Filling plugging device for plugging structural heart fistula

Abstract

The invention discloses a filling plugging device for plugging a structural heart fistula, which solves the problems that the existing plugging device cannot adapt to the form of a diseased fistula and cannot effectively plug a diseased fistula damaged target area, so that backflow and even falling occur when the diseased fistula damaged target area is plugged, and comprises a plugging guide assembly, a plugging disc group and a self-adaptive plugging device, the plugging guide assembly comprises a plugging guide wire and a plugging composite tube; the self-adaptive plugging device is arranged, the self-adaptive plugging device can inject filling gel according to the sizes of different diseased fistula damaged target areas to achieve flexible adjustment of the expansion volume of the self-adaptive plugging device, after the self-adaptive plugging device injects embolism microspheres / gel, the fistula space can be rapidly filled, and a physical barrier is formed; the device has the functions of self-adaption and complete plugging of irregular sinus tracts, so that healing of surrounding tissues and sealing of fistula are promoted, and meanwhile, the device can also support the plugging disc group, so that it is guaranteed that the plugging disc group stably clamps a target area.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a filling occluder for blocking structural heart disease fistula. Background Art

[0002] Cardiac fistula, also known as heart fistula, refers to an abnormal blood flow channel inside the heart or between the heart and large blood vessels. This abnormal channel may be congenital or acquired. The cardiac fistula occluder is a medical device used to treat cardiac fistula. Through local implantation, it can effectively restore the patient's heart function and is suitable for patients with congenital heart disease.

[0003] Chinese patent CN114041835B discloses a recyclable occluder for treating congenital heart disease, comprising a first umbrella-shaped net, a flow-blocking tube, and a second umbrella-shaped net connected in sequence, wherein a first blocking end is fixed to the middle of the outer side of the first umbrella-shaped net, and a second blocking end is fixed to the middle of the outer side of the second umbrella-shaped net; a connecting rod is arranged in the inner cavity of the first umbrella-shaped net, the connecting rod is rotatably connected to the first blocking end, and a push rod is detachably connected to the other end of the connecting rod, the connecting rod has the same diameter as the push rod, and the end of the push rod passes through the flow-blocking tube and the second blocking end in sequence. Head; a connecting tube is sleeved on the outer side of the pushing rod, and one end of the connecting tube is detachably connected to the second blocking end; a limiting piece is fixed to the end of the second blocking end away from the second umbrella-shaped net, and a positioning groove is provided at the end of the connecting rod away from the first blocking end, and the limiting piece is matched with the positioning groove; however, the existing occluders cannot adapt to the shape of the diseased fistula, and thus cannot effectively block the damaged target area of ​​the diseased fistula, which leads to reflux or even falling off when blocking the damaged target area of ​​the diseased fistula. In view of the above problems, we propose a filling occluder for blocking structural heart disease fistulas. Summary of the invention

[0004] The purpose of the present invention is to address the deficiencies in the prior art and provide a filling occluder for blocking structural heart disease fistulas, thereby solving the problem that the prior occluders are unable to adapt to the shape of the diseased fistula and thus cannot effectively block the damaged target area of ​​the diseased fistula, thereby causing reflux or even falling off when blocking the damaged target area of ​​the diseased fistula.

[0005] The flow-blocking tube of the existing occluder cannot adapt to the thickness of the interval, and thus cannot adapt to be adsorbed on the damaged target area of ​​the diseased fistula, resulting in the risk of falling off when blocking the damaged target area of ​​the diseased fistula. In view of the above problems, we propose a filling occluder for blocking structural heart disease fistulas. In short, the filling occluder for blocking structural heart disease fistulas includes a blocking guide assembly, a blocking disc group, and an adaptive occluder for supporting and connecting the blocking disc group. The blocking guide assembly includes a blocking guide wire and a blocking composite tube. The blocking disc group includes at least one group of adaptive blocking discs, an inner blocking ring, an elastic connecting net, an arc-shaped reinforcing plate, and at least one group of anti-falling adsorption parts. When blocking the fistula of a structural heart disease, the blocking guide wire and the blocking composite tube are passed through the blocking disc group and extended into the adaptive occluder, and then the blocking guide wire is pushed to the damaged target area of ​​the diseased fistula, and the blocking disc group and the adaptive occluder are wrapped by a pushing catheter, and then the blocking composite tube and the pushing catheter are simultaneously pushed to the damaged target area of ​​the diseased fistula, and then the pushing catheter is withdrawn, so that the adaptive blocking disc, the inner blocking ring, the elastic connecting net, the arc-shaped reinforcing plate, the anti-falling adsorption part, and the adaptive occluder are popped out, and the adaptive blocking disc clamps the damaged target area of ​​the diseased fistula. At the same time, when the adaptive blocking disc is popped out, the arc-shaped reinforcing plate pushes the anti-falling adsorption part to unfold from the adaptive blocking disc, thereby assisting the adaptive blocking disc and the inner blocking ring to be adaptively adsorbed on the damaged target area of ​​the diseased fistula, and finally, based on the size of the damaged target area of ​​the diseased fistula, embolic microspheres / gel are injected into the blocking composite tube, so that the embolic microspheres / gel enter the adaptive occluder, so that the adaptive occluder expands and seals the damaged target area of ​​the diseased fistula, thereby achieving the blocking of the damaged target area of ​​the diseased fistula. In the embodiment of the present invention, an adaptive occluder is provided. The adaptive occluder can not only support the occluding disc group, thereby ensuring that the occluding disc group firmly clamps the target area, but also can inject filling gel based on the size of different diseased fistula damaged target areas to flexibly adjust its own expansion volume, thereby effectively blocking blood flow. After the adaptive occluder is injected with embolic microspheres / gel, it can quickly fill the fistula space to form a physical barrier, and has the function of adaptively and completely blocking irregular sinus tracts, thereby promoting the healing of surrounding tissues and the closure of fistulas, thereby avoiding symptoms of chest tightness, palpitations, increased cardiac load, and heart failure in patients due to the occluder falling off.

[0006] The present invention is implemented as follows: a filling occluder for blocking a structural heart disease fistula, the filling occluder for blocking a structural heart disease fistula comprising:

[0007] A plugging guide assembly, the plugging guide assembly comprising a plugging guide wire and a plugging composite tube slidably sleeved outside the plugging guide wire;

[0008] A plugging disc assembly, which is slidably sleeved on the outside of the plugging composite tube, and is used to plug the diseased fistula position and is adaptively adsorbed on the diseased fistula damaged target area;

[0009] An adaptive occluder for supporting and connecting the occluding disc assembly, the adaptive occluder is also slidably sleeved on the outside of the occluding composite tube, and the adaptive occluder is also used to fill and occlude the damaged target area of ​​the diseased fistula;

[0010] The adaptive occluder comprises:

[0011] The occluder body is arranged between the adaptive occluding discs, and the occluder body is fixedly connected to the adaptive occluding discs, and the occluder body is sleeved outside the occluding composite tube;

[0012] The occluder support part is arranged in the occluder body, and the occluder support part is also fixedly connected to the adaptive occluding disk, and the occluder support part is used to support the occluder body.

[0013] The occluder body comprises:

[0014] An expandable sealing membrane, wherein the expandable sealing membrane is sleeved on the outside of the occluder support portion, and the two sides of the expandable sealing membrane are respectively fixedly connected to the adaptive occluding disk, and the expandable sealing membrane is made of E-PTFE material, one end of the occluding composite tube extends into the expandable sealing membrane, and a occluding glue injection hose is detachably installed at the end of the occluding composite tube, and the occluding glue injection hose is also slidably connected to the occluding guide wire, and the occluding glue injection hose is used to inject embolic microspheres / gel into the expandable sealing membrane, and a filling expansion cavity is provided in the expandable sealing membrane;

[0015] At least one group of membrane micropores is provided, wherein the membrane micropores are opened on the outer wall of the expandable sealing membrane.

[0016] Wherein, the blocking disc assembly comprises:

[0017] at least one set of adaptive blocking disks;

[0018] An inner sealing ring disposed within the adaptive sealing disk;

[0019] An elastic connection net, which is arranged between the adaptive blocking disk and the inner blocking ring, and is used to support the adaptive blocking disk;

[0020] An arc-shaped reinforcing plate, the arc-shaped reinforcing plate is fixedly installed in the adaptive sealing disk, the arc-shaped reinforcing plate is used to support the adaptive sealing disk and assist in stabilizing the adaptive sealing disk and the inner sealing ring;

[0021] At least one group of anti-falling adsorption parts, wherein the anti-falling adsorption parts are arranged in the adaptive occluding disc, and the anti-falling adsorption parts are used to assist the adaptive occluding disc and the inner occluding ring to be adaptively adsorbed on the target area of ​​the diseased fistula rupture.

[0022] Preferably, the elastic connection net comprises:

[0023] At least one set of elastic annular ribs, wherein the elastic annular ribs are arranged between the adaptive blocking disk and the inner blocking ring;

[0024] At least one group of axial reinforcing ribs is circumferentially arranged between the adaptive sealing disk and the inner sealing ring, and the axial reinforcing ribs are respectively fixedly connected to the adaptive sealing disk, the inner sealing ring and the elastic annular ribs.

[0025] Preferably, the anti-falling adsorption part comprises:

[0026] An anti-falling swing seat, wherein the anti-falling swing seat is fixedly mounted on the end of the arc-shaped reinforcing plate;

[0027] At least one set of anti-falling swing arms, wherein the anti-falling swing arms are detachably mounted on the anti-falling swing seat;

[0028] The anti-falling squeezing ball is detachably mounted on the end of the anti-falling swing arm, and is used to assist the adaptive sealing disc and the inner sealing ring to be adaptively adsorbed on the target area of ​​the diseased fistula rupture.

[0029] Preferably, the sealing disc assembly further comprises:

[0030] An auxiliary stabilizing portion, the auxiliary stabilizing portion is arranged between the inner sealing ring and the arc-shaped reinforcing plate, and the auxiliary stabilizing portion is used to assist in stabilizing the inner sealing ring and the adaptive sealing disk;

[0031] The auxiliary stabilizing part comprises:

[0032] A stabilizing extrusion plate, wherein the stabilizing extrusion plate is detachably mounted in the middle of the arc-shaped reinforcing plate;

[0033] At least one set of stabilizing positioning grooves, the stabilizing positioning grooves being disposed in the stabilizing extrusion disk;

[0034] A stable extrusion block slidably connected to the stable positioning groove.

[0035] Preferably, the auxiliary stabilizing portion further includes:

[0036] A stable swing rod, one end of which is fixedly connected to the stable extrusion block, the middle part of which is rotatably connected to the swing rod limit seat through a bearing, and the swing rod limit seat is fixedly installed on the inner blocking ring;

[0037] A stabilizing extrusion ring is fixedly mounted on the end of the stabilizing swing rod, and is used to extrude the elastic connecting net to assist in stabilizing the inner sealing ring and the adaptive sealing disk.

[0038] Preferably, the occluder supporting portion comprises:

[0039] At least one group of external reinforcing ribs are circumferentially arranged on the outside of the expandable sealing membrane, and both ends of the external reinforcing ribs are fixedly connected to the adaptive sealing disk respectively. The length of the external reinforcing ribs ranges from 1 to 12 mm to meet different widths of blocked fistulas.

[0040] Compared with the prior art, the embodiments of the present application have the following beneficial effects:

[0041] In the embodiment of the present invention, the adaptive occluder can not only inject filling gel based on the size of different diseased fistula damaged target areas to flexibly adjust its own expansion volume, but also can quickly fill the fistula space to form a physical barrier after the adaptive occluder is injected with embolic microspheres / gel, and has the function of adaptively and completely blocking irregular sinus tracts, thereby promoting the healing of surrounding tissues and the closure of fistulas, and can also support the occluding disc group, thereby ensuring that the occluding disc group firmly clamps the target area, and can also inject filling gel based on the size of different diseased fistula damaged target areas to flexibly adjust its own expansion volume, thereby effectively blocking blood flow, and can quickly fill the fistula space to form a physical barrier after the adaptive occluder is injected with embolic microspheres / gel, and has the function of adaptively and completely blocking irregular sinus tracts, thereby promoting the healing of surrounding tissues and the closure of fistulas.

[0042] In an embodiment of the present invention, a sealing disc group is provided, and the sealing disc group is composed of an adaptive sealing disc, an inner sealing ring, an elastic connecting net, an arc-shaped reinforcing plate, and an anti-falling adsorption part. Compared with the prior art, the use of the arc-shaped reinforcing plate and the anti-falling adsorption part can assist the adaptive sealing disc and the inner sealing ring to be adaptively adsorbed on the diseased fistula damaged target area, thereby avoiding the risk of the adaptive sealing disc and the inner sealing ring falling off when fixing and sealing the diseased fistula damaged target area. The coordinated cooperation of the arc-shaped reinforcing plate and the anti-falling adsorption part not only facilitates the transportation and installation of the sealing disc group, but also enables the sealing disc group to adapt to diseased fistula damaged target areas of different sizes.

[0043] In the embodiment of the present invention, an anti-falling adsorption part is provided, which is composed of an anti-falling swing seat, an anti-falling swing arm, and an anti-falling squeezing ball. When the sealing disc group is transported, the anti-falling swing seat, the anti-falling swing arm, and the anti-falling squeezing ball can be wrapped by the adaptive sealing disc, so as not to occupy the conveying space. After the adaptive sealing disc is unfolded, the anti-falling swing seat, the anti-falling swing arm, and the anti-falling squeezing ball can be driven by the arc-shaped reinforcing plate, so as to achieve expansion and wall adhesion, thereby avoiding the falling of the inner sealing ring and the adaptive sealing disc.

[0044] In the embodiment of the present invention, an auxiliary stabilizing part is provided, and the auxiliary stabilizing part is composed of a stable extrusion disk, a stable extrusion block, a stable swing rod, and a stable extrusion ring. The auxiliary stabilizing part cooperates with the stable extrusion disk, the stable extrusion block, the stable swing rod, and the stable extrusion ring, so that when the arc reinforcing plate bends outward, the stable swing rod and the stable extrusion ring can reversely support the elastic connecting net, thereby avoiding deformation and collapse of the elastic connecting net, the inner sealing ring and the adaptive sealing disk, thereby ensuring the normal operation of the sealing disk group. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 It is a schematic diagram of the structure of a filling occluder for blocking a structural heart disease fistula provided by the present invention.

[0046] Figure 2 It is a schematic diagram of the three-dimensional structure of the filling occluder provided by the present invention for blocking structural heart disease fistula.

[0047] Figure 3 It is a front view of the filling occluder provided by the present invention for occluding structural heart disease fistula.

[0048] Figure 4 The figure is a side view of a filling occluder provided by the present invention for occluding a structural heart disease fistula.

[0049] Figure 5 yes Figure 4 AA section view.

[0050] Figure 6 It is a structural schematic diagram of the sealing disc group provided by the present invention.

[0051] Figure 7 It is an axonometric diagram of the sealing disc assembly provided by the present invention.

[0052] Figure 8 It is a top view of the sealing disc assembly provided by the present invention.

[0053] Fig. 9 yes Figure 6 A is a partial enlarged schematic diagram of the middle part.

[0054] Fig.10 It is a structural schematic diagram of the auxiliary stabilizing part provided by the present invention.

[0055] Fig.11 It is a schematic diagram of the three-dimensional structure of the auxiliary stabilizing part provided by the present invention.

[0056] Fig.12 It is a schematic structural diagram of the adaptive occluder provided by the present invention.

[0057] Fig.13 It is an axonometric diagram of the adaptive occluder provided by the present invention.

[0058] Fig.14 This is a front view of the adaptive occluder provided by the present invention.

[0059] In the figure: 1-plugging guide assembly, 11-plugging guide wire, 12-plugging composite tube, 13-plugging injection hose, 2-plugging disc group, 21-adaptive plugging disc, 22-inner plugging ring, 23-elastic connecting net, 231-elastic annular rib, 232-axial reinforcement rib, 24-arc reinforcement plate, 25-auxiliary stabilization part, 251-stable extrusion disc, 252-stable positioning groove, 253-stable extrusion block, 254-stable swing rod, 255-swing rod limit seat, 256-stable extrusion ring, 26-anti-falling adsorption part, 261-anti-falling swing seat, 262-anti-falling swing arm, 263-anti-falling extrusion ball, 3-adaptive occluder, 31-expandable sealing membrane, 32-filling expansion cavity, 33-external reinforcement rib, 34-membrane micropore. DETAILED DESCRIPTION

[0060] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by technicians in the technical field of this application; the terms used in the specification of the application herein are only for the purpose of describing specific embodiments and are not intended to limit this application; the terms "including" and "having" and any variations thereof in the specification and claims of this application and the above-mentioned drawings are intended to cover non-exclusive inclusions. The terms "first", "second", etc. in the specification and claims of this application or the above-mentioned drawings are used to distinguish different objects, not to describe a specific order.

[0061] Existing occluders cannot adapt to the shape of diseased fistulas, and thus cannot effectively block damaged target areas of diseased fistulas, which results in reflux or even falling off when blocking damaged target areas of diseased fistulas. To address the above problems, we propose a filling occluder for blocking structural heart disease fistulas. In short, the filling occluder for blocking structural heart disease fistulas includes a blocking guide assembly 1, a blocking disc group 2, and an adaptive occluder 3 for supporting and connecting the blocking disc group 2. The blocking guide assembly 1 includes a blocking guide wire 11 and a blocking composite tube 12. The blocking disc group 2 includes at least one group of adaptive blocking discs 21, an inner blocking ring 22, an elastic connecting net 23, an arc-shaped reinforcing plate 24, and at least one group of anti-falling adsorption parts 26. When blocking a structural heart disease fistula, the blocking guide wire 11 and the blocking composite tube 12 are passed through the blocking disc group 2 and extended into the adaptive occluder 3, and then the blocking guide wire 11 is pushed to the damaged target area of ​​the diseased fistula, and the blocking disc group 2 and the adaptive occluder 3 are wrapped by a pushing catheter, and then the blocking composite tube 12 and the pushing catheter are simultaneously pushed to the damaged target area of ​​the diseased fistula, and then the pushing catheter is pulled out, so that the adaptive occluding disc 21, the inner blocking ring 22, the elastic connecting net 23, the arc-shaped reinforcing plate 24, the anti-falling adsorption part 26, and the adaptive occluder 3 are ejected, and the adaptive The occluding disc 21 clamps the target area of ​​the diseased fistula damage. At the same time, when the adaptive occluding disc 21 pops out, the arc-shaped reinforcing plate 24 pushes the anti-falling adsorption part 26 to unfold from the adaptive occluding disc 21, thereby assisting the adaptive occluding disc 21 and the inner occluding ring 22 to be adaptively adsorbed on the target area of ​​the diseased fistula damage. Finally, based on the size of the target area of ​​the diseased fistula damage, embolic microspheres / gel are injected into the occluding composite tube 12, so that the embolic microspheres / gel enter the adaptive occluder 3, so that the adaptive occluder 3 expands and seals the target area of ​​the diseased fistula damage, thereby achieving the occlusion of the target area of ​​the diseased fistula damage. In the embodiment of the present invention, an adaptive occluder 3 is provided. The adaptive occluder 3 can not only support the occluding disc group 2, thereby ensuring that the occluding disc group 2 firmly clamps the target area, but also can inject filling gel based on the size of different diseased fistula damaged target areas to flexibly adjust its own expansion volume, thereby effectively blocking blood flow. After the adaptive occluder 3 is injected with embolic microspheres / gel, it can quickly fill the fistula space to form a physical barrier, and has the function of adaptively and completely blocking irregular sinus tracts, thereby promoting the healing of surrounding tissues and the closure of fistulas.

[0062] It should be noted that the target area of ​​cardiac fistula may be a ventricular septal defect, atrial septal defect, patent ductus arteriosus, or aortic sinus aneurysm rupture target area.

[0063] The embodiment of the present invention provides a filling occluder for occluding a structural heart disease fistula, such as Figure 1-Figure 5 As shown, the filling occluder for blocking structural heart disease fistula comprises:

[0064] A plugging guide assembly 1, the plugging guide assembly 1 comprising a plugging guide wire 11 and a plugging composite tube 12 slidably sleeved outside the plugging guide wire 11;

[0065] In the embodiment of the present invention, the blocking guide wire 11 can be made of stainless steel, nickel-titanium alloy or cobalt-chromium alloy, and the diameter of the blocking guide wire 11 can be 0.2-0.8 mm. The main function of the blocking composite tube 12 is to pull and push the blocking disc group 2 and the adaptive occluder 3. At the same time, the blocking composite tube 12 is also used to inject embolic microspheres / gel into the adaptive occluder 3. At the same time, the pushing catheter is used to wrap the blocking disc group 2 and the adaptive occluder 3. The pushing catheter and the blocking composite tube 12 are both existing technologies, and the gel-conducting method thereof will not be elaborated here.

[0066] The blocking disc group 2 is slidably sleeved on the outside of the blocking composite tube 12, and the blocking disc group 2 is used to block the diseased fistula position and adaptively adsorbed on the diseased fistula damaged target area;

[0067] The adaptive occluder 3 is used to support and connect the occluding disc group 2. The adaptive occluder 3 is also slidably sleeved on the outside of the occluding composite tube 12. The adaptive occluder 3 is also used to fill and occlude the damaged target area of ​​the diseased fistula.

[0068] like Figure 12-14 As shown, the adaptive occluder 3 includes:

[0069] The occluder body is disposed between the adaptive occluding disks 21, and the occluder body is fixedly connected to the adaptive occluding disks 21, and the occluder body is sleeved outside the occluding composite tube 12;

[0070] The occluder support part is arranged in the occluder body, and is also fixedly connected to the adaptive occluding disk 21 , and is used to support the occluder body.

[0071] Wherein, the occluder body comprises:

[0072] The expandable sealing membrane 31 is used to block irregular sinus tracts. When the embolic microparticles are injected, the expandable sealing membrane 31 has the function of adaptively and completely blocking irregular sinus tracts. The expandable sealing membrane 31 is sleeved on the outer side of the occluder support portion. Both sides of the expandable sealing membrane 31 are fixedly connected to the adaptive occluding disk 21 respectively. The expandable sealing membrane 31 is made of E-PTFE material. One end of the occluding composite tube 12 extends into the expandable sealing membrane 31, and a occluding injection hose 13 is detachably installed at the end of the occluding composite tube 12. The occluding injection hose 13 is also slidably connected to the occluding guide wire 11. The occluding injection hose 13 is used to inject embolic microspheres / gel into the expandable sealing membrane 31. A filling expansion cavity 32 is provided in the expandable sealing membrane 31.

[0073] It should be noted that the expandable sealing membrane 31 can be made of an expandable and shrinkable material such as E-PTFE material. The expandable sealing membrane 31 is in the shape of a cylindrical, cylindrical or disc-shaped structure, and the two ends of the expandable sealing membrane 31 can be fixedly connected to the adaptive sealing disk 21 by spot welding. One end of the blocking guide wire 11 and the blocking composite tube 12 extend into the expandable sealing membrane 31, and one end of the expandable sealing membrane 31 can be provided with a fixing buckle for fixing the blocking guide wire 11 and the blocking composite tube 12, and the embolic microspheres / gel can be made of polydimethylsiloxane (PDMS).

[0074] At least one group of membrane micropores 34 is provided on the outer wall of the expandable sealing membrane 31 .

[0075] In this embodiment, the membrane micropores 34 are arranged on the outer wall of the expandable sealing membrane 31 to ensure that the expandable sealing membrane 31 is firmly attached to the target area of ​​the diseased fistula rupture, so that the expandable sealing membrane 31 adaptively blocks the target area of ​​the diseased fistula rupture, thereby avoiding the self-adaptive occluder 3 from falling off.

[0076] In the embodiment of the present invention, an adaptive occluder 3 is provided. The adaptive occluder 3 can not only support the occluding disc group 2, thereby ensuring that the occluding disc group 2 firmly clamps the target area, but also can inject filling gel based on the size of different diseased fistula damaged target areas to flexibly adjust its own expansion volume, thereby effectively blocking blood flow. After the adaptive occluder 3 is injected with embolic microspheres / gel, it can quickly fill the fistula space to form a physical barrier, and has the function of adaptively and completely blocking irregular sinus tracts, thereby promoting the healing of surrounding tissues and the closure of fistulas.

[0077] Among them, Figure 6-Figure 8 As shown, the blocking disc set 2 includes:

[0078] At least one set of adaptive blocking disks 21;

[0079] An inner sealing ring 22 disposed within the adaptive sealing disk 21;

[0080] It should be noted that the adaptive sealing disk 21 can be an elliptical or disc-shaped structure, and the adaptive sealing disk 21 is symmetrically arranged on both sides of the adaptive occluder 3, and each group of the adaptive sealing disk 21 is symmetrically arranged with two groups of inner sealing rings 22, and the inner sealing ring 22 can specifically be a hollow circular ring or round frame.

[0081] An elastic connection net 23, wherein the elastic connection net 23 is disposed between the adaptive blocking disk 21 and the inner blocking ring 22, and the elastic connection net 23 is used to support the adaptive blocking disk 21;

[0082] An arc-shaped reinforcing plate 24, wherein the arc-shaped reinforcing plate 24 is fixedly installed in the adaptive blocking disk 21, and the arc-shaped reinforcing plate 24 is used to support the adaptive blocking disk 21 and to assist in stabilizing the adaptive blocking disk 21 and the inner blocking ring 22;

[0083] At least one set of anti-falling adsorption parts 26, wherein the anti-falling adsorption parts 26 are arranged in the adaptive occluding disk 21, and the anti-falling adsorption parts 26 are used to assist the adaptive occluding disk 21 and the inner occluding ring 22 to be adaptively adsorbed on the target area of ​​the diseased fistula rupture.

[0084] In this embodiment, the materials of the adaptive sealing disk 21, the inner sealing ring 22, and the elastic connecting net 23 can be memory materials made of nickel-titanium alloy, stainless steel or biodegradable materials, and the arc-shaped reinforcement plate 24 is made of elastic nickel-titanium alloy, and the two ends of the arc-shaped reinforcement plate 24 are fixedly connected to the inner wall of the adaptive sealing disk 21 by welding or mortise and tenon joints.

[0085] In this embodiment, when blocking a structural heart disease fistula, the blocking guide wire 11 and the blocking composite tube 12 are passed through the blocking disc group 2 and extended into the adaptive occluder 3, and then the blocking guide wire 11 is pushed to the target area of ​​the diseased fistula damage, and the blocking disc group 2 and the adaptive occluder 3 are wrapped by a push catheter, and then the blocking composite tube 12 and the push catheter are simultaneously pushed to the target area of ​​the diseased fistula damage, and then the push catheter is pulled out, so that the adaptive blocking disc 21, the inner blocking ring 22, the elastic connecting net 23, the arc-shaped reinforcing plate 24, the anti-falling adsorption part 26, and the adaptive occluder 3 are ejected. The adaptive sealing disc 21 clamps the target area of ​​the diseased fistula damage. At the same time, when the adaptive sealing disc 21 pops out, the arc-shaped reinforcing plate 24 pushes the anti-falling adsorption part 26 to unfold from the adaptive sealing disc 21, thereby assisting the adaptive sealing disc 21 and the inner sealing ring 22 to be adaptively adsorbed on the target area of ​​the diseased fistula damage. Finally, based on the size of the target area of ​​the diseased fistula damage, embolic microspheres / gel are injected into the sealing composite tube 12, so that the embolic microspheres / gel enter the adaptive occluder 3, so that the adaptive occluder 3 expands and seals the target area of ​​the diseased fistula damage, thereby achieving the occlusion of the target area of ​​the diseased fistula damage.

[0086] In the embodiment of the present invention, a sealing disc group 2 is provided, and the sealing disc group 2 is composed of an adaptive sealing disc 21, an inner sealing ring 22, an elastic connecting net 23, an arc-shaped reinforcing plate 24, and an anti-falling adsorption part 26. Compared with the prior art, the use of the arc-shaped reinforcing plate 24 and the anti-falling adsorption part 26 can assist the adaptive sealing disc 21 and the inner sealing ring 22 to be adaptively adsorbed on the diseased fistula damaged target area, thereby avoiding the risk of the adaptive sealing disc 21 and the inner sealing ring 22 falling off when fixing and blocking the diseased fistula damaged target area. The coordinated cooperation of the arc-shaped reinforcing plate 24 and the anti-falling adsorption part 26 not only facilitates the transportation and installation of the sealing disc group 2, but also enables the sealing disc group 2 to adapt to diseased fistula damaged target areas of different sizes.

[0087] In a further preferred embodiment of the present invention, Figure 6 As shown, the elastic connection net 23 includes:

[0088] At least one group of elastic annular ribs 231, wherein the elastic annular ribs 231 are arranged between the adaptive blocking disk 21 and the inner blocking ring 22;

[0089] At least one group of axial reinforcing ribs 232 is circumferentially arranged between the adaptive sealing disk 21 and the inner sealing ring 22, and the axial reinforcing ribs 232 are fixedly connected to the adaptive sealing disk 21, the inner sealing ring 22 and the elastic annular ribs 231 respectively.

[0090] In this embodiment, the elastic annular ribs 231 can be provided with 2-12 groups, and the circumference of the elastic annular ribs 231 increases successively from the inside to the outside, and the axial reinforcement ribs 232 are circumferentially arranged between the adaptive sealing disk 21 and the inner sealing ring 22, and the connection modes of the axial reinforcement ribs 232 with the adaptive sealing disk 21, the inner sealing ring 22 and the elastic annular ribs 231 can be closed connection or open connection, wherein the closed connection can be achieved by continuous laser welding, thereby reducing the metal coverage rate, and making the elastic connection net 23 easier to expand and adhere to the wall, and the adjacent elastic annular ribs 231 and axial reinforcement ribs 232 cross to form multiple groups of rectangular, fan-shaped, diamond or hexagonal structures.

[0091] In a further preferred embodiment of the present invention, Fig. 9 As shown, the anti-falling adsorption part 26 includes:

[0092] An anti-falling swing seat 261, wherein the anti-falling swing seat 261 is fixedly mounted on the end of the arc-shaped reinforcing plate 24;

[0093] At least one set of anti-falling swing arms 262, wherein the anti-falling swing arms 262 are detachably mounted on the anti-falling swing seat 261;

[0094] The anti-falling squeezing ball 263 is detachably mounted on the end of the anti-falling swing arm 262, and is used to assist the adaptive sealing disc 21 and the inner sealing ring 22 to be adaptively adsorbed on the target area of ​​the diseased fistula rupture.

[0095] In this embodiment, the anti-falling swing seat 261, the anti-falling swing arm 262, and the anti-falling squeezing ball 263 can also be made of elastic alloy material, and the anti-falling swing seat 261 is fixedly installed on the end of the arc reinforcing plate 24 by plugging or riveting, the anti-falling swing arm 262 can be an arc rod, a rectangular rod or an "L"-shaped rod structure, and the outer wall of the anti-falling squeezing ball 263 is coated with biodegradable material to avoid immune rejection when the anti-falling squeezing ball 263 adheres to the wall.

[0096] When the adaptive sealing disk 21 is unfolded, the state of the arc reinforcing plate 24 is changed from an inwardly concave state to being pulled by the adaptive sealing disk 21, thereby changing to an outwardly supporting and squeezing state of the adaptive sealing disk 21, thereby strengthening the supporting and wall-adhering performance of the adaptive sealing disk 21. At the same time, the anti-falling swing seat 261, the anti-falling swing arm 262, and the anti-falling squeezing ball 263 can be driven by the arc reinforcing plate 24, and then swing and unfold from the adaptive sealing disk 21, thereby achieving expansion and wall-adhering, and avoiding the falling of the inner sealing ring 22 and the adaptive sealing disk 21.

[0097] In the embodiment of the present invention, an anti-falling adsorption part 26 is provided, and the anti-falling adsorption part 26 is composed of an anti-falling swing seat 261, an anti-falling swing arm 262, and an anti-falling squeezing ball 263. When the sealing disk group 2 is transported, the anti-falling swing seat 261, the anti-falling swing arm 262, and the anti-falling squeezing ball 263 can be wrapped by the adaptive sealing disk 21, so as not to occupy the conveying space. After the adaptive sealing disk 21 is unfolded, the anti-falling swing seat 261, the anti-falling swing arm 262, and the anti-falling squeezing ball 263 can be driven by the arc-shaped reinforcing plate 24, so as to achieve expansion and wall adhesion, thereby avoiding the falling of the inner sealing ring 22 and the adaptive sealing disk 21.

[0098] In a further preferred embodiment of the present invention, Figure 6 As shown, the blocking disc set 2 also includes:

[0099] The auxiliary stabilizing portion 25 is disposed between the inner sealing ring 22 and the arc-shaped reinforcing plate 24 , and is used to assist in stabilizing the inner sealing ring 22 and the adaptive sealing disk 21 .

[0100] In the embodiment of the present invention, an auxiliary stabilizing portion 25 is provided, and the auxiliary stabilizing portion 25 is composed of a stabilizing extrusion disk 251, a stabilizing extrusion block 253, a stabilizing swing rod 254, and a stabilizing extrusion ring 256. The auxiliary stabilizing portion 25 is linked and coordinated by the stabilizing extrusion disk 251, the stabilizing extrusion block 253, the stabilizing swing rod 254, and the stabilizing extrusion ring 256, so that when the arc reinforcing plate 24 bends outward, the stabilizing swing rod 254 and the stabilizing extrusion ring 256 can reversely support the elastic connecting net 23, thereby avoiding deformation and collapse of the elastic connecting net 23, the inner sealing ring 22 and the adaptive sealing disk 21, thereby ensuring the normal operation of the sealing disk group 2.

[0101] like Figure 10-11 As shown, the auxiliary stabilizing portion 25 includes:

[0102] A stable extrusion plate 251, which is detachably mounted in the middle of the arc-shaped reinforcing plate 24. The stable extrusion plate 251 is fixedly mounted on the outer wall of the middle of the arc-shaped reinforcing plate 24 by mortise and tenon or snap-fitting. The stable extrusion plate 251 may be a circular plate or an annular plate;

[0103] At least one set of stabilizing positioning grooves 252, the stabilizing positioning grooves 252 are provided in the stabilizing extrusion plate 251;

[0104] A stable extrusion block 253 is slidably connected to the stable positioning groove 252 .

[0105] In this embodiment, the stabilizing positioning grooves 252 are circumferentially arranged in the stabilizing extrusion disk 251. The stabilizing positioning grooves 252 can be rectangular grooves or arc grooves, and the inner walls of the stabilizing positioning grooves 252 are polished. The stabilizing extrusion blocks 253 can be spherical blocks or columnar block structures.

[0106] A stable swing rod 254, one end of which is fixedly connected to the stable extrusion block 253, and the middle part of the stable swing rod 254 is rotatably connected to the swing rod limit seat 255 through a bearing, and the swing rod limit seat 255 is fixedly installed on the inner blocking ring 22;

[0107] The stabilizing extrusion ring 256 is fixedly mounted on the end of the stabilizing swing rod 254 . The stabilizing extrusion ring 256 is used to extrude the elastic connecting net 23 , and assist in stabilizing the inner sealing ring 22 and the adaptive sealing disk 21 .

[0108] In this embodiment, the number of the stabilizing swing rods 254 can be four groups or six groups, and one end of the stabilizing swing rod 254 is fixedly connected to the stabilizing extrusion block 253 by welding. The stabilizing swing rod 254 can be a bent rod or an arc-shaped rod structure. The stabilizing swing rod 254 and the stabilizing extrusion ring 256 are made of the same material as the adaptive sealing disk 21, the inner sealing ring 22, and the elastic connecting net 23, and the stabilizing extrusion ring 256 can be an arc-shaped ring or an "L"-shaped ring structure.

[0109] During installation, after the adaptive sealing disk 21 is unfolded, the state of the arc-shaped reinforcing plate 24 is changed from an inwardly concave state to an outwardly supporting and extruding state of the arc-shaped reinforcing plate 24. When the arc-shaped reinforcing plate 24 bends outward, it can drive the stable extrusion disk 251 and the stable positioning groove 252 to move, so that the stable positioning groove 252 pushes the stable swing rod 254 and the stable extrusion ring 256 to reversely support the elastic connecting net 23.

[0110] In an embodiment of the present invention, the occluder supporting portion comprises:

[0111] At least one group of external reinforcing ribs 33 are provided on the outside of the expandable sealing membrane 31 in the circumferential direction, and both ends of the external reinforcing ribs 33 are fixedly connected to the adaptive sealing disk 21 respectively.

[0112] In this embodiment, the number of external reinforcing ribs 33 can be 3-6 groups, and the external reinforcing ribs 33 are made of nickel alloy or titanium alloy, so as to achieve stable support for the expandable sealing membrane 31. It should be noted that the length range of the external reinforcing ribs 33 is 1-12 mm, which is used to meet different widths of blocked fistulas.

[0113] In summary, the present invention provides a filling occluder for blocking structural heart disease fistula. When blocking structural heart disease fistula, the blocking guide wire 11 and the blocking composite tube 12 are passed through the blocking disc group 2 and extended into the adaptive occluder 3. Then, the blocking guide wire 11 is pushed to the damaged target area of ​​the diseased fistula. The blocking disc group 2 and the adaptive occluder 3 are wrapped by a pushing catheter. Then, the blocking composite tube 12 and the pushing catheter are simultaneously pushed to the damaged target area of ​​the diseased fistula. Then, the pushing catheter is withdrawn, so that the adaptive blocking disc 21, the inner blocking ring 22, the elastic connecting net 23, the arc-shaped reinforcing plate 24, and the anti-falling adsorption part 25 are connected. 26. The adaptive occluder 3 pops out, and the adaptive occluding disc 21 clamps the target area of ​​the diseased fistula damage. At the same time, when the adaptive occluding disc 21 pops out, the arc-shaped reinforcing plate 24 pushes the anti-falling adsorption part 26 to unfold from the adaptive occluding disc 21, thereby assisting the adaptive occluding disc 21 and the inner occluding ring 22 to be adaptively adsorbed on the target area of ​​the diseased fistula damage. Finally, based on the size of the target area of ​​the diseased fistula damage, embolic microspheres / gel are injected into the sealing composite tube 12, so that the embolic microspheres / gel enter the adaptive occluder 3, so that the adaptive occluder 3 expands and seals the target area of ​​the diseased fistula damage, thereby achieving the occlusion of the target area of ​​the diseased fistula damage.

[0114] In the embodiment of the present invention, an adaptive occluder 3 is provided. The adaptive occluder 3 can not only support the occluding disc group 2, thereby ensuring that the occluding disc group 2 firmly clamps the target area, but also can inject filling gel based on the size of different diseased fistula damaged target areas to flexibly adjust its own expansion volume, thereby effectively blocking blood flow. After the adaptive occluder 3 is injected with embolic microspheres / gel, it can quickly fill the fistula space to form a physical barrier, and has the function of adaptively and completely blocking irregular sinus tracts, thereby promoting the healing of surrounding tissues and the closure of fistulas.

[0115] In the embodiment of the present invention, a sealing disc group 2 is provided, and the sealing disc group 2 is composed of an adaptive sealing disc 21, an inner sealing ring 22, an elastic connecting net 23, an arc-shaped reinforcing plate 24, and an anti-falling adsorption part 26. Compared with the prior art, the use of the arc-shaped reinforcing plate 24 and the anti-falling adsorption part 26 can assist the adaptive sealing disc 21 and the inner sealing ring 22 to be adaptively adsorbed on the diseased fistula damaged target area, thereby avoiding the risk of the adaptive sealing disc 21 and the inner sealing ring 22 falling off when fixing and blocking the diseased fistula damaged target area, and the coordinated cooperation of the arc-shaped reinforcing plate 24 and the anti-falling adsorption part 26 not only facilitates the transportation and installation of the sealing disc group 2, but also enables the sealing disc group 2 to adapt to diseased fistula damaged target areas of different sizes, thereby avoiding the patient's chest tightness, palpitations, increased cardiac load, and heart failure due to the occluder falling off.

[0116] It should be noted that, for the above-mentioned embodiments, for the sake of simplicity, they are all described as a series of action combinations, but those skilled in the art should know that the present invention is not limited by the described order of actions, because according to the present invention, some steps may be performed in other orders or simultaneously. Secondly, those skilled in the art should also know that the embodiments described in the specification are all preferred embodiments, and the actions and modules involved are not necessarily required by the present invention.

[0117] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the scope of protection of the invention. Obviously, the described embodiments are only some embodiments of the present invention, rather than all embodiments. Based on these embodiments, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention. Although the present invention has been described in detail with reference to the above embodiments, ordinary technicians in this field can still combine, add, delete or make other adjustments to the features in the various embodiments of the present invention according to the circumstances without conflict, without making creative work, so as to obtain different other technical solutions that do not deviate from the concept of the present invention in essence, and these technical solutions also belong to the scope of protection of the present invention.

Claims

1. A filling occluder for blocking a structural heart disease fistula, the filling occluder for blocking a structural heart disease fistula comprising: A plugging guide assembly (1), the plugging guide assembly (1) comprising a plugging guide wire (11) and a plugging composite tube (12) slidably sleeved outside the plugging guide wire (11); The blocking disc assembly (2) is characterized in that the blocking disc assembly (2) is slidably sleeved on the outside of the blocking composite tube (12), and the blocking disc assembly (2) is used to block the diseased fistula position and is adaptively adsorbed on the diseased fistula damaged target area; An adaptive occluder (3) for supporting and connecting the occluding disc assembly (2), the adaptive occluder (3) also being slidably sleeved on the outside of the occluding composite tube (12), and the adaptive occluder (3) also being used to fill and occlude the target area of ​​the diseased fistula damage; The adaptive occluder (3) comprises: An occluder body, the occluder body being arranged between the adaptive occluding disks (21), the occluder body being fixedly connected to the adaptive occluding disks (21), and the occluder body being sleeved outside the occluding composite tube (12); An occluder support portion disposed in the occluder body, the occluder support portion is also fixedly connected to the adaptive occluding disk (21), and the occluder support portion is used to support the occluder body; The occluder body comprises: An expandable sealing membrane (31), the expandable sealing membrane (31) is used to block irregular sinus passages, the expandable sealing membrane (31) is sleeved on the outer side of the occluder support portion, the two sides of the expandable sealing membrane (31) are respectively fixedly connected to the adaptive occluding disk (21), the expandable sealing membrane (31) is made of E-PTFE material, one end of the occluding composite tube (12) extends into the expandable sealing membrane (31), and the end of the occluding composite tube (12) is detachably installed with a occluding injection hose (13), the occluding injection hose (13) is also slidably connected to the occluding guide wire (11), the occluding injection hose (13) is used to inject embolic microspheres / gel into the expandable sealing membrane (31), and a filling expansion cavity (32) is provided in the expandable sealing membrane (31); At least one group of membrane micropores (34), wherein the membrane micropores (34) are opened on the outer wall of the expandable sealing membrane (31).

2. The filling occluder for blocking a structural heart disease fistula according to claim 1, characterized in that: The blocking disc assembly (2) comprises: at least one set of adaptive blocking disks (21); An inner sealing ring (22) arranged in the adaptive sealing disk (21); An elastic connection net (23), the elastic connection net (23) being arranged between the adaptive blocking disk (21) and the inner blocking ring (22), the elastic connection net (23) being used to support the adaptive blocking disk (21); An arc-shaped reinforcing plate (24), wherein the arc-shaped reinforcing plate (24) is fixedly mounted inside the adaptive blocking disk (21), and the arc-shaped reinforcing plate (24) is used to support the adaptive blocking disk (21) and to assist in stabilizing the adaptive blocking disk (21) and the inner blocking ring (22); At least one group of anti-falling adsorption parts (26), wherein the anti-falling adsorption parts (26) are arranged in the adaptive occluding disc (21), and the anti-falling adsorption parts (26) are used to assist the adaptive occluding disc (21) and the inner occluding ring (22) in adaptively adsorbing on the target area of ​​the diseased fistula rupture.

3. The filling occluder for blocking a structural heart disease fistula according to claim 1, characterized in that: The elastic connection net (23) comprises: At least one group of elastic annular ribs (231), wherein the elastic annular ribs (231) are arranged between the adaptive blocking disk (21) and the inner blocking ring (22); At least one group of axial reinforcing ribs (232), wherein the axial reinforcing ribs (232) are circumferentially arranged between the adaptive sealing disk (21) and the inner sealing ring (22), and the axial reinforcing ribs (232) are respectively fixedly connected to the adaptive sealing disk (21), the inner sealing ring (22) and the elastic annular ribs (231).

4. The filling occluder for blocking a structural heart disease fistula according to claim 3, characterized in that: The anti-falling adsorption part (26) comprises: An anti-falling swing seat (261), wherein the anti-falling swing seat (261) is fixedly mounted on the end of the arc-shaped reinforcing plate (24); At least one set of anti-falling swing arms (262), wherein the anti-falling swing arms (262) are detachably mounted on the anti-falling swing seat (261).

5. The filling occluder for blocking a structural heart disease fistula according to claim 4, characterized in that: The anti-falling adsorption part (26) further comprises: An anti-drop-off squeezing ball (263) is detachably mounted on the end of the anti-drop-off swing arm (262). The anti-drop-off squeezing ball (263) is used to assist the adaptive sealing disc (21) and the inner sealing ring (22) to be adaptively adsorbed on the target area of ​​the diseased fistula damage.

6. The filling occluder for blocking a structural heart disease fistula according to claim 5, characterized in that: The blocking disc assembly (2) further comprises: An auxiliary stabilizing portion (25), wherein the auxiliary stabilizing portion (25) is arranged between the inner sealing ring (22) and the arc-shaped reinforcing plate (24), and the auxiliary stabilizing portion (25) is used to assist in stabilizing the inner sealing ring (22) and the adaptive sealing disk (21).

7. The filling occluder for blocking a structural heart disease fistula according to claim 6, characterized in that: The auxiliary stabilizing portion (25) comprises: A stabilizing extrusion plate (251), wherein the stabilizing extrusion plate (251) is detachably mounted in the middle of the arc-shaped reinforcing plate (24); At least one set of stabilizing positioning grooves (252), wherein the stabilizing positioning grooves (252) are arranged in the stabilizing extrusion disk (251); A stable extrusion block (253) is slidably connected to the stable positioning groove (252).

8. The filling occluder for blocking a structural heart disease fistula according to any one of claims 3 to 7, characterized in that: The auxiliary stabilizing portion (25) further comprises: A stable swing rod (254), one end of which is fixedly connected to the stable extrusion block (253), a middle portion of which is rotatably connected to a swing rod limit seat (255) via a bearing, and the swing rod limit seat (255) is fixedly mounted on the inner sealing ring (22); A stabilizing extrusion ring (256), wherein the stabilizing extrusion ring (256) is fixedly mounted on the end of the stabilizing swing rod (254), and the stabilizing extrusion ring (256) is used to extrude the elastic connection net (23) to assist in stabilizing the inner sealing ring (22) and the adaptive sealing disk (21).

9. The filling occluder for blocking a structural heart disease fistula according to claim 2, characterized in that: The occluder support part includes: At least one group of external reinforcing ribs (33), wherein the external reinforcing ribs (33) are circumferentially arranged on the outside of the expandable sealing membrane (31), and both ends of the external reinforcing ribs (33) are respectively fixedly connected to the adaptive sealing disk (21).

10. The filling occluder for blocking structural heart disease fistula as claimed in claim 9, wherein the length of the outer reinforcing rib (33) ranges from 1 to 12 mm to meet the requirements of blocking different fistula widths.

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