WO2023125743A1

WO2023125743A1 - Filter and anti-embolism protection device

Info

Publication number: WO2023125743A1
Application number: PCT/CN2022/143118
Authority: WO
Inventors: 吴斯蔚; 李宏卫; 韩彬彬; 宋佳伟; 张子衡; 金巧蓉
Original assignee: 上海微盾医疗科技有限公司
Priority date: 2021-12-29
Filing date: 2022-12-29
Publication date: 2023-07-06
Also published as: CN116407318A

Abstract

A filter (100) and an anti-embolism protection device. The filter (100) is of a mesh structure formed by weaving braided filaments (110); the filter (100) has a natural form and a contracted form; in the natural form, the filter (100) has a tubular support main body (120) both ends of which are open; an proximal end portion (140) of the filter (100) comprises a connecting portion (150) formed by gathering the braided filaments (110) to one side of the axis of the support main body (120), and the braided filaments (110) form a proximal-end opening of the support main body (120) at the proximal end portion (140).

Description

Filter and anti-embolism protection device

related application

This application claims the priority of the Chinese patent application filed on December 29, 2021 with application number 202111647542.4 and titled "Filter and Anti-Embolic Protection Device", which is hereby incorporated by reference in its entirety.

technical field

The present application relates to the technical field of medical devices, in particular to a filter and an anti-embolism protection device.

Background technique

Thrombus, oil droplets, bacterial clots, tumor cells, etc. Thrombocytosis, oil droplets, bacterial clots, tumor cells, etc. are produced during cardiac surgery or aortic surgery, such as cardiac surgery, heart bypass, catheter-based interventional cardiac surgery, and ascending aortic surgery Polymers, or embolic material such as atheroma debris that have broken off the artery wall. These substances will block small arteries after entering the brain with the blood, resulting in local cerebral vascular embolism, which has become an important complication of heart and aortic surgery.

Anti-embolic protection devices provide embolic protection during cardiac surgery or aortic surgery, preventing embolic material from entering the brain. The current anti-embolism protection device mainly consists of a delivery device, a filter and a push rod. The filter is usually connected by a filter element and a support frame. The main body is positioned at the aortic arch. The filter element adopts a planar or arc-shaped sheet design to intercept embolic material, thereby providing a certain deflection effect. However, this type of filter has high requirements for positioning and delivery, high requirements for surgical skills, poor compliance with the curved and complex structure of the aortic arch, and is not convenient for doctors to operate and use.

Contents of the invention

Based on this, it is necessary to provide a filter and an anti-embolism protection device that can facilitate positioning and ensure accurate positioning and compliance for the current problem of high filter positioning and poor compliance.

A filter, the filter is a mesh structure woven with braided silk, the filter has a natural shape and a shrunken shrinkage shape, and in the natural shape, the filter has a tubular shape with two A support body with an open end, the proximal part of the filter includes a connecting part formed by braiding wires gathered to one side of the support body axis, and the braiding wires form the support body at the proximal part Proximal opening.

In one of the embodiments, the supporting body includes a skeleton structure and a filter mesh structure, the filter mesh structure and the skeleton structure form a jacket structure, and the mesh aperture of the skeleton structure is larger than that of the mesh structure of the filter mesh structure. Pore diameter.

In one embodiment, the skeleton structure is braided by metal wires, and the filter mesh structure is braided by polymer wires.

In one of the embodiments, the distal portion of the filter has a flaring structure, and the proximal cross-sectional dimension of the distal portion is smaller than the distal cross-sectional dimension of the distal portion.

In one of the embodiments, in the longitudinal section of the distal end, the cross-sectional profile of the longitudinal section is linear and/or arc-shaped;

The flaring inclination angle of the distal portion is about 10°-30°.

In one of the embodiments, the distal end of the filter has a plurality of arc segments distributed in the circumferential direction, and the arc segments are formed by bending the braided wire outwards at the circumferential edge of the supporting body. become.

In one of the embodiments, the opening at the distal end of the supporting body is circular, elliptical, polygonal, straight-line spliced, curved, or straight-curve spliced;

The proximal opening of the supporting body is elliptical, polygonal, linear spliced, curved or straight and curved spliced.

In one of the embodiments, the lumen inner diameters of the supporting body are equal along the axial direction;

Alternatively, the inner diameter of the lumen of the supporting body is arranged in a stepped shape along the axial direction.

In one of the embodiments, the supporting body has a supporting upper side and a supporting lower side distributed on both sides of the axis of the supporting body, and the axial length of the supporting upper side is greater than the axial length of the supporting lower side.

In one embodiment, the axial length of the upper side of the support is about 90 mm to 120 mm, and the axial length of the lower side of the support is about 30 mm to 90 mm.

In one of the embodiments, the braided wires are connected to form the connecting part by means of connectors, welding or bonding; and/or, the diameter of the connecting part ranges from about 0.2 mm to 0.5 mm.

In one of the embodiments, the filter further includes an anti-coagulation coating, and the anti-coagulation coating is coated on the surface of the supporting body.

In one of the embodiments, the filter has a thickness ranging from about 0.2 mm to 1 mm;

The diameter of the inscribed circle of the mesh in the mesh structure is about 0.05 mm to 0.5 mm.

In one of the embodiments, the filter is pre-bent to form the natural shape.

An anti-embolism protection device, comprising a delivery structure, a push rod, and a filter according to any one of the above-mentioned technical features;

The delivery structure includes a delivery sheath and an operation end, the push rod is movably arranged in the delivery sheath, and one end of the push rod is connected to the operation end, and the other end of the push rod is connected to the operation end. The connection part of the filter is connected.

In one of the embodiments, the push rod is detachably connected to the filter.

In one of the embodiments, the push rod includes a bendable section and a support section, one end of the bendable section is connected to the connecting part, the other end of the bendable section is connected to the support section, and the support section Connect to the operator terminal.

After adopting the above technical solution, the application at least has the following technical effects:

In the filter and anti-embolism protection device of the present application, the filter adopts braided silk to form a mesh structure, and the tubular mesh structure can adapt to the complex curved structure of the aortic arch, better covering the brachiocephalic artery and the left common carotid artery and the physiological length of the left subclavian artery. During the release of the filter into a free form, the outer wall of the filter can fit the inner wall of the lumen of the aortic arch in all directions in the circumferential direction, so as to increase the friction between the filter and the aortic arch and make the positioning of the filter more accurate. At the same time, It also has better compliance and adhesion. The filter of the present application is woven into a tubular mesh structure with braided wire to adapt to the complex curved structure of the aortic arch, and to ensure accurate positioning of the filter, with good compliance and wall-attachment, which can reduce the positioning and delivery requirements, and is more effective for surgery. It requires low operating skills and is convenient for doctors to operate.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects and advantages of the invention will be apparent from the description, drawings and claims.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application or the conventional technology, the following will briefly introduce the accompanying drawings that need to be used in the description of the embodiments or the traditional technology. Obviously, the accompanying drawings in the following description are only the present invention For the embodiments of the application, those skilled in the art can also obtain other drawings based on the disclosed drawings without creative effort.

Fig. 1 is a structural schematic diagram of a filter connection push rod according to an embodiment of the present application;

Fig. 2 is the left side view of filter shown in Fig. 1;

Fig. 3 is a partial structural schematic diagram of the filter shown in Fig. 1;

Fig. 4 is a schematic diagram of the partial structure of the filter connecting the push rod and the delivery sheath shown in Fig. 1;

Fig. 5 is a structural schematic diagram of the filter shown in Fig. 1 using shape memory metal to prepare braided wire;

FIG. 6 is a structural schematic diagram of the filter shown in FIG. 1 using shape memory metal and polymer materials to prepare braided filaments.

Among them: 100, filter; 110, braided wire; 120, support main body; 121, support upper side; 122, support lower side; 123, skeleton structure; 124, filter mesh structure; 130, distal part; 131, arc 140, the proximal part; 150, the connecting part; 200, the push rod; 300, the delivery sheath.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the application with reference to the drawings in the embodiments of the application. Apparently, the described embodiments are only some of the embodiments of the application, not all of them. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

In order to make the above-mentioned purpose, features and advantages of the present application more obvious and understandable, the specific implementation manners of the present application will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, the present application can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Back", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Clockwise", "Counterclockwise", "Axial" , "radial", "circumferential" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the application and simplifying the description, rather than indicating or implying the referred device or Elements must have certain orientations, be constructed and operate in certain orientations, and thus should not be construed as limiting the application.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

In this application, terms such as "installation", "connection", "connection" and "fixation" should be interpreted in a broad sense, for example, it can be a fixed connection or a detachable connection, unless otherwise clearly specified and limited. , or integrated; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise specified limit. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations.

In the present application, unless otherwise clearly specified and limited, a first feature being "on" or "under" a second feature may mean that the first and second features are in direct contact, or that the first and second features are indirect through an intermediary. touch. Moreover, "above", "above" and "above" the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. "Below", "beneath" and "beneath" the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature.

It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. As used herein, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions are for the purpose of illustration only and are not intended to represent the only embodiments.

Referring to FIG. 1 to FIG. 4 , this embodiment provides a filter 100 . The filter 100 is used in an anti-embolism protection device for filtering embolic substances, preventing embolic substances from entering the brachiocephalic artery, left common carotid artery, and left subclavian artery through the aortic arch, and preventing embolic substances from entering the brain with the blood. Avoid the risk of intraoperative and postoperative stroke by avoiding embolic material from clogging smaller arteries in the brain. Moreover, after the filter 100 is applied to the anti-embolism protection device, it can adapt to the complex curved structure of the aortic arch, ensure accurate positioning of the filter 100, have good compliance and wall-attachment, can reduce the positioning and delivery requirements, and greatly improve surgical operation. Low skill requirements, easy for doctors to operate. The structure of the specific embodiment of the filter 100 is introduced below.

Referring to FIG. 1 to FIG. 4 , in one embodiment, the filter 100 is woven into a mesh structure using braided wires 110 , and one end of the filter 100 is used to connect the push rod 200 . The filter 100 has a natural form and a contracted form after contraction. In the natural form, the filter 100 has a tubular support body 120 with two ends open. The proximal part 140 of the filter 100 includes a The braided wires 110 gather to the connecting portion 150 formed on one side of the axis of the support body 120 , and the braided wires 110 form a proximal opening of the support body 120 at the proximal end portion 140 .

The filter 100 is the main structure of the anti-embolism protection device, and is used to filter embolic substances. The proximal end of the filter 100 can be connected with the push rod 200 of the anti-embolism protection device, and the distal end of the filter 100 is a free end. It can be understood that the proximal end here refers to the end of the filter 100 close to the delivery device, and the distal end refers to the end of the filter 100 away from the delivery device, and the proximal end is close to the doctor and the distal end is away from the doctor. Moreover, for other components of the anti-embolism protection device, the configurations of the proximal end and the distal end are substantially the same, and will not be repeated here.

The filter 100 can be delivered to the aortic arch in the contracted configuration, and the filter 100 can be brought into abutment with the lumen inner wall of the aortic arch during release of the filter 100 to the natural configuration at the aortic arch. Specifically, the proximal end of the filter 100 is connected to one end of the push rod 200, and the other end of the push rod 200 passes through the delivery sheath 300 of the delivery device and is connected to the operating end of the delivery device. Operating the push rod 200 through the operating end can make the push rod 200 drive the filter 100 to move into the delivery sheath 300 . At this point, the filter 100 is delivered through the delivery sheath 300 to the vicinity of the aortic arch. Operate the operating end so that the push rod 200 pushes the filter 100 out of the delivery sheath 300, so that the filter 100 is released at the aortic arch and abuts against the inner wall of the lumen of the aortic arch. At this time, the outer wall of the filter 100 can be in contact with The inner wall of the lumen of the aortic arch is fully attached in the circumferential direction, and the blood is filtered in the lumen of the aortic arch through the filter 100 to block embolic substances and prevent embolic substances from entering the brain.

Specifically, the filter 100 is woven into a net-like structure using braided wire 110, and the overall shape is tubular, that is, the net-like structure encloses a tubular inner cavity. The filter 100 in this form can filter embolic substances and has a deflection effect. Blocking embolic substances enter the cerebral circulation along the direction of blood flow along the brachiocephalic artery, left common carotid artery, and left subclavian artery. In this way, it is possible to prevent embolic material from entering the smaller arteries in the brain, preventing the embolic material generated during the operation from entering the brain and causing intraoperative risk and postoperative stroke.

The filter 100 is a tubular mesh structure, which can self-adjust its own size, adapt to the inner diameter of the lumen of the aortic arch, achieve better compliance of the lumen, and adapt to the complex anatomical structure of the aortic arch, thereby achieving better adhesion. walled. The filter 100 has a natural form after release and a contracted form after contraction. The filter 100 is delivered near the aortic arch in a collapsed configuration and released in a natural configuration within the lumen of the aortic arch. That is, the filter 100 can be contracted and released. When the filter 100 is subjected to an external force, the filter 100 shrinks to a contracted form under the external force. When the external force applied to the filter 100 disappears, the filter 100 can be automatically released to a natural state.

The delivery of the filter 100 to the aortic arch can be achieved by the contraction and release of the filter 100 . Specifically, the push rod 200 drags the filter 100 to make the filter 100 enter the delivery sheath 300, and the delivery sheath 300 will squeeze the filter 100, so that the filter 100 shrinks to a contracted shape. When the delivery sheath 300 is delivered to the vicinity of the aortic arch, the push rod 200 pushes the filter 100 to move the filter 100 out of the delivery sheath 300. At this time, the filter 100 is no longer squeezed by the delivery sheath 300, and the filter 100 can be released. to natural form.

Moreover, the filter 100 is released to a natural state, and the tubular support body 120 can abut against the lumen inner wall of the aortic arch, so as to adhere to the lumen inner wall of the aortic arch in all directions in the circumferential direction. In this way, the friction force between the filter 100 and the inner wall of the aortic arch can be increased, preventing the filter 100 from sliding in the aortic arch, so that the position of the filter 100 in the aortic arch is fixed, preventing the filter 100 from rotating and/or The displaced displacement, thereby preventing the embolic material from escaping.

Referring to FIGS. 1 to 4 , specifically, the filter 100 has a tubular support body 120 with both ends open, and the filter 100 also includes a proximal portion 140 and a distal portion 130 . The proximal end of the filter 100 is the proximal portion 140 and the distal end of the filter 100 is the distal portion 130 . The proximal part 140 of the filter 100 includes a connection part 150 formed by gathering the braided wire 110 to one side of the axis of the support body 120, and the braided wire 110 forms the proximal end of the support body 120 at the proximal part 140 An opening, forming a distal opening of the supporting body 120 at the distal portion 130 .

The filter element 100 is woven into a hollow tubular shape by using braided wire 110 , and the surface of the filter 100 is net-shaped. Along the axial direction of the filter 100 ie the length direction of the filter 100 , the filter 100 is divided into a distal portion 130 , a supporting body 120 and a proximal portion 140 . A distal portion 130 is formed at one end of the support body 120 toward the far end, and a proximal portion 140 is formed at one end of the support body 120 toward the proximal end, and the filter 100 also has a connecting portion 150, and the connecting portion 150 is arranged on the proximal portion 140 , the connecting portion 150 is used to connect the end of the push rod 200 . The supporting body 120 plays a supporting role, and the various structures of the filter 100 are supported by the supporting body 120. As shown in FIG. Section 150.

The distal opening is located at the distal portion 130 of the filter 100, and the distal opening enables the filter 100 to form an open structure. When the filter 100 is located in the lumen of the aortic arch, the distal end 130 can contact the inner wall of the aortic arch lumen through the edge of the distal opening to act as an anchor, limiting the displacement of the filter 100 in the movement and rotation direction, avoiding The position of the filter 100 is shifted to ensure the filtering effect of the filter 100 on embolic substances.

The proximal opening is located at the proximal portion 140 of the filter 100, and the braided wire 110 converges at the proximal portion 140 and converges to the upper side of the axis of the support body 120, so that the proximal opening and the axis of the support body 120 are inclined at a certain angle. . Moreover, the braided wire 110 converges to the support body 120 at the proximal end 140 to form a rod-shaped connecting portion 150 , and the connection between the filter 100 and the push rod 200 is realized through the connecting portion 150 .

The filter 100 is braided into a tubular support body 120 by braiding wire 110, and the proximal part 140 and the distal part 130 are formed by braiding at both ends of the support body 120, that is, the proximal part 140, the support body 120 and the distal part 130 adopt The braided wire 110 is integrally braided and formed. The filter 100 is formed by integral weaving, the structure is more stable, and it is convenient for transportation and positioning.

The filter 100 in the above embodiment is woven into a tubular mesh structure by braiding wire 110 to adapt to the complex curved structure of the aortic arch, and the tubular filter 100 is easy to position in the aortic arch and can ensure accurate positioning, even if the The deflection can also ensure its anti-embolism effect, has good compliance and wall adhesion, can reduce the positioning and delivery requirements, requires low surgical operation skills, and is easy for doctors to operate.

Referring to FIG. 1 to FIG. 4 , in one embodiment, the braided wire 110 is made of biocompatible material. That is to say, the braided filament 110 is made of biocompatible material, and then the braided filament 110 is woven into the filter 100 with a mesh structure. After the filter 100 is braided and formed by using braided wire 110 made of biocompatible material, it can avoid poisonous effect on the human body.

In one embodiment, the braided filaments are made of one or more kinds of materials. That is to say, the braided wire 110 can be made of one biocompatible material, or can be made of multiple biocompatible materials. In this embodiment, the filter 100 is braided with a braided wire 110 made of a biocompatible material, such as a 0.02mm shape memory metal wire, with a pore size of 0.1mm.

The filter 100 may be formed by weaving at least two types of braided wires 110 . Optionally, at least two types of braided filaments 110 can be combined in one or more forms such as braiding, sewing, bonding, and hot pressing to ensure reliable connection between the braided filaments 110 .

Referring to FIG. 1 to FIG. 4 , in one embodiment, the biocompatible material includes one or more of shape memory metal, polymer material, elastic metal, polymer film material and stretchable material. It can be understood that the biocompatible material is not limited in principle, and shape memory metal or polymer material can be used, as long as the filter 100 can be woven into a mesh structure and has a natural shape and a contracted shape.

Referring to FIG. 1 to FIG. 5 , in an embodiment of the present application, a filter 100 is braided with a type of braided wire 110 to form a support body 120 , and the support body 120 is braided with a metal wire. That is to say, in this embodiment, the braided wire 110 used for the supporting body 120 is made of shape memory metal.

Referring to FIG. 6 , in another embodiment of the present application, the supporting body 120 includes a skeleton structure 123 and a filter mesh structure 124 , the filter mesh structure 124 and the skeleton structure 123 form a jacket structure, and the skeleton structure 123 The mesh aperture is larger than the mesh aperture of the filter mesh structure 124 . That is to say, in this embodiment, the supporting body 120 plays a supporting role through the skeleton structure 123 to ensure the supporting effect of the filter 100, thereby making the overall structure of the free-form filter 100 stable when released; the filter mesh structure 124 can play a role in intercepting Embolic substances and the role of maintaining smooth blood flow, to ensure the anti-embolism effect.

Further, the skeleton structure 123 is braided by metal wires, and the filter mesh structure 124 is braided by polymer wires. That is to say, the braided wire 110 made of metal material is woven into a skeleton structure 123, and the braided wire 110 made of polymer material is braided into a filter mesh structure 124, and the combination of the filter mesh structure 124 and the skeleton structure 123 plays a role in preventing Embolism.

The skeleton structure 123 braided with metal wires has a low weaving density, which can make the overall shape and structure of the filter 100 stable after being released, and at the same time, achieve the positioning effect of the filter 100 at the aortic arch after being released. The filter mesh structure 124 woven by polymer silk has a high weaving density and a relatively high porosity, and plays the usual role of intercepting embolic substances and maintaining blood flow.

Optionally, the combination of metal wire and polymer wire can be in one or more forms such as weaving, sewing, bonding, hot pressing, etc., to ensure that the braided wire 110 of the two materials is connected reliably, thereby ensuring the use of the filter 100 performance. Optionally, the metal wire can be made of shape memory metal or other elastic metals. Optionally, the shape memory metal may be titanium-nickel alloy, gold-cadmium alloy, copper-zinc alloy or other metals with shape memory function. Optionally, the polymer filaments can be made of polymer materials such as polymer membranes, ductile materials, or other polymer materials.

1 to 4, in one embodiment, the distal portion 130 is a flaring structure, and the proximal cross-sectional size of the distal portion 130 is smaller than the distal cross-section of the distal portion 130 size. That is to say, the cross-sectional dimension of the distal portion 130 increases from the end connected to the support body 120 to the end away from the support body 120, so that the distal portion 130 gradually expands outward in the radial direction to increase the thickness of the distal portion 130. The cross-sectional dimension enables further positioning of the filter 100 in the lumen of the aortic arch.

It can be understood that when the filter 100 is released at the aortic arch, the position of the filter 100 in the lumen of the aortic arch is fixed, that is, the filter 100 cannot move left and right or up and down, so as not to affect the anti-embolism effect of the filter 100. Here, the left, right, up, and down directions are based on the directions shown in FIG. 1 . After the filter 100 is installed in the aortic arch, the orientation of the anatomical structure of the aortic arch is consistent with the orientation of the filter 100 .

In this way, when the filter 100 is released, the flared distal end portion 130 can abut against the inner wall of the lumen of the aortic arch, which has a good positioning effect and prevents the filter 100 from being displaced during the surgical operation. The displacement here includes the forward and backward displacement caused by inevitable interference with other instruments, as well as the left and right deflection displacement of the filter 100, so as to prevent the embolic material from escaping.

Referring to FIG. 1 to FIG. 4 , in an embodiment, in the longitudinal section of the distal end portion 130 , its longitudinal section profile is linear and/or arc-shaped. That is to say, the distal portion 130 may be in a regular trumpet shape or in an irregular trumpet shape. When the profile shape of the longitudinal section extends in a straight line or in an arc, the distal portion 130 is in a regular trumpet shape. When the profile shape of the longitudinal section is a combination of a straight line and an arc, the distal portion 130 is an irregular trumpet shape. Regardless of whether the distal end portion 130 is in a regular trumpet shape or an irregular trumpet shape, the distal end portion 130 can have a flaring structure to achieve further positioning of the filter 100 and achieve a good fixing effect.

It is worth noting that the longitudinal section refers to a section parallel to the axis of the filter 100 , and the cross section refers to a section perpendicular to the axis of the filter 100 .

Referring to FIG. 1 to FIG. 4 , in one embodiment, the flare angle of the distal portion 130 ranges from about 10° to 30°. The inclination angle refers to the angle range between the tangent at the flaring of the distal portion 130 and the central axis of the filter 100 . When the profile shape of the longitudinal section is linear, the included angle between the linear profile and the central axis of the filter 100 is about 10°-30°. When the profile shape of the longitudinal section is arc-shaped or a combination of straight-line and arc-shaped, the included angle between the tangent direction at the flaring of the distal portion 130 and the filter 100 is about 10°-30°. When the flaring inclination angle of the distal portion 130 is within the above range, the positioning effect of the filter 100 can be ensured, and at the same time, the inner wall of the lumen of the aortic arch will not be damaged.

1 to 4, in one embodiment, the distal end portion 130 of the filter has a plurality of arc-shaped segments 131 distributed in the circumferential direction, and the arc-shaped segments are supported by the braided wire 110 on the The peripheral edge of the main body 120 is bent outward. That is to say, the distal portion 130 is provided with multiple arc segments 131 at the edge, and each arc segment 131 is spliced at the end of the distal portion 130 along the circumferential direction. The braiding wire 110 is braided at the end of the distal part 130 to form an arc segment 131, which can prevent the tip formed by braiding the braiding wire 110 on the distal side of the distal part 130, and prevent the tip from piercing the inner wall of the aortic arch, ensuring safety sex.

Referring to FIG. 1 to FIG. 4 , in one embodiment, the opening at the distal end of the support body 120 is circular, elliptical, polygonal, straight-line spliced, curved, or straight-curve spliced. The proximal opening of the supporting body 120 is elliptical, polygonal, straight line spliced, curved or straight line and curved spliced. That is to say, the distal portion 130 is circular, oval or irregular. The proximal portion 140 is oval or irregular in shape.

Referring to FIG. 1 to FIG. 4 , in an embodiment, the cross-sectional shape of the braided wire 110 is round or flat. The filter 100 is formed by braiding the braided wire 110, and the cross-sectional shape of the braided wire 110 is not limited in principle, as long as it can be braided into a mesh structure. Exemplarily, the filter 100 can be braided by using the braided wire 110 whose cross-sectional shape is round or flat. Of course, in other embodiments of the present application, the cross-sectional shape of the braided wire 110 may also be other shapes such as ellipse, polygon and so on.

In one embodiment, when the cross section of the braided wire 110 is circular, the diameter of the circular braided wire 110 ranges from about 0.05 mm to 0.3 mm. When the cross-section of the braided wire 110 is flat, the flat braided wire 110 has a thickness ranging from about 0.02 mm to 0.1 mm, and a width ranging from about 0.05 mm to 0.5 mm.

After the braided wire 110 in the above-mentioned size range is used to weave the filter 100 with a mesh structure, it can ensure that the overall size of the filter 100 is within a specified range, so that the filter 100 can be applied to the lumen of the aortic arch to realize the prevention of embolic substances. filter.

Referring to FIG. 1 to FIG. 4 , in an embodiment, the outer diameter of the support body 120 in a natural state is larger than the inner diameter of the lumen of the aortic arch. That is to say, the outer diameter of the supporting body 120 in a natural state after release is larger than the inner diameter of the lumen of the aortic arch. In this way, after the filter 100 is released at the aortic arch, the support body 120 can be closely attached to the inner wall of the aortic arch, increasing the friction between the filter 100 and the aortic arch, and has a good positioning effect, so that the filter 100 can be placed in the aortic arch. The position is fixed, preventing the filter 100 from being displaced in the lumen of the aortic arch, and ensuring the filtering effect of the filter 100 .

Optionally, the outer diameter of the support body 120 in a natural state is about 1.05 to 1.3 times the inner diameter of the lumen of the aortic arch. That is to say, the outer diameter of the support body 120 in a natural state is slightly larger than the inner wall of the lumen of the aortic arch. This can ensure that the support body 120 fits closely with the inner wall of the lumen of the aortic arch, and at the same time, it will not cause the support body 120 to fail to expand in the lumen of the aortic arch, ensuring that the position of the filter 100 is fixed, and at the same time, it will not affect the embolic material. filter effect.

Referring to FIG. 1 to FIG. 4 , in one embodiment, the inner diameter of the lumen of the support body 120 is equal along the axial direction; or, the inner diameter of the lumen of the support body 120 is arranged in a stepped shape along the axial direction. It can be understood that the structural form of the inner diameter of the lumen of the support body 120 along the axial direction is not limited in principle, as long as it can adapt to the shape of the lumen of the aortic arch.

Optionally, the lumen inner diameters of the support body 120 are equal along the axial direction. That is to say, the inner diameter of the lumen of the support body 120 has an equal-diameter structure along the axial direction, and the inner diameter of the lumen of the support body 120 is equal everywhere along the axial direction. Of course, in other embodiments of the present application, the inner diameter of the lumen of the support body 120 is arranged in a stepped shape along the axial direction. That is to say, the inner diameter of the lumen of the support body 120 has a variable diameter structure along the axial direction. Optionally, the inner diameter of the lumen of the support body 120 may be designed to be gradually reduced according to the anatomical structure of the aortic arch, so that the filter 100 fits well with the inner wall of the lumen of the aortic arch.

1 to 4, in one embodiment, the supporting body 120 has a supporting upper side 121 and a supporting lower side 122 distributed on both sides of the axis of the supporting body 120, and the axial length of the supporting upper side 121 is greater than the axial length of the support lower side 122 . The supporting upper side 121 can be in contact with the upper side of the blood vessel of the aortic arch, and the supporting lower side 122 can be in contact with the lower side of the blood vessel of the aortic arch.

Regarding the aortic arch anatomy, the aortic arch has a vascular superior side and a vascular inferior side, which is an anatomically fixed direction of the aortic arch. For this reason, the filter 100 of the present application designs the supporting body 120 to support the upper side 121 and the supporting lower side 122, the supporting upper side 121 abuts against the upper side of the blood vessels of the aortic arch, and the supporting lower side 122 abuts against the blood vessels of the aortic arch. The supporting upper side 121 and the supporting lower side 122 are shown in FIG. 1 .

Moreover, the supporting upper side 121 plays the role of anti-embolism protection and deflection, and can prevent embolic substances from entering the cerebral circulation along the blood flow direction along the brachiocephalic artery, left common carotid artery and left subclavian artery. The supporting function of the supporting lower side 122 is to reduce the material of the supporting lower side 122 as much as possible on the premise of achieving the positioning effect, and reduce the contact area between the supporting lower side 122 and the inner wall of the lumen of the aortic arch, thereby reducing the time required for the delivery sheath 300 to enter and exit. Resistance to reduce the impact on blood flow.

It is worth noting that the installation orientation of the support body 120 and the aortic arch cannot be changed. This is due to the limitation of the different functions of the support upper side 121 and the support lower side 122. If the position of the support body 120 in the lumen of the aortic arch changes, the support upper side 121 cannot effectively prevent embolic material, which will cause embolic material into the brain.

Therefore, the connection part 150 of the filter 100 of this embodiment is located on the upper side, and only ensuring that the connection part 150 corresponds to the upper side of the blood vessel during use can ensure that after the filter 100 is released at the aortic arch, the support upper side 121 can be aligned with the aortic arch. The lower side of the support body 122 can be in contact with the lower side of the blood vessel of the aortic arch, and, through the dual positioning of the support body 120 and the distal part 130, the position of the filter 100 at the aortic arch is guaranteed to be fixed after release, avoiding the filter 100 The displacement of the filter 100 ensures that the filter 100 can effectively filter the embolic material.

Referring to FIG. 1 to FIG. 4 , in one embodiment, the axial length of the supporting upper side 121 is about 90 mm to 120 mm, and the axial length of the supporting lower side 122 is about 30 mm to 90 mm. That is to say, when the support upper side 121 is in the above range, the anti-embolism effect can be ensured, and when the support lower side 122 is in the above range, the resistance of entering and exiting the input sheath can be reduced while ensuring the positioning effect.

Referring to FIG. 1 to FIG. 4 , in an embodiment, the diameter of the connecting portion 150 is about 0.2 mm˜0.5 mm. That is to say, the braiding wires 110 of each path gather together at the proximal end 140 to form a connecting portion 150 , and the diameter of the connecting portion 150 is the overall outer diameter of the braiding wires 110 gathered together. The outer diameter of the connecting portion 150 is within the above range, which can facilitate the connection with the push rod 200 and facilitate the operation of the filter 100 by the push rod 200 .

In one embodiment, the braided wires 110 are connected by a connector, welding or bonding to form the connecting portion 150 . That is to say, after the braided wires 110 are gathered at the proximal end 140 , they are fixed by connectors, welding or bonding, so as to ensure that the braided wires 110 are reliably gathered and fixed to form the connecting portion 150 .

In one embodiment, the filter 100 further includes an anti-coagulation coating, and the anti-coagulation coating is coated on the surface of the support body 120 . After the anticoagulant coating is applied on the surface of the supporting body 120 , it can prevent the blood from coagulating on the mesh structure of the supporting body 120 , thereby avoiding blocking the aortic arch and ensuring smooth flow of blood.

In one embodiment, the filter 100 has a thickness ranging from about 0.2 mm to 1 mm. When the thickness of the filter 100 is within the above range, it can avoid affecting the shrinkage and release performance of the filter 100 , and ensure the structural strength of the filter 100 , thereby ensuring the performance of the filter 100 .

Referring to FIG. 1 to FIG. 4 , in one embodiment, the diameter of the inscribed circle of the mesh in the mesh structure is about 0.05 mm to 0.5 mm. That is to say, the diameter of the inscribed circle of the mesh of the filter 100 ranges from about 0.05 mm to 0.5 mm. This can prevent the passage of embolic substances, ensure the filtering effect of embolic substances, and at the same time, not affect the flow of blood.

Referring to Fig. 5, in one embodiment of the present application, the supporting body 120 is braided by a braided wire 110 made of a shape memory metal material, and the diameter of the braided wire 110 is 0.02mm, and the braided wire 110 is used to weave a filter After the device 100, its aperture size is about 0.1mm. Referring to Fig. 6, in another embodiment of the present application, the braided wires 110 are polymer wires and metal wires respectively, the diameter of the metal wires is 0.3mm, and the metal wires are used to weave into a skeleton structure 123, the aperture of which is about 10mm, and the height The molecular filaments have a diameter of 0.05 mm, and are woven into a filter mesh structure 124 with polymer filaments, and the pore diameter is about 0.1 mm.

In one embodiment, the filter 100 is pre-bent into a natural shape. That is, the pre-curved shape of the filter 100 is consistent with the shape of the aortic arch. That is to say, after the filter 100 is formed, the support body 120 is pre-bent so that the filter 100 can basically keep the shape of the aortic arch. In this way, when the filter 100 is released in the aortic arch, the natural shape of the filter 100 can better fit the anatomical structure of the inner wall of the lumen of the aortic arch, ensuring the adherence of the filter 100 .

Referring to Fig. 1 to Fig. 4, after the filter 100 of this embodiment is released at the aortic arch, the filter 100 woven into a tubular shape using a braided wire 110 can cover the physiological length of the brachiocephalic artery, the left common carotid artery and the left subclavian artery, Play the role of filtering embolic substances, preventing embolic substances from entering the brain during the injury process and causing intraoperative risk and postoperative stroke. Moreover, after the filter 100 is braided into a tubular shape by using the braided wire 110, it has good deformation resilience, and it can be properly extended and contracted according to the shape of the aortic arch, and can be realized by adjusting the diameter of the lumen of the supporting body 120. Excellent lumen compliance, adapting to the complete and complex anatomical structure of the aortic arch, so as to achieve better adherence and avoid the escape of embolic material.

After the filter 100 is released at the aortic arch, the supporting body 120 can abut against the inner wall of the lumen of the aortic arch, and has a good positioning effect, so that the position of the filter 100 in the lumen of the aortic arch is fixed. Moreover, the filter 100 is provided with a flaring structure at the distal end 130, and an arc segment 131 is provided on the edge of the distal end 130 to reduce damage to the inner wall of the aortic arch. At the same time, the distal end 130 is slightly outwardly The expansion can contact the inner wall of the lumen of the aortic arch to play an anchoring role, so that the position of the filter 100 in the lumen of the aortic arch remains stable and is not easy to be displaced, further realizing the fixation of the filter 100 .

Referring to Figures 1 to 4, the present application also provides an anti-embolism protection device, including a delivery structure, a push rod 200, and the filter 100 described in any of the above-mentioned embodiments; the delivery structure includes a delivery sheath 300 and an operating end , the push rod 200 is movably arranged in the delivery sheath 300, and one end of the push rod 200 is connected to the operating end, and the other end of the push rod 200 is connected to the connecting portion 150 of the filter 100 connect. In this way, the operating end can drive the push rod 200 to move into or out of the delivery sheath 300 .

When the anti-embolism protection device of the present application is in use, the connecting part 150 of the filter 100 is connected to one end of the push rod 200, and the other end of the push rod 200 is connected to the operating end of the delivery device through the delivery sheath 300 of the delivery device. By dragging the push rod 200 through the operating end, the push rod 200 can drive the filter 100 to move into the delivery sheath 300 . At this point, the filter 100 is delivered through the delivery sheath 300 to the vicinity of the aortic arch. Operate the operating end, so that the push rod 200 pushes the filter 100 out of the delivery sheath 300, so that the filter 100 is released at the aortic arch, and abuts against the inner wall of the aortic arch, and passes through the filter 100 in the lumen of the aortic arch The blood is filtered to block embolic material and prevent it from entering the brain.

After the anti-embolism protection device of the present application adopts the filter 100 of the above-mentioned embodiment, the filter 100 can be accurately positioned in the lumen of the aortic arch, and has good compliance and wall-attachment, which can reduce the positioning and delivery requirements, and greatly improve the operation efficiency. It requires low operating skills and is convenient for doctors to operate.

In one embodiment, the push rod 200 is detachably connected to the filter 100 . The detachable connection can facilitate the disassembly of the push rod 200 and the filter 100 . It is understandable that during the operation, when encountering complex operations with many instrument components, the push rod 200 can be temporarily withdrawn from the aortic arch before other instruments enter, so as to provide more operating space for other instruments and reduce the impact on other instruments. Interfering with the operation of the instrument, at the same time, the filter 100 located at the aortic arch can still play an anti-embolic effect. After other instruments pass through the aortic arch or after the operation is completed, the push rod 200 is connected to the connecting portion 150 of the filter 100 to realize recovery of the filter 100 .

Optionally, the connection part 150 and the push rod 200 are threaded, clamped or otherwise detachably connected to realize the detachable connection between the connection part 150 and the push rod 200 . In this way, the push rod 200 can be temporarily withdrawn, reserve space for the operation of other devices, and reduce interference with other devices. After the operation of other devices is completed, the filter 100 is connected to the push rod 200 to withdraw the filter 100 in vitro.

In one embodiment, the push rod 200 includes a bendable section and a support section, one end of the bendable section is connected to the connecting part 150, the other end of the bendable section is connected to the support section, and the support section segment is connected to the operating terminal. The bendable section is capable of bending with the filter 100 . Optionally, bendable pipe fittings such as a braided section, a threaded section, or a hypotube can be used for the curved section.

That is to say, the part where the push rod 200 is connected to the filter 100 has flexibility, so that the curvature adjustment at the connecting part 150 can be realized. It can be understood that after the filter 100 is released at the aortic arch, the filter 100 can drive the curved section of the push rod 200 to bend, so that the filter 100 can better adapt to the curved path entering the aortic arch, so that the filter 100 has a better lumen compliance.

The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.

The above-mentioned embodiments only express several implementation modes of the present application, and the description thereof is relatively specific and detailed, but should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the scope of protection of the patent application should be based on the appended claims.

Claims

A filter, characterized in that, the filter is a mesh structure woven with braided silk, the filter has a natural shape and a shrunken shrinkage shape, and in the natural shape, the filter It has a tubular support body with two ends open, the proximal part of the filter includes a connecting part formed by braiding wires gathered to one side of the axis of the support body, and the braiding wires are formed at the proximal part. The proximal opening of the supporting body.
The filter according to claim 1, wherein the supporting body comprises a skeleton structure and a filter mesh structure, the filter mesh structure and the skeleton structure are in a jacket structure, and the mesh aperture of the skeleton structure is larger than The mesh aperture of the filter mesh structure.
The filter according to claim 2, characterized in that, the skeleton structure is woven by metal wires, and the filter mesh structure is woven by polymer wires.
The filter according to claim 1, wherein the distal portion of the filter is a flaring structure, and the cross-sectional dimension of the proximal side of the distal portion is smaller than that of the distal side of the distal portion cross-sectional dimensions.
The filter according to claim 4, characterized in that, in the longitudinal section of the distal portion, the cross-sectional profile of the longitudinal section is linear and/or arc-shaped;

The flaring inclination angle of the distal portion is about 10°-30°.
The filter according to claim 1, characterized in that, the distal end of the filter has a plurality of arc-shaped segments distributed in the circumferential direction, and the arc-shaped segments are formed by the braided wire on the support body. The peripheral edge is bent outward.
The filter according to claim 1, wherein the distal opening of the supporting body is circular, elliptical, polygonal, straight line spliced, curved, or straight line and curve spliced;

The proximal opening of the supporting body is elliptical, polygonal, linear spliced, curved or straight and curved spliced.
The filter according to any one of claims 1 to 7, wherein the lumen inner diameters of the supporting body are equal along the axial direction;

Alternatively, the inner diameter of the lumen of the supporting body is arranged in a stepped shape along the axial direction.
The filter according to any one of claims 1 to 7, characterized in that, the supporting body has a supporting upper side and a supporting lower side distributed on both sides of the axis of the supporting body, and the axial direction of the supporting upper side The length is greater than the axial length of the underside of the support.
The filter according to claim 9, wherein the axial length of the support upper side is about 90 mm to 120 mm, and the axial length of the support lower side is about 30 mm to 90 mm.
The filter according to any one of claims 1 to 7, characterized in that, the braided wires are connected to form the connecting portion by means of connectors, welding or bonding; and/or,

The diameter range of the connecting portion is about 0.2mm˜0.5mm.
The filter according to any one of claims 1 to 7, characterized in that the filter further comprises an anti-coagulation coating, and the anti-coagulation coating is coated on the surface of the supporting body.
The filter according to any one of claims 1 to 7, wherein the thickness of the filter ranges from about 0.2 mm to 1 mm;

The diameter of the inscribed circle of the mesh in the mesh structure is about 0.05 mm to 0.5 mm.
The filter according to any one of claims 1 to 7, characterized in that, the filter is pre-bent to form the natural shape.
An anti-embolism protection device, characterized in that it comprises a delivery structure, a push rod and the filter according to any one of claims 1 to 14;

The delivery structure includes a delivery sheath and an operation end, the push rod is movably arranged in the delivery sheath, and one end of the push rod is connected to the operation end, and the other end of the push rod is connected to the operation end. The connection part of the filter is connected.
The anti-embolism protection device according to claim 15, wherein the push rod is detachably connected to the filter.
The anti-embolism protection device according to claim 15, wherein the push rod comprises a bendable section and a support section, one end of the bendable section is connected to the connecting part, and the other end of the bendable section is connected to The support segment is connected to the operating end.