A blocking device

Abstract

The present invention provides a sealing device, comprising a first sealing member and a second sealing member arranged opposite to each other; the first sealing member comprises a deformable first clamping portion, and a first connecting portion is provided on a side of the first clamping portion facing the second sealing member; the second sealing member comprises a deformable second clamping portion, and a second connecting portion is provided on a side of the second clamping portion facing the first sealing member; in the relative direction of the first sealing member and the second sealing member, the size of the first connecting portion is larger than the size of the first clamping portion, and the size of the second connecting portion is larger than the size of the second clamping portion; the first connecting portion and the second connecting portion are connected and located in a defect gap to be sealed, and the first clamping portion and the second clamping portion are clamped on the wall surfaces around the gap.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a blocking device. Background Art

[0002] Heart defect occluder is an implantable medical device for the treatment of congenital heart defects. In 1974, King and MiRRs completed the first transcatheter interventional treatment of secundum atrial septal defect (ASD). Since then, with the continuous improvement of occlusion devices, especially since 1997, with the launch of AmpRatzer nickel-titanium alloy braided occluder, nickel-titanium alloy braided occluder has been widely used in the interventional treatment of congenital heart diseases such as atrial septal defect (ASD), ventricular septal defect (VSD), patent ductus arteriosus (PDA) and patent foramen ovale (PFO). At present, minimally invasive surgery with transcatheter interventional occluder is an important method for the treatment of congenital heart diseases such as ASD, VSD, PDA and PFO.

[0003] The occluder in the prior art generally includes two parallel disc occluding surfaces, which are fixed by clamping only the two disc occluding surfaces after release. The clamping force of such occluder is limited, and it is easy to shift or even fall off. Summary of the invention

[0004] In view of the problems in the background technology, the present invention provides a blocking device, comprising a first blocking member and a second blocking member arranged opposite to each other;

[0005] The first blocking member includes a deformable first clamping portion, and a first connecting portion is provided on a side of the first clamping portion facing the second blocking member; the second blocking member includes a deformable second clamping portion, and a second connecting portion is provided on a side of the second clamping portion facing the first blocking member; in the relative direction between the first blocking member and the second blocking member, the size of the first connecting portion is larger than the size of the first clamping portion, and the size of the second connecting portion is larger than the size of the second clamping portion;

[0006] The first connecting portion and the second connecting portion are connected and located in the defect gap to be blocked, and the first clamping portion and the second clamping portion are clamped on the wall surfaces around the gap.

[0007] In some embodiments, the first clamping portion is symmetrical about the center of the first connecting portion, and the second clamping portion is symmetrical about the center of the second connecting portion.

[0008] In some embodiments, the first clamping portion is bent toward the second blocking member, and the second clamping portion is bent toward the first blocking member.

[0009] In some embodiments, the first clamping portion and the second clamping portion have different bending curvatures.

[0010] In some embodiments, the first clamping portion and the second clamping portion are umbrella-shaped or petal-shaped.

[0011] In some embodiments, the first clamping portion includes a plurality of first lobes circumferentially arranged around the first connecting portion, and the second clamping portion includes a plurality of second lobes circumferentially arranged around the second connecting portion.

[0012] In some embodiments, the first lobes and the second lobes are annular, and adjacent first lobes are arranged to cross each other, and adjacent second lobes are arranged to cross each other.

[0013] In some embodiments, the first lobe and the second lobe are in a strip shape.

[0014] In some embodiments, after the first connection portion is connected to the second connection portion, the first lobe and the second lobe are arranged crosswise.

[0015] In some embodiments, the blocking device is made of a degradable material.

[0016] In some embodiments, the first blocking member and the second blocking member are double-layer hollow structures or single-layer solid structures.

[0017] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

[0018] The sealing device provided by the present invention is limited in the connection direction between the first connecting part and the second connecting part, the size of the first connecting part is larger than the size of the first clamping part, and the size of the second connecting part is larger than the size of the second clamping part, so that when the first connecting part is connected to the second connecting part, the opposite sides of the first clamping part and the second clamping part will inevitably be squeezed and deformed against each other to form a pre-tightening force, thereby firmly and stably clamping on both sides, with good clamping force, and not easy to deviate or fall off. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The above and other features and advantages of the present invention will be more clearly understood through the following detailed description in conjunction with the accompanying drawings, in which:

[0020] Figure 1 A schematic diagram of the disassembly of the first blocking member and the second blocking member in Example 1;

[0021] Figure 2 is a schematic diagram of the connection between the first blocking member and the second blocking member in Example 1;

[0022] Figure 3A schematic diagram of the disassembly of the first blocking member and the second blocking member in Example 2;

[0023] Figure 4 is a schematic diagram of the connection between the first blocking member and the second blocking member in Example 2;

[0024] Figure 5 Schematic diagram of the separation between the first blocking member and the second blocking member in Example 3 Figure 1 ;

[0025] Figure 6 Schematic diagram of the separation between the first blocking member and the second blocking member in Example 3 Figure 2 ;

[0026] Figure 7 Schematic diagram of the separation between the first blocking member and the second blocking member in Example 3 Figure 3 ;

[0027] Figure 8 This is a diagram showing the use status of the blocking device in Example 3;

[0028] Fig. 9 This is a three-dimensional schematic diagram of the first blocking member and the second blocking member in Example 4 after being connected;

[0029] Fig.10 It is a side view of the first blocking member and the second blocking member after being connected in Example 4;

[0030] Fig.11 It is a front view of the first blocking member and the second blocking member after being connected in Example 4;

[0031] Fig.12 This is a three-dimensional schematic diagram of the first blocking member and the second blocking member after being connected in Example 5;

[0032] Fig.13 is a cross-sectional view of the first blocking member and the second blocking member after being connected in Example 5;

[0033] Fig.14 This is a front view of the first blocking member and the second blocking member after being connected in Example 5. DETAILED DESCRIPTION

[0034] The present invention will be described in more detail below with reference to the accompanying drawings showing embodiments of the present invention. However, the present invention may be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are set forth in order to achieve a full and complete disclosure and to enable those skilled in the art to fully understand the scope of the present invention. In these drawings, the sizes and relative sizes of layers and regions may be exaggerated for clarity.

[0035] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0036] The present invention provides a sealing device, comprising a first sealing member and a second sealing member arranged opposite to each other; the first sealing member comprises a first deformable clamping portion, and a first connecting portion is provided on the side of the first clamping portion facing the second sealing member; the second sealing member comprises a second deformable clamping portion, and a second connecting portion is provided on the side of the second clamping portion facing the first sealing member; in the relative direction between the first sealing member and the second sealing member, the size of the first connecting portion is greater than the size of the first clamping portion, and the size of the second connecting portion is greater than the size of the second clamping portion; when in use, the first connecting portion and the second connecting portion are connected and located in a defect gap to be sealed, and the first clamping portion and the second clamping portion are clamped on the wall surfaces around the gap.

[0037] The present invention limits the connection direction between the first connection part and the second connection part, and the size of the first connection part is larger than the size of the first clamping part, and the size of the second connection part is larger than the size of the second clamping part, so that when the first connection part is connected to the second connection part, the opposite sides of the first clamping part and the second clamping part will inevitably be squeezed and deformed against each other to form a pre-tightening force or interpenetrate with each other, so that during use, the first clamping part and the second clamping part are opened and clamped on both sides of the gap wall to form a clamping force, so that they are firmly and stably clamped on both sides of the wall around the gap, with good clamping force, and not easy to deviate or fall off.

[0038] The occluding device provided by the present invention is applicable to atrial septal defect (ASD), ventricular septal defect (VSD), patent ductus arteriosus (PDA) and patent foramen ovale, etc., and is not limited here.

[0039] The following is a specific explanation using atrial septal defect as an example.

[0040] Example 1

[0041] Reference Figure 1-2 The present invention provides a blocking device, including a first blocking member 110 and a second blocking member 120, wherein the first blocking member 110 and the second blocking member 120 are arranged opposite to each other.

[0042] In this embodiment, the first blocking member 110 includes a first clamping portion 111 and a first connecting portion 112, and the first connecting portion 112 is arranged on the side of the first clamping portion 111 facing the second blocking member 120; the second blocking member 120 includes a second clamping portion 121 and a second connecting portion 122, and the second connecting portion 122 is arranged on the side of the second clamping portion 121 facing the first blocking member 110. The first connecting portion 112 and the second connecting portion 122 are connected and arranged in the defect gap on the atrial septum, and the first clamping portion 111 and the second clamping portion 121 are used to clamp on both sides of the atrial septum for fixing.

[0043] Among them, the first connecting portion 112 is preferably arranged at the center position of one side of the first clamping portion 111, that is, the first connecting portion 112 is symmetrical about the center of the first clamping portion 111; the second connecting portion 122 is arranged at the center position of one side of the second clamping portion 121, that is, the second connecting portion 122 is symmetrical about the center of the second clamping portion 121. Such a design is conducive to ensuring the uniformity of the clamping force when the first clamping portion 111 and the second clamping portion 121 are clamped during use. Of course, in other embodiments, the setting position of the first connecting portion 112 on the first clamping portion 111 and the setting position of the second connecting portion 122 on the first clamping portion 121 can also be adjusted according to specific circumstances, and there is no limitation here.

[0044] In this embodiment, the first clamping portion 111 is curved from the center to the outer edge toward the second blocking member 120, and the second clamping portion 121 is curved from the center to the outer edge toward the first blocking member 110. Figure 1 As shown in ; wherein the first clamping portion 111 and the second clamping portion 121 can be specifically umbrella-shaped, petal-shaped or other shapes, which are not limited here and can be adjusted according to specific circumstances. The arc-shaped first clamping portion 111 and the second clamping portion 121 disclosed above are conducive to ensuring the clamping effect between the two.

[0045] Further, in the relative direction between the first blocking member 110 and the second blocking member 120, that is, in the connection direction between the first connecting portion 112 and the second connecting portion 122, the size R111 of the first connecting portion 112 is larger than the size R112 of the first clamping portion, and the size R121 of the second connecting portion 122 is larger than the size R122 of the second clamping portion 121; such a configuration enables, when the first connecting portion 112 is connected to the second connecting portion 122, the opposite sides of the first clamping portion 111 and the second clamping portion 121 are squeezed against each other to form a preload force F, such as Figure 2 As shown in , when in use, the pre-tightening force F is converted into a clamping force applied to the walls on both sides of the atrial septum to achieve clamping and fixation.

[0046] Of course, in other embodiments, the implementation method of the size difference between the first connecting portion 112 and the first clamping portion 111, and the size difference between the second connecting portion 121 and the second clamping portion 122 is not limited to the above description, and can be adjusted according to specific circumstances, and is not limited here.

[0047] In this embodiment, the first connection part 112 and the second connection part 122 can be connected by riveting / adhesion / hot melt / fasteners / tightening ties / tightening knots / hooks / snaps, etc., which are not limited here and can be adjusted according to specific circumstances.

[0048] In this embodiment, the first clamping portion 111 of the first blocking member 110 and the second clamping portion 121 of the second blocking member 120 are preferably deformable elastic structures so that they can be squeezed and deformed to generate a pre-tightening force to achieve clamping.

[0049] In this embodiment, the first sealing member 110 and the second sealing member 120 are preferably made of degradable materials; because non-degradable sealing devices still exist in the defect site for a long time after endothelialization, which is prone to long-term complications and adverse effects, including atrioventricular conduction block, valve damage, residual shunt, cardiac wear, nickel allergy, etc.; the sealing device made of degradable materials can complete the effect of sealing the defect after being implanted in the human body. After the sealing is completed, the materials constituting the sealing device degrade in the body and are eventually metabolized into CO2 and water by the body and excreted from the body, thereby preventing the human body from being affected by foreign objects for a long time.

[0050] Furthermore, the degradable materials include, but are not limited to, polylactic acid (PRA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PRGA), polyhydroxyalkanoic acid ester (PHA), polydioxanone (PDO) or polycaprolactone (PCR), etc., which are not limited here.

[0051] Of course, in other embodiments, the first blocking member 110 and the second blocking member 120 may also be made of memory alloys such as NiTi, etc. Blocking members made of such materials are more conducive to satisfying the setting of the preload force.

[0052] In this embodiment, the first blocking member 110 and the second blocking member 120 adopt a double-layer hollow structure. Figure 1-2 As shown in , its advantage is that each layer of the double-layer hollow structure is relatively thin, has better elasticity, is easier to set up the release mechanism, and is easy to recycle and release. Of course, in other embodiments, the first blocking member 110 and the second blocking member 120 may not be a double-layer hollow structure, and can be adjusted according to specific needs, which is not limited here.

[0053] In this embodiment, the first blocking member 110 and the second blocking member 120 can be integrally prepared by silk thread weaving, cutting, 3D printing and other processes, and then assembled and used after being prepared separately. The present invention does not limit the timing of assembly. The first blocking member 110 and the second blocking member 120 can be assembled before leaving the factory and sterilized and packaged for shipment. The first blocking member 110 and the second blocking member 120 can also be sterilized and packaged separately, and then connected and installed for use before surgery. When in use, the blocking device is compressed into the conveying device and conveyed to the target position; during surgery, a certain reference object is required to determine whether the blocking device has reached the target position, and generally the release state of the blocking device is observed by developing.

[0054] Example 2

[0055] Reference Figure 3-4 This embodiment is an adjustment based on embodiment 1.

[0056] In this embodiment, the first blocking member 110 and the second blocking member 120 adopt a single-layer solid structure, which is thinner than a double-layer hollow structure. Its advantages are less material, low cost, small space occupation, and easier to load into the conveying device.

[0057] In this embodiment, the remaining structures of the blocking device can refer to the description in Embodiment 1 and are not limited here.

[0058] Example 3

[0059] Reference Figure 5-8 This embodiment is an adjustment based on embodiment 1.

[0060] In this embodiment, the first clamping portion 111 and the second clamping portion 121 are in an umbrella shape.

[0061] Specifically, the first clamping portion 111 includes a plurality of first lobes 113, which are evenly distributed around the first connecting portion 122, and adjacent first lobes 113 are overlapped and cross-arranged to form an umbrella-shaped first clamping portion 111; similarly, the second clamping portion 121 also includes a plurality of second lobes 123, which are evenly distributed around the second connecting portion 122, and adjacent second lobes 123 are overlapped and cross-arranged to form an umbrella-shaped second clamping portion 121.

[0062] The first leaflet 113 and the second leaflet 123 are annular, and one end converges to the center and is respectively connected to the first connection part 112 and the second connection part 122. In this embodiment, a plurality of circumferentially evenly distributed annular leaflets are used to form the first clamping part and the second clamping part. Of course, in other embodiments, the shape of the leaflets is not limited to the above, and can be adjusted according to specific circumstances.

[0063] In this embodiment, the radial dimensions of the first clamping portion 111 and the second clamping portion 121 may be the same. Figure 5 As shown in , it can also be one large and one small, such as Figure 6 The first clamping portion 111 and the second clamping portion 121 may also be bent at different curvatures, for example, the first clamping portion 111 is flat and the second clamping portion 121 is concave and shaped like an umbrella. Figure 7 As shown in , there is no limitation here and it can be adjusted according to specific needs.

[0064] When using, Figure 8 As shown, the first connecting portion 112 and the second connecting portion 122 are connected in the defect gap 131 on the atrial septum 130, and the first clamping portion 111 and the second clamping portion 121 are clamped on both sides of the atrial septum 130. The curvature of each first leaflet 113 and the second leaflet 123 is stretched and pressed against the walls on both sides of the atrial septum 130 to achieve stable clamping.

[0065] In this embodiment, the remaining structures of the blocking device can refer to the description in Embodiment 1 and are not limited here.

[0066] Example 4

[0067] like Figure 9-11 This embodiment is an adjustment based on embodiment 3.

[0068] In this embodiment, the sizes of the first lobe 113 and the second lobe 123 are larger than those in Example 3, the number is less than that in Example 3, and the degree of curvature is greater than that in Example 3, so that the first clamping portion 111 and the second clamping portion 121 in this embodiment are petal-shaped as a whole.

[0069] Furthermore, when the first leaflet 113 is larger than the second leaflet 123, after the first connection portion 112 is connected to the second connection portion 122, each second leaflet 123 extends into the first leaflet 113 and is arranged crosswise. At this time, there is no antagonistic force between the first leaflet 113 and the second leaflet 123. Figure 10-11 As shown in ; when the device is implanted at the target position, the first clamping part 111 and the second clamping part 121 are blocked by the atrial septum, and a larger clamping force is formed after being stretched open, clamping on the walls on both sides of the atrial septum; the clamping part of the occlusion device in this embodiment is looser than that in the above-mentioned embodiment, but it avoids stress relaxation caused by long-term extrusion before use, and has the advantage of better fatigue resistance.

[0070] In this embodiment, the remaining structures of the blocking device can refer to the description in Embodiment 3 and are not limited here.

[0071] Example 5

[0072] like Figure 12-14 This embodiment is an adjustment based on embodiment 4.

[0073] In this embodiment, the first lobe 113 and the second lobe 123 are in the shape of curved strips; when the first blocking member 110 is connected to the second blocking member 120, the first lobe 113 and the second lobe 123 are arranged crosswise and at intervals, such as Fig.14 As shown in , this design is beneficial to further ensure the clamping preload effect.

[0074] In this embodiment, the remaining structures of the blocking device can refer to the description in Embodiment 4 and are not limited here.

[0075] Those skilled in the art will appreciate that the present invention can be implemented in many other specific forms without departing from its own spirit or scope. Although the implementation of the present invention has been described, it should be understood that the present invention should not be limited to these embodiments, and those skilled in the art can make changes and modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims

1. A blocking device, characterized in that: It comprises a first blocking member and a second blocking member which are arranged opposite to each other; The first blocking member includes a deformable first clamping portion, and a first connecting portion is provided on a side of the first clamping portion facing the second blocking member; the second blocking member includes a deformable second clamping portion, and a second connecting portion is provided on a side of the second clamping portion facing the first blocking member; in the relative direction between the first blocking member and the second blocking member, the size of the first connecting portion is larger than the size of the first clamping portion, and the size of the second connecting portion is larger than the size of the second clamping portion; The first connecting portion and the second connecting portion are connected and located in the defect gap to be blocked, and the first clamping portion and the second clamping portion are clamped on the wall surface around the gap; When the first clamping portion and the second clamping portion are umbrella-shaped or petal-shaped, the first clamping portion includes a plurality of first lobes circumferentially arranged around the first connecting portion, and the second clamping portion includes a plurality of second lobes circumferentially arranged around the second connecting portion; the first lobes and the second lobes are annular, and adjacent first lobes are cross-arranged with each other, and adjacent second lobes are cross-arranged with each other; after the first connecting portion is connected to the second connecting portion, the first lobes and the second lobes are cross-arranged.

2. The blocking device according to claim 1, characterized in that: The first clamping portion is symmetrical about the center of the first connecting portion, and the second clamping portion is symmetrical about the center of the second connecting portion.

3. The blocking device according to claim 1 or 2, characterized in that: The first clamping portion is bent toward the second blocking member, and the second clamping portion is bent toward the first blocking member.

4. The blocking device according to claim 3, characterized in that: The first clamping portion and the second clamping portion have different bending arcs.

5. The blocking device according to claim 1, characterized in that: The blocking device is made of degradable material.

6. The blocking device according to claim 1, characterized in that: The first blocking member and the second blocking member are double-layer hollow structures or single-layer solid structures.

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