WO2024088206A1

WO2024088206A1 - Occluder

Info

Publication number: WO2024088206A1
Application number: PCT/CN2023/125896
Authority: WO
Inventors: 赖柳; 邱礼彪
Original assignee: 先健科技(深圳)有限公司
Priority date: 2022-10-26
Filing date: 2023-10-23
Publication date: 2024-05-02
Also published as: CN117918918A

Abstract

An occluder (100), comprising a main body portion (110), a deformation receiving portion (120) located at a proximal or distal end of the main body portion (110), and a gathering member (130), wherein one end of the deformation receiving portion (120) is connected to the main body portion (110), and the other end of the deformation receiving portion (120) is constrained in the gathering member (130); and the deformation receiving portion (120) at least partially protrudes in a radial manner from the main body portion (110), and the gathering member (130) is located in a groove formed by means of recessing a distal end of the deformation receiving portion (120) facing the main body portion (110), and is located outside the deformation receiving portion (120). The deformation receiving portion (120) at least partially protrudes radially from the main body portion (110), so that the portion of the deformation receiving portion (120) protruding toward a radially outer side of the main body portion (110) is excessively squeezed by an inner wall of a blood vessel; and the protruding portion of the deformation receiving portion (120) facing toward the radially outer side of the main body portion (110) drives the deformation receiving portion (120) to move toward the center direction of the main body portion (110), so that the gathering member (130) is received by the deformation receiving portion (120), thereby reducing the contact area between the gathering member (130) and blood, and reducing the probability of thrombosis.

Description

Occluder

Technical Field

The present invention relates to the field of medical devices, and in particular to an occluder.

Background technique

This section merely provides background information related to the present disclosure and is not necessarily prior art.

Abnormal vascular access refers to abnormal vascular traffic in the body in a non-physiological state due to congenital developmental abnormalities, postnatal compensation or trauma. Many common clinical diseases are accompanied by abnormal vascular access. For example, complex cyanotic congenital heart disease is often accompanied by thick side branches from the aorta to the pulmonary artery; complex arteriovenous aneurysms and arteriovenous fistulas in different parts; coronary artery ventricular fistulas, abnormal morphological intracardiac defects of congenital heart disease, abnormal blood vessels in the body, and blood vessels that need to be closed due to surgical operations, etc.

In the prior art, a vascular occluder is usually implanted in a blood vessel to block an abnormal vascular channel. The vascular occluder is usually fixed at both ends with a metal cap and a plug head. The capping heads protrude outward from both ends of the occluder, and the ends are prone to thrombosis, which is not good for human health.

Summary of the invention

Based on this, it is necessary to provide an occluder, comprising a main body, a deformation receiving portion and a gathering piece arranged at the proximal or distal end of the main body, one end of the deformation receiving portion is connected to the main body, the other end of the deformation receiving portion is constrained in the gathering piece, the deformation receiving portion at least partially protrudes radially out of the main body, the gathering piece is located in a groove formed by the distal end surface of the deformation receiving portion being recessed toward the main body, and is located outside the deformation receiving portion.

Optionally, the deformable accommodation portion includes a protruding portion and a contracting portion. In the axial cross-section of the occluder, the left contour line of the main body, the left contour line of the protruding portion and the left contour line of the contracting portion are connected in sequence, and the contracting portion is connected to the gathering piece; wherein the deformable accommodation portion extends from the position connected to the main body toward the radial outside of the main body to form the protruding portion, and then bends toward the center of the main body to form the contracting portion. On the cross-section perpendicular to the longitudinal center axis of the occluder, the projection of the deformable accommodation portion completely covers the projection of the main body.

Optionally, the anti-deformation performance of the raised portion is greater than that of the main body, and the convergence portion and the main body All-in-one connection.

Optionally, the protrusion is coated with a coating or provided with a supporting rod.

Optionally, the deformable receiving portion comprises a wire mesh, and the diameter or wire width of the wire at the protruding portion is greater than the diameter or wire width of the wire at the gathering portion.

Optionally, the occluder further comprises a flow-blocking membrane, the circumferential edge of which is connected to the part where the diameter of the deformation receiving portion is the largest.

Optionally, the deformation accommodation portion includes a plurality of braided wires, the braided wires are braided to form the deformation accommodation portion, and the flow-blocking membrane is sewn at the intersection of the braided wires.

Optionally, the occluder further comprises a connecting piece, one end of which is connected to the flow-blocking membrane, and the other end of which is connected to the most proximal end or the most distal end of the deformation receiving portion.

Optionally, the flow-blocking film completely covers the deformation receiving portion and fits closely to the inner wall of the deformation receiving portion.

Optionally, the occluder further comprises a fixing disk, which is connected to an end of the main body away from the deformation receiving portion, and a diameter of the fixing disk is greater than a diameter of the main body.

Optionally, the weaving density of the fixing disk is greater than the weaving density of the main body.

Compared with the prior art, the occluder of the present invention has the following beneficial effects:

After the occluder is implanted in the blood vessel, the deformation accommodation portion at least partially radially protrudes the main body, so that the portion of the deformation accommodation portion protruding toward the radial outside of the main body is excessively squeezed by the inner wall of the blood vessel (compared with the main body), and the protruding portion of the deformation accommodation portion toward the radial outside of the main body moves toward the radial center direction of the main body (in the direction of arrow f), and at the same time, the squeezing force is transmitted to the end of the deformation accommodation portion (i.e., the end connected to the gathering piece), and then the end of the deformation accommodation portion is moved toward the center direction of the main body (i.e., the direction of arrow f) under the action of the squeezing force through the end surface of the gathering piece located at the farthest end of the deformation accommodation portion facing the groove formed by the depression of the main body, so that the end of the deformation accommodation portion moves toward the center direction of the main body (i.e., the direction of arrow f), so that the gathering piece is accommodated by the deformation accommodation portion, thereby reducing the contact area between the gathering piece and the blood, thereby reducing the probability of thrombosis.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic structural diagram of an occluder in Embodiment 1 of the present invention;

FIG2 is an enlarged schematic diagram of the structure at A in FIG1 of the present invention;

FIG3 is a schematic diagram of the structure of a folding member in Embodiment 1 of the present invention;

FIG4 is a schematic diagram of the structure of the occluder after being implanted into a blood vessel in Embodiment 1 of the present invention;

FIG5 is an enlarged schematic diagram of the structure at B in FIG1 of the present invention;

FIG6 is a schematic diagram of the structure of the coating attached to the occluder in the first embodiment of the present invention;

FIG7 is a schematic structural diagram of a coating and a deformation receiving portion in the first embodiment of the present invention;

FIG8 is an enlarged schematic diagram of the structure at point A in FIG7 of the present invention;

FIG9 is a schematic diagram of the connection structure between the support rod and the wire mesh in the second embodiment of the present invention;

FIG10 is a schematic diagram of the unfolded structure of the screen and the support rods in the second embodiment of the present invention;

FIG. 11 is a schematic diagram of the structure of the occluder in the third embodiment of the present invention.

Detailed ways

In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

In the field of interventional medical devices, the “distal end” is defined as the end away from the operator during surgery, and the “proximal end” is defined as the end close to the operator during surgery. “Axial” refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, and “radial” refers to the direction perpendicular to the above axial direction.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

Embodiment 1

This embodiment provides an occluder 100, which can be used for intravascular intervention to occlude abnormal vascular channels, arteriovenous aneurysms, arteriovenous fistulas, coronary artery ventricular fistulas, abnormal morphological intracardiac defects of congenital heart diseases, and other lesions.

As shown in Figures 1 to 4, the occluder 100 includes a main body 110, a deformation receiving portion 120 provided at the proximal or distal end of the main body 110, and a folding piece 130, one end of the deformation receiving portion 120 is connected to the main body 110, and the other end of the deformation receiving portion 120 is constrained in the folding piece 130.

The occluder 100 may be a mesh structure formed by weaving braided wires or cutting metal parts, and the mesh structure has a certain elasticity. The material forming the occluder 100 includes a metal material or a polymer material, the metal material includes any one of nickel-titanium-based shape memory alloy, iron-based shape memory alloy, copper-based shape memory alloy or stainless steel wire, and the polymer material includes any one of absorbable polylactic acid wire, absorbable chitin fiber or absorbable surgical suture.

The main body 110 and the deformation receiving portion 120 can be integrally connected or welded. The integral connection refers to the metal material being integrally formed by laser cutting or integrally woven by braided wire. The main body 110 is generally tubular in structure, and the side wall of the main body 110 is a mesh structure to provide good wall adhesion. One end of the deformation receiving portion 120 is connected to an axial end of the main body 110, and the deformation receiving portion 120 is located on one axial side of the main body 110. The end of the deformation receiving portion 120 away from the main body 110 is connected to the retracting member 130.

As shown in FIG. 2 , the deformable receiving portion 120 at least partially protrudes radially from the main body 110. The main body 110 may first extend along the axial direction of the main body 110, then extend toward the radial outer side of the main body 110, and then bend toward the radial center of the main body 110 to connect with the retracting member 130 to form the deformable receiving portion 120. The main body 110 may also directly extend along the radial outer side of the main body 110, then bend toward the radial center of the main body 110 and extend close to one side of the main body 110 to connect with the retracting member 130 to form the deformable receiving portion 120. It can be understood that, on a cross section perpendicular to the longitudinal central axis of the occluder 100, the axial projection of the deformable receiving portion 120 completely covers the main body 110, that is, the deformable receiving portion 120 completely covers one axial end of the main body 110. It can be understood that the diameter of the portion of the deformable receiving portion 120 extending radially toward the main body 110 is greater than the maximum diameter of the main body 110.

As shown in FIG. 2 , the retracting member 130 is located in a groove formed by the end surface of the farthest end 125 of the deformation receiving portion 120 facing the main body 110, wherein the farthest end 125 of the deformation receiving portion 120 refers to the end point of the deformation receiving portion 120 farthest from the main body 110 in the axial direction. The retracting member 130 is arranged close to the radial center of the main body 110, and the position where the retracting member 130 is connected to the deformation receiving portion 120 refers to the position where the retracting member 130 gathers the deformation receiving portion 120, and can also refer to the position where one end of the retracting member 130 fits the deformation receiving portion 120. It can be understood that the position where the retracting member 130 is connected to the deformation receiving portion 120 is spaced from the farthest end 125 of the deformation receiving portion 120. That is, the position where the retracting member 130 is connected to the deformation receiving portion 120 has a spacing distance x1 from the farthest end 125 of the deformation receiving portion 120.

As shown in FIG3 , one end of the folding member 130 is sealed, and the other end is provided with a receiving hole 131 . One end of the deformable receiving portion 120 is folded into the receiving hole 131 and then fixedly connected to the folding member 130. The sealing end of the folding member 130 faces the side of the deformable receiving portion 120 away from the main body 110. It can be understood that in other embodiments, one end of the deformable receiving portion 120 can be directly welded or bonded to the folding member 130.

In this way, as shown in FIG4 , after the occluder 100 is implanted in the blood vessel, the deformation receiving portion 120 at least partially protrudes radially from the main body 110, so that the portion of the deformation receiving portion 120 protruding radially outward from the main body 110 is excessively squeezed by the inner wall of the blood vessel (compared with the main body 110), and the protruding portion of the deformation receiving portion 120 toward the radial outer side of the main body 110 moves toward the radial center direction of the main body 110 (the direction of arrow f1), and at the same time, the squeezing force is transmitted to the end of the deformation receiving portion 120 (i.e., the end connected to the retracting member 130), and then the end surface of the retracting member 130 located at the farthest end 125 of the deformation receiving portion 120 faces the groove formed by the depression of the main body 110, so that the end of the deformation receiving portion 120 moves toward the center direction of the main body 110 (i.e., the direction of arrow f2) under the action of the squeezing force, so that the retracting member 130 is accommodated by the deformation receiving portion 120, thereby reducing the contact area between the retracting member 130 and the blood, thereby reducing the probability of thrombosis.

Please go back to Figure 2. The deformation accommodation portion 120 includes a protrusion 123 and a convergence portion 124. In the axial cross-section of the occluder, the left contour line a1 of the main body 110, the left contour line a2 of the protrusion 123 and the left contour line a3 of the convergence portion 124 are connected in sequence, and the end of the convergence portion 124 away from the protrusion 123 is connected to the gathering piece 130; wherein, the deformation accommodation portion 120 extends from the position connected to the main body 110 toward the radial outside of the main body 110 to form the protrusion 123, and then bends toward the center of the main body 110 to form the convergence portion 124.

In this embodiment, the main body 110, the protrusion 123 and the convergence portion 124 are integrally connected. The protrusion 123 can be formed by extending the main body 110 toward the radial outside. The convergence portion 124 can be formed by bending the protrusion 123 toward the center of the main body 110 and connecting with the gathering piece 130. The maximum diameter d2 of the convergence portion 124 is smaller than the diameter d1 of the main body 110, and the maximum diameter d3 of the protrusion 123 is larger than the diameter d1 of the main body, that is, d3>d1>d2, and the convergence portion 124 is located on the radial inside of the main body 110.

As shown in FIG. 4 , after the occluder 100 is implanted in the blood vessel, the protrusion 123 is excessively squeezed by the inner wall of the blood vessel, and then pushes the contraction portion 124 to move toward the side close to the main body 110 (in the direction of arrow f1), and the contraction portion 124 drives the folding piece 130 to move toward the main body 110 (in the direction of arrow f2), and the side wall of the folding piece 130 fits against the side wall of the contraction portion 124 to achieve the accommodation of the folding piece 130.

In this embodiment, the deformation accommodation portion 120 includes a first deformation accommodation portion 121, which is located at the distal end of the main body 110. The main body 110 extends radially outward toward the distal end to form a distal end. The protruding portion 1211 further extends toward the radial center of the proximal end to form a distal converging portion 1212. In a cross section perpendicular to the longitudinal center axis of the occluder, the projection of the first deformable receiving portion 121 completely covers the projection of the main body 110.

It can be understood that in some embodiments, as shown in FIG. 5 , the deformation accommodation portion 120 further includes a second deformation accommodation portion 120 , and the second deformation accommodation portion 120 is located at the proximal side of the main body 110 .

It should be noted that the first deformation receiving portion 121 and the second deformation receiving portion 122 are radially symmetrically arranged at the two axial ends of the main body 110, and the second deformation receiving portion 122 includes a proximal receiving portion 1222 and a proximal protrusion 1221. The main body 110 extends radially outward toward the proximal side to form a proximal protrusion 1211, and then extends toward the radial center of the distal side to form a proximal receiving portion 1222. The axial projection of the second deformation receiving portion 120 completely covers the main body 110. A conveying fitting 140 is provided at the second deformation receiving portion 120, and a connecting hole is provided at one end of the conveying fitting 140, and the proximal receiving portion 1222 is closed in the connecting hole. The other end of the conveying fitting 140 is detachably connected to the conveyor. For example, a threaded hole for cooperating with the conveyor is provided at the other end of the conveying fitting 140, and the conveyor is threadedly engaged with the threaded hole.

It can be understood that in some embodiments, as shown in FIG. 2 , the ratio of the maximum diameter d2 of the protrusion 123 to the maximum diameter d1 of the main body 110 is between 1.05-1.3, for example, the ratio of the maximum diameter d2 of the protrusion 123 to d1 of the main body 110 can be 1.05, 1.1, 1.2, 1.25 or 1.3. In this way, it can be ensured that the protrusion 123 has a sufficient protrusion amount to be squeezed by the inner wall of the blood vessel, and the deformation amount of the protrusion 123 after being squeezed can push the contraction part 124 to move toward the main body 110, and it can avoid the difficulty of sheathing caused by the excessive diameter of the protrusion 123.

It can be understood that in some embodiments, the protrusion 123 and the convergence portion 124 can be arranged along the circumference of the main body 110 to form a deformation receiving portion 120 that completely covers the protrusion 123 and the convergence portion 124 in the circumference. In other embodiments, the protrusion 123 and the convergence portion 124 can be partially arranged in the circumference of the deformation receiving portion 120. For example, the protrusion 123 and the convergence portion 124 can be arranged only on one side of the circumference of the deformation receiving portion 120, or the protrusion 123 and the convergence portion 124 can be arranged in some areas in the circumference, and the protrusion 123 and the convergence portion 124 can not be arranged in some areas. As long as the protrusion 123 can drive the convergence portion 124 to move toward the radial center of the main body 110 after being squeezed, the convergence portion 124 can clamp or wrap the gathering member 130.

It is understood that in some embodiments, the raised portion 123 and the convergent portion 124 can be formed by heat setting. For example, a model with a deformed receiving portion 120 protruding outward is provided, a tubular member formed by weaving or cutting is sleeved on the model, and then the tubular member is heat-formed to obtain the protruding portion 123 and the contracting portion 124.

In this embodiment, the anti-deformation performance of the protrusion 123 is greater than the anti-deformation performance of the main body 110, the convergence portion 124 is integrally connected to the main body 110, and the area of a single mesh of the convergence portion 124 is smaller than the area of a single mesh of the main body 110.

It should be noted that the anti-deformation performance refers to the ability of the occluder 100 to resist deformation caused by the extrusion of external force. The stronger the anti-deformation performance, the greater the external force required for the part to be deformed. The anti-deformation performance can be measured by using a dynamometer. For example, in one embodiment, the anti-deformation performance test method of the protrusion 123 is as follows: the pressure head of the dynamometer is in contact with the outer wall of the protrusion 123. At this time, the reading of the dynamometer display is adjusted to zero, and then the ruler is adjusted so that the pointer points to zero and then the pressure is applied. When the displacement ruler moves to 30% of the diameter of the protrusion 123, the force value displayed on the dynamometer is recorded. The anti-deformation performance of the main body 110 is as follows: the pressure head of the dynamometer is in contact with the outer wall of the main body 110. At this time, the reading of the dynamometer display is adjusted to zero, and then the ruler is adjusted so that the pointer points to zero and then the pressure is applied. When the displacement ruler moves to 30% of the diameter of the main body 110, the force value displayed on the dynamometer is recorded. In this embodiment, the main body 110 and the gathering portion 124 are woven or cut as a whole, and the weaving structure or cutting structure of the main body 110 and the gathering portion 124 are the same. The only difference is that when the gathering portion 124 is constrained by the gathering piece 130, the area of a single mesh on the gathering portion 124 is smaller than the area of a single mesh on the main body 110.

In this way, the anti-deformation performance of the protrusion 123 is greater than the anti-deformation performance of the main body 110, and the anti-deformation performance of the main body 110 is similar to the anti-deformation performance of the convergence portion 124, so that the anti-deformation performance of the protrusion 123 is greater than the anti-deformation performance of the main body 110.

In this embodiment, as shown in Figures 2 and 6, the protrusion 123 and the gathering portion 124 can be formed by weaving a braided wire as a whole. At the position where the protrusion 123 is located, the two intersecting braided wires are fixedly connected at the intersection, for example, they can be welded or sewed. At the position where the gathering portion 124 is located, the two intersecting braided wires are movably connected at the intersection, that is, the two intersecting braided wires can move relative to each other. In this way, after the protrusion 123 is subjected to force, the two intersecting braided wires at the protrusion 123 are difficult to produce adaptive slippage at the intersection, and have greater anti-deformation performance. At the gathering portion 124, the two intersecting braided wires are movably connected. The braided wire can produce adaptive sliding and be more easily deformed, so that the anti-deformation performance of the protruding portion 123 is greater than the anti-deformation performance of the contracting portion 124.

It can be understood that in other embodiments, the raised portion 123 and the convergent portion 124 can be integrally cut to form a wire mesh, and the wire diameter of the wire mesh at the raised portion 123 is larger than the wire diameter at the convergent portion 124. For example, at the raised portion 123, the wire diameter or width is between 0.1-0.2 mm, specifically, it can be 0.1, 0.12, 0.15 or 0.2 mm. At the convergent portion 124, the wire diameter or width is between 0.05-0.15 mm, specifically, it can be 0.05, 0.08, 0.1, 0.12 or 0.15 mm. The wire with a larger diameter or width has a stronger rigidity, so that the anti-deformation performance at the raised portion 123 is greater than the anti-deformation performance at the convergent portion 124.

In this way, after the occluder 100 is implanted in the blood vessel, the anti-deformation performance of the protruding portion 123 is greater than the anti-deformation performance of the contracting portion 124, so that the protruding portion 123 is harder and difficult to deform, thereby promoting the transmission of the extrusion force to the contracting portion 124, and then the protruding portion 123 can push the contracting portion 124 to move, and the anti-deformation performance of the contracting portion 124 is less than the anti-deformation performance of the contracting portion 124, so that the contracting portion 124 is softer, thereby facilitating the contracting portion 124 to wrap around the closing piece 130 and promote the accommodation of the closing piece 130.

As shown in FIG. 6 , in this embodiment, the protrusion 123 is coated with a coating 160 , which is used to enhance the anti-deformation performance of the protrusion 123 . The coating 160 includes any one of a titanium oxide coating, a titanium nitride coating or a titanium nitride ceramic coating.

The coating 160 includes any one of a titanium oxide coating, a titanium nitride coating or a titanium nitride ceramic coating. It is understood that in one embodiment, the titanium nitride coating 160 is applied to the inner wall or outer wall of the protrusion 123 by the following steps: (1) heat treatment: heat treatment of the protrusion 123; (2) surface pretreatment: cleaning the oxide layer and contaminants on the surface of the protrusion 123; (3) ion sputtering cleaning: placing the pretreated protrusion 123 in a vacuum chamber, introducing argon gas, applying a negative bias, and using glow discharge to clean the protrusion 123; Plasma performs ion sputtering cleaning on its surface; (4) Pseudo-diffusion layer deposition: after ion sputtering cleaning, turn on one or more cold cathode vacuum arc ion sources with filtering devices; (5) Sub-layer film plating: after completing the pseudo-diffusion layer, alternately coat pure titanium and titanium and titanium nitride; (6) Cycle selection: repeat step (5); (7) Plating of pure titanium nitride layer: turn on one or more ion sources to plate a pure titanium nitride layer with a thickness of 200 to 400 nm. After reaching the thickness, turn off the ion source, gas and bias. After the titanium oxide coating is applied to the position where the protrusion 123 is located, on the one hand, titanium oxide forms crystals on the surface of the wire of the protrusion 123. The crystals increase the stiffness of the wire, thereby increasing the overall rigidity of the protrusion 123 and promoting the transmission of the extrusion force; on the other hand, through The over-coating coating 160 increases the anti-deformation performance of the protrusion 123, reduces the difficulty of processing the anti-deformation performance at the protrusion 123, and reduces the difficulty of product manufacturing. It can be understood that in some embodiments, the coating 160 can be only provided on the protrusion 123, or can be provided on the protrusion 123 and the main body 110 at the same time.

As shown in FIG. 2 , the occluder 100 further includes a flow-blocking membrane 150 , and a circumferential edge of the flow-blocking membrane 150 is connected to the largest diameter portion of the deformation receiving portion 120 .

The baffle film 150 includes any one of a PTFE baffle film, a PET baffle film, and a PU baffle film. The circumferential contour of the baffle film 150 is set corresponding to the circumferential contour of the deformation accommodation portion 120. The maximum diameter of the deformation accommodation portion 120 refers to the maximum diameter of the protrusion 123. The position of the baffle film 150 is set corresponding to the position of the maximum diameter at the protrusion 123. The circumferential edge of the baffle film 150 is in contact with the inner wall of the protrusion 123 at the maximum diameter. The baffle film 150 can be sutured, bonded or hot-pressed to the inner wall of the protrusion 123 at the maximum diameter.

It can be understood that in other embodiments, the blocking film 150 can also be connected to other positions of the inner wall of the protrusion 123 and the convergence portion 124 or to the restraining member. For example, in one embodiment, the blocking film 150 is connected to the gathering member 130 by a suture at the center of the blocking film 150. For another example, in other embodiments, the blocking film 150 can also be connected to the inner wall of the convergence portion 124.

It can be understood that in other embodiments, the blocking film 150 can also be connected to the outer wall of the deformation receiving portion 120 and completely cover the deformation receiving portion 120, and the blocking film 150 is spaced apart from the end of the gathering member away from the main body 110, so that after the protrusion 123 pushes the gathering portion 124 to move toward the main body 110 and the gathering portion 124 wraps the gathering member 130, it can prevent the sealed end of the gathering member 130 from piercing the blocking film 150. On the other hand, sewing the blocking film 150 to the outer side of the deformation receiving portion 120 can also effectively reduce the difficulty of sewing the blocking film 150.

In this way, by connecting the circumferential edge of the baffle film 150 to the part with the largest diameter of the deformation receiving part 120, on the one hand, the baffle film 150 can completely cover the deformation receiving part 120, so that the baffle film 150 can block the blood flow at the deformation receiving part 120, thereby increasing the blocking effect of the occluder 100; on the other hand, the baffle film 150 can constrain the part with the largest diameter at the deformation receiving part 120, thereby further increasing the anti-deformation performance of the protrusion 123.

As shown in FIG. 7 , the occluder 100 further includes a connector, one end of which is connected to the flow-blocking membrane 150. The middle part is connected, and the other end of the connecting piece is connected to the farthest end 125 of the deformation receiving portion 120.

It should be noted that the connector includes any one of a suture thread and a braided wire. One end of the connector is sewn to the middle part of the flow-blocking membrane 150, and the middle part refers to the part between the circumferential edge of the flow-blocking membrane 150 and the center of the flow-blocking membrane 150. Specifically, the position where the connector is sewn to the flow-blocking membrane 150 can be set corresponding to the farthest end 125 of the deformation accommodation portion 120. The farthest end 125 of the deformation accommodation portion 120 refers to the position where the protrusion 123 is connected to the convergence portion 124, which is the inflection point where the protrusion 123 is bent toward the center of the main body 110, and the other end of the connector is sewn to the farthest end 125 of the deformation accommodation portion 120. In the present embodiment, there are two connectors, and the two connectors are radially symmetrically arranged on both sides of the gathering member 130. It can be understood that in other embodiments, there are multiple connectors, and the multiple connectors are arranged in a central circumferential array of the flow-blocking membrane 150.

After the occluder 100 is implanted in the blood vessel, the position where the protrusion 123 is connected to the contraction portion 124 (i.e., the farthest end 125 of the deformable housing portion 120) is squeezed by the inner wall of the blood vessel and moves toward the center of the main body 110. The farthest end 125 of the deformable housing portion 120 drives the baffle film 150 to protrude toward the inner wall close to the deformable housing portion 120 through the conveying fitting 140. The baffle film 150 can cover the seams of the grid to increase the blocking effect of the baffle film 150.

As shown in FIG. 8 , the deformation receiving portion 120 includes a plurality of braided wires, all of which intersect to form a mesh structure, and the flow-blocking membrane 150 is sewn at the intersections of the braided wires.

In this embodiment, the braided wire includes a first braided wire 126 and a second braided wire 127, the first braided wire 126 and the second braided wire 127 intersect to form an intersection a1, the flow-blocking film 150 is fitted with the intersection a1, the suture thread passes through the inner side of the flow-blocking film 150 and is located outside the intersection a1, and then bypasses a1 to enter the inner side of the flow-blocking film 150, and this cycle is repeated many times to achieve the suture connection at the intersection of the flow-blocking film 150 and the braided wire, and the suture thread is wound around the intersection, and the suture thread will form a constraint on the intersection of the braided wire. In the process of the protrusion 123 being compressed, the suture thread constrains the relative movement of the first braided wire 126 and the second braided wire 127, thereby increasing the anti-deformation performance of the protrusion 123. It can be understood that the flow-blocking film 150 can be sutured to all the intersections of the braided wires at the maximum diameter of the protrusion 123, or it can be sutured to some of the intersections of the braided wires at the maximum diameter of the protrusion 123.

The advantage of such a configuration is that the deformation receiving portion 120 is formed by the intersection of the braided wires, and the flow blocking film 150 is sutured at the intersection of the braided wires, so that the suture line can constrain the intersection, increasing the braided wire at the intersection. The difficulty of slipping under pressure increases the anti-deformation performance of the protrusion 123, so that after the protrusion 123 is under pressure, the force can be transmitted to the end of the protrusion 123 to squeeze the contraction portion 124 to move toward the main body 110.

Embodiment 2

The difference between this embodiment and the first embodiment is that, as shown in FIG. 9 , the deformation accommodation portion 220 includes a wire mesh 228 and a plurality of support rods 229 , all support rods 229 are connected to the wire mesh 228 and are arranged along the circumference of the wire mesh 228 , and the support rods 229 extend from the main body 210 to the protrusion 223 .

In this embodiment, the occluder 200 is formed by laser cutting of a tubular metal part. At the deformed receiving portion 220, the tubular metal part is formed into a mesh structure after laser cutting. As shown in FIG10 , in the partially unfolded configuration of the mesh structure, a plurality of support rods 229 are arranged in an equidistant array along the width direction, and the diameter or rod width of the support rods 229 is between 0.15 and 0.4. For example, the diameter or rod width of the support rods 229 can be 0.15, 0.18, 0.25, 0.3 or 0.4. In the enclosed configuration of the mesh structure (i.e., the three-dimensional configuration of the occluder 200), the support rods 229 are arranged along the axial direction of the occluder 200, and a plurality of support rods 229 are arranged in a circumferential array along the occluder 200. The support rods 229 constitute the main support skeleton of the occluder 200, providing sufficient radial support force for the occluder 200. The support rod 229 extends from the main body 210 to the protrusion 223, that is, the support rod 229 extends from the main body 210 to the farthest end 225 of the deformation receiving portion 220. The support rod 229 provides a certain anti-deformation performance for the protrusion 223. It can be understood that the support rod 229 can be provided only on the protrusion 223, or can be provided on the protrusion 223 and the main body 210 at the same time.

The wire mesh 228 is located between two adjacent support rods 229 and is integrally connected to the two adjacent support rods 229. The diameter or rod width of the wire in the wire mesh 228 is between 0.08 and 0.2. Specifically, the diameter or rod width of the wire in the wire mesh 228 can be 0.08, 0.1, 0.15 or 0.2. The rod width or diameter of the wire in the wire mesh 228 is smaller than the rod width or diameter of the support rod 229, and the wire mesh 228 has good deformation performance to better fit the inner wall of the blood vessel. For the position where the convergence portion 224 is located, since there is only the wire mesh 228, the deformation performance of the wire mesh 228 is greater than the deformation performance of the support rod 229, so that the convergence portion 224 has better deformation performance than the protrusion 223.

After the occluder 200 is implanted in a blood vessel, the protrusion 223 is squeezed by the inner wall of the blood vessel, and the support rod 229 has a larger rod diameter and is difficult to deform, so that the support rod 229 is squeezed and drives the contraction part 224 to move toward the radial center of the main body 210, and the contraction part follows the contraction part 224 to move toward the radial center of the main body 210. Movement, and the gathering piece is wrapped by the gathering portion 224.

The present embodiment does not limit the number of support rods 229, and the number of support rods 229 can be two, and the two support rods 229 are radially symmetrically arranged on the deformation receiving portion 220. It can be understood that in other embodiments, the number of support rods 229 can also be 3, 4, 5 or 6, and multiple support rods 229 are circumferentially arranged on the wire mesh 228.

It is understood that in other embodiments, the wire mesh 228 is formed by weaving braided wires, and the support rod 229 is inserted into the wire mesh 228. For example, in one embodiment, the braided wires on the wire mesh 228 have multiple intersections in the axial direction, and the support rod 229 is interwoven with the multiple intersections in turn to achieve the connection between the support rod 229 and the wire mesh 228. In other embodiments, the support rod 229 can also be welded to the intersections to achieve the connection between the support rod 229 and the wire mesh 228.

The advantage of such an arrangement is that, through the deformation accommodation portion 220 including a wire mesh 228 and a plurality of support rods 229, all the support rods 229 are connected to the wire mesh 228 and are arranged along the circumference of the wire mesh 228, so that the support rods 229 can enhance the anti-deformation performance of the wire mesh 228, and the support rods 229 extend from the main body 210 to the raised portion 223, so that the anti-deformation performance at the raised portion 223 can be enhanced, and only the wire mesh 228 is arranged at the convergence portion 224, so that the anti-deformation performance of the raised portion 223 is greater than the anti-deformation performance of the convergence portion 224, thereby promoting the stress transfer at the raised portion 223 to the convergence portion 224.

As shown in FIG9 , the flow-blocking film 250 completely covers the deformed accommodation portion 220 and fits the inner wall of the deformed accommodation portion 220. In the present embodiment, the flow-blocking film 250 fits the inner wall of the deformed accommodation portion 220, the flow-blocking film 250 is connected to the inner wall of the deformed accommodation portion 220, and the contour of the flow-blocking film 250 is arranged corresponding to the contour of the inner wall of the deformed accommodation portion 220. The flow-blocking film 250 can be sutured, bonded or hot-pressed with the inner wall of the deformed accommodation portion 220. Thus, by setting the flow-blocking film 250 to completely cover the deformed accommodation portion 220 and fit the inner wall of the deformed accommodation portion 220, the area covered by the flow-blocking film 250 at the deformed accommodation portion 220 is maximized, thereby increasing the blocking effect of the occluder 200.

Embodiment 3

The difference between this embodiment and the first embodiment is that, as shown in FIG. 11 , the occluder 300 further includes a fixing disk 380 , which is connected to an end of the main body 310 away from the deformation receiving portion 320 , and the diameter of the fixing disk 380 is greater than the diameter of the main body 310 .

The fixing plate 380 includes a wire mesh, which can be formed by weaving a braided wire or by laser cutting a metal tubular member. The fixing plate 380 is connected to the main body 310 through a fixing member. For example, in one embodiment, a first fixing hole is provided at one end of the fixing member, and an end of the fixing portion close to the fixing plate 380 is fixed in the first fixing hole, and a second fixing hole is provided at the other end of the fixing member, and an end of the fixing plate 380 close to the fixing portion is fixed in the fixing hole, thereby achieving the connection between the fixing plate 380 and the main body 310. The diameter of the fixing plate 380 is greater than the diameter of the main body 310, which means that the diameter d4 of the fixing plate 380 is greater than the diameter d1 of the main body 310.

After the occluder 300 is implanted in the blood vessel, the fixing plate 380 fits against the inner wall of the blood vessel at the distal side of the main body 310. The side wall of the fixing plate 380 has a mesh structure, which enables the fixing plate 380 to fit well with the inner wall of the blood vessel, thereby increasing the friction between the fixing plate 380 and the inner wall of the blood vessel, thereby increasing the anti-displacement performance of the occluder 300 and preventing the occluder 300 from being displaced due to the erosion of the blood flow.

The weaving density of the fixing plate 380 is greater than the weaving density of the main body 310 .

It should be noted that the braiding density refers to the number of intersections of the wires per unit area. After the fixed disk 380 is unfolded, the number of intersections of the wires per unit area (cm ² ) is greater than the number of intersections of the wires of the main body 310. For example, in other embodiments, after the fixed disk 380 is unfolded, the number of intersections of the wires per unit area is between 70-144, specifically, the number of intersections of the wires per unit area is: 70, 73, 81, 96, 124, or 144. The number of intersections of the wires per unit area of the main body 310 is between 30-70, specifically, the number of intersections of the wires per unit area is 30, 32, 36, 43, 51, 64, or 70.

In this way, by setting the weaving density of the fixed disk 380 greater than the weaving density of the main body 310, the number of intersections of the wires per unit area of the fixed disk 380 is greater than the number of intersections of the wires of the main body 310, thereby increasing the contact area between the fixed disk 380 and the inner wall of the blood vessel, increasing the static friction between the fixed disk 380 and the inner wall of the blood vessel, and further increasing the fixing effect of the occluder 300.

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

The above-mentioned embodiments only express several implementation methods of the present invention, and the description is relatively specific and detailed, but it cannot be understood as limiting the scope of the invention patent. It should be pointed out that for ordinary technicians in this field, several modifications and changes can be made without departing from the concept of the present invention. Furthermore, all of these belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be based on the attached claims.

Claims

An occluder, characterized in that it includes a main body, a deformation receiving portion and a folding piece arranged at the proximal end or the distal end of the main body, one end of the deformation receiving portion is connected to the main body, and the other end of the deformation receiving portion is constrained in the folding piece, the deformation receiving portion at least partially protrudes radially from the main body, and the folding piece is located in a groove formed by the distal end of the deformation receiving portion being concave to the main body, and is located outside the deformation receiving portion.
The occluder according to claim 1 is characterized in that the deformation accommodation portion includes a protruding portion and a contracting portion, and in an axial cross-section of the occluder, the left contour line of the main body, the left contour line of the protruding portion and the left contour line of the contracting portion are connected in sequence, and the contracting portion is connected to the gathering piece; wherein the deformation accommodation portion extends from a position connected to the main body toward the radially outer side of the main body to form the protruding portion, and then bends toward the center of the main body to form the contracting portion, and in a cross-section perpendicular to the longitudinal center axis of the occluder, the projection of the deformation accommodation portion completely covers the projection of the main body.
The occluder according to claim 2, characterized in that the anti-deformation performance of the protrusion is greater than the anti-deformation performance of the main body, and the contraction portion is integrally connected to the main body.
The occluder according to claim 2, characterized in that the protrusion is coated with a coating or provided with a support rod.
The occluder according to claim 2, characterized in that the deformable receiving portion comprises a wire mesh, and the diameter or wire width of the wire at the raised portion is greater than the diameter or wire width of the wire at the contracting portion.
The occluder according to claim 1 is characterized in that it also includes a flow-blocking membrane, and the circumferential edge of the flow-blocking membrane is connected to the largest diameter of the deformation receiving portion.
The occluder according to claim 6, characterized in that the deformable accommodation portion comprises a plurality of braided wires, the braided wires are woven to form the deformable accommodation portion, and the flow-blocking membrane is sutured at the intersection of the braided wires.
The occluder according to claim 7 is characterized in that it also includes a connecting piece, one end of which is connected to the flow-blocking membrane, and the other end of which is connected to the most proximal end or the most distal end of the deformation receiving portion.
The occluder according to claim 6, characterized in that the flow-blocking membrane completely covers the deformation receiving portion and fits against the inner wall of the deformation receiving portion.
The occluder according to claim 1 is characterized by further comprising a fixing disk, wherein the fixing disk is connected to an end of the main body away from the deformation receiving portion, and the diameter of the fixing disk is greater than the diameter of the main body.
The occluder according to claim 9, characterized in that the weaving density of the fixing disk is greater than the weaving density of the main body.