second rete 12, and preferably, first rete 11 adopts Polytetrafluoroethylene (PTFE) that the lubricity is better, and second rete 12 adopts block polyether amide (Pcbax) metal film etc. to, the concatenation of different materials can be adopted to second rete 12 of first pipe portion 1, second pipe portion 2, third pipe portion 3.

The guide sheath 10 further includes a fixing member 15 fixedly provided at the distal end of the third tube part 3 of the guide tube part, and the fixing member 15 of the present embodiment is a developing ring. The developing ring is fixed between the first film layer 11 and the second film layer 12 by means of hot melting or welding.

The guiding sheath 10 further comprises a connecting member 14 having a distal end fixedly connected to the fixing member 15, and an operation portion 4 rotatably connected to a proximal end of the catheter portion. The connecting piece 14 is located between the first film layer 11 and the second film layer 12 and extends along the axial direction of the conduit part, so that the axis of the connecting piece 14 is parallel to and does not coincide with the axis of the conduit part, and the connecting piece 14 can drive the second conduit part 2 to bend.

The guiding sheath 10 further includes an ultrasound generator 5 disposed at the distal end of the catheter portion (i.e., the distal end position of the second catheter portion 2), a power line 16 and a signal transmission line 17 connected to the ultrasound generator 5 and disposed in the catheter wall of the catheter portion (i.e., between the first membrane layer 11 and the second membrane layer 12), and an ultrasound connector 6 disposed at the proximal end of the catheter portion and connected to the power line 16 and the signal transmission line 17, wherein the ultrasound connector 6 may be connected to other devices.

As shown in fig. 4 to 7, embodiment 1 is shown, in which the connecting member 14 is only one steel wire, the distal end of the connecting member 14 is fixedly connected to the developing ring, and the proximal end is wound around the operating portion 4, and at this time, the connecting member 14 is only one connection point with the developing ring, so that when the operating portion 4 is rotated, the conduit portion can be bent only in one direction, and the bendable angle range is 0 to 90 °, and the angle range shown in fig. 7 is 0 ° and 30 °.

As shown in fig. 4 and 8 to 11, the embodiment 2 is shown, in which the connecting member 14 is also a steel wire, but both end portions of the connecting member 14 (i.e. the distal end of the connecting member 14) are fixedly connected to the opposite sides of the fixing member 15, respectively, and the middle position of the connecting member 14 is wound around the operating portion 4, so that the connecting member 14 is divided into two parts by the operating portion 4, which is expressed in terms of upper and lower parts, for example, when the operating portion 4 is rotated clockwise, the upper connecting member 14 is extended, the lower connecting member 14 is correspondingly shortened, and the second tube portion 2 of the catheter portion is rotated downward by a certain angle; when the operating part 4 is rotated counterclockwise, the upper connecting member 14 is shortened, the lower connecting member 14 is correspondingly extended, and the second pipe part 2 of the conduit pipe part is rotated upward by a certain angle. The description here is made with the second pipe portion 2 being on the same line as the first pipe portion 1 and the third pipe portion 3, that is, with the second pipe portion 2 having a bending angle of 0 ° as a starting position. The duct section of example 2 can thus be bent in both directions, both of which can be bent in the range of 0 to 90 °, and the angle ranges shown in fig. 11 are 0 ° and ± 30 °.

As shown in fig. 12 to 16, the embodiment 3 is shown in which the operation portion includes a first operation portion 41 movably connected to the proximal end of the catheter portion, and a second operation portion 42 movably connected to the proximal end of the catheter portion, the connection members include a first connection member 21 wound around the first operation portion 41, and a second connection member 22 wound around the second operation portion 42, two distal ends of the first connection member 21 are respectively disposed on two opposite sides of the fixing member 15, two distal ends of the second connection member 22 are respectively disposed on two opposite sides of the fixing member 15, and the two distal ends of the first connection member 21 and the two distal ends of the second connection member 22 are uniformly distributed along the circumferential direction of the fixing member 15, so that the tip end of the catheter portion can be rotated by 360 ° by simultaneously operating the first operation portion 41 and the second operation portion 42. That is, the embodiment 3 corresponds to the embodiment 2 in which a set of the operation portion and the connection member is added.

The operation portion 4 of embodiments 1 to 3 may be provided at the proximal end portion of the catheter portion, or may be provided at the proximal end side portion of the catheter portion, preferably at the proximal end side portion of the catheter portion, so that it is possible to facilitate the placement of the hemostatic valve 7 at the proximal end portion of the catheter portion. With embodiment 3, the first operating part 41 and the second operating part 42 are located on both sides of the catheter part, so that the layout at the handle 54 for guiding the sheath 10 is more reasonable.

In this embodiment, the bending direction and the bending angle of the front end of the catheter portion can be precisely controlled by rotating the operation portion 4, for example, the diameter of the operation portion 4 can be adjusted by calculation, so that the front end of the catheter portion can be bent by a certain angle, for example, 1 °, 2 °, 3 °, and the like, every time the operation portion is rotated by 4 circles.

The guide sheath 10 of the present embodiment further includes a three-way valve 8 communicating with the proximal end of the catheter portion, and the medical care worker can introduce physiological saline, thrombolytic drug, and the like into the catheter portion through the three-way valve 8, and can also perform aspiration of thrombus by connecting an aspiration pump 19 to the three-way valve 8.

This embodiment is through operator operation portion 4 for operation portion 4 moves and drives the motion of connecting piece 14, and connecting piece 14 further pulls the pipe wall, makes pipe portion buckle, thereby makes the skew of producing the angle between the distal end of pipe portion and the near-end of pipe portion, thereby is convenient for adjust the angle of guide sheath 10 head according to clinical needs, for example can be used as guide sheath 10 and get into in the blood vessel, through the regulation of head end angle, can be more convenient insert branching blood vessel etc..

As shown in fig. 17-19: the screen assembly includes a filter rod 31, a first screen 32 fixedly mounted to a distal end of the filter rod 31 and having an open position and a collapsed position. The first screen 32 is shown in fig. 17 as an open proximally directed basket, the first screen 32 is shown in fig. 18 as a shuttle, and the first screen 32 is shown in fig. 19 as a pocket open proximally. All three screen assemblies can be fitted with the suction tube assembly of this embodiment, as shown in figures 3a, 3b, 3 c.

The outer diameter of filter rod 31 is 0.1-1 mm, preferably 0.035in, so that filter rod 31 can be used as a guide wire to facilitate other components to enter a desired position along filter rod 31.

The manner in which the screen assembly enters the blood vessel through the aspiration tube body 60 and extends to the distal end of the thrombus can be accomplished in a conventional manner known in the art, for example, by loading the screen assembly into the sheath 18 and then advancing the sheath 18 through the aspiration channel of the aspiration tube body 60. The first filter 32 can be loaded in the sheath 18 in the closed state, and in the open state, the outer diameter of the first filter 32 (i.e. the maximum distance between the expanded cross sections of the first filter 32) is larger than or equal to the inner diameter of the blood vessel, so that the first filter 32 can filter thrombus passing through the first filter 32 well, and the thrombus is prevented from flowing to other parts.

As shown in fig. 20-22: the thrombolysis stirring assembly comprises a first guide pipe 51, a second guide pipe 52 sleeved outside the first guide pipe 51 in a sliding manner, a stirrer 53 arranged at the far end of the first guide pipe 51 and having an opened state and a folded state, a handle 54 fixedly connected with the near end of one of the first guide pipe 51 and the second guide pipe 52, and an operating part 55 slidably connected with the handle 54, wherein the operating part 55 is fixedly connected with the near end of the other one of the first guide pipe 51 and the second guide pipe 52; when the operating member 55 slides relative to the handle 54, the first guide tube 51 and the second guide tube 52 slide relative to each other to switch the agitator 53 between the open state and the collapsed state; when the agitator 53 is in a collapsed state, the outer diameter of the agitator 53 is 6F or less, preferably 5.5F or less, and more preferably 5F or less.

Wherein the agitator 53 is a mesh basket woven by a plurality of wires 56, and both ends of each wire 56 are respectively located at the proximal end and the distal end of the first conduit 51, i.e. the axial direction of each wire 56 extends along the axial direction of the first conduit 51, but at least a part of the wires 56 rotate around the first conduit 51 at a certain angle and at least a part of the wires 56 intersect, wherein the specific angle can be set according to the required density and size of the woven mesh basket. The wire 56 is made of one or more of nitinol, stainless steel wire, high molecular polymer, etc.

The deployment degree of the stirrer 53 can be controlled by the second catheter 52, so that medical personnel can conveniently control the distance between the stirrer 53 and the vessel wall and the fitting degree according to actual needs, and the use is more convenient; and the stirrer 53 is woven by the silk threads 56, and when the stirrer is in a folded state, the outer diameter is very small, so that the size of the second catheter 52 can be reduced, a larger space is reserved for an aspiration channel, and the thrombus extraction efficiency is improved.

One embodiment (not shown): the far ends and the near ends of the wires are fixedly arranged on the first guide pipe, and the opening and the folding of the stirrer and the unfolding degree of the stirrer are determined by the size of the folded stirrer in the second guide pipe. When the stirrer is in a furled state, the stirrer is completely positioned in the second guide pipe; when the agitator is in the open state, at least a portion of the agitator disengages the second conduit; when the agitator is completely detached from the second conduit, the agitator is opened to a maximum state. This embodiment may control the diameter of the agitator after it has been collapsed by controlling the inner diameter of the second conduit.

Another embodiment mode is as follows: as shown in fig. 20-22: the distal end of the first conduit 51 extends out of the second conduit 52; the distal end of each wire 56 is fixedly connected with the first catheter tube 51, and the proximal end is fixedly connected with the second catheter tube 52; when the first guide duct 51 is moved toward the proximal end with respect to the second guide duct 52, the agitator 53 is opened, and the larger the degree of expansion of the agitator 53 as the first guide duct 51 is moved the longer, the larger the outer diameter of the agitator 53, as shown in fig. 21; when the first catheter tube 51 is moved distally relative to the second catheter tube 52 until the wire 56 is straightened, the agitator 53 is in a collapsed state, in which the outer diameter of the agitator 53 is at a minimum, substantially conforming to the first catheter tube 51, as shown in fig. 20. The proximal end of the second conduit 52 is fixedly connected with the handle 54, the first conduit 51 passes through the handle 54 and the proximal end extends out of the handle 54, the handle 54 is provided with a slide slot 57 extending along the proximal and distal directions, the operating member 55 is inserted in the slide slot 57 and is fixedly connected with the first conduit 51, so that when the operating member 55 is slid towards the proximal end, the first conduit 51 moves along with the proximal end, and the stirrer 53 is opened; otherwise, the agitator 53 is folded.

In yet another embodiment: as shown in fig. 23-27: this embodiment has the effect of generating ultrasonic waves to break thrombus, wherein the thrombolysis stirring assembly further comprises a plurality of ultrasonic generators 81 fixedly arranged on the wire 56, power lines 82 and signal transmission lines 83 connected with the ultrasonic generators 81, and ultrasonic connectors 84 arranged on the handle 54 and connected with the power lines 82 and the signal transmission lines 83. In this embodiment, the wire 56 has an internal lumen, the first catheter 51 or the second catheter 52 also has an internal lumen, and the power line 82 and the signal transmission line 83 pass through the internal lumen of the wire 56 and the internal lumen of the first catheter 51 or the second catheter 52 to connect the ultrasound generator 81 and the ultrasound connector 84. For the solution in which both ends of the wire 56 are fixed to the first guide tube 51, the power line 82 and the signal transmission line 83 are inserted from the internal channel of the first guide tube 51; for the arrangement in which the distal end of the wire 56 is secured to the first catheter 51 and the proximal end is secured to the second catheter 52, the power wire 82 and signal transmission wire 83 are routed from the interior lumen of the second catheter 52.

In this embodiment, the diameter of the ultrasonic generator 81 is 0.2 to 0.4mm, preferably 0.3mm, the outer diameter of the filament 56 is 0.2 to 0.3mm, preferably 0.25mm, and the inner diameter of the filament 56 is 0.1 to 0.2mm, preferably 0.15 mm.

The ultrasonic generator 81 is fixed to the wire 56 by welding.

The stirrer 53 of the above embodiment can be used in combination with the suction tube assembly and the thrombolysis stirring assembly.

The thrombolytic stirring assembly also has a function of introducing thrombolytic drugs, and the specific structure can be shown in fig. 22, the first catheter 51 has a thrombolytic channel extending along the axial direction inside, the proximal end of the first catheter 51 is provided with an injection hole 58 communicated with the thrombolytic channel and used for injecting thrombolytic drugs, the distal end of the first catheter 51 and/or the stirrer 53 is provided with a plurality of thrombolytic holes 59 for the thrombolytic drugs to enter the blood vessel, wherein fig. 22 shows a structure that the thrombolytic holes 59 are positioned on the first catheter 51, the plurality of thrombolytic holes 59 are uniformly distributed along the axial direction of the first catheter 51, and the plurality of thrombolytic holes 59 are positioned between the proximal end and the distal end of the stirrer 53. The overall length of the plurality of thrombolytic holes 59, i.e. the distance between the most distal thrombolytic hole 59 and the most proximal thrombolytic hole 59, is smaller than the distance between the proximal and distal ends of the stirrer 53 in the open state.

The steps of the operation by adopting the thrombus treatment system are as follows:

1. the 0.035in guidewire is first fed into the designated location,

2. the 0.035in guidewire is inserted into the guidewire port at the head end of a 6F dual lumen sheath 18 (as shown in fig. 28), the sheath 18 with the filter assembly loaded thereon is pushed along the guidewire through the desired lesion, the sheath 18 is then withdrawn, the filter assembly is opened (as shown in fig. 29), the sheath 18 and guidewire are finally withdrawn,

3. inserting 13.6F dilator 9 (shown in fig. 30) into suction tube assembly, then pushing along filter rod 31 to a designated location in the body, pushing suction tube body 60 to push the suction head out of guide sheath 10 and open, withdrawing dilator 9 (shown in fig. 31),

4. inserting the thrombolysis stirring component into the suction tube body 60 along the filter rod 31 and pushing the thrombolysis stirring component to the thrombus part, wherein the stirrer 53 is positioned between the far end of the suction head and the first filter screen 32 (as shown in fig. 32), firstly injecting thrombolysis medicine into a thrombolysis channel of the first conduit 51 from the injection hole 58, then injecting the thrombolysis medicine into the thrombus dissolving channel from the thrombolysis hole 59, dissolving thrombus at the position of the thrombus, after the thrombolysis is finished, operating the operating piece 55 to slide towards the near end to drive the first conduit 51 to slide towards the near end, opening the stirrer 53, repeatedly dragging the handle 54 back and forth to break and collect the insoluble thrombus, or starting the ultrasonic generator 81 to generate ultrasonic waves; meanwhile, the suction pump 19 is arranged on the three-way valve 8 at the near end of the suction pipe body 60 to apply negative pressure to the suction pipe body 60 for suction, the recovery bag 23 is connected on the suction pump 19 for collecting thrombus, the drift of large thrombus can be prevented in the dragging process,

5. after the operation is finished, the thrombolytic stirring component is withdrawn from the body, the guide wire is pushed to the front end of the filter screen component through the suction pipe body 60 again, the sheath pipe 18 is inserted into the suction pipe body 60 along the guide wire and pushed to the front end of the filter screen component, the suction pump is connected to the three-way valve of the sheath pipe 18, negative pressure is applied to the sheath pipe 18 to suck the broken thrombus intercepted in the first filter screen 32, the suction pump is connected with a recovery bag for collecting the thrombus, the suction negative pressure is preferably not more than 0.02Mpa so as to reduce the influence on the deformability of the erythrocyte and reduce the occurrence of hemolysis,

6. after the suction is finished, the sheath tube 18 and the guide wire are withdrawn together, then the suction pump 19 is connected to the suction tube body 60 for suction again to remove residual thrombus, then the filter screen assembly is pulled back to enable the first filter screen 32 to be completely withdrawn into the suction tube body 60, the suction tube body 60 is pulled to enable the suction head to be completely withdrawn into the guide sheath tube 10, the hemostatic valve 7 is locked, and the whole system is withdrawn to finish the operation.

The embodiment can avoid thrombus drifting to the downstream of blood flow in the dragging, thrombolysis and suction processes while not blocking the blood flow in the blood vessel in the operation process. The embodiment can effectively remove large-area acute and subacute thrombus in the inferior vena cava by combining the functions in the vein. Can dissolve the thrombus earlier when reply old thrombus of inferior vena cava, then pull through the agitator to cooperation heavy-calibre suction head and filter screen subassembly protection use this apparatus can remove a large amount of thrombus in the inferior vena cava under the circumstances of guaranteeing relative safety, protection venous valve and venous blood vessel wall, the amount of blood loss is controllable, and operating procedure is simple, shortens operation time, alleviates the patient and is in hospital the expense.

The above embodiments are merely illustrative of the technical ideas and features of the present invention, and the purpose thereof is to enable those skilled in the art to understand the contents of the present invention and implement the present invention, and not to limit the protection scope of the present invention. All equivalent changes and modifications made according to the spirit of the present invention should be covered within the protection scope of the present invention.

Claims

1. A thrombus treatment system, characterized by: comprises a suction pipe component, a thrombolysis stirring component, a filter screen component and a suction pump,

2. A thrombus treatment system, characterized by: comprises a suction pipe component, a thrombolysis stirring component, a filter screen component and a suction pump,

3. A thrombus treatment system according to claim 1 or 2, wherein: the suction head include that a plurality of near-ends are connected suction tube main part distal end and be the filter screen backing sheet that petal form distributes, cover at least the second filter screen of filter screen backing sheet near-end, work as the suction head be in when the open mode, it is a plurality of the distal end of filter screen backing sheet enclose to close and be the suction mouth, just the distal end of filter screen backing sheet can contact with the blood vessel inner wall.

4. A thrombus treatment system according to claim 3, wherein: the far end of the filter screen support sheet is smooth.

5. A thrombus treatment system according to claim 1 or 2, wherein: the suction head is formed by a second screen which extends from its proximal end to its distal end for 2-9mm when the suction head is in the deployed state and is not in contact with the inner wall of the vessel.

6. A thrombus treatment system according to claim 1 or 2, wherein: the suction head is formed by a second filter screen, and when the suction head is in an unfolded state, the second filter screen extends 10-18mm from the near end to the far end and is attached to the inner wall of the blood vessel.

7. A thrombus treatment system according to claim 1 or 2, wherein: the suction tube assembly further comprises an accommodating tube which is sleeved outside the suction tube main body and limits the suction head to be in a folded state, and when the suction head penetrates into the guide channel of the guide sheath tube, the accommodating tube relatively moves from the far end of the suction tube main body to the near end of the suction tube main body.

8. A thrombus treatment system according to claim 1 or 2, wherein: the agitator is capable of controlling the degree of deployment by the second conduit.

9. A thrombus treatment system according to claim 8, wherein: the stirrer is formed by weaving a plurality of silk threads, and two ends of each silk thread are respectively fixed at the near end and the far end of the first catheter.

10. A thrombus treatment system according to claim 8, wherein: the distal end of the first catheter extends out of the second catheter; the stirrer comprises a plurality of wires; the far end of each silk thread is fixedly connected with the first catheter, and the near end of each silk thread is fixedly connected with the second catheter.

11. A thrombus treatment system according to claim 9 or 10, wherein: at least some of said filaments intersecting; rotating at least a portion of said wire around said first conduit by an angle; the silk thread is made of one or more of nickel-titanium alloy, stainless steel wires and high molecular polymers.

12. A thrombus treatment system according to claim 9 or 10, wherein: the thrombolysis stirring component also comprises a plurality of ultrasonic generators fixedly arranged on the silk thread, a power line and a signal transmission line which are connected with the ultrasonic generators, and an ultrasonic joint which is arranged on the handle and is connected with the power line and the signal transmission line.

13. A thrombus treatment system according to claim 12, wherein: the wire has an internal lumen, the first catheter or the second catheter also has an internal lumen, and the power line and the signal transmission line are located in the internal lumen of the wire and the internal lumen of the first catheter or the second catheter.

14. A thrombus treatment system according to claim 13, wherein: the diameter of the ultrasonic generator is 0.2-0.4 mm, and the outer diameter of the silk thread is 0.2-0.3 mm.

15. A thrombus aspiration system according to claim 14, wherein: the inner diameter of the silk thread is 0.1-0.2 mm.

16. A thrombus treatment system according to claim 8, wherein: the distal end of the first catheter extends out of the second catheter; the stirrer comprises a plurality of wires; the far end of each silk thread is fixedly connected with the first catheter, and the near end of each silk thread is fixedly connected with the second catheter.

17. A thrombus treatment system according to claim 1 or 2, wherein: the proximal end of the first catheter is provided with an injection hole for injecting thrombolytic drugs, and a plurality of thrombolytic holes for the thrombolytic drugs to enter the blood vessel are formed at the distal end of the first catheter and/or the stirrer.

18. A thrombus treatment system according to claim 1 or 2, wherein: the first filter screen is in a basket or pocket shape with an opening facing the near end, or the first filter screen is in a shuttle shape.