Endoluminal implant, suturing method and vascular plug system

By providing an intraluminal implant formed by interlacing multiple strands of braided wire, it solves the problem of requiring a large amount of filler in the existing false lumen embolization technology, and achieves more efficient and convenient false lumen sealing and thrombosis effects. .

CN119302784APending Publication Date: 2025-01-14HANGZHOU WEIQIANG MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202311164953.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-07-14
Filing Date
2023-09-08
Publication Date
2025-01-14

AI Technical Summary

Technical Problem

The existing pseudo-lumen embolization technology requires a large amount of filler, which is inefficient, high cost, and complex in operation, making it difficult to effectively block and treat aortic dissection pseudo-lumen.

Method used

An intraluminal implant is provided, which includes a supporting frame and an intima. The supporting frame is a grid-like structure formed by interweaving multiple braided wires. The intima is fixed on the supporting frame and fixed by sutures to form an undulating wave. The shape is adapted to the shape of the false lumen and implanted into the target cavity through a delivery sheath.

Benefits of technology

Through the use of intraluminal implants, it can be expanded and molded at one time, and less material can be used to seal the false cavity. The cost is lower, the operation is more convenient, the efficiency is higher, and it can adapt to more diverse and complex cavity shapes. , reduce blood flow to the false lumen and enhance thrombosis in the false lumen.

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Abstract

The invention provides an intracavity implant, a suturing method and a blood vessel plug system. The intracavity implant comprises a supporting framework and an inner membrane, the supporting framework is of a tubular structure with an inner cavity, the inner membrane is fixed to the inner cavity of the supporting framework, and the inner membrane is of a tubular structure with an inner cavity; the supporting framework comprises a plurality of supporting sections and connecting sections which are sequentially arranged in a crossed mode in the axial direction, and the outer surface of the supporting framework is in a concave-convex wave shape in the axial direction. The cross section sizes of the near-end supporting part and the far-end supporting part are smaller than those of the other supporting sections; the intracavitary implant provided by the invention can be expanded and formed at one time, and compared with a spring coil embolism technology, the artificial cavity can be blocked by using less materials, so that the cost is relatively low; and in addition, the forming mode is low in requirement for an operator, operation is more convenient and faster, and efficiency is higher.
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Description

[0001] This application is based on the application with CN application number 2023108713275 and application date 2023-7-14, and claims its priority. The disclosed content of the CN application is hereby introduced into this application as a whole. Technical Field

[0002] The present application relates to the technical field of medical devices, and in particular to an intracavitary implant, a suturing method and a vascular plug system. Background Art

[0003] Aortic dissection (AD) is caused by local damage to the aortic intima. High-pressure blood flows into the damaged blood vessel wall, causing the media to tear, splitting the intact aortic wall structure into two, and forming a dissection cavity in the gap between the inner and outer walls of the dissection. To distinguish it from the aortic cavity, the dissection cavity is called the false cavity, and the aortic cavity is called the true cavity. AD has an acute onset, rapid progression, and a very high mortality rate.

[0004] TEVAR (transluminal endovascular repair of aortic dissection) is an intravascular interventional treatment technology. Because of its advantages such as no need for thoracotomy, laparotomy, less trauma, and quick recovery, it has gradually replaced open surgery and become the preferred option for treating AD. The purpose of this technology is to block the primary rupture, reduce the pressure of the false lumen, reshape the true lumen of the aorta, and promote thrombosis of the false lumen. Although the proximal rupture of AD is closed by TEVAR surgery, aortic dissection may still form. This is because the reverse blood flow at the distal rupture causes continuous perfusion of the false lumen, making it impossible for the false lumen to thrombose. A large number of clinical trials have shown that a patent false lumen increases the risk of chronic aortic dilatation and death.

[0005] False lumen embolization technology is one of the treatment options to solve the problem of reverse blood flow from the distal rupture to continuously perfuse the false lumen after TEVAR surgery, and the false lumen cannot be thrombosed and continues to expand. This technology blocks the reverse blood flow of the distal rupture by filling the false lumen with interventional therapy. "The aortic vascular embolization device is released in the aortic vascular area and the blood flow in the false lumen can be seen to be reduced on imaging" is the definition of the success of false lumen embolization technology and the goal of its development. At present, the most widely used technology in clinical practice is direct embolization therapy, that is, filling the false lumen with biological glue and spring coils, etc. The treatment principle is to deliver the spring coil or biological glue to the lesion false lumen through the delivery sheath through interventional therapy, change the local hemodynamic factors, promote thrombosis, and then achieve the closure and treatment of the false lumen. However, the volume of the false lumen is large and the shape is different. Although the spring coil can match the shape of the false lumen, a large number of spring coils are needed to fill the false lumen, which is inefficient, costly, and complicated to operate. Summary of the invention

[0006] In order to solve the problem that a large amount of fillers are required in the current false lumen embolization technology, the present application provides an intracavitary implant, a suturing method and a vascular plug system.

[0007] In some embodiments, the present application provides an intracavitary implant, which includes a support frame, the support frame is a tubular structure with an inner cavity, and the two axial ends of the support frame are set to a closed state, and the support frame is a grid-like structure with multiple meshes formed by interlacing multiple braided wires;

[0008] The inner membrane is fixed to the inner cavity of the supporting frame, and the inner membrane is a tubular structure with an inner cavity;

[0009] The support frame includes a plurality of support segments and connecting segments which are sequentially arranged crosswise along the axial direction, the support segments protrude from the inner cavity of the support frame relative to the connecting segments, and the connecting segments are recessed radially toward the inner cavity of the support frame relative to the support segments, so that the outer surface of the support frame presents an undulating wave shape along the axial direction;

[0010] The support segment located at the proximal end of the intracavitary implant is named as the proximal support portion, and the support segment located at the distal end of the intracavitary implant is named as the distal support portion, and at least one support segment is provided between the proximal support portion and the distal support portion;

[0011] The cross-sectional dimensions of the proximal support portion and the distal support portion are smaller than the cross-sectional dimensions of the other support segments.

[0012] In other embodiments, the present application provides a method for suturing an intracavitary implant, comprising a suture and an intracavitary implant; at least one opening is provided on the inner membrane, and the edge of at least one side of the opening on the inner membrane is alternately penetrated through at least two axially adjacent meshes by a suture around the circumference of a supporting frame to fix the inner membrane to the supporting frame.

[0013] In some further embodiments, the present application provides a vascular plug system, comprising a delivery sheath and an intraluminal implant, wherein the delivery sheath is used to load the intraluminal implant and deliver the intraluminal implant into a target cavity.

[0014] The technical solution of the intracavitary implant described above can achieve cavity occlusion and treatment through at least one intracavitary implant, and the intracavitary implant can adapt to the shape of the false cavity; the intracavitary implant can be expanded and formed at one time, and compared with the spring coil embolization technology, the false cavity can be blocked with less material, and the cost is lower; and its molding method has lower requirements on the operator, and the operation is more convenient and efficient; by designing the size difference of the intracavitary implant at different axial positions, it is helpful to reduce the difference in axial deformation of the intracavitary implant, and it is helpful to make the axial regions of the intracavitary implant fit the intracavitary wall more evenly after axial stretching, thereby helping to improve the ability of the intracavitary implant to adapt to more diverse and complex cavity shapes, and help to better reduce the blood flow from the true cavity to the false cavity, and help to enhance thrombosis in the false cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a schematic structural diagram of an intracavitary implant provided in the first embodiment of the present application;

[0016] Figure 2-1 to Figure 2-5 A schematic diagram of the cross-sectional morphology of the support skeleton is shown;

[0017] Figure 3 is another schematic diagram of the structure of the intracavitary implant;

[0018] Figure 4 is a schematic structural diagram of the outer contour of the intracavitary implant;

[0019] Figure 5 A schematic diagram showing the structure of an intracavitary implant provided with three rows of developing objects;

[0020] Figure 6 A schematic diagram showing another structural method of fixing the inner membrane;

[0021] Figure 7 It is a schematic diagram of the structure of the local densification suture of the intracavitary implant with a convex crescent-shaped cross-sectional shape;

[0022] Figure 8 The schematic diagram of the structure of the local densification suture of the intracavitary implant with a cross-sectional shape of a crescent shape;

[0023] Fig. 9 is a schematic diagram of an exemplary local structure of a circular fixed site;

[0024] Fig.10 for Figure 1 A schematic diagram of the enlarged structure at A in the middle;

[0025] Fig.11 A schematic diagram of the structure of an intracavitary implant provided with functional ribs is shown;

[0026] Fig.12Another schematic diagram of the structure of an intracavitary implant provided with functional ribs is shown;

[0027] Fig.13 Another structural schematic diagram showing an intracavitary implant provided with functional ribs;

[0028] Fig.14 The schematic diagram of the suture trajectory of the first segment is completed;

[0029] Fig.15 Complete the schematic diagram for the suture trajectory of the first segment and the second segment;

[0030] Fig.16 Complete schematic diagrams for the suture trajectories of the first segment, the second segment, and the third segment;

[0031] Fig.17 A schematic diagram of a possible application scenario of an intracavitary implant provided in the third embodiment of the present application;

[0032] Fig.18 A schematic diagram of possible application scenarios of a vascular plug system provided in the fourth embodiment of the present application.

[0033] Figure numerals: 1, intracavitary implant; 10, supporting skeleton; 101, first mesh ring; 102, second mesh ring; 103, third mesh ring; 104, first entry mesh hole; 105, first exit mesh hole; 106, second entry mesh hole; 107, second exit mesh hole; 11, supporting section; 12, connecting section; 121, first connecting part; 122, transition part; 123, second connecting part; 13, proximal supporting part; 14, distal supporting part; 15, proximal mesh cover; 151, Raised portion; 152, recessed portion; 16, distal mesh cover; 17, first area; 18, second area; 19, connection; 20, inner membrane; 21, first membrane portion; 22, second membrane portion; 23, opening; 24, first segment; 25, second segment; 26, third segment; 30, proximal connector; 40, distal connector; 50, development mark; 60, fixation site; 70, suture; 2, delivery sheath; 3, true cavity; 4, false cavity; 5, rupture; 6, functional ribs. DETAILED DESCRIPTION

[0034] The following embodiments of the present application are described in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0035] In the description of the embodiments of the present application, it should be noted that the term "integrated molding" means that in the process of forming one of the multiple components, the component is connected to other components, and there is no need to connect the two components together through further processing (such as bonding, welding, snap connection, screw connection). The terms in the specification and claims of this application and the above-mentioned drawings are only for describing specific embodiments and are not intended to limit this application.

[0036] The end of the implant close to the operator is defined as the proximal end, and the end away from the operator is defined as the distal end; the highest point of the implant protruding toward the outside of the implant is defined as the crest, and the lowest point recessed toward the inside of the implant is defined as the trough; "axial" refers to the direction parallel to the axis of the implant, and "radial" refers to the direction perpendicular to the axis of the implant; "cross-section" refers to the radial section of the implant, and "axial section" refers to the axial section of the implant; "oversize" refers to the ratio of the reduced diameter of the implant after it is released in the target cavity to the diameter in the natural state.

[0037] like Figure 1 As shown, Figure 1 1 is a schematic diagram of the structure of the intracavitary implant 1 provided in the first embodiment of the present application. The intracavitary implant 1 provided in the present application is implanted into the target cavity through a delivery sheath to block the target cavity. The target cavity includes but is not limited to the false lumen of aortic dissection, and also refers to lesions that need to be blocked, such as hemangiomas and blood vessels.

[0038] In some embodiments, the intracavitary implant 1 is oversized in design, and its interference is 10-40%.

[0039] The intracavitary implant 1 includes a support frame 10 and an inner membrane 20, wherein the inner membrane 20 is fixed to the support frame 10. For example, the inner membrane 20 is fixed to the support frame 10 by suturing with sutures 70. The inner membrane 20 is located in the inner cavity of the support frame 10.

[0040] The support frame 10 is a tubular structure with an inner cavity. The support frame 10 can stretch and shrink radially to improve the fit between the intracavitary implant 1 and the interior of the cavity and protect the fragile outer wall of the false cavity, thereby better adapting to the complex cavity morphology.

[0041] The cross-sectional shape of the support frame 10 is a crescent shape, a lower dark crescent shape, a convex crescent shape, a dark crescent shape or a full moon shape, such as Figure 2-1 to Figure 2-5 As shown, Figure 2-1 The cross-sectional shape of the support frame 10 is crescent-shaped. Figure 2-2 The cross-sectional shape of the support frame 10 is shown to be a lower crescent shape. Figure 2-3 The cross-sectional shape of the support frame 10 is shown to be a convex crescent shape. Figure 2-4 The cross-sectional shape of the support frame 10 is shown to be a crescent shape. Figure 2-5 The cross-sectional shape of the supporting skeleton 10 is shown to be a full moon shape.

[0042] The cross-sectional shapes of the crescent type, the lower crescent type, the convex crescent type and the crescent type all include a long diameter D1 and a short diameter D2. The short diameter D2 of the crescent type, the lower crescent type, the convex crescent type and the crescent type increases in sequence. The diameter (D1 / D2) of the full moon type is greater than the short diameter D2 of the convex crescent type and the crescent type.

[0043] In some embodiments, the major diameters D1 of the crescent-shaped, convex-shaped, semi-lunar-shaped, or full-moon-shaped shapes may be the same or different.

[0044] In some embodiments, the cross section of the support frame 10 includes a long diameter D1 and a short diameter D2. For easy distinction, along the axial direction of the support frame 10, the long diameter D1 can divide the cross section of the support frame 10 into a first region 17 with a larger cross section and a second region 18 with a smaller cross section. The curvature of the first region 17 is larger than that of the second region 18. In other words, the curvature of the outer surface of the region of the support frame 10 where the first region 17 is located is larger, and the curvature of the outer surface of the region of the support frame 10 where the second region 18 is located is smaller, and appears flatter than the first region 17.

[0045] In some embodiments, for a crescent-shaped cross-section of the support frame 10, the second region 18 is recessed toward the inner cavity of the intracavitary implant 1. For a lower crescent-shaped cross-section of the support frame 10, the outer surface of the second region 18 is substantially flat. For a crescent-shaped or full-moon-shaped cross-section of the support frame 10, the second region 18 is convex away from the inner cavity of the intracavitary implant 1.

[0046] The various forms of the intracavitary implant 1 can better adapt to the complex and diverse anatomical structures of the cavity, and are conducive to improving the adhesion of the intracavitary implant 1 to the wall of the cavity.

[0047] Please continue reading Figure 1 The support frame 10 may be a grid structure with multiple meshes formed by interlacing multiple strands of braided wires. The support frame 10 with a grid structure and the inner membrane 20 can reduce the blood flow in the cavity (eg, false lumen).

[0048] The intracavitary implant 1 is a mesh braided wire stent as a whole, which provides good flexibility. At the same time, the lower radial support force of the braided wire is more suitable for soft false lumens. The axial shortening characteristic of the mesh braided wire stent allows the intracavitary implant 1 to adapt to the complex axial shape of the false lumen, which helps to avoid further expansion of the outer wall of the false lumen.

[0049] In one or more embodiments, the diameter of the braided wire is 20-90 inches, which is beneficial for improving the flexibility of the support skeleton 10 while maintaining good radial support force, and is beneficial for better application in soft false lumens.

[0050] The support frame 10 includes a plurality of support segments 11 and connecting segments 12 which are arranged crosswise in sequence along the axial direction. The cross-sectional dimensions of the support segments 11 are larger than the cross-sectional dimensions of the connecting segments 12, so that the outer surface of the support frame 10 presents an undulating and staggered shape along the axial direction. In other words, the support segments 11 protrude from the inner cavity of the support frame 10 relative to the connecting segments 12, and the connecting segments 12 are recessed radially toward the inner cavity of the support frame 10 relative to the support segments 11, which is conducive to the intracavitary implant 1 being implanted into the target cavity without tearing or damaging the blood vessel wall as the blood vessel pulsates.

[0051] The depth of the depression of the connecting segment 12 compared to the supporting segment 11 can be 1-5 mm. By controlling the excessive depression of the connecting segment 12, it is helpful to reduce the influence of the connecting segment 12 on the structural stability and radial supporting force of the supporting segment 11, which is helpful for the intracavitary implant 1 to better maintain the predetermined shape, thereby adapting to more complex and curved cavity shapes. The proximal and distal ends of the intracavitary implant 1 are used for anchoring in the target cavity, and the middle part is designed with a structure of a crest (supporting segment 11) and a trough (connecting segment 12), which, combined with the characteristics of the braided wire, provides good compliance for the intracavitary implant 1.

[0052] The axial length of the support segment 11 is greater than the axial length of the connecting segment 12. The axial length of the support segment 11 is at least 2-6 times the axial length of the connecting segment 12. The design of a larger axial length of the support segment 11 is conducive to increasing the contact area between the support skeleton 10 and the cavity, increasing the anchoring ability of the intracavitary implant 1, and helping to reduce the risk of displacement of the intracavitary implant 1 under the action of force.

[0053] In one or more embodiments, the outer surface of the support segment 11 is non-arc-shaped. In other words, the outer surface of the support segment 11 is a plane parallel to the central axis M of the intracavitary implant 1, which is beneficial to further increase the contact area between the support skeleton 10 and the cavity.

[0054] In one or more embodiments, the outer surface of the supporting segment 11 is arc-shaped.

[0055] The mesh density of the supporting segment 11 is smaller than that of the connecting segment 12, that is, the mesh size of the connecting segment 12 is smaller, so that the connecting segment 12 has a larger stretching and / or shortening size, which is beneficial to increase the flexibility of the intracavitary implant 1 and help the intracavitary implant 1 better conform to the complex morphology of the cavity.

[0056] Along the axial direction of the supporting skeleton 10, the connecting section 12 includes a first connecting portion 121, a transition portion 122 and a second connecting portion 123, wherein the transition portion 122 is closer to the central axis M of the intracavitary implant 1 than the first connecting portion 121 and the second connecting portion 123. The first connecting portion 121 is closer to the distal end of the intracavitary implant 1 than the second connecting portion 123. The first connecting portion 121 is used to connect to the supporting segment 11 on the distal side of the connecting segment 12, and the second connecting portion 123 is used to connect to the supporting segment 11 on the proximal side of the connecting segment 12. In one or more embodiments, the first connecting portion 121 and the second connecting portion 123 are inclined so that the connecting section 12 can be roughly V-shaped or U-shaped. In some embodiments, the transition portion 122 is arc-shaped. It can be understood that the connecting section 12 can also be other shapes, such as square or W-shaped.

[0057] The mesh density of the first connection portion 121 and the second connection portion 123 can be smaller than the mesh density of the transition portion 122, which is beneficial to further improve the flexibility of the support frame 10 and better adapt to the complex anatomical morphology of the cavity. At the same time, more buffering is given to the fluid (such as blood) in the cavity, which is beneficial to the deposition of the fluid (such as blood) in the connection section 12, thereby promoting thrombosis in the false cavity, for example.

[0058] For the sake of distinction, the support segment 11 at the proximal end of the intracavitary implant 1 is named as the proximal support portion 13, and the support segment 11 at the distal end of the intracavitary implant 1 is named as the distal support portion 14. At least one support segment 11 is provided between the proximal support portion 13 and the distal support portion 14.

[0059] In one or more embodiments, Figure 3 As shown, Figure 3 2 is another structural schematic diagram of the intracavitary implant 1 provided by the present application (the inner membrane 20 is omitted). The cross-sectional dimensions of the proximal support portion 13 and the distal support portion 14 are smaller than the cross-sectional dimensions of the other support segments 11 .

[0060] In some embodiments, the cross-section of the intracavitary implant 1 includes a long diameter D1 and a short diameter D2, and the long diameter D1 and the short diameter D2 of the proximal support portion 13 and the distal support portion 14 are both smaller than the long diameter D1 and the short diameter D2 of the other support segments 11, that is, the long diameter D1 of the proximal support portion 13 and the distal support portion 14 is smaller than the long diameter D1 of the other support segments 11, and the short diameter D2 of the proximal support portion 13 and the distal support portion 14 is smaller than the short diameter D2 of the other support segments 11.

[0061] In some embodiments, the cross-section of the intracavitary implant 1 is circular, and the diameters (D1 / D2) of the proximal support portion 13 and the distal support portion 14 may be smaller than the diameters (D1 / D2) of the other support segments 11.

[0062] During the axial stretching of the intracavitary implant 1, the support segment 11 between the proximal support portion 13 and the distal support portion 14 may be concave, that is, the deformation degree of different axial regions of the intracavitary implant 1 is different, and the deformation of the support segment 11 located in the middle is relatively large. The support segment 11 located in the middle is concave compared with the proximal support portion 13 and the distal support portion 14, resulting in uneven wall adhesion at various axial positions of the intracavitary implant 1. By reducing the cross-sectional dimensions of the proximal support portion 13 and the distal support portion 14, the cross-sectional dimensions of the support segment 11 located in the middle are relatively large, which is conducive to reducing the difference in axial deformation of the intracavitary implant 1, and is conducive to making the axial regions of the intracavitary implant 1 more evenly adhere to the intracavitary wall after axial stretching, thereby helping to improve the ability of the intracavitary implant 1 to adapt to more diverse and complex cavity morphologies, and is conducive to better reducing the flow of blood from the true cavity to the false cavity, and is conducive to enhancing thrombosis in the false cavity.

[0063] In some embodiments, the cross-sectional dimensions of the inner membrane 20 located at the proximal support portion 13 and the distal support portion 14 are smaller than the cross-sectional dimensions of the inner membrane 20 located at other support segments 11 .

[0064] In some embodiments, the cross-sectional dimensions of the proximal support portion 13 and the distal support portion 14 are 1-3 mm smaller than the cross-sectional dimensions of other support segments 11, with an error of 1%-10% allowed.

[0065] For example, the cross section of the intracavitary implant 1 includes a long diameter D1 and a short diameter D2, and the long diameter D1 and the short diameter D2 of the proximal support portion 13 and the distal support portion 14 are both about 1-3 mm smaller than the long diameter D1 and the short diameter D2 of the other support segments 11.

[0066] For example, if the cross section of the intracavitary implant 1 is circular, the diameters (D1 / D2) of the proximal support portion 13 and the distal support portion 14 are both about 1-3 mm smaller than the diameters (D1 / D2) of the other support segments 11.

[0067] In one or more embodiments, please continue to refer to Figure 1 The intracavitary implant 1 further comprises a proximal connecting member 30 and a distal connecting member 40. The proximal end surface of the support frame 10 is fixed to the proximal connecting member 30. The distal end surface of the support frame 10 is fixed to the distal connecting member 40.

[0068] In some embodiments, the central axis M of the proximal end of the support frame 10 is fixed to the proximal end connector 30 , and the central axis M of the distal end of the support frame 10 is fixed to the distal end connector 40 .

[0069] The support frame 10 further includes a proximal mesh cover 15 and a distal mesh cover 16. The proximal mesh cover 15 is the proximal end surface of the support frame 10, and the distal mesh cover 16 is the distal end surface of the support frame 10. The proximal mesh cover 15 is fixed to the proximal side of the proximal support part 13, and the distal mesh cover 16 is fixed to the distal side of the distal support part 14.

[0070] In some embodiments, the proximal mesh cover 15 and the distal mesh cover 16 both include a raised portion 151 and a recessed portion 152, wherein the raised portion 151 is raised in a direction away from the connecting section 12, and the recessed portion 152 is recessed in a direction close to the connecting section 12. The recessed portion 152 is arranged around the central axis M of the intracavitary implant 1, and the raised portion 151 is arranged around the periphery of the recessed portion 152, so that the two end surfaces of the support frame 10 in the axial direction have a better flow-guiding effect. In some embodiments, the raised curvature of the raised portion 151 is an arc, and the recessed curvature of the recessed portion 152 is an arc.

[0071] The end surface arrangement of the proximal mesh cover 15 and the distal mesh cover 16 is conducive to reducing the length and area of ​​the axial non-adherent part of the intracavitary implant 1. After the intracavitary implant 1 is implanted into the target cavity, the protrusion 151 of the proximal mesh cover 15 located at the proximal end can better conform to the flow direction of the fluid (such as blood), reduce the impact force of the fluid on the intracavitary implant 1, and reduce the impact force of the fluid on the inner membrane 20, thereby improving the stability of the intracavitary implant 1. After the intracavitary implant 1 is implanted into the target cavity, the distal mesh cover 16 located at the distal end is conducive to reducing the blood backflow in the false cavity, which is conducive to blood thrombosis in the false cavity.

[0072] In some embodiments, the recessed portion 152 of the proximal mesh cover 15 is disposed around the central axis M of the proximal connector 30 , and the raised portion 151 of the proximal mesh cover 15 is disposed around the outer periphery of the recessed portion 152 .

[0073] In some embodiments, the recessed portion 152 of the distal mesh cover 16 is disposed around the central axis M of the proximal connector 30 , and the raised portion 151 of the distal mesh cover 16 is disposed around the outer periphery of the recessed portion 152 .

[0074] In some embodiments, along the radial direction of the support frame 10, the mesh density on the proximal mesh cover 15 and / or the distal mesh cover 16 gradually increases toward the direction close to the central axis M of the support frame 10. Along the radial direction of the support frame 10, the mesh density on the proximal mesh cover 15 and / or the distal mesh cover 16 gradually decreases toward the direction close to the central axis M of the support frame 10. The different settings of the meshes on the proximal mesh cover 15 and / or the distal mesh cover 16 are conducive to better disturbing the fluid and promoting thrombosis in the false lumen.

[0075] In some embodiments, the proximal connector 30 is used to connect to the delivery sheath, such as by threaded connection, so as to implant the intracavitary implant 1 into the target cavity.

[0076] like Figure 4 As shown, Figure 4 It is a structural schematic diagram of the outer contour of the intracavitary implant 1. The intracavitary implant 1 also includes a plurality of developing marks 50. Taking the case where there are at least three developing marks 50 as an example, two developing marks 50 are fixed to the distal end of the supporting skeleton 10, and the two developing marks 50 on the distal end of the supporting skeleton 10 are located at both ends of the long diameter D1 / diameter direction of the supporting skeleton 10. There is also a developing mark 50 fixed on the side of the supporting skeleton 10 and located at the center line L of the surface where it is located. The center line L is parallel to the central axis M of the intracavitary implant 1. The setting position of at least three developing marks 50 is conducive to improving the release accuracy of the intracavitary implant 1.

[0077] In some embodiments, at least three development marks 50 are located on the outer surface where the second region 18 is located, wherein two development marks 50 are fixed to the distal end of the support frame 10, and the two development marks 50 on the distal end of the support frame 10 are located at both ends of the long diameter D1 direction of the support frame 10. Another development mark 50 is fixed to the position of the center line L of the outer surface where the second region 18 is located, and the center line L of the outer surface where the second region 18 is located is parallel to the central axis M of the intracavitary implant 1. The development mark 50 is located at one-third of the position close to the distal end in the axial direction of the intracavitary implant 1, which is convenient for judging whether the release position of the distal end of the intracavitary implant 1 that first emerges from the delivery sheath is at the target position. If it is not at the target position, the intracavitary implant 1 can be promptly recovered into the delivery sheath to readjust the release position.

[0078] The arrangement of at least three development marks 50 is beneficial to improving the release accuracy of the intracavitary implant 1 .

[0079] In some embodiments, the support frame 10 at the location where the development mark 50 is located may also have the development material.

[0080] In some embodiments, the remaining positions of the support frame 10 are provided with corresponding development marks 50 according to actual needs. For example, at least two development marks 50 are provided at the proximal end of the support frame 10, the two development marks 50 are located at both ends of the long diameter D1 direction of the support frame 10, and the two development marks 50 are located on the outer surface where the second area 18 is located.

[0081] like Figure 5 As shown, Figure 5The schematic diagram of the structure of the intracavitary implant 1 with three rows of imaging materials is shown (the inner membrane 20 is omitted). In one or more embodiments, the outer surface where the second area 18 is located is provided with at least three rows of imaging materials, and each row of imaging materials is provided with at least two imaging marks 50. At least two rows of imaging materials are respectively located at the proximal support portion 13 and the distal support portion 14, and at least one row of imaging materials is located at the axial middle of the support section 11 in the axial middle of the intracavitary implant 1. At least two imaging marks 50 on each row of imaging materials are respectively located at both ends of the direction of the long diameter D1 of the support skeleton 10. This arrangement of imaging materials forms a positioning surface on the surface where the second area 18 is located, so as to better judge the release needs of different positions of the intracavitary implant 1, for example, the outer surface of the positioning surface is more adherent to the wall, so as to facilitate the positioning surface to be attached to the side of the false cavity close to the true cavity, improve the sealing of the intracavitary implant, and reduce the damage to the fragile inner wall of the false cavity, while the surface where the first area 17 is located is more conducive to adapting to the tortuous shapes of various shapes of the false cavity.

[0082] In some embodiments, at least three rows of imaging objects, each row of imaging objects having at least two imaging marks 50 , form at least two columns of imaging objects, and a connecting line of at least three imaging marks 50 in each column of imaging objects is substantially parallel to the central axis M of the intracavitary implant 1 .

[0083] In some embodiments, for at least two developing marks 50 on each row, the distance d between the developing mark 50 and the end of the corresponding supporting skeleton 10 in the direction of the major axis D1 is the circumferential length of one mesh or less than the circumferential length of one mesh, so as to better judge the positions of different surfaces of the intracavitary implant 1 and different positions of the same surface, thereby improving the overall release accuracy of the intracavitary implant 1.

[0084] The provision of the inner membrane 20 is beneficial to further promote thrombosis in the false lumen.

[0085] Please continue reading Figure 1 The inner membrane 20 is a tubular structure with an inner cavity. The inner membrane 20 is fixed to the support frame 10, and the inner membrane 20 is located in the inner cavity of the support frame 10. The inner membrane 20 is a tubular structure with closed ends at both ends in the axial direction.

[0086] The cross-sectional shape of the inner membrane 20 is roughly the same as the cross-sectional shape of the support frame 10. The cross-sectional shape of the inner membrane 20 can also be a crescent shape, a convex crescent shape, a dark crescent shape, or a full moon shape.

[0087] In some embodiments, the inner membrane 20 includes a plurality of first membrane portions 21 and at least one second membrane portion 22. The first membrane portion 21 and the second membrane portion 22 are arranged crosswise in sequence along the axial direction. The cross-sectional dimension of the first membrane portion 21 is larger than the cross-sectional dimension of the second membrane portion 22, so that the outer surface of the inner membrane 20 presents an undulating wave shape along the axial direction. In other words, the first membrane portion 21 protrudes from the inner cavity of the inner membrane 20 relative to the second membrane portion 22, and the second membrane portion 22 is recessed radially toward the inner cavity of the inner membrane 20 relative to the first membrane portion 21. The inner membrane 20 is set to a concave-convex shape, which is conducive to giving the fluid more buffering, facilitating the deposition of the fluid on the inner membrane 20, and promoting thrombosis of the false cavity.

[0088] In some embodiments, the inner membrane 20 is fixed to the support frame 10 at different positions to form an undulating wave shape.

[0089] The axial lengths of different first membrane portions 21 may be the same or different. The axial lengths of different second membrane portions 22 may be the same or different. The axial length of the first membrane portion 21 and the axial length of the second membrane portion 22 may be the same or different.

[0090] The position where the inner membrane 20 is fixed to the support frame 10 is named as the fixing site 60, and the fixing site 60 may be annular, and the annular fixing site 60 is arranged around the circumference of the support frame 10. The fixing site 60 may be non-annular, for example, at least one arc segment or a plurality of fixing points.

[0091] At least one annular fixing site 60 for fixing the inner membrane 20 is provided on the supporting segment 11 .

[0092] It can be understood that the annular fixing site 60 can be a continuous annular structure or a discontinuous annular structure.

[0093] In some embodiments, the two axial ends of the support segment 11 serve as annular fixing sites 60 of the inner membrane 20 .

[0094] Or the middle part of the support segment 11 in the axial direction serves as the annular fixing site 60 of the inner membrane 20, such as Figure 6 As shown, Figure 6 A schematic structural diagram of another fixing method of the inner membrane 20 is shown.

[0095] In some embodiments, Figure 6 As shown, the connecting segment 12 has an annular fixing site 60 fixed to the inner membrane 20. Of course, the annular fixing site 60 on the connecting segment 12 can also be omitted.

[0096] In some embodiments, the axial ends of the inner membrane 20 are fixed to the proximal connector 30 and the distal connector 40 respectively.

[0097] In some embodiments, the inner membrane 20 is sutured and fixed to the supporting frame 10 by sutures 70 .

[0098] like Figure 7-Figure 9 As shown, Figure 7 The schematic diagram of the structure of the local densification suture of the intracavitary implant with a convex crescent cross-sectional shape is shown. Figure 8 The schematic diagram of the structure of the intracavitary implant with a partial densification suture having a crescent-shaped cross-sectional shape is shown. Fig. 9 FIG. 4 is a schematic diagram of an exemplary local structure of the annular fixing site 60 .

[0099] In some embodiments, the junction 19 of the first region 17 and the second region 18 is set in an arc, and the number of suture needles at the junction 19 of the first region 17 and the second region 18 is greater than the number of suture needles in other regions of the intracavitary implant 1. The junction 19 of the first region 17 and the second region 18 is cross-threaded through each mesh adjacent to the circumference by sutures 70 to increase the number of suture needles. The outer surface of the first region 17 and the second region 18 can be sutured across multiple meshes to reduce the number of suture needles. It can be understood that the outer surface of the first region 17 and the second region 18 can be sutured through each mesh in the circumference to increase the number of suture needles.

[0100] In some embodiments, please refer to Figure 1 The outer surface of the inner membrane 20 presents an undulating wave shape along the axial direction, and the depression depth of the second membrane portion 22 on the inner membrane 20 is 2-5mm. The depression depth of the second membrane portion 22 of the inner membrane 20 is greater than the depression depth of the connecting section 12 of the support frame 10. The difference in the concave and convex design of the inner membrane 20 and the support frame 10 is conducive to giving more buffering to the fluid, which is conducive to the deposition of the fluid on the inner membrane 20 and promoting the thrombosis of the false lumen.

[0101] In some embodiments, at least one second membrane portion 22 is correspondingly provided on the side of the connecting section 12 of the supporting skeleton 10 close to the central axis M, and the recessed depth of the second membrane portion 22 located on the side of the connecting section 12 close to the central axis M is greater than the recessed depth of the connecting section 12 of the supporting skeleton 10.

[0102] In some embodiments, at least one second membrane portion 22 is correspondingly provided on one side of the support segment 11 of the support skeleton 10 close to the central axis M, and the depression depth of the second membrane portion 22 located on the side of the support segment 11 close to the central axis M is less than the depression depth of the second membrane portion 22 located on the side of the connecting segment 12 close to the central axis M. Alternatively, the depression depth of the second membrane portion 22 on the inner membrane 20 may be the same as the depression depth of the connecting segment 12 on the support skeleton 10. Alternatively, at least one connecting segment 12 may have the same depression depth as at least one second membrane portion 22. Alternatively, a part of the same connecting segment 12 and the second membrane portion 22 may have the same depression depth, while another part of the same connecting segment 12 and the second membrane portion 22 may have different depression depths.

[0103] It is understood that the number of the second membrane parts 22 of the inner membrane 20 can be the same as or different from the number of the connecting sections 12 of the support frame 10. Alternatively, the inner membrane 20 is not limited to the periodic cross arrangement of the first membrane parts 21 and the second membrane parts 22 along the axial direction of the support frame 10.

[0104] The first membrane portion 21 and the second membrane portion 22 may be regularly or irregularly arranged on the periphery of the inner membrane 20. The first membrane portion 21 and the second membrane portion 22 may be a raised circular block and a recessed circular block, respectively, or may be a flat circular block and a raised / or recessed circular block, respectively, or the shape is not limited to a circle, and the inner membrane 20 having an uneven surface may also be within the protection scope of the present application.

[0105] In one or more embodiments, please refer to Fig.10 , Fig.10 for Figure 1 The enlarged structural diagram of the A in the middle. The inner membrane 20 is provided with at least one opening 23, which is helpful to reduce the risk of gas in the fluid entering the inner cavity of the inner membrane 20 to form a gas embolism.

[0106] At least one opening 23 is an annular structure disposed circumferentially around the inner membrane 20 , and the opening 23 divides the inner membrane 20 into at least two separate membrane sections along the axial direction.

[0107] At least two openings 23 are annular structures arranged around the circumference of the inner membrane 20, so as to divide the inner membrane 20 into at least three membrane sections along the axial direction, so that the inner membrane 20 forms a split multi-section inner membrane 20.

[0108] “At least one opening 23 is an annular structure circumferentially arranged around the inner membrane 20” or “at least two openings 23 are annular structures circumferentially arranged around the inner membrane 20” can be understood that openings 23 of other shapes can be provided at other positions of the inner membrane 20 and can be located at local positions of the inner membrane 20.

[0109] In some embodiments, corresponding annular fixing sites 60 are provided on the support frame 10 to fix both ends of each membrane segment to the support frame 10 .

[0110] In some embodiments, two ends of each membrane section are sutured and fixed to the support frame 10 by different suture lines 70 .

[0111] In some embodiments, at least one mesh is spaced between each axially adjacent membrane segment.

[0112] In some embodiments, each axially adjacent membrane segment is cross-stitched and fixed to the support frame 10 by the same suture line 70, but the gap openings 23 between each adjacent membrane segment can still be retained.

[0113] For the sake of distinction, the three membrane-like objects are named as the first segment 24, the second segment 25 and the third segment 26, which are arranged in sequence along the axial direction of the inner membrane 20. The first segment 24 is located at the distal end of the support frame 10, and the third segment 26 is located at the proximal end of the support frame 10.

[0114] In some embodiments, the axial length of the second segment 25 is greater than the axial lengths of the first segment 24 and the third segment 26. The first segment 24 is fixed to the distal mesh cover 16 of the support frame 10, and the third segment 26 is fixed to the proximal mesh cover 15 of the support frame 10. The arrangement positions of the first segment 24 and the third segment 26 are conducive to blocking the reverse blood flow from perfusing the false lumen, and are conducive to playing the role of immediately blocking the reverse blood flow, thereby promoting the thrombosis of the false lumen.

[0115] In one or more embodiments, Fig.11 As shown, Fig.11 The schematic diagram of the structure of the intracavitary implant 1 provided with the functional ribs 6 is shown (the inner membrane 20 is omitted). At least one functional rib 6 is fixed on the support frame 10, and the length direction of the functional rib 6 is arranged along the central axis M of the intracavitary implant 1. The functional rib 6 is used to increase the radial support force of the intracavitary implant 1, and is conducive to reducing the axial shortening of the intracavitary implant 1, which is conducive to reducing the displacement of the intracavitary implant 1.

[0116] In some embodiments, the functional ribs 6 are located on the first region 17 or the second region 18 .

[0117] In some embodiments, the functional rib 6 may be a rod-shaped structure additionally fixed to the intracavitary implant 1 , or may be a wire diameter of at least one braided wire in the intracavitary implant 1 that is larger than the wire diameters of other braided wires.

[0118] In one or more embodiments, Fig.12 As shown, Fig.12Another schematic diagram of the structure of the intracavitary implant 1 with functional ribs 6 is shown (the inner membrane 20 is omitted). The length direction of the functional ribs 6 is arranged at an angle along the central axis M of the intracavitary implant 1, that is, the length direction of the functional ribs 6 is inclined on the intracavitary implant 1.

[0119] In at least one embodiment, Fig.13 As shown, Fig.13 Another structural schematic diagram of an intracavitary implant 1 with functional ribs 6 is shown (the inner membrane 20 is omitted). At least one functional rib 6 is disposed around the intracavitary implant 1; in some embodiments, at least one functional rib 6 is disposed around the support segment 11 between the proximal support portion 13 and the distal support portion 14, which is beneficial to improve the radial support force of the middle support segment 11, improve the wall adhesion effect of the intracavitary implant 1, and better play the anti-reflux effect.

[0120] In at least one embodiment, the functional ribs 6 are spirally wound around the peripheral wall of the intracavitary implant 1 to form a multi-circle ring.

[0121] In one or more embodiments, the axial length of the functional rib 6 is the axial length of at least one supporting segment 11 .

[0122] In one or more embodiments, the axial length of the functional rib 6 is at least 1 / 3 of the axial length of the supporting skeleton 10 .

[0123] The second embodiment of the present application provides a method for suturing an intracavitary implant 1 .

[0124] The inner membrane 20 is sutured and fixed to the support frame 10 by sutures 70. For example, the inner membrane 20 has three sections of membrane along the axial direction, and the three sections of membrane from the distal end to the proximal end of the intracavitary implant 1 are respectively the first section 24, the second section 25 and the third section 26.

[0125] like Figure 14-16 As shown ( Figure 14-15 The protrusion, the recess 152, the proximal connection member 30, the distal connection member 40 and part of the inner membrane 20 are hidden. Fig.16 Hiding the protrusion, the recess 152, the proximal connecting member 30 and the distal connecting member 40, Figure 14-16 In order to clearly see the suture line 70, the two ends of the suture line 70 are still retained for example, and the end of the first segment 24 close to the second segment 25 is passed through the suture line 70 around the circumference of the support frame 10 and alternately penetrated through at least two axially adjacent meshes to fix the first segment 24 on the support frame 10.

[0126] One end of the second segment 25 close to the first segment 24 is alternately penetrated through at least two axially adjacent meshes around the circumference of the support frame 10 by means of sutures 70 , so as to fix the second segment 25 on the support frame 10 .

[0127] One end of the second segment 25 close to the third segment 26 is alternately penetrated through at least two axially adjacent meshes around the circumference of the support frame 10 by means of sutures 70 , so as to further reinforce and fix the second segment 25 on the support frame 10 .

[0128] One end of the third segment 26 close to the second segment 25 is alternately penetrated through at least two axially adjacent meshes around the circumference of the support frame 10 by means of sutures 70 , so as to fix the third segment 26 on the support frame 10 .

[0129] The following is an example of the specific suturing steps of the first segment 24, please refer to Fig.14 :

[0130] A combination of multiple meshes located on the same horizontal line W in the circumferential direction is defined as a mesh ring, and the horizontal line is perpendicular to the central axis M and the center line L. Three rows of mesh rings adjacent in the axial direction are named as the first mesh ring 101, the second mesh ring 102 and the third mesh ring 103, respectively, and the first mesh ring 101, the second mesh ring 102 and the third mesh ring 103 are arranged in sequence from the distal end to the proximal end of the intracavitary implant 1.

[0131] Step 1: Place the proximal end of the first segment 24 on the horizontal line W on the circumference of the second mesh ring 102, so that the proximal end of the first segment 24 is flush with the horizontal line W on the circumference of the second mesh ring 102;

[0132] Step 2: The head end of the suture thread 70 is passed from the outside of one mesh hole (named as the first entry mesh hole 104) of the third mesh ring 103 to the inside of the first entry mesh hole 104, and then the head end crosses the second mesh ring 102 and passes through the membrane layer of the first segment 24 from one mesh hole (named as the first exit mesh hole 105) of the first mesh ring 101 and passes out to the outside of the first exit mesh hole 105;

[0133] Step 3: Following step 2, the head end crosses the second mesh ring 102 and penetrates from the outside of another mesh hole (named as the second penetration mesh hole 106) of the third mesh ring 103 to the inside of the second penetration mesh hole 106, and then the head end crosses the second mesh ring 102 and penetrates from another mesh hole (named as the second penetration mesh hole 107) of the first mesh ring 101 through the membrane layer of the first segment 24 and passes out to the outside of the second penetration mesh hole 107;

[0134] The first entry mesh hole 104 and the second entry mesh hole 106 may be disposed adjacent to each other along the circumference of the third mesh ring 103, and the first exit mesh hole 105 and the second exit mesh hole 107 may be disposed adjacent to each other along the circumference of the first mesh ring 101;

[0135] Step 4: Repeat steps 2 and 3, and the head end of the suture 70 is tied to the braided wire of the first mesh hole 104 after wrapping around the support frame 10. The end of the suture 70 can be tied to the braided wire of the mesh hole where the head end of the suture 70 is located.

[0136] In some embodiments, along the circumference of the third mesh ring 103 , at least one mesh is spaced between the first penetration mesh hole 104 and the second penetration mesh hole 106 .

[0137] In some embodiments, along the circumference of the first mesh ring 101 , at least one mesh is spaced between the first mesh hole 105 and the second mesh hole 107 .

[0138] In some embodiments, along the axial direction of the intracavitary implant 1 , a plurality of second mesh rings 102 are spaced between the first mesh ring 101 and the third mesh ring 103 .

[0139] In some implementations, the meshes on the first mesh ring 101 are used as exit holes, and the meshes on the third mesh ring 103 are used as entry holes, which is not limited here.

[0140] The two ends of the second segment 25 in the axial direction are fixed to the support frame 10 by the same suturing method as the first segment 24. Fig.15 .

[0141] The end of the third segment 26 close to the second segment 25 is fixed to the support frame 10 by the same sewing method as the first segment 24. Fig.16 .

[0142] In some embodiments, the suture fixation method for the remaining positions of the inner membrane 20 is to alternately penetrate meshes along the circumference of the same mesh ring to form an annular fixation site 60. The number of meshes between two adjacent penetration meshes and penetration meshes in the circumferential direction can be one, two, three or more.

[0143] In some embodiments, each axially adjacent membrane segment is also cross-stitched and fixed to the support frame 10 by the same suture line 70, but the gap openings 23 between each adjacent membrane segment can still be retained.

[0144] Please refer to Fig.17 The third embodiment of the present application provides an exemplary application scenario of an intracavitary implant 1, taking the blocking of the false lumen 4 of aortic dissection that continues to expand under the influence of reverse blood flow after TEVAR surgery as an example. The intracavitary implant 1 enters the false lumen 4 of the aorta from the rupture 5 at the distal end of the true lumen 3 through a delivery sheath and is released into the false lumen 4 of the aorta. The proximal end of the intracavitary implant 1 can be located at the distal end of the false lumen 4, and the distal end of the intracavitary implant can be located at the proximal end of the false lumen 4. The state of the intracavitary implant 1 after being released in the false lumen 4 is as follows: Fig.17 shown.

[0145] The fourth embodiment of the present application provides a vascular plug system, such as Fig.18 As shown, it includes a delivery sheath 2 and an intracavitary implant 1 of any of the above embodiments, and the delivery sheath 2 is used to load the intracavitary implant 1 and implant the intracavitary implant 1 into the target cavity.

[0146] The connection method between the intracavitary implant 1 and the delivery sheath 2 increases the fault tolerance of the operation. If the release position of the intracavitary implant 1 deviates from the target position after one expansion and molding, the intracavitary implant 1 can be recovered and released again before the connection between the delivery sheath 2 and the intracavitary implant 1 is loosened.

[0147] In some embodiments, the delivery sheath 2 can refer to the occluder locking system for delivering the occluder in CN111803166A, or the interventional medical device pushing device in CN111803168A, etc.

[0148] For any of the above embodiments, the materials of the inner membrane 20 and the suture 70 include but are not limited to at least one of polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), thermoplastic polyurethanes (TPU), silicone rubber, polyvinyl alcohol (PVA), hydrogel, expanded polytetrafluoroethylene, polyethylene, high-density polyethylene, polyethylene terephthalate and other polymer materials. For example, the inner membrane 20 can be made of ePTFE material, and the suture 70 can be made of PET material.

[0149] The support frame 10 can be cut by laser from a material having a shape memory effect; or it can be woven from a filamentary material having a shape memory effect. The material having a shape memory effect includes, but is not limited to, at least one of stainless steel, tungsten alloy, cobalt-chromium alloy, and nickel-titanium alloy.

[0150] The material of the development mark 50 can be made of a material with good X-ray opacity, strong corrosion resistance and good biocompatibility, and can be gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium or alloys of these materials. The development mark 50 can be in various forms such as ring, wire, belt or dot, and can be fixed on the support frame 10 by suturing, stamping, inlaying, hot melting, bonding, welding or riveting.

[0151] The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any technician familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present application, which should be included in the protection scope of the present application. Therefore, the protection scope of the present application should be based on the protection scope of the claims.

Claims

1. An intracavitary implant, characterized in that: include: The support frame is a tubular structure with an inner cavity, and the two axial ends of the support frame are set to a closed state. The support frame is a grid-like structure with multiple meshes formed by interlacing multiple braided wires; The inner membrane is fixed to the inner cavity of the supporting frame, and the inner membrane is a tubular structure with an inner cavity; The support frame includes a plurality of support segments and connecting segments which are sequentially arranged crosswise along the axial direction, the support segments protrude from the inner cavity of the support frame relative to the connecting segments, and the connecting segments are recessed radially toward the inner cavity of the support frame relative to the support segments, so that the outer surface of the support frame presents an undulating wave shape along the axial direction; The support segment located at the proximal end of the intracavitary implant is named as the proximal support portion, and the support segment located at the distal end of the intracavitary implant is named as the distal support portion, and at least one support segment is provided between the proximal support portion and the distal support portion; The cross-sectional dimensions of the proximal support portion and the distal support portion are smaller than the cross-sectional dimensions of the other support segments.

2. The intracavitary implant according to claim 1, characterized in that The cross-section of the intracavitary implant 1 includes a long diameter D1 and a short diameter D2, the long diameter D1 of the proximal support portion 13 and the distal support portion 14 is smaller than the long diameter D1 of the other support segments 11, and the short diameter D2 of the proximal support portion 13 and the distal support portion 14 is smaller than the short diameter D2 of the other support segments 11.

3. The intracavitary implant according to claim 1, characterized in that The cross-sectional shape of the supporting skeleton is at least one of a convex crescent, a pseudo-moon and a full-moon shape; the cross-sectional shapes of the convex crescent and the pseudo-moon shape include a long diameter D1 and a short diameter D2, the short diameter D2 of the convex crescent shape is smaller than the short diameter D2 of the pseudo-moon shape, and the diameter of the full-moon shape is larger than the short diameter D2 of the convex crescent and the pseudo-moon shape.

4. The intracavitary implant according to claim 1, characterized in that The cross-sectional shape of the supporting skeleton presents at least one of a crescent shape, a lower crescent shape, a convex crescent shape, a crescent shape or a full moon shape; the cross-sectional shapes of the crescent shape, the lower crescent shape, the convex crescent shape and the crescent shape include a long diameter D1 and a short diameter D2, and the short diameter D2 of the crescent shape, the lower crescent shape, the convex crescent shape and the crescent shape increases successively, and the diameter of the full moon shape is greater than the short diameter D2 of the crescent shape, the lower crescent shape, the convex crescent shape and the crescent shape.

5. The intracavitary implant according to any one of claims 1 to 4, characterized in that The cross-sectional dimensions of the proximal support portion and the distal support portion are 1-3 mm smaller than the cross-sectional dimensions of other support segments.

6. The intracavitary implant according to any one of claims 1 to 4, characterized in that The outer surface of the support segment is a plane parallel to the central axis of the intracavitary implant.

7. An intracavitary implant according to any one of claims 1 to 4, characterized in that The depth of the depression of the connecting section compared to the supporting section is 1-5 mm.

8. The intracavitary implant according to any one of claims 1 to 4, characterized in that The axial length of the supporting section is greater than the axial length of the connecting section.

9. The intracavitary implant according to any one of claims 1 to 4, characterized in that The mesh density of the supporting section is smaller than that of the connecting section.

10. The intracavitary implant according to any one of claims 1 to 4, characterized in that Along the axial direction of the supporting skeleton, the connecting section includes a first connecting portion, a transition portion and a second connecting portion arranged in sequence from the distal end to the proximal end. The transition portion is closer to the central axis of the intracavitary implant than the first connecting portion and the second connecting portion; the mesh density of the first connecting portion and the second connecting portion is smaller than the mesh density of the transition portion.

11. The intracavitary implant according to any one of claims 1 to 4, characterized in that The support frame also includes a proximal mesh cover and a distal mesh cover, the proximal mesh cover is fixed to the proximal side of the support segment located at the proximal end, and the distal mesh cover is fixed to the distal side of the support segment located at the distal end, so that the support frame forms a tubular structure with closed end surfaces at both ends; the axial ends of the inner membrane are closed end surfaces, and the two axial end surfaces of the inner membrane are respectively located at the proximal mesh cover and the distal mesh cover; at least one of the proximal mesh cover and the distal mesh cover includes a protruding portion and a recessed portion, the protruding portion is convex in the direction away from the inner cavity of the support frame, and the recessed portion is recessed in the direction close to the inner cavity of the support frame.

12. The intracavitary implant according to claim 11, characterized in that The recessed portion is arranged around the central axis of the intracavitary implant, and the raised portion is arranged around the periphery of the recessed portion.

13. The intracavitary implant according to any one of claims 1 to 4, characterized in that The support frame is provided with a positioning surface, on which at least three rows of developing materials are provided, each row of developing materials is provided with at least two developing marks, wherein at least two rows of developing materials are respectively located at two ends of the axial direction of the support frame, and at least two developing marks on each row of developing materials are respectively located at two ends close to the major diameter D1 direction of the support frame.

14. The intracavitary implant according to claim 13, characterized in that For at least two development marks in each row, a distance d between the development marks and the end of the corresponding support frame in the direction of the major diameter D1 is the circumferential length of one mesh or less than the circumferential length of one mesh.

15. The intracavitary implant according to any one of claims 1 to 4, characterized in that At least one functional rib is fixed on the supporting frame; The axial length of the functional rib is at least 1 / 3 of the axial length of the supporting frame, and the length direction of the functional rib is arranged along the central axis of the intracavitary implant, or the length direction of the functional rib is arranged at an angle to the central axis of the intracavitary implant; Either the functional ribs are spirally wound and fixed on the peripheral wall of the intracavitary implant to form a multi-circle ring, or at least one functional rib is surrounded and fixed on the peripheral wall of the intracavitary implant.

16. The intracavitary implant according to any one of claims 1 to 4, characterized in that The periphery of the inner membrane presents a concave-convex morphology.

17. The intracavitary implant according to claim 16, characterized in that The inner membrane includes multiple first membrane portions and multiple second membrane portions, and the multiple first membrane portions and the multiple second membrane portions are cross-arranged in sequence along the axial direction. The first membrane portion protrudes out of the inner cavity of the inner membrane relative to the second membrane portion, and the second membrane portion is recessed radially toward the inner cavity of the inner membrane relative to the first membrane portion, so that the outer surface of the inner membrane presents an undulating wave shape along the axial direction.

18. The intracavitary implant according to claim 17, characterized in that The recessed depths of the plurality of second film portions are the same or different.

19. The intracavitary implant according to claim 17, characterized in that The first membrane portion and the second membrane portion are regularly or irregularly arranged on the periphery of the inner membrane, and at least one of the first membrane portion and the second membrane portion is a protruding block structure.

20. The intracavitary implant according to claim 17, characterized in that The cross-sectional dimensions of the inner membrane located at the proximal support portion and the distal support portion are smaller than the cross-sectional dimensions of the inner membrane located at other support segments.

21. The intracavitary implant according to any one of claims 1 to 4, characterized in that At least two openings are arranged on the inner membrane, and the at least two openings are annular structures arranged circumferentially around the inner membrane. The at least two openings can divide the inner membrane into at least three separate membrane sections.

22. The intracavitary implant according to claim 21, characterized in that The at least two openings are annular structures arranged circumferentially around the inner membrane, and the at least two openings can divide the inner membrane into at least three separate membrane sections along the axial direction.

23. The intracavitary implant according to claim 22, characterized in that The three membrane-like objects formed are named the first segment, the second segment and the third segment respectively. The first segment, the second segment and the third segment are arranged in sequence from the distal end to the proximal end of the inner membrane; the axial length of the second segment is greater than the axial lengths of the first segment and the third segment.

24. An intracavitary implant according to any one of claims 21 to 23, characterized in that The support frame is provided with an annular fixing site to fix the axial ends of each membrane section on the support frame.

25. The intracavitary implant according to claim 24, characterized in that There is at least one mesh between each of the adjacent membrane sections in the axial direction.

26. The intracavitary implant according to any one of claims 1 to 4, characterized in that The inner membrane is a tubular structure with closed ends at both axial ends.

27. The intracavitary implant according to claim 26, characterized in that A proximal mesh cover is provided at the proximal end of the support frame, and a distal mesh cover is provided at the distal end of the support frame, so that the support frame is a tubular structure with closed ends at both axial ends; the two axial ends of the inner membrane are respectively fixed to the proximal mesh cover and the distal mesh cover.

28. A method for suturing an intracavitary implant, characterized in that: The invention comprises a suture and an intracavitary implant according to any one of claims 1 to 27; the inner membrane is provided with at least one opening, and the edge of at least one side of the opening on the inner membrane is alternately penetrated through at least two axially adjacent meshes by sutures around the circumference of a supporting frame to fix the inner membrane to the supporting frame.

29. A vascular plug system, characterized in that: The invention comprises a delivery sheath and the intracavitary implant according to any one of claims 1 to 27, wherein the delivery sheath is used for loading the intracavitary implant and delivering the intracavitary implant into a target cavity.

Citation Information

Patent Citations

  • Occluder and occluder locking system

    CN111803166A

  • Pushing device for interventional medical instruments

    CN111803168A