CN114948091A

CN114948091A - Blood vessel thrombus taking device

Info

Publication number: CN114948091A
Application number: CN202210903199.3A
Authority: CN
Inventors: 唐纯海; 李飞; 许永松; 吴健; 郭琦; 崔巍; 唐航; 刘昊; 王锐; 王金磊
Original assignee: BEIJING TAIJIE WEIYE TECHNOLOGY CO LTD
Current assignee: Beijing Taijieweiye Technology Co.,Ltd.
Priority date: 2022-07-29
Filing date: 2022-07-29
Publication date: 2022-08-30
Anticipated expiration: 2042-07-29
Also published as: CN114948091B

Abstract

The invention discloses a blood vessel thrombus taking device, which comprises: the device comprises a catheter, an operation handle connected to the near end of the catheter, a guide wire penetrating through the catheter and the near end of which is connected to the operation handle and controlled by the operation handle, a sleeve sleeved outside the guide wire, a net basket arranged at the far end of the guide wire, and a balloon arranged on the guide wire and communicated with the sleeve. Through set up basket and sacculus simultaneously on the seal wire, and then make the sacculus when expanding or after expanding narrow region, the thrombus that the basket can catch the escape avoids the bold thrombus to drop and causes intracranial vascular jam after flowing to encephalic.

Description

Blood vessel thrombus taking device

Technical Field

The invention relates to the technical field of interventional therapy, in particular to a vascular thrombus removal device.

Background

The narrow lesion area of the extracranial blood vessel is treated in the prior art by the following method.

The catheter is first inserted into a diseased region (stenotic region) of a blood vessel by a catheter carrying a balloon, and then the balloon is inflated by pressurizing the balloon to expand the stenotic region, so that the catheter can pass through the stenotic region.

Then, the catheter carrying the balloon is withdrawn from the blood vessel, the catheter carrying the basket is used for extending into the lesion region of the blood vessel again and passing through the expanded stenosis region, then the basket is pulled out of the catheter by using the guide wire, the basket is released and expanded, and then the guide wire drives the basket to move towards the lesion region to pick up the thrombus. And finally, pulling the mesh basket carrying the thrombus into the catheter by using the guide wire, and withdrawing the catheter from the blood vessel to finish thrombus removal.

However, the above-mentioned methods for treating a vascular lesion region in the prior art have the following drawbacks:

1. the expansion of the lesion area by the balloon is liable to cause the thrombus (at least part of the thrombus) to fall off and escape towards the intracranial blood vessel (or distal blood vessel), which may occur during the replacement of the balloon and the basket, and if the escaped thrombus is large, the distal blood vessel is liable to be blocked.

2. In the thrombus taking process by utilizing the basket, if the thrombus amount is large, a large amount of thrombus can be accumulated on the basket, so that resistance is easily generated on the flow of normal blood, and intracranial temporary defects are easily caused in the thrombus taking process. It can be understood that the mesh wires forming the basket can be used for cutting the picked thrombus and enabling the cut thrombus (the thrombus cut by the mesh wires is small and cannot block a far-end blood vessel) to pass through the meshes of the mesh wires so as to reduce the thrombus picking amount and further reduce the resistance to blood.

3. The conical basket with better retractility is limited by the structure of meshes of the prior mesh wire structure, after the basket is expanded, a plurality of pointed convex areas are formed at the front end of the basket, the diameter enveloped by the pointed convex areas is the largest, therefore, the pointed convex areas belong to the supporting positions of blood vessels, and the pointed convex areas easily cause damage to blood vessel walls.

Disclosure of Invention

In view of the above technical problems in the prior art, embodiments of the present invention provide a vascular embolectomy device.

In order to solve the technical problem, the embodiment of the invention adopts the following technical scheme:

a vascular embolectomy device, comprising: the device comprises a catheter, an operation handle connected to the near end of the catheter, a guide wire penetrating through the catheter and the near end of which is connected to the operation handle and controlled by the operation handle, a sleeve sleeved outside the guide wire, a net basket arranged at the far end of the guide wire, and a balloon arranged on the guide wire and communicated with the sleeve.

Preferably, the basket comprises a basket body which is conical when opened and is constructed by enveloping the mesh wires, and a passivation part, wherein the distal end of the basket body is provided with a pointed convex area which is formed by combining the ends of the mesh wires into a circle; wherein:

the passivation member has a plurality of arches on a front side formed by bending filaments, the plurality of arches enclosing a loop-shaped structure, a rear side of the passivation member being attached to the cusped region of the basket body;

the net wire of the net basket body is sharpened towards one side of the blood vessel.

Preferably, the front side of each arch of the blunting member is curved inwards.

Preferably, each passivation member is surrounded by a plurality of said filaments, each of said filaments being bent to form an arch, each adjacent two of said filaments being connected at a rear end and forming an attachment end; wherein:

the attaching end of the passivation part is correspondingly connected with the pointed convex area of the basket body.

Preferably, the cross-section of the filament body is rectangular, the main body of the cross-section of the mesh is rectangular, and the mesh is sharpened by forming sharp points on the short sides of the rectangular cross-section of the wire mesh.

Preferably, the rear end of the basket body is connected to the basket body by a support spring.

Preferably, the basket body is formed by engraving nickel titanium alloy.

Preferably, a developing mark is arranged in the balloon, and a developing mark is arranged at the rear end of the basket body.

Preferably, the balloon is a semi-compliant balloon or a compliant balloon.

Preferably, the filaments are obtained by cutting nitinol wires.

Compared with the prior art, the blood vessel thrombus removal device disclosed by the invention has the beneficial effects that:

1. through set up basket and sacculus simultaneously on the seal wire, and then make the sacculus when expanding or after expanding narrow region, the thrombus that the basket can catch the escape avoids the bold thrombus to drop and causes intracranial vascular jam after flowing to encephalic.

2. Through add passivation parts at the rear end of basket body, and then make passivation parts replace the sharp protruding region of the rear end of basket body and support the vascular wall, and then can effectively reduce the basket and support or cause the damage to normal vascular wall along the blood vessel removal in-process.

3. Utilize the point protruding region support vascular wall of passivation part replacement basket for the net silk of basket body can sharpen in order to realize cutting the thrombus of being caught and picking up, and then avoids a large amount of thrombus to pile up in basket department, and then can effectively reduce the basket and pick up the resistance of thrombus in-process to blood.

The summary of various implementations or examples of the technology described in this disclosure is not a comprehensive disclosure of the full scope or all features of the disclosed technology.

Drawings

In the drawings, which are not necessarily drawn to scale, like reference numerals may describe similar components in different views. Like reference numerals having letter suffixes or different letter suffixes may represent different instances of similar components. The drawings illustrate various embodiments, by way of example and not by way of limitation, and together with the description and claims, serve to explain the inventive embodiments. The same reference numbers will be used throughout the drawings to refer to the same or like parts, where appropriate. Such embodiments are illustrative, and are not intended to be exhaustive or exclusive embodiments of the present apparatus or method.

Fig. 1 is a schematic structural diagram of a vascular thrombus removal device provided by the invention.

Fig. 2 is an enlarged view of a portion of fig. 1.

Fig. 3 is a schematic structural diagram of a basket in the vascular embolization device provided by the present invention.

Fig. 4 is a sectional view taken along line a-a of fig. 3.

Fig. 5 is a schematic structural diagram of a passivation component of a basket in the vascular embolization device provided by the present invention.

Fig. 6 is a sectional view taken along line B-B of fig. 5.

Fig. 7 is a first usage state view of the vascular embolectomy device provided by the invention.

Fig. 8 is a view in the direction C of fig. 7.

Fig. 9 is a second use state view of the vascular embolectomy device provided by the invention.

Fig. 10 is a view showing a third state of use of the vascular embolectomy device provided by the present invention.

Reference numerals:

10-a basket; 11-basket body; 111-mesh; 1111-cusp; 112-mesh; 113-a cusp convex region; 12-a passivating component; 121-arch structure; 122-inflected region; 123-filament; 20-a balloon; 30-a catheter; 31-a pressurizing port; 40-a guide wire; 50-a cannula; 60-development marking; 70-developing the mark; 80-support springs; 90-a manipulation handle; 100-blood vessels; 101-a stenotic region; 102-Thrombus.

Detailed Description

Unless defined otherwise, technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. The use of "first," "second," and similar terms in the present application do not denote any order, quantity, or importance, but rather the terms are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that the element or item preceding the word comprises the element or item listed after the word and its equivalent, but does not exclude other elements or items. The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", and the like are used merely to indicate relative positional relationships, and when the absolute position of the object being described is changed, the relative positional relationships may also be changed accordingly.

To maintain the following description of the embodiments of the present invention clear and concise, a detailed description of known functions and known components of the invention have been omitted.

As shown in fig. 1 and 2, the embodiment of the invention discloses a blood vessel thrombectomy device, which comprises: a steering handle 90, a catheter 30, a guidewire 40, a cannula 50, a balloon 20, a basket 10, and

visualization markers

60, 70.

The proximal end of the guide wire 40 is connected to the control handle 90, the catheter 30 is sleeved outside the guide wire 40, the sleeve 50 is sleeved outside the guide wire 40 and is located in the catheter 30, the basket 10 is installed at the distal end of the guide wire 40, the balloon 20 is located behind the basket 10 and is communicated with the sleeve 50, and the control handle 90 is provided with a pressurizing port 31 for pressurizing the balloon 20 through the sleeve 50 to expand the balloon 20.

Prior to use, the basket 10 and balloon 20 are deflated in the catheter 30.

When the embolectomy is performed, the distal end of the catheter 30 is advanced into the blood vessel 100 from the opening of the blood vessel 100, the stenotic region 101 of the blood vessel 100 is fed by the manipulation handle 90, the balloon 20 is caused to correspond to the stenotic region 101, then, the basket 10 and the balloon 20 are pulled out from the distal end of the catheter 30, as shown in fig. 7, the basket 10 is positioned in front of the balloon 20 (defined as the front or distal direction in the blood flow direction) and is inflated and expanded to be supported on the wall of the blood vessel 100, the balloon 20 is inflated by the inflation port 31 of the manipulation handle 90 to expand the stenotic region 101, and during the expansion of the stenotic region 101 by the balloon 20, thrombus 102 that may be pulled out from the stenotic region 101 is captured by the basket 10 while flowing in the intracranial blood vessel 100 direction.

After the operation of expanding the stenosed region 101 by using the balloon 20, as shown in fig. 9 and 10, the balloon 20 is deflated, the basket 10 is dragged by using the guide wire 40 to move the basket 10 backward for picking up the thrombus 102 at the stenosed region 101, then the basket 10 is continuously dragged by using the guide wire 40, finally the balloon 20 and the basket 10 are gathered in the catheter 30, and then the catheter 30 is withdrawn from the blood vessel 100, thereby completing the thrombus picking-up operation.

Preferably, a support spring 80 is provided between the basket 10 and the distal end of the guide wire 40, the support spring 80 allowing the basket 10 to move under some rigid constraint at the distal end of the guide wire 40 to accommodate the tortuous configuration of the vessel 100.

Preferably, a visualization mark 70 is provided at the rear end of the basket 10, and two visualization marks 60 are provided inside the balloon 20 for displaying the position of the basket 10 and the balloon 20 in the blood vessel 100, thereby making it clear to the operator whether the balloon 20 and the basket 10 have entered the predetermined position.

As shown in fig. 3 to 6, a preferred embodiment of the present invention discloses a basket 10 of a structure, the basket 10 including a basket body 11 and a passivation member 12. The basket body 11 is tapered after expansion and the basket body 11 is formed by attaching a plurality of wires 111 at intervals along its length such that the basket body 11 forms a plurality of mesh openings 112. Also, the basket 10 is formed in such a manner that the rear end of the basket body 11 inevitably forms a ring of the cusp region 113 formed by the attachment of the mesh wires 111.

The passivation member 12 is enclosed by the plurality of filaments 123 into a loop-shaped structure and a plurality of arches 121 on the front side, and specifically, each filament 123 is bent into a forward arch 121, and each adjacent two filaments 123 are attached at the rear end, so that the passivation member 12 is enclosed by the plurality of filaments 123 into a loop of arches 121 on the front side. And, the anterior side of each arch 121 is curved inward to form a recurved region 122.

The plurality of filaments 123 of the passivation member 12 are attached at the rear end in the same number and position as the pointed convex regions 113 of the basket body 11, and the passivation member 12 is connected in front of the basket body 11 by the one-to-one correspondence between the attached end at the rear end thereof and the pointed convex region 113 at the front end of the basket body 11. For example, the attachment end may be attached to the pointed raised area 113 using a heat staking process. And the diameter of the passivation means 12 is made slightly larger than the diameter of the circle enveloped by the cusp region 113 of the basket body 11. This allows the basket 10 to expand and the blunt member 12 to directly contact the wall of the vessel 100 to support the wall of the vessel 100 without the basket body 11 contacting the normal wall of the vessel 100.

As shown in fig. 4, before the basket body 11 is made of the mesh 111 or after the basket body 11 is made, the side of the mesh 111 facing the wall of the blood vessel 100 is sharpened, for example, the basket body 11 is made of the mesh 111 having a rectangular cross section, the short side of the cross section of the mesh 111 faces outward (toward the wall of the blood vessel 100), and the sharp point 1111 is formed on the short side.

As shown in fig. 6, the filament 123 is made of the same material as the mesh 111, and the filament 123 has a rectangular cross section, and the long side of the cross section of the filament 123 faces outward (toward the wall of the blood vessel 100) when the passivation member 12 is manufactured.

As shown in fig. 7, after the basket 10 is expanded, the passivation member 12 is used to directly contact the wall of the blood vessel 100, and the pointed convex region 113 of the basket body 11 is not directly contacted with the wall of the blood vessel 100 or the contact force is reduced due to the existence of the passivation member 12, the passivation member 12 actually supports the wall of the blood vessel 100 through the arch structure 121 which surrounds a circle, the support region of the arch structure 121 is larger than that of the pointed convex region 113, the contact stress generated by the contact with the blood vessel 100 is greatly reduced, and the contact stress is further reduced by contacting the long side of the cross section of the filament 123 with the wall of the blood vessel 100.

Importantly, the blunting member 12 instead of the cusp region 113 contacts the wall of the blood vessel 100, so that the mesh 111, especially the mesh 111 slightly away from the blunting member 12, can be sharpened, so that when a large amount of thrombus 102 is encountered, as shown in fig. 10, when the thrombus 102 moves towards the basket 10 and contacts the basket 10, the mesh 111 can cut the thrombus 102, thereby cutting a portion of the thrombus 102 into small pieces, and the cut pieces of thrombus 102 flow through the mesh 112 to the intracranial blood vessel 100. And the thrombus 102 cut into small pieces does not cause obstruction to the intracranial blood vessel 100.

The blood vessel 100 thrombus removal device provided by the invention has the advantages that:

1. by arranging the basket 10 and the balloon 20 on the guide wire 40, the basket 10 can capture escaped thrombus 102 when or after the balloon 20 expands the narrow region 101, so as to prevent the intracranial blood vessel 100 from being blocked due to the falling of a large thrombus 102 flowing into the cranium.

2. By additionally arranging the passivation part 12 at the rear end of the basket body 11, the passivation part 12 replaces the sharp convex area 113 at the rear end of the basket body 11 to support the wall of the blood vessel 100, so that the damage to the normal wall of the blood vessel 100 caused by the basket 10 in the process of supporting or moving along the blood vessel 100 can be effectively reduced.

3. Utilize the passivation part 12 to replace the sharp convex region 113 of basket 10 to support blood vessel 100 wall for the net silk 111 of basket body 11 can sharpen and cut the thrombus 102 of being caught and picking up, and then avoids a large amount of thrombus 102 to pile up in basket 10 department, and then can effectively reduce basket 10 and pick up the resistance to blood of thrombus 102 in-process.

The parameters of the relevant components in terms of dimensions, materials used, etc. are described below.

1. The mesh wire 111 of the basket body 11 and the wire 123 of the passivation part 12 can be made of nickel-titanium alloy wire, nickel-titanium-platinum wire (DFT), cobalt-chromium-nickel alloy wire, platinum-iridium alloy wire, platinum-tungsten alloy wire, and the like. The above shape of the basket 10 is formed by a plurality of processes such as heat treatment, acid pickling and polishing.

2. The rear end of the basket 10 and the developing mark in the balloon 20 can be made of platinum-iridium alloy, platinum-tungsten alloy, tantalum and other metal materials.

3. The support spring 80 may be made of a stainless material and has an outer diameter ranging from 0.3 to 0.7 mm.

4. The guidewire 40 may be made of nitinol or 304 stainless steel. The guidewire 40 may be divided into sections of varying diameter ranges.

5. The guide wire 40 is made of nickel-titanium alloy or 304 stainless steel, the guide wire 40 is designed in 7 sections, the total length of the guide wire 40 is 1800 plus 2100mm, wherein the section L1 is positioned in the inner cavity of the supporting spring 80, the outer diameter range is 0.05-0.15mm, the length is 3-50mm, the section L2 is positioned in the distal sleeve 504, the section L2 is a taper grinding area, the taper grinding area and the sleeve 50 are tightly wrapped or wrapped, the outer diameter of the wrapping section of the sleeve 50 is 0.3-0.7mm, and the length is 5-100 mm; the L3 section is positioned inside the balloon 20, the diameter range is 0.10-0.40mm, and the length is 10-60 mm; l4 is a taper change area with a length range of 50-100 mm; l5 is a constant region with a diameter range of 0.15-0.45mm and a length of 100-200 mm; l6 is a taper change region with a length range of 300-500 mm; l7 is a constant diameter zone with a diameter in the range of 0.20-0.60mm, and the surface of L7 segment can be coated with PTFE to reduce friction.

6. The balloon 20 is a semi-compliant balloon 20 or a compliant balloon 20, and is made of polymer materials such as Pebax, silica gel, rubber, polyurethane and the like, and the balloon 20 has an outer diameter range of 1.5-6.0mm and a length of 10-60mm in a filling state.

Moreover, although exemplary embodiments have been described herein, the scope of the present invention includes any and all embodiments based on the present invention with equivalent elements, modifications, omissions, combinations (e.g., of various embodiments across), adaptations or alterations. The elements of the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. It is intended, therefore, that the specification and examples be considered as exemplary only, with a true scope and spirit being indicated by the following claims and their full scope of equivalents.

The above description is intended to be illustrative and not restrictive. For example, the above-described examples (or one or more versions thereof) may be used in combination with each other. For example, other embodiments may be used by those of ordinary skill in the art upon reading the above description. In addition, in the above-described embodiments, various features may be grouped together to streamline the disclosure. This should not be interpreted as an intention that a disclosed feature not claimed is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that these embodiments may be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

The above embodiments are only exemplary embodiments of the present invention, and are not intended to limit the present invention, and the scope of the present invention is defined by the claims. Various modifications and equivalents may be made by those skilled in the art within the spirit and scope of the present invention, and such modifications and equivalents should also be considered as falling within the scope of the present invention.

Claims

1. A vascular embolectomy device, comprising: the device comprises a catheter, an operation handle connected to the near end of the catheter, a guide wire penetrating through the catheter and the near end of which is connected to the operation handle and controlled by the operation handle, a sleeve sleeved outside the guide wire, a net basket arranged at the far end of the guide wire, and a balloon arranged on the guide wire and communicated with the sleeve.

2. The vessel embolectomy device of claim 1, wherein the basket comprises a flared cone-shaped basket body configured by a wire envelope, and a blunting member, the distal end of the basket body having a pointed convex region formed by the ends of the wire joined to form a loop; wherein:

the net silk of the net basket body sharpens towards one side of the blood vessel.

3. The vascular embolectomy device of claim 2, wherein the anterior side of each arch of the blunting member is curved inward.

4. The vascular embolectomy device of claim 2, wherein each blunting member is surrounded by a plurality of filaments, each filament is bent to form an arch, and each adjacent two filaments are connected at a rear end and form an attachment end; wherein:

5. The vascular embolectomy device of claim 2, wherein the cross-section of the wire body is rectangular, the main body of the cross-section of the mesh wire is rectangular, and the mesh wire is sharpened by forming sharp points on the short sides of the rectangular cross-section of the wire mesh.

6. The vascular embolectomy device of claim 1, wherein the rear end of the basket body is connected to the basket body by a support spring.

7. The vascular embolectomy device of claim 1, wherein the basket body is sculpted from nitinol.

8. The vascular embolectomy device of claim 1, wherein a visualization mark is arranged in the balloon, and a visualization mark is arranged at the rear end of the basket body.

9. The vascular embolectomy device of claim 1, wherein the balloon is a semi-compliant balloon or a compliant balloon.

10. The vascular embolectomy device of claim 2, wherein the wire body is cut from nitinol wire.