阅读说明：本技术 一种碎栓组件及血管血栓处理装置 (Broken bolt assembly and blood vessel thrombus treatment device ) 是由 冯海全 李长胜 冯浩翔 白丽平 马双全 郭昊天 于 2021-08-06 设计创作，主要内容包括：本发明提供一种碎栓组件及血管血栓处理装置。其包括内芯管和设置在内芯管的远端且具有展开状态和收拢状态的碎栓刀具,该碎栓刀具包括沿内芯管的轴向设置的第一切割部件和第二切割部件；第一切割部具有多个第一网孔,在碎栓刀具处于展开状态且第一切割部投影在碎栓刀具的横截面上时,多个第一网孔均呈第一正六边形且相邻两个第一正六边形共用一条边；第二切割部具有多个第二网孔,在所述碎栓刀具处于展开状态且第二切割部投影在碎栓刀具的横截面上时,多个第二网孔均呈第二正六边形相邻两个第二正六边形共用一条边；第一正六边形的边长大于第二正六边形的边长。本发明碎栓效率高,安全性强,容易操作,适应血管直径范围大,可满足临床使用要求。(The invention provides a thrombus breaking assembly and a blood vessel thrombus treatment device. The bolt breaking cutter comprises an inner core pipe and a bolt breaking cutter which is arranged at the far end of the inner core pipe and has an unfolding state and a folding state, wherein the bolt breaking cutter comprises a first cutting part and a second cutting part which are arranged along the axial direction of the inner core pipe; the first cutting part is provided with a plurality of first meshes, when the bolt breaking cutter is in an unfolded state and the first cutting part is projected on the cross section of the bolt breaking cutter, the first meshes are all in a first regular hexagon, and two adjacent first regular hexagons share one edge; the second cutting part is provided with a plurality of second mesh holes, and when the bolt breaking cutter is in a spreading state and the second cutting part is projected on the cross section of the bolt breaking cutter, the plurality of second mesh holes share one edge by two adjacent second regular hexagons in a second regular hexagon; the side length of the first regular hexagon is larger than that of the second regular hexagon. The invention has high thrombus breaking efficiency, strong safety, easy operation and large adaptive range of blood vessel diameter, and can meet the clinical use requirement.)

1. A plug assembly characterized in that the plug assembly comprises an inner core tube (3) and a plug cutter (4) which is arranged at the far end of the inner core tube (3) and has an unfolded state and a folded state, the plug cutter (4) comprises a first cutting part (41) and a second cutting part (42) which are arranged along the axial direction of the inner core tube (3), and the first cutting part (41) is arranged at the near end of the second cutting part (42);

the first cutting component (41) is provided with a plurality of first mesh holes (411), when the bolt breaking cutter (4) is in an unfolded state and the first cutting component (41) is projected on the cross section of the bolt breaking cutter (4), the plurality of first mesh holes (411) are all in a first regular hexagon (413), and two adjacent first regular hexagons (413) share one side;

the second cutting component (42) is provided with a plurality of second meshes (421), when the bolt breaking cutter (4) is in an unfolded state and the second cutting component (42) is projected on the cross section of the bolt breaking cutter (4), the plurality of second meshes (421) are all in a second regular hexagon (423), and two adjacent second regular hexagons (423) share one side;

the side length of the first regular hexagon (413) is larger than the side length of the second regular hexagon (423).

2. The tumbler assembly of claim 1, wherein a plurality of the first regular hexagons (413) have equal side lengths and a plurality of the second regular hexagons (423) have equal side lengths.

3. The tumbler assembly according to claim 1, wherein the outer circumference of the first regular hexagon (413) located inside is distributed with six first regular hexagons (413); and/or six second regular hexagons (423) are distributed on the periphery of the second regular hexagon (423) positioned inside.

4. The tumbler assembly according to claim 1, wherein the proximal end of the first cutting member (41) is planar and the plane is perpendicular to the axial center line of the first cutting member (41), the plane being the first regular hexagon (413) located at the center when the tumbler cutter (4) is in the deployed state and the first cutting portion is projected on the cross-section of the tumbler cutter (4);

and/or the distal end part of the second cutting part (42) is a plane which is perpendicular to the axial line of the second cutting part (42), and the plane is the second regular hexagon (423) which is positioned at the center when the bolt breaking cutter (4) is in the unfolding state and the second cutting part (42) is projected on the cross section of the bolt breaking cutter (4).

5. A breaker assembly as claimed in any one of claims 1 to 4 wherein the sides of the first regular hexagon (413) are 1.5 to 3.5 times as long as the sides of the second regular hexagon (423).

6. A tumbler assembly according to claim 1, wherein the plurality of first mesh openings (411) are formed by fixedly connected or integrally formed first wires, wherein the first filaments forming the first mesh (411) at the proximal end form a first plane (4111), the first filaments forming the remaining first mesh (411) form a second plane (4112) near the proximal end of the first cutting member (41) and a third plane (4113) intersecting the second plane (4112), the second plane (4112) gradually moves away from the axial center line of the first cutting member (41) from the proximal end to the distal end, one end of the third plane (4113) intersecting the second plane (4112) is at a smaller distance from the axis of the first cutting member (41) than the other end of the third plane (4113) is at a smaller distance from the axis of the first cutting member (41);

and/or the presence of a gas in the gas,

the plurality of second meshes (421) are formed by fixedly connecting or integrally forming second wires, wherein the second wires forming the second meshes (421) at a distal end part form a fourth plane (4211), the second wires forming the rest of the second meshes (421) form a fifth plane (4212) close to the distal end part of the second cutting component (42) and a sixth plane (4213) intersecting with the fifth plane (4212), the fifth plane (4212) gradually gets away from the axial line of the second cutting component (42) from the proximal end to the distal end, and the distance between one end of the sixth plane (4213) intersecting with the fifth plane (4212) and the axial line of the second cutting component (42) is smaller than the distance between the other end of the sixth plane (4213) and the axial line of the second cutting component (42).

7. The tumbler assembly according to claim 6, wherein the third plane (4113) is perpendicular to an axis of the first cutting member (41); and/or the sixth plane (4213) is perpendicular to the axis of the second cutting member (42).

8. The crash bolt assembly according to claim 1, wherein said first cutting member (41) further has a plurality of first cutting wires (412), proximal ends of said plurality of first cutting wires (412) being connected to said outermost first mesh openings (411); and/or the second cutting member (42) is also provided with a plurality of second cutting wires (422), and the proximal ends of the plurality of second cutting wires (422) are connected with the outermost second mesh holes (421).

9. The deadbolt assembly of claim 8, wherein said deadbolt cutter (4) further comprises a connecting member (43), a proximal end of said connecting member (43) being fixedly connected or integrally formed with a distal end of said first cutting wire (412) and/or a distal end of said outermost first mesh opening (411), a distal end of said connecting member being fixedly connected or integrally formed with a proximal end of said second cutting wire (422) and/or a proximal end of said outermost second mesh opening (421).

10. The tumbler assembly according to claim 1, wherein the proximal end of the first cutting member (41) has a cross-sectional area smaller than the cross-sectional area of the distal end thereof and the proximal end of the second cutting member (42) has a cross-sectional area larger than the cross-sectional area of the distal end thereof when the tumbler cutters (4) are in the deployed state.

11. The breaker assembly of claim 1 wherein said first cutting member (41) has a maximum outer diameter equal to a maximum outer diameter of said second cutting member (42) when said breaker knife (4) is in a deployed condition; the maximum outer diameter is 3-20 mm.

12. The crash bolt assembly according to claim 9, wherein the connecting member (43) is more flexible than the first cutting member (41) and the second cutting member (42); the connecting member (43) is capable of engaging a blood vessel when deployed.

13. The tumbler assembly according to claim 9, wherein the connecting member (43) comprises two connecting units having the same structure, each connecting unit comprises a plurality of peaks and valleys periodically arranged along the circumferential direction, each adjacent peak is a period, and each adjacent two connecting units are staggered on the circumferential surface by a distance of one half period.

14. The breaker assembly of claim 1 wherein the axis of the breaker cutter (4) and the axis of the core tube (3) coincide; the near end of the bolt breaking cutter (4) is fixedly connected with the inner core pipe (3).

15. The deadbolt assembly of claim 1, further comprising a pusher tube (5) slidably mounted on said core tube (3), said deadbolt cutter (4) extending out of a distal end of said pusher tube (5) when said deadbolt cutter (4) is in a deployed state.

16. A vascular thrombus treatment device (1) comprising an aspiration catheter (2) having an aspiration channel, an aspiration pump (6) in communication with a proximal end of the aspiration catheter (2), characterized in that the vascular thrombus treatment device (1) comprises the thrombus assembly of any one of claims 1 to 15.

Technical Field

The invention relates to the field of medical instruments, in particular to a thrombus crushing assembly and a blood vessel thrombus treatment device.

Background

Venous Thromboembolism (VTE) mainly includes lower limb deep venous thrombosis (LEDVT) and Pulmonary Embolism (PE), the disease incidence rate of the disease can reach 0.1% -0.2%, the disease incidence rate is certainly increased year by year with the aging becoming more and more serious, and the existing data prove that the disease incidence rate is increased year by year. Once venous thrombosis occurs, the blood coagulation process of the body is dominant, and the anticoagulation treatment is a link of blocking the activation of blood coagulation factors in the thrombosis process by applying medicaments in a targeted manner. Commonly used anticoagulant drugs include two broad classes: heparin and coumarin derivatives. Benefits of anticoagulant therapy include prevention of deep vein thrombosis, pulmonary embolism, and stroke. Negative effects of anticoagulant therapy include increased risk of bleeding and side effects of anticoagulant drugs.

In order to effectively remove thrombus, recover blood flow, relieve lower limb swelling of patients and reduce postthrombosis syndrome, a plurality of clinical treatment methods are provided. Among them, Percutaneous Mechanical Thrombosis (PMT) is a relatively new intervention recommended by the FDA in the united states. The thrombectomy instrument is transferred to the thrombus part, and has the advantages of higher thrombus clearing efficiency, minimal invasion, quick curative effect and low thrombolytic drug consumption through multiple functions of mechanical thrombus breaking, thrombolysis and chemical thrombolysis.

Intravascular therapy has now become an effective and important treatment for acute pulmonary embolism. At present, the common treatment modes mainly comprise treatment operation modes such as guide wire catheter thrombus breaking, thrombus suction, catheter thrombus dissolving and the like. When the existing apparatus is used alone to remove thrombus, the effect of removing massive thrombus is not ideal.

Disclosure of Invention

The invention aims to provide a novel broken bolt component which has a good effect on removing thrombus, particularly large thrombus.

In order to solve the technical problems, the invention adopts the following technical scheme:

the invention provides a broken bolt assembly, which comprises an inner core tube and a broken bolt cutter which is arranged at the far end of the inner core tube and has an unfolded state and a folded state, wherein the broken bolt cutter comprises a first cutting part and a second cutting part which are arranged along the axial direction of the inner core tube, and the first cutting part is positioned at the near end of the second cutting part;

the first cutting member is provided with a plurality of first mesh openings, when the bolt breaking cutter is in a spreading state and the first cutting member is projected on the cross section of the bolt breaking cutter, the plurality of first mesh openings are all in a first regular hexagon and two adjacent first regular hexagons share one side;

the second cutting component is provided with a plurality of second mesh openings, and when the bolt breaking cutter is in a spreading state and the second cutting component is projected on the cross section of the bolt breaking cutter, the plurality of second mesh openings are all in a second regular hexagon and two adjacent second regular hexagons share one side;

the side length of the first regular hexagon is larger than that of the second regular hexagon.

The thrombus-breaking assembly provided by the invention has meshes with different sizes, so that the thrombus-breaking process can be divided into two times, the thrombus blocks are cut into larger thrombus blocks through the first meshes, and then the thrombus blocks are cut into smaller thrombus blocks through the second meshes, and the thrombus-breaking assembly has better removal effect on thrombus with various sizes, especially large thrombus blocks.

The projections of the first mesh and the second mesh in the pipe diameter direction of the inner core pipe are regular hexagons, the density is high, the effective cutting range is wider, and the thrombus cutting efficiency is higher.

Specifically, the side lengths of the first regular hexagons are equal, and the side lengths of the second regular hexagons are equal.

The thrombus block size after cutting is more even, and the suction device of being convenient for clears away the thrombus block after the cutting totally.

Specifically, six first regular hexagons are distributed on the periphery of the first regular hexagon positioned inside; and/or six second regular hexagons are distributed on the periphery of the second regular hexagon positioned inside. Therefore, a high-density and high-centering structure is formed, the stability of the broken bolt cutter in a spreading state is better, and the cutting efficiency is higher.

Specifically, the proximal end of the first cutting member is a plane perpendicular to the axial line of the first cutting member, and the plane is a first regular hexagon located at the center when the bolt breaking cutter is in the unfolded state and the first cutting portion is projected on the cross section of the bolt breaking cutter;

and/or the distal end part of the second cutting component is a plane which is perpendicular to the axial line of the second cutting component, and when the bolt breaking cutter is in a spreading state and the second cutting part is projected on the cross section of the bolt breaking cutter, the plane is a second regular hexagon positioned at the center.

In particular, the proximal end of the first cutting member has a cross-sectional area smaller than the cross-sectional area of the distal end thereof and the proximal end of the second cutting member has a cross-sectional area larger than the cross-sectional area of the distal end thereof when the rock bolt cutter is in the deployed state.

The first cutting part and the second cutting part are approximately conical, so that the safety and the stability are further improved, and the unfolding and folding operations are more convenient.

Preferably, the side length of the first regular hexagon is 1.5-3.5 times of that of the second regular hexagon, and a great deal of research shows that the thrombus removing tool has high thrombus removing efficiency within the specific multiple range.

Specifically, the plurality of first meshes are formed by fixedly connecting or integrally forming first wires, wherein the first wires forming the first meshes at the proximal end form a first plane, the first wires forming the rest of the first meshes form a second plane close to the proximal end of the first cutting member and a third plane intersecting with the second plane, the second plane is gradually far away from the axial lead of the first cutting member from the proximal end to the distal end, and the distance between one end of the third plane intersecting with the second plane and the axial lead of the first cutting member is smaller than the distance between the other end of the third plane and the axial lead of the first cutting member;

and/or the presence of a gas in the gas,

the second meshes are formed by fixedly connecting or integrally forming second wires, wherein the second wires forming the second meshes at the far end part form a fourth plane, the second wires forming the rest of the second meshes form a fifth plane close to the far end part of the second cutting component and a sixth plane intersected with the fifth plane, the fifth plane is gradually far away from the axial lead of the second cutting component from the near end to the far end, and the distance between one end of the sixth plane intersected with the fifth plane and the axial lead of the second cutting component is smaller than the distance between the other end of the sixth plane and the axial lead of the second cutting component.

The first silk thread and the second silk thread are respectively made by laser cutting of a NiTi alloy pipe, and then through heat setting, electrochemical polishing and acid pickling, and have a cutting function.

Further, the third plane is perpendicular to the axis of the first cutting member; and/or the sixth plane is perpendicular to the axis of the second cutting member.

The first cutting part forms a platform structure retreating step by step from the near end to the far end, and the structure is of a stepped pyramid structure, and/or the second cutting part forms a platform structure retreating step by step from the far end to the near end, and the structure is of a stepped pyramid structure, so that the structure is rigorous and stable, high in safety and easy to manufacture.

Specifically, the first cutting member further has a plurality of first cutting wires whose proximal ends are connected to the outermost first mesh openings; and/or the second cutting member is also provided with a plurality of second cutting wires, and the proximal ends of the plurality of second cutting wires are connected with the outermost second mesh holes.

Further, the bolt breaking tool further comprises a connecting part, the proximal end of the connecting part is fixedly connected with or integrally formed with the distal end of the first cutting wire and/or the distal end of the outermost first mesh, and the distal end of the connecting part is fixedly connected with or integrally formed with the proximal end of the second cutting wire and/or the proximal end of the outermost second mesh.

The first cutting wire and the second cutting wire have the same cutting function, are the same as the first wire and the second wire, and are respectively manufactured by laser cutting, heat setting, electrochemical polishing and acid washing of NiTi alloy pipes.

Specifically, when the bolt breaking cutter is in a spreading state, the maximum outer diameter of the first cutting part is equal to the maximum outer diameter of the second cutting part.

The bolt breaking cutter is similar to an olive shape or a shuttle shape on the whole, has high centering performance and good stability and is easy to unfold or fold.

Specifically, when the bolt breaking cutter is in a spreading state, the maximum outer diameter of the first cutting component and the maximum outer diameter of the second cutting component are 3-20 mm.

Further, the connecting member has a flexibility greater than the flexibility of the first cutting member and the flexibility of the second cutting member; the connecting member is capable of engaging a blood vessel when deployed.

In particular, the connecting member may be used to maintain the centering of the breaking bits during the breaking process.

More specifically, the connecting member may be integrally woven with the first cutting member and the second cutting member.

Further, the length of the connection member may be designed according to the degree of bending of the blood vessel.

Furthermore, the connecting part comprises two connecting units with the same structure, each connecting unit comprises a plurality of peaks and valleys which are periodically arranged along the circumferential direction, the tops of the adjacent two peaks are in a period, the two connecting units are staggered on the circumferential surface, and the staggered distance is one half of the period. When the connecting component is in an unfolding state, the connecting component has good centering performance and high stability, can be attached to the vessel wall, has certain elasticity, and can be instantly unfolded in a direction away from an axial line or folded in a direction close to the axial line in the circumferential surface direction. If the bolt breaking cutter is connected with the inner core pipe through the connecting part, the first cutting part and the second cutting part are driven to be unfolded and folded by unfolding and folding of the connecting part.

Specifically, the two connecting units are respectively formed by integrally weaving silk threads or integrally cutting the silk threads by laser.

More specifically, the diameter of the wire forming the connection unit is preferably 0.1mm to 1.0 mm. Specifically, the axial lead of the bolt breaking cutter is superposed with the axial lead of the inner core tube.

Specifically, the proximal end of the bolt breaking cutter is fixedly connected with the inner core tube.

More specifically, the proximal end of the bolt breaking cutter is fixedly connected with the inner core tube through a connecting piece, the connecting piece is connected with the inner core tube in a welding or bonding mode, and the connecting piece is connected with the proximal end of the bolt breaking cutter in a welding or bonding mode or is integrally formed with the bolt breaking cutter.

Further preferably, the connecting piece and the proximal end of the bolt breaking cutter are formed by laser cutting or weaving. Preferably, the connecting member is fixedly connected to the distal end or a portion near the distal end of the inner core tube.

Preferably, the distal end of the inner core tube is located between the proximal and distal ends of the thrombolytic cutter.

Specifically, the plug crushing assembly further comprises a propelling pipe which is sleeved on the inner core pipe in a sliding mode, and when the plug crushing cutter is in the unfolding state, the plug crushing cutter extends out of the far end of the propelling pipe.

When the near end of the inner core tube gradually approaches and extends out of the far end of the propelling tube, the broken bolt cutter extends out of the far end of the propelling tube and is unfolded, and when the inner core tube is withdrawn, the broken bolt cutter retracts back the propelling tube and is gradually folded.

Further, the inner core pipe can freely move in the propelling pipe, and the propelling pipe moves along the axial direction of the inner core pipe, so that the outer diameter of the broken bolt cutter in the unfolding state can be adjusted by adjusting the length of the broken bolt cutter extending out of the far end of the propelling pipe, the broken bolt cutter is adapted to blood vessels with different pipe diameters, and the injury to the blood vessel wall is avoided.

Before use, the bolt breaking cutter is folded in the propelling pipe. During the use, pass the thrombus position with the propulsion pipe earlier, then withdraw the propulsion pipe, make garrulous bolt cutter expand automatically, first cutting parts carries out the cutting once, cuts apart into bold or well piece with the thrombus piece, then carries out the secondary cutting through second cutting parts, further breaks up the thrombus, cuts the broken thrombus that rotatory inner core pipe can be better through making a round trip to drag.

Specifically, the proximal end of the inner core tube is communicated with a drug delivery device, so that the drug is conveniently delivered.

Specifically, the far end of the bolt breaking cutter is fixedly connected with or integrally formed with a free section extending forwards, and a developing ring is arranged on the free section, so that the bolt breaking cutter is convenient to position.

The second aspect of the invention also provides a vascular thrombus treatment device, which comprises an suction catheter with a suction channel and a suction pump communicated with the proximal end of the suction catheter, wherein the vascular thrombus treatment device comprises the thrombus crushing assembly for the vascular thrombus treatment device.

Specifically, the maximum outer diameter of the thrombus breaking cutter can be adjusted according to the conditions of blood vessels and thrombus, and can be adjusted according to the size of the suction pump, and the suction catheter is matched with the thrombus breaking assembly to ensure that the thrombus blocks after thrombus breaking operation can be timely, quickly and conveniently pumped out of a human body by the suction pump.

Further, the outer diameter of the suction catheter is 6F-14F. Prior art aspiration catheters may be used.

Furthermore, the suction catheter comprises a catheter part with the suction channel, an operation part movably connected to the near end of the catheter part, a fixing part fixedly arranged on the catheter part, a connecting part which is respectively connected with the operation part and the fixing part and can bend the far end of the catheter part by operating the operation part, and a developing ring fixedly arranged at the far end of the catheter part.

Specifically, the proximal ends of the suction catheter, the inner core tube and the pushing tube are all provided with hemostatic valves.

According to some embodiments, the operation portion includes a first controller and a second controller, and the bending direction and the bending angle of the front end of the catheter can be precisely controlled by rotating the first controller and the second controller, for example, the diameter of the controller can be adjusted by calculation, so that the front end of the catheter can be bent by a certain angle, for example, 1 °, 2 °, 3 °, etc., every rotation, and of course, in order to avoid too much work intensity of the medical staff, the bending angle of the catheter caused by every rotation of the controller can be set to 5 °, etc.

The first controller and the second controller are operated by an operator, so that the first controller and the second controller move to drive the connecting piece to move, the fixing piece is further pulled by the connecting piece, the catheter wall is further pulled, the catheter is bent, and the angle deviation is generated between the far end of the catheter and the near end of the catheter, so that the angle of the head of the catheter can be adjusted according to clinical needs.

More specifically, the first and second controls are located on either side of the catheter, such that placement of the hemostasis valve at the proximal end of the catheter may be facilitated.

The proximal end is defined herein as the side of the thrombus treatment device that is adjacent to the medical practitioner when the device is in use; the distal end is defined on the side of the thrombus treatment device away from the medical personnel when the device is in use.

The steps of adopting the vascular thrombus treatment device to perform the operation are as follows:

1. firstly, a guide wire is sent to a specified position;

2. delivering the suction catheter and the dilator into the lesion, and withdrawing the dilator;

3. pushing the broken bolt component to the front end of the lesion part along the guide wire through the suction catheter, retracting the pushing tube, unfolding the broken bolt cutter, carrying out broken bolt by using the broken bolt cutter, generating negative pressure by using a suction pump, and retracting the broken bolt cutter;

4. if necessary, other bolt breaking cutters can be pushed to enter the diseased region for further treatment, and after the operation is finished;

5. adjusting the angle of the suction catheter to suck the thrombus again;

6. after the procedure is completed, the aspiration catheter is withdrawn.

Compared with the prior art, the invention has the following advantages:

the thrombus breaking component provided by the invention is suitable for cutting thrombus blocks with different sizes, especially larger thrombus blocks, has high cutting efficiency, can prevent blood vessel damage and incomplete thrombus removal, has strong safety, is easy to operate, can reduce the treatment time of a patient, has reasonable structural design, and can reduce the manufacturing difficulty and the production cost of a cutter.

Drawings

FIG. 1 is a schematic structural view of a vascular thrombus treatment device of an embodiment (with a thrombolysis tool in a deployed state);

FIG. 2 is a schematic structural view of the embodiment of the tumbler assembly (tumbler cutters in an extended state);

FIG. 3 is a schematic perspective view of the embodiment of the bolt breaking cutter;

FIG. 4 is a front view of an embodiment of a tumbler cutter;

FIG. 5 is a perspective view in cross-section of an embodiment of a bolt breaking cutter;

FIG. 6 is a perspective view of a first cutting member of the bolt breaking cutter according to the embodiment;

FIG. 7 is a perspective view of a first cutting member of the embodiment of a deadbolt cutter in cross-section;

FIG. 8 is a perspective view of a second cutting element of the embodiment of the deadbolt cutter;

FIG. 9 is a perspective view of a second cutting member of the embodiment of a deadbolt cutter in cross-section;

FIG. 10 is a block diagram of a coupling part of a breaker bit according to an embodiment;

FIG. 11 is a schematic view of the construction of the suction catheter of the embodiment;

FIG. 12 is an enlarged fragmentary view at A of the suction catheter of the embodiment;

wherein, 1, the blood vessel thrombus processing device; 2. a suction catheter; 21. a conduit portion; 22. a first controller; 23. a second controller; 24. a fixing member; 25. a connecting member; 3. an inner core tube; 4. a bolt breaking cutter; 41. a first cutting member; 411. a first mesh; 4111. a first plane; 4112. a second plane; 4113. a third plane; 412. a first cutting wire; 413. a first regular hexagon; 42. a second cutting member; 421. a second mesh; 4211. a fourth plane; 4212. a fifth plane; 4213. a sixth plane; 422. a second cutting wire; 423. a second regular hexagon; 43. a connecting member; 431. a first connecting unit; 432. a second connection unit; 44. a connecting member; 45. a free section; 5. a propulsion tube; 6. a suction pump; 7. a thrombus collection bag; 81. a first developing ring; 82. a second developing ring; 9. a hemostatic valve; 10. a three-way valve; 11. a guidewire.

Detailed Description

The present invention has been described in detail in order to enable those skilled in the art to understand the invention and to practice it, and it is not intended to limit the scope of the invention, and all equivalent changes and modifications made according to the spirit of the present invention should be covered by the present invention.

The invention will be further described with reference to examples of embodiments shown in the drawings to which the invention is attached.

The blood vessel thrombus treatment device 1 shown in fig. 1 comprises an aspiration catheter 2 having an aspiration channel, an aspiration pump 6 communicating with the proximal end of the aspiration catheter 2, and a thrombus collection bag 7, and the blood vessel thrombus treatment device 1 comprises a thrombus crushing assembly for the blood vessel thrombus treatment device 1.

As shown in fig. 2, the plug breaking assembly comprises an inner core tube 3, a plug breaking cutter 4 which is arranged at the far end of the inner core tube 3 and has an unfolding state and a folding state, the plug breaking cutter 4 further comprises a propelling tube 5 which is sleeved on the inner core tube 3 in a sliding mode, and when the plug breaking cutter 4 is in the unfolding state, the plug breaking cutter 4 extends out of the far end of the propelling tube 5.

As shown in fig. 3 to 5, the plug crushing cutter 4 includes a first cutting member 41 and a second cutting member 42 provided along the axial direction of the core tube 3, and a connecting member 43 for connecting the first cutting member 41 and the second cutting member 42.

The first cutting member 41 is located at the proximal end of the second cutting member 42 as shown in fig. 2. When the mincing knife 4 is in the deployed state, the proximal end of the first cutting member 41 has a smaller cross-sectional area than the distal end thereof, and the proximal end of the second cutting member 42 has a larger cross-sectional area than the distal end thereof. When the bolt breaking cutter 4 is in the unfolded state, the maximum outer diameter of the first cutting member 41 is equal to the maximum outer diameter of the second cutting member 42. The inner core pipe 3 can freely move in the propelling pipe 5, and through propelling pipe 5 along 3 axial displacement of inner core pipe, the external diameter when adjusting the length that garrulous bolt cutter 4 stretches out the distal end of propelling pipe 5 and adjust garrulous bolt cutter 4 expansion state to this adapts to the blood vessel of different pipe diameters, avoids producing the injury to the vascular wall. In this embodiment, when the embolus crushing cutter 4 is in the unfolded state, the adjustable range of the maximum outer diameter of the first cutting member 41 and the maximum outer diameter of the second cutting member 42 is 20mm, and the adjustable range of the outer diameters of the first cutting member 41 and the second cutting member 42 is 3-20 mm. In other embodiments, the maximum outer diameter of the thrombus removal tool 4 can be adjusted according to the condition of the blood vessel and thrombus, and the size of the suction pump 6, and the suction catheter 2 is matched with the thrombus removal assembly to ensure that the thrombus blocks after the thrombus removal operation can be timely, quickly and conveniently sucked out of the human body by the suction pump 6.

As shown in FIG. 2, the proximal end of the first cutting member 41 is fixedly connected to the inner core tube 3 by a connecting member 44. in this embodiment, the distal end of the inner core tube 3 extends to the proximal end of the first cutting member 41. in other embodiments, the distal end of the inner core tube 3 may extend between the proximal end of the first cutting member 41 and the distal end of the second cutting member 42. In this embodiment, the coupling member 44 is integrally formed with the proximal end of the first cutting member 41, and the proximal end of the coupling member 44 is formed into a ring which is fixedly coupled to the core tube 3 by welding or bonding. The distal end of the second cutting member 42 extends away from the second cutting member 42 to form a free section 45, and the free section 45 is provided with a first developing ring 81.

As shown in fig. 5, the first cutting portion has a plurality of first mesh openings 411, when the rag bolt cutter 4 is in an unfolded state and the first cutting portion is projected on the cross section of the rag bolt cutter 4, the plurality of first mesh openings 411 are all in a first regular hexagon 413, and two adjacent first regular hexagons 413 share one side; the second cutting part is provided with a plurality of second mesh holes 421, when the latch cutter 4 is in an unfolded state and the second cutting part is projected on the cross section of the latch cutter 4, the plurality of second mesh holes 421 are all in a second regular hexagon 423, and two adjacent second regular hexagons 423 share one side. The side length of the first regular hexagon 413 is greater than the side length of the second regular hexagon 423. Specifically, the side length of the first regular hexagon 413 is 1.5-3.5 times that of the second regular hexagon 423. In the present embodiment, the side length of the first regular hexagon 413 is 2.0 times that of the second regular hexagon 423, and the maximum outer diameter of the first cutting member and the maximum outer diameter of the second cutting member are 18 mm.

As shown in fig. 7, six first regular hexagons 413 are distributed on the outer periphery of the first regular hexagon 413 located inside, the proximal end portion of the first cutting member 41 is a plane perpendicular to the axial line of the first cutting member 41, and the plane is the first regular hexagon 413 located at the center when the plug cutter 4 is in the unfolded state and the first cutting portion is projected on the cross section of the plug cutter 4.

In this embodiment, the projection of the first cutting member 41 on the cross section of the bolt breaking tool 4 includes 7 complete first regular hexagons 413, 1 first regular hexagon 413 is located at the center of the projection of the first cutting member 41 on the cross section of the bolt breaking tool 4, and the centers of the remaining 6 first regular hexagons 413 are all located on concentric circles with the center of the projection of the first cutting member 41 on the cross section of the bolt breaking tool 4 as the center.

As shown in fig. 6, the plurality of first meshes 411 are formed of first wires fixedly connected or integrally formed, wherein the first wires forming the first meshes 411 at the proximal end portion form a first plane 4111, the first wires forming the remaining first meshes 411 form a second plane 4112 near the proximal end portion of the first cutting member 41 and a third plane 4113 intersecting the second plane 4112, the second plane 4112 is gradually distant from the axis of the first cutting member 41 from the proximal end to the distal end, and the distance from the end of the third plane 4113 intersecting the second plane 4112 to the axis of the first cutting member 41 is smaller than the distance from the other end of the third plane 4113 to the axis of the first cutting member 41.

In the present embodiment, the third plane 4113 is perpendicular to the axis of the first cutting member 41. The first cutting member 41 forms a platform structure which gradually retreats from the near end to the far end, and is similar to a stepped pyramid structure, and has the advantages of rigorous and stable structure, high safety, easiness in manufacturing and the like.

Specifically, the inclination angle of the second plane 4112 to the axial line of the first cutting member 41 is independently 25 ° to 75 °, preferably 30 ° to 50 °, and 30 ° in the present embodiment.

As shown in fig. 6 and 7, the first cutting member 41 further has a plurality of first cutting wires 412, proximal ends of the plurality of first cutting wires 412 are fixedly connected or integrally formed with the outermost first mesh 411, distal ends of the plurality of first cutting wires 412 are fixedly connected or integrally formed with the connecting member 43, and the first cutting wires 412 have the same cutting function as the first wires.

As shown in fig. 9, the distal end portion of the second cutting member 42 is a plane perpendicular to the axial line of the second cutting member 42, and the plane is a second regular hexagon 423 located at the center when the rock bolt cutter 4 is in the deployed state and the second cutting portion is projected on the cross section of the rock bolt cutter 4.

In this embodiment, the projection of the second cutting member 42 on the cross section of the latch tool 4 includes 31 complete second regular hexagons 423, 1 second regular hexagon 423 is located at the center of the projection of the second cutting member 42 on the cross section of the latch tool 4, the centers of 6 second regular hexagons 423 are all located on a concentric circle with the center of the projection of the second cutting member 42 on the cross section of the latch tool 4 as the center, the centers of 12 second regular hexagons 423 are all located on another concentric circle with the center of the projection of the second cutting member 42 on the cross section of the latch tool 4 as the center, and the centers of the remaining 12 second regular hexagons 423 are all located on another concentric circle with the center of the projection of the second cutting member 42 on the cross section of the latch tool 4 as the center.

As shown in fig. 8, the plurality of second meshes 421 are formed of fixedly connected or integrally formed second wires, wherein the second wires forming the second meshes 421 at the distal end portion form a fourth plane 4211, the second wires forming the remaining second meshes 421 form a fifth plane 4212 near the distal end portion of the second cutting member 42 and a sixth plane 4213 intersecting the fifth plane 4212, the fifth plane 4212 is gradually distant from the axial line of the second cutting member 42 from the proximal end to the distal end, and one end of the sixth plane 4213 intersecting the fifth plane 4212 is located at a smaller distance from the axial line of the second cutting member 42 than the other end of the sixth plane 4213 is located at a smaller distance from the axial line of the second cutting member 42.

In the present embodiment, the sixth plane 4213 is perpendicular to the axis of the second cutting member 42. The second cutting component 42 also forms a platform structure which gradually retreats from the near end to the far end, and is similar to a stepped pyramid structure, and has the advantages of rigorous and stable structure, high safety, easiness in manufacturing and the like; the bolt breaking cutter 4 is similar to an olive shape or a shuttle shape on the whole, has high centering performance and good stability and is easy to unfold or fold.

Specifically, the inclination angle of the second plane 4112 to the axial line of the first cutting member 41 is independently 25 ° to 75 °, preferably 30 ° to 50 °, and 30 ° in the present embodiment.

As shown in fig. 8 and 9, the second cutting unit 42 further has a plurality of second cutting wires 422, distal ends of the plurality of second cutting wires 422 are connected to or integrally formed with the outermost second mesh 421, and proximal ends of the plurality of second cutting wires 422 are connected to or integrally formed with the connecting member 43. The second cutting wire 422 performs the same cutting function as the second wire.

As shown in fig. 10, the connection member 43 includes a first connection unit 431 and a second connection unit 432 having the same structure, the first connection unit 431 and the second connection unit 432 respectively include a plurality of peaks and valleys periodically arranged in the circumferential direction, two adjacent peaks are one period, and the first connection unit 431 and the second connection unit 432 are arranged in a staggered manner on the circumferential surface by a distance of one half period. The connecting member 43 may be used to maintain the centering of the mincing knife 4 during the mincing process. In this embodiment, each connection unit includes 12 peaks and 12 valleys. The flexibility of the connecting member 43 is greater than the flexibility of the first cutting member 41 and the flexibility of the second cutting member 42; the connecting member 43 can be attached to the blood vessel when deployed. The length of the connecting member 43 in the axial direction of the thrombectomy cutter 44 is set so that the connecting member 43 is in the expanded state according to the condition of the blood vessel, and the thrombectomy cutter has good centering property, high stability, can be attached to the blood vessel wall, has a certain degree of elasticity, and can be expanded in the direction away from the axial line or folded in the direction close to the axial line instantly in the circumferential direction. If the breaker knife 4 is connected to the inner tube by the connecting member 43, the expansion and contraction of the connecting member 43 will bring the expansion and contraction of the first cutting member 41 and the second cutting member 42.

In this embodiment, the first wire and the second wire are respectively made by laser cutting a NiTi alloy pipe, and then by heat setting, electrochemical polishing, and acid washing, and have a cutting function.

In this embodiment, the suction catheter 2 is a suction catheter 2 of the prior art, and has an outer diameter of 14F. In other embodiments, the suction catheter 2 can be used with other sizes of suction catheters, and preferably, the suction catheter 2 has an outer diameter of 6F to 14F.

As shown in fig. 11, the suction catheter 2 includes a catheter part 21 having a suction passage, an operation part movably connected to a proximal end of the catheter part 21, a fixing member 24 fixedly provided on the catheter part 21, a connector 25 connected to the operation part and the fixing member 24, respectively, and capable of bending a distal end of the catheter part 21 by operating the operation part, and a second developing ring 82 fixedly provided on a distal end of the catheter part 21.

As shown in fig. 5, the operation portion includes a first controller 22 and a second controller 23, the first controller 22 and the second controller 23 are located at two sides of the catheter, the connection member 25 is a control wire, and the bending direction and the bending angle of the front end of the catheter can be precisely controlled by rotating the first controller 22 and the second controller 23, for example, the diameter of the controller can be adjusted by calculation, so that the front end of the catheter can be bent by a certain angle, such as 1 °, 2 °, 3 ° or the like, for each rotation of the catheter, and of course, in order to avoid an excessive working strength of the medical staff, the bending angle of the catheter caused by each rotation of the controller can be set to 5 ° or the like.

The first controller 22 and the second controller 23 are operated by an operator, so that the first controller 22 and the second controller 23 move to drive the connecting piece 25 to move, the connecting piece 25 further pulls the fixing piece 24, and further pulls the catheter wall, so that the catheter bends, and an angle deviation is generated between the far end of the catheter and the near end of the catheter, so that the angle of the head of the catheter can be adjusted according to clinical needs, for example, after the suction catheter 2 enters a blood vessel, the bifurcation blood vessel can be inserted more conveniently through adjusting the bending angle of the head of the catheter, or the angle can be adjusted to suck thrombus and the like at a specific position.

In this embodiment, as shown in fig. 1, a hemostatic valve 9 is disposed at the proximal ends of the suction catheter 2, the inner core tube 3 and the pusher tube 5.

In this embodiment, as shown in fig. 1, the proximal side walls of the inner core tube 3 and the pusher tube 5 are also connected to the three-way valve 10 of the drug delivery device, so that different drugs can be delivered to the thrombus site.

The blood vessel thrombus treatment device 1 of this embodiment can reach fine thrombectomy effect when can not block the blood flow in the blood vessel at the operation in-process, and operating procedure is simple, shortens the operating time, alleviates patient's expense in hospital greatly.