CN113813015B

CN113813015B - Thrombectomy support with strong capture force and thrombectomy device

Info

Publication number: CN113813015B
Application number: CN202111155520.6A
Authority: CN
Inventors: 刘朝生; 陈兵; 张志军
Original assignee: Guangdong Bomai Yuantong Medical Technology Co ltd
Current assignee: Guangdong Bomai Yuantong Medical Technology Co ltd
Priority date: 2021-09-29
Filing date: 2021-09-29
Publication date: 2022-05-27
Anticipated expiration: 2041-09-29
Also published as: CN113813015A

Abstract

The invention discloses a bolt taking support with strong capturing force and a bolt taking device, wherein the bolt taking support comprises a support body and a push wire, the push wire is connected with one end of the support body, the support body is of a net barrel structure formed by a plurality of closed-loop meshes, a plurality of ring connecting parts are arranged at intervals along the transverse axis direction of the support body, each ring connecting part comprises a plurality of connecting beams with bending deformation structures, each closed-loop mesh comprises a plurality of first meshes and a plurality of second meshes, and a first protrusion extending inwards from a rib beam on one side of each second mesh is arranged in each second mesh; according to the thrombus taking support, when the support body meets a tortuous blood vessel, the bending angle of the support body can be flexibly changed in a self-adaptive manner, so that the capability of the thrombus taking support for passing through the tortuous blood vessel is effectively improved, the thrombus taking capability of the thrombus taking support for taking large thrombus is effectively improved through the arrangement of the second meshes in the specific shape, and the thrombus is not easy to fall off from the support body by adopting the branch protrusions and the valve structure.

Description

Thrombectomy support with strong capture force and thrombectomy device

Technical Field

The invention relates to the technical field of medical instruments for mechanically taking thrombus, in particular to a thrombus taking support with strong capture force and a thrombus taking device.

Background

The stent is used for removing thrombus as a main means for treating acute cerebral ischemia at the present stage, effectively prolongs the treatment time window, improves the blood vessel recanalization rate and reduces the operation time. The existing commercial stent for thrombus removal shows some problems in the thrombus removal process, such as poor bending property of the stent and difficulty in passing through tortuous vessels; the stent is not stably embedded with thrombus, so that the thrombus removal or thrombus extraction efficiency is low.

Disclosure of Invention

The invention aims to provide an embolectomy stent and an embolectomy device with strong trapping force, which improve the capability of passing through tortuous vessels and trapping thrombus.

In order to achieve the purpose, the invention discloses a bolt-removing bracket with strong capture force, which is characterized by comprising a bracket body and a push wire, wherein the push wire is connected with one end of the bracket body, the bracket body is of a net cylinder structure formed by a plurality of closed-loop meshes, a plurality of rings of connecting parts are arranged at intervals along the transverse axis direction of the bracket body, each ring of connecting part comprises a plurality of connecting beams with bending deformation structures, each connecting beam is used for transversely connecting two adjacent closed-loop meshes, each closed-loop mesh comprises a plurality of first meshes and a plurality of second meshes, a first protrusion extending inwards from a rib beam on one side of each second mesh is arranged in each second mesh, and the first protrusion is of a closed-loop structure.

Preferably, at least one circle of the connecting part is arranged in the proximal section, the middle section and the distal section of the stent body respectively.

Preferably, the connecting beam is of an S-shaped structure.

Preferably, the diameter of the connecting beam is smaller than or equal to the diameter of the rib beam of the closed loop mesh.

Preferably, the length of the connecting beam is 300um-500 um.

Preferably, the number of the second mesh openings is 6 to 10, and the area of the second mesh openings is 4 to 6 times the area of the first mesh openings.

Preferably, the first support lug comprises a first rib and a second rib, one end of the first rib and one end of the second rib are connected with each other to form a free protruding end in the second mesh, and the other end of the first rib and the other end of the second rib are respectively connected with a rib beam on one side of the second mesh.

Preferably, the second meshes are arranged on the stent body in a ribbon-shaped spiral manner.

Preferably, second branch protrusions are arranged in the closed-loop meshes in the distal section of the stent body, and the second branch protrusions can warp towards the inner space of the stent body.

Preferably, the second branch protrusion extends from the distal end section of the stent body to the proximal end section.

Preferably, the second branch protrusions are arranged in a circumferential array around a transverse axis of the stent body.

Preferably, a plurality of pairs of valves are arranged in the stent body, two diaphragms in each pair of valves are respectively oppositely arranged on two sides in the stent body, and free ends of the two diaphragms respectively extend towards the proximal end section of the stent body.

Preferably, the base of the valve has a curvature.

Preferably, the developing device further comprises a developing structure, and the developing structure can provide full-section development for the stent body from the proximal section to the distal section.

Preferably, the developing structure comprises a developing ring, a plurality of developing wires and a plurality of developing points; the developing ring is arranged at the joint of the proximal section of the bracket body and the push wire; the plurality of developing wires are wound on the stent body in a crossed manner and extend from the proximal end section to the distal end section; a plurality of developing points are arranged at the distal section of the stent body.

Preferably, the developing structure comprises a developing ring, a developing coating layer arranged on the closed-loop mesh and a plurality of developing points; the developing ring is arranged at the joint of the proximal section of the bracket body and the push wire; the developable coating extends from the proximal section to the distal section; and a plurality of developing points are arranged at the distal section of the stent body.

The invention also discloses an embolectomy device, which comprises a microcatheter, an introducing sheath and the embolectomy bracket as in any one of claims 1-16, wherein the microcatheter is sleeved outside the push wire, the bracket body can be pressed into the microcatheter, and the microcatheter is connected with the introducing sheath through a microcatheter connecting piece.

Compared with the prior art, the thrombus removal bracket has the following technical effects:

1. because two adjacent closed loop meshes are connected through the connecting beam with the bending deformation structure along the direction of the transverse shaft of the stent body, when the stent body encounters a tortuous blood vessel, the bending angle of the stent body can be adaptively and flexibly changed, so that the capability of the thrombus taking stent passing through the tortuous blood vessel is effectively improved;

2. the second mesh effectively improves the capability of the thrombus taking support in capturing massive thrombus and is not easy to fall off;

3. through the arrangement of a plurality of pairs of valves, the falling of the bolt block in the process of withdrawing is effectively avoided.

Drawings

Fig. 1 is a schematic perspective view of a thrombectomy support according to an embodiment of the present invention.

Fig. 2 is a sectional view of the tampon support of fig. 1.

Fig. 3 is an enlarged structural view of a portion a in fig. 2.

FIG. 4 is a schematic view of a portion of the embolic stent of FIG. 1.

FIG. 5 is another schematic structural view of a portion of the embolic stent of FIG. 1.

Fig. 6 is a schematic view of the valve of fig. 1 in a closed state.

FIG. 7 is a schematic plan view of an embodiment of the embolectomy device of the present invention, wherein the embolectomy support is in a compressed state.

FIG. 8 is a schematic plan view of an embodiment of the present invention in the form of an embolectomy device, wherein the embolectomy stent is in an expanded, deployed state.

Detailed Description

In order to explain technical contents, structural features, and objects and effects of the present invention in detail, the following detailed description is given with reference to the accompanying drawings in conjunction with the embodiments.

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

It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings that is solely for the purpose of facilitating the description and simplifying the description, and 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 considered as limiting the present application.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

It should be noted that the terms "proximal" and "distal" are used herein in a relative positional relationship with respect to an operator of the thrombectomy stent of the present application, where the end closer to the operator is referred to as the proximal end, the end farther from the operator is referred to as the distal end, and an intermediate section is between the proximal end and the distal end.

First embodiment, as shown in fig. 1 to fig. 3, the present embodiment discloses a thrombus extraction stent for extracting thrombus, which includes a stent body 100 and a push wire 101, wherein the stent body 100 is a mesh tube structure composed of a plurality of closed loop meshes 1, and the closed loop meshes 1 are formed by connecting a plurality of sequentially connected rib beams end to end, so that the stent body 100 has a self-expansion effect, that is, when the stent body 100 is released in a blood vessel, the stent body 100 tied together can be automatically expanded to form a long-strip-shaped mesh tube for the blood thrombus to enter. Along the cross axis direction of support body 100, the interval is provided with a plurality of circles connecting portion 2, and each circle connecting portion 2 includes a plurality of tie-beams 20 that have the deformation structure of bending, and each tie-beam 20 is used for two adjacent closed loop meshes 1 of transverse connection. In this embodiment, since the two adjacent closed loops of mesh 1 are connected by the connection beam 20 having the bending deformation structure, when the stent body 100 encounters a tortuous blood vessel, the connection beam 20 causes the stent body 100 to undergo adaptive bending deformation, so that the stent body 100 smoothly passes through the tortuous portion of the blood vessel, thereby effectively improving the ability of the embolectomy stent to pass through the tortuous blood vessel.

It should be noted that the stent body 100 may be made of a nickel-titanium material or a polymer material, specifically, may be made by cutting a nickel-titanium tube with laser, or may be made by cutting a nickel-titanium plate with laser and then crimping and heat setting, or may be further made by weaving a nickel-titanium wire, or may be made of an elastic plastic material. In addition, the push wire 101 and the stent body 200 can be connected by winding, extrusion, medical adhesion, laser welding, fusion welding of polymer materials, and the like.

Specifically, at least one connection portion 2 is disposed in the proximal section L1, the middle section L2 and the distal section L3 of the stent body 100. In this embodiment, the connecting portions 2 including the connecting beams 20 are respectively disposed in the proximal section L1, the middle section L2 and the distal section L3 of the stent body 100, so that each section of the stent body 100 can smoothly pass through a tortuous blood vessel, and the ability of the embolectomy stent to pass through the tortuous blood vessel is further improved. More specifically, the coupling beam 20 has an S-shaped structure, which effectively ensures the bending deformation capability of the coupling beam 20.

Further, to ensure the flexibility of the bridge 20, the diameter d1 of the bridge 20 is smaller than the diameter d2 of the tendon of the closed loop mesh 1, and preferably, d1 is 0.8 to 1 times of d 2. The length of the coupling beam 20 is preferably 300um to 500um, and more preferably 350um to 450 um.

In the second embodiment, please refer to fig. 1, fig. 2 and fig. 4, the embolectomy stent disclosed in the present embodiment includes the same structure as the embolectomy stent disclosed in the first embodiment, and the closed-loop mesh 1 is further improved. Specifically, the closed-loop cell 1 includes a plurality of first cells 10 and a plurality of second cells 11, and the area S2 of the second cells 11 is much larger than the area S1 of the first cells 10. It should be noted here that the concept "much larger" means: one value is at least 3 times greater than the other value, for example, S2 is at least 3 times greater than S1. Therefore, as long as one value is ensured to be at least 3 times greater than the other value, the requirement of "far greater" in the embodiment can be met, and the specific multiple is set by the skilled person according to experience, which is not limited here. Preferably, the area of the second mesh 11 in the present embodiment is 4 to 6 times the area of the first mesh 10, and the number of the second mesh 11 is preferably 6 to 10.

In the stent body 100 of the embodiment, the first mesh 10 can provide higher radial supporting force, the second mesh 11 can ensure that thrombus is embedded into the stent body 100 more completely and the contact surface with the vessel wall is reduced, and the mixed design of the first mesh 10 and the second mesh 11 also ensures that the stent body 100 has high elasticity

Further, the second cells 11 are provided with first lugs 3 extending from the ribs on one side into the cells, and the first lugs 3 are in a closed loop structure. In the expansion process after the stent body 100 is released, thrombus enters the stent body 100 from the region Q0 outside the first processes 3 in the second meshes 11, and when the stent body 100 is withdrawn, the first processes 3 have the function of preventing the thrombus from being detached again, which is favorable for stabilizing the thrombus when the thrombus stent is taken out and passing through a tortuous blood vessel, and reduces the risk of thrombus detachment. In this embodiment, the area of the inner region Q1 defined by the first branch 3 is much smaller than the area of the second cell 11.

Specifically, the first protrusions 3 include first ribs 30 and second ribs 31, one ends of the first ribs 30 and the second ribs 31 are connected to each other to form free protruding ends located in the second meshes 11, and the other ends of the first ribs 30 and the second ribs 31 are respectively connected to the ribs on one side of the second meshes 11. Preferably, the diameter of the closed annular region defined by the first branch 3 decreases from the inside to the inside of the ribs of the second mesh 11, in order to avoid the first branch 3 interfering with the entry of the massive thrombus.

Further, as shown in fig. 2, the second meshes 11 are spirally arranged on the stent body 100 in a ribbon shape, so that the thrombus is fully embedded into the stent body 100, the stent body 100 is ensured to be tightly attached to the blood vessel, and the risk of thrombus removal is reduced.

In a third embodiment, please refer to fig. 1, fig. 2 and fig. 5, the embolectomy stent disclosed in the present embodiment includes a structure similar to that of the embolectomy stent disclosed in the first embodiment, and further improves the closed-loop mesh 1. Specifically, the second branch protrusions 4 are arranged in the closed-loop meshes 1 in the distal end section L3 of the stent body 100, and the second branch protrusions 4 can warp toward the inner space of the stent body 100. Preferably, the second branch protrusion 4 extends from the distal end section L3 to the proximal end section L1 of the stent body 100. When the stent body 100 is retracted after releasing the thrombus, the second branch protrusion 4 is moderately warped and deformed inside the stent body 100 under the extrusion of the thrombus, so that a better anti-falling effect of the thrombus is provided, and an anti-escape line is formed. In this embodiment, the second branch protrusions 4 are arranged circumferentially around the lateral axis of the stent body 100, and the arrangement density of the second branch protrusions 4 can be freely selected. The second branch processes 4 comprise third ribs 40 and fourth ribs 41, one ends of the third ribs 40 and the fourth ribs 41 are splayed and opened to be respectively connected with two ribs of the closed loop mesh 1, and the other ends of the third ribs 40 and the fourth ribs 41 are gradually close to and connected with each other, so that the free ends of the second branch processes 4 are of a thorn-shaped structure, and the second branch processes 4 are prevented from influencing thrombus to enter the closed loop mesh 1. Preferably, the second branch 4 is disposed within the first cell 10.

In a fourth embodiment, please refer to fig. 1, fig. 2, fig. 5 and fig. 6, in addition to the same structure as the embolectomy stent disclosed in the first embodiment, the stent body 100 further includes a plurality of pairs of valves 5, two diaphragms of each pair of valves 5 are respectively disposed at two sides of the stent body 100 (see fig. 6), and free ends of the two diaphragms respectively extend toward the proximal section L1 of the stent body 100. When the stent body 100 is advanced in the direction of the distal section L3, the distance between the free ends of the two diaphragms in the pair of valves 5 is opened under the influence of the blood flow, so that a blood clot passes through the valves 5. When the stent body 100 is pushed towards the direction of the proximal section L1, under the action of blood flow, the distance between the free ends of the two diaphragms in the pair of valves 5 is reduced, so that the blood clot is blocked by the valves 5, a better anti-thrombus falling effect can be provided, and an anti-escape line is formed.

As shown in fig. 5 and 6, the valve 5 is a TPU film with a base having a curvature. The valve 5 and the stent body 100 are bonded and fixed by TPU solution.

Fifth embodiment, as shown in fig. 1 and 2, and fig. 4 and 5, the thrombectomy stent disclosed in this embodiment includes the same structure as the thrombectomy stent disclosed in the first embodiment, and a developing structure is further disposed on the stent body 100, and the developing structure can provide full-segment development from the proximal segment L1 to the distal segment L3 on the stent body 100, thereby facilitating the overall monitoring of the thrombectomy stent. Preferably, the development structure includes a development ring 60, development wires 61, and development spots 62. Visualization ring 60 is disposed at the junction of proximal segment L1 and pushwire 101. A plurality of visualization wires 61 are cross-wound around the stent body 100 and extend from the proximal segment L1 to the distal segment L3. Several visualization points 62 are provided at distal segment L3.

Under the assistance of X-ray and angiography technologies, the developing point 62 is convenient for observing the actual position of the farthest end of the stent body 100 reaching the blood vessel, the developing wire 61 can clearly judge the contact condition of the stent body 100 and the blood vessel thrombus, and the working length of the stent body 100 can be identified through the matching of the developing ring 60 and the developing point 62. In the embolectomy operation process, the doctor can make clear the release position of the stent body 100 through the above-mentioned developing structure, and whether the stent body 100 is tightly attached to the vascular wall is judged, thereby being beneficial to the operation and judgment of the doctor and further improving the embolectomy efficiency.

Specifically, the materials of the developing ring 60, the developing wire 61 and the developing point 62 include, but are not limited to, platinum, gold, platinum-iridium alloy, tantalum, and other radiopaque materials, and the developing ring 60 and the developing point 62 may be rings, coils made of wire, or sheets, and fixed by laser welding, or soldering/gold/silver welding.

Further, the developing ring 60 may be fixed to the push wire 101 by laser welding, soldering, or gold-tin welding. The developing dots 62 are formed by caulking the developing material into the circular holes of the first mesh 10 at the end away from the holder body 100, and the size thereof is controlled to be about 0.3 mm.

In some more specific embodiments, the developing wire 61 is attached to the rib in a spirally wound manner in the axial direction of the stent body 100.

Specifically, the diameter of the developing wire 61 is 30-50um, preferably 35-40um, one or more developing wires 61 are wound or crossed from inside to outside along the rib beam from the proximal end of the stent body 100 to the distal end, the developing wires are wound or crossed from inside to outside along different paths after bypassing the distal end, the developing wires are returned to the proximal end, and the developing wires are wound or crossed from inside to outside along different paths to the distal end, or the steps are repeated in a circulating manner until the rib beam of the stent body 100 is completely wound or crossed from inside to outside and attached by the developing wires 61.

Preferably, the developing wire 61 may be one or more, one developing wire 61 is attached to the sequentially connected ribs in a spiral winding manner starting from the proximal end and following different paths, or a plurality of developing wires 61 are attached to the sequentially connected ribs in a spiral winding manner starting from the proximal end and following different paths, respectively.

In another embodiment, the developing structure comprises a developing ring 60, a developing coating (not shown) disposed on the closed-loop mesh 1, and a plurality of developing points 62, i.e., the developing wire 61 in the above embodiment is replaced by the developing coating; the developing ring 60 is arranged at the joint of the proximal end section L1 of the bracket body 100 and the push wire 101; the developable coating extends from the proximal segment L1 to the distal segment L3 of the stent body 100; several visualization points 62 are provided at the distal section L3 of the stent body 100.

Specifically, the development coating may be sprayed on the sequentially connected ribs along a plurality of different paths.

Specifically, gold and platinum are preferred as the material of the developing coating layer.

According to another aspect of the present application, an embodiment of the present application further provides an embolectomy device, as shown in fig. 7 and 8, comprising the embolectomy stent (stent body 100 and push wire 101), microcatheter 102 and introducer sheath (not shown) in the above-mentioned embodiments. The microcatheter 102 is sleeved outside the push wire 101, and the stent body 100 can be pressed into the microcatheter 102, and the microcatheter 102 is connected with the introducing sheath through a microcatheter connecting piece.

The self-expanding stent body 100 has a radially compressed, contracted state (fig. 7) and a radially expanded, expanded state (fig. 8). Before use, the stent body 100 is in a radial compression state, has a smaller outer diameter and is pre-installed in an introduction sheath, when the stent is used, the stent body 100 is introduced into the microcatheter 102 through an auxiliary instrument, the microcatheter 102 and the push wire 101 are pushed to a lesion position where thrombus is to be taken out in a compression state, the position of the stent body 100 is kept unchanged, the microcatheter 102 is retracted, the stent body 100 is separated from the microcatheter 102 and can be in a release state again, and then the push wire 101 is operated to enter blood clots into the stent body 100.

The above disclosure is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the scope of the present invention, therefore, the present invention is not limited by the appended claims.

Claims

1. The bolt taking support with the strong capturing force is characterized by comprising a support body and a push wire, wherein the push wire is connected with one end of the support body, the support body is of a net drum structure formed by a plurality of closed-loop meshes, a plurality of rings of connecting parts are arranged at intervals along the transverse axis direction of the support body, each ring of connecting part comprises a plurality of connecting beams with bending deformation structures, each connecting beam is used for transversely connecting two adjacent closed-loop meshes, and the diameter of each connecting beam is smaller than or equal to that of a rib beam of each closed-loop mesh;

the closed-loop meshes comprise a plurality of first meshes and a plurality of second meshes, the second meshes are internally provided with first supporting protrusions extending from the rib beams on one side of the second meshes to the inside of the meshes, and the first supporting protrusions are of a closed ring structure;

second branch bulges are arranged in a plurality of closed loop meshes in the distal section of the stent body and can be warped towards the inner space of the stent body;

the second branch protrusion extends from the distal end section of the stent body to the proximal end section;

the second branch bulges are arranged around the transverse shaft of the bracket body in a circumferential direction;

the stent is characterized in that a plurality of pairs of valves are arranged in the stent body, two diaphragms in each pair of valves are respectively oppositely arranged on two sides in the stent body, and the free ends of the two diaphragms respectively extend towards the direction of the proximal end section of the stent body.

2. The strong capture thrombectomy stent of claim 1, wherein at least one ring of said connecting portions are disposed within the proximal, intermediate and distal sections of the stent body.

3. The strong capture thrombectomy support of claim 1, wherein the connecting beam is S-shaped.

4. The embolectomy support of claim 1, wherein the length of the connecting beam is 300-500 um.

5. The thrombectomy stent with strong capturing force according to claim 1, wherein the number of the second meshes is 6 to 10, and the area of the second meshes is 4 to 6 times the area of the first meshes.

6. The embolectomy stent with strong capturing force according to claim 1, wherein the first projection comprises a first rib and a second rib, one end of the first rib and one end of the second rib are connected with each other to form a free protruding end in the second mesh, and the other end of the first rib and the other end of the second rib are respectively connected with a rib on one side of the second mesh.

7. The embolectomy stent with strong capturing force according to claim 1, wherein the second mesh is arranged in a ribbon-like spiral on the stent body.

8. The strong capture embolectomy stent of claim 1, wherein the base of the valve has curvature.

9. The strong capture thrombectomy stent of claim 1, further comprising visualization structure providing full-scale visualization from proximal to distal segments on the stent body.

10. The embolectomy support of claim 9, wherein the visualization structure comprises a visualization ring, visualization wires, and visualization points; the developing ring is arranged at the joint of the proximal section of the bracket body and the push wire; the plurality of developing wires are wound on the stent body in a crossed manner and extend from the proximal end section to the distal end section; a plurality of developing points are arranged at the distal section of the stent body.

11. The thrombus removal stent with strong capturing force according to claim 9, wherein the developing structure comprises a developing ring, a developing coating layer disposed on the closed-loop mesh, and a plurality of developing points; the developing ring is arranged at the joint of the proximal section of the bracket body and the push wire; the developable coating extends from the proximal section to the distal section; and a plurality of developing points are arranged at the distal section of the stent body.

12. An embolectomy device, comprising a microcatheter, an introducing sheath and the embolectomy stent of any of claims 1-11, wherein the microcatheter is sleeved outside the push wire, the stent body can be pressed into the microcatheter, and the microcatheter is connected with the introducing sheath through a microcatheter connecting piece.