CN108852466B

CN108852466B - Thrombus taking device

Info

Publication number: CN108852466B
Application number: CN201810769730.6A
Authority: CN
Inventors: 顾建平; 成正辉; 尹周; 苏浩波; 王端诚; 楼文胜
Original assignee: Hunan Epte Medical Equipment Co ltd
Current assignee: Hunan Epte Medical Equipment Co ltd
Priority date: 2018-07-13
Filing date: 2018-07-13
Publication date: 2021-07-06
Anticipated expiration: 2038-07-13
Also published as: CN108852466A

Abstract

The invention discloses a thrombus remover, which comprises: the bolt taking piece has self-expansibility; the core shaft is used for driving the embolectomy piece to move from an entrance wound on one side of the thrombus on the blood vessel to an exit wound on the other side of the thrombus, so that the embolectomy piece drives the thrombus to move out of the exit wound. In the thrombectomy ware in this application, get the embolism and go into the way and go out the way differently, only need set up to connect get the embolism in order to promote get the dabber of embolism motion through the thrombus can, get after the release after the embolism reaches thrombus department, continue to remove according to former direction, the thrombus can remove along with getting the embolism, until getting the embolism and taking out the thrombus from shifting out the wound. For the lesion section of the long thrombus section, the mandrel is easier to pass through, the passing rate of the thrombus passing by the thrombus extractor is increased, the thrombus extraction efficiency can be improved, and the success rate of the operation can be improved.

Description

Thrombus taking device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a thrombus extractor.

Background

The intravascular embolism is a common and frequently encountered disease in clinic, and refers to abnormal coagulation of blood in blood vessels, wherein the coagulation reason can be an external induction factor or a genetic factor. Thrombus is often formed in a human body, and emboli formed in blood of the human body can cause partial or complete blockage of blood vessels and block blood supply at the far ends of the blood vessels. The formed thrombus may also fall off, and the blood flow blocks blood vessels of other parts, so that ischemia and hypoxia of tissues and organs of the corresponding parts are caused, and finally, the pathologies of necrosis, edema and the like of the tissues or organs are caused.

Clinically, there are different treatments according to the location of the thrombus and the severity of the thromboembolism, and one of the treatments is to remove the formed thrombus. However, in the long thrombus lesion section, the thrombus removal efficiency of the current thrombus remover is low, so that the success rate of the operation is relatively low.

Therefore, how to improve the success rate of the operation and the efficiency of thrombus removal is a technical problem which needs to be solved by the technicians in the field at present.

Disclosure of Invention

In view of the above, the present invention provides an embolectomy device, which can improve the success rate of the operation and the embolectomy efficiency.

In order to achieve the purpose, the invention provides the following technical scheme:

a thrombectomy device, comprising:

a plug member, said plug member having self-expanding properties;

the core shaft is used for driving the embolectomy piece to move from an entrance wound on one side of the thrombus on the blood vessel to an exit wound on the other side of the thrombus, so that the embolectomy piece drives the thrombus to move out of the exit wound.

Preferably, soft heads are arranged at two ends of the mandrel, and the hardness of the soft heads is smaller than that of the mandrel.

Preferably, only one end of the mandrel is provided with a soft head, and the hardness of the soft head is smaller than that of the mandrel.

Preferably, one end of the mandrel is provided with a soft head, and the other end of the mandrel is provided with a soft head connecting piece used for detachably connecting the soft head, so that the mandrel can form a closed loop structure connected end to end; the hardness of the soft head is less than that of the mandrel.

Preferably, the thrombus removing device further comprises a first catheter for collecting thrombus at the removing wound of the blood vessel, wherein the first catheter is a through structure with two open ends, so that the mandrel passes through the first catheter.

Preferably, the apparatus further comprises a second catheter for assisting entry of the embolectomy member into the blood vessel at the entry wound of the blood vessel, the embolectomy member being movably retractable in the second catheter.

Preferably, the developing marker is connected to the bolt taking piece and/or the mandrel.

Preferably, the number of the bolt taking pieces is several, and all the bolt taking pieces are sequentially arranged along the extension direction of the mandrel.

Preferably, the latch member is a bracket.

Preferably, the bolt is a mesh basket with a mesh structure.

The invention provides a bolt extractor which comprises a bolt extracting piece and a mandrel. The bolt taking piece has self-expansion shape. The thrombus taking part is connected to the mandrel, and the mandrel is used for driving the thrombus taking part to move from the entrance wound on one side of the thrombus to the exit wound on the other side of the thrombus on the blood vessel so that the thrombus is driven by the thrombus taking part to move out of the exit wound.

In the thrombus taking device, the mandrel is used for driving the thrombus taking piece to move from an entrance wound to an exit wound, the entrance path of the thrombus taking piece is different from the exit path of the thrombus, and the thrombus taking piece can be released and expanded before reaching the thrombus. The thrombus removal device comprises a thrombus removal device, a thrombus removal device and a control device, wherein the thrombus removal device is used for removing thrombus; the outlet of the thrombus refers to a pipeline for the thrombus to move out of the blood vessel along with the embolectomy piece, and particularly refers to a pipeline from a position where the thrombus does not move along with the embolectomy piece to a position where the thrombus is moved out of a wound.

When the released thrombus taking piece reaches the thrombus, the thrombus continues to move in the original direction, and the thrombus can move along with the thrombus taking piece until the thrombus is taken out of the removal wound by the thrombus taking piece. For the lesion section of the long thrombus section, the mandrel is easier to pass through, the passing rate of the thrombus passing by the thrombus extractor is increased, the thrombus extraction efficiency can be improved, and the success rate of the operation can be improved.

In addition, in the prior art, the thrombus taking device adopting the same tube for the thrombus entering path and the thrombus exiting path, when in operation, the wound of the thrombus taking device entering the blood vessel and the wound of the thrombus exiting the blood vessel are usually the same. Because the embolectomy piece has self-expansibility, the existing embolectomy piece needs to be restrained by a small-diameter catheter firstly, the embolectomy piece is sent into a blood vessel under the assistance of the small-diameter catheter, the small-diameter catheter penetrates through a thrombus position and then is withdrawn to release the embolectomy piece, so that the embolectomy piece can capture thrombus. For lesions with long sections of thrombus, it is not easy for small diameter catheters to pass through the thrombus section. Compare in this current thrombectomy ware, thrombectomy ware in this application only needs to set up the dabber that can drive thrombectomy spare motion, need not to set up the restriction of minor diameter pipe and gets the thrombectomy spare and run through the thrombus, and the diameter of dabber can set up the minor diameter pipe that is far less than in this application, can greatly improve the success rate of thrombectomy.

In addition, the embolectomy piece usually moves from the far end to the near end, and in the process of moving the embolectomy piece, the embolectomy piece can block the far end of the thrombus, so that the thrombus broken in the embolectomy process can be prevented from flowing into other tissues and organs along with blood, the risk of far-end embolism is reduced, and a far-end protector does not need to be additionally placed or the blood flow is blocked.

In a preferred embodiment of the embolectomy device provided by the application, the number of embolectomy pieces is a plurality, and all the embolectomy pieces are sequentially arranged along the extending direction of the mandrel, so that the embolectomy efficiency of a long thrombus lesion section can be further improved. In addition, due to the fact that the thrombus taking member is different from the thrombus outlet path, the problem that the space at the far end of the blood vessel is not enough to accommodate a plurality of thrombus taking members in thrombus taking can be solved

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.

FIG. 1 is a first use view of the embolectomy device provided by the present invention;

FIG. 2 is a schematic structural diagram of a first embodiment of a thrombus removal device provided by the present invention;

FIG. 3 is a block diagram of a first type of bolt remover provided by the present invention;

FIG. 4 is a block diagram of a second type of bolt remover provided by the present invention;

FIG. 5 is a block diagram of a third type of embolectomy device provided by the present invention;

FIG. 6 is a block diagram of a fourth type of embolectomy device provided by the present invention;

FIG. 7 is a block diagram of a fifth type of embolectomy device provided by the present invention;

FIG. 8 is a block diagram of a sixth type of embolic element in the embolic device provided by the present invention;

FIG. 9 is a schematic structural diagram of a second embodiment of a thrombus removal device provided by the present invention;

FIG. 10 is a schematic structural diagram of a third embodiment of a thrombus removal device provided by the present invention;

FIG. 11 is a schematic structural diagram of a fourth embodiment of a thrombus removal device provided by the present invention;

FIG. 12 is a schematic structural diagram of a fifth embodiment of a thrombus removal device provided by the present invention;

FIG. 13 is a schematic structural view of a sixth embodiment of a thrombus removal device provided by the present invention;

FIG. 14 is a schematic structural diagram of a seventh embodiment of a thrombus removal device provided by the present invention;

FIG. 15 is a schematic structural diagram of an eighth embodiment of a thrombus removal device provided by the present invention;

fig. 16 is a second use of the embolectomy device provided by the present invention.

In fig. 1 to 16, 1-mandrel, 2-soft head, 3-bolt taking part, 31-basket with two open ends, 32-basket with one open end and one closed end of first type, 33-basket with one open end and one closed end of second type, 34-basket with two closed ends, 35-porous basket, 351-porous polymer membrane, 352-metal framework, 4-developing marker, 41-spring developing marker, 42-filament developing marker, 43-annular developing marker, 5-second catheter, 6-entrance wound, 7-first catheter, 8-exit wound, 9-thrombus and 10-soft head connecting part.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The core of the invention is to provide a thrombus removal device which can improve the success rate of the operation and the thrombus removal efficiency.

In one embodiment of the present invention, referring to fig. 1 and 2, the bolt extractor comprises a bolt member 3 and a mandrel 1. The embolectomy member 3 has self-expandable properties, and can be contracted to decrease its volume or released to increase its volume, and the embolectomy member 3 can be used to cut and capture the thrombus 9. The bolt is connected to the mandrel. The mandrel is used for driving the thrombus taking part 3 to move from the entrance wound 6 on one side of the thrombus to the exit wound 8 on the other side of the thrombus on the blood vessel, so that the thrombus taking part drives the thrombus to move out of the exit wound 8. Removal wound 8 is a different wound on the vessel than access wound 6.

By adopting the thrombus extractor, the mandrel 1 can pass through the lesion section of the long thrombus 9 easily, so that the passing rate of the thrombus extractor through the thrombus 9 is increased, and the thrombus extraction efficiency and the success rate of the operation can be improved; meanwhile, in the process of moving the thrombus taking piece 3, the thrombus taking piece 3 can block the far end of the thrombus 9, so that the thrombus 9 broken in the thrombus taking process can be prevented from flowing into tissue organs of other parts along with blood, and the risk of far-end embolism is reduced.

The mandrel 1 can be in a filament, rod or strip structure and has certain breaking resistance and tensile strength. The mandrel 1 is mainly used for connecting the soft head 2, the bolt taking piece 3, the developing indication mark 4 and the like, and is convenient for releasing and recovering the bolt taking piece 3 in vitro operation. In order to meet different clinical requirements, the mandrel 1 can be made of different materials in different sections, and can also be made of the same material in different size structures. The material of the mandrel 1 may be a metal, such as: niti, stainless steel, etc.; may be a polymer such as PTFE, PI, etc.; it can also be a composite of multiple materials, such as: the Niti wire with the PTFE coating can ensure certain fracture resistance and tensile strength, can ensure smooth surface and has better trafficability characteristic. The length of the mandrel 1 can be adjusted according to clinical requirements, and one end of each bolt taking piece 3 can be longer, and the other end of each bolt taking piece can be shorter, as shown in fig. 9; it is also possible that all the access members 3 have a similar length at both ends, as shown in fig. 14.

The mandrel 1 may be inserted into the plug 3, or may be connected only to the end of the plug 3.

Wherein, at least one end of the mandrel 1 can be provided with a soft head 2, and the hardness of the soft head 2 is less than that of the mandrel 1. The soft head 2 makes the thrombus taking device not easy to damage blood vessels and scratch instruments. The specific hardness of the soft head 2 can be adjusted according to the application position of the apparatus, and the material can be metal material, high polymer material or the combination of the metal material and the high polymer material.

Specifically, the soft heads 2 can be arranged at the two ends of the mandrel 1, the blood vessels cannot be damaged at the two ends of the mandrel 1, and the whole mandrel 1 can completely enter the blood vessels. When the thrombus removal device is used, the first soft head 2 of the mandrel 1 can enter a blood vessel from the entrance wound 6, the mandrel 1 continuously moves, the second soft head 2 of the mandrel 1 also enters the blood vessel from the entrance wound 6, after the first soft head 2 on the mandrel and the thrombus 9 are removed from the removal wound 8, the mandrel 1 can continue to move in the original direction until the second soft head 2 can also be directly removed from the removal wound 8, and therefore the thrombus removal device can be conveniently taken out of the blood vessel without damaging the blood vessel.

Or, the soft head 2 can be arranged at only one end of the mandrel 1, which is beneficial to reducing the manufacturing cost. In this case, only one end of the soft tip 2 may be inserted into the blood vessel, and the other end may not be inserted into the blood vessel at all times. After one end of the mandrel 1 provided with the soft head 2 enters the blood vessel from the entrance wound 6, the mandrel 1 moves along the original direction until the thrombus is removed from the exit wound 8 along with the thrombus taking piece. Then, thrombus on the thrombus taking device can be cleaned, and the mandrel 1 drives the cleaned thrombus taking piece to move reversely so as to realize the taking-out of the mandrel 1.

Referring to fig. 15, one end of the mandrel 1 may be provided with a soft head and the other end is provided with a soft head connector 10 for detachably connecting the soft head, so that the mandrel 1 can form a closed loop structure in an end-to-end manner.

When in use, please refer to fig. 16, one end of the mandrel 1, which is provided with the soft head 2, can be sent into the blood vessel from the entrance wound and continuously moved, after the thrombus is driven by the embolectomy member to move out of the blood vessel from the exit wound, the soft head connecting member 10 positioned outside the blood vessel is connected with the soft head 2, so that the mandrel 1 forms a closed loop, and meanwhile, the thrombus attached on the embolectomy member is cleaned.

Then, the mandrel 1 is continuously pulled along the original moving direction to move, so that the embolectomy piece enters the blood vessel again to carry out embolectomy. After the thrombus is taken out of the blood vessel, the thrombus on the thrombus taking piece can be cleaned up, the process of pulling the closed mandrel 1 to move is repeated, and the thrombus taking operation is continuously carried out for a plurality of times until the thrombus in the blood vessel is thoroughly removed. After that, the soft head 2 is disconnected from the soft head connecting piece 10 end to end, and the bolt remover is withdrawn. The using method can avoid the problem that the core shaft 1 needs to be fed into the bolt taking process for many times, and is convenient for improving the bolt taking efficiency for many times. Wherein, the soft head connector 10 can be selected from the materials of the soft head 2.

Further, the embolectomy device may further comprise a first catheter 7 for collecting the thrombus 9 at the removal wound 8 of the blood vessel, wherein the first catheter 7 is a through structure with two open ends so that the mandrel 1 passes through the first catheter 7. Referring to fig. 1, the mandrel 1 enters the blood vessel from the entrance wound 6 and drives the thrombus 9 to move toward the exit wound 8 on the blood vessel, the first catheter 7 is inserted into the exit wound 8 on the blood vessel, and the mandrel 1 drives the thrombus 9 to directly move into the first catheter 7, so that the thrombus 9 can be conveniently collected, and the injury of the thrombus to the exit wound 8 can be avoided.

On the basis of any of the above embodiments, referring to fig. 1, the embolectomy device may further comprise a second catheter 5 for assisting the embolectomy member 3 in entering the blood vessel at the entrance wound 6 of the blood vessel, wherein the embolectomy member 3 can be movably retracted in the second catheter 5.

In use, the entry path of the thrombus removal member and the exit path of the thrombus 9 are selected, and the entry wound 6 and the exit wound 8 which are respectively positioned at two sides of the thrombus 9 are determined. The first catheter 7 is placed along the path of the thrombus 9 and the second catheter 5 is placed along the path of the embolectomy. The mandrel 1 is pushed through the thrombus section, into the first catheter 7 and out of the body. The first catheter 7 and the second catheter 5 are fixed, and the mandrel 1 is pulled out toward the first catheter 7 side to pull the thrombus 9 into the first catheter 7. Wherein the embolectomy member 3 is expandable to the same diameter as the blood vessel within the blood vessel. The mandrel 1 is pushed towards the removal wound 8, the mandrel 1 penetrates through thrombus 9, the embolectomy piece 3 can move along with the mandrel 1, the thrombus 9 is cut and captured by the embolectomy piece 3 along with the continuous movement of the mandrel 1 and the embolectomy piece 3, and the thrombus 9 can enter the first catheter 7 at the removal wound 8 along with the embolectomy piece 3 and the mandrel 1 to complete the recanalization of the blood vessel.

Since the embolectomy device 3 may be bulky after release, the vessel may be damaged during entry of the released state into the body or into the vessel. In this embodiment, the embolectomy member 3 can be firstly contracted in the second catheter 5, and then sent into the blood vessel from the entrance wound 6 through the second catheter 5, and the embolectomy member 3 is pushed out of the second catheter 5 for release inside the blood vessel, but the second catheter 5 does not need to pass through the thrombus 9, so that the embolectomy member 3 can conveniently enter the blood vessel, the embolectomy efficiency is further improved, and the injury to the patient is reduced.

On the basis of any of the above embodiments, referring to fig. 3, the embolectomy device may further include a visualization mark 4 connected to the embolectomy member 3 and/or the mandrel 1. One or more development indicators may be provided in one bolt remover, and in particular, the development indicators 4 may be provided at both ends of each bolt removing member 3. The developing indication mark 4 has poor X-ray permeability, and is convenient for observing the position and the shape of the thrombus taking device in the blood vessel of the human body in the operation process. The materials commonly used for the development marker 4 are metal materials with poor X-ray permeability, such as: gold, platinum, tantalum, tungsten, and the like; or a polymer material doped with a poor X-ray transmitting material, such as: doped with BaSO₄、Bi₂O₃The polymer material of (1). The development emblem 4 may be provided in various forms, and specifically, the development emblem 4 may be a spring-like development emblem 41, an annular development emblem 43, or a thread-like development emblem 42. The developing marker 4 may be connected to the plug 3 or the mandrel 1 by welding, adhesion, winding, or fusion.

On the basis of any of the above embodiments, the number of the bolt-taking members 3 is several, specifically, one or at least two, and all the bolt-taking members 3 are sequentially arranged along the extending direction of the mandrel 1. The number of the thrombus taking pieces 3 on the thrombus taking device can be infinitely increased until clinical requirements are met, so that a plurality of thrombi 9 or long thrombi can be captured by the thrombus taking pieces 3, repeated thrombus taking operation is not needed, the operation is simple, and the thrombus taking effect 9 can be improved. In addition, the distal embolectomy member 3 may act as a distal protector, preventing the flow of fragmented thrombus 9 into the distal vessel, causing an embolism.

Furthermore, the thrombus taking part 3 can be a bracket, and the thrombus cutting effect is relatively good.

Or the bolt taking piece 3 can be a net basket with a filter screen structure, so that the protection effect is relatively good. Further, the latch member 3 may be a basket 31 with two open ends, a basket 34 with two closed ends, or a basket with one open end and one closed end. The basket with one open end and one closed end can be specifically a first type basket 32 with one open end and one closed end, the opening of which is an inclined plane, and a second type basket 33 with one open end and one closed end, the opening of which is a non-inclined plane; a porous basket 35 may be used, as shown in fig. 8, and more specifically, the porous basket may be formed by compounding a porous polymer film and a metal skeleton, or may be a fully metal member. The same basket can be assembled on the same bolt taking device, as shown in fig. 9; different kinds of baskets can also be fitted, as shown in fig. 10. The radial force of the net basket, the diameter of the net basket, the number of the net baskets, the density degree of each grid and the pattern structure can be adjusted according to the clinical requirements of the apparatus. In addition, the opening direction of the basket can be set to be completely installed according to the blood flow direction and clinical requirements, as shown in fig. 9; or all installed upside down, as in fig. 11; or partially forward and partially reverse, as shown in fig. 12. The embolectomy device can be assembled by baskets with the same diameter, as shown in figure 9; or baskets of different diameters can be assembled, as shown in fig. 13. The processing method of the net basket can be that the metal pipe is cut by laser, as shown in fig. 4 and 5; or may be woven from metal wires, as shown in fig. 6 and 7.

The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other.

The embolectomy device provided by the invention is described in detail above. The principles and embodiments of the present invention are explained herein using specific examples, which are presented only to assist in understanding the method and its core concepts. It should be noted that, for those skilled in the art, it is possible to make various improvements and modifications to the present invention without departing from the principle of the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.

Claims

1. A embolectomy device, comprising:

a plug (3), the plug (3) having self-expanding properties;

the core shaft (1), the embolectomy piece (3) is connected to the core shaft (1), the core shaft (1) is used for driving the embolectomy piece (3) to move from an entrance wound (6) on one side of a thrombus (9) on a blood vessel to an exit wound (8) on the other side of the thrombus (9), so that the embolectomy piece (3) drives the thrombus (9) to move out of the exit wound (8);

one end of the mandrel is provided with a soft head (2), and the other end of the mandrel is provided with a soft head connecting piece used for detachably connecting the soft head (2), so that the mandrel (1) can form a closed loop structure connected end to end;

the number of the bolt taking pieces (3) is at least two, and all the bolt taking pieces (3) are sequentially arranged along the extension direction of the mandrel (1);

the bolt taking piece (3) is a net basket with a filter screen structure, and the net basket is a closed net basket with an opening at one end;

the opening directions of all the net baskets are the same, and all the net baskets are installed in a forward mode or in an inverted mode.

2. The embolectomy device of claim 1, wherein the hardness of the soft head (2) is less than the hardness of the mandrel (1).

3. The embolectomy device of claim 1, further comprising a first catheter (7) for harvesting thrombus (9) at the removal wound (8) of the blood vessel, the first catheter (7) being a through structure open at both ends to allow the mandrel to pass through the first catheter (7).

4. The embolectomy device of claim 3, further comprising a second catheter (5) for assisting the embolectomy member (3) in accessing the blood vessel at the access wound (6) of the blood vessel, the embolectomy member (3) being movably retractable in the second catheter (5).

5. The embolectomy device of claim 1, further comprising a visualization marker (4) attached to the embolectomy member (3) and/or the mandrel (1).