CN112263356A

CN112263356A - Embolic protection device

Info

Publication number: CN112263356A
Application number: CN202011241001.7A
Authority: CN
Inventors: 汪泽辉; 夏洁; 李爽
Original assignee: Suzhou Zhongtian Medical Device Technology Co ltd
Current assignee: Suzhou Zhongtian Medical Device Technology Co ltd
Priority date: 2020-11-09
Filing date: 2020-11-09
Publication date: 2021-01-26

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an embolism protection device. The embolism protection device comprises a base body and a filter screen, wherein the base body is of an annular structure, the base body is sequentially divided into a plurality of local sections, and the elasticity of each local section is gradually changed. The base body has two states of contraction and expansion, so that the base body can enter a predetermined blood vessel in the contracted state and then be attached to the inner wall of the blood vessel in the expanded state. One end of the filter screen is arranged on the base body to form an open end, the other end of the filter screen is a closed end, and a plurality of filter holes are distributed in the filter screen. The matrix of the embolic protection device is sequentially divided into a plurality of local sections, and the elasticity of each local section is gradually changed to increase the deformability of the matrix, so that the matrix can be tightly attached to the inner walls of blood vessels with a plurality of diameters and can be reliably positioned and matched. The embolic protection device of the present invention has a wide range of applications.

Description

Embolic protection device

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an embolism protection device.

Background

In order to prevent the thrombus from flowing to the downstream in the upstream and causing intracranial cerebral embolism and causing ischemic stroke, a thrombus filtering device is arranged between the upstream and the downstream of the blood vessel in the operation process. When a dropped thrombus exists in the operation process, the blood can normally pass through the thrombus filtering device and flow to the downstream of the blood vessel. However, the detached thrombus is intercepted by the thrombus filter device and does not flow downstream of the blood vessel.

Because the diameters of the blood vessels of different patients are different, and the diameters of the blood vessels at different positions of the same patient are also different, a plurality of thrombus filtering devices with different specifications need to be arranged so as to adapt to the blood vessels with different diameters.

In conclusion, the conventional thrombus filter device has a small application range.

Disclosure of Invention

The invention aims to provide an embolism protection device, which solves the problem that the application range of the existing thrombus filtering device is small.

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

an embolic protection device comprising:

the base body is of an annular structure and is sequentially divided into a plurality of local sections, and the elasticity of each local section is gradually changed; the matrix has two states of contraction and expansion, so that the matrix can enter a preset blood vessel in the contraction state and then is attached to the inner wall of the blood vessel in the expansion state;

the filter screen, the one end of filter screen install in the base member to form the open end, the other end of filter screen is the blind end, it has a plurality of filtration pores to distribute on the filter screen.

Preferably, in the embolic protection device described above, the embolic protection device comprises a guide wire connected to the connection point of the base body.

Preferably, in the embolic protection device described above, said base body is formed by bending a string until it is joined end-to-end, and said connection point is formed at the end-to-end connection; a straight line passing through the connecting point and the center of the base body is a first straight line, and the intersection point of the first straight line and the base body is the connecting point and the relative intersection point; the intersection point of the straight line which is perpendicular to the first straight line and passes through the circle center and the base body is a first side intersection point and a second side intersection point.

Preferably, in the embolic protection device as described above, said rope body is formed by twisting at least two wires.

Preferably, in the embolic protection device described above, the twist gradually decreases in the direction from the opposite intersection to the first side intersection and to the connection point, and the twist gradually decreases in the direction from the opposite intersection to the second side intersection and to the connection point.

Preferably, in the embolic protection device described above, the twist of the first side intersection point is the same as the twist of the second side intersection point, and/or the twist of the opposite intersection point is a multiple of the twist of the connection point.

Preferably, in the embolic protection device as described above, the rope is of a monofilament structure or the rope is formed by twisting at least two metal wires with the same twist everywhere, the diameter of the rope gradually decreases in the direction from the opposite intersection point to the first side intersection point and to the connection point, and the diameter of the monofilament gradually decreases in the direction from the opposite intersection point to the second side intersection point and to the connection point.

Preferably, in the embolic protection device described above, the twist of each of the first side intersection point and the second side intersection point is greater than the twist of the connection point and the opposite intersection point.

Preferably, in the embolic protection device described above, the twist from the first side intersection to the connection point gradually decreases, the twist from the first side intersection to the opposite intersection gradually decreases, the twist from the second side intersection to the connection point gradually decreases, and the twist from the second side intersection to the opposite intersection gradually decreases.

Preferably, in the embolic protection device, the filter screen has a conical structure, and the diameter of the filter screen gradually decreases from the open end to the closed end.

The embolic protection device of the present invention has the beneficial effects of: the base member divide into a plurality of local sections in proper order, and the elasticity of every local section is the gradual change to increase the deformability of base member, thereby can make the inner wall of base member and the blood vessel of a plurality of diameters closely laminate, and reliable location cooperation. The embolic protection device of the present invention has a wide range of applications.

Drawings

FIG. 1 is a schematic diagram of the construction of an embolic protection device according to an embodiment of the present invention;

FIG. 2 is a block diagram of the base of an embolic protection device according to an embodiment of the present invention;

FIG. 3 is a diagram showing the state of use of the embolic protection device of example 1 of the present invention;

FIG. 4 is a structural view of an embolic protection device in a retracted state according to embodiment 1 of the present invention;

FIG. 5 is a structural view of a base body of an embolic protection device according to example 1 of the present invention;

FIG. 6 is a development of the base body of the embolic protection device of example 1 of the present invention;

FIG. 7 is a structural view of a base body of an embolic protection device according to example 2 of the present invention;

FIG. 8 is a deployed view of the base of an embolic protection device according to example 2 of the present invention;

FIG. 9 is a structural view of a base body of an embolic protection device according to example 3 of the present invention;

figure 10 is a deployment view of the base of an embolic protection device according to example 3 of the present invention.

The component names and designations in the drawings are as follows:

the embolic protection device 100, a base body 10, a connection point 11, an opposite intersection point 12, a first side intersection point 13, a second side intersection point 14, an arc line 15, a filter screen 20, a filter hole 21, an open end 22, a guide wire 30, a blood vessel 40, a lesion 50, thrombus 51, and a harvesting member 60.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting of the invention. It should be further noted that, for the convenience of description, only some of the structures related to the present invention are shown in the drawings, not all of the structures.

In the description of the present invention, unless expressly stated or limited otherwise, the terms "connected," "connected," and "fixed" are to be construed broadly, e.g., as meaning permanently connected, removably connected, or integral to one another; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.

In the description of the present embodiment, the terms "upper", "lower", "right", etc. are used in an orientation or positional relationship based on that shown in the drawings only for convenience of description and simplicity of operation, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used only for descriptive purposes and are not intended to have a special meaning.

Fig. 1 is a schematic diagram of the construction of an embolic protection device 100 according to an embodiment of the present invention. FIG. 2 is a block diagram of the base 10 of the embolic protection device 100 according to an embodiment of the present invention. Fig. 3 is a diagram showing the state of use of the embolic protection device 100 according to embodiment 1 of the present invention. As shown in fig. 1 to 3, the present embodiment discloses an embolic protection device 100, the embolic protection device 100 comprises a base body 10 and a filter screen 20, the base body 10 is a ring-shaped structure, the base body 10 is sequentially divided into a plurality of partial sections, and the elastic force of each partial section is gradually changed. The substrate 10 has two states, a contracted and an expanded state, such that the substrate 10 can enter a predetermined blood vessel 40 in the contracted state and then conform to the inner wall of the blood vessel 40 in the expanded state. One end of the filter screen 20 is mounted on the base 10 to form an open end 22, the other end of the filter screen is a closed end, and a plurality of filter holes 21 are distributed on the filter screen 20.

The matrix 10 of the embolic protection device 100 of the present embodiment is sequentially divided into a plurality of local segments, and the elastic force of each local segment is gradually changed to increase the deformability of the matrix 10, so that the matrix 10 can be closely attached to the inner walls of the blood vessels 40 with a plurality of diameters, and the positioning and matching are reliable. The embolic protection device 100 of the present embodiment has a wide range of applications.

In addition, the base body 10 of the present embodiment has suitable elasticity, and can be reliably positioned at a predetermined position without damaging the blood vessel 40 after being attached to the inner wall of the blood vessel 40 having a certain diameter range.

Specifically, during the operation of the medical practitioner on the lesion 50 upstream of the blood vessel 40, the thrombus 51 sloughed off from the lesion 50 flows toward the embolic protection device 100, wherein the direction of the flow of the blood is shown as the direction X in fig. 3. Blood is able to flow downstream of the blood vessel 40 through the filtering holes 21 of the sieve 20, the thrombus 51 being intercepted by the sieve 20 and being located in the sieve 20.

The embolic protection device 100 of the present embodiment is capable of filtering the thrombus 51 in the blood without blocking the normal flow of the blood, thereby ensuring that the downstream blood vessel 40 is not embolized even if the thrombus 51 is generated during the interventional procedure.

Preferably, the embolic protection device 100 comprises a guidewire 30, the guidewire 30 being connected to the attachment point 11 of the substrate 10. The guidewire 30 functions to deliver the embolic protection device 100 to the target lesion and serves as a guide wire for subsequent interventional procedures, subsequent catheters, visualization catheters, balloons, embolectomy devices, aspiration catheters, stent transporters, retrieval catheters, and the like after release of the embolic protection device 100 is complete. The guide wire 30 may be made of biocompatible metal (such as nitinol, stainless steel, or cobalt-chromium alloy) or polymer (such as nylon, PI, or PET), and has an outer diameter of 0.010-0.038 Inch, preferably 0.014 Inch.

After the base body 10 of this embodiment is opened, the screen 20 is also opened. There is no gap between the base 10 and the inner wall of the blood vessel 40 within a certain diameter range, and the base is tightly attached, so that the thrombus 51 can not pass between the base 10 and the inner wall of the blood vessel 40, and can only enter the filter screen 20 and be intercepted in the filter screen 20 by the filter screen 20.

The base body 10 and the inner wall of the blood vessel 40 have a certain supporting force therebetween, which enables the base body 10 to be positioned at a predetermined position of the blood vessel 40 without damaging the blood vessel 40. The base body 10 of the present embodiment can be reliably positioned at a predetermined position at all times under the impact force of blood, and is not displaced.

The screen 20 may be attached to the base 10 by means of adhesive, heat fusion, welding, sewing, or the like. Preferably, the screen 20 is of a conical configuration, with the screen 20 tapering in diameter in the direction from the open end 22 to the closed end. In other embodiments, screen 20 may also be cylindrical or windsock shaped. The diameter of the filtration pores 21 of the sieve 20 may be 80 μm to 200. mu.m, with 100 μm to 120. mu.m being preferred. The filtering holes 21 are distributed over the entire surface of the filtering net 20 to ensure the normal circulation of blood. The material of the filter screen 20 may be a polymer film formed by physical or other means.

Preferably, this embodiment may provide two limit points on the guide wire 30, and the substrate 10 may slide along the guide wire 30 in the space between the two limit points.

FIG. 5 is a schematic diagram of the base body 10 of the embolic protection device 100 according to example 1 of the present invention. Fig. 6 is a development view of the base body 10 of the embolic protection device 100 of example 1 of the present invention. As shown in fig. 5 and 6, the base body 10 is preferably formed by bending a rope until the rope is connected end to end, and a connection point 11 is formed at the end to end connection. The straight line passing through the center of the base 10 and the connection point 11 is a first straight line, and the intersection point of the first straight line and the base 10 is the connection point 11 and the opposite intersection point 12. The intersection points of the straight line perpendicular to the first straight line and passing through the center of the circle and the base 10 are a first side intersection point 13 and a second side intersection point 14.

The substrate 10 can be obtained by winding a die and then performing heat treatment at a certain temperature and for a certain time, or by winding and shaping a metal rope into a circular structure in other suitable manners.

Preferably, the rope is formed by at least two wires by means of twisting. For example, the number of wires may be 2-4. The metal wire has certain elasticity and can be twisted. In other embodiments, the rope can also be formed by twisting filaments of other materials. The diameter of the rope body can be 0.1mm-0.5 mm. Of these, 0.3mm is preferable.

Preferably, the twist gradually decreases in the direction from the relative intersection point 12 to the first side intersection point 13 and to the connection point 11, and the twist gradually decreases in the direction from the relative intersection point 12 to the second side intersection point 14 and to the connection point 11.

Preferably, the twist of the first side intersection 13 is the same as the twist of the second side intersection 14, and the twist of the opposite intersection 12 is a multiple of the twist of the connection point 11. For example, the twist relative to the intersection 12 is twice the twist of the connection point 11.

The diameter of the substrate 10 of this embodiment may be 3mm to 10mm, with a preferred range being 5.5mm to 7.5 mm.

In other embodiments, the substrate 10 may also be oval.

Fig. 4 is a block diagram of the embolic protection device 100 in a retracted state according to embodiment 1 of the present invention. After the procedure is completed, the embolic protection device 100 is retrieved through the retriever 60, as shown in fig. 4. The collecting member 60 is a sheath, and the connecting point 11 enters the sheath during the collecting process. Since the elasticity of the partial section of the base body 10 of the embodiment is gradually changed, when the diameter of the blood vessel 40 is smaller than the diameter of the base body 10, the base body 10 can be bent, and the arc line 15 shown in fig. 4 is partially formed, at this time, the base body 10 can still be tightly attached to the inner wall of the blood vessel 40, and has enough radial supporting force, so as to be reliably positioned at the predetermined position.

Since the elasticity of the local section of the base body 10 of the present embodiment is gradually changed, the angle between the force applied to the blood vessel 40 by the opposite intersection point 12 of the present embodiment and the length direction of the blood vessel 40 is relatively large. During the retrieval process, the thrombus 51 collected in this embodiment is less likely to fall off the screen 20, compared to the conventional embolic protection device 100.

Example 2

This embodiment is substantially the same as embodiment 1 except that: the elastic gradation of the local section of the matrix 10 is achieved differently:

the embodiment realizes the change of elasticity by the change of the diameter of the rope body. The larger the diameter, the greater the elasticity, the smaller the diameter, the smaller the elasticity, and the gradual reduction of the diameter can make the elasticity of the local section of the base body 10 gradually changed.

FIG. 7 is a schematic diagram of the base body 10 of the embolic protection device 100 according to example 2 of the present invention. Fig. 8 is a development of the base body 10 of the embolic protection device 100 of example 2 of the present invention.

As shown in fig. 7 and 8, preferably, the rope is of a monofilament structure, the diameter of the rope is gradually reduced in the direction from the opposite intersection point 12 to the first side intersection point 13 and to the connection point 11, and the diameter of the monofilament is gradually reduced in the direction from the opposite intersection point 12 to the second side intersection point 14 and to the connection point 11.

The rope body of the embodiment can also be formed by twisting at least two metal wires, but the twist degrees at each position are the same, but the diameters of the metal wires are different, and then the following effects are achieved: the diameter of the cord body gradually decreases in the direction from the opposite point 12 to the first side point 13 and to the connection point 11, and the diameter of the monofilament gradually decreases in the direction from the opposite point 12 to the second side point 14 and to the connection point 11.

Example 3

This embodiment is substantially the same as embodiment 1 except that: the direction of the elastic transition of the partial segment of this embodiment is different from that of embodiment 1.

FIG. 9 is a schematic diagram of the base body 10 of the embolic protection device 100 according to example 3 of the present invention. Figure 10 is a deployment view of the base 10 of an embolic protection device 100 according to example 3 of the present invention.

As shown in fig. 9 and 10, it is preferable that the twist of the first side intersection point 13 and the second side intersection point 14 are each greater than the twist of the connection point 11 and the opposite intersection point 12.

Preferably, the twist of the first side intersection 13 and the second side intersection 14 is the same. The twist level at the connection point 11 and the relative intersection point 12 is the same.

Preferably, the twist from the first side intersection 13 to the connection point 11 is gradually decreased, the twist from the first side intersection 13 to the opposite intersection 12 is gradually decreased, the twist from the second side intersection 14 to the connection point 11 is gradually decreased, and the twist from the second side intersection 14 to the opposite intersection 12 is gradually decreased.

It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Numerous obvious variations, adaptations and substitutions will occur to those skilled in the art without departing from the scope of the invention. And are neither required nor exhaustive of all embodiments. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. An embolic protection device, comprising:

the elastic base is characterized by comprising a base body (10), wherein the base body (10) is of an annular structure, the base body (10) is sequentially divided into a plurality of local sections, and the elasticity of each local section is gradually changed; the matrix (10) has two states of contraction and expansion, so that the matrix (10) can enter a predetermined blood vessel (40) in the contracted state and then is attached to the inner wall of the blood vessel (40) in the expanded state;

filter screen (20), the one end of filter screen (20) install in base member (10) to form open end (22), the other end of filter screen is the blind end, it has a plurality of filtration pores (21) to distribute on filter screen (20).

2. Embolic protection device according to claim 1, wherein the embolic protection device comprises a guide wire (30), the guide wire (30) being connected to a connection point (11) of the base body (10).

3. Embolic protection device according to claim 2, wherein the base body (10) is formed by bending one rope body until an end-to-end connection is formed, and the connection point (11) is formed at the end-to-end connection; a straight line passing through the center of the base body (10) and the connection point (11) is a first straight line, and the intersection point of the base body (10) and the first straight line is the connection point (11) and the relative intersection point (12); the intersection point of a straight line which is perpendicular to the first straight line and passes through the circle center and the base body (10) is a first side intersection point (13) and a second side intersection point (14).

4. Embolic protection device according to claim 3, wherein the cord body is formed by at least two wires by twisting.

5. Embolic protection device according to claim 4, wherein the twist is gradually decreasing in the direction of the relative intersection point (12) to the first side intersection point (13) and to the connection point (11), and the twist is gradually decreasing in the direction of the relative intersection point (12) to the second side intersection point (14) and to the connection point (11).

6. Embolic protection device according to claim 5, wherein the twist of the first side intersection point (13) and the second side intersection point (14) is the same and/or the twist of the opposite intersection point (12) is a multiple of the twist of the connection point (11).

7. Embolic protection device according to claim 3, wherein the rope is of monofilament structure or is formed by twisting at least two metal wires with the same twist everywhere, the diameter of the rope gradually decreases in the direction of the relative intersection point (12) to the first side intersection point (13) and to the connection point (11), and the diameter of the monofilament gradually decreases in the direction of the relative intersection point (12) to the second side intersection point (14) and to the connection point (11).

8. Embolic protection device according to claim 4, wherein the twist of the first side intersection point (13) and the second side intersection point (14) is larger than the twist of the connection point (11) and the opposite intersection point (12).

9. Embolic protection device according to claim 8, wherein the twist from the first side intersection (13) to the connection point (11) is gradually decreasing, the twist from the first side intersection (13) to the opposite intersection (12) is gradually decreasing, the twist from the second side intersection (14) to the connection point (11) is gradually decreasing, and the twist from the second side intersection (14) to the opposite intersection (12) is gradually decreasing.

10. Embolic protection device according to claim 1, wherein the screen (20) is of conical configuration, the screen (20) decreasing in diameter in the direction from the open end (22) to the closed end.