CN211022807U - Plugging device - Google Patents

Abstract

The utility model relates to a plugging device, including sealed dish and the mount of being connected with sealed dish, the mount includes the connecting portion of being connected with sealed dish and at least one supporter, at least one supporter from connecting portion to the distal end radiation and after cooperating and forming the depressed area, through buckling to near-end extension and form a plurality of unsettled supporting sections that separate each other, plugging device still includes at least one film body, a part of at least one film body at least cladding two adjacent supporting sections, and until the end of cladding supporting section; the supporting section is provided with at least one first fixing part and at least one first fixing part near the tail end of the supporting section, and the at least one first fixing part is matched with the at least one first fixing part so as to fix a part of at least one film body on the supporting section. The utility model discloses a plugging device can give two adjacent supporting sections of cantilever type mount certain radial restraint to avoid the supporting section excessively outwards to open or inwards draw close the risk that brings.

Description

Plugging device

Technical Field

The utility model relates to an intervene medical instrument technical field, especially relate to an internal open-ended plugging device for shutoff human or animal body.

Background

Plugging devices such as left atrial appendage occluders, atrial septal defect occluders, aneurysm occluders and the like are increasingly trusted by doctors and patients due to the characteristics that the plugging device has excellent plugging realization structure and almost no complications which can endanger life exist after being implanted into the bodies of the patients. Particularly, the suspended parts of the supporting rods of the occluder with the cantilever type structure are not constrained with each other, so that the occluder can be better adapted to parts to be occluded with different structures in the body.

However, just because the unsettled part of each bracing piece does not have the restraint each other, use the shutoff of left auricle as an example, implant internal back, probably because the influence of the structure of the inside cavity of left auricle and pectinate muscle, and cause the terminal outwards open angle of partial bracing piece too big, not only can not make the inner wall of bracing piece effectively laminate left auricle, and the terminal of bracing piece probably contacts with the inner wall of left auricle, thereby at the in-process that the heart is beated, because there is the looks friction, can make the inner wall of left auricle damaged, and then lead to appearing the pericardial effusion and even wearing the operation risk of left auricle inner wall.

SUMMERY OF THE UTILITY MODEL

Based on this, it is necessary to provide a new occlusion device for the above technical problem of the existing cantilever type occlusion device that the supporting rods are not constrained to each other, thereby causing the above surgical risks.

A plugging device comprises a sealing disc and a fixed frame which is connected with the sealing disc and positioned on one side of the sealing disc, wherein the fixed frame comprises a connecting part connected with the sealing disc and at least one supporting body, the at least one supporting body radiates out from the connecting part to the far end and is matched with the connecting part to form a recessed area, then the supporting body extends to the near end through bending to form a plurality of mutually separated suspended supporting sections, the plugging device further comprises at least one film body, and one part of at least one film body at least covers two adjacent supporting sections until the tail end of the supporting section is covered; the supporting section is provided with at least one first fixing part and at least one first fixing part near the tail end of the supporting section, and the at least one first fixing part is matched with the at least one first fixing part so as to fix a part of the at least one film body on the supporting section.

In one embodiment, at least one of the support sections is parallel to the central axis of the occlusion device.

In one embodiment, at least one of the support sections further comprises a curved section formed by bending an end of the support section towards the inside of the occlusion device.

In one embodiment, the first fixing portion is at least one through hole or a protrusion provided on the supporting section.

In one embodiment, the through hole is located on a central axis of the support section.

In one embodiment, the projection is provided at an end of the support section.

In one embodiment, at least one anchor is provided on at least one of the support sections, the anchor facing the sealing plate, and at least one second fixing portion and at least one second fixing member are provided between the anchor and the first fixing portion, the at least one second fixing portion cooperating with the at least one second fixing member to fix a portion of the at least one membrane body to the support section.

In one embodiment, at least one third fixing portion and at least one third fixing member are further disposed on the supporting body between the connecting portion and the anchor, and the at least one third fixing portion is matched with the at least one third fixing member to fix a portion of the at least one thin film body on the supporting body.

In one embodiment, the edge of the portion of the at least one film body covering the end of the support section is flush with the end of the support section or extends outward beyond the end of the support section.

In one embodiment, at least a portion between two adjacent support sections is not covered by the at least one film body.

The blocking device can lead the film body used for coating the fixing frame to be coated to the tail ends of at least two adjacent supporting sections all the time, and the edge part of the film body is stably fixed on the at least two adjacent supporting sections through the matching of the first fixing part and the first fixing part which are arranged near the tail ends of the supporting sections, so that mutual radial constraint is formed between the at least two adjacent supporting sections, partial supporting sections can be prevented from being excessively opened outwards or excessively closed inwards after the fixing frame is released, meanwhile, the film body can be prevented from falling off from the fixing frame, and the damage of the tail ends of the supporting sections to internal tissues caused by scratching and the like can be avoided.

Drawings

FIG. 1 is a schematic view of the external structure of the occluding device of example 1;

FIG. 2 is a schematic structural view of the plugging device in FIG. 1 after a portion of the thin film body on the fixing frame is removed;

FIG. 3 is a schematic view showing the structure of another occluding device of example 1 after a part of a thin film body on a fixed frame is removed;

FIG. 4 is an enlarged view of the support section of FIG. 2;

fig. 5 is another schematic structural diagram of the plugging device of embodiment 1, in which the first fixing portion is engaged with the first fixing member;

fig. 6 is another schematic structural view illustrating the first fixing portion and the first fixing member of the plugging device in accordance with embodiment 1;

fig. 7 is another schematic structural view illustrating the first fixing portion and the first fixing member of the plugging device in accordance with embodiment 1;

fig. 8 is another schematic structural view illustrating the first fixing portion and the first fixing member of the plugging device in accordance with embodiment 1;

fig. 9 is another schematic structural view of the plugging device of embodiment 1, in which the first fixing portion is engaged with the first fixing member;

fig. 10 is a structural schematic view of the occluding device of example 1 in which the holder is unfolded to be flat;

FIG. 11 is a schematic view showing another stent of the occluding device of embodiment 1 deployed in a flat configuration;

FIG. 12 is a schematic view showing another stent of the occluding device of embodiment 1 deployed in a flat configuration;

FIG. 13 is a schematic structural view of the occluding device of example 2;

fig. 14 is another structural view of the holder of the occluding device of embodiment 2.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in 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 invention and are not intended to limit the invention.

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 further described in detail with reference to the following specific examples. The occlusion device of the present invention can be implanted in the body tissue of a human or animal body having an opening for occluding the opening, preferably, but not limited to, left atrial appendage occlusion and aneurysm occlusion.

Example 1

Embodiment 1 provides a plugging device 100, referring to fig. 1, comprising a flexible sealing disc 110 and a flexible fixing frame 120 connected to the sealing disc 110 and located on one side of the sealing disc 110, wherein the sealing disc 110 and the fixing frame 120 can be connected directly or through at least one connecting member. The connecting member may be a flexible or rigid connecting member, which may be connected to one end of each of the sealing plate 110 and the fixing frame 120 by a sleeving connection or a welding connection. In this embodiment, referring to fig. 2, the sealing disc 110 is directly connected to the fixing frame 120, and specifically, a distal end of the sealing disc 110 extends into the connecting portion 121 located at the proximal end of the fixing frame 120 and is fixed.

The sealing disc 110 may be made of at least one metal wire (e.g. nitinol wire) with superelasticity and shape memory or biocompatible polymer wire, and after being woven into a mesh tube, the two ends of the mesh tube are respectively closed and fixed by a sleeve 111, and then heat-shaped into a flat shape or a disc shape, etc., which is not limited as long as the shape can seal the tissue opening after being implanted in vivo. The sleeve 111 at the proximal end of the sealing disk 110 may not only capture the proximal end of the wire, but may also be removably attached, such as by threading, to the distal end of a delivery device that delivers the occluding device 100. A sleeve (not shown) at the distal end of the sealing disc 110 is used not only to constrict the distal end of the wire but also to connect with the proximal end of the fixation frame 120. The inside of the sealing disk 110 is provided with at least one thin film body (not shown) to enhance the sealing performance of the sealing disk 110. Wherein, the thin film body can be a PET film or other polymer film, and the sealing disc 110 provided with the thin film body can prevent blood flowing from one side of the sealing disc 110 to the other side through the sealing disc 110.

In another embodiment, the sealing disc 110 may be made of at least one metal tube with super-elasticity and shape memory properties, such as a nitinol tube, which is laser cut and then heat set into a flat or disc shape, etc., without limitation, so long as it is capable of sealing a tissue opening after being implanted in a body. In another embodiment, the sealing disk 110 may be formed of at least one metal rod having superelastic and shape memory properties, such as a disk shape, but is not limited to a shape that will occlude a tissue opening after implantation in a body.

The fixing frame 120 includes a connecting portion 121 connected to the sealing disk 110, and a plurality of supports 122. The connecting portion 121 may be a hollow nitinol tube, or a hollow tubular member woven from at least one nitinol wire. The supporting bodies 122 radiate from the distal end of the connecting portion 121 to the distal end and cooperate to form a recessed area, and then extend to the proximal end by bending to form a plurality of spaced suspended supporting sections 123, and the ends of the supporting sections 123 enclose to form a proximal opening. The suspended supporting section 123 may be formed by a suspended portion at one end of a single supporting body 122, which is not connected to the connecting portion 121, or may be formed by a suspended portion of two or more supporting bodies 122 gathered together, and in this embodiment, the supporting section 123 is formed by a suspended portion of two supporting bodies 122 gathered together in fig. 2 as an example. The suspended support sections 123 are arranged at intervals along the circumferential direction of the fixing frame 120. In practical production, a plurality of struts 122 may be cut from one end of a nitinol tube in a direction toward the other end, and then the struts 122 are expanded by a mold and then heat-treated to be shaped, wherein the uncut portion of the nitinol tube is the connecting portion 121.

In other embodiments, the supporting body 122 may also be made of at least one metal wire (e.g., a nickel-titanium wire) having superelasticity and shape memory property, specifically, the supporting body 122 may be a single nickel-titanium wire, or may be formed by winding or weaving two or more metal wires; one end of the plurality of supporting bodies 122 is connected to the connecting portion 121, and the rest is in an umbrella shape by heat setting, thereby obtaining the fixing frame 120 having a distal recessed area and a proximal opening.

In other embodiments, the fixing frame 120 may include a connection portion 121 and a supporting body 122 connected to the connection portion 121. The fixing frame 120 with a distal concave area and a proximal opening can be obtained by heat setting a flared or tubular elastic material into an umbrella shape, wherein the connecting portion 121 is located at the end of the elastic material with the smaller outer diameter, the portion of the elastic material except the connecting portion 121 is the supporting body 122, and the supporting body 122 occupies most of the elastic material. The wall of the support 122 may or may not have a plurality of openings evenly distributed.

The fixing frame 120 is provided with at least one thin film body 130. At least one film body 130 completely covers the outer surface of the fixing frame 120 from the distal end to the proximal end of the fixing frame 120, so that a portion of the film body 130 covers each supporting section 123 to the end 124 of the supporting section 123, that is, along the circumferential direction of the fixing frame 120, every two adjacent supporting sections 123 are covered by the film body 130, that is, the film body 130 connects the supporting sections 123 in series along the circumferential direction of the fixing frame 120, and in addition, the recessed area at the distal end of the fixing frame 120 is also covered by the film body 130. Because the outer surface of the fixing frame 120 is completely covered by at least one thin film body 130, the thin film body 130 not only can enable the fixing frame 120 to have a good sealing effect, but also can provide certain radial constraint for each supporting section 123, so that the situation that one or more supporting sections 123 are too outward opened or inward closed compared with other supporting sections 123 after the occlusion device 100 is released is avoided, and certain scratches on the tissues in the body due to the fact that the supporting bodies 122 directly contact the tissues in the body can also be avoided due to the soft characteristic of the thin film body 130. Specifically, the thin film body 130 has the characteristics of softness, thinness, compressibility and elasticity, so that in the process that the fixing frame 120 is pushed out after being put into a conveying device such as a sheath tube, the thin film body 130 is always attached to the supporting body 122 of the fixing frame 120 and folded and unfolded along with the supporting body 122, thereby reducing or even avoiding the risk of kinking between the supporting bodies 122 and ensuring smooth operation.

In other embodiments, the film body 130 disposed on the fixing frame 120 may only cover each supporting section 123, and does not need to cover the recessed area at the distal end of the fixing frame 120, in which case the film body 130 may be a ring-shaped film covering at least one turn of the side surface of the fixing frame 120. The annular film can radially restrict the degree of outward opening or inward closing of each support section 123, and can also avoid the scratch of the part of each support body 122 coated by the annular film due to the direct contact with the tissue in the body.

It is understood that in other embodiments, a portion of at least one film body 130 disposed on the fixing frame 120 covers at least one or more sets of two adjacent supporting sections 123 and the gap between two adjacent supporting sections 123 and up to the end 124 of the supporting sections 123, and each set of two adjacent supporting sections 123 may be adjacent to another set of two adjacent supporting sections 123 along the circumferential direction of the fixing frame 120, or include one same supporting section 123, or be separated by one or more supporting sections 123, which may be set according to the actual situation of the internal body structure. In this embodiment, two adjacent supporting segments 123 form a group, and in other embodiments, two or more adjacent supporting segments 123 may form a group, for example, three or four supporting segments 123 continuously spaced along the circumferential direction of the fixing frame 120 form a group, and the like, which is not limited herein. Further, development marks or the like may be provided on some of the supporting sections 123 to assist in placing the plugging device 100, so that two adjacent supporting sections 123 covered by the film body 130 and connected in series can be located at a desired position after being released. Such an occluding device 100 not only enables radial constraint of portions of the suspended support segments 123, but also avoids some scratching of the body tissue by the support segments 123 directly contacting the body tissue due to the flexible nature of the thin film body 130.

Because the existing mode that the film body 130 is coated on the fixing frame 120 by using the adhesive has low stability, the part of the film body 130 which should be originally fixed on the fixing frame 120 is easy to fall off from the fixing frame 120, so that the fixing frame 120 loses the sealing effect. In this embodiment, for each supporting section 123, a first fixing portion 127 (refer to fig. 4) and a first fixing element 125 are disposed on the supporting section 123 near the end 124 of the supporting section 123, and the first fixing portion 127 is engaged with the first fixing element 125 to firmly fix a portion of the film body 130 covering the fixing frame 120 on the supporting section 123, so as to prevent the supporting section 123 from losing the original radial constraint and the anti-scratch protection for the internal tissues due to the falling-off of the film body 130 covering the supporting section 123.

The occluding device 100 has a central axis L, and the central axis L of the occluding device 100 can coincide with the central axis of the connecting portion 121. in this embodiment, all of the support segments 123 include a curved segment 126, and the curved segment 126 is formed by bending the distal ends 124 of the support segments 123 toward the interior of the occluding device 100, thereby avoiding the distal ends 124 of the support segments 123 from scratching tissue after the occluding device 100 is released in vivo.

In other embodiments, only one or several of the supporting segments 123 may include the bending segment 126, and the bending segment 126 is formed by bending the end 124 of the supporting segment 123 toward the inside of the occluding device 100, thereby avoiding the end 124 of the supporting segment 123 provided with the bending segment 126 from scratching the tissue after the occluding device 100 is released in vivo.

In other embodiments, referring to FIG. 3, each of the support segments 123 ' does not include the curved segment 126, and all of the support segments 123 ' are parallel to the central axis L of the occluding device 100 ', such support segments 123 ' being effective to engage the interior wall of the left atrial appendage lumen. in other embodiments, only one or more of the support segments 123 ' are parallel to the central axis L of the occluding device 100 ', and other support segments 123 ' can extend outwardly or inwardly relative to the central axis L of the occluding device 100 ', such an arrangement being relatively flexible, and portions of the support segments 123 ' can be selectively configured to engage the interior wall of the left atrial appendage lumen to accommodate the particular configuration of the left atrial appendage lumen.

Referring to fig. 2 and 4, the first fixing portion 127 is at least one through hole formed in the supporting section 123, and the through hole is near the end 124 of the supporting section 123. Further, the through hole is located on the central axis of the supporting section 123, and since the through hole is located relatively in the center, the metal rod at the position of the through hole on the supporting section 123 is relatively not too weak and is not easily broken. In other embodiments, referring to fig. 5, the through hole (i.e. the first fixing portion 127) near the end 124 of the supporting section 123 is located at the side edge of the supporting section 123, and the outer diameter of the portion of the supporting section 123 with the through hole is larger than the outer diameter of the portion of the supporting section 123 without the through hole, so that the portion of the supporting section 123 with the through hole still has sufficient supporting strength and is not easy to break.

In other embodiments, referring to fig. 6-9, the first fixing portion 127 may also be at least one protrusion disposed on the supporting section 123, and the shape of the protrusion is not limited, and may be a circle or other irregular shape, preferably a shape without a sharp point. The projections may be imperforate or may be annular and have a perforated configuration (similar to that shown in figure 5). Referring to fig. 6, the first fixing portion 127 is a protrusion disposed on the supporting section 123. Referring to fig. 7, the first fixing portion 127 is two protrusions disposed on the lateral surface of the supporting section 123, and the relative positions of the two protrusions are not limited as long as the two protrusions can cooperate with each other to firmly fix the fixing member on the supporting section 123. Referring to fig. 8 and 9, the first fixing portion 127 is four protrusions disposed on the side of the supporting section 123, and further, the four protrusions are disposed two by two symmetrically around the supporting section 123. The first fixing element 125 engaged with the first fixing element 127 may be a suture, or may be a flexible component made of other materials for fixing.

In addition, a protrusion may be disposed at the end 124 of the support section 123, and in other embodiments, the protrusion may be a bulb formed by heat-melting the end 124 of the support section 123. The edge portion of the film body 130 can completely wrap the ball head, and a portion of the film body 130 (the portion located at the end 124 of the supporting section 123) can be sewn and fixed on the supporting section 123 by a sewing thread passing through the film body 130 and wrapping around the root of the ball head. Further, in other embodiments, the ball head may be further perforated for fixing a portion of the film body 130 to the ball head of the supporting section 123 after the fixing member passes through the through hole.

In other embodiments, the supporting section 123 is provided with more than one first fixing portion 127 and at least one first fixing element 125 near the end 124 thereof, and each first fixing portion 127 is matched with at least one first fixing element 125 to firmly fix a portion of the film body 130 arranged on the fixing frame 120 on the supporting section 123, so as to enhance the firmness of the film body 130 covering the fixing frame 120 and prevent the film body 130 from falling off.

Further, referring to fig. 2 and 4, each supporting section 123 is provided with an anchor 140 facing the sealing plate 110, and a second fixing portion 128 and a second fixing member 129 are further provided between the anchor 140 and the first fixing portion 127, the second fixing portion 128 may be the same as the first fixing portion 127 provided near the end 124 of the supporting section 123 in any of the above embodiments, and the second fixing member 129 may be the same as the first fixing member 125 provided near the end 124 of the supporting section 123 in any of the above embodiments. The second fixing portion 128 disposed near the anchor 140 cooperates with the second fixing member 129 to firmly fix a portion of the film body 130 covering the fixing frame 120 (a portion adjacent to the anchor 140) on the supporting section 123, and since the anchor 140 is inserted into the inner wall tissue of the left atrial appendage cavity after being released, the stability of the fixing frame 120 in fixing the occlusion device 100 in the left atrial appendage cavity and the tightness of the film body 130 covering the fixing frame 120 are enhanced, so that the fixing frame 120 has a stronger sealing performance. In other embodiments, at least one anchor 140 facing the sealing plate 110 is disposed on at least one supporting section 123, and at least one second fixing portion 128 and at least one second fixing member 129 are disposed between the anchor 140 and the first fixing portion 127, the second fixing portion 128 may be the same as the first fixing portion 127 disposed near the end 124 of the supporting section 123 in any of the above embodiments, and the second fixing member 129 may be the same as the first fixing member 125 disposed near the end 124 of the supporting section 123 in any of the above embodiments; the at least one second fixing portion 128 disposed near the anchor 140 cooperates with the at least one second fixing member 129 to firmly fix a portion of the at least one film body 130 covering the fixing frame 120 to the supporting section 123. In other embodiments, the anchor 140 may not be disposed on the fixation frame 120, and the fixation frame 120 itself may provide support for the occluding device 100 after release within the cavity, thereby securing at least a portion of the occluding device 100 within the cavity of the left atrial appendage.

In addition, due to the structural and dimensional characteristics of the thin film body 130 coated on the outer surface of the fixing frame 120, the edge of the thin film body is a distance beyond the root of the anchor 140, so that when the anchor 140 pierces the inner wall of the cavity of the left auricle to a certain depth, the thin film body 130 can block and control the penetration of the anchor 140 to a certain extent, the effect of effectively controlling the depth of the anchor 140 penetrating the inner wall of the cavity of the left auricle can be achieved, and the excessive damage to the inner wall of the cavity of the left auricle caused by uneven stress is reduced. Under extreme conditions, a certain anchor 140 punctures the inner wall of the cavity of the left auricle, and according to the existing left auricle occluder, blood in the left auricle can permeate into the pericardial cavity from the punctured position, so that pericardial effusion can be caused, cardiac arrest can be caused seriously, and life is critical. However, in the present embodiment, once the inner wall of the left atrial appendage is punctured by the anchor 140, the thin membrane 130 covers the punctured position immediately, and promotes the formation of micro-thrombus nearby, so as to block the punctured hole by the thrombus, prevent blood from penetrating into the pericardial cavity, and reduce the risk of pericardial effusion and even cardiac arrest. Meanwhile, the thin film body 130 can accelerate the thrombosis of the blood inside the left auricle, so as to promote the myogenesis of the left auricle and accelerate the myogenesis of the whole left auricle.

Furthermore, two sets of third fixing portions 1210 and three fixing members 1211 are further disposed on the supporting body 122 between the connecting portion 121 and the anchor 140, one set of the third fixing portions 1210 and one set of the third fixing members 1211 are configured to cooperate with each other to fix a portion of the film body 130 covering the fixing frame 120 (the portion located between the connecting portion 121 and the anchor 140) on the supporting body 122, the two third fixing portions 1210 may be the same as the first fixing portions 127 disposed near the end 124 of the supporting section 123 in any of the above embodiments, and the corresponding two third fixing members 1211 may be the same as the first fixing members 125 disposed near the end 124 of the supporting section 123 in any of the above embodiments. The two third fixing portions 1210 are preferably disposed at positions near the maximum outward-extending curvature of the support body 122 and at positions at the distal end of the anchor 140 and near the anchor 140, respectively. It is understood that, in other embodiments, the arrangement positions of the two third fixing portions 1210 are not limited thereto, the number of the two third fixing portions 1210 may be more than two, and the plurality of third fixing portions 1210 and the plurality of third fixing members 1211 may be uniformly or non-uniformly distributed on the supporting body 122 between the connecting portion 121 and the anchor 140 according to actual requirements. The third fixing portion 1210 and the third fixing member 1211 disposed between the connecting portion 121 and the anchor 140 can firmly fix the thin film body 130 covering the fixing frame 120 on the fixing frame 120, so as to prevent the thin film body 130 from falling off to prevent the distal end of the occlusion device 100 from being blocked and prevent the tissue from being scratched. In other embodiments, one or more sets of third fixing portions 1210 and third fixing members 1211 may be further disposed on the supporting body 122 between the connecting portion 121 and the anchor 140, and the third fixing portions 1210 are respectively matched with the corresponding third fixing members 1211 to firmly fix a portion of the thin film body 130 covering the fixing frame 120 on the supporting body 122, so as to prevent the thin film body 130 from falling off.

In this embodiment, the edge of the portion of the fixing frame 120 covering the end 124 of the supporting section 123 of the thin film body 130 is flush with the end 124 of the supporting section 123, so that not only a certain radial constraint can be generated on the adjacent supporting sections 123 covered by the thin film body 130, but also the damage of the end 124 of the supporting section 123 to the internal body tissue can be reduced. In other embodiments, the edge portion of the film body 130 covering the fixing frame 120 can completely wrap the ball of the end 124 of the supporting section 123, so that the edge of the portion of the fixing frame 120 covering the end 124 of the supporting section 123 of the film body 130 extends outward beyond the end 124 of the supporting section 123. In other embodiments, the edge portion of the film body 130 covering the fixing frame 120 may extend outward beyond the end 124 of the supporting section 123, but does not wrap the end 124 of the supporting section 123, and preferably, the edge portion of the film body 130 extends outward beyond the end 124 of the supporting section 123 and is gathered around the connecting portion 121, so as to achieve double sealing of the fixing frame 120.

In this embodiment, as shown in fig. 10, the linear distances from each point on the edge of at least one film body 130 of the cover fixing frame 120 to the center of the film body 130 are all equal, for example, the film body 130 is regular circular. In other embodiments, as shown in FIG. 11, the linear distance between each point on the edge of at least one membrane body 130 of the cover fixing frame 120 and the center of the membrane body 130 is not equal, for example, the edge of the membrane body 130 is wavy, and the membrane body 130 with wavy edge is easier to retract into the sheath tube and requires less conveying force than the circular membrane body 130.

In other embodiments, as shown in fig. 12, the at least one membrane body 130 covering the fixing frame 120 does not cover a portion (area a in fig. 12) between one or more adjacent sets of two supporting sections 123, such membrane body 130 is more easily retracted into the sheath tube and requires less conveying force than the circular membrane body 130 in fig. 10.

When the occlusion device 100 in any of the above embodiments is delivered from the outside of the body to the inside of the body, it is constrained to be approximately linear by the lumen of a delivery device such as a sheath; taking the sheath as an example, when releasing in vivo, the sheath is withdrawn towards the proximal end, the fixing frame 120 located at the distal end firstly extends out from the cavity of the sheath, and the distal ends of the supporting bodies 122 on the fixing frame 120 are firstly expanded radially outwards, then bent towards the proximal end, and continue to extend towards the proximal end along with the release of the proximal end part of the fixing frame 120 from the sheath until the fixing frame returns to the heat-set shape. The released anchor 120 may be fixed to the inner wall of the body tissue having the cavity, such as the left atrial appendage, to fix the occluding device 100 to the body tissue. Thereafter, the sheath is further withdrawn toward the proximal end, and the sealing disk 110 protruding from the cavity of the sheath is expanded to a flat or disk shape after heat setting, thereby covering the opening of the site to be plugged and smoothly achieving plugging.

Example 2

The same parts of the occluding device 200 of the embodiment 2 and the occluding device 100 of the embodiment 1 are not described again, and the differences between the two are mainly described below. Referring to fig. 13 and 14 together, in example 2, one or more wires are used as a main body part of a fixing frame 220 of the occluding device 200, and after being knitted, the main body part is heat-set into an umbrella-shaped knitted net, and one end of a binding wire of the knitted net is connected with a connecting part 221 by welding or bonding. The wires on the mesh grid may be divided into a plurality of support bodies 222 having a supporting function, and generally, a continuous length of the wires on the mesh grid extending from one end connected to the connecting portion 221 to the other end of the mesh grid may be regarded as one support body 222. In this embodiment, the mesh grid is made of a plurality of wires, and one wire is a support 222. In other embodiments, the support 222 may be formed by winding or weaving one or more wires, such that the support 222 has a stronger supporting force than the support 222 formed by a single wire. The woven mesh comprises a plurality of grids 224 formed by enclosing the supporting bodies 222, one end of the woven mesh, which is not connected with the connecting part 221, is provided with a plurality of suspended supporting sections 223, and the supporting sections 223 are arranged at intervals along the circumferential direction of the fixing frame 220 and enclose the proximal opening part of the fixing frame 220. In this embodiment, the shape of the supporting segment 223 is a curved line that curves toward the inside of the fixing frame 220, and in other embodiments, the shape of the supporting segment 223 may be a V-shape as shown in fig. 14 (the V-shaped supporting segment 223 may be formed by connecting the ends of the two supporting bodies 222), or may be another shape such as a U-shape, as long as the ends thereof are not liable to damage the body tissue, and no limitation is made herein.

The first fixing portion 225, the second fixing portion 226, and the third fixing portion 227 disposed on the fixing frame 220 may be at least one mesh 224 formed by at least one metal wire wound or woven together, or at least two portions where at least two metal wires are wound or crossed, and may be disposed near the end of the supporting section 223 or at any other position on the fixing frame 220 as required. Further, the mesh 224 selected as the fixing portion is located near the central axis of the supporting section 223, and since the selected mesh 224 is located relatively in the center, the wire at the position of the fixing portion on the supporting section 223 is not too weak and is not easily broken.

In other embodiments, it is understood that the various protrusions provided on the support 122 in embodiment 1 may also be provided on the support 222 in embodiment 2, and the shapes, materials, functions and the like thereof are the same, and are not described herein again.

Compared to the occluding device 100 of example 1, the occluding device 200 of example 2 does not require holes to be formed in the support body 222 to obtain the first fixing portion 225, the second fixing portion 226, and the third fixing portion 227, and therefore does not affect the strength of the support body 222.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only represent some embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims (10)

1. A plugging device comprises a sealing disc and a fixed frame which is connected with the sealing disc and positioned on one side of the sealing disc, wherein the fixed frame comprises a connecting part connected with the sealing disc and at least one supporting body, the at least one supporting body radiates out from the connecting part to the far end and is matched with the connecting part to form a recessed area, and then extends to the near end through bending to form a plurality of mutually separated suspended supporting sections; the supporting section is provided with at least one first fixing part and at least one first fixing part near the tail end of the supporting section, and the at least one first fixing part is matched with the at least one first fixing part so as to fix a part of the at least one film body on the supporting section.

2. The occlusion device of claim 1, wherein at least one of the support sections is parallel to a central axis of the occlusion device.

3. The occlusion device of claim 1, wherein at least one of the support sections further comprises a curved section formed by a tip of the support section curving toward an interior of the occlusion device.

4. The occlusion device of any of claims 1-3, wherein the first fixation portion is at least one through hole or protrusion provided on the support section.

5. The occlusion device of claim 4, wherein the through-hole is located on a central axis of the support section.

6. The occlusion device of claim 4, wherein the protrusion is disposed at a distal end of the support section.

7. The occlusion device of claim 4, wherein at least one anchoring barb is provided on at least one of the support sections facing the sealing disc, and wherein at least one second securing portion and at least one second securing member are provided between the anchoring barb and the first securing portion, the at least one second securing portion cooperating with the at least one second securing member to secure a portion of the at least one membrane body to the support section.

8. The occlusion device of claim 7, wherein at least one third fixation portion and at least one third fixation member are further provided on the support body between the connection portion and the anchor spike, at least one third fixation portion cooperating with at least one third fixation member to secure a portion of the at least one membrane body to the support body.

9. The occlusion device of claim 1, wherein the at least one membrane body covers the end of the support section with an edge flush with or outwardly beyond the end of the support section.

10. The occlusion device of claim 9, wherein at least a portion between adjacent ones of said support sections is uncovered by said at least one membrane body.

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