阅读说明：本技术 缺血性卒中的取栓支架 (Thrombus taking support for ischemic stroke ) 是由 熊丹 邢雷 戴威骏 吴晓帆 程宇镳 其他发明人请求不公开姓名 于 2021-08-27 设计创作，主要内容包括：本申请提出一种缺血性卒中的取栓支架,所述取栓支架包括：支架,所述支架为用于固定血栓的框架结构；芯丝,所述芯丝连接于所述支架的远端；套管,所述套管连接于所述支架的近端；以及手柄,所述手柄安装有能够相对于所述手柄沿前后方向滑动或者能够相对于所述手柄转动的按钮,所述套管连接于所述按钮,通过操作所述按钮能够使所述套管沿所述前后方向移动,从而对所述支架施力,其中在向前推动所述按钮时,所述支架能够扩张,在向后拉动或扳动所述按钮时,所述支架能够收缩。通过采用上述技术方案,在支架收缩时,使支架的近端移动,血栓收入导引导管过程中,血栓与支架可以固定稳定。(The application provides a support is tied in getting of ischemic stroke, it includes to get to tie the support: the stent is a frame structure for fixing thrombus; a core wire attached to a distal end of the stent; a cannula connected to the proximal end of the stent; and a handle, the handle is provided with a button which can slide along the front-back direction relative to the handle or can rotate relative to the handle, the sleeve is connected with the button, the sleeve can move along the front-back direction by operating the button so as to apply force to the bracket, the bracket can expand when the button is pushed forwards, and the bracket can contract when the button is pulled or pulled backwards. Through adopting above-mentioned technical scheme, when the support shrink, make the near-end of support remove, the thrombus income guide catheter in-process, the thrombus can be fixed stably with the support.)

1. An embolectomy support of ischemic stroke, comprising:

the stent (1), the stent (1) is a frame structure for fixing thrombus;

a core wire (2), the core wire (2) being connected to the distal end of the stent (1);

a cannula (3), the cannula (3) being connected to the proximal end of the stent (1); and

a handle (4), the handle (4) is provided with a button which can slide along the front-back direction (X) relative to the handle (4) or can rotate relative to the handle (4), the sleeve (3) is connected with the button (5), the sleeve (3) can be moved along the front-back direction (X) by operating the button (5) so as to apply force to the bracket (1), wherein the handle (4) is provided with a button, the sleeve (3) can be moved along the front-back direction (X) by operating the button (5), and the bracket (1) is applied with force, and the bracket (1) is provided with a support structure

The stent (1) is expandable when the button (5) is pushed forward,

when the button (5) is pulled or pulled backwards, the bracket (1) can be retracted.

2. The thrombus removal support for ischemic stroke according to claim 1, wherein the handle (4) is used for holding when using the thrombus removal support.

3. The thrombus removal support for ischemic stroke according to claim 1, wherein the sleeve (3) is tubular, and the sleeve (3) is sleeved on the core wire (2).

4. Ischemic stroke embolectomy holder according to claim 1, characterized in that the handle (4) and/or the button (5) is provided with a locking structure which locks the button (5) relative to the handle (4).

5. The thrombus removal stent for ischemic stroke according to claim 1, wherein the stent (1) has a multi-layered sub-stent.

6. Ischemic stroke embolectomy holder according to claim 1, characterized in that the handle (4) is provided with graduated markings beside the button (5) for marking the diameter of the holder (1) when the button (5) is in different positions.

7. Ischemic stroke embolectomy holder according to claim 6, wherein the button (5) is provided with a pointer pointing to the graduated markings.

8. The thrombus removal support for ischemic stroke according to claim 1, wherein the distal end of the support (1) is formed with a protector which is bent with respect to the sleeve (3).

9. The ischemic stroke embolectomy stent of claim 1, wherein the hardness of the distal portion of the sleeve (3) is less than the hardness of the proximal portion of the sleeve (3).

10. The thrombus removal stent for ischemic stroke according to claim 1, wherein the stent (1) is a mesh structure formed by weaving or etching.

Technical Field

The application belongs to the field of medical equipment, in particular to a thrombus removal support for ischemic stroke.

Background

Ischemic stroke is also called cerebral infarction, and is called stroke or stroke in traditional Chinese medicine. The disease is caused by blood supply disorder of local brain tissue areas caused by various reasons, and the ischemic and hypoxic lesion necrosis of the brain tissue is caused, so that the clinically corresponding nerve function deficiency expression is generated. Cerebral infarction is divided into main types such as cerebral thrombosis, cerebral embolism, lacunar infarction and the like according to different pathogenesis.

Cerebral thrombosis is the most common type of cerebral infarction, accounting for about 60% of all cerebral infarctions, and so the so-called "cerebral infarction" actually refers to cerebral thrombosis.

Interventional therapy includes intravascular mechanical thrombectomy and arterial thrombolysis.

(1) The mechanical thrombus removal in the blood vessel can obviously improve the prognosis of patients with cerebral arterial thrombosis caused by acute aortic occlusion. In 2018, the diagnosis and treatment guideline for acute ischemic stroke recommends a conditional medical institution, and a clinical medical team trained by the guideline carries out the diagnosis and treatment guideline for acute ischemic stroke, so that the indication of mechanical thrombus removal in blood vessels is strictly mastered.

(2) Arterial thrombolysis, which makes thrombolysis medicine directly reach local part of thrombus, theoretically, the blood vessel recanalization rate is higher than that of venous thrombolysis, and the bleeding risk is reduced. However, because of the lack of clinical evidence demonstrating the benefits of arterial thrombolysis, current first-line intravascular therapy is mechanical embolectomy.

For patients with stroke who are delivered to the hospital in a timely manner, the conventional treatment regimen is drug thrombolysis, but the optimal window time for drug thrombolysis (the time from onset of the disease to treatment) is within 4 hours, while the short thrombolysis time window results in less than 10% of patients receiving effective thrombolytic therapy; second, drug thrombolysis is essentially ineffective against larger thrombi.

In order to solve the above-mentioned problem of drug thrombolysis, a method of mechanically eliminating thromboembolism has become a research focus in recent years:

in the patent "endovascular thrombectomy and embolectomy device" of CN101396295A, a thrombectomy device is provided with a thrombectomy spring and a basket in a contracted or released state, the basket is arranged at the far end of the thrombectomy device, the thrombi are caught by the winding of the thrombectomy spring, and the basket is used for taking out blood clots and thrombus fragments generated in the thrombectomy process so as to protect the far end of the blood vessel.

In the utility model of CN200620164685.4, the utility model is a thrombus-taking device, which comprises an umbrella with two long and one short three-claws with elastic memory function, and a thrombus-taking device with a circular structure formed by the peripheral attached net, wherein the three-claws are closed by pulling the push-pull rod outwards to fold the thrombus into the umbrella part and take out the thrombus. However, the above significant drawback is that in the case of a visually undetectable thrombus, the basket or mesh form of the catcher often fails to capture the clot and results in a failed thrombus removal.

The most clinically used thrombus removal systems are Solitaire by ev3, usa and TrevoDevice by Stryker, usa. The design of both is very similar, and the methods of use are nearly identical. The whole instrument is accommodated in a micro-catheter with an inner diameter of less than 0.6 mm. During interventional operation, the doctor pushes the microcatheter sleeved with the instrument to cross thrombus and then pushes out the core instrument. After the device ensheathes the thrombus, the microcatheter is slowly withdrawn to transfer the ensheathed thrombus into the catheter guide tube with the larger inner diameter.

As shown in fig. 1, the prior art has a thrombus removal stent capable of controlling expansion, which comprises a stent 1, a core wire 2, a sleeve 3, a handle 4 and a button 5. The button 5 is slidably mounted to the handle 4 in the front-rear direction X with respect to the handle 4, one end of the sleeve 3 is connected to the proximal end of the holder 1, and the other end of the sleeve 3 is connected to the handle 4. One end of the core wire 2 is connected to the distal end of the stent 1, and the other end of the core wire 2 is connected to the button 5. The push button 5 is withdrawn to expand the stent 1, and the push button 5 is pushed forward to contract the stent 1. The button 5 can control the far end of the stent 1 to move towards the near end of the stent 1 under the traction of the core wire 2, so that the stent 1 expands.

The thrombus taking stent capable of controlling expansion needs to be moderately contracted before being retracted into a guide catheter, so that thrombus can be conveniently retracted into the guide catheter, but in the contraction process of the stent 1, the near end of the stent 1 is fixed, and the far end of the stent 1 moves forwards, so that thrombus moves to the far end of the stent 1 along with the stent 1, and thrombus is easy to fall off.

Disclosure of Invention

The application aims to provide the thrombus taking support, so that thrombus is not easy to fall off from the support when the support contracts.

The application provides a support is tied in getting of ischemic stroke, it includes to get to tie the support:

the stent is a frame structure for fixing thrombus;

a core wire attached to a distal end of the stent;

a cannula connected to the proximal end of the stent; and

a handle having a push button mounted thereon to be slidable in a front-rear direction with respect to the handle or rotatable with respect to the handle, and a sleeve connected to the push button and movable in the front-rear direction by operating the push button to apply force to the holder, wherein the push button is provided with a guide hole for guiding the sleeve to move in the front-rear direction, and the guide hole is formed in a wall of the sleeve

When the button is pushed forwards, the stent can expand,

the bracket is able to retract when the button is pulled or squeezed rearwardly.

Preferably, the handle is used for holding when the thrombectomy support is used.

Preferably, the sleeve is tubular, and the sleeve is sleeved on the core wire.

Preferably, the handle and/or the button are provided with a locking structure that locks the button relative to the handle.

Preferably, the scaffold has a multi-layered sub-scaffold.

Preferably, the handle is provided with scale marks, which are located beside the button and are used for marking the diameter of the bracket when the button is at different positions.

Preferably, the button is provided with a pointer, the pointer pointing to the scale markings.

Preferably, the distal end of the stent is formed with a protector that is bent with respect to the sleeve.

Preferably, the hardness of the distal portion of the cannula is less than the hardness of the proximal portion of the cannula.

Preferably, the stent is a mesh structure formed by weaving or etching.

By adopting the technical scheme, when the stent contracts, the proximal end of the stent moves, and the thrombus and the stent can be fixed and stable in the process of taking the thrombus into the guide tube.

Drawings

Fig. 1 shows a schematic structural view of a prior art embolectomy stent.

Fig. 2 shows a schematic structural view of a thrombectomy stent according to an embodiment of the present application.

Fig. 3 shows a partial enlarged view of an embolectomy stent (stent-expanded state) and a thrombus according to an embodiment of the present application.

Fig. 4 shows a partial enlarged view of a thrombectomy stent (stent contracted state) and a thrombus according to an embodiment of the present application.

Fig. 5 shows a schematic view of a stent, core wire and sleeve configuration of an embolectomy device according to an embodiment of the present application.

Fig. 6 shows an enlarged view of a structure of one of the brackets of the embolectomy device according to an embodiment of the present application.

Fig. 7 shows another stent structure diagram of an embolectomy device according to an embodiment of the present application.

FIG. 8 shows a schematic structural view of a stent, core wire and sleeve of an embolectomy device according to another embodiment of the present application.

Fig. 9 shows a schematic structural view of a holder of a thrombectomy device according to another embodiment of the present application.

Fig. 10 shows a schematic structural view of another stent of a thrombectomy device according to another embodiment of the present application.

FIG. 11 shows a schematic structural view of a stent, core wire and sleeve of a thrombectomy device according to yet another embodiment of the present application.

Fig. 12 shows a schematic structural view of a holder of a thrombectomy device according to still another embodiment of the present application.

Description of the reference numerals

1 support

2-core filament

3 casing

4 handle

5 push button

100 thrombus

X is in the front-back direction.

Detailed Description

In order to more clearly illustrate the above objects, features and advantages of the present application, a detailed description of the present application is provided in this section in conjunction with the accompanying drawings. This application is capable of embodiments in addition to those described herein, and is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this application pertains and which fall within the limits of the appended claims. The protection scope of the present application shall be subject to the claims.

As shown in fig. 2 to 4, the present application proposes a thrombectomy stent, which comprises a stent 1, a core wire 2, a sleeve 3, a handle 4 and a button 5.

In the following description, the end of the stent 1 close to the handle 4 (operator) is referred to as the proximal end (right end in fig. 2) of the stent 1, and the end of the stent 1 far from the handle 4 (operator) is referred to as the distal end (left end in fig. 2) of the stent 1.

One end of the core wire 2 is connected to the distal end of the stent 1, and the other end of the core wire 2 is connected to the handle 4.

One end of the sleeve 3 is connected to the proximal end of the holder 1 and the other end of the sleeve 3 is connected to the button 5.

The sleeve 3 may be a hollow cylinder, the core wire 2 is sleeved with the sleeve 3, and the sleeve 3 may slide relative to the core wire 2 along the front-back direction X.

Further, the sleeve 3 may be woven using a metal wire, may be made of a metal tube, or may be formed by combining a metal wire and a metal tube. The metal tube may be cut (e.g. laser cut) in the axial direction of the tube to form a spiral structure in the wall of the tube, which spiral structure may adjust the hardness of the metal tube, resulting in a better fracture resistance of the sleeve 3. The pitch of the helical structure may be different at different parts of the cannula 3, so that corresponding sections of the cannula 3 have a suitable stiffness, e.g. the proximal pitch of the cannula 3 is smaller and the distal pitch of the cannula 3 is larger.

Generally, the hardness of the distal part of the cannula 3 is less than that of the proximal part of the cannula 3, the distal part of the cannula 3 is softer and easier to move in the blood vessel, and the proximal part of the cannula 3 is harder and easier to transmit the pushing force. The distal end of the sleeve 3 (the portion near the stent 1) uses a softer structure (e.g., a wire braid, a metal tube with a helical structure, or a combination of both); a stiffer structure (e.g., a metal tube without a helical structure) is used for the proximal end of the cannula 3 (the portion near the handle 4).

The handle 4 is provided with a button 5 which can slide in the front-rear direction X relative to the handle 4, and the sleeve 3 can be driven to move in the front-rear direction X by pushing and pulling the button 5 in the front-rear direction X, so that the proximal end of the stent 1 moves in the front-rear direction X. When the thrombectomy support is used, the handle 4 is used for holding, and the button 5 can be controlled by fingers.

The handle 4 and/or the button 5 are provided with locking structures that lock the button 5 relative to the handle 4 so that the shape of the stand 1 can be maintained.

Preferably, the handle 4 may be provided with graduation marks located beside the button 5 for marking the displacement of the button 5 in relation to the diameter of the holder 1. The button 5 is provided with a pointer, and the pointer points to the scale marks, so that the position of the button 5 can accurately correspond to the scale marks.

The stent 1 may have a mesh structure formed by weaving, etching, or the like, the stent 1 may be deformed by applying a force in the front-rear direction X, and when both end portions of the stent 1 approach each other by an external force, the stent 1 may be expanded to increase the diameter of the stent 1, and the expanded stent 1 may have a spindle shape having a thick middle portion and thin both end portions.

The distal end of the stent 1 is formed with a protection part (also called tip), the protection part is bent relative to the sleeve 3, the protection part can be made of soft materials, and the protection part is beneficial to steering the stent 1 in the blood vessel and avoids the stent 1 from damaging the blood vessel. It will be appreciated that the protection may also be straight when not subjected to external forces and does not have to be bent with respect to the sleeve 3.

When the operation button 5 moves forward, the sleeve 3 can push the proximal end of the stent 1 to be close to the distal end of the stent 1, so that the stent 1 expands.

When the operation button 5 moves backwards, the sleeve 3 can pull the proximal end of the bracket 1 away from the distal end of the bracket 1, so that the bracket 1 is contracted.

The stent 1 may comprise multiple layers of sub-stents that may co-expand or contract as the stent 1 expands or contracts. The multilayer sub-stent can ensure that the thrombus and the stent 1 are fixed stably and the thrombus is not easy to fall off.

Specifically, as shown in fig. 5 to 7, the stent 1 includes an inner layer embolectomy mesh 11 and an outer layer embolectomy mesh 12, and in a state of not being bound by an external force, the radial dimension of the outer layer embolectomy mesh 12 is larger than that of the inner layer embolectomy mesh 11 as a whole, and the outer layer embolectomy mesh 12 wraps the outside of the inner layer embolectomy mesh 11. The inner layer embolism taking net 11 and the outer layer embolism taking net 12 can be different types of embolism taking nets, the inner layer embolism taking net 11 can be an adjustable embolism taking net, the inner layer embolism taking net 11 can be woven, and is also called a woven embolism taking net, the outer layer embolism taking net 12 can be a self-expansion type embolism taking net, and the outer layer embolism taking net 12 can be carved and is also called a carved embolism taking net. The inner layer embolectomy mesh 11 and the outer layer embolectomy mesh 12 can be made of nickel titanium alloy, and the nickel titanium alloy has elasticity. The degree of densification of the network may vary in different parts of the stent 1.

The proximal end of the inner layer embolectomy mesh 11 is connected to the cannula 3, the distal end of the inner layer embolectomy mesh 11 is connected to the core wire 2, and the core wire 2 can slide in the forward and backward directions relative to the cannula 3. The inner layer embolectomy mesh 11 can be expanded to a shape with thin ends and thick middle by pulling the core wire 2 towards the proximal end by operating the button 5, so that the inner layer embolectomy mesh 11 is embedded into the thrombus.

The proximal end of the outer layer embolectomy mesh 12 is connected to the sleeve 3, and after the outer layer embolectomy mesh 12 is removed from the constraint of the guide catheter, the distal end of the outer layer embolectomy mesh 12 can be expanded by means of the memory property of the distal end so as to be embedded into thrombus.

One end of the core wire 2 is connected to the distal end of the inner layer embolization mesh 11, and the other end of the core wire 2 is connected to the button 5. One end of the cannula 3 is connected to the proximal ends of the inner layer embolectomy mesh 11 and the outer layer embolectomy mesh 12, and the other end of the cannula 3 is connected to the handle 4.

The inner layer embolectomy mesh 11 can be deformed by applying a force in the front-rear direction, and when the two end portions of the inner layer embolectomy mesh 11 approach under the action of an external force, the inner layer embolectomy mesh 11 can be expanded to enlarge the diameter of the inner layer embolectomy mesh 11, and the expanded inner layer embolectomy mesh 11 can be in a spindle shape with a thick middle and thin two ends. The inner layer embolectomy net 11 can have elasticity, and the expanded inner layer embolectomy net 11 can have the tendency of recovering the original state under the effect of the elasticity.

Before use, the inner layer embolectomy mesh 11 and the outer layer embolectomy mesh 12 are in a contracted state. When in use, the outer layer thrombus taking net 12 is embedded into thrombus by means of the expansion of shape memory property of the nickel-titanium alloy after the constraint is removed, and the inner layer thrombus taking net 11 is adjustably expanded and embedded into the thrombus through the core wire 2.

In one possible embodiment, as shown in fig. 8-10, the stent 1 comprises an inner layer embolization mesh 11 and an outer layer embolization mesh 12, the inner layer embolization mesh 11 and the outer layer embolization mesh 12 may be the same type of embolization mesh, and both the inner layer embolization mesh 11 and the outer layer embolization mesh 12 may be woven adjustable embolization meshes.

The sleeve 3 comprises an inner sleeve 31 and an outer sleeve 32, the outer sleeve 32 is sleeved on the inner sleeve 31, and the core wire 2 passes through the inner sleeve 31. The proximal end of the inner screen 11 is attached to the inner sleeve 31 and the distal end of the inner screen 11 is attached to the core wire 2. The proximal end of the outer embolization mesh 12 is attached to the outer sleeve 32, and the distal end of the outer embolization mesh 12 is attached to the core wire 2.

In one possible embodiment, as shown in fig. 11 and 12, the stent 1 comprises an inner layer embolization mesh 11 and an outer layer embolization mesh 12, the inner layer embolization mesh 11 and the outer layer embolization mesh 12 may be different types of embolization meshes, the inner layer embolization mesh 11 may be a self-expanding embolization mesh, and the outer layer embolization mesh 12 may be an adjustable embolization mesh.

The proximal ends of the inner layer embolectomy mesh 11 and the outer layer embolectomy mesh 12 are both connected to the sleeve 3, and the distal end of the outer layer embolectomy mesh 12 is connected to the core wire 2.

It will be appreciated that the inner screen 11 cannot be controlled for expansion and that if it is oversized it may interfere with the outer screen 12 and therefore the inner screen 11 is not oversized. The inner layer embolectomy mesh 11 is limited by the outer layer embolectomy mesh 12, and the inner layer embolectomy mesh 11 can expand sufficiently after the outer layer embolectomy mesh 12 expands controllably.

Preferably, the stent 1 may be made of a material that can be developed by a developing instrument, or the stent 1 may include a developing material, for example, including a plurality of developing points, so that the stent 1 can be observed by the developing instrument.

As shown in fig. 2 to 4, during the operation, the stent 1 firstly passes through the thrombus 100, and then the button 5 is pushed forward to move the sleeve 3 forward, so that the stent 1 expands to fix the thrombus 100 to the stent 1. The thrombus 100 is moved along the blood vessel in the direction outside the body, gradually approaching the opening of the guiding catheter. Thereafter, the handle 4 is grasped to retract the whole thrombus removal stent, and the thrombus 100 can be collected through the guide catheter. Before the stent 1 and the thrombus 100 enter the guide catheter, the stent 1 is contracted to some extent, so that the stent 1 and the thrombus 100 can enter the guide catheter. The handle 4 is kept still, namely the button 5 is pulled backwards under the condition that the whole position of the thrombectomy support is not moved, and the sleeve 3 is pulled backwards to be easily controlled. When the stent 1 is contracted, the distal end position of the stent 1 is not changed, the proximal end guide catheter of the stent 1 moves, the thrombus 100 is stably fixed to the stent 1, the thrombus 100 is not easily detached, and even if the thrombus 100 is detached, the thrombus 100 can be easily accommodated in the guide catheter along with the movement of the proximal end of the stent 1.

It is to be understood that the push button is not limited to moving relative to the handle 4 in the front-rear direction X, but may be configured to be rotatable relative to the handle 4, in which case the push button may also be referred to as a trigger. At this time, for example, when the button is rotated (or pulled) backward away from the stent 1, the button moves the sleeve 3 backward (moves toward the proximal end), thereby contracting the stent 1.

While the present application has been described in detail with reference to the above embodiments, it will be apparent to those skilled in the art that the present application is not limited to the embodiments described in the present specification. The present application can be modified and implemented as a modified embodiment without departing from the spirit and scope of the present application defined by the claims. Therefore, the description in this specification is for illustrative purposes and does not have any limiting meaning for the present application.