Atrial shunt decompression device, knitting device and knitting method thereof

Abstract

The present invention discloses an atrial shunt decompression device. In the atrial shunt decompression device, a left plate and a right plate are connected by a waist and are integrally formed; the left plate, the waist and the right plate are woven by a single braided wire. The single-wire weaving method can achieve the end fixation of all braided wires by a nut, reduce the number of nuts used, and reduce the size of the nuts, so that the cortex layer can be easily formed.

Description

Technical Field

[0001] The present invention relates to the technical field of structural design of equipment for interventional surgery to treat atrial shunts, and in particular to an atrial shunt decompression device, a knitting device and a knitting method thereof. Background Art

[0002] Heart failure is a common and potentially fatal disease that strikes humans, with suboptimal clinical outcomes often leading to illness, morbidity and / or death despite maximal treatment. In particular, "diastolic heart failure" refers to the clinical syndrome of heart failure that occurs in the absence of compensated left ventricular systolic function (ejection fraction) and in the absence of significant valvular disease. The disease is characterized by left ventricular stiffness with decreased compliance and impaired relaxation, resulting in elevated end-diastolic pressure. Approximately one-third of heart failure patients suffer from diastolic heart failure, and there are few proven effective treatments. The symptoms of diastolic heart failure are due, at least in large part, to elevated left atrial pressure. Elevated left atrial pressure (LAP) occurs in several abnormal cardiac conditions, including heart failure (HF). In addition to diastolic heart failure, a large number of other medical conditions, including left ventricular systolic dysfunction and heart valve disease, can cause elevated left atrial pressure. Both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) can exhibit elevated LAP. It is hypothesized that both subgroups of HF may benefit from a reduction in LAP, which in turn reduces the systolic preload on the left ventricle, the left ventricular end-diastolic pressure (LVEDP). It may also reduce stress on the pulmonary circulation, thereby reducing the risk of pulmonary edema, improving breathing, and improving patient comfort.

[0003] In the prior art, there is a shunt that is woven with multiple braided wires and then delivered to the atrial septum of the patient's heart through an interventional device. However, the shunt devices in the prior art are all woven with multiple wires and require multiple nuts to fix. In addition, there are too many braided wires, so larger nuts are required to fix them, which makes it difficult to form a cortical layer on the surface of the nut, and the adaptability to the human body is seriously reduced. In addition, the fixation of the multi-wire braided nut can easily affect the balance of the shunt and affect the use effect of the shunt device. Summary of the invention

[0004] In view of this, the main purpose of the present invention is to provide a device, a braiding device and a braiding method thereof, which can be used to fix the ends of all braided wires by means of a single-wire braiding method, thereby reducing the number of nuts used and the size of the nuts, and conveniently forming an atrial shunt decompression device, a braiding device and a braiding method of the cortical layer.

[0005] To achieve the above object, the technical solution of the present invention is achieved as follows:

[0006] An atrial shunt decompression device comprises: a left disc, a right disc and a waist portion, wherein the left disc and the right disc are connected and formed as one piece through the waist portion; the left disc, the waist portion and the right disc are woven by a single braided wire.

[0007] In a preferred embodiment, the braided wires are woven in an alternating manner in warp and weft, the braided wires are woven through the waist position multiple times, and adjacent warp braided wires and / or adjacent weft braided wires at the waist position are respectively bonded together.

[0008] In a preferred embodiment, among the braided wires at the waist, every adjacent continuous 2-6 warp braided wires and / or every adjacent continuous 2-6 weft braided wires at the waist position are respectively bonded together.

[0009] In a preferred embodiment, among the braided wires at the waist, every three consecutive warp braided wires and / or every three consecutive weft braided wires at the waist position are respectively bonded together.

[0010] In a preferred embodiment, for every three adjacent warp braiding wires or weft braiding wires, the two braiding wires on both sides are bent toward the middle braiding wire, and the two braiding wires on both sides are along the direction of the middle braiding wire, and the two braiding wires at the other end of the middle braiding wire are bent and woven separately.

[0011] In a preferred embodiment, the braided wires that are mutually attached in the warp direction and / or the weft direction are fixed by spirally winding the ends of the braided wires.

[0012] In a preferred embodiment, the ends of the braided wires are spirally wound and fixed at the intersections of the braided wires that are bonded in the warp or weft directions, and between two intersections of the braided wires that are bonded in the same radial or weft directions, the ends of the spirally wound braided wires are bonded along the radial or weft directions.

[0013] In a preferred embodiment, it also includes: a closing wire, which is used at one end of the left disk to close the support at the bend of the braided wire and extends obliquely to the disk surface of the right disk, and is fixed by a nut at the disk surface of the right disk.

[0014] In a preferred embodiment, the closing wire pair is braided in an "S" shape at the bending part of the braided wire.

[0015] In a preferred embodiment, the aperture of the closing wire after closing the bending part of the braided wire is larger than the inner aperture of the waist.

[0016] In a preferred embodiment, the closing wire extends obliquely to the waist, is transversely wound and woven 1-8 times at the waist, and the end extends obliquely to the disk surface of the right disk and is fixed by the nut.

[0017] In a preferred embodiment, the closing wire is arranged in an "S" shape at the waist and woven between the warp braiding wires that fit together and the braiding wires at the intersections formed by the braiding wires that fit together.

[0018] In a preferred embodiment, the diameters of the upper end, the middle part and the lower end of the inner diameter of the waist are all the same.

[0019] In a preferred embodiment, the nut of the right disk surface is arranged on one side of the upper surface of the disk surface.

[0020] In a preferred embodiment, the direction of the nut hole of the upper nut on the disk surface of the right disk is parallel to the disk surface plane of the right disk.

[0021] In a preferred embodiment, the closing thread is in a flat thread structure at the waist.

[0022] A braiding device for an atrial shunt decompression device comprises: a braided body mold of a tubular structure, wherein the outer wall of the braided body mold is evenly fixedly connected with limiting pins, so that the braided wire is limitedly wound around the outer wall of the braided body mold through the limiting pins.

[0023] In a preferred embodiment, the limiting pins include: upper bending limiting pins, upper waist limiting pins, lower waist limiting pins and lower bending limiting pins, and the upper bending limiting pins and lower bending limiting pins are arranged on the upper and lower sides of the weaving body mold; the upper waist limiting pins and lower waist limiting pins are arranged between the upper bending limiting pins and the lower bending limiting pins.

[0024] In a preferred embodiment, the number of the upper bending limiting pins is the same as the number of the lower bending limiting pins, and the number of the upper waist limiting pins is the same as the number of the lower waist limiting pins.

[0025] In a preferred embodiment, the planes on which the upper bending limiting pins, the upper waist limiting pins, the lower waist limiting pins and the lower bending limiting pins are respectively located are parallel to each other.

[0026] In a preferred embodiment, the distance between the upper bending limit pin and the upper waist limit pin is equal to the distance between the lower bending limit pin and the lower waist limit pin.

[0027] In a preferred embodiment, there are 12 upper bending limit pins and 12 lower bending limit pins.

[0028] In a preferred embodiment, each of the lower bending limiting pins is on the mid-vertical plane of the line connecting two adjacent upper bending limiting pins, or each of the lower bending limiting pins is directly below the upper bending limiting pins.

[0029] In a preferred embodiment, the braided body mold is provided with a wire threading groove along the vertical direction of the cylinder wall.

[0030] In a preferred embodiment, the limiting pins are all connected in the wire threading groove.

[0031] A method for preparing an atrial shunt decompression device comprises the following steps:

[0032] S1. Select any lower bending limit pin as the starting limit pin, and place the braided wire along the outer wall of the braided body mold from the starting limit pin and around the outer wall of the braided body mold obliquely for one circle to the upper bending limit pin corresponding to the starting limit pin;

[0033] S2, winding the braided wire obliquely downwards around one end of the upper bending limit pin to the lower bending limit pin adjacent to the starting limit pin; then continue to obliquely wind the braided wire around the lower bending limit pin to the adjacent upper bending limit pin, and then wind the braided wire obliquely downwards around one end of the upper bending limit pin to the next adjacent lower bending limit pin;

[0034] S3, repeat step S2 until the density of the entire woven mesh reaches the set density to form a woven body;

[0035] S4, removing all the limiting pins on the braided body mold, and separating the cylindrical braided body mold from the inner cavity of the braided body;

[0036] S5, the cylindrical structure braided body is subjected to first thermoplastic molding;

[0037] S6, placing the closing wire sleeve on the bending part of the braiding wire at the upper bending limit pin position, and wrapping the braiding wire in an "S" shape at the bending part of each upper bending limit pin to tighten the braiding wire to a set diameter to close the opening;

[0038] S7, when the closing wire is extended obliquely to the upper waist opening, the middle waist opening and the lower waist opening, it is changed to a horizontal spiral of 1-8 turns, and an "S" shape is formed at each intersection of the braiding wire to close the opening with a set diameter;

[0039] S8, placing the closing wire sleeve at the bending position of the lower bending limit pin of the braided wire, and winding it in an "S" shape at the bending position of each lower bending limit pin to weave into a set diameter closing;

[0040] S9, below the lower bending limit pin, the end of the braided wire is fixed by a nut;

[0041] S10, the braided body after the closing wire is closed is placed in a fixed mold for a second thermoplastic shaping.

[0042] In a preferred embodiment, in step S6, the two ends of the closing wire are fixed by the nut.

[0043] In a preferred embodiment, the closing wire is folded in half for use, and at the folded part of the closing wire, it is sleeved onto the bending part of the braiding wire at the upper bending limit pin; the two ends of the closing wire are respectively crossed in an "S" shape and woven around and through the bending of all the upper bending limit pins.

[0044] In a preferred embodiment, in step S2, when winding upward from the lower bending limit pin to the upper bending limit pin, it passes between two adjacent upper waist limit pins and lower waist limit pins; when winding upward from the lower bending limit pin to the upper bending limit pin, it passes between two adjacent upper waist limit pins and lower waist limit pins.

[0045] In a preferred embodiment, during the oblique winding process of the braiding wire, 2 to 6 consecutive braiding wires along the same direction are passed through the same pair of upper waist limiting pins and lower waist limiting pins.

[0046] In a preferred embodiment, during the oblique winding process of the braiding wire, each braiding wire needs to be woven inside and outside every 2-6 braiding wires between the upper bending limit pin and the upper waist limit pin, and between the lower bending limit pin and the lower waist limit pin.

[0047] In a preferred embodiment, during the oblique winding process of the braiding wire, three consecutive braiding wires along the same direction are passed through the same pair of upper waist limiting pins and lower waist limiting pins.

[0048] In a preferred embodiment, during the oblique winding of the braided wire, between the upper bending limit pin and the upper waist limit pin, and between the lower bending limit pin and the lower waist limit pin, each braided wire needs to be woven in and out every three braided wires. The present invention has the following beneficial effects:

[0049] The atrial shunt decompression device has a left disc and a right disc connected by a waist and integrally formed; the left disc, the waist and the right disc are woven by a single braided wire. The single-wire weaving method enables the ends of all braided wires to be fixed by a nut, reduces the number of nuts used, and reduces the size of the nut, which can easily form a cortical layer. This solves the problem in the prior art that the nuts required for multiple braided wires are large in size, making it difficult to form a cortical layer, and that nuts are required to be used to fix the left and right discs, resulting in an unbalanced structure and uneven force.

[0050] The atrial shunt decompression device uses a braiding device, including: a braided body mold of a cylindrical structure, the outer wall of the braided body mold is evenly fixedly connected with a limiting pin, so that the braided wire is limitedly wound around the outer wall of the braided body mold through the limiting pin. The braiding method of the single wire can be met, and the molding of the single wire braided shunt decompression device is ensured.

[0051] The preparation method of the atrial shunt decompression device includes: weaving, thermoplastic molding, weaving closing wires, fixing ends with nuts, and thermoplastic molding again; the weaving method is simple and easy to process, and can even be produced in small batches by hand to reduce costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Figure 1 A top view of an atrial shunt pressure relief device according to one embodiment of the present disclosure;

[0053] Figure 2 is a side view of an atrial shunt pressure relief device according to one embodiment of the present disclosure;

[0054] Figure 3 A bottom view of an atrial shunt pressure relief device according to one embodiment of the present disclosure;

[0055] Figure 4 is a cross-sectional view of an atrial shunt pressure relief device according to one embodiment of the present disclosure;

[0056] Figure 5 A front view of a device for using an atrial shunt pressure relief device according to one embodiment of the present disclosure;

[0057] Figure 6 A top view of a braided device for use with an atrial shunt pressure relief device according to one embodiment of the present disclosure;

[0058] Figure 7 It is a partially enlarged schematic diagram of a braided body in a braiding method of an atrial shunt decompression device according to one embodiment of the present disclosure.

[0059]

Main component symbol description

[0060] 1. Left plate, 2. Right plate, 3. Waist, 4. Nut;

[0061] 10. braided yarn, 11. warp braided yarn, 12. weft braided yarn, 13. intersection;

[0062] 20. Weaving body mold, 21. Limiting pins, 211. Upper bending limiting pins, 212. Upper waist limiting pins, 213. Lower waist limiting pins, 214. Lower bending limiting pins. DETAILED DESCRIPTION

[0063] The atrial shunt decompression device, the weaving device and the weaving method of the present invention are further described in detail below in conjunction with the accompanying drawings and embodiments of the present invention.

[0064] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0065] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0066] It should be noted that the terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchangeable where appropriate, so that the embodiments of the present application described herein can be implemented in an order other than those illustrated or described herein, for example. In addition, the terms "including" and "having" and any of their variations are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units that are clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0067] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0068] like Figure 1 , Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 6 and Figure 7As shown, the atrial shunt decompression device includes: a left plate 1 and a right plate 2 respectively arranged at the interval between the left atrium and the right atrium; and a waist 3 for connecting the left plate 1 and the right plate 2, and the left plate 1 and the right plate 2 are connected and formed as one piece through the waist 3.

[0069] In order to reduce the requirements for the size of the fixings (rivets, nuts, etc.) required for fixing the ends of the braided wires, the left plate 1, the waist 3 and the right plate 2 are formed by weaving a single braided wire 10. After the braided wire 10 is woven, the entire structure is in an integral shape, and all the braided wires 10 are connected to each other to ensure the strength of the entire decompression device. The size of the fixings (rivets, nuts, etc.) required for the two braided wires 10 is much smaller than the braiding method of multiple wires (more than one) in the prior art (the fixings used in the decompression device of the present application are 1 / 5-1 / 2 of the fixings in the prior art), which can greatly reduce the size of the interventional device. Furthermore, the scope of interventional surgery is expanded, and the treatment effect can also be met for patients with thinner blood vessels such as children or the elderly. In the prior art, the decompression device is all woven by multi-wires, and single-wire weaving cannot be used. In particular, in the weaving method of the prior art, the braided wire can only be woven obliquely from one direction to another, and only multiple braided wires can meet the requirements of the weaving density. There is a technical bias among technicians in the prior art against the monofilament weaving method, and it is generally believed that the monofilament weaving method cannot be used, which has led to the monofilament weaving method not being studied. Especially in mechanized production, the multi-filament weaving method in the prior art can speed up the processing process, so the monofilament weaving method has always been subject to technical bias by researchers in the industry.

[0070] Furthermore, the smaller the size of the fixing part, the closer the fixing part fits to the surface of the right disk, and the more convenient the endothelialization is, the more adaptable it is to the internal fluid of the body.

[0071] In order to increase the size of the mesh of the waist 3 without lowering the waist, and reduce the density of the mesh; and then reduce the thickness of the cortical layer formed at the waist 3, and further avoid the cortical layer at the waist 3 being too thick. During the long-term use of the decompression device, the cortical layer blocks the inner hole inside the waist 3, and then reduces the diversion effect of the decompression device. The braided wire 10 is woven in a warp and weft interlaced manner, and the braided wire 10 is woven through the waist 3 position for many times. The adjacent warp braided wires 11 and / or adjacent weft braided wires 12 at the waist 3 position are respectively bonded together (the adjacent warp braided wires 11 at the waist 3 position are bonded together; and / or the adjacent weft braided wires 12 are bonded together; here, the radial braided wires 11 and the weft braided wires 12 only have the function of braiding, and there is no other connection relationship between them). And the bonded braided wires can be some longitudinal and / or some weft braided wires bonded, not necessarily all the braided wires must be bonded, of course, all the braided wires can be bonded. The overall strength of the braided wires 10 that are attached together is not reduced, and the strength of a single braided wire (the braided wires that are attached together are one strand) is also increased, thereby improving the strength stability of the entire decompression device.

[0072] Preferably, in the braided wires 10 of the waist 3, every adjacent continuous 2-6 warp braided wires 11 and / or every adjacent continuous 2-6 weft braided wires 12 at the waist 3 are respectively bonded together. That is, the first to the second or sixth braided wires are bonded together. The number of each braided wire is not necessarily the same, as long as the waist 3 structure is balanced and stable, and not all bonded braided wires are necessarily the same.

[0073] Further preferably, in the braided wires 10 of the waist 3, each adjacent continuous three warp braided wires 11 and / or each adjacent continuous three weft braided wires 12 are respectively attached together at the waist 3. That is, preferably, the number of radial braided wires 11 and the number of weft braided wires 12 are both multiples of 3, so that each braided wire is the same, and all the braided wires are just stranded together, and the balance of the waist 3 structure is achieved.

[0074] Specifically, the weaving structure of the three braided wires is: for every three adjacent warp braided wires 11 or weft braided wires 12, the two braided wires 10 on both sides are bent toward the middle braided wire 10, and the two braided wires 10 on both sides are along the direction of the middle braided wire 10, and the two braided wires 10 at the other end of the middle braided wire 10 are bent and woven separately. That is: the position where the braided wires are attached together is a strand-shaped braided wire, and at the two ends of the strand-shaped braided wire, the three braided wires are forked and separated; the three braided wires can be divided into: left wire, middle wire and right wire, and the left wire and the right wire are attached to the middle wire at the two ends of the strand-shaped braided wire respectively to form a strand-shaped braided wire.

[0075] In order to further ensure the binding force between the multiple wires in each braided wire (for example, when three braided wires are stranded together, the direct adhesion strength is not enough and they are easy to separate, so that the effect of the three braided wires stranded together disappears.), the braided wires 10 that are mutually adhered in the warp and / or weft directions are spirally wound and fixed through the ends of the braided wires 10. Only the two ends of the strand-shaped braided wire are spirally wound and fixed, which ensures the strength of the strand-shaped braided wire and avoids the waist compression size being too large to affect the intervention.

[0076] Of course, in another embodiment, in order to ensure the binding strength of the strand-shaped braided wire, the end of the braided wire 10 is spirally wrapped and fixed at the intersection 13 of the braided wire 10 that is bonded in the warp or weft direction, and the end of the spirally wound braided wire 10 is bonded along the radial or weft direction of the braided wire 10 between two intersection points 13 of the braided wire 10 that is bonded in the same radial or weft direction.

[0077] In order to ensure the fixed support effect on the bend of the braided wire (i.e., the upper end of the braided body), the decompression device also includes: a closing wire, which is used at one end of the left disc 1 to close and support the braided wire 10 at the bend, and all the braided wires are connected into one at the upper bend through the closing wire to ensure the fixing strength. The end of the closing wire extends obliquely to the disk surface of the right disc 2, and is fixed by a nut 4 at the disk surface of the right disc 2. The overall connection strength of the closing wire is ensured, and other fixing parts are avoided to increase the size of the decompression device. The left disc 1 has no rivets to avoid eccentric stress at the end of the left disc 1, thereby increasing the symmetry of the disk surface and the stability of the waist structure.

[0078] In order to ensure the fixing strength of the braided wire, the closing wire pair is braided in an "S" shape at the bend of the braided wire 10. Thus, the braided wire and the closing wire interact with each other, which not only realizes the support and fixation of the braided wire, but also avoids the closing wire from slipping, further ensuring the fixing strength of the braided wire.

[0079] Since there are many structural bends at the bends of the braided wire 10, it is easy to form a cortical layer at the bends, and in order to cover the bends, the thickness of the cortical layer is usually relatively large. In order to avoid the bends of the braided wire 10 limiting the waist aperture, thereby limiting the decompression flow of the shunt decompression device. The aperture of the closing wire after closing the bend of the braided wire 10 is larger than the inner aperture of the waist 3, thereby ensuring that the shunt size of the entire decompression device is limited by the aperture of the waist.

[0080] In order to further ensure the support strength of the waist 3 and thus the strength of the entire decompression device, the closing wire extends obliquely to the waist 3, is transversely wound and braided 1-8 times on the waist 3, and the end extends obliquely to the disk surface of the right disk 2 and is fixed by the nut 4.

[0081] In order to ensure the fixed connection strength of the closing wire at the waist 3, the closing wire is arranged in an "S" shape at the waist 3 and woven between the braided wires 10 at the intersection 13 formed by the warp braided wires that fit together and the braided wires that fit together, so that the closing wire is fixed by the braided wire 10 to ensure the fixed position of the closing wire, thereby ensuring the supporting effect on the waist 3.

[0082] Preferably, the diameters of the upper, middle and lower ends of the inner diameter of the waist 3 are the same, so as to ensure the effect of reducing pressure and diverting the inner hole of the waist 3.

[0083] Preferably, the nut 4 of the right plate 2 is arranged on one side of the upper surface of the plate, which is equivalent to the nut offset, so that the nut 4 fits the atrial septum better and promotes the coverage of the nut 4 by endothelialization.

[0084] In order to facilitate the recovery or replacement of the decompression device, the nut hole direction of the nut 4 on the upper side of the right disk 2 is parallel to the disk plane of the right disk 2. During the recovery or replacement process, a set of threads can be set inside the interventional device, and the threads can be inserted into the position of the decompression device, and the horizontal nut can be sleeved by the threads, so that the entire decompression device can be pulled into the interventional pipeline, thereby realizing the recovery of the entire decompression device and reducing the risk of surgery.

[0085] In order to further improve the supporting effect of the closing wire at the waist 3, preferably, the closing wire is a flat wire structure at the waist 3. Preferably, the flat wire is not directly pressed, and the entire closing wire is integrally formed, and the cross-sectional area at the flat wire structure is larger than the cross-sectional area at other positions of the closing wire.

[0086] The present invention also discloses a weaving device for use with an atrial shunt decompression device, comprising: a weaving body mold 20 of a tubular structure that supports and fixes the weaving wire, the outer wall of the weaving body mold 20 being evenly fixedly connected with limiting pins 21, so that the weaving wire 10 is limitedly wound around the outer wall of the weaving body mold 20 by the limiting pins 21, and the weaving direction of the weaving wire can be changed by the action of the limiting pins 21, thereby limiting the weaving structure of the weaving wire, thereby forming a weaving body.

[0087] The limiting pin 21 includes: an upper bending limiting pin 211 for limiting the bending of the braided wire 10 from top to bottom, an upper waist limiting pin 212 and a lower waist limiting pin 213 for adjusting the braiding direction of the braided wire 10, and a lower bending limiting pin 214 for limiting the bending of the braided wire from bottom to top. The upper bending limiting pin 211 and the lower bending limiting pin 214 are arranged on the upper and lower sides of the braiding body mold 20, not completely to the end, and a certain space is reserved at the upper and lower ends to facilitate the subsequent braiding work. Of course, in order to achieve the restriction on the direction of the braided wire 10, the upper waist limiting pin 212 and the lower waist limiting pin 213 are arranged between the upper bending limiting pin 211 and the lower bending limiting pin 214.

[0088] Of course, in order to ensure that each limiting pin 21 can be used and avoid redundant limiting pins 21, and the redundant limiting pins 21 interfere with the knitting work of the knitting personnel on the knitting body, the number of the upper bending limiting pins 211 is the same as the number of the lower bending limiting pins 214, and the number of the upper waist limiting pins 212 is the same as the number of the lower waist limiting pins 213.

[0089] Furthermore, in order to ensure that during the weaving process, the upper bending limit pin 211, the upper waist limit pin 212, the lower waist limit pin 213 and the lower bending limit pin 214 are located between the limit pins at various positions, and the planes where they are located are parallel to each other.

[0090] In order to ensure that the left plate 1 and the right plate 2 are symmetrical with each other, the distance between the upper bending limit pin 211 and the upper waist limit pin 212 is equal to the distance between the lower bending limit pin 213 and the lower waist limit pin 214.

[0091] Further preferably, in practice, it is found that in the most reasonable structure of the atrial decompression device, it is most reasonable to have 12 upper bending limit pins 211 and 12 lower bending limit pins 212, which can achieve a stronger shunting effect and avoid excessive braiding wire density that affects the intervention process.

[0092] In order to ensure that the entire woven decompression device is more reasonable in structure, especially all the upward braiding wires and the downward braiding wires have the same inclination angle (that is, the radial braiding wires and the weft braiding wires have the same angle with the central axis of the decompression device), each lower bending limit pin 214 is on the mid-vertical plane of the line connecting two adjacent upper bending limit pins 211, or each lower bending limit pin 214 is directly below the upper bending limit pin 211.

[0093] In order to facilitate the insertion of the braiding wire 10 and ensure the braiding strength, the braiding body mold 20 is provided with a wire threading groove 22 along the vertical direction of the cylinder wall. When the braiding wire 10 needs to be wound around the lower side of the braiding wire 10 during the weaving process, the braiding wire can pass through the wire threading groove 22 to facilitate weaving.

[0094] Of course, for the fixing strength of the limiting pin 21 and the convenience of the weaving process, the limiting pin 21 is connected to the threading groove 22. Preferably, the end of the limiting pin 21 is threaded and is connected with the threaded hole opened at the bottom of the threading groove 22.

[0095] The present invention also discloses a method for preparing an atrial shunt decompression device, comprising the following steps:

[0096] S1. Select any lower bending limit pin 214 as the starting limit pin (just for the convenience of writing the plan, the meaning is clear), and the braiding wire 10 is obliquely arranged along the outer wall of the braiding body mold 20 from the starting limit pin around the outer wall of the braiding body mold 20 to the upper bending limit pin 211 corresponding to the starting limit pin (in order to facilitate the braiding personnel to observe the braiding position accurately, the upper bending limit pin just above is selected. In the specific braiding process, and when the automatic braiding can be realized in the later stage, the upper bending limit pins 211 at different positions can be selected);

[0097] S2, the braided wire is wound around one end of the upper bending limit pin 211 obliquely downward to the lower bending limit pin 214 adjacent to the starting limit pin (for example, obliquely upward from bottom to top, the adjacent lower bending limit pin 214 at this location is: a lower bending limit pin 214 on the left side of the starting limit pin); then continue to be wound around the lower bending limit pin 214 obliquely to the adjacent upper bending limit pin 211 (similar to step S1), and then the braided wire 10 is wound around one end of the upper bending limit pin 211 obliquely downward to the next adjacent lower bending limit pin 214;

[0098] S3, repeating step S2 until the density of the entire braided mesh reaches the set density, forming a braided body (it can also be understood that the braided wires are evenly woven on the outer wall of the braided body mold 20);

[0099] S4, remove all the limiting pins 21 on the braided body mold 20 (the limiting pins 21 are detachably connected, and the braided body and the braided body mold 20 can be conveniently separated by conveniently removing them), and separate the cylindrical braided body mold 20 from the inner cavity of the braided body;

[0100] S5. The cylindrical braided body is subjected to the first thermoforming (ensuring that the entire braided body maintains a certain structural shape);

[0101] S6, the closing wire sleeve is arranged at the bending part of the braiding wire 10 at the position of the upper bending limit pin 211, and the closing wire sleeve is wound in an "S" shape at each bending part of the upper bending limit pin 211 and braided and tightened to a set diameter;

[0102] S7, when the closing wire is extended obliquely to the upper waist opening, the middle waist opening and the lower waist opening, it is changed to a horizontal spiral of 1-8 turns, and the crossing point 13 of each braiding wire 10 is wound in an "S" shape to weave into a set diameter closing;

[0103] S8, the closing wire sleeve is arranged at the bending position of the lower bending limit pin of the braiding wire 10, and the bending position of each lower bending limit pin 214 is wound in an "S" shape to weave into a set diameter closing;

[0104] S9, below the lower bending limit pin 214, the end of the braided wire 10 is fixed by a nut 4;

[0105] S10, the braided body after the closing wire is closed is placed in a fixed mold for a second thermoplastic shaping, and the desired product is obtained by molding, such as Figure 1-4 .

[0106] Preferably, in step S6 , the two ends of the closing wire are fixed by nuts 4 .

[0107] The closing wire is folded in half for use (which can further ensure the limiting and fixing effect at the bend of the upper bending limit pin 211), and at the folded part of the closing wire, it is sleeved onto the bend of the braiding wire 10 at the upper bending limit pin 211; the two ends of the closing wire are respectively crossed in an "S" shape and wrapped around and woven through all the bends of the upper bending limit pins 211.

[0108] Preferably, in step S2, when winding upward from the lower bending limit pin 214 to the upper bending limit pin 211, it passes through between the two adjacent upper waist limit pins 212 and the lower waist limit pins 213; when winding upward from the lower bending limit pin 214 to the upper bending limit pin 211, it passes through between the two adjacent upper waist limit pins 212 and the lower waist limit pins 213, thereby ensuring a better fixation effect on the braided wire.

[0109] Preferably, during the oblique winding process of the braided wire 10, 2 to 6 consecutive braided wires 10 along the same direction are passed through the same pair of upper waist limiting pins 212 and lower waist limiting pins 213.

[0110] Further preferably, during the oblique winding process of the braiding wire 10, between the upper bending limit pin 211 and the upper waist limit pin 212, and between the lower bending limit pin 214 and the lower waist limit pin 213, each braiding wire 10 needs to be woven inside and outside every 2-6 braiding wires 10.

[0111] Preferably, during the oblique winding process of the braided wire 10, three consecutive braided wires 10 along the same direction are passed through the same pair of upper waist limiting pins 212 and lower waist limiting pins 213.

[0112] Preferably, during the oblique winding process of the braiding wire 10, each braiding wire 10 needs to be woven inside and outside every three braiding wires 10 between the upper bending limit pin 211 and the upper waist limit pin 212, and between the lower bending limit pin 214 and the lower waist limit pin 213.

[0113] The above description is only a preferred embodiment of the present invention and is not intended to limit the protection scope of the present invention.

Claims

1. An atrial shunt decompression device, characterized in that: include: A left plate (1), a right plate (2) and a waist portion (3), wherein the left plate (1) and the right plate (2) are connected and formed into one piece via the waist portion (3); The left plate (1), the waist (3) and the right plate (2) are woven by a single braiding wire (10); The braided wires (10) are woven in an interlaced manner in warp and weft, and the braided wires (10) are woven through the waist (3) position for multiple times, and adjacent warp braided wires (11) and adjacent weft braided wires (12) at the waist (3) position are respectively bonded together, thereby increasing the size of the mesh of the waist (3), reducing the density of the mesh, and reducing the thickness of the cortical layer formed at the waist (3); Among the braided wires (10) of the waist (3), three adjacent and continuous warp braided wires (11) and three adjacent and continuous weft braided wires (12) at the waist (3) are respectively bonded together; For every three adjacent warp braiding wires (11) and weft braiding wires (12), two braiding wires (10) on both sides are bent toward the middle braiding wire (10), and the two braiding wires (10) on both sides are bent along the direction of the middle braiding wire (10), and the two braiding wires (10) at the other end of the middle braiding wire (10) are separately braided; The ends of the braided wires (10) are spirally wound and fixed at the intersections (13) of the braided wires (10) that are bonded in the warp or weft directions, and the ends of the spirally wound braided wires (10) are bonded along the braided wires (10) in the radial or weft directions between two intersections (13) of the braided wires (10) that are bonded in the same radial or weft directions.

2. The atrial shunt pressure relief device according to claim 1, characterized in that: It also includes: a closing wire, which is used at one end of the left disk (1) to close the support at the bend of the braided wire (10), and extends obliquely to the disk surface of the right disk (2), and is fixed at the disk surface of the right disk (2) by a nut (4).

3. The atrial shunt pressure relief device according to claim 2, characterized in that: The closing wire pair is braided in an "S" shape at the bending position of the braiding wire (10).

4. The atrial shunt pressure relief device according to claim 2, characterized in that: The aperture of the closing wire after closing the bending part of the braided wire (10) is larger than the inner aperture of the waist (3).

5. The atrial shunt pressure relief device according to claim 2, characterized in that: The closing wire extends obliquely to the waist (3), is transversely wound and woven 1 to 8 times at the waist (3), and the end portion extends obliquely to the disk surface of the right disk (2) and is fixed by the nut (4).

6. The atrial shunt pressure relief device according to claim 5, characterized in that: The closing wire is arranged in an "S" shape around the waist (3) and woven between the warp braided wires that fit together and the braided wires (10) at the intersection (13) formed by the braided wires that fit together.

7. The atrial shunt pressure relief device according to claim 5, characterized in that: The diameters of the upper end, the middle part and the lower end of the inner diameter of the waist (3) are all the same.

8. The atrial shunt pressure relief device according to claim 5, characterized in that: The nut (4) of the disk surface of the right disk (2) is arranged on one side of the upper surface of the disk surface.

9. The atrial shunt pressure relief device according to claim 8, characterized in that: The direction of the nut hole of the upper nut (4) on the disk surface of the right disk (2) is parallel to the disk surface plane of the right disk (2).

10. The atrial shunt pressure relief device according to claim 2, characterized in that: The closing thread is in a flat thread structure at the waist (3).

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