CN216060638U - Occlusion device - Google Patents

Abstract

The utility model relates to an occlusion instrument, which comprises an anchoring piece, a sealing device and a fixing device, wherein the sealing device and the fixing device are connected with each other; the anchor is provided on the fixation means and/or the sealing means. According to the utility model, by arranging the anchoring piece, after the plugging device is implanted into a human body, the anchoring piece is abutted against the surface of the human tissue instead of piercing the human tissue, so that the damage to the human tissue is avoided, and further, the damage and enlargement of a wound caused by the movement of the human tissue are further avoided.

Description

Occlusion device

Technical Field

The utility model relates to the technical field of medical instruments, in particular to an occlusion instrument.

Background

Occlusion devices, particularly medical implant devices, typically need to remain in the implanted position for a period of time after implantation into the body.

In recent years, in patients with non-valvular ward fibrillation, stroke due to atrial fibrillation, 90% of which originates from the left atrial appendage. There are clinical data showing that when atrial fibrillation, the resection of the left atrial appendage during cardiac surgery can reduce the incidence of stroke, which suggests a hazard of the left atrial appendage in thromboembolism. Since the left atrial appendage is the pit for a thrombus, plugging the opening of the left atrial appendage can eliminate the basis for thrombus formation in the left atrial appendage. Generally, the left atrial appendage occluder is used as a medical implant device to occlude the opening of the left atrial appendage, which is an effective way to prevent stroke caused by atrial fibrillation.

In order to effectively block the left auricle, a left auricle blocking device needs to be implanted into the left auricle for a long time so as to realize the blocking effect. Therefore, the left auricle occluder needs to have a certain anchoring structure, so that the left auricle occluder can be stably occluded in the left auricle for a long time, and the problems of embolism of instruments and the like caused by falling off of the left auricle occluder are avoided.

In order to achieve long-term stability of the left atrial appendage occluder in occlusion of the left atrial appendage, a plurality of anchoring structures with sharp head ends, such as anchors or anchors hooks, are usually disposed on the left atrial appendage occluder support (at the junction of the left atrial appendage occluder and the atrial appendage wall) to penetrate into the atrial appendage wall, thereby achieving long-term implantation stability. However, the anchoring structure with the sharp head end in the shape of the anchor spike or the anchor hook is easy to puncture the wall of the auricle, which causes complications such as hydropericardium and the like, and endangers the life of the patient. Meanwhile, since the auricle moves with the heart in a systolic and diastolic manner, if the anchoring is performed in a puncturing manner, the anchoring position may cause greater breakage due to the movement of the auricle. Such problems also arise in other body implants, and therefore, there is a need to design an anchoring structure for an occlusion device that has anchoring stability while avoiding the introduction of sharp-tipped structures.

SUMMERY OF THE UTILITY MODEL

In view of the above, there is a need to provide a new occlusion device for the problem of the prior art that the anchoring structure of the occlusion device penetrates the body tissue.

An occlusion instrument, the occlusion instrument comprising an anchor, and a sealing device and a fixation device connected to each other, the fixation device comprising a first mesh structure, the first mesh structure comprising a connection portion and an anchoring portion, the connection portion being connected between the anchoring portion and the sealing device, the connection portion extending distally to form a cone-shaped structure with a distal opening, the distal end of the cone-shaped structure bending outward toward the proximal end to form the anchoring portion; the anchoring piece is arranged on the fixing device and/or the sealing device and is used for being clamped into a sunken area of a target cavity after the plugging device is implanted into the target cavity with the sunken area so as to mutually anchor the plugging device and the target cavity.

In one embodiment, the fixing device comprises a covering film arranged on the surface of the first reticular structure, and the anchoring part and/or the covering film is provided with an anchoring part.

In one embodiment, the anchor comprises at least one anchor unit having one or more of a spherical, hemispherical, drop-shaped, cylindrical, conical, polyhedral, annular, umbrella-shaped, disc-shaped, radial configuration.

In one embodiment, the anchor further comprises a connecting unit connecting the anchor unit to the fixation device or the sealing device.

In one embodiment, the anchors are positioned outside of the covering membrane and extend obliquely outward relative to the covering membrane, and the opening angle of the anchors is 20-60 degrees.

In one embodiment, the connection unit comprises a telescopic rod, one end of the rod is connected with the anchoring unit, and the other end of the rod is fixedly connected with the fixing device or the sealing device.

In one embodiment, the anchoring unit is interposed between the first mesh structure and the covering membrane, and the covering membrane on the outer surface of the anchoring unit protrudes in a direction away from the axis of the occlusion device.

In one embodiment, the sealing device includes a second mesh structure with an anchor disposed thereon.

In one embodiment, the occlusion device comprises a plurality of the anchoring units, the plurality of anchoring units being located on a plurality of cross-sections of the occlusion device when the occlusion device is in a deployed state; and/or a plurality of the anchoring units are located on a plurality of cross sections of the occlusion device when the occlusion device is in a radially compressed state.

In one embodiment, the anchoring unit is provided with micro-thorns.

According to the plugging device provided by the utility model, the anchoring piece is arranged, and after the plugging device is implanted into a human body, the anchoring piece is clamped into the gap of the human tissue to realize anchoring instead of puncturing the human tissue, so that the damage to the human tissue is avoided, and further the damage and enlargement of a wound caused by the movement of the human tissue are further avoided. Under the condition of ensuring good anchoring capability, the normal work of the plugging device is realized.

Drawings

FIG. 1 is a schematic view showing an implanted state of a blocking instrument according to embodiment 1 of the present invention;

FIG. 2 is a schematic structural view of a blocking instrument according to example 1 of the present invention;

FIG. 3 is a schematic structural view of a first net-like structure of a blocking instrument according to example 1 of the present invention;

FIG. 4 is a schematic structural view of a coating film of the occluding device of example 1 of the present invention;

FIG. 5 is a schematic structural view of an anchor of the occlusion instrument in example 1 of the present invention;

fig. 6 is a schematic structural view of an anchor member of the occlusion instrument in embodiment 2 of the present invention;

FIG. 7 is a schematic structural view of an anchor of the occlusion instrument in example 3 of the present invention;

FIG. 8 is an exploded view of the anchor of FIG. 7;

fig. 9 is a schematic structural view of an anchor of the occlusion instrument in embodiment 4 of the present invention;

FIG. 10 is a schematic structural view of an anchor of the occlusion instrument in example 5 of the present invention;

FIG. 11 is a schematic structural view of an anchor of an occluding device according to another embodiment of the present invention;

fig. 12 is a schematic structural view of an anchor member of the occlusion instrument in embodiment 6 of the present invention;

fig. 13 is a schematic structural view of an anchor of the occlusion instrument in example 7 of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the utility model and are not intended to limit the utility model.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle.

The technical solution of the present invention will be described in further detail with reference to specific examples.

Example 1

Referring to fig. 1, fig. 1 is a schematic structural view of an occlusion device 100 according to embodiment 1 of the present invention, in which the occlusion device 100 is disposed in a target cavity 200. The target cavity 200 may be any cavity in a living body, and may also be a cavity of other implants implanted in a living body, and the present invention is not limited to the type of the target cavity 200. For ease of understanding, the present invention is illustrated with the left atrial appendage as the target cavity 200, and a large number of comb-like muscles 210 are present on the inner wall of the left atrial appendage to facilitate the systolic-diastolic behavior of the left atrial appendage. The adjacent pectinate muscle 210 and the inner wall of the left atrial appendage (the lower atrial appendage wall 220) enclose a recessed region 230 having an opening.

Referring also to fig. 2, the occluding device 100 includes a fixation device 10 and a sealing device 20 connected to the fixation device 10. The fixation device 10 and the sealing device 20 are arranged in the axial direction of the occlusion instrument 100, and the fixation device 10 and the sealing device 20 are connected by a connection device (e.g., a cannula or the like, not shown). The sealing device 20 is located at the proximal end of the occlusion device 100 and the fixation device 10 is located at the distal end of the occlusion device 100. The occluding device 100 has a compressed state such that the occluding device 100 can be housed within a sheath to facilitate delivery of the occluding device 100 to a site to be occluded and, in addition, upon release of the radial constraint on the occluding device 100, the occluding device 100 returns to the deployed state as shown in figure 2.

The fixing device 10 includes a first net structure 11, and the first net structure 11 includes a plurality of supporting wires 111, and the plurality of supporting wires 111 surround to form a mesh 113. The "one" supporting filament 111 defined in the present invention is a plurality of supporting filaments 111, which are divided by using the intersection point 112 (or intersection point) of the supporting filaments 111 as a virtual dividing point, and for some first mesh structures 11 actually formed by weaving only one continuous supporting filament 111, the supporting filaments 111 are also included according to the definition of the present invention.

In this embodiment, the first net structure 11 can be woven by a plurality of supporting wires 111, or can be obtained by cutting a pipe (e.g., a shape memory alloy pipe or a polymer material pipe). The support wire 111 may be a single wire structure or a plurality of wires spirally wound. The material of the support wire 111 may be selected from one or more of a metal material (e.g., nickel titanium), a polymer material, and an inorganic non-metal material. The present invention does not limit the material and structure of the first net structure 11, as long as the first net structure 11 has a certain radial supporting force.

Referring to fig. 3, the first mesh structure 11 includes a connecting portion 114, an anchoring portion 115 and a contracting portion 116, the connecting portion 114 is connected between the anchoring portion 115 and the sealing device 20, and the connecting portion 114 extends towards the distal end to form a tapered structure with a distal opening. The distal end of the cone-like structure curves outwardly toward the proximal end to form an anchor portion 115. The anchoring portion 115 is substantially tubular and is arranged around the outside of the connecting portion 114, and the anchoring portion 115 is arranged at a distance from or against the sealing means. The constricted portion 116 is formed by extending the proximal end of the anchoring portion 115 while being bent inward and surrounds the outside of the connecting portion 114. In other embodiments, the constriction 116 may be omitted.

Referring to fig. 4, in the present embodiment, the surface of the first net structure 11 is provided with a covering film 30, and the covering film 30 can partially or completely cover the distal opening of the connecting portion 114. As shown in FIG. 4, the cover film 30 only partially covers the outer surface of the first web, but at least covers the distal opening of the connecting portion 114. It will be appreciated that in other embodiments, the overlay film 30 is a spherical film that completely covers the outer surface of the first web. Alternatively, the covering membrane 30 may include at least one annular membrane secured to at least a portion of the outer surface of the anchoring portion 115 surrounding the distal opening of the connecting portion 114, exposing at least a portion of the distal opening.

The cover 30 may not allow thrombus to pass but may allow a small amount of blood flow, or may not allow thrombus to pass nor allow blood flow. The cover 30 may have a plurality of openings, and the cover 30 may have a permeability function, i.e., block thrombus by blood flow, by setting the opening ratio and/or the pore size. The surface of the cover film 30 may also be plated or covered with an anticoagulant (e.g., heparin) or other compound, or the surface of the cover film 30 may also be treated to impart antithrombin properties.

The sealing device 20 includes a second net structure, which is formed by weaving a plurality of woven wires into a net tube, and the ends of the net tube are closed and fixed by a distal plug (not shown). The mesh tube is then heat set into a disc, cylinder or plug shape, etc., resulting in a second mesh structure for occluding the target cavity 200 (e.g., the left atrial appendage). The first mesh structure 11 and the second mesh structure may be formed by separating an integrated mesh structure by a sleeve, or the first mesh structure 11 and the second mesh structure may be formed by splitting, for example, the first mesh structure 11 and the second mesh structure are respectively manufactured and then connected by a sleeve. At least one layer of film (not shown) may be disposed inside the second net structure, and the edges of the film are fixed on the woven wires at the edges of the second net structure. The thin film body is used for preventing blood flow from one side to the other side of the second reticular structure.

In other embodiments, the second mesh structure may be woven from a plurality of woven filaments, including a waist portion (not shown) and a disc portion (not shown), the waist portion being fixedly attached to a distal end of the disc portion. Wherein, the disk part and the waist part are enclosed into a cavity. The second net structure can be provided with three thin film bodies (not shown), wherein one thin film body is fixedly connected to the inner side of the disk part, and the other two thin film bodies are fixedly connected to the inner side of the waist part. Due to the arrangement of the thin film body, the sealing performance of the sealing device is enhanced, and thrombus is prevented from entering the left atrial appendage. It is understood that in other embodiments, the number of the thin film bodies of the sealing device may be other than the number of the thin film bodies of the embodiment, and the utility model is not limited thereto.

Referring to fig. 4, at least one anchor 12 may be disposed on the fixture 10. Referring to fig. 5, the anchor 12 includes at least one anchor unit 121 and a connecting unit 122. In this embodiment, the anchoring unit 121 is a protrusion, and the protrusion is spherical, so that when the anchoring unit 121 is clamped or inserted into the gap of the comb muscle 210 in the left auricle, the comb muscle 210 is not damaged due to the existence of the tip. In addition, in order to further reduce the stimulation of the anchoring unit 121 to the auricle wall 220 and the pectinate muscle 210, the anchoring unit 121 may have a smooth outer surface by polishing, coating with a biocompatible lubricious coating, or the like.

In other embodiments, the protrusion may also be hemispherical, drop-shaped, cylindrical, conical, polyhedral. It should be noted that the protrusion is not the only expression of the anchoring unit 121, and the anchoring unit 121 may be configured in various structures such as a ring, an umbrella, a disc, a radial shape, etc., as long as the anchoring unit 121 is ensured to be capable of being adaptively clamped or extended into a gap in the human tissue or abut against the human tissue. The material used for making the anchoring unit 121 may be one or more selected from metal, polymer or inorganic non-metal materials, for example, a harder material such as nitinol, ceramic, PTFE, PET, etc., or a soft material such as silica gel, wire, etc. may be used.

The size of the anchoring unit 121 may be set according to a specific use scenario. In the present embodiment, since the occlusion device 100 is used for occluding the left atrial appendage, the maximum dimension (diameter) of the anchoring unit 121 is between 0.1mm and 3 mm. For example, the maximum size of the anchoring unit 121 is 1.5mm to 2.5mm, and it should be noted that when the anchoring unit 121 is smaller than 1.5mm, the depth of the anchoring unit 121 clamped into the tissue is insufficient, and the anchoring capability is weak; when the size of the anchoring unit 121 is larger than 2.5mm, the difficulty of the anchoring unit 121 to be caught in the tissue increases, and sometimes it is impossible to be caught in the tissue gap entirely. In summary, the anchor unit 121 is generally selected to have a size of about 2 mm.

Referring to fig. 4 and 5, in the present embodiment, the anchoring unit 121 is connected to the supporting wire 111 through the connecting unit 122. The connecting unit 122 is substantially rod-shaped, one end of which is located inside the covering membrane 30 and connected to the first mesh structure 11 (for example, the connecting unit 122 is formed by extending the supporting wires 111 outwards), and the other end of which is located outside the covering membrane 30 and extends outwards towards the proximal end and is connected to the at least one anchoring unit 121. The length of the connection unit 122 can be 0.2 mm-4 mm, and in the unfolded state, the included angle (hereinafter referred to as the opening angle) between the connection line at the two ends of the connection unit 122 and the axis of the fixing device 10 is 0-90 °. If the length of the connecting unit 122 is too long, the anchoring element 12 cannot completely enter the tissue gap, thereby affecting the implantation diameter of the occlusion device 100 and the degree of fit with the human tissue, and also making the occlusion device 100 difficult to sheath; when the opening angle of the connecting unit 122 is too small, the anchoring unit 121 is too close to the fixing device 10, and thus cannot be clamped into a tissue gap or abut against the tissue; the too large opening angle of the connecting unit 122 not only causes the plugging device 100 to be difficult to sheath, but also causes the acting force of the tissue on the anchoring unit 121 to be along the direction of the connecting unit 122 after the anchoring unit 121 is clamped into a tissue gap or abuts against the tissue, and at this time, the too large opening angle of the connecting unit 122 causes the component force of the anchoring unit 121 along the axial direction to be reduced, thereby causing the anchoring capability of the plugging device 100 to be reduced. In the present embodiment, the length of the connection unit 122 is 0.5mm-2mm, and the opening angle is 20 ° -60 °.

In other embodiments, the connection unit 122 may be made of a hard metal, a hard polymer material, or the like, and the connection unit 122 may also be made of a flexible material, such as a rod, a wire, a thread, or an elastic rope structure formed by a soft polymer material, an inorganic material, or a flexible metal. The connection unit 122 and the anchoring unit 121 may be combined by welding, bonding, heat fusing, tangling, and the like. Wherein, flexible connecting unit 122 makes anchoring unit 121 move in a certain area, makes anchoring unit 121 can block in the comb 210 interval of different shape, different depth, has strengthened anchor 12 and recessed area 230 matching nature, can reduce anchor 12 to the stimulation of auricle wall 220 and comb 210 at the same time.

When a plurality of anchoring units 121 are present, in order to facilitate the entry and exit of the sheath, parameters such as the connecting position of the connecting unit 122 and the fixing device 10, the length and the opening angle of the connecting unit 122, and the like can be adjusted to enable the plurality of anchoring units 121 to be located on a plurality of cross sections of the fixing device 10, so that the problem of excessive stress concentration when the sheath enters and exits can be avoided.

In other embodiments, the anchoring unit 121 may be connected with the covering membrane 30, the first mesh structure 11, or the sealing device 20 of the fixation device 10 through the connection unit 122. Of course, the anchoring unit 121 can also be directly connected to the fixing device 10 and/or the sealing device 20, and compared to the direct connection method, the anchoring unit 121 of the present embodiment is connected to the fixing device 10 through the connecting unit 122, so that the anchoring unit 121 can be more easily and firmly snapped into the recessed area 230, and the anchoring performance is better.

In the present embodiment, by providing the anchoring elements 12, after the occluding device 100 is delivered to the target cavity 200, the anchoring elements 12 are clamped into the recessed area 230 of the human tissue along with the expansion of the fixing device, and the fixing device 10 has a certain radial supporting force, so that the anchoring elements 12 are not easy to fall out of the recessed area 230, and the occluding device 100 is more stably anchored to the target cavity 200 (such as the left atrial appendage); on the other hand, the anchoring member 12 is only supported on the surface of the human tissue and does not pierce the human tissue, so that the damage to the human tissue is avoided, and further the damage and enlargement of the wound caused by the movement of the human tissue are avoided.

It should be noted that, in addition to avoiding the introduction of the sharp-pointed structure, the occlusion device 100 in this embodiment has other technical effects, since the comb-shaped muscle generates contraction and relaxation movements along with the heart movement, the solution of anchoring with the barbs (i.e. the sharp-pointed ends) is prone to cause the problem of penetrating too deep into the wall of the left atrial appendage and even penetrating the wall of the left atrial appendage, and inevitably leads to the expansion of the wound at the penetrating position due to the movement, resulting in the reduction of the anchoring capability. For the present embodiment, since the comb-shaped muscles at the left auricle position are in a criss-cross mesh structure, the anchors 12 of the occlusion instrument 100 in the present embodiment can be well held by the comb-shaped muscles when being clamped into the gaps between the comb-shaped muscles, and due to contraction and relaxation of the comb-shaped muscles, the anchors 12 that are not completely clamped into the gaps of the comb-shaped muscles during the implantation phase gradually and completely clamp into the gaps along with the movement of the comb-shaped muscles, and if there are anchor units 121 that are not clamped into the gaps during the implantation phase, the anchors can also be adaptively clamped into the gaps along with the movement of the comb-shaped muscles, that is, the occlusion instrument 100 in the present embodiment further and adaptively increases the anchoring ability after implantation, and maintains good anchoring ability in cooperation with the contraction and relaxation of the comb-shaped muscles.

Referring to fig. 4 again, in the present embodiment, the plurality of anchoring units 121 are located on the outer surface of the fixing device 10, and the plurality of anchoring units 121 are circumferentially distributed at intervals, and the distances between every two adjacent anchoring units 121 are substantially equal. Since the plurality of anchoring units 121 are provided, the probability of the anchoring units 121 being caught in the recessed region 230 of the inner surface of the left atrial appendage can be increased to obtain a better anchoring effect.

In other embodiments, the plurality of anchoring units 121 are likewise arranged at intervals, but distributed over the fixation device 10 and/or the sealing device 20, and the plurality of anchoring units 121 are located on a plurality (i.e. at least 2) of the cross-sections (i.e. the planes perpendicular to the axial direction) of the occlusion device 100 when the occlusion device 100 is in the deployed state. This has the advantage that the plurality of anchoring units 121 can be snapped into different recessed regions 230 (e.g. gaps of different comb muscles 210) in the left atrial appendage, respectively, when the occlusion device 100 is in the deployed state, further improving the anchoring effect. In addition, when the occlusion device 100 is in the radially compressed state, the plurality of anchoring units 121 are also located on a plurality of cross sections of the occlusion device 100, so as to avoid the problem that when the occlusion device 100 is in the radially compressed state, the plurality of anchoring units 121 are gathered on the same cross section, which causes an overlarge radial size, and cannot be received into a sheath tube with a small radial size or causes a difficulty in sheath collection.

Example 2

Referring to fig. 6, the present embodiment is substantially the same as the occlusion device 100 described in embodiments 1 and 2, and the same portions of the two are not described herein again, but the main difference is that the connection unit 132 is a retractable structure, for example, the connection unit 132 is a spring structure. The connecting unit 132 in this embodiment can drive the anchoring unit 131 to move in multiple directions, but at the same time, applies a restoring force to the anchoring unit 131 in the direction of recovering, so that the good anchoring capability is always provided when the auricle contracts and relaxes.

In addition, since the left atrial appendage can move in a systolic manner with the pulsation of the heart, the anchoring unit 131 can be adaptively displaced with the systolic movement of the atrial appendage, so that the comb-shaped muscle 210 and/or the atrial appendage wall 220 are not damaged or worn by the movement of the left atrial appendage.

Example 3

Referring to fig. 7, the present embodiment is substantially the same as the occlusion device 100 described in embodiments 1 and 2, and the same portions thereof are not described again, but the main difference is that the anchor 14 includes an anchoring unit 141 and a connecting unit 142, and the anchoring unit 141 and the connecting unit 142 are rotatably connected.

Referring to fig. 8 and fig. 8 are schematic exploded views of anchor 14, anchor unit 141 includes a first anchor unit 1411 and a second anchor unit 1412, a receiving cavity 1421 is disposed on connecting unit 142, wherein receiving cavity 1421 is used for receiving second anchor unit 1412, second anchor unit 1412 is spherical, second anchor unit 1412 is snapped into receiving cavity 1421 and can rotate in receiving cavity 1421 along multiple directions, and the diameter of second anchor unit 1412 is greater than the opening diameter of receiving cavity 1421, so that second anchor unit 1412 cannot be separated from receiving cavity 1421 along connecting unit 142 but can rotate freely in receiving cavity 1421.

The second anchoring unit 1412 can drive the first anchoring unit 1411 to rotate relative to the connecting unit 142 in multiple directions, so as to reduce the damage of the end of the anchoring element to the wall 220 and the comb-shaped muscle 210 of the left atrial appendage during the systolic and diastolic processes.

In other embodiments, a groove may be provided on the anchoring unit 141, and a protrusion (not shown) adapted to the groove may be provided on the connecting unit 142, and the groove and the protrusion cooperate to allow the anchoring unit 141 and the connecting unit 142 to be rotatably connected.

Example 4

Referring to fig. 9, the present embodiment is substantially the same as the occlusion device 100 described in embodiments 1 to 3, and the same portions thereof are not described again, but the main difference is that the anchoring unit 151 is disposed on the surface of the covering membrane 30, and the anchoring unit 151 is disposed on the covering membrane 30 by suturing, heat fusing, tangling, bonding, etc., for example, the suture of the present embodiment can pass through a through hole (not shown) of the anchoring unit 151 to suture and fix the covering membrane 30 and the anchoring unit 151 to each other.

In another embodiment, the anchoring unit 151 is located between the support wire 111 and the covering membrane 30, and the covering membrane 30 is tightly attached to the surface of the anchoring unit 151 to form a convex structure, thereby performing the anchoring function.

Example 5

Referring to fig. 10, the present embodiment is substantially the same as the occlusion device 100 described in embodiments 1 to 4, and the same portions thereof are not described again, but the main difference is that the anchor 17 includes a flexible connection unit 172 and a plurality of anchor units 171.

It should be understood that the structure of the comb muscles 210 is complex and the gaps are not uniformly distributed, and that in general, when the anchoring units 171 fail to enter the gaps between the comb muscles 210, the anchoring units 171 press the comb muscles 210, which have a certain anchoring ability, but only when the anchoring units 171 of the anchors 17 protrude or snap into the recessed areas 230 (see fig. 1), the better anchoring ability is obtained. Including multiple anchoring units 171 in one anchor 17 increases the probability that an anchoring unit 171 of an anchor 17 will extend into or snap into recessed region 230.

In this embodiment, the flexible connecting unit 172 is connected in series with a plurality of anchoring units 171, and the plurality of anchoring units are fixedly or movably connected to the flexible connecting unit 172. The flexible connecting unit 172 is connected to the cover film 30 (see fig. 4) by heat fusion, entanglement, adhesion, sewing, or the like; or two through holes are formed in the cover film 30, and then both ends of the flexible connecting unit 172 are respectively passed through the two through holes and fixed to each other. In other embodiments, after the two ends of the flexible connecting unit 172 penetrate through the covering film 30, the flexible connecting unit 172 may be connected to the supporting wires 111 by welding, heat fusing, entanglement, adhesion, or the like. In general, both ends of the flexible connecting unit 172 are fixed to the covering membrane 30 and/or the supporting wire 111 to prevent the anchoring unit 171 from losing anchoring ability due to large-amplitude swing.

In addition, the relative positions of the plurality of anchoring units 171 are limited by the flexible connecting unit 172, so that the stimulation of the anchoring units to the atrial wall 220 during the contraction and relaxation of the atrial appendage can be effectively reduced, namely, the anchoring units 171 can freely move along with the contraction and relaxation of the atrial appendage.

The flexible connection unit 172 is made of a wire or an elastic string having high toughness, elasticity, and strength. In this embodiment, the knot 1721 is formed at the end of the flexible connection unit 172 by knotting or melting, and the size of the knot 1721 is suitable to prevent the flexible connection unit 172 from falling off.

Referring to fig. 11, in another embodiment, the movable distance of the flexible connecting unit 172 is increased, and the risk of the anchoring unit 171 falling into other tissues such as the auricle wall 220 due to the loose knot 1721 is avoided. The flexible linkage elements 172 may be connected end to form an enclosed structure.

Example 6

Referring to fig. 12 (fig. 12 does not show the covering membrane 30), the present embodiment is substantially the same as the occlusion device 100 described in embodiments 1 to 5, and the same portions thereof are not repeated herein, but the main difference is that the anchoring unit 181 is located outside the covering membrane 30 (referring to fig. 4, the covering membrane 30 may be located inside the first mesh structure 11), and the anchoring unit 181 is connected to the covering membrane 30 and/or the supporting wire 111 through at least three connecting units 182 extending in different directions, and the specific connection manner may refer to the previous embodiment.

The connecting units 182 may not be made of any material having no elasticity or flexibility, such as hard metal, hard polymer material, etc., but at least one of the connecting units needs to be made of a material having elasticity or flexibility, such as a rod, wire, thread or elastic rope structure formed by soft polymer material, inorganic material, or flexible metal, etc. To ensure that the anchoring units 181 can be pressed into the meshes 113 during radial compression of the occluding device 100. Since the anchoring portion 115 and the contracting portion 116 (see fig. 3) of the first mesh structure 11 of the fixation device 10 bring the stent graft 30 into the turn-over direction during the process of taking in the sheath, the anchoring units 181 disposed outside the stent graft 30 are also turned over from the outside of the occlusion device 100 (see fig. 2) to the inside of the occlusion device 100, and the anchoring units 181 are connected to the stent graft 30 and/or the supporting wires 111 in a plurality of directions by two or more connecting units 182, so that the stress on the anchoring units 181 can be more balanced, and the anchoring units 181 can be surely pressed into the meshes 113 during the process of radially compressing the occlusion device 100.

Example 7

Referring to fig. 13 (fig. 13 does not show the fixing device 10 connected to the anchoring element 19), the present embodiment is substantially the same as the occlusion device 100 described in embodiments 1-6, and the same portions are not described again, but the main difference is that the outer surface of the anchoring unit 191 is further provided with a micro-piercing structure 193 to increase the friction between the anchoring element 19 and the recessed region 230 and improve the anchoring stability. The micro-barbed structure 193 may be provided on the outer surface of the anchoring unit 191 through adhesion, laser cutting, melting, welding, or the like.

When anchor 19 is positioned within recessed region 230, micro-piercing structure 193 can pierce into comb muscle 210 or atrial appendage wall 220. In order to prevent complications such as pericardial effusion caused by the puncture of the microphyte structure 193 on the wall 220 of the auricle, on one hand, the length of the microphyte structure 193 can be properly adjusted, for example, the length of the microphyte structure 193 is smaller than 1mm, in this embodiment, the length of the microphyte structure 193 is 0.2 mm-0.8 mm. On the other hand, it is possible to arrange the distribution region of the micro-piercing structures 193 appropriately, for example, to arrange the micro-piercing structures 193 at the proximal and/or distal region of the anchoring unit 191 toward the pectinate muscle 210, while not arranging the micro-piercing structures 193 at the outer region of the anchoring unit 191 toward the atrial appendage wall 220. In addition, to further reduce the irritation of the anchoring member 19 to the atrial appendage wall 220, the anchoring elements 191 may also have a smooth outer surface toward the lateral region of the atrial appendage wall 220 by polishing, coating with a biocompatible lubricious coating, or the like.

In this embodiment, the micro-puncture structure 193 and the anchoring unit 191 are integrally formed, for example, the anchoring unit 191 having the micro-puncture structure 193 is manufactured by using a mold bonding point contact melting and other integrally forming methods, so as to avoid the micro-puncture structure 193 from falling off during sheath access and implantation to cause complications such as embolism and ensure excellent bonding strength, and the bonding strength between the micro-puncture structure 193 and the anchoring unit 191 needs to be detected in the product preparation process, so as to ensure that the bonding strength between the micro-puncture structure 193 and the anchoring unit 191 is greater than 10N.

It will be appreciated that while the foregoing examples 1-7 generally describe embodiments in which the anchor is provided on the fixation device, in other embodiments the anchor may also be provided on the sealing device in a similar manner.

It should be noted that the technical features of the above-described embodiments may be arbitrarily combined. For the sake of brevity, all possible combinations of features in the above-described embodiments will not be described, but rather, the scope of the description should be construed as broadly as the claims, so long as there is no contradiction between the combinations of features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the utility model. Furthermore, it should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. An occlusion instrument, comprising an anchor, and a sealing device and a fixation device connected to each other, wherein the fixation device comprises a first mesh structure, the first mesh structure comprises a connection portion and an anchor portion, the connection portion is connected between the anchor portion and the sealing device, the connection portion extends distally to form a cone-shaped structure with a distal opening, and the distal end of the cone-shaped structure bends outward toward the proximal end to form the anchor portion; the anchoring piece is arranged on the fixing device and/or the sealing device and is used for being clamped into a sunken area of a target cavity after the plugging device is implanted into the target cavity with the sunken area so as to mutually anchor the plugging device and the target cavity.

2. The occlusion device of claim 1, wherein the fixation device includes a covering membrane disposed on a surface of the first mesh structure, and wherein an anchor is disposed on the anchoring portion and/or the covering membrane.

3. The occlusion device of claim 1, wherein the anchor comprises at least one anchor unit having one or more of a spherical, hemispherical, drop-shaped, cylindrical, conical, polyhedral, annular, umbrella-shaped, disc-shaped, radial configuration.

4. The occlusion device of claim 3, wherein the anchor further comprises a connection unit connecting the anchor unit to the fixation device or the sealing device.

5. The occlusion device of claim 2, wherein the anchors are positioned outside of the covering membrane and extend obliquely outward relative to the covering membrane, the anchors having an angle of deployment of 20 ° -60 °.

6. The occlusion device of claim 4, wherein the connection unit comprises a telescopic rod, one end of the rod being connected to the anchoring unit and the other end being fixedly connected to the fixation means or the sealing means.

7. The occlusion device of claim 3, wherein the fixation device further includes a covering membrane disposed on a surface of the first mesh structure, the anchoring unit being interposed between the first mesh structure and the covering membrane, the covering membrane on an outer surface of the anchoring unit projecting in a direction away from an axis of the occlusion device.

8. The occlusion device of claim 1, wherein the sealing device comprises a second mesh structure having an anchor disposed thereon.

9. The occlusion device of claim 3, wherein the occlusion device comprises a plurality of the anchoring units, the plurality of anchoring units being located on a plurality of cross-sections of the occlusion device when the occlusion device is in a deployed state; and/or a plurality of the anchoring units are located on a plurality of cross sections of the occlusion device when the occlusion device is in a radially compressed state.

10. The occlusion device of any of claims 3, 4, 6, 7, 9, wherein the anchoring unit is provided with micro-barbs.

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