Interventional instrument for atrial septum and manufacturing method

Abstract

The application relates to an interventional instrument for a heart atrial septum and a manufacturing method. The interventional instrument comprises a first support frame and a second support frame. The manufacturing method is as follows: a cylindrical net is formed by using a wire weaving cylinder; a wire of a first preset point on the first support frame is pulled to expand to form a first passage with a through hole shape; the first preset point is located at a peripheral area of the first support frame; an outer edge of the first support frame is pushed to move to the center at the first preset point, so that an inner side of the first passage is folded and connected to form a notch-shaped first passage at the first preset point; a wire of a second preset point on the second support frame is pulled to expand to form a second passage, wherein the first passage is oppositely arranged with the second passage and is suitable for forming a transseptal passage. The interventional instrument is produced through the above manufacturing method. The interventional instrument can be reliably implanted, and a transseptal passage can be established on the heart atrial septum after implantation.

Description

[0001] This application is a divisional application of the following parent application:

[0002] The application date for the parent case was August 6, 2021.

[0003] The parent application's application number is: 202110901860.2;

[0004] The invention title of the parent application is: Interventional device for the atrial septum and manufacturing method. Technical Field

[0005] This invention relates to the medical field, and more particularly to interventional devices for the atrial septum and methods of manufacturing them. Background Technology

[0006] The atrial septum is located between the left and right atria and serves as a partition separating them. In some patients with heart disease, abnormal pathways exist due to congenital defects, such as atrial septal defects or patent foramen ovale.

[0007] In addition, some heart disease treatments may leave defects that cannot heal on their own, such as atrial fibrillation electrophysiological therapy, left atrial appendage occlusion, transcatheter mitral valve replacement, transcatheter mitral valve repair and other minimally invasive left ventricular surgeries.

[0008] Currently, for abnormal pathways and defects in the atrial septum, transseptal interventional medical devices, such as occluders, are typically used for closure. However, after closure with these devices, it is usually impossible to re-establish a transseptal pathway in the atrial septum, which poses a significant risk to the patient's subsequent treatment.

[0009] In addition, if a septum reappears near the atrial septum after the patient has undergone closure using an interventional medical device, and the two septa are close together, the interventional medical device used again will inevitably overlap with the previously used medical device, resulting in a larger interventional thickness at the overlapping area, which will put greater pressure on the atrial septum.

[0010] On the other hand, when the interventional device is first inserted into the atrial septum, it may not be able to fully fuse and fix itself to the atrial septum, posing a risk of slipping relative to the atrial septum. Summary of the Invention

[0011] To address the aforementioned technical problems, the present invention aims to provide an interventional device for the atrial septum and a method for manufacturing it. At least one of the first and second support frames of the interventional device has a notch-shaped passage that can form a trans-septal passage with a passage on the other support frame. This allows for the re-establishment of a trans-septal passage through the support frame of the interventional device. The notch-shaped passage allows adjacent interventional devices to be staggered, preventing overlap and enabling adjacent interventional devices to interlock and limit each other.

[0012] To achieve the above objectives, the present invention provides a method for manufacturing an interventional device for the atrial septum, comprising:

[0013] Use metal wire to weave a tubular mesh;

[0014] The first pre-gathering section of the tubular mesh is gathered to form the first gathering point;

[0015] The second pre-gathering section of the tubular mesh is gathered to form a second gathering point;

[0016] A middle end is selected between the first pre-gathering point and the second pre-gathering point of the tubular mesh to form a middle gathering point;

[0017] Along the central axis of the tubular mesh, the first convergence point and the intermediate convergence point are brought close together and pressed together to form a first support frame.

[0018] Along the central axis of the tubular mesh, the second convergence point and the intermediate convergence point are brought close together and pressed together to form a second support frame.

[0019] Move the metal wire at the first preset point on the first support frame to expand and form the first passage;

[0020] The metal wire at the second preset point on the second support frame is moved to expand and form a second passage, wherein the first passage is disposed opposite to the second passage and is adapted to form a diaphragm passage.

[0021] Preferably, the process of plucking the metal wire at the first preset point on the first support frame to expand and form the first passage includes: the first preset point is located in the peripheral area of ​​the first support frame, and plucking the metal wire at the first preset point forms the first passage in the shape of a through hole.

[0022] The metal wire at the second preset point on the second support frame is moved to expand and form a second passage, including: the second preset point is located in the peripheral area of ​​the second support frame, and the metal wire at the second preset point is moved to form a through hole-shaped second passage.

[0023] Preferably, after the metal wire at the first preset point is turned to form the first passage in the shape of a through hole, the following steps are taken: pushing the outer edge of the first support frame to move towards the center at the first preset point, so that the inner side of the first passage in the shape of a through hole is folded and connected to form the first passage in the shape of a notch at the first preset point.

[0024] After the metal wire at the second preset point is moved to form the second passage in the shape of a through hole, the process includes: pushing the outer edge of the second support frame to move towards the center at the second preset point, so that the inner side of the second passage in the shape of a through hole is folded and connected to form the second passage in the shape of a notch at the second preset point.

[0025] Preferably, the metal wire at the first preset point on the first support frame is moved to expand and form the first passage, including: pushing the outer edge of the first support frame to move towards the center at the first preset point to form a notch-shaped first passage at the first preset point;

[0026] The metal wire at the second preset point on the second support frame is moved to expand and form a second passage, including: pushing the outer edge of the second support frame to move towards the center at the second preset point to form a notch-shaped second passage at the second preset point.

[0027] Preferably, the method for manufacturing the interventional device for the atrial septum further includes: setting pathway markings on the preset metal wires of the tubular mesh.

[0028] Preferably, the first end and the second end of the tubular mesh respectively form the first pre-receiving point and the second pre-receiving point; or:

[0029] The first end of the tubular mesh is folded inward or outward along the axis of the tubular mesh by a predetermined distance, and the first end and the corresponding tubular mesh are then gathered to form the intermediate gathering point; the second end of the tubular mesh is gathered to form the second gathering point; the overlapping end of the folded tubular mesh is gathered to form the first gathering point.

[0030] According to another aspect of the invention, the invention further provides an interventional device for the atrial septum, comprising a support frame having an extended state and a retracted state; in the retracted state, the support frame retracts into an elongated configuration; in the extended state, the support frame comprises:

[0031] The first support frame has a notch-shaped first passageway;

[0032] The second supporting framework has a second pathway;

[0033] A connector is provided in which the first support frame and the second support frame are disposed opposite to each other, and the first passage and the second passage are disposed opposite to each other. The two ends of the connector are respectively connected to the first support frame and the second support frame.

[0034] Preferably, the first support frame and the second support frame each include at least two support arms, with two adjacent support arms of the first support frame forming the first passage and two adjacent support arms of the second support frame forming the second passage.

[0035] Preferably, the end of the support arm away from the center of the first support frame or the center of the second support frame has a first arc segment, and a third arc segment is provided between two adjacent support arms. The support arm also has a second arc segment located between the first arc segment and the third arc segment. The shape of the first arc segment is adapted to the shape of the third arc segment, and one support arm of one interventional device is adapted to engage with the third arc segment between two adjacent support arms of another interventional device.

[0036] Preferably, the interventional device for the atrial septum further includes a blood flow blocking element disposed in the first access and / or the second access;

[0037] The interventional device for the atrial septum also includes pathway markers disposed around the first pathway and / or the second pathway.

[0038] Preferably, the side of the first support frame facing the second support frame is an arc-shaped surface;

[0039] And / or, the side of the second support frame facing the first support frame is an arc-shaped surface.

[0040] Preferably, the first support frame has a first distal end face and a first proximal end face;

[0041] The support frame further includes a first connector having a first end and a second end, the first end being connected to the first distal end face, the second end extending beyond the first proximal end face, and the diameter of the first end being greater than the diameter of the second end.

[0042] Preferably, the second support frame has a second distal end face and a second proximal end face, the second distal end face being disposed opposite to the first proximal end face;

[0043] The support frame further includes a second connector having a third end and a fourth end, the third end being connected to the second proximal end face, the fourth end extending beyond the second distal end face, and the diameter of the third end being larger than the diameter of the fourth end.

[0044] Preferably, the second proximal end face has a mounting groove, and the support frame further includes a first gathering structure mounted in the mounting groove, the first gathering structure being connected to the conveying device.

[0045] Compared with the prior art, the interventional device for the atrial septum and its manufacturing method provided by the present invention have at least one of the following advantages:

[0046] 1. The interventional device for atrial septum and manufacturing method provided by the present invention, wherein at least one of the first support frame and the second support frame of the interventional device has a notch-shaped passage that can form a septal passage with the passage on the other support frame, allowing the septal passage to be re-established through the support frame of the interventional device, and the notch-shaped passage allows adjacent interventional devices to be staggered without overlapping, and allows adjacent interventional devices to be mutually locked and limited.

[0047] 2. The interventional device for atrial septum and manufacturing method provided by the present invention, wherein the first support frame and / or the second support frame of the interventional device have a plurality of spaced support arms, and a first passage and / or a second passage are formed between adjacent support arms. The plurality of mutually spaced support arms can reduce the volume of the support frame in the contracted state, which facilitates the insertion of the interventional device.

[0048] 3. The interventional device for atrial septum and its manufacturing method provided by the present invention have a matching arc between the arc of the first arc segment at the distal end of the support arm of the interventional device and the arc of the third arc segment between two adjacent support arms, which enables the support frame to be better staggered with the adjacent support frames. Attached Figure Description

[0049] The preferred embodiments will now be described in a clear and easy-to-understand manner, in conjunction with the accompanying drawings, to further explain the above-mentioned characteristics, technical features, advantages, and implementation methods of the present invention.

[0050] Figure 1 This is an application diagram of an interventional device for the atrial septum according to a preferred embodiment of the present invention;

[0051] Figure 2a and Figure 2b This is a structural diagram of an interventional device for the atrial septum according to a preferred embodiment of the present invention;

[0052] Figure 3a and Figure 3b This is a structural diagram of the contracted and deployed states of an interventional device for the atrial septum according to a preferred embodiment of the present invention.

[0053] Figure 4 Figure 4b as well as Figure 4c This is a structural diagram of the support frame of an interventional device for the atrial septum according to a preferred embodiment of the present invention;

[0054] Figure 5a and Figure 5b This is a structural diagram of a modified embodiment of the support frame for an interventional device for the atrial septum according to a preferred embodiment of the present invention;

[0055] Figure 6a , Figure 6b as well as Figure 6c This is a structural diagram of a blood flow barrier membrane for an interventional device used in the atrial septum according to a preferred embodiment of the present invention;

[0056] Figure 7a , Figure 7b as well as Figure 7c This is a structural diagram of the support frame of an interventional device for the atrial septum according to a preferred embodiment of the present invention;

[0057] Figure 7d and Figure 7e This is a structural diagram of the connector of an interventional device for the atrial septum according to a preferred embodiment of the present invention;

[0058] Figure 8a and Figure 8b This is a flowchart of a preferred embodiment of the present invention for manufacturing an interventional device for the atrial septum.

[0059] Explanation of icon numbers:

[0060] Support frame 100, first support frame 1, first access 10, support arm 11, first arc segment 111, second arc segment area 112, third arc segment area 113, first distal end face 114, first proximal end face 115, central area 12, peripheral area 13, second support frame 2, second access 20, second distal end face 211, second proximal end face 212, mounting groove 2120, connector 3, first connector 41, first end 411, second end 412, second connector 42, third end 421, fourth end 422, first convergence structure 43, second convergence structure 44, access marker 45, tubular mesh 50, first pre-convexity 51, second pre-convexity 52, mesh 53, blood flow blocking element 6, delivery device 200, sheath 300, inferior vena cava 400, left ventricle 501, right ventricle 502, atrial septum 503. Detailed Implementation

[0061] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0062] To keep the drawings concise, each figure only schematically shows the parts relevant to the invention, and these do not represent the actual structure of the product. Furthermore, to facilitate understanding, in some figures, only one of components with the same structure or function is schematically depicted, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0063] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0064] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0065] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0066] Reference manual attached Figures 1 to 8b The present invention describes an interventional device for the atrial septum, wherein at least one of the first and second support frames of the interventional device has a notch-shaped passage that can form a septal passage with the passage on the other support frame, allowing the septal passage to be re-established through the support frame of the interventional device. The notch-shaped passage allows adjacent interventional devices to be staggered without overlapping, and allows adjacent interventional devices to be mutually locked and limited.

[0067] Reference manual attached Figure 2a and Figure 2b Specifically, the interventional device includes a support frame 100, which has an extended state and a retracted state. (See attached instruction manual.) Figure 3aIn the contracted state, the support frame 100 contracts into an elongated configuration; refer to the attached specification. Figure 3b In the unfolded state, the support frame 100 includes a first support frame 1, a second support frame 2, and a connector 3. The first support frame 1 has a notch-shaped first passage 10; the second support frame 2 has a second passage 20. The first support frame 1 and the second support frame 2 are disposed opposite to each other, and the first passage 10 and the second passage 20 are disposed opposite to each other. The two ends of the connector 3 are respectively connected to the first support frame 1 and the second support frame 2.

[0068] It should be noted that, in this preferred embodiment, the fact that the first passage 10 and the second passage 20 are arranged opposite each other does not require that the shapes of the first passage 10 and the second passage 20 be exactly the same and completely aligned. A portion of the first passage 10 and a portion of the second passage 20 may also form a diaphragm-penetrating passage. As long as a diaphragm-penetrating passage can be formed through the first passage 10 and the second passage 20, the specific shapes of the first passage 10 and the second passage 20 should not constitute a limitation on the present invention.

[0069] Reference manual attached Figure 1 During use, when the support frame 100 is in the contracted state, the interventional device can be delivered via the delivery device 200 along the sheath 300 in the inferior vena cava 400 to the gap between the left ventricle 501 and the right ventricle 502. The interventional device unfolds at the gap in the atrial septum 503 to the unfolded state, with the first support frame 1 and the second support frame 2 located on the left and right sides of the atrial septum, respectively. The connector 3 passes through the gap in the atrial septum, thereby closing the gap in the atrial septum 503.

[0070] Preferably, the second passage 20 on the second support frame 2 is also notched; that is, both the first passage 10 on the first support frame 1 and the second passage 20 on the second support frame 2 are notched. Optionally, the second passage 20 can also be a circular hole. (See attached specification) Figure 4a The first passage 10 on the first support frame 1 has two passage forms: notch-shaped and through-hole-shaped. The second passage 20 on the second support frame 2 also has two passage forms: notch-shaped and through-hole-shaped.

[0071] Reference manual attached Figure 2a and Figure 2bThe first support frame 1 and / or the second support frame 2 each include at least one support arm 11. The gap between the two sides of the support arm 11 of the first support frame 1 and the adjacent portion on the first support frame 1 forms the first passage 10, and the gap between the two sides of the support arm 11 of the second support frame 2 and the adjacent portion on the second support frame 2 forms the second passage 20.

[0072] It is worth mentioning that setting the first support frame 1 and the second support frame 2 as mutually spaced support arms 11 can reduce the volume of the first support frame 1 and the second support frame 2 in the contracted state, making it easier to deliver them through the inferior venous cavity to the atrial septum.

[0073] Reference manual attached Figure 4b The support arm 11 has a first arc-shaped segment 111 at one end away from the center of the first support frame 1 or the center of the second support frame 2, and a third arc-shaped segment 113 between two adjacent support arms 11. The support arm 11 also has a second arc-shaped segment 112 located between the first arc-shaped segment 111 and the third arc-shaped segment 113. The shape of the first arc-shaped segment 111 is adapted to the shape of the third arc-shaped segment 113, and one support arm 11 of one interventional device is adapted to engage with the third arc-shaped segment 113 between two adjacent support arms 11 of another interventional device.

[0074] Setting the connection between the support arm 11 and adjacent support arms 11 as an arc-shaped transition can prevent the support arm 11 from damaging the atrial septum and improve the safety of interventional devices.

[0075] Preferably, the support arm 11 has a generally symmetrical structure. A first arc segment 111, a second arc segment 112, and a third arc segment 113 are connected sequentially. The first arc segment 111 starts from point A and extends to point B, forming the radial outer edge of the support arm 11. The second arc segment 112 starts from point B and extends to point C. The third arc segment 113 starts from point C and extends to point D. The first arc segment 111 and the second arc segment 112 have the same bending direction and a certain turning angle at point B. The second arc segment 112 and the third arc segment 113 have opposite bending directions and are tangent at point C.

[0076] The first arc segment 111 bends outward radially, and the center of the arc roughly coincides with the center of the first support frame 1 or the second support frame 2. The angle of the center of the arc can be between 10° and 20°, preferably 15°, and the arc length can be between 2mm and 12mm.

[0077] At point B, the first arc segment 111 transitions to the second arc segment 112. The connection angle between the first arc segment 111 and the second arc segment 112 can be between 90° and 160°. Preferably, the transition between the first arc segment 111 and the second arc segment 112 is smooth, and the preferred connection angle is not less than 100°. The radius of the arc of the second arc segment 112 can be approximately 1 / 5 to 1 / 2 of the radius of the arc of the first arc segment 111, and the preferred ratio is 1 / 3. The central angle of the second arc segment 112 can be between 60° and 90°, and the preferred angle is 75°.

[0078] At point C, the second arc segment 112 turns towards the third arc segment 113, and the two are approximately tangent at point C. The third arc segment 113 curves radially inward from point C to point D. The radius of the arc of the third arc segment 113 can be approximately 1 / 5 to 1 / 2 of the radius of the arc of the first arc segment, preferably 1 / 4, that is, the radius of the arc of the third arc segment can be set to be greater than the radius of the arc of the second arc segment. The central angle of the third arc segment 113 can be between 60° and 90°, preferably 75°.

[0079] Preferably, refer to the appendix to the instruction manual. Figure 4b and Figure 4c The first support frame 1 and the second support frame 2 each have a central region 12 and a peripheral region 13. The central region 12 is approximately an inscribed circle tangent to the third arc segment 113, and the center O of the inscribed circle approximately coincides with the center of the first support frame 1 and the second support frame 2. The first passage 10 is formed in the peripheral region 13 of the first support frame 1, and the second passage 20 is formed in the peripheral region 13 of the second support frame 2. When the support frame 100 provided by the present invention is in the unfolded state and is installed on the atrial septum, the central region of the first support frame 1 and the central region of the second support frame 2 can seal the defects on the atrial septum, and the peripheral regions of the first support frame 1 and the peripheral regions of the second support frame 2 are respectively sandwiched on both sides of the atrial septum.

[0080] Understandably, the shape of the support arm 11 can be set to any applicable shape, that is, the first support frame 1 and / or the second support frame 2 can be set to any applicable shape, and the shape setting of the first support frame 1 and / or the second support frame 2 should not be a limitation of the present invention. The dimensions of the first support frame 1 and the second support frame 2 can also be set to be different. Increasing the size of the first support frame 1 within a certain range may be beneficial to the stability of the interventional device 100 and to coping with higher blood pressure in the left atrium.

[0081] Reference manual attached Figure 5a and Figure 5b In a modified embodiment of the present invention, the first support frame 1 and / or the second support frame 2 are each composed of two support arms 11. The support frame 100 is formed by the alternating connection of the first support frame 1 and the second support frame 2. The overlapping portion of the support frame 1 and the second support frame 2 forms the central region 12, and the non-overlapping portion of the support frame 1 and the second support frame 2 forms the peripheral region 13. The gap between two adjacent support arms 11 forms the first passage 10 and / or the second passage 20. In this modified embodiment, the support arms 11 have greater freedom of shape adjustment. During shape adjustment, the surface area of ​​the peripheral region 13 is kept larger than the surface area of ​​the central region 12, which is beneficial for the interventional device 100 to maintain the atrial septum tissue.

[0082] It should also be noted that the clamping force of the first support frame 1 and the second support frame 2 when clamped on the atrial septum can withstand a force of at least 2N, preferably at least 6N, which can resist the impact of cardiac blood flow and preserve human tissue at the defect site on the atrial septum.

[0083] Preferably, refer to the appendix to the instruction manual. Figure 6a , Figure 6b as well as Figure 6c The interventional device for the atrial septum further includes a blood flow obstruction member 6 disposed in the first access 10 and / or the second access 20. The interventional device for the atrial septum also includes access markings 45 disposed around the first access 10 and / or the second access 20. (Refer to the appendix of the instruction manual.) Figure 4b .

[0084] Preferably, the blood flow blocking element 6 is composed of electrospun polymeric materials or synthetic fabrics. Electrospun polymeric materials include, for example, polylactide (PLA), polylactide-glycolic acid (PLGA), polycaprolactone (PLC), polyacrylonitrile (PAN), lactide-caprolactone copolymer (PLCL), polygyconate, and peptides. Electrospun polymers are more conducive to endothelialization, have faster biodegradation times, reduce thrombus formation, and are easily punctured, which helps interventional instruments pass through more easily after the atrial septum defect has been closed. Various synthetic fabrics can be non-degradable materials, such as polyethylene terephthalate (PET), or biospun polyurethane.

[0085] The blood flow blocking element 6 can be fixed to the support frame 100 by heat riveting, sewing, molding, bonding, weaving, or any suitable method. The blood flow blocking element 6 can be located inside or outside the support frame 100, and can cover the entire support frame 100, preferably distributed in the metal covering of the support frame 100, i.e., the support arm 11 and the central region 12 connecting the support arm 11; in some embodiments, the blood flow blocking element 6 can also be arranged only at the diaphragm passage.

[0086] The pathway marker 45 is used to mark the positions of the first pathway 10 and / or the second pathway 20 under fluorescence fluoroscopy or ultrasound equipment, guiding the operator to quickly reach the diaphragm-penetrating pathway position. The pathway marker 45 can be placed at the edge of the diaphragm-penetrating pathway, with one or more markers. The material of the pathway marker 45 can be a metal or alloy material easily affected by detection, or various compound coatings. The metal material can be medical stainless steel, palladium, iridium, tungsten, platinum, or their alloys.

[0087] Reference manual attached Figure 7a , 7b And 7c, in some embodiments, the side of the second support frame 2 facing the first support frame 1 is an arc-shaped surface. Setting the side of the second support frame 2 facing the first support frame 1 as an arc-shaped surface allows the side of the first support frame 1 facing the second support frame 2 to better fit the atrial septum during use, improving the stability of the support frame 100 installed in the atrial septum.

[0088] Reference manual attached Figure 7a Furthermore, the first support frame 1 has a first distal face 114 and a first proximal face 115. The support frame 100 also includes a first connector 41. The first connector 41 has a first end 411 and a second end 412. The first end 411 is connected to the first distal face 114, and the second end 412 extends beyond the first proximal face 115, with the diameter of the first end 411 being larger than the diameter of the second end 412. In other words, the first connector 411 is an inverted cone structure extending from the first distal face 114 to the first proximal face 115. By setting the inverted cone shape of the first connector 41, the first proximal face 115 can have an appropriate tension towards the first distal face 114, causing the first support frame 1 to tend to move closer to the second support frame 2, thereby improving the stability of the installation of the first support frame 1 and the second support frame 2. In addition, the first end 411 of the first connector 41 can also more easily facilitate the coverage of the first support frame 1 by human tissue, allowing the interventional device to fuse with the atrial septum more quickly.

[0089] Understandably, in some embodiments, the first end 411 and the second end 412 of the first connector 41 may be configured in other ways, such as extending outward from the first distal end surface 114 and the first proximal end surface 115, respectively. The configuration of the first connector 41 is not a limitation of this invention.

[0090] Preferably, the diameter of the first end 411 is about 5%-15% of the diameter of the first support frame 1, and the distance between the first end 411 and the second end 412 of the first connector 41 is about 1mm-3mm.

[0091] Reference manual attached Figure 7b The second support frame 2 has a second distal surface 211 and a second proximal surface 212, with the second distal surface 211 disposed opposite to the first proximal surface 114. The support frame 100 also includes a second connector 42. The second connector 42 has a third end 421 and a fourth end 422, the third end 421 being connected to the second distal surface 211, and the fourth end 422 extending beyond the second distal surface 211, with the diameter of the third end 421 being larger than the diameter of the fourth end 422. Similar to the first connector 41, the second connector 42 is also a conical structure, capable of applying appropriate pressure to the second distal surface 211, causing the second distal surface 211 to tend to move towards the first support frame 1, thereby allowing the first support frame 1 and the second support frame 2 to better clamp the atrial septum.

[0092] Preferably, the first connector 41 is located at the geometric center of the first support net 1, and the second connector 42 is located at the geometric center of the second support net 2.

[0093] Preferably, the two ends of the connector 3 are respectively connected to the first connector 41 and the second connector 42, and the two ends of the connector 3 are integrally formed with the first connector 41 and the second connector 42. (See attached specification) Figure 7d In some modified embodiments of the present invention, the first connecting body 41 and the second connecting body 42 are connected to form the connecting member 3. (See attached specification) Figure 7e The first connector 41 and the second connector 42 are connected by the second convergence structure 44.

[0094] Preferably, the connector 3 is a columnar body with a length of approximately 1-3 mm and a diameter of approximately 1-3 mm. The connector 3 can also be other shapes, including but not limited to a cone shape, and the specific shape of the connector 3 should not constitute a limitation of the present invention. The number of connectors 3 can be one or more, and the number of connectors 3 should not constitute a limitation of the present invention.

[0095] Reference manual attached Figure 7b The second proximal end face 212 has a mounting groove 2120. The support frame 100 also includes a first gathering structure 43 mounted in the mounting groove 2120, the first gathering structure 43 being connected to the conveying device.

[0096] On the one hand, the first constriction structure 43 can limit the second support frame 2, so that the second support frame 2 maintains a preset shape; on the other hand, the first constriction structure 43 can also be used to connect with the delivery device of interventional surgery, through which the support frame 100 can be delivered to the atrial septum via blood vessels.

[0097] Preferably, the first convergence structure 43 is cylindrical, with a height of 1mm-3mm and a base diameter of 1mm-3mm. The first convergence structure 43 can also be spherical or any other suitable shape. The material of the first convergence structure 43 is mostly metal, such as medical stainless steel or nickel-titanium alloy, which are suitable for interventional devices.

[0098] Reference manual attached Figure 8a and Figure 8b According to another aspect of the present invention, the present invention further provides a method for manufacturing an interventional device for the atrial septum, comprising:

[0099] 301: Use 50mm diameter tubular mesh woven from metal wire;

[0100] 302: The first pre-gathering section 51 of the tubular mesh 50 is gathered to form a first gathering point;

[0101] 303: The second pre-gathering section 52 of the tubular mesh is gathered to form a second gathering point;

[0102] 304: Select an intermediate end between the first pre-gathering point 51 and the second pre-gathering point 52 of the tubular mesh 50 to form an intermediate gathering point;

[0103] 305: Along the central axis of the tubular mesh 50, the first convergence point and the intermediate convergence point are brought close together and pressed together to form a first support frame 1.

[0104] 306: Along the central axis of the tubular mesh 50, the second convergence point and the intermediate convergence point are brought close together and pressed together to form a second support frame 2.

[0105] 307: Move the metal wire at the first preset point on the first support frame 1 to expand and form the first passage 10;

[0106] 308: Move the metal wire at the second preset point on the second support frame 2 to expand and form the second passage 20, wherein the first passage 10 is disposed opposite to the second passage 20 and is adapted to form a diaphragm passage.

[0107] It should be noted that the sequence numbering of the above methods is only for the purpose of more conveniently and clearly illustrating the present invention, and the sequence numbering should not constitute a limitation on the present invention. The order of each step can be adjusted according to actual needs.

[0108] Preferably, in step 301, the metal wire is a nitinol wire. The diameter of the metal wire can be between 0.02mm and 0.2mm, and the number can be 12, 18, 24, 30, 36, 42, or 48 wires. After weaving, the metal wire forms multiple meshes 53. The angle between the near and far ends of each mesh 53 is α, i.e., the angle along the axial direction, which is a small acute angle. In a preferred embodiment, the angle is 30°. This angle is then basically shaped so that the tubular mesh 50 has N mesh rows. Refer to the attached specification. Figure 8a The grid angle α of each row of the grid is approximately the same. Refer to the attached instruction manual. Figure 8a The woven mesh remains roughly cylindrical and in a relatively relaxed state. This angle can be changed by force, and the relative positions between the wires can be altered by manipulating it.

[0109] In steps 302-304, the first convergence point, the second convergence point, or the third convergence point can be formed using an annular convergence member or by thermal pressing. It is understood that the specific method of forming the first convergence point, the second convergence point, and the third convergence point should not constitute a limitation of the present invention.

[0110] Step 307: Moving the metal wire at the first preset point on the first support frame to expand and form the first passage includes:

[0111] 3071: The first preset point is located in the peripheral area of ​​the first support frame 1, and the metal wire at the first preset point is moved to form the first passage 10 in the shape of a through hole.

[0112] Step 308: Moving the metal wire at the second preset point on the second support frame to expand and form the second passage includes:

[0113] 3081: The second preset point is located in the peripheral area of ​​the second support frame 2. Moving the metal wire at the second preset point forms the second passage 20 in the shape of a through hole.

[0114] Further, after step 3071: moving the metal wire at the first preset point to form the first passage 10 in the shape of a through hole, the following is included:

[0115] 3072: Move the first pre-retracted point on the outer edge of the first support frame 1 toward the center, so that the inner side of the through hole-shaped first passage 10 is folded and connected to form a notch-shaped first passage 10 outside the first pre-retracted point.

[0116] Further, after step 3081: moving the metal wire at the second preset point to form the second passage 20 in the shape of a through hole, the following is included:

[0117] 3082: Move the second pre-retracted point on the outer edge of the second support frame 2 toward the center, so that the inner side of the through hole-shaped second passage 20 is folded and connected to form a notch-shaped second passage 20 outside the second pre-retracted point.

[0118] It should be noted that in steps 3072 and 3082 above, the first passage 10 and the second passage 20 in the form of through holes are formed first, and then the first passage 10 and the second passage 20 in the form of through holes are squeezed and connected to form the first passage 10 and the second passage 20 in the form of notches. This can improve the stability of the structure of the first passage 10 and the second passage 20 in the form of notches.

[0119] Reference manual attached Figure 8b Optionally, in a modified embodiment of the present invention, the first support frame 1 and the second support frame 2 can be directly squeezed to form a notch-shaped first passage 10 and a notch-shaped second passage 20. For example, in step 307: moving the metal wire at a first preset point on the first support frame 1 to expand and form the first passage includes: moving the first pre-retracted point on the outer edge of the first support frame 1 towards the center to form a notch-shaped first passage 10 outside the first pre-retracted point. In step 308: moving the metal wire at a second preset point on the second support frame 2 to expand and form the second passage 20 includes: moving the second pre-retracted point on the outer edge of the second support frame 2 towards the center to form a notch-shaped second passage 20 outside the second pre-retracted point.

[0120] Furthermore, the method for manufacturing the interventional device for the atrial septum further includes:

[0121] 309: Passage markings 45 are provided on the preset metal wires of the tubular mesh 50.

[0122] Preferably, the passage mark 45 is an annular metal ring mounted on the metal wire. Step 309 can be performed either after step 309 or after steps 307 and 308. After the metal wire is moved in steps 307 and 308, the annular passage mark 45 can also fix the moved metal wire.

[0123] Further, in steps 302-304, preferably, the first end and the second end of the tubular mesh 50 respectively form the first pre-gathering point 51 and the second pre-gathering point 52, the first end and the second end of the tubular mesh 50 respectively converge to form the first convergence point and the second convergence point, and the middle end is the middle part of the tubular mesh 50.

[0124] In some modified embodiments of the present invention, before the tubular mesh 50 is gathered and pressed, the tubular mesh 50 is first rolled up. After the first end of the tubular mesh 50 is rolled inward or outward along the axis of the tubular mesh for a predetermined distance, the first end and the corresponding tubular mesh 50 are gathered to form the intermediate gathering point; the second end of the tubular mesh 50 is gathered to form the second gathering point; and the overlapping end of the rolled-up tubular mesh is gathered to form the first gathering point.

[0125] For example, 20 of the grid rows N are selected, and the tubular mesh 50 is rolled inward or outward at approximately 1 / 4 of its axial position. The first end of the tubular mesh 50 is approximately at approximately 1 / 3 of its axial position after rolling. Metal is gathered at approximately 1 / 3 of its axial position and at the other end of the original tubular mesh 50, respectively, using a gathering member or thermal pressing. Reverse forces are applied at approximately 1 / 3 of its axial position and at both ends of the newly formed end point after rolling, compressing it into an approximately planar mesh. Reverse forces are also applied at approximately 1 / 3 of its axial position and at the other end of the original tubular mesh 50, compressing it into an approximately planar mesh.

[0126] In other examples, 30 of the grid rows N are selected, and the tubular mesh 50 is rolled inward or outward approximately at the centerline of the axial direction, with the two ends of the original tubular mesh roughly overlapping. At approximately 1 / 3 of the rolled-up position, the metal is gathered at the two ends that roughly overlap with the original tubular mesh 50, using gathering tools or thermal pressing, etc. Reverse forces are applied at approximately 1 / 3 of the rolled-up position and at the two ends of the new end formed after the roll-up, compressing it into an approximately planar mesh. Reverse forces are applied at approximately 1 / 3 of the rolled-up position and at the two ends that roughly overlap with the original tubular mesh 50, compressing it into an approximately planar mesh.

[0127] Refer to the instruction manual appendix Figure 8a and 8b On the approximate planar network, the axial angle α of the grid 53 is converted into a radial angle β facing the center and the outer edge. The metal material is close to each other in the central region 12. The radial angle β of the grid 53 close to the central region 12 becomes smaller. The radial angle β of the first grid row N close to the center is set at 5°-15°. Starting from the second grid row N close to the center, the radial angle β returns to about 30°. The radial angle β of the grid 53 close to the edge may be larger, with a maximum angle not exceeding 150°.

[0128] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A method for manufacturing an interventional device for the atrial septum, characterized in that, The interventional device includes a support frame, the support frame comprising a first support frame and a second support frame, and the manufacturing method includes: Use metal wire to weave a tubular mesh; The first pre-gathering section of the tubular mesh is gathered to form the first gathering point; The second pre-gathering section of the tubular mesh is gathered to form a second gathering point; A middle end is selected between the first pre-gathering point and the second pre-gathering point of the tubular mesh to form a middle gathering point; The first support frame is formed by bringing the first convergence point and the intermediate convergence point close together and pressing the tubular mesh between the first convergence point and the intermediate convergence point along the central axis of the tubular mesh. The second support frame is formed by bringing the second convergence point close to the intermediate convergence point along the central axis of the tubular mesh and pressing the tubular mesh between the second convergence point and the intermediate convergence point. The metal wire at the first preset point on the first support frame is moved to expand and form a through-hole-shaped first passage; the first preset point is located in the peripheral area of ​​the first support frame; the outer edge of the first support frame is pushed to move towards the center at the first preset point, so that the inner side of the first passage is folded and connected to form a notch-shaped first passage at the first preset point. The metal wire at the second preset point on the second support frame is moved to expand and form a second passage, wherein the first passage is disposed opposite to the second passage and is adapted to form a diaphragm passage.

2. The method for manufacturing an interventional device for the atrial septum according to claim 1, characterized in that, The metal wire at the second preset point on the second support frame is moved to expand and form a second passage, including: the second preset point is located in the peripheral area of ​​the second support frame, and the metal wire at the second preset point is moved to form a through hole-shaped second passage.

3. The method for manufacturing an interventional device for the atrial septum according to claim 1, characterized in that, The first support frame has a first distal end face and a first proximal end face. The support frame also includes a first connector, which has a first end and a second end. The first end is connected to the first distal end face, and the second end extends beyond the first proximal end face. The second support frame has a second distal end face and a second proximal end face, the second distal end face being disposed opposite to the first proximal end face, the support frame further includes a second connector, the second connector having a third end and a fourth end, the third end being connected to the second distal end face, and the fourth end extending beyond the second distal end face; The first connector and the second connector are configured such that the diameter of the first end is greater than the diameter of the second end, and the diameter of the third end is greater than the diameter of the fourth end.

4. A method for manufacturing an interventional device for the atrial septum according to any one of claims 1-3, characterized in that, Also includes: Path markers are set around the first path and / or the second path.

5. A method for manufacturing an interventional device for the atrial septum according to any one of claims 1-3, characterized in that, Also includes: The side of the first support frame facing the second support frame is set as an arc-shaped surface; And / or, the side of the second support frame facing the first support frame is set as an arc-shaped surface.

6. A method for manufacturing an interventional device for the atrial septum according to any one of claims 1-3, characterized in that: The first and second ends of the tubular mesh respectively form the first pre-collection point and the second pre-collection point; or: The first end of the tubular mesh is folded inward or outward along the axis of the tubular mesh by a predetermined distance, and the first end and the corresponding tubular mesh are then gathered to form the intermediate gathering point; the second end of the tubular mesh is gathered to form the second gathering point; the overlapping end of the folded tubular mesh is gathered to form the first gathering point.

7. An interventional device for the atrial septum, characterized in that, Made by the manufacturing method of any one of claims 1-6 for an interventional device for the atrial septum; The support frame further includes a connector. The first support frame and the second support frame are arranged opposite to each other, and the first passage and the second passage are arranged opposite to each other. The two ends of the connector are respectively connected to the first support frame and the second support frame. The first support frame and the second support frame each include at least two support arms. Two adjacent support arms of the first support frame form the first passage, and two adjacent support arms of the second support frame form the second passage.

8. The interventional device for the atrial septum according to claim 7, characterized in that, The support arm has a first arc segment at one end away from the center of the first support frame or the center of the second support frame, and a third arc segment between two adjacent support arms. The support arm also has a second arc segment located between the first arc segment and the third arc segment. The shape of the first arc segment is adapted to the shape of the third arc segment, and one support arm of one interventional device is adapted to engage with the third arc segment between two adjacent support arms of another interventional device.

9. The interventional device for the atrial septum according to claim 7 or 8, characterized in that, The interventional device for the atrial septum further includes a blood flow blocking element disposed in the first access and / or the second access; The first support frame includes three support arms.

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