WO2021089064A2

WO2021089064A2 - Thrombus extraction device and thrombus extraction system for aorta and branch arteries thereof

Info

Publication number: WO2021089064A2
Application number: PCT/CN2021/070760
Authority: WO
Inventors: 刘昌伟; 狄潇
Original assignee: 刘昌伟; 狄潇
Priority date: 2019-11-08
Filing date: 2021-01-08
Publication date: 2021-05-14
Also published as: CN110680458A; WO2021089064A3

Abstract

A thrombus extraction device and a thrombus extraction system for the aorta and branch arteries thereof, relating to the field of medical instruments. The thrombus extraction device for the aorta and branch arteries thereof comprises a guide tube (10), a guide wire tube (20), an outer sheath (30), and a collection assembly (40). The guide wire tube (20) penetrates the guide tube (10), and a front end of the guide wire tube (20) extends out of the guide tube (10). The collection assembly (40) is arranged at the front end of the guide wire tube (20), and comprises a filter mesh sleeve (41) sleeved on the guide wire tube (20), an elastic ring (42), and ties (43). A mesh bottom of the filter mesh sleeve (41) is arranged on an outer wall of the guide tube (10), and a mesh opening ring of the filter mesh sleeve (41) is arranged on the elastic ring (42). One end of each of the plurality of ties (43) is connected to the elastic ring (42), and the other end passes through the guide wire tube (20) to the outside of the guide wire tube (20). The outer sheath (30) is sleeved on the outside the guide tube (10), and is able to move along the length direction of the guide tube (10), thereby retracting or releasing the collection assembly (40). The invention is able to cooperate with a thrombus extraction balloon assembly (60) to extract a tumor thrombus, and is able to effectively prevent the risk of distal-end embolization during a thrombus removal process.

Description

Aorta and its branch arteries thrombus removal device and thrombus removal system

Technical field

This application relates to the field of medical devices, and specifically to a thrombectomy device and thrombectomy system for the aorta and its branch arteries.

Background technique

Embolic lesions of the aorta and its first-level branch arteries have always been a difficult point in vascular surgery. The minimally invasive thrombus aspiration method can extract acute thrombosis, but it cannot handle subacute and chronic thrombus, let alone the tumor thrombus, and there is a risk of thrombus easy to fall off and cause distal embolism; minimally invasive catheter thrombolysis method It can dissolve acute thrombosis and some subacute thrombosis, but it is also unable to deal with tumor thrombus, and there is a high risk of bleeding and the risk of thrombus shedding leading to distal embolism.

In summary, it is difficult to handle tumor thrombi in the prior art, and there is a risk that the thrombus is easy to fall off during the thrombus removal process, which may cause distal embolization.

Summary of the invention

The purpose of the present application is to provide an aortic and its branch arterial thrombus removal device and thrombus removal system, which can collect thrombus or tumor thrombus after balloon thrombus removal, thereby preventing the risk of distal embolization.

Based on the above objectives, the aortic and its branch arterial thrombus removal device provided by the present application includes: a guide tube, a guide wire tube, an outer sheath, and a collection component;

The guide wire tube passes through the guide tube, and the front end of the guide wire tube extends from the guide tube;

The collection component is arranged at the front end of the guide wire tube, and the collection component includes a filter sleeve, an elastic ring and a binding wire sleeved on the guide wire tube;

The mesh bottom of the filter sleeve is arranged on the outer wall of the guide tube, and the mesh opening of the filter sleeve is looped on the elastic ring; one end of the plurality of binding wires is connected to the elastic ring, and the other end Lead through the guide wire tube to the outside of the guide wire tube;

The outer sheath is sheathed on the outside of the guide tube and can move along the length direction of the guide tube, so as to retract or release the collection assembly.

In this technical solution, since the mesh bottom of the filter sleeve is connected to the outer wall and the mesh opening is connected to the elastic ring, in the released state, the filter sleeve can collect the thrombus or tumor thrombus dragged into the aorta by the thrombus removal balloon assembly, and then Utilize the binding thread to close the elastic ring and the filter cover, wrap the filter cover and the elastic ring with the outer sheath, and withdraw the embolization device from the aorta and its branch arteries along the guide wire to complete the embolization process, effectively preventing Risk of distal embolism during embolectomy.

Further, when the elastic ring is in a released state, the filter sleeve has a cone shape.

In this technical solution, since the filter sleeve is in the shape of a funnel, thrombus or tumor thrombus can be intercepted and collected, thereby avoiding the risk of distal embolism.

Further, the filter screen cover adopts a membrane structure, and a plurality of through holes are arranged on it; or, the filter screen cover is woven with metal wires.

In this technical solution, the role of the through hole is to pass blood, thereby avoiding blockage of the aorta in the process of collecting thrombus or tumor thrombus.

Further, a guide head is provided on the guide wire tube, and the guide head is in the shape of a cone.

In this technical solution, since the guide head is set in a cone shape, it is convenient to break the tissue and enter the aorta, so that the thrombus removal device can reach the surgical site smoothly.

Further, a plurality of threading holes are provided on the peripheral side of the guide wire tube, and the threading holes are communicated with the inside of the guide wire tube.

In this technical solution, using multiple threading holes on the circumference of the guide wire tube, multiple binding threads can be led to the outside through the threading holes and the threading tube in turn, and then the elastic ring can be controlled to close or release through the multiple binding threads. .

Further, a metal wire that can be identified under X-ray irradiation is wound on the surface of the elastic ring.

In this technical solution, the metal wire is provided to facilitate the doctor to observe the position of the elastic ring in the human body under X-ray irradiation.

Further, a fixing component is provided at the tail end of the guide tube, and the fixing component is used to fix the tail end of the binding wire.

Further, the fixing assembly includes a branch catheter and a connector, the branch catheter is arranged on the side wall of the guide tube and communicates with the inside of the guide wire tube, and the connector is detachable from the branch catheter Connection, the connector is used to connect the tie wire.

In this technical solution, since the connector is connected to the tie wire, when the connector is fixed on the branch catheter, the elastic ring is in a released state, which can be used to collect thrombus or tumor thrombus; when the connector is away from the branch catheter, the tie wire pulls the elastic ring to be in a closed state , To achieve the storage of thrombus or tumor thrombus.

Further, the tail end of the guide tube is provided with a water injection hole, which is used to fill liquid between the guide tube and the outer sheath to discharge air, so as to avoid the influence of the air on the human body during the thrombus removal process.

The present application provides an aortic thrombus removal system, a thrombus removal balloon assembly, a guide wire, and the thrombus removal device according to any one of the above;

The thrombus removal balloon assembly is used to drag the thrombus or tumor thrombus in the branch artery into the aorta;

The guide wire is inserted into the guide wire tube in the thrombus removal device, and under the guidance of the guide wire, the thrombus removal device enters the aorta, and then the thrombus or tumor is treated by the filter sleeve. Shut to collect.

The aortic and its branch arterial thrombus removal device and thrombus removal system provided in this application have the following technical effects:

Since the bottom of the filter sleeve is connected to the outer wall, and the mesh opening is connected with the elastic ring, in the released state, the filter sleeve can collect the thrombus or tumor thrombus dragged by the thrombus removal balloon assembly into the aorta, and then use the binding thread to make elastic The ring is folded together with the filter cover, the filter cover and the elastic ring are wrapped by the outer sheath, and the aorta and its branch artery thrombus removal device is withdrawn along the guide wire to complete the thrombus removal process. It can not only cooperate with the thrombus removal balloon assembly Removal of tumor thrombus can effectively prevent the risk of distal embolism during thrombus removal.

Description of the drawings

In order to more clearly illustrate the specific embodiments of this application or the technical solutions in the prior art, the following will briefly introduce the drawings that need to be used in the specific embodiments or the description of the prior art. Obviously, the appendix in the following description The drawings are some embodiments of the application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

FIG. 1 is a schematic diagram of the aortic and its branch artery embolization device in the released state provided in the first embodiment of the application; FIG.

2 is a schematic diagram of the collection assembly provided in the first embodiment of the application in a folded state;

FIG. 3 is a schematic diagram of the aortic and its branch artery embolization device provided in the first embodiment of the application in a collapsed state; FIG.

4 is a schematic diagram of a partial structure of the guide wire tube provided in the first embodiment;

5 is a schematic diagram of another structure of the aortic and its branch arterial thrombus removal device provided in the first embodiment of the application;

6 is a flowchart of steps A to C in the thrombus removal method provided in the second embodiment of the application;

FIG. 7 is a flowchart of steps D to E in the thrombus removal method provided in the second embodiment of the application;

FIG. 8 is a flowchart of steps F to H of the aortic and its branch arterial thrombus removal device of another structure in the thrombus removal method provided in the second embodiment of the application; FIG.

FIG. 9 is a flowchart of steps I to J of the aortic and its branch arterial embolization device adopting another structure in the embolization method provided in the second embodiment of the application.

Icon: 10-Guide tube; 11-Branch catheter; 12-Connector; 13-Water injection hole; 20-Guide wire tube; 21-Guide head; 22-Thread hole; 30-Outer sheath; 40-Collection assembly; 41 -Filter cover; 411-through hole; 42-elastic ring; 43-binding wire; 50-hard guide wire; 60-plug-removing balloon assembly.

Detailed ways

The technical solution of the present application will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the description of this application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. The indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the pointed device or element must have a specific orientation or a specific orientation. The structure and operation cannot therefore be understood as a limitation of this application. In addition, the terms "first", "second", and "third" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance.

In the description of this application, it should be noted that the terms "installation", "connection", and "connection" should be understood in a broad sense, unless otherwise clearly specified and limited. For example, it can be a fixed connection or a detachable connection. Connected or integrally connected; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components. For those of ordinary skill in the art, the specific meanings of the above-mentioned terms in this application can be understood under specific circumstances.

Example one

The aorta and its branch arterial thrombus removal device provided in the present application, on the one hand, can collect the tumor thrombus when the thrombus removal balloon assembly drags the tumor thrombus to the aorta, so as to realize the thrombus removal of the tumor thrombus; on the other hand, It can also effectively prevent the risk of distal embolism during thrombectomy.

As shown in FIGS. 1, 2 and 3, the present application provides a thrombus removal device for the aorta and its branch arteries, which includes a guide tube 10, a guide wire tube 20, an outer sheath 30 and a collection assembly 40.

The function of the guide wire tube 20 is to pierce a hard guide wire 50. The guide wire tube 20 is inserted into the guide tube 10, and the front end of the guide wire tube 20 extends from the guide tube 10. When used, the guide wire tube 20 is required. It is fixedly connected to the guide tube 10, so that the guide wire tube 20 can drive the guide tube 10 to move;

The collection assembly 40 is disposed at the front end of the guide wire tube 20, and the collection assembly 40 includes a filter cover 41, an elastic ring 42 and a binding wire 43 sheathed on the guide wire tube 20.

The mesh bottom of the filter sleeve 41 is set on the outer wall of the guide tube 10, and the mesh opening of the filter sleeve 41 is looped on the elastic ring 42; one end of the plurality of binding wires 43 is connected to the elastic ring 42, and the other end passes through the guide wire tube 20 And lead to the outside of the guide wire tube 20;

When the restraint wire 43 is pulled, the elastic ring 42 is closed under the action of the restraint wire 43, thereby closing the mesh opening of the filter cover 41 to realize the storage of thrombus or tumor thrombus;

When the restraint wire 43 is released, the elastic ring 42 returns to its original shape under the action of its own elastic force, so that the mesh opening of the filter cover 41 is opened, so that the thrombus or tumor thrombus can be collected;

The outer sheath 30 is sleeved on the outside of the guide tube 10 and can move along the length direction of the guide tube 10.

When the filter cover 41 is in the collapsed state, the outer sheath 30 can be used to close the filter cover 41 to the inside, thereby facilitating the removal of the thrombus removal device outside the body;

When the thrombus removal device enters the preset position in the aorta, the outer sheath 30 is moved away from the collection assembly 40, and the collection assembly 40 is released, so that the filter cover 41 can collect thrombus or tumor thrombus.

In the technical solution of the present application, since the mesh bottom of the filter sleeve 41 is connected to the outer wall of the guide wire tube 20, and the mesh port is connected with the elastic ring 42, in the released state, the filter sleeve 41 can drag the embolization balloon assembly into the aorta The thrombus or tumor thrombus is collected, and then the elastic ring 42 and the filter cover 41 are gathered by the binding thread 43, the filter cover 41 and the elastic ring 42 are wrapped by the outer sheath 30, and the rigid guide wire 50 is withdrawn. The thrombus removal device for the aorta and its branch arteries completes the thrombus removal process, not only can cooperate with the thrombus removal balloon assembly to remove the tumor thrombus, but also can effectively prevent the risk of distal embolization during the embolization process.

In an optional embodiment of the present application, when the elastic ring 42 is in the released state, the filter sleeve 41 is expanded into a funnel shape, which can intercept and collect thrombus or tumor thrombus, and avoid the risk of distal embolism.

In an alternative embodiment of the present application, referring to Figure 1, the mesh opening position of the filter cover 41 can be set to face the guide head 21. The aorta and its branch arterial thrombus removal device of this type of structure (the first Structure) Mainly suitable for embolism removal from the inferior branch of the aorta;

In addition, referring to Figure 5, the mesh opening position of the filter cover 41 can also be set back to the guide head 21. The aorta and its branch artery thrombus removal device (the second structure) of this structure is mainly suitable for the aorta Take the bolt from the upper branch.

In an alternative embodiment of the present application, the filter cover 41 adopts a membrane structure, and a plurality of through holes 411 are provided thereon. The function of the through hole 411 is to pass blood, thereby avoiding blockage of the aorta during the process of collecting thrombus or tumor thrombus.

In addition, as an optional embodiment, the filter cover 41 can also be woven with metal wires.

In an alternative embodiment of the present application, a guide head 21 is provided on the guide wire tube 20, and the guide head 21 is provided at the front end of the guide wire tube 20 and is located upstream of the collection assembly 40, and the guide head 21 is in the shape of a cone. The cone-shaped guide head 21 facilitates breaking the tissue into the aorta, so that the thrombus removal device can reach the surgical site smoothly.

As shown in FIG. 4, in an optional embodiment of the present application, a plurality of threading holes 22 are provided on the peripheral side of the guide wire tube 20, and the threading holes 22 are in communication with the inside of the guide wire tube 20. Using the multiple threading holes 22 on the peripheral side of the guide wire tube 20, the multiple binding threads 43 connected to the elastic ring 42 can be led to the outside through the threading holes 22 and the threading tube in turn, and then pass through the multiple binding threads 43 Control the folding or releasing of the elastic ring 42.

In an alternative embodiment of the present application, the surface of the elastic ring 42 is wound with a metal wire that can be easily identified under X-ray irradiation. By providing the metal wire, it is convenient for the doctor to observe the position of the elastic ring 42 in the human body under X-ray irradiation.

In addition, the edge of the elastic ring 42 can also be set in a wave-shaped structure, so that the elastic ring 42 can be gathered by the tie line 43.

As shown in FIGS. 1 to 3, in an alternative embodiment of the present application, a fixing component is provided at the tail end of the guide tube 10, and the fixing component is used to fix the tail end of the tie wire 43. Further, the above-mentioned fixing assembly includes a branch catheter 11 and a connector 12, the branch catheter 11 is arranged on the side wall of the guide tube 10 and communicates with the inside of the guide wire tube 20, and the connector 12 is detachably connected to the branch catheter 11 and connected The head 12 is used to connect the tie wire 43.

In this technical solution, the tie wire 43 can be introduced into the branch catheter 11 through the guide wire tube 20 and connected to the connector 12. Since the connector 12 is connected to the tie wire 43, when the connector 12 is fixed on the branch catheter 11, it is elastic The ring 42 is in the released state and can be used to collect thrombus or tumor thrombus; when the connecting head 12 is away from the branch catheter 11, the binding wire 43 pulls the elastic ring 42 to be in a retracted state, so as to store the thrombus or tumor thrombus.

In addition, a water injection hole 13 is also provided at the tail end of the guide tube 10 for filling liquid between the guide tube 10 and the outer sheath 30 to discharge air, thereby avoiding air being brought into the human body during the removal of the thrombus. Danger to the human body.

Example two

As shown in FIGS. 6 and 7, an embodiment of the present application provides an aortic embolization removal system, which includes an embolization removal balloon assembly 60, a rigid guide wire 50, and the embolization removal system provided in the first embodiment above. The device (it can be the plug removal device of the first structure or the plug removal device of the second structure).

It should be noted that since the structure of the bolt removal device has been described in the first embodiment, it will not be repeated in this embodiment.

The thrombus removal balloon assembly 60 is used to drag the thrombus or tumor thrombus in the branch artery into the aorta;

The hard guide wire 50 is inserted into the guide wire tube 20 in the thrombus removal device, and the thrombus removal device is inserted into the aorta under the guidance of the hard guide wire 50, and the thrombus or tumor thrombus is treated by the filter cover 41. Collect it.

The following describes the embolectomy method using the aortic embolization system provided in the present application. When the aortic embolization system includes the first structure of the aorta and its branch artery embolization device, the embolization method is applied to the lower aortic branch. The way is to take the bolt; referring to Figure 6 and Figure 7, the steps are as follows:

Step A, introduce the aorta and its branch artery thrombus removal device from the femoral artery puncture point along the hard guide wire 50 passage;

Step B: Position the aorta and its branch artery embolization device in the aorta below the opening of the renal artery, and withdraw the outer sheath 30 horizontally, and release the elastic ring 42 and the filter cover 41 in the collection assembly 40 to make the filter cover 41 is in an open mouth state;

Step C, performing the balloon thrombus removal operation, the thrombus removal is completed, and the thrombus falls into the filter cover 41;

Step D: Lift the binding wire 43 to adjust the elastic ring 42 and the filter cover 41 to a closed state;

Step E: Push up the outer sheath 30 to wrap the elastic ring 42 and the filter cover 41 into the outer sheath 30;

In step F, the aorta and its branch artery embolization device are withdrawn along the rigid guide wire 50.

8 and 9, when the aortic embolization system includes the second structure of the aorta and its branch artery embolization device, the embolization method is applied to the upper aortic branch for embolization: the steps are as follows:

Step F, introduce the aorta and its branch arterial thrombus removal device from the femoral artery puncture point along the hard guide wire 50 passage;

Step E: Push down the outer sheath 30 to wrap the elastic ring 42 and the filter cover 41 into the outer sheath 30;

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the application, not to limit them; although the application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: It is still possible to modify the technical solutions described in the foregoing embodiments, or equivalently replace some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the embodiments of the present application. range.

Claims

A thrombus removal device for aorta and its branch arteries, which is characterized in that it comprises a guide tube, a guide wire tube, an outer sheath and a collection component;

The guide wire tube passes through the guide tube, and the front end of the guide wire tube extends from the guide tube;

The collection assembly is arranged at the front end of the guide wire tube, and the collection assembly includes a filter sleeve, an elastic ring and a binding wire sleeved on the guide wire tube;

The mesh bottom of the filter sleeve is arranged on the outer wall of the guide tube, and the mesh opening of the filter sleeve is looped on the elastic ring; one end of the plurality of binding wires is connected to the elastic ring, and the other end Lead through the guide wire tube to the outside of the guide wire tube;

The outer sheath is sheathed on the outside of the guide tube and can move along the length direction of the guide tube, so as to close or release the collection assembly.
The aorta and its branch arterial thrombus removal device according to claim 1, characterized in that, when the elastic ring is in a released state, the filter sleeve is in the shape of a funnel.
The aorta and its branch arterial thrombus removal device according to claim 1, wherein the filter cover adopts a membrane structure with a plurality of through holes provided thereon; or, the filter cover is braided with metal wires. to make.
The aorta and its branch arterial thrombus removal device according to claim 1, wherein a guide head is provided on the guide wire tube, and the guide head is in the shape of a cone.
The aorta and its branch arterial thrombus removal device according to claim 1, wherein a plurality of threading holes are provided on the peripheral side of the guide wire tube, and the threading holes are in communication with the inside of the guide wire tube. .
The aorta and its branch arterial thrombus removal device according to claim 1, wherein a metal wire that can be identified under X-ray irradiation is wound on the surface of the elastic ring.
The aorta and its branch arterial thrombus removal device according to any one of claims 1-6, wherein the tail end of the guide tube is provided with a fixing component, and the fixing component is used to fix the restraint wire The tail end is fixed.
The aorta and its branch arterial thrombus removal device according to claim 7, wherein the fixing assembly comprises a branch catheter and a connector, and the branch catheter is arranged on the side wall of the guide tube and is connected to the The inside of the guide wire tube is communicated, the connector is detachably connected to the branch catheter, and the connector is used to connect the restraint wire.
The aorta and its branch arterial thrombus removal device according to claim 1, wherein the tail end of the guide tube is provided with a water injection hole for filling liquid between the guide tube and the outer sheath To expel the air.
An aortic thrombus retrieval system, which is characterized by comprising a thrombus retrieval balloon assembly, a guide wire, and the thrombus retrieval device according to any one of claims 1-9;

The thrombus removal balloon assembly is used to drag the thrombus or tumor thrombus in the branch artery into the aorta;

The guide wire is inserted into the guide wire tube in the thrombus removal device, and under the guidance of the guide wire, the thrombus removal device enters the aorta, and then the thrombus or tumor is treated by the filter sleeve. Shut to collect.