Implant device

Abstract

The present application relates to an implant device, comprising an implant body, the implant body comprising a first and a second occlusion disc and a waist, the first occlusion disc comprising a first inner disc face and a first outer disc face, and a first support face connecting the first inner disc face and the first outer disc face, the first inner disc face and the first outer disc face are both convex arc faces facing away from the waist, the first support face extends outward from the edge of the first inner disc face, the second occlusion disc comprising a second inner disc face and a second outer disc face, the second inner disc face and the second outer disc face are both convex arc faces facing away from the waist, the implant body has a compressed state, a stretched state and a natural state, in the natural state, the ratio of the maximum outer diameter of the waist to the maximum outer diameter of the second occlusion disc is 1:5-1:2, and the ratio of the maximum outer diameter of the first occlusion disc to the maximum outer diameter of the second occlusion disc is 10:6-10:9, so that the clamping effect is good, the damage to the tissue is small, and the stability and sealing performance are good.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to an implantable device for treating ventricular septal perforation or ventricular septal defect. Background Technology

[0002] Ventricular septal perforation (VSR) is a secondary ventricular septal defect caused by ischemia and rupture of the ventricular septum after acute myocardial infarction (AMI). It is a serious complication following AMI. The incidence is higher in men than women, and it mostly occurs after the initial myocardial infarction. Once VSR occurs, it leads to left-to-right blood shunting, reducing systemic blood volume and increasing pulmonary blood volume. Patients may experience hypotension, low cardiac output syndrome, pulmonary edema, left / right ventricular dysfunction, oliguria, dyspnea, and even multiple organ failure.

[0003] Therefore, the treatment of ventricular septal perforation is crucial. Because ventricular septal perforation differs significantly from congenital ventricular septal defects in terms of formation mechanisms and pathophysiology, the treatment methods also differ considerably. Current treatment methods mainly include drug therapy, surgery, and interventional therapy. Medical drug therapy aims to improve symptoms and cardiac function, creating an opportunity for subsequent surgery or interventional treatment. Surgical treatment involves repairing the ventricular septal perforation through open-chest surgery. However, because the ventricular septal tissue is extremely fragile in the early stages of perforation, surgery usually requires at least two to four weeks to allow the tissue to heal initially and ensure suture strength. This, however, is not conducive to alleviating patient suffering or reducing mortality.

[0004] Currently, in interventional closure treatment, existing occluders are only simple improvements based on congenital ventricular septal defect occluders, and still have problems such as easy damage to the fragile tissue at the ventricular septal perforation site, residual shunt, and unstable fixation.

[0005] It should be noted that the information disclosed in the background section of this application is intended only to enhance the understanding of the general background of this application, and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0006] In view of this, the purpose of the present invention is to provide an implantation device that aims to reduce secondary damage to myocardial tissue by the device and improve surgical safety and the stability and sealing of the implanted product.

[0007] To achieve the above objectives, the present invention provides an implantation device for sealing holes in the ventricular septum, comprising an implant body, the implant body including a first sealing disc and a second sealing disc arranged opposite to each other, and a waist portion connecting the first sealing disc and the second sealing disc;

[0008] The first occlusion disc includes a first inner disc surface and a first outer disc surface arranged opposite to each other, and a first support surface connecting the first inner disc surface and the first outer disc surface. Both the first inner disc surface and the first outer disc surface are arc surfaces that convex away from the waist. The first support surface extends outward from the edge of the first inner disc surface to attach to one side surface of the interventricular septum.

[0009] The second sealing disc includes a second inner disc surface and a second outer disc surface arranged opposite to each other, both of which are arc surfaces protruding away from the waist.

[0010] The implant body has a compressed state, a stretched state, and a natural state. In the natural state, the ratio of the maximum outer diameter of the waist to the maximum outer diameter of the second occlusion disc is 1:5 to 1:2, and the ratio of the maximum outer diameter of the first occlusion disc to the maximum outer diameter of the second occlusion disc is 10:6 to 10:9.

[0011] In one embodiment, under natural conditions, the minimum axial distance between the first sealing disc and the second sealing disc is 1mm-5mm.

[0012] In one embodiment, the second occlusion disc includes a second support surface connecting the second inner disc surface and the second outer disc surface, the second support surface extending outward from the edge of the second inner disc surface for attaching to the other side surface of the interventricular septum.

[0013] In one embodiment, the first support surface and / or the second support surface is a plane or an arc surface protruding towards the waist. In its natural state, the width of the first support surface is h1, the width of the second support surface is h2, and 0 < h2 ≤ h1 ≤ 8 mm.

[0014] In one embodiment, under natural conditions, the thickness of the first sealing disc is greater than or equal to the thickness of the second sealing disc.

[0015] In one embodiment, under natural conditions, the ratio between the thickness of the second sealing disc and the thickness of the first sealing disc is ≤3:5, and the thickness of the second sealing disc is ≤3.5mm.

[0016] In one embodiment, the waist section is a cylindrical structure with a hollow region, and the two ends of the cylindrical structure are respectively connected to the first inner disk surface and the second inner disk surface.

[0017] In one embodiment, the first outer disc surface forms a first annular recess facing the waist around the central axis of the implant body, and the second outer disc surface forms a second annular recess facing the waist around the central axis of the implant body; the depth of the first annular recess is ≤4.5mm, and the depth of the second annular recess is ≤4.5mm.

[0018] In one embodiment, in its natural state, the maximum outer diameter of the waist is 7mm-14mm, the height of the waist is 6mm-10mm, and in its stretched state, the implanted device can provide a clamping force of 0.4N to 6N.

[0019] In one embodiment, the implant body defines a guidewire cavity extending through its own axis; the implant body has opposing proximal and distal ends, the distal end is provided with a distal fixation member having a first inner hole communicating with the hollow region of the waist, the proximal end is provided with a proximal fixation member having a second inner hole communicating with the hollow region of the waist.

[0020] In one embodiment, at least one of the distal fixation member and the proximal fixation member employs a double-layered cannula, wherein the outer cannula of the double-layered cannula is sleeved on the outside of the corresponding end of the implant body, and the inner cannula of the double-layered cannula with an inner lumen is embedded in the corresponding first inner hole and / or second inner hole, and the space in which the inner lumen of the embedded inner cannula communicates with the hollow region of the waist defines the guidewire lumen.

[0021] In one embodiment, both the distal fixation member and the proximal fixation member employ the double-layer sleeve, and the proximal fixation member and the distal fixation member share an inner sleeve with an inner cavity, such that one of the inner sleeves extends from the first inner hole through the hollow region of the waist to the second inner hole.

[0022] In one embodiment, the outer diameter of the distal fixing member is 0.6mm-3.5mm, the wall thickness of the inner sleeve of the double-layer sleeve is greater than or equal to the wall thickness of the outer sleeve of the double-layer sleeve, the wall thickness of the outer sleeve is greater than 0.05mm, and the inner diameter of the inner sleeve is greater than 0.8mm.

[0023] In one embodiment, the implantation device further includes a covering membrane disposed inside and / or outside the implant body, and the covering membrane has slits for a guide wire to pass through, the slits being openable and closable.

[0024] In one embodiment, an auxiliary structure connected to the membrane is provided around the gap, the auxiliary structure being used to promote the closure of the gap by utilizing its own restoring force.

[0025] In one embodiment, the auxiliary structure is a coil arranged around the gap, with both ends of the coil connected to the coating along the length of the gap, and the portion of the coil between the two ends being closer to the gap in the width direction than the two ends.

[0026] In one embodiment, the distal end has a tip member to configure the implantation device as an expander for puncturing tissue.

[0027] In one embodiment, the outer diameter of the waist portion when the implant body is in a stretched state is smaller than the outer diameter of the waist portion when the implant body is in a natural state.

[0028] As described above, the present invention provides an implantation device that optimizes the ratio between the maximum outer diameter of the lumbar region and the maximum outer diameter of the second occlusion disc in its natural state to 1:5 to 1:2, and further optimizes the ratio between the maximum outer diameter of the first occlusion disc and the maximum outer diameter of the second occlusion disc in its natural state to 10:6 to 10:9. Designing the implant body according to these dimensions increases the clamping force provided by the lumbar region to the occlusion discs on both sides, while also increasing the sealing performance of the implantation device and allowing the second occlusion disc to better conform to the tissue, reducing blood shunting. Simultaneously, by providing a first support surface, the fulcrum for the first occlusion disc to clamp the ventricular septum is increased, and the contact between the first occlusion disc and the ventricular septum is changed from line contact to surface contact, making the implantation device more stable in the clamped state and minimizing tissue damage. Attached Figure Description

[0029] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0030] Figure 1 This is a front view of the implantation device according to an embodiment of the present invention;

[0031] Figure 2 yes Figure 1 A cross-sectional view of the implanted device along the BB line, without showing the membrane;

[0032] Figures 3a-3b These are overall cross-sectional views of the implantation device according to an embodiment of the present invention, and show the covering membrane;

[0033] Figure 4 This is a schematic diagram showing the dimensions of the waist, the first support surface, and the second support surface in the implantation device according to an embodiment of the present invention;

[0034] Figure 5 This is a schematic diagram showing the state of the implantation device of the present invention after it has been implanted in the body and positioned at the ventricular septal perforation.

[0035] Figure 6 This is a schematic diagram showing the outer diameter of the two sealing discs and the outer diameter of the waist in an embodiment of the present invention;

[0036] Figure 7 This is a schematic diagram showing the recess dimensions and thickness of the two sealing discs in an embodiment of the present invention;

[0037] Figure 8 This is a top view of any one of the coatings in the embodiments of the present invention;

[0038] Figure 9 This is a top view of any one of the embodiments of the present invention after adding a coil to the film;

[0039] Figure 10 This is a schematic diagram of a traditional surgical method for delivering implanted devices;

[0040] Figure 11 This is a schematic diagram of the implant delivery device according to an embodiment of the present invention;

[0041] Figure 12 This is a delivery state diagram of the implantation device of the present invention when used as an expander according to an embodiment of the invention;

[0042] Figure 13 This is a schematic diagram of an implantation device according to an embodiment of the present invention, which defines a guidewire cavity, wherein the dashed box represents a guidewire cavity that is disposed through the axial direction;

[0043] Figure 14 This is a schematic diagram of the installation of the double-layer sleeve in an embodiment of the present invention;

[0044] Figure 15 This is a schematic diagram of the structure when the proximal fixation member and the distal fixation member share a single inner sleeve in an embodiment of the present invention;

[0045] Figure 16 This is a schematic diagram of the structure of the spring tube in an embodiment of the present invention;

[0046] Figure 17 These are the experimental results of clamping force at different heights provided by this invention;

[0047] Figure 18 The results are experimental findings on clamping force under different outer diameters and different disc spacings provided by this invention.

[0048] In the attached image:

[0049] 1-Implantation device; 2-Implant body; 2a-Proximal end; 2b-Distal end; 22-First occlusion disc; 221-First inner disc surface; 222-First outer disc surface; 223-First support surface; 224-First annular recess; 21-Second occlusion disc; 211-Second inner disc surface; 212-Second outer disc surface; 213-Second support surface; 214-Second annular recess; 23-Waist; 3-Distal fixation member; 341-Outer sleeve; 342-Inner sleeve; 343-Inner cavity of the inner sleeve; 4-Proximal fixation member; 5-Delivery connector; 6-Cover Membrane; 62-Second coating section; 61-First coating section; 7-Gap; 8-Fixing point; 9-Auxiliary structure; 10-Guide wire cavity; 11-Guide wire; 12-Delivery sheath; 13-Operating lever; 14-Sheath core; a-Maximum outer diameter of the waist; b-Height of the waist; c-Minimum axial distance between the first and second sealing discs (referred to as disc spacing); d-Maximum outer diameter of the second sealing disc; e-Maximum outer diameter of the first sealing disc; f-Thickness of the second sealing disc; g-Thickness of the first sealing disc; h1 is the width of the first support surface, h2 is the width of the second support surface. Detailed Implementation

[0050] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are simplified and not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of the present invention.

[0051] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or” unless otherwise expressly indicated. In the description of the invention, unless otherwise stated, “a plurality” means two or more, and “a number” means the quantity is not limited. Furthermore, numerous specific details are set forth in the following description to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described to avoid confusion with the invention. Relational terms such as “first,” “second,” etc., are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly specify the number of technical features indicated. It should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Those skilled in the art can understand the specific meaning of the above terms in the present invention according to the specific circumstances.

[0052] In the following description, for ease of description, the terms "axial," "circumferential," and "radial" are used; "axial" refers to the direction along the central axis of the implanted device, "circumferential" refers to the direction around the central axis of the implanted device, and "radial" refers to the direction perpendicular to the central axis of the implanted device. It is understood that "proximal" and "distal" in this application refer to the relative orientation, position, and direction of the components or movements relative to each other from the perspective of the physician using the implanted device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the implanted device closer to the surgeon during normal operation, while "distal" generally refers to the end farther from the surgeon.

[0053] The core idea of ​​this invention is to provide an implantable device to solve the problems of existing occluders, such as easy damage to fragile ventricular septum tissue, residual shunt, and unstable fixation.

[0054] The implantable device provided by this invention is used to seal holes in the ventricular septum, where the hole may refer to a ventricular septal perforation or ventricular septal defect. This implantable device can reduce damage to the ventricular septal tissue while providing appropriate clamping force, ensuring the stability and sealing of the implanted device, and reducing residual shunts.

[0055] The following description is in conjunction with the accompanying drawings. In the following description, the treatment of ventricular septal perforation is used as an example, and the dimensions described in this application should be understood as the structural dimensions of the implanted device in its natural state.

[0056] refer to Figures 1 to 2 , Figures 3a-3b as well as Figure 4 This invention provides an implantation device 1, comprising an implant body 2. The implant body 2 includes a first sealing disc 22 and a second sealing disc 21 arranged opposite to each other along its own axial direction, and a waist portion 23 connecting the second sealing disc 21 and the first sealing disc 22. The implant body 2 is typically integrally woven and forms an I-shaped structure with the second sealing disc 21, the first sealing disc 22, and the waist portion 23. The first sealing disc 22 and the second sealing disc 21 can be circular or elliptical discs, preferably circular discs for easy retrieval. The waist portion 23 is columnar, generally cylindrical, and preferably tubular.

[0057] refer to Figure 5 In one application scenario, the implantable device 1 is used to treat a ventricular septal perforation (VSR). When the implantable device 1 is placed at the VSR, the first occlusion disc 22 is the portion of the implantable device 1 near the left ventricle (LV), the second occlusion disc 21 is the portion of the implantable device 1 near the right ventricle (RV), and the waist portion 23 is inserted into the VSR. The first occlusion disc 22 and the second occlusion disc 21 are respectively arranged on both sides of the VSR along the thickness direction of the ventricular septum, and both the first occlusion disc 22 and the second occlusion disc 21 extend into the normal myocardial tissue surrounding the VSR. The central position of the occlusion disc 22 is also not attached to the surface of the interventricular septum (IVS) corresponding to the left ventricle, thus avoiding the fragile myocardial tissue near the ventricular septal perforation. The central position of the second occlusion disc 21 is also not attached to the surface of the interventricular septum (IVS) corresponding to the right ventricle, thus avoiding the fragile myocardial tissue near the ventricular septal perforation. At this time, the edges of the first occlusion disc 22 and the second occlusion disc 21 extend to the normal myocardial tissue around the ventricular septal perforation (VSR) and clamp it, ultimately achieving the purpose of blocking the ventricular septal perforation (VSR).

[0058] refer to Figures 3a-3bFurthermore, the implantation device 1 also includes a covering membrane 6, which is a dense, liquid-impermeable film, typically made of materials such as polytetrafluoroethylene. The covering membrane 6 is disposed inside and / or outside the implant body 2, and can regulate the flow of liquid inside and / or outside the implant body 2 to further enhance the sealing performance. The covering membrane 6 extends radially and / or circumferentially along the implant body 2. Radial extension can be understood as the covering membrane 6 spreading radially along the implant body 2; circumferential extension can be understood as the covering membrane 6 surrounding the implant body 2 circumferentially to cover the sides of the implant body 2. Here, this application does not impose any particular limitation on the arrangement of the covering membrane 6 on the implant body 2.

[0059] In one embodiment, the coating 6 includes a first coating portion 62 and a second coating portion 61. The first coating portion 62 is disposed in the interlayer of the first sealing disk 22 and extends radially along the first sealing disk 22 to cover at least a portion of the mesh of the first sealing disk 22. The second coating portion 61 is disposed in the interlayer of the second sealing disk 21 and extends radially along the second sealing disk 21 to cover at least a portion of the mesh of the second sealing disk 21. The second coating portion 61 and the first coating portion 62 can be disposed simultaneously or selectively disposed. The thickness of the first coating portion 62 is less than or equal to the thickness of the first sealing disk 22, and the thickness of the second coating portion 61 is less than or equal to the thickness of the interlayer of the second sealing disk 21.

[0060] In another embodiment, the covering 6 includes a third covering portion (not shown) arranged around the waist portion 23 outside the implant body 2, and / or, the third covering portion is arranged around the second occlusion disc 21 and the first occlusion disc 22 outside the implant body 2. This further reduces residual shunt and improves occlusion performance. The third covering portion, the first covering portion 62, and the second covering portion 61 can be provided simultaneously or two of them can be selected.

[0061] In one illustrated example, the second membrane portion 61 is provided only in the interlayer of the second sealing disk 21, and the first membrane portion 62 is provided in the interlayer of the first sealing disk 22. This reduces residual diversion and improves sealing performance.

[0062] Furthermore, addressing the shortcomings of existing occluders, this invention optimizes the structure of the implantation device 1, enabling it to provide suitable clamping force without damaging the fragile ventricular septum tissue. Compared to existing technologies, the implantation device 1 provided by this invention offers better overall fixation stability, better sealing, and reduces residual shunt.

[0063] The implant body 2 typically has a natural state, a stretched state, and a compressed state. The natural state refers to the naturally unfolded state when there is no external force constraint. The stretched state refers to the state in which the implant body 2 is stretched when the implant device 1 is placed at the ventricular septal perforation (VSR). When delivered in the delivery system, it constitutes a compressed state.

[0064] refer to Figure 2 The first sealing disc 22 includes a first inner disc surface 221 and a first outer disc surface 222 arranged opposite to each other. The first inner disc surface 221 is integrally connected to the waist portion 23 at its inner ring position. The first inner disc surface 221 is arranged facing the interventricular septum. Both the first inner disc surface 221 and the first outer disc surface 222 are arc surfaces convex away from the waist portion 23. The first inner disc surface 221 and the second outer disc surface 222 have the same or different curvatures, thereby forming a sandwich between the first inner disc surface 221 and the first outer disc surface 222. Further, a first covering portion 62 is disposed in this sandwich.

[0065] Similarly, the second sealing disc 21 includes a second inner disc surface 211 and a second outer disc surface 212 arranged opposite to each other. The second inner disc surface 211 is integrally connected to the waist portion 23 at its inner ring position. The second inner disc surface 211 is arranged facing the interventricular septum. Both the second inner disc surface 211 and the second outer disc surface 212 are arcuate surfaces convex away from the waist portion 23. The second inner disc surface 211 and the second outer disc surface 212 have the same or different curvatures, wherein a sandwich layer of the second sealing disc 21 is formed between the second inner disc surface 211 and the second outer disc surface 212. Further, a second covering portion 61 is disposed in this sandwich layer.

[0066] Continue to refer to Figure 2 The first occlusion disc 22 also includes a first support surface 223, which connects the first inner disc surface 221 and the first outer disc surface 222. The first support surface 223 extends outward from the edge of the first inner disc surface 221 and surrounds the first occlusion disc 22. In this configuration, the inner central arc-shaped portion formed by the first inner disc surface 221 avoids fragile tissue near the ventricular septum perforation as much as possible, while the first support surface 223 acts as a support leg to fully adhere to the healthy myocardial tissue on one side of the ventricular septum, thus increasing stability during clamping. The first support surface 223 is an arc-shaped surface or a plane protruding towards the second occlusion disc 21. Therefore, by adding a fulcrum through the first support surface 223 and changing the contact between the first occlusion disc 22 and the myocardial tissue from line contact to surface contact, the implantation device 1 becomes more stable when clamped.

[0067] In some embodiments, the second inner disc surface 211 and the second inner disc surface 212 have different curvatures and are connected to each other through their outer ring ends. In other embodiments, the second occlusion disc 21 further includes a second support surface 213, which connects the second inner disc surface 211 and the second outer disc surface 212. The second support surface 213 extends outward from the edge of the second inner disc surface 211 and surrounds the second occlusion disc 21. Similarly, the inner central arc-shaped portion formed by the second inner disc surface 211 can avoid fragile tissue near the ventricular septum perforation as much as possible, while the second support surface 213 forms a support to fully adhere to the healthy myocardial tissue on the other side of the ventricular septum, thus further increasing the stability during clamping. The second support surface 213 is an arc-shaped surface convex towards the second occlusion disc 21 or is simply a plane. Understandably, by adding another fulcrum through the second support surface 213, the contact between the second occlusion disc 21 and the myocardial tissue can be changed from line contact to surface contact, making the implantation device 1 more stable in the clamped state.

[0068] refer to Figure 4 The width of the first support surface 223 is h1, and the width of the second support surface 213 is h2. h1 and h2 refer to the chord length (corresponding to the arc surface) or line length (corresponding to the plane) between two points. The widths of the first support surface 223 and the second support surface 213 should not be too large or too small. In this case, under natural conditions, 0 < h2 ≤ h1 ≤ 8 mm, and more preferably 0 < h2 ≤ h1 ≤ 5 mm. When these support surfaces are designed with this size, the implanted device 1 has good stability in the clamped state, while also avoiding contact with fragile tissue near the ventricular septal perforation.

[0069] Furthermore, the first support surface 223 is smoothly connected to the first inner disk surface 221 and the first outer disk surface 222, respectively, and the second support surface 213 is smoothly connected to the second inner disk surface 211 and the second outer disk surface 212, respectively, so as to avoid cutting the tissue at the transition part and improve fatigue performance.

[0070] like Figure 4 As shown, in one embodiment, in its natural state, the transition connection between the first support surface 223 and the first inner disk surface 221 is provided with a fillet r-1, the transition connection between the first support surface 223 and the first outer disk surface 222 is provided with a fillet r-2, the transition connection between the second support surface 213 and the second inner disk surface 211 is provided with a fillet r-3, and the transition connection between the second support surface 213 and the second outer disk surface 212 is provided with a fillet r-4. Preferably, the radius (r) of these fillets satisfies: 0 < r ≤ 8 mm, and more preferably 0 < r ≤ 5 mm. However, it is understood that when the support surface itself is an arc surface, the fillets can be omitted, so that the support surface is directly tangent to the inner disk surface and the outer disk surface respectively, thus achieving a smooth transition connection.

[0071] For further reference Figure 3a and Figure 7 The implant body 2 has a proximal end 2a and a distal end 2b. The distal end 2b is disposed on the first occlusion disc 22, and the proximal end 2a is disposed on the second occlusion disc 21. The distal end 2b is disposed on the outer ring of the first outer disc surface 222, and the proximal end 2a is disposed on the outer ring of the second outer disc surface 212. Both the proximal end 2a and the distal end 2b are composed of braided filaments.

[0072] Furthermore, the radial dimensions of the sealing disc are optimized to improve clamping force and sealing performance. (Reference) Figure 6 In its natural state, the maximum outer diameter of both the first sealing disc 22 and the second sealing disc 21 is greater than the maximum outer diameter of the waist portion 23 (corresponding to dimension a). Furthermore, the ratio of the maximum outer diameter of the first sealing disc 22 (corresponding to dimension e) to the maximum outer diameter of the second sealing disc 21 (corresponding to dimension d) is 10:6 to 10:9, and the ratio of the maximum outer diameter of the waist portion 23 (corresponding to dimension a) to the maximum outer diameter of the second sealing disc 21 (corresponding to dimension d) is 1:5 to 1:2. Preferably, the ratio of the maximum outer diameter of the first sealing disc 22 (corresponding to dimension e) to the maximum outer diameter of the second sealing disc 21 (corresponding to dimension d) is 10:7 to 10:8.5. Preferably, the ratio of the maximum outer diameter of the waist portion 23 (corresponding to dimension a) to the maximum outer diameter of the second sealing disc 21 (corresponding to dimension d) is 1:4 to 2:5. This increases the clamping force provided by the waist 23 to the two occlusion discs, while also increasing the sealing of the implanted device 1 and allowing the second occlusion disc 21 to fit better with the tissue, reducing blood shunting.

[0073] As described above, the implant body 2 also includes a stretched state after implantation into human tissue. Furthermore, the occlusion performance can be improved by optimizing the radial dimensions of the waist portion 23. Specifically, the outer diameter of the waist portion 23 when the implant body 2 is in the stretched state is smaller than the outer diameter of the waist portion 23 when the implant body 2 is in the natural state. It is worth noting that the outer diameter of the waist portion 23 when the implant body 2 is in the natural state is larger than the diameter of the ventricular septal perforation, and the height of the waist portion 23 when the implant body 2 is in the natural state does not exceed the thickness of the ventricular septum. Thus, when the implant device 2 is implanted into the human body and fixed at the ventricular septal perforation, a gap is formed between the stretched waist portion 23 and the ventricular septal perforation, which can prevent the waist portion 23 from radially compressing the fragile tissue at the ventricular septal perforation.

[0074] Further research revealed that traditional occluders typically have a relatively thick waist. When the occluder is placed at the ventricular septal perforation, the waist contacts the perforation, using the radial support provided by the thick waist to fix the occluder. At this time, the surfaces of the two occluding discs adhere closely to the surface of the ventricular septum to seal the perforation, but the discs do not clamp the ventricular septum tightly; they merely adhere. Thus, the waist completely fills the ventricular septal perforation and radially compresses the diseased myocardium, easily causing myocardial fragmentation and residual shunts. To address this problem, existing technology reduces the radial dimension of the waist, preventing it from contacting the ventricular septal perforation. It is generally believed that the larger the gap between the waist and the perforation, the better. After reducing the radial dimension of the waist, the clamping force of the two occluding discs is used to fix the ventricular septum and seal the perforation. Current technology aims to ensure that the two occluding discs effectively seal the ventricular septal perforation while minimizing the radial dimension of the waist. Further research has found that when the waist is too narrow, the surfaces of the occlusion discs on both sides are sucked into the ventricular septum tissue for fixation, rather than being secured by clamping force. This can lead to myocardial infarction and tissue erosion, which is undesirable. The usual approach is to increase the waist height to prevent the occlusion discs from being sucked into the ventricular septum tissue. However, simply increasing the waist height can cause the occluder to become unstable.

[0075] Therefore, the outer diameter and height of waist 23 were further optimized. Specifically, refer to... Figure 4 In its natural state, the maximum outer diameter of the waist 23 (corresponding to dimension a) is 7mm-14mm, and the height of the waist 23 (corresponding to dimension b) is 6mm-10mm. Thus, in the stretched state, the maximum outer diameter of the stretched waist 23 is smaller than the diameter of the ventricular septum perforation, ensuring that the stretched waist 23 does not come into contact with the ventricular septum perforation, avoiding secondary damage to the tissue at the ventricular septum perforation site. At the same time, it ensures that the waist 23 has good tensile elasticity, which can both prevent the two occlusion discs from being sucked into the ventricular septum tissue and generate sufficient elastic force to enhance the clamping force of the two occlusion discs on the ventricular septum.

[0076] For reference Figure 5 It is understood that when the implanted device 1 is placed at the ventricular septal perforation (VSR), the waist portion 23 is stretched axially, which reduces the outer diameter of the waist portion 23. The outer diameter of the stretched waist portion 23 will be much smaller than the diameter of the ventricular septal perforation (VSR), which can prevent the waist portion 23 from contacting the hole and increasing tissue damage at the hole. At the same time, the stretched waist portion 23 generates elasticity, which can cause the second occlusion disc 21 and the first occlusion disc 22 to clamp the ventricular septum (IVS) without causing the disc surfaces of the two occlusion discs to be sucked into the ventricular septal tissue, thereby ensuring the stability of fixation and occlusion effect, and reducing the impact on the ventricular septal tissue.

[0077] Understandably, although the radial dimension of the lumbar region 23 is larger than the diameter of the ventricular septal perforation in its natural state, in actual operation, the lumbar region 23 will undergo axial stretching to clamp the ventricular septum. After stretching, the radial dimension of the lumbar region 23 will be smaller than the radial dimension of the ventricular septal perforation. This can minimize the contact area between the lumbar region 23 and the ventricular septal perforation, while ensuring that the stretched lumbar region 23 can provide sufficient elasticity to the occlusion discs on both sides. This allows the implanted device 1 to be fixed without relying on the radial support force of the lumbar region 23, thereby preventing the radial support force of the lumbar region 23 from damaging the lesion tissue at the ventricular septal perforation, avoiding secondary damage to the lesion tissue, and also avoiding complications such as residual shunt.

[0078] Furthermore, the disc spacing was optimized to further improve clamping force and sealing performance. The minimum axial distance between the second sealing disc 21 and the first sealing disc 22 was set to 1mm-5mm, more preferably 1mm-4mm. This ensures that both sealing discs adhere tightly to the interventricular septum wall and maintain clamping force on the interventricular septum.

[0079] Figure 17 Experimental results of clamping force at different waist heights are provided, with three waist heights selected: b: 6mm; b: 10mm; and b: 12mm. From Figure 17 It can be seen that, with other conditions remaining unchanged and only the height of the waist 23 being changed, the optimal parameter for clamping force is selected. In its natural state, the height of the waist 23 is 6mm-10mm. At this height, the clamping force of the two discs is neither too large nor too small, effectively clamping the ventricular septum without damaging the ventricular septum tissue or being drawn into it. Furthermore, it can be seen that even increasing the height of the waist 23 does not increase the clamping force; in fact, it decreases. Therefore, simply increasing the waist height does not solve the problem. Of course, decreasing the waist height will increase the clamping force, but excessive clamping force will over-compress the ventricular septum tissue, causing damage. More preferably, in its natural state, the height of the waist 23 is 6mm-8mm, which further improves the occlusion performance.

[0080] Figure 18 Experimental results of clamping force under different outer diameters and disc spacings are also provided, including three sets of experimental data: a: 14 mm, c: 5 mm; a: 7 mm, c: 4 mm; a: 4 mm, c: 4 mm; a: 4 mm, c: 5 mm. Figure 18It can be seen that, with other conditions remaining constant and only the outer diameter of the waist section 23 and the distance between the two discs changed, the optimal parameters that are beneficial to the clamping force are selected. That is, in the natural state, the maximum outer diameter of the waist section 23 is 7mm-14mm, and the distance between the two discs does not exceed 5mm, preferably 1mm-4mm. At this time, the clamping force of the two discs is appropriate, which can not only clamp the ventricular septum well, but also prevent damage to the ventricular septum tissue during the clamping process, and prevent it from being sucked into the ventricular septum tissue. It can also be seen that when the outer diameter of the waist section 23 is too small, the clamping force is also small, and the clamping is not stable. Further preferably, in the natural state, the maximum outer diameter of the waist section 23 is 7mm-13mm, and the minimum distance between the two occlusion discs is 1mm-3.5mm. In this way, the occlusion performance can be further improved.

[0081] Optionally, under tension, the clamping force provided by the implantation device 1 satisfies: 0.4N ≤ F ≤ 6N. Wherein: F represents the clamping force, in Newtons (N). This clamping force ensures good overall clamping effect of the implantation device 1, reduces damage to tissues, guarantees stability and sealing, and reduces residual shunting.

[0082] Furthermore, by optimizing the thickness of the sealing disc, the clamping force and sealing performance are further improved. It is understandable that when the curvature of the inner and outer surfaces of any sealing disc is inconsistent, the thickness described in this article represents the maximum thickness of the sealing disc. (Reference) Figure 7 In one embodiment, the thickness of the second occlusion disc 21 (corresponding to dimension f) is less than or equal to the thickness of the first occlusion disc 22 (corresponding to dimension g), where g and f are independent of the thickness of the covering membrane 6. Preferably, the ratio of the thickness (f) of the second occlusion disc 21 to the thickness (g) of the first occlusion disc 22 is ≤3:5, and the thickness (f) of the second occlusion disc 21 is ≤3.5mm. Thus, when the implantation device 1 clamps the ventricular septum, it allows the first occlusion disc 22 to deform more to increase the clamping force, while ensuring that the surface of the second occlusion disc 21 is fixed on healthy myocardial tissue without damaging the fragile ventricular septum tissue. Furthermore, it ensures a tight fit between the second occlusion disc 21 and the ventricular septum tissue, improving the clamping force and sealing of the second occlusion disc 21 and the entire implantation device 1, and reducing blood flow.

[0083] Continue to refer to Figure 7The first occlusion disc 22 and the second occlusion disc 21 may further be defined with recesses. These recesses enhance the deformation capability of the occlusion discs towards the waist 23, thereby improving the clamping force and sealing performance of the disc surfaces. Regarding the recesses, the first occlusion disc 22 is defined with a first annular recess 224, and the second occlusion disc 21 is defined with a second annular recess 214. The first outer disc surface 222 of the first occlusion disc 22 forms a first annular recess 224 recessed towards the waist 23 around the central axis of the implant body 2, and the second outer disc surface 212 of the second occlusion disc 21 forms a second annular recess 214 recessed towards the waist 23 around the central axis of the implant body 2. The recesses enhance the deformation capability of the occlusion discs towards the interventricular septum, allowing the occlusion discs to better adhere to the interventricular septum wall, further improving the clamping force and sealing performance of the disc surfaces. Preferably, the depth of the first annular recess 224 (corresponding to dimension j) is ≤4.5mm, and the depth of the second annular recess 214 (corresponding to dimension i) is ≤4.5mm, thereby improving the clamping force and sealing performance of the disc surface.

[0084] Return to reference Figure 2 , Figures 3a-3b Furthermore, the implantation device 1 also includes a distal fixation member 3, which is fixed to the distal end 2b of the implant body 2. The distal fixation member 3 is coaxially arranged with the waist 23. The distal fixation member 3 can restrain the braided wire ends at the distal end 2b to prevent the braided wires from unraveling. Preferably, the distal fixation member 3 has a first inner hole communicating with the hollow region of the waist 23, which allows the guide wire 11 to pass through.

[0085] The implantation device 1 also includes a proximal fixation member 4, which is fixed to the proximal end 2a of the implant body 2. The proximal fixation member 4 is coaxially arranged with the waist 23. The proximal fixation member 4 can restrain the braided wire ends at the proximal end 2a to prevent the braided wires from unraveling. Preferably, the proximal fixation member 4 has a second inner hole that communicates with the hollow region of the waist 23, and the second inner hole allows the guide wire 11 to pass through.

[0086] In one embodiment, a conveying connector 5 is also mounted on the proximal fixing member 4. The conveying connector 5 is used for detachable connection with the conveying system, such as a threaded connection between the conveying connector 5 and the operating lever 13 in the conveying system. The conveying connector 5 is coaxially arranged with the proximal fixing member 4, for example, the conveying connector 5 is sleeved on the outside of the proximal fixing member 4. However, it should be understood that the conveying connector 5 and the proximal fixing member 4 can be integrally formed, or they can be formed separately and then assembled together. This application does not limit this.

[0087] Furthermore, the conveying connector 6 has a third inner hole that communicates with the second inner hole, through which the guide wire 11 can pass.

[0088] Preferably, the waist portion 23 is a cylindrical structure having the hollow region described above, and the two ends of the cylindrical structure are respectively connected to the first inner disk surface 221 and the second inner disk surface 211.

[0089] Next reference Figure 10 and Figure 11 The delivery method of the implantation device 1 provided by the present invention will be further described.

[0090] like Figure 10 As shown, the traditional delivery method involves first establishing a track from the vein to the aorta using guidewire 11, and then advancing the delivery sheath 12 and sheath core 14 (i.e., the dilator) together along the guidewire 11 to the vicinity of the ventricular septal perforation (IVS) location. However, existing occluders cannot pass through the guidewire 11 themselves. Therefore, before implanting the occluder, the sheath core 14 and guidewire 11 need to be withdrawn before the occluder is advanced. During this procedure, the delivery sheath 12 is susceptible to significant bending changes due to the withdrawal of the sheath core 14, potentially damaging myocardial tissue. It should be recognized that the delivery sheath 12 required for surgery generally has a large bend, and during the withdrawal of the sheath core 14, the delivery sheath 12 may surge forward, potentially damaging the ventricular wall tissue and causing myocardial tissue injury, thus increasing the risk of the procedure.

[0091] In this regard, refer to Figure 13 The implant body 2 provided by the present invention preferably includes a guidewire lumen 10 extending along its own axis, allowing the guidewire 11 to pass through the entire implant device 1 via the guidewire lumen 10. Therefore, the guidewire 11 can be retained from the start to the end of the surgery without removal, and no re-establishment of the track is required when changing instruments. This not only allows for faster surgery but also avoids damage to the valves and myocardial tissue caused by the absence of a re-established track. More specifically, as... Figure 11 As shown, in one application scenario, the implantable device 1 can be used as an expander for punctured tissue. In this case, the sheath core 14 can be omitted. Thus, after the guidewire 11 passes through the implantable device 1, it can be inserted and replaced without removing the guidewire 11, allowing for the insertion and replacement of instruments while maintaining the original access. Of course, during the operation, an existing expander can be used, or the implantable device 1 can be used instead of the expander, depending on the actual needs. Replacing the expander with the implantable device 1 eliminates the step of removing the sheath core 14, saving surgical time, increasing surgical safety, shortening the learning curve, and improving surgical efficiency.

[0092] The implantation device 1 should possess a certain degree of rigidity and stiffness to facilitate tissue puncture during delivery. Preferably, the implant body 2 is formed by cross-weaving 24 to 144 braided filaments to ensure the overall strength and rigidity of the implant body 2, maintaining its stability in support and clamping. The implant body 2 can be woven from metal wire or polymer filaments; the specific material is not limited. Furthermore, such as... Figure 12 As shown, during delivery within the delivery sheath 12, the first occlusion disc 22 itself can retract into a folded umbrella shape, which facilitates tissue puncture by the first occlusion disc 22. Furthermore, the distal end 2b of the implant body 2 preferably has a pointed member, making it easier for the entire implantation device 1 to enter the patient's body and successfully puncture tissue. For example, in this embodiment, the distal fixation member 3 can directly constitute the pointed member. Of course, the implantation device 1 can also be completely retrieved.

[0093] For easier understanding, please refer to Figure 12 , Figure 12 This illustrates the situation where the implantation device 1 is held within the delivery sheath 12. For example... Figure 12 As shown, without using the sheath core 14, the implantation device 1 is entirely held within the delivery sheath 12. At this time, the implantation device 1 can be pushed forward using the operating lever 13, causing the first occlusion disc 22 to be partially exposed beyond the distal end of the delivery sheath 12, facilitating tissue puncture. The operating lever 13 can push and pull the implantation device 1 along the axial direction of the delivery sheath 12 to perform operations such as delivery, release, and retrieval of the implantation device 1. The distal end of the operating lever 13 is detachably connected to the delivery connector 5 of the second occlusion disc 22.

[0094] In this embodiment, the distal fixation member 3 constitutes a tip component. Preferably, the outer diameter of the distal fixation member 3 is 0.6mm-3.5mm. When the distal fixation member 3 is designed with this size, it is convenient for the implantation device 1 to puncture the tissue smoothly.

[0095] In addition, to facilitate the passage of guide wire 11, such as Figure 8 and Figure 9 As shown, both the first covering part 62 and the second covering part 61 have a slit 7 at their center, allowing the guidewire 11 to pass through. When the guidewire 11 is withdrawn, the slit 7 automatically closes to improve sealing, block blood flow, and better achieve endothelialization. Preferably, the length of the slit 7 is 0.5mm-8mm, and the width of the slit 7 is ≤1.0mm. This allows guidewires of conventional sizes 11 to pass through the slit 7, and the smaller the width, the better the seal.

[0096] like Figure 8 As shown, in one embodiment, the first coating portion 62 and / or the second coating portion 61 are each provided with a slit 7 at a suitable location (including but not limited to the center). Figure 9As shown, in another embodiment, an auxiliary structure 9 connected to the covering film 6 can be provided around the gap 7, utilizing the self-restoring force of the auxiliary structure 9 to promote better closure of the gap 7. The auxiliary structure 9 is similar to a mechanical switch, capable of opening and closing on its own. The simplest way is to use silk threads to make the auxiliary structure 9, with both ends of the silk thread fixed to the covering film 6, and the middle part between the two ends of the silk thread positioned close to the gap 7 and able to move freely. When the guide wire 11 passes through the gap 7, the middle part of the silk thread automatically opens, and when the guide wire 11 is removed, the middle part automatically returns to its original position. In this embodiment, the auxiliary structure 9 is a coil composed of silk threads, which is arranged around the gap 7 and forms a shape similar to a fish mouth, that is, the two ends of the coil along the length direction of the gap 7 are connected to the covering film 6, and the part of the coil located between the two ends is closer to the gap 7 in the width direction of the gap 7 than the two ends. The coil can be fixed to the covering film 6 by other methods such as sewing or bonding, and multiple fixing points 8 can be formed during fixing. The material of the coil is preferably a shape memory alloy or other polymer material with shape memory function.

[0097] As described above, the implantation device 1 defines a guidewire cavity 10, which needs to pass through the distal fixator 3, proximal fixator 4, delivery connector 5, implant body 2, and covering membrane 6 along the axial direction of the implantation device 1. In practice, after the implant body 2 is woven and formed, the waist 23 has a hollow area for the guidewire 11 to pass through, and the distal fixator 3, proximal fixator 4, and delivery connector 5 all have internal holes for the guidewire 11 to pass through. The distal fixator 3 and proximal fixator 4 are both sheaths, which can be single-layered or double-layered, preferably double-layered. At least one of the distal fixator 3 and proximal fixator 4 can be a double-layered sheath. The arrangement of the distal fixator 3 and proximal fixator 4 will be further explained below.

[0098] like Figure 14 As shown, in one example, the double-layered cannula includes an outer cannula 341 and an inner cannula 342, with the inner cannula 342 having an inner cavity 343. During actual installation, the outer cannula 341 and the inner cannula 342 are nested sequentially from the outside to the inside at the corresponding ends of the implant body 2. Taking the proximal fixation member 3 as an example, the outer cannula 341 is fitted onto the outside of the proximal end 2a of the implant body 2, and the inner cannula 342 is embedded in the inner cavity of the proximal end 2a of the implant body 2. At this time, the inner cavity 343 of the inner cannula 342 can define the guidewire lumen 10. Continuing with the proximal fixation member 3 as an example, the proximal end 2a of the implant body 2, the outer cannula 341, and the inner cannula 342 can be connected by crimping or welding.

[0099] The outer sheath 341 and inner sheath 342 can be made of metal materials, such as stainless steel, or polymer materials, such as polyether block polyamide or polytetrafluoroethylene. Using a double-layer sheath can better restrain the braided end of the implant body 2, ensuring the guidewire pathway is stably formed and guaranteeing product functionality.

[0100] In some embodiments, the distal fixation member 3 and the proximal fixation member 4 each employ an inner sleeve 342, and the two inner sleeves 342 are independently disposed at the ends of the implant body 2, and do not form a whole.

[0101] In another embodiment, such as Figure 15 As shown, the distal fixation member 3 and the proximal fixation member 4 share an inner sleeve 342 with an inner cavity 343. The inner sleeve 342 extends from the first inner hole of the distal fixation member 3 through the hollow region of the waist portion 23 and into the second inner hole of the proximal fixation member 4. At this point, the inner cavity 343 of the inner sleeve 342 defines the guide wire cavity 10. With the inner sleeve 342 configured in this way, both ends of the inner sleeve 342 are fixed, while the middle section can be stretched and extended. This method can further enhance the clamping force, making it safer and more effective.

[0102] The advantage of using a shared inner cannula 342 is that, after the implantation device 1 is inserted into the body and before the guidewire 11 is withdrawn, the length and shape of the guidewire 11 within the waist 23 can be constrained and further controlled by the inner cannula 342. This makes it less likely that the guidewire 11 will get stuck at the first inner hole of the distal fixator 3 and the second inner hole of the proximal fixator 4, making the surgery safer. Figure 16 As shown, the shared inner sleeve 342 can be made of spring tube, and a spring tube with a high tensile density can be selected. Of course, it is not limited to spring tube in practice.

[0103] Preferably, the wall thickness of the inner sleeve 342 is greater than or equal to the wall thickness of the outer sleeve 341, the wall thickness of the outer sleeve 341 is greater than 0.05 mm, and the inner diameter of the inner sleeve 342 is greater than 0.8 mm. This allows for better maintenance of the guide wire passage and reduces the likelihood of the guide wire 11 getting stuck.

[0104] In summary, compared with the prior art, the implantation device provided by the present invention has at least the following advantages:

[0105] (1) The ratio between the maximum outer diameter of the waist in its natural state and the maximum outer diameter of the second occlusion disc is optimized to 1:5 to 1:2, and the ratio between the maximum outer diameter of the first occlusion disc and the maximum outer diameter of the second occlusion disc in its natural state is optimized to 10:6 to 10:9. When designing the implant body according to these dimensions, the clamping force provided by the waist to the occlusion discs on both sides can be increased, while the sealing performance of the implant device can be increased, and the second occlusion disc can fit better with the tissue, reducing blood shunting. At the same time, by setting the first support surface, the fulcrum when the first occlusion disc clamps the ventricular septum is increased, and the contact between the first occlusion disc and the ventricular septum is changed from line contact to surface contact, making the implant device more stable in the clamped state and minimizing damage to the tissue.

[0106] (2) The maximum outer diameter of the waist was optimized to 7mm-14mm, and the height of the waist was optimized to 6mm-10mm. An unexpected effect was that, while ensuring a gap existed between the waist and the diseased myocardium at the ventricular septum opening, the waist could be axially stretched and generate elastic force. This elastic force could cause the two occlusion discs to clamp the ventricular septum, but would not cause the disc surfaces of the two occlusion discs to be sucked into the ventricular septum tissue. This improved the clamping force and sealing, reduced residual shunts, and reduced the impact on the ventricular septum tissue. Since the clamping force provided by the implanted device in the stretched state met the requirements of 0.4N to 6N, within this range, the overall clamping effect of the implanted device was good, which also reduced tissue damage, ensured stability and sealing, and reduced residual shunts.

[0107] (3) Optimize the minimum distance between the two sealing discs to 1mm-4mm to further improve clamping force and sealing performance.

[0108] (4) By optimizing the thickness of the two occlusion discs, the implanted device can deform more to increase the clamping force when clamped and fixed, while ensuring that the surface of the second occlusion disc is fixed on healthy myocardial tissue and will not damage the fragile ventricular septal perforation tissue. It also makes the second occlusion disc fit tightly with the tissue, improves the clamping force and sealing of the second occlusion disc and the entire implanted device, and reduces blood flow.

[0109] (5) After setting pits on the outer surfaces of the two sealing discs, the deformation capacity of the sealing discs can be enhanced, and the clamping force and sealing performance of the disc surfaces can be further improved.

[0110] (6) The implantable device itself has a guidewire lumen, allowing the guidewire to pass through the device. This ensures the guidewire remains in place from the start to the end of the procedure without prior removal, and eliminates the need to rebuild the track when changing instruments. This not only allows for faster surgery but also avoids damage to the valves and myocardial tissue caused by track reconstruction. In particular, the implantable device can replace the dilator for tissue puncture, eliminating the need for core removal, saving surgical time, increasing surgical safety, shortening the learning curve, and improving surgical efficiency.

[0111] In summary, the implantable device provided by this invention is suitable for treating ventricular septal perforation or ventricular septal defect. It relies on the product's stretched state to clamp and fix it, which has a good clamping force while minimizing tissue and vascular damage.

[0112] Finally, it should be noted that balancing the performance of the implanted device requires considering the impact of various factors on its performance, as these factors influence each other. This is a major challenge in occluder design. The technical concept provided by this invention is to address this from all aspects, striving to optimize the implanted device to improve clamping force and sealing performance while minimizing damage to myocardial tissue and reducing residual shunts. For example, conventional occluder designs often only consider whether the waist is very thick or very thin, without deeply studying the impact of various factors on the overall performance of the device. In particular, existing technologies often only consider a thinner waist as better. However, determining the optimal waist diameter is extremely difficult. For example, it's easy to conceive of reducing the waist diameter to prevent it from contacting the tissue at the ventricular septal perforation site. However, reducing the waist diameter might decrease tensile strength, resulting in insufficient clamping force, or even risk the disc being sucked into the tissue. To address this, those skilled in the art might consider increasing the waist height. While increasing the waist height can prevent the disc from being sucked into the tissue, it reduces the clamping force, making the occluder unstable and affecting its occlusion performance. In other words, setting the clamping force of the occluder without relying on the radial support force provided by the waist is very challenging and cannot be determined through a limited number of trials. Various factors form an organic whole; a change in one affects the whole. This invention provides a technical solution that balances the clamping force without relying on the radial support force of the waist, fundamentally different from existing technologies.

[0113] It should be noted that those skilled in the art can make various improvements and additions without departing from the method of this invention, and these improvements and additions should also be considered within the scope of protection of this invention. Any modifications, alterations, and variations made by those skilled in the art without departing from the spirit and scope of this invention, based on the disclosed technical content, are equivalent embodiments of this invention; furthermore, any modifications, alterations, and variations made to the above embodiments based on the essential technology of this invention still fall within the scope of the technical solution of this invention.

Claims

1. An implantable device for sealing holes in the ventricular septum, characterized in that, The implant body includes an integrally woven implant body, which includes a first occlusion disc and a second occlusion disc arranged opposite to each other, and a waist section connecting the first occlusion disc and the second occlusion disc; The first occlusion disc includes a first inner disc surface and a first outer disc surface arranged opposite to each other, and a first support surface connecting the first inner disc surface and the first outer disc surface. Both the first inner disc surface and the first outer disc surface are arc surfaces that convex away from the waist. The first support surface extends outward from the edge of the first inner disc surface to attach to one side surface of the interventricular septum. A sandwich layer of the first occlusion disc is formed between the first inner disc surface and the first outer disc surface. The second sealing disc includes a second inner disc surface and a second outer disc surface arranged opposite to each other, and a second support surface connecting the second inner disc surface and the second outer disc surface. Both the second inner disc surface and the second outer disc surface are arc surfaces that convex away from the waist. The second support surface extends outward from the edge of the second inner disc surface to attach to the other side surface of the interventricular septum. A sandwich layer of the second sealing disc is formed between the second inner disc surface and the second outer disc surface. The first support surface is a plane or an arc surface protruding towards the second sealing plate, and the second support surface is a plane or an arc surface protruding towards the first sealing plate. In its natural state, the width of the first support surface is h1, and the width of the second support surface is h2, where 0 < h2 ≤ h1 ≤ 8 mm. The implant body has a compressed state, a stretched state, and a natural state. In the natural state, the ratio of the maximum outer diameter of the waist to the maximum outer diameter of the second occlusion disc is 1:5 to 1:2, and the ratio of the maximum outer diameter of the first occlusion disc to the maximum outer diameter of the second occlusion disc is 10:6 to 10:

9.

2. The implantation device according to claim 1, characterized in that, Under natural conditions, the minimum axial distance between the first sealing disc and the second sealing disc is 1mm-5mm.

3. The implantation device according to claim 1, characterized in that, Under natural conditions, the thickness of the first sealing disc is greater than or equal to the thickness of the second sealing disc.

4. The implantation device according to claim 3, characterized in that, Under natural conditions, the ratio of the thickness of the second sealing disc to the thickness of the first sealing disc is ≤3:5, and the thickness of the second sealing disc is ≤3.5mm.

5. The implantation device according to claim 1, characterized in that, The waist section is a cylindrical structure with a hollow area, and the two ends of the cylindrical structure are respectively connected to the first inner disk surface and the second inner disk surface.

6. The implantation device according to claim 1, characterized in that, The first outer disc surface forms a first annular depression facing the waist around the central axis of the implant body, and the second outer disc surface forms a second annular depression facing the waist around the central axis of the implant body; the depth of the first annular depression is ≤4.5mm, and the depth of the second annular depression is ≤4.5mm.

7. The implantation device according to claim 1, characterized in that, In its natural state, the maximum outer diameter of the waist is 7mm-14mm, and the height of the waist is 6mm-10mm. In its stretched state, the implanted device can provide a clamping force of 0.4N~6N.

8. The implantation device according to claim 1, characterized in that, The implant body defines a guidewire cavity that extends through it along its own axis; the implant body has a proximal end and a distal end, the distal end is provided with a distal fixation member, the distal fixation member has a first inner hole that communicates with the hollow region of the waist, the proximal end is provided with a proximal fixation member, the proximal fixation member has a second inner hole that communicates with the hollow region of the waist.

9. The implantation device according to claim 8, characterized in that, At least one of the distal fixation member and the proximal fixation member adopts a double-layered cannula. The outer cannula of the double-layered cannula is sleeved on the outside of the corresponding end of the implant body. The inner cannula of the double-layered cannula with an inner lumen is embedded in the corresponding first inner hole and / or second inner hole. The space in which the inner lumen of the embedded inner cannula communicates with the hollow region of the waist defines the guidewire lumen.

10. The implantation device according to claim 9, characterized in that, Both the distal fixation member and the proximal fixation member employ the double-layered sleeve. Furthermore, the proximal fixation member and the distal fixation member share an inner sleeve with an inner cavity, such that one of the inner sleeves extends from the first inner hole through the hollow region of the waist and into the second inner hole. The inner cavity of the inner sleeve defines the guide wire cavity.

11. The implantation device according to claim 9 or 10, characterized in that, The outer diameter of the distal fixing member is 0.6mm-3.5mm, the wall thickness of the inner sleeve of the double-layer sleeve is greater than or equal to the wall thickness of the outer sleeve of the double-layer sleeve, the wall thickness of the outer sleeve is greater than 0.05mm, and the inner diameter of the inner sleeve is greater than 0.8mm.

12. The implantation device according to claim 1, characterized in that, The implantation device further includes a covering membrane disposed inside and / or outside the implant body, and the covering membrane has slits for the passage of a guide wire, the slits being openable and closable.

13. The implantation device according to claim 12, characterized in that, An auxiliary structure connected to the membrane is provided around the gap, and the auxiliary structure is used to promote the closure of the gap by utilizing its own restoring force.

14. The implantation device according to claim 13, characterized in that, The auxiliary structure is a coil arranged around the gap. The two ends of the coil along the length of the gap are connected to the film. The portion of the coil between the two ends is closer to the gap than the two ends are in the width direction of the gap.

15. The implantation device according to claim 8, characterized in that, The distal end has a pointed member to configure the implanted device as an expander for puncturing tissue.

16. The implantation device according to claim 8, characterized in that, The outer diameter of the waist when the implant body is in a stretched state is smaller than the outer diameter of the waist when the implant body is in a natural state.

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