CN114145810B

CN114145810B - Thrombolysis device and application method thereof

Info

Publication number: CN114145810B
Application number: CN202111607599.1A
Authority: CN
Inventors: 张小武; 康小然; 蔡文彬; 武效金; 顾玲玉
Original assignee: Sano Shenchang Medical Technology Co ltd
Current assignee: Sano Shenchang Medical Technology Co ltd
Priority date: 2021-12-24
Filing date: 2021-12-24
Publication date: 2024-01-30
Anticipated expiration: 2041-12-24
Also published as: CN114145810A

Abstract

The invention relates to the technical field of medical instruments, in particular to a thrombus taking device and a using method thereof. A thrombolytic device comprising: the thrombus taking bracket is provided with a bracket body and a protective umbrella rotatably connected to the far end of the bracket body, and the centers of the bracket body and the protective umbrella are provided with through holes which are suitable for penetrating through the inner tube; one end of the middle tube is connected with the proximal end of the bracket body, and the middle tube is communicated with the through hole of the bracket body; the inner tube penetrates through the middle tube, and then penetrates through the support body and the protective umbrella after penetrating out of the middle tube, and the inner tube is fixedly connected with the far end of the protective umbrella. According to the thrombus taking device provided by the invention, after the thrombus taking support is released in a blood vessel, the protective umbrella and the support body of the thrombus taking support can be controlled through the inner tube to stretch and retract, so that the expansion size of the protective umbrella and the support body is controlled, and the expanded support body can clear more thrombus and has the advantage of convenience in operation.

Description

Thrombolysis device and application method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a thrombus taking device and a using method thereof.

Background

At present, acute ischemic stroke (commonly known as cerebral infarction) becomes a healthy killer of people. Once the blood vessel is blocked, if the blood vessel cannot be dredged within the effective time, large-area cerebral infarction can occur, and the longer the time, the larger the cerebral cell infarct area. In clinical treatment, thrombolytic therapy has a certain effect, but only a few patients can be treated due to the limitation of time window. The mechanical thrombus taking is favorable for the thrombus taking device to restore the blood flow perfusion of the acute occluded cerebral blood vessel in time, and has the advantages of high blood vessel recanalization rate, low complications and obviously prolonged treatment time window.

When the existing thrombus taking support is used for taking thrombus, the microcatheter is guided by the microcatheter to pass through the thrombus part, and then the support sleeved on the microcatheter is released for taking thrombus.

However, the existing thrombus-taking stent can only rely on the elastic expansion of the stent after being released in a blood vessel, and the expansion size can not be adjusted according to the actual situation in the blood vessel, and the thrombus can not be completely removed due to insufficient expansion force at the thrombus position.

Disclosure of Invention

Therefore, the invention aims to solve the technical problem that the thrombus removing stent in the prior art is easy to cause the defect that thrombus cannot be completely removed because the thrombus removing stent expands in a blood vessel only by virtue of self elasticity, thereby providing a thrombus removing device capable of adjusting the expansion diameter of the thrombus removing stent and a using method of the thrombus removing device.

In order to solve the above problems, the present invention provides a thrombus removing device, comprising:

the thrombus taking bracket is provided with a bracket body and a protective umbrella rotatably connected to the far end of the bracket body, and the centers of the bracket body and the protective umbrella are provided with through holes which are suitable for penetrating through the inner tube;

one end of the middle tube is connected with the proximal end of the bracket body, and the middle tube is communicated with the through hole of the bracket body;

the inner tube penetrates through the middle tube, and then penetrates through the support body and the protective umbrella after penetrating out of the middle tube, and the inner tube is fixedly connected with the far end of the protective umbrella.

Optionally, the bracket body is provided with a plurality of thrombus taking units which are connected in turn in a rotating way.

Optionally, the diameters of a plurality of said thrombolytic units decrease sequentially from the proximal end to the distal end.

Optionally, the protection umbrella is connected with the thrombus taking unit and/or the two adjacent thrombus taking units are connected through a rotating shaft.

Optionally, the method further comprises: the outer tube is sleeved outside the middle tube, and the distal end of the outer tube is suitable for accommodating the thrombus taking support.

Optionally, the portion of the outer tube for extending into the blood vessel is provided with an inflatable balloon.

Optionally, the proximal end of the outer tube is connected with a first locking member, the proximal end of the middle tube is a rigid tube, the rigid tube passes through the first locking member, and the first locking member is used for locking the middle tube.

Optionally, the middle pipe passes through the first locking piece and then is connected with the second locking piece, and the inner pipe passes through the second locking piece, and the second locking piece is used for locking the inner pipe.

Optionally, the outer tube and the first locking member and/or the middle tube and the second locking member are connected through a luer connector.

The application method of the thrombus taking device is also provided, and comprises the following steps:

the inner tube is kept motionless, and the protective umbrella and the bracket body are driven to move along the axial direction by axially moving the middle tube;

when the middle tube is moved towards the far end along the axial direction, the protective umbrella and the bracket body are expanded outwards along the radial direction;

the umbrella and the stent body contract radially inwardly when the middle tube is moved axially proximally.

The technical scheme of the invention has the following advantages:

1. according to the thrombus taking device provided by the invention, after the thrombus taking support is released in a blood vessel, the protective umbrella and the support body of the thrombus taking support can be controlled through the inner tube to stretch and retract, so that the expansion size of the protective umbrella and the support body is controlled, and the expanded support body can clear more thrombus and has the advantage of convenience in operation.

2. The thrombus taking device provided by the invention has the advantages that the stent body is provided with the plurality of thrombus taking units which are connected in a rotating way in sequence, the diameters of the plurality of thrombus taking units are reduced in sequence from the near end to the far end, so that the thrombus taking unit which is most suitable for a human blood vessel is found from the thrombus taking units with different diameters to take the thrombus, and the suitability of the thrombus taking device and a target lesion blood vessel is realized.

3. According to the thrombus taking device provided by the invention, the protection umbrella is connected with the thrombus taking units through the rotating shaft, the two adjacent thrombus taking units are connected through the rotating shaft, the design of the rotating shaft effectively improves the overall flexibility of the bracket body, and sufficient radial supporting force can be provided for the thrombus taking units.

4. The invention further provides a thrombus taking device which comprises an outer tube sleeved outside the middle tube, wherein the distal end of the outer tube is suitable for accommodating a thrombus taking bracket, so that the bracket body is in a compressed state when entering a blood vessel, and the bracket body is ensured to smoothly enter a human body.

5. The part of the outer tube, which is used for extending into the blood vessel, of the thrombus taking device provided by the invention is provided with the expandable saccule, and the saccule is fixed in the blood vessel after expansion so as to fix the outer tube, thereby ensuring the stability of the stent body, the middle tube and the inner tube when moving in the outer tube.

6. The invention provides a thrombus taking device, wherein the proximal end of an outer tube is connected with a first locking member, the proximal end of a middle tube is a rigid tube, the rigid tube passes through the first locking member, and the first locking member is used for locking the middle tube so as to realize the fixation and separation between the outer tube and the middle tube; the middle pipe passes through the first locking piece and then is connected with the second locking piece, the inner pipe passes through the second locking piece, and the second locking piece is used for locking the inner pipe so as to realize the fixation and separation between the middle pipe and the inner pipe. The design of the two locking parts realizes the relative movement among the outer tube, the middle tube and the inner tube, and simultaneously can also play a role in sealing, so that blood can not flow out from the spaces among the outer tube, the middle tube and the inner tube.

7. According to the thrombus taking device provided by the invention, the outer tube is connected with the first locking piece through the luer connector, the middle tube is connected with the second locking piece through the luer connector, and the luer connector is used for realizing the connection between the tube and the locking piece.

8. The use method of the thrombus taking device provided by the invention has the advantages that the outer diameters of the protective umbrella and the bracket body can be adjusted only by keeping the inner tube still and driving the protective umbrella and the bracket body to axially move after axially moving the middle tube, and the operation steps are simple.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic structural view of a thrombus removing device according to an embodiment of the present invention.

Fig. 2 is a schematic view of the outer tube assembly of fig. 1.

Fig. 3 is a schematic view of the middle tube assembly shown in fig. 1.

Fig. 4 is a schematic structural view of a rotating shaft of the middle tube assembly shown in fig. 3.

FIG. 5 is a schematic view of the protective umbrella of the middle tube assembly shown in FIG. 3.

Fig. 6 is a schematic structural view of the inner tube assembly shown in fig. 1.

Fig. 7 is a schematic view of a second embodiment of the middle tube assembly shown in fig. 1.

Fig. 8 is a schematic view of the structure of the thrombus removal device provided in an embodiment of the present invention in a target diseased vessel.

Reference numerals illustrate: 100. an outer tube assembly; 101. an outer tube; 102. a first joint; 200. a middle tube assembly; 210. a protective umbrella; 211. a tip; 212. braiding ropes; 220. a bracket body; 221. a thrombus taking unit; 222. developing points; 230. a rotating shaft; 240. a flexible tube; 250. a rigid tube; 260. a second joint; 300. an inner tube assembly; 301. an end portion; 302. an inner tube; 303. marking; 304. a third joint; 400. a first locking member; 401. a second locking member; 500. a micro-guide wire; 510. thrombus; 520. a balloon; 530. balloon catheter.

Detailed Description

The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.

The invention provides a thrombus taking device, comprising: a thrombus taking bracket having a bracket body and a protective umbrella 210 rotatably connected to a distal end of the bracket body 220, the centers of the bracket body 220 and the protective umbrella 210 having a through hole adapted to pass through the inner tube 302; one end of the middle tube is connected with the proximal end of the bracket body 220, and the middle tube is communicated with the through hole of the bracket body 220; the inner tube 302 is arranged in the middle tube in a penetrating way, the inner tube 302 penetrates through the bracket body 220 and the protective umbrella 210 after penetrating out of the middle tube, and the inner tube 302 is fixedly connected with the distal end of the protective umbrella 210.

According to the thrombus taking device provided by the invention, after the thrombus taking support is released in a blood vessel, the protective umbrella and the support body of the thrombus taking support can be controlled through the inner tube to stretch and retract, so that the expansion size of the protective umbrella and the support body is controlled, and the expanded support body can clear more thrombus and has the advantage of convenience in operation, and the operation efficiency can be greatly improved.

As shown in fig. 1, the thrombolysis device includes: the inner tube assembly 300, the middle tube assembly 200 and the outer tube assembly 100 are sleeved in sequence from inside to outside. The proximal end of the outer tube assembly 100 is connected with a first locking member 400, and the first locking member 400 is used for locking the middle tube assembly 200 so as to realize the relative movement between the outer tube assembly 100 and the middle tube assembly 200; the middle tube assembly 200 is connected with the second locking member 401 after passing through the first locking member 400, and the second locking member 401 is used for locking the inner tube assembly 300 so as to realize the relative movement between the middle tube assembly 200 and the inner tube assembly 300. By the arrangement of the first locking member 400 and the second locking member 401, the relative movement between the outer tube assembly 100, the middle tube assembly 200 and the inner tube assembly 300 is achieved. Specifically, the first locking member 400 and the second locking member 401 may be Y-type hemostatic valves.

As shown in fig. 2, the outer tube assembly 100 includes an outer tube 101 and a first joint 102, wherein the outer tube 101 is connected with a first locking member 400 through the first joint 102, so as to connect the outer tube assembly 100 with the first locking member 400, and then the middle tube assembly 200 is locked or released through the first locking member 400, so that the outer tube assembly 100 and the middle tube assembly 200 can move relatively. Specifically, the first connector 102 may be a luer connector. The outer tube 101 is a commonly used microcatheter for nerve intervention, and is composed of an inner layer PTFE film, a middle layer metal woven mesh, an outer layer PEBAX, and a hydrophilic coating structure uniformly coated on the outer layer. Alternatively, the outer tube 101 may be a polymer such as PA.

As shown in fig. 3, the middle tube assembly 200 includes a thrombolytic stent, a flexible tube 240, a rigid tube 250 and a second connector 260 connected in sequence from the distal end to the proximal end, the flexible tube 240 being designed so that the middle tube assembly 200 does not cause injury to the vessel when moved within the vessel. The rigid tube 250 passes through the first locking member 400 so that the first locking member 400 is locked, blood between the rigid tube 250 and the outer tube 101 is not discharged in a locked state, the rigid tube 250 is connected to the second locking member 401 through the second connector 260, and the inner tube assembly 300 is locked or released through the second locking member 401, so that the middle tube assembly 200 and the inner tube assembly 300 can relatively move. In particular, the second connector 260 may be a luer connector. The rigid tube 250 is made of a memory alloy nickel-titanium tube and the flexible tube 240 is made of a flexible molecular tube. Alternatively, the rigid tube 250 may be machined from stainless steel tubing, the flexible tube 240 may be laser cut to provide a spiral or continuous hinge structure to enhance the overall flexibility of the tube, or the rigid tube 250 and flexible tube 240 may be laser cut from the same nitinol tube.

As shown in fig. 3, the thrombus-taking stand has a stand body 220 and a protective umbrella 210 rotatably coupled to a distal end of the body, wherein centers of the stand body 220 and the protective umbrella 210 have a through hole adapted to pass through an inner tube 302. The thrombus taking bracket is integrally processed by a nickel-titanium alloy tube, has lower metal coverage rate, and the design of the lower metal coverage rate can effectively reduce the risk of damage to the inner wall of a blood vessel.

As shown in fig. 3, the stent body 220 is provided with five thrombus removing units 221 which are sequentially and rotatably connected, the diameters of the five thrombus removing units 221 are sequentially reduced from the proximal end to the distal end and are in tapered arrangement, and the outer diameters range is 1.0-6.0mm, so that the stent body is good in adaptability with a target lesion blood vessel. Alternatively, the number of units of the thrombolytic unit 221 is 2, 3 or even more. As shown in fig. 6, in an alternative embodiment, five thrombolysis units 221 are tapered with diameters sequentially increasing from the proximal end to the distal end.

As shown in fig. 3, the thrombus removing unit 221 is uniformly distributed with a plurality of developing points 222, and the developing points 222 are designed to improve the overall developing property of the thrombus removing bracket, so that the position of the thrombus removing unit 221 and the expanded outer diameter size thereof can be determined in the operation.

As shown in fig. 3, the protection umbrella 210 is connected with the thrombus taking unit 221 through a rotating shaft 230, and two adjacent thrombus taking units 221 are connected through the rotating shaft 230, and the rotating shaft 230 is provided with flexibility for improving the whole thrombus taking bracket and can also provide enough radial supporting force for the thrombus taking unit 221.

As shown in fig. 4, the rotation shafts 230 are hinged to form a multi-degree-of-freedom snake bone chain, thereby realizing multi-angle rotation of the thrombus removing unit 221 and providing sufficient radial supporting force for the thrombus removing unit 221.

As shown in fig. 5, the distal end of the protective umbrella 210 is a compact tip 211 formed by mixing 32 nickel-titanium alloy wires and platinum wires, and the compact tip 211 has overall full developability, and can effectively filter the fine thrombus 510. Alternatively, the umbrella 210 may be formed by braiding other numbers of nickel-titanium alloy wires and platinum wires. The proximal end of protective umbrella 210 is comprised of 8 braided strands 212, each braided strand 212 being braided from nitinol wires for better adherence.

As shown in fig. 6, the inner tube assembly 300 is composed of an end 301, an inner tube 302, a marker 303, and a third joint 304 in this order from the distal end to the proximal end. The end 301 is made of silica gel material, so as to effectively prevent the damage to the inner wall of the blood vessel. Alternatively, the end 301 may be made of soft medical polymer materials such as PEBAX (block polyether amide resin) and rubber. The inner tube 302 is a PEEK (polyether ether ketone) tube with flexibility and hardness, and the distal end of the inner tube 302 is welded and fixed with the distal end of the protective umbrella 210. Alternatively, the inner tube 302 may be formed of a PA (polyamide, commonly called nylon) tube, a PI (polyimide) tube, a PTFE (polytetrafluoroethylene) tube, or a metal wire braided hose, and the distal end of the inner tube 302 and the distal end of the protective umbrella 210 may be fixed by adhesion. The marking 303 on the proximal end of the inner tube 302 is used to help the physician adjust the relative positions of the inner tube assembly 300 and the proximal end of the thrombus removal stent, thereby controlling the size of the stretching or compression deformation of the distal thrombus removal unit 221 to meet the target lesion vessels of different sizes.

As shown in fig. 8, the inner tube 302 has a passageway therein that allows the micro-guidewire 500 to pass through, the micro-guidewire 500 providing a guide for the embolic device to enter the target lesion vessel. The portion of the outer tube 101 for extending into the blood vessel is further sleeved with a balloon catheter 530, and an expandable balloon 520 is arranged on the outer wall of the balloon catheter 530.

The application method of the thrombus taking device comprises the following steps:

holding the inner tube 302 stationary, driving the protective umbrella 210 and the stand body 220 to move in the axial direction by moving the middle tube in the axial direction;

the umbrella 210 and the stent body 220 expand radially outwardly when the middle tube is moved axially toward the distal end;

the umbrella 210 and the stent body 220 contract radially inward when the middle tube is moved axially proximally.

The thrombus taking device provided by the invention has the advantages of simple and convenient operation steps.

It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. And obvious variations or modifications thereof are contemplated as falling within the scope of the present invention.

Claims

1. A thrombolytic device, comprising:

a thrombus taking bracket, which is provided with a bracket body (220) and a protective umbrella (210) rotatably connected with the far end of the bracket body (220), wherein the centers of the bracket body (220) and the protective umbrella (210) are provided with through holes which are suitable for penetrating through an inner pipe (302);

one end of the middle tube is connected with the proximal end of the bracket body (220), and the middle tube is communicated with the through hole of the bracket body (220);

the inner tube assembly (300) sequentially comprises an end part (301), an inner tube (302), a mark (303) and a third joint (304) from the far end to the near end, wherein the mark (303) is arranged at the near end of the inner tube (302);

the inner tube (302) is arranged in the middle tube in a penetrating way, the inner tube (302) penetrates through the bracket body (220) and the protective umbrella (210) after penetrating out of the middle tube, and the inner tube (302) is fixedly connected with the far end of the protective umbrella (210);

the bracket body (220) is provided with a plurality of thrombus taking units (221) which are connected in turn in a rotating way;

the protection umbrella (210) is connected with the thrombus taking units (221) and/or the two adjacent thrombus taking units (221) through rotating shafts (230), and the rotating shafts (230) are hinged to form a snake bone chain with multiple degrees of freedom;

the diameters of the plurality of thrombus taking units (221) are sequentially reduced from the proximal end to the distal end and are arranged in a tapered mode, and the outer diameter range is 1.0-6.0mm.

2. The thrombolytic device of claim 1, further comprising: the outer tube (101) is sleeved outside the middle tube, and the distal end of the outer tube (101) is suitable for accommodating the thrombus taking support.

3. The thrombectomy device according to claim 2, wherein the outer wall of the portion of the outer tube (101) extending into the vessel is further provided with an inflatable balloon (520).

4. A thrombectomy device according to claim 3, wherein a first locking member (400) is connected to the proximal end of the outer tube (101), the proximal end of the middle tube is a rigid tube (250), the rigid tube (250) passes through the first locking member (400), and the first locking member (400) is configured to lock the middle tube.

5. The thrombectomy device according to claim 4, wherein the middle tube is connected to a second locking member (401) after passing through the first locking member (400), the inner tube (302) passes through the second locking member (401), and the second locking member (401) is configured to lock the inner tube (302).

6. The thrombectomy device according to claim 5, wherein the outer tube (101) and the first locking member (400) and/or the middle tube and the second locking member (401) are connected by a luer fitting.