Method for manufacturing a braided stent and braided stent

Abstract

The present application provides a method for manufacturing a woven bracket and a woven bracket, the method for manufacturing the woven bracket comprising: forming a frustum mold, wherein the frustum mold comprises a base plate and a plurality of first bosses and a plurality of second bosses located on the base plate; the plurality of first bosses are located in a first circumferential area of ​​the frustum mold, and the plurality of second bosses are located in a second circumferential area of ​​the frustum mold, and the first circumferential area and the second circumferential area have a height difference; a woven wire is wound along the plurality of first bosses and the plurality of second bosses to form a closed woven bracket; wherein the portion of the woven bracket wound around at least a portion of the plurality of first bosses is annular, and the portion of the woven bracket wound around the plurality of second bosses is arc-shaped.

Description

Technical Field

[0001] The present application relates to, but is not limited to, the field of medical device technology, and in particular to a method for manufacturing a braided stent and a braided stent. Background Art

[0002] Interventional surgery is an optional treatment for various cardiovascular-related diseases, including heart valve disease. The native valves (such as the aortic valve, pulmonary valve, atrioventricular valve, etc.) in biological organisms, such as the test subject, play a vital role in the functioning of the blood circulation system. If you suffer from congenital or acquired valve diseases, such as aortic mitral valve or valve calcification, the valve may not open and close normally, which will increase the heart load and affect the blood supply to other organs. Transcatheter Valve Therapies (TVR) is a treatment for heart valve disease. Guided by a guidewire, the stent is delivered to the valve area and the native valve is propped open. The artificial valve on the stent replaces the native valve to work. This method avoids surgical open-chest surgery, reduces the trauma of the treatment process, and is also suitable for some elderly or physically weak patients.

[0003] During TVR surgery, the presence of calcified tissue can prevent the valve stent from properly fitting with the annulus, potentially leading to blood ejection from the poorly fitted area and causing leakage. Currently, there are two main methods for intraoperatively assessing leakage: 1) injecting contrast agent and monitoring its flow under X-rays; 2) assessing leakage using color Doppler ultrasound. Both methods rely on two-dimensional medical images to determine leakage and are unable to accurately locate areas of poor fit. Summary of the Invention

[0004] An embodiment of the present application provides a method for manufacturing a woven stent and a woven stent. The woven stent manufactured by the manufacturing method provided in the present application serves as a carrying structure of a detection device and is sent to a detection position to accurately locate the area where the valve ring and the valve stent are poorly fitted, thereby solving the problem in related technologies that in the process of judging whether perivascular leakage occurs through two-dimensional medical images, the area where the poor fitting cannot be accurately located.

[0005] The technical solution of the embodiment of the present application is implemented as follows:

[0006] A method for manufacturing a braided stent, comprising:

[0007] forming a truncated cone mold, wherein the truncated cone mold comprises a base plate and a plurality of first bosses and a plurality of second bosses located on the base plate; the plurality of first bosses are located in a first circumferential region of the truncated cone mold, the plurality of second bosses are located in a second circumferential region of the truncated cone mold, and the first circumferential region and the second circumferential region have a height difference;

[0008] A braided wire is wound along the multiple first bosses and the multiple second bosses to form a closed braided bracket; wherein the portion of the braided bracket wound around at least some of the multiple first bosses is annular, and the portion of the braided bracket wound around the multiple second bosses is arc-shaped.

[0009] A braided stent, wherein a detection device is mounted on a side wall near an arcuate portion of a partial mesh of the braided stent; the detection device transmits a detection signal to an external receiving device via a wired or wireless method;

[0010] The radial inner side and the radial outer side of the braided stent are both covered with a skirt section, wherein the skirt section is used to fix the detection device;

[0011] Wherein, the detection device is used in the process of placing the valve stent, when the bottom area of ​​the valve stent is close to the valve ring area of ​​the detection object, the woven stent is aligned with the bottom area, and the detection device is aligned with the bottom grid of the valve stent, and the detection device outputs a detection signal to the external receiving device; wherein, among all the detection signals output by the detection devices, the signal with abnormal fluctuation indicates that paravalvular leakage occurs near the detection device.

[0012] The manufacturing method of the woven stent provided in the present application includes: forming a frustum mold, wherein the frustum mold includes a base plate and a plurality of first bosses and a plurality of second bosses located on the base plate; the plurality of first bosses are located in the first circumferential area of ​​the frustum mold, and the plurality of second bosses are located in the second circumferential area of ​​the frustum mold, and the first circumferential area and the second circumferential area have a height difference; using a woven wire to wrap along the plurality of first bosses and the plurality of second bosses to form a closed woven stent; wherein the portion of the woven stent wrapped around at least part of the plurality of first bosses is annular, and the portion of the woven stent wrapped around the plurality of second bosses is arc-shaped; the woven stent manufactured by the above manufacturing method is used as a carrying structure of the detection device and is sent to the detection position to accurately locate the area where the valve stent and the valve ring are poorly fitted, thereby solving the problem in the related art that the poorly fitting area cannot be accurately located in the process of judging whether perivascular leakage occurs through two-dimensional medical images. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 Schematic diagram of the process of manufacturing the braided stent provided in the embodiment of the present application Figure 1 ;

[0014] Figure 2 Schematic diagram of the manufacturing process of the braided stent provided in the embodiment of the present application Figure 1 ;

[0015] Figure 3 A schematic diagram of a detection device provided in an embodiment of the present application mounted on a braided stent;

[0016] Figure 4 A schematic diagram of the deployment of a valve stent provided in an embodiment of the present application;

[0017] Figure 5 Schematic diagram of the placement of the braided stent and the detection device provided in the embodiment of the present application when measuring fit;

[0018] Figure 6 Schematic diagram of the process of manufacturing the braided stent provided in the embodiment of the present application Figure 2 ;

[0019] Figure 7 Schematic diagram of the process of manufacturing the braided stent provided in the embodiment of the present application Figure 3 ;

[0020] Figure 8 Schematic diagram of the manufacturing process of the braided stent provided in the embodiment of the present application Figure 2 ;

[0021] Figure 9 Schematic diagram of the manufacturing process of the braided stent provided in the embodiment of the present application Figure 3 ;

[0022] Figure 10 Schematic diagram of the process of manufacturing the braided stent provided in the embodiment of the present application Figure 4 ;

[0023] Figure 11 The structural diagram of the tripod provided in the embodiment of the present application Figure 1 ;

[0024] Figure 12 A schematic diagram of the structure of the braided bracket provided in an embodiment of the present application, wherein the ring is hung on the hook of the tripod;

[0025] Figure 13 Schematic diagram of a traction rope passing through a lifting ring and a threading hole provided in an embodiment of the present application;

[0026] Figure 14 A schematic diagram of a traction rope provided in an embodiment of the present application being led out from a lead-in port after being looped around once;

[0027] Figure 15A schematic diagram of a wire provided in an embodiment of the present application being connected to a detection device and passing through a lifting ring and being led out from a lead-in port;

[0028] Figure 16 A schematic diagram of a valve ring and a valve stent that are poorly fitted together and cause circumferential leakage when a valve stent is placed, as provided in an embodiment of the present application;

[0029] Figure 17 A schematic diagram of the relative positions of the support arm, artificial valve, detection device and cardiac sinus provided in an embodiment of the present application;

[0030] Figure 18 Schematic diagram of aligning a valve stent, a braided stent, a detection device, and a support arm before compression provided in an embodiment of the present application;

[0031] Figure 19 A schematic diagram of using a catheter sheath to push down and start compressing the stent after the lock buckle and the locking element are aligned according to an embodiment of the present application;

[0032] Figure 20 A schematic diagram of a valve stent provided in an embodiment of the present application being housed in a proximal catheter sheath and then delivered to the cardiac sinus region via a guidewire;

[0033] Figure 21 A schematic diagram of the embodiment of the present application showing the catheter sheath being withdrawn upwards to completely release the valve stent;

[0034] Figure 22 A schematic diagram of storing a braided stent and withdrawing it from a detection object provided in an embodiment of the present application. DETAILED DESCRIPTION

[0035] It should be understood that the “embodiments of the present application” or “the aforementioned embodiments” mentioned throughout the specification mean that the specific features, structures or characteristics related to the embodiments are included in at least one embodiment of the present application. Therefore, “in the embodiments of the present application” or “in the aforementioned embodiments” appearing throughout the specification do not necessarily refer to the same embodiment. In addition, these specific features, structures or characteristics can be combined in one or more embodiments in any suitable manner. In the various embodiments of the present application, the size of the serial numbers of the above-mentioned processes does not mean the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application. The serial numbers of the above-mentioned embodiments of the present application are for description only and do not represent the advantages and disadvantages of the embodiments.

[0036] In order to make the purpose, technical solutions and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings. The described embodiments should not be regarded as limiting this application. All other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein are for the purpose of describing the embodiments of this application only and are not intended to limit this application.

[0038] In the embodiments of the present application, the "inflow end" and "outflow end" of the artificial heart valve stent and its components, the artificial heart valve and its components are defined according to the direction of blood flow in the ventricular diastolic state, wherein the "inflow end" refers to the end close to the blood inflow side or the ventricular side; the "outflow end" refers to the end close to the blood outflow side or the aorta side. "Axial" refers to the direction parallel to the line connecting the center of the outflow end and the center of the inflow end. "Radial" refers to the direction perpendicular to or approximately perpendicular to the axial direction. "Circumferential" refers to the direction surrounding the axial direction.

[0039] The artificial heart valve stent has two states: a radially compressed delivery state and a radially expanded natural state. In the delivery state, the artificial heart valve stent is radially compressed by external force, allowing it to fit into a sheath with a smaller radial dimension, allowing it to be delivered to the heart via a delivery device. In the natural state, the artificial heart valve stent is free from external force and naturally expands radially.

[0040] The present invention provides a method for manufacturing a braided stent. Figure 1 Shown, including:

[0041] Step 101: forming a frustum mold.

[0042] See also Figure 2 As shown, the frustum mold 11 includes a base plate 111 and a plurality of first bosses 112 and a plurality of second bosses 113 located on the base plate; the plurality of first bosses are located in the first circumferential area 114 of the frustum mold, and the plurality of second bosses are located in the second circumferential area 115 of the frustum mold, and the first circumferential area 114 and the second circumferential area 115 have a height difference.

[0043] In the embodiment of the present application, the boss includes but is not limited to a frustum, a prism, a cylinder, an elliptical cylinder or a prism.

[0044] Step 102 : Winding the braided wire along the plurality of first bosses and the plurality of second bosses to form a closed braided stent.

[0045] See also Figure 2 As shown, the braided wire 12 is wound along the plurality of first bosses 112 and the plurality of second bosses 113 to form a closed braided stent 1 .

[0046] Among them, see Figure 2 and Figure 3As shown, the portion of the braided stent 1 wound around at least some of the first bosses 112 is in a ring shape 13 , and the portion of the braided stent 1 wound around the second bosses 113 is in an arc shape 14 .

[0047] In some embodiments, a braided wire is wound along a plurality of first bosses and a plurality of second bosses, and each grid on the finally formed braided stent has a ring; wherein, when each grid has a ring, some of the rings are used to fix the delivery device to the braided stent, and the remaining rings can be used to guide the wires and / or traction ropes, and the lead-in port on the head of the delivery device can also be used to guide the traction rope and / or wires. At this time, when a wired method is used to transmit the detection signal, the wire is connected to the detection device and then passes through the ring, and then gathers at the lead-in port of the delivery device, thereby leading it outside the body of the detection object and connecting it to the measurement circuit.

[0048] In other embodiments of the present application, after the braided wire is wound along multiple first bosses and multiple second bosses to form a closed braided stent in step 102, a shaping technology can be used to shape the formed closed braided stent; in this way, the shape of the braided stent is maintained and it will not be deformed even after the truncated cone mold is removed.

[0049] In other embodiments of the present application, a braided wire formed of metal wires is provided before winding with the braided wire; wherein the braided wire is a single wire comprising a single metal wire, or the braided wire is at least two wires composed of at least two metal wires.

[0050] Here, the metal wire includes but is not limited to stainless steel, nickel-titanium alloy and other wires that have good compatibility with the blood of the test subject.

[0051] After the braided stent is manufactured, in a feasible application scenario where a detection device is mounted, see Figure 3 As shown, a detection device 2 for measuring whether perioperative leakage occurs is mounted on a braided support 1. Further, the braided support 1 equipped with the detection device 2 is described. In a partial grid of the braided support 1, a detection device 2 is mounted on the side wall close to the arc portion; the detection device 2 sends the detection signal to an external receiving device via a wired manner; wherein, the detection device 2 is provided with an electronic sensing element, which changes its resistance, inductance or capacitance value under the influence of a detection variable (such as pressure, flow or deformation, etc.), and the external receiving device supplies power to the detection device 2, and at the same time analyzes the current and voltage of the electronic sensing element to obtain properties such as resistance, inductance or capacitance value, and further derives the value of the detection variable from the properties of the electronic sensing element.

[0052] The radial inner side and the radial outer side of the braided stent are both covered with a skirt section, wherein the skirt section is used to fix the detection device;

[0053] Among them, the detection device is used during the placement process of the valve stent. When the bottom area of ​​the valve stent is close to the valve ring area of ​​the detection object, the woven stent is aligned with the bottom area, and the detection device is aligned with the bottom grid of the valve stent, the detection device outputs a detection signal to an external receiving device; among the detection signals output by all detection devices, the signal with abnormal fluctuation indicates that paravalvular leakage occurs near the detection device.

[0054] In other embodiments of the present application, in another feasible application scenario of the mounted detection device, the difference from the above-mentioned mounting scheme is that the above-mentioned mounting scheme adopts a wired detection device, while in this embodiment, a wireless detection device can be adopted. At this time, the wireless detection device can be mounted on the side wall of the bottom grid of the valve stent, and the radial inner and radial outer sides of the valve stent are both covered with a skirt section, wherein the skirt section is used to fix the wireless detection device; the detection device is used to output a detection signal to an external receiving device when the bottom area of ​​the valve stent is in close contact with the valve ring area of ​​the detection object during the placement of the valve stent; wherein, among the detection signals output by all detection devices, the signal with abnormal fluctuation indicates that paravalvular leakage occurs near the detection device corresponding to the signal. A wireless detection device is essentially a simple radio frequency antenna or RCL resonant circuit with an electronic sensing element. The electronic sensing element changes its resistance, inductance, or capacitance value under the influence of the detection variable (such as pressure, flow, or deformation). Under the action of an external excitation signal, a current is generated inside the wireless detection device and a wireless signal is emitted. The frequency, argument, or power of this signal is affected by the resistance, capacitance, or inductance of the electronic sensing element, and therefore indirectly carries information about the detection variable. By analyzing the frequency, argument, or power of the signal, the value of the detection variable can be derived.

[0055] For example, combined Figure 3 As shown, the skirt section is a layer of polymer film 3 wrapped around the inner and outer sides of the braided stent when carrying a detection device. It is used to fix the detection device and prevent the electrodes of the detection device from contacting blood. The film is made of a material with good sealing and blood compatibility, such as a porous polytetrafluoroethylene membrane (ePTFE). For example, the detection device is carried on part of the mesh of the braided stent; the detection device is not carried on the remaining mesh of the braided stent. The remaining mesh includes the mesh that penetrates the hook of the delivery structure. These meshes are located where the support arm is placed between the two artificial valve leaflets, so as to achieve the appropriate placement of the detection device.

[0056] For example, the shape of the stent for clinical transcatheter implantation of artificial valves can generally be simplified to something like Figure 4shape. With the vertical direction as the central axis, after the valve stent 4 is unfolded, its pattern is mainly composed of quadrilateral grids; the grid is similar to a rhombus, and along the vertical direction, the grid sides on the same side are equal, while the grid sides on different sides are different; the quadrilateral grids along the horizontal direction have the same shape; in order to prevent obstruction of coronary intervention surgery, some valve stents have hollowed-out or increased grid length parts; for different valve stent designs, the bottom area of ​​the valve stent 4 is the bottom grid 41 of the stent, which is usually the area in contact with the valve ring, and is suitable for placing a detection device in this area. The lock buckle 42 of the valve stent 4 is a fixed structure, which is used to fix the valve stent on the conveying structure and control the release of the valve stent.

[0057] Combine Figure 5 As shown, Figure 5 The placement positions of the woven stent and the detection device when measuring the fit are shown. The woven stent produced in this application is used as a carrying structure of the detection device and is sent to the detection position to accurately locate the area with poor fit at the detection position, thereby solving the problem in the related art of using two-dimensional medical images to judge whether peritoneal leakage occurs and being unable to accurately locate the area with poor fit.

[0058] The present application provides a method for manufacturing a woven stent, which includes: forming a frustum mold, wherein the frustum mold includes a base plate and a plurality of first bosses and a plurality of second bosses located on the base plate; the plurality of first bosses are located in a first circumferential area of ​​the frustum mold, and the plurality of second bosses are located in a second circumferential area of ​​the frustum mold, and the first circumferential area and the second circumferential area have a height difference; a woven wire is wound along the plurality of first bosses and the plurality of second bosses to form a closed woven stent; wherein the portion of the woven stent wound around at least part of the plurality of first bosses is annular, and the portion of the woven stent wound around the plurality of second bosses is arc-shaped; the woven stent manufactured by the above-mentioned manufacturing method is sent to the detection position as a carrying structure of the detection device to accurately locate the area with poor fitting at the detection position, thereby solving the problem in the related art that whether circumferential leakage occurs is judged by two-dimensional medical images, and the area with poor fitting cannot be accurately located.

[0059] The present invention provides a method for manufacturing a braided stent. Figure 6 Shown, including:

[0060] Step 201: forming a frustum mold.

[0061] Among them, the frustum mold includes a base plate and multiple first bosses and multiple second bosses located on the base plate; the multiple first bosses are located in the first circumferential area of ​​the frustum mold, and the multiple second bosses are located in the second circumferential area of ​​the frustum mold, and the first circumferential area and the second circumferential area have a height difference.

[0062] Step 202: Wind one end of the braided wire along the first and second bosses according to a fixed winding trajectory until one end of the braided wire passes through each first boss and each second boss.

[0063] Step 203: Wrap one end of the braided wire with the other end of the braided wire to form a closed braided stent.

[0064] Here, after one end of the braided wire is wrapped around the other end of the braided wire, the two ends of the braided wire can be further fixed, for example, by using welding, clamps and other fixing methods, and fixing one end of the braided wire, also known as the starting end, and the other end of the braided wire, also known as the ending end, on a nearby metal wire to form a stable closed braided bracket.

[0065] The portion of the braided stent wound around at least some of the first bosses among the plurality of first bosses is annular, and the portion of the braided stent wound around the plurality of second bosses is arc-shaped.

[0066] In the embodiment of the present application, in step 202, one end of the braided wire is wound along the first boss and the second boss according to a fixed winding trajectory until one end of the braided wire passes through each first boss and each second boss. Figure 7 The steps shown achieve:

[0067] Step 2021: Use one end of the braided wire to wrap along the first boss and the second boss in sequence according to a first fixed winding trajectory. During the winding process, the adjacent first bosses and second bosses that the one end of the braided wire passes through in sequence are in different circumferential areas.

[0068] For example, see Figure 8 As shown, the first fixed winding trajectory is the trajectory along arrow a-arrow b-arrow c. Here, when one end of the braided wire is wound along the first boss and the second boss in sequence according to the first fixed winding trajectory, the part wound on at least part of the first boss when passing through the first boss is annular.

[0069] Step 2022: Use one end of the braided wire to wrap around the adjacent first boss that is in the same circumferential area as the first boss at the starting position.

[0070] For example, see Figure 8 As shown, taking the first boss at the position indicated by 21 as the first boss at the starting position as an example, one end of the braided wire is wound around the adjacent first boss in the same circumferential area as the first boss at the starting position, that is, the first boss at the position indicated by 22. At this point, the winding of the first fixed winding trajectory is completed.

[0071] Step 2023: Use one end of the braided wire to turn in the opposite direction of symmetry with the middle boss of the frustum mold as the axis.

[0072] For example, see Figure 8 As shown, the middle boss of the round table mold is located at Figure 8 The position indicated by 23.

[0073] Step 2024: Use one end of the braided wire to wrap along the second boss and the first boss in sequence according to the second fixed winding trajectory. During the winding process, the adjacent second bosses and first bosses that one end of the braided wire passes through in sequence are in different circumferential areas.

[0074] For example, see Figure 8 As shown, the second fixed winding trajectory is the trajectory along arrow d-arrow e-arrow f. Here, when one end of the braided wire is wound along the second boss and the first boss in sequence according to the second fixed winding trajectory, the part wound on at least part of the first boss when passing through the first boss is annular.

[0075] For example, see Figure 8 As shown, after completing the winding of the first fixed winding trajectory, one end of the braided wire is turned to the opposite direction of symmetry with the middle boss of the conical mold at the position indicated by 23 as the axis, and the second boss at the position indicated by 24 is taken as the second boss at the starting position as an example. One end of the braided wire is wound around the adjacent second boss in the same circumferential area as the second boss at the starting position, that is, the second boss at the position indicated by 25. At this point, the winding of the second fixed winding trajectory is completed.

[0076] Step 2025: until one end of the braided wire passes through each first boss and each second boss.

[0077] For example, see Figure 9 As shown, until one end of the braided wire passes through each first boss and each second boss, the subsequent Figure 9 As shown at position 31 , one end of the braided wire is wound around the other end of the braided wire to form a closed braided stent 1 .

[0078] In some embodiments, a line segment formed by winding one end of the braided wire along the first boss and the second boss in sequence according to a first fixed winding trajectory, and a line segment formed by winding one end of the braided wire along the second boss and the first boss in sequence according to a second fixed winding trajectory form upper and lower intersection points when they intersect, thereby improving the overall stability of the braided bracket.

[0079] For example, see Figure 9 As shown, the upper and lower interlaced points are as follows Figure 9 As shown in the 32 position.

[0080] In other embodiments, a line segment formed by winding one end of the braided wire along the second boss and the first boss in sequence according to a second fixed winding trajectory and a line segment formed by winding one end of the braided wire along the first boss and the second boss in sequence according to the first fixed winding trajectory form a winding point when they intersect, thereby further improving the overall stability of the braided bracket.

[0081] The present invention provides a method for manufacturing a braided stent. Figure 10 As shown, the method for manufacturing the braided stent includes:

[0082] Step 301: forming a bottom plate of a frustum mold.

[0083] In the embodiment of the present application, step 301 of forming the bottom plate of the truncated cone mold can be achieved by the following method: forming the bottom plate of the truncated cone mold according to a preset fixed inclination angle.

[0084] Step 302: Position the first circumferential area and the second circumferential area on the bottom plate using the height of the bottom area of ​​the valve stent as the height difference between the first circumferential area and the second circumferential area.

[0085] Step 303: Dispose a plurality of first bosses in the first circumferential region, and dispose a plurality of second bosses in the second circumferential region.

[0086] The frustum mold formed in this way includes a base plate and a plurality of first bosses and a plurality of second bosses located on the base plate; the plurality of first bosses are located in the first circumferential area of ​​the frustum mold, and the plurality of second bosses are located in the second circumferential area of ​​the frustum mold, and the first circumferential area and the second circumferential area have a height difference.

[0087] Furthermore, the angle formed by the bottom surface of the base plate close to the second boss and the side surface of the truncated cone mold is equal to the preset fixed inclination angle; the angle formed by the arc portion of the woven bracket corresponding to the second boss and the radial cross-section of the woven bracket is equal to the preset fixed inclination angle.

[0088] Step 304 : Use a braided wire to wrap around the plurality of first bosses and the plurality of second bosses to form a closed braided stent.

[0089] The portion of the braided stent wound around at least some of the first bosses among the plurality of first bosses is annular, and the portion of the braided stent wound around the plurality of second bosses is arc-shaped.

[0090] After the braided wire is wound along the plurality of first bosses and the plurality of second bosses to form a closed braided stent in step 304 , a shaping technique may be used to shape the formed closed braided stent.

[0091] Step 305: bend the portion of the braided stent corresponding to the first boss inward.

[0092] Step 306: Using shaping technology to shape the bent braided stent.

[0093] Here, the upper part of the braided stent is tilted inward, and after forming a certain angle, it is heat-set again. In this way, on the one hand, it is convenient to connect the conveying device to the annular structure of the braided stent. On the other hand, the inward tilt of the upper part of the braided stent is conducive to the transportation, compression and release of the braided stent.

[0094] In a practical production scenario, take a single metal wire to make a braided stent as an example, such as Figure 8 As shown, the angle of the truncated cone of the truncated cone mold is equal to the inclination angle of the bottom of the braided stent; it should be noted that the angle of the truncated cone and the inclination angle of the bottom of the braided stent are determined by the inclination angle of the bottom of the valve stent, that is, the inclination angle of the bottom of the braided stent is equal to the inclination angle of the bottom of the valve stent. The truncated cone mold is provided with a first boss also called an upper boss, and a second boss also called a lower boss. The distance between the upper and lower bosses and the number of bosses are determined by the structure of the valve stent. For example, the distance between the upper and lower bosses is close to the height of the bottom area of ​​the valve stent; the number of bosses in a circumference should be equal to the number of single-layer grids of the valve stent in a circumference. Here, the steps of making the stent are described in five steps. The first step, reference Figure 8 The wire is wound with the help of the boss, starting from the first end, also known as the starting end, and when it passes the upper boss, the wire wraps around once to form a ring like a hanging ring. After wrapping around once, the second end, also known as the end, is reached. Figure 8 In the second step, the metal wire is turned with the middle boss as the axis, and then the winding is carried out according to the method of the first step. In order to make the structure of the bracket more compact, during the winding process of the second step, the metal wires are crossed and overlapped to form upper and lower staggered points, forming Figure 9 The structure indicated by 32. Step 3, reference Figure 9 , wrap the starting end and the end end together to form a closed loop of wire. This part of the winding structure is called a closed loop structure. In order to ensure that the winding will not loosen, welding, clamps and other methods are used to fix the starting end and the end end to the nearby wire. The fourth step is to use heat setting technology to maintain the shape of the braided bracket and it will not deform even after the mold is removed. The fifth step is to refer to Figure 3 , tilt the upper part of the braided bracket inward, and after forming a certain angle, heat-set it again.

[0095] In a feasible detection scenario, the woven stent produced by the present application is equipped with a detection device, the bottom area of ​​the valve stent is close to the valve ring area of ​​the detection object, the woven stent is aligned with the bottom area, and the detection device is aligned with the bottom grid of the valve stent. Here, the woven stent is transported, compressed and released by a conveying structure such as a tripod.

[0096] The overall conveying structure Figure 11 The tripod 5 shown in the figure is used as an example for explanation; the boss on the head of the tripod is a locking member 51, and the locking member 51 is connected to the tripod. Figure 4 The lock buckles 42 on the valve stent shown correspond to each other, so that the valve stent can be fixed on the tripod. The lock and lock buckle shown in this application are just one example, and their shapes can be adjusted according to the actual valve stent design; the recessed part is the guide wire port 52, and the hollow area 53 is used to pass the guide wire. Below the head are three support arms 54, and the bottom of the support arm is a hook 501, and the hook has a threading hole 502. Two of the support arms are inlaid with markers, such as a first marker 503 and a second marker 504, and the markers are made of X-ray opaque materials, such as gold; the first marker 503 and the second marker 504 of the two support arms are in different positions, so with the help of the position of the markers, the three support arms can be distinguished under the angiography image. Figure 12 The connection between the tripod and the bracket is shown. The three hooks are inserted into the corresponding rings respectively. No detection device is placed on the mesh of the hooks. In order to further fix the connection between the tripod and the bracket, a traction rope is inserted between the rings and the holes, such as Figure 13 In addition, the traction rope is interlaced through all the rings and finally guided to the outside of the body through the lead port for control, as shown in FIG. Figure 14 As shown. Since the braided stent is made of wound metal wire, the support arm alone may not be able to fully control the stent's retraction and extension; therefore, a traction rope is added as a safety mechanism. By tightening or loosening the traction rope, the stent's retraction and release can be actively controlled. The lead hole on the tripod head can be used not only to guide the traction rope, but also to guide the wire. Figure 15 As shown, the wires are connected to the detection device and then pass through the hanging ring, and then gathered at the lead-in port, thereby being led out of the body and connected to the measurement circuit.

[0097] The aforementioned Figure 5 The relative position of the braided stent during valve stent placement is shown. For ease of illustration, the tripod, wires, traction cables, and valve leaflets are omitted. The bottom region of the valve stent is in close contact with the annulus region of the test subject, with the braided stent aligned with the bottom region, and the detection device aligned with the bottom grid of the valve stent. The electronic sensing element in the detection device can be a sensor, including but not limited to a strain gauge pressure sensor, a piezoresistive pressure sensor, a capacitive pressure sensor, and a fiber optic pressure sensor. The use of microelectromechanical system technology allows for control of sensor size, ensuring that the dimensions of the detection device and implant system are not affected. Through the bottom grid, the sensor's element that senses pressure changes can contact the annulus region. Figure 16The image shows a situation where the valve stent and the valve annulus are not in good contact, with a gap area appearing between the two. Blood flows out of the gap, forming a peripheral leak. Therefore, in this area, the detection device is in contact with the flowing blood. When the valve stent and the valve annulus are in good contact, the detection device is in contact with the valve annulus, so the output signal is stable. When the valve stent and the valve annulus are not in good contact and a peripheral leak occurs, the detection device is in contact with the blood. Since the blood passes through the gap area and generates a jet, the pressure fluctuation caused by the jet will be fed back to the detection device, causing its output signal to be different from the signals of other detection devices. In addition, after using a traction rope to shrink the braided stent, the detection device is in direct contact with the blood. At this time, the device can be used to measure blood pressure inside the ventricle or the aorta. Figure 17 The relative positions of the support arms and artificial valve leaflets are shown. For ease of demonstration, only the valve leaflets, support arms, braided stents, and detection devices are shown. It can be seen that the support arms are placed between the two artificial valve leaflets. When the valve stent is implanted, the artificial valve is aligned with the native valve, so the detection devices between each two support arms correspond to the left coronary sinus, right coronary sinus, and non-coronary sinus, respectively. In actual operation, all detection devices are numbered in advance and the relative position relationship between each detection device and the support arm is recorded; the position of the left coronary sinus, right coronary sinus, and non-coronary sinus is distinguished through angiographic images, and the support arms between different aortic sinuses are distinguished based on markers; finally, the detection device number corresponding to each aortic sinus is determined based on the relative position relationship between the support arm and the detection device. Finally, by finding the number of the detection device that outputs the abnormal signal, the area where the perianal leak occurs can be located.

[0098] In a feasible peritoneal leakage detection scenario, the process of implanting a braided stent equipped with a detection device and an artificial valve stent into the test object is described. Before implanting the valve stent into the test object, the stent and the braided stent need to be placed in the catheter sleeve together. First, refer to Figure 18 First, determine the relative positions of the valve stent and the braided stent. The detection device corresponds to the bottom grid of the valve stent, and ensure that the wire and traction rope are placed in the lead-in area. The hollow catheter passes through and is fixed in the hollow area of ​​the tripod. The guide wire is inserted into the hollow catheter, and the entire device can be sent into the detection object following the guide wire. Figure 18 The valve leaflets are omitted in the figure. In fact, the support arm should be placed between the two valve leaflets, such as Figure 18 Align the lock buckle with the lock piece, then buckle the guide sheath and compress it, as shown in Figure 19 The catheter sheath continues to compress downwards, and the traction cable is tightened at the same time until the entire device is received in the catheter sheath, and then sent along the guide wire to the vicinity of the cardiac sinus, as shown in the figure. Figure 20 Then the stent can be released. The stent release process is the opposite of the stent storage process. The stent is removed from the catheter sheath and the traction cable is relaxed. Figure 19It can also be understood as the state before the stent is fully released. Before the stent is fully released, the leakage is confirmed. Figure 19 The state of the support arm is then determined by the angiographic image and the markers on the support arm to determine the corresponding area of ​​the detection device; the output signal of the detection device is checked, and if an abnormal detection device signal is found, the position of the support is adjusted for the area, and the support is completely released after the adjustment is completed. Figure 21 Finally, the catheter sheath is pushed down again to retract the support arm and braided stent into the sheath, and then Figure 22 As shown, the braided structure is withdrawn from the test object by the delivery structure.

[0099] The braided stent provided by this application has at least the following beneficial effects:

[0100] 1. It assists the operator to accurately locate the location of paravalvular leakage, which can reduce the use of contrast agents. With the control of the traction cable, the braided stent can be re-contracted, and the test object can be withdrawn after the operation without affecting the work of the implanted valve.

[0101] 2. The stent equipped with the detection device is woven from a single metal wire and does not require laser cutting technology, so the manufacturing process is relatively simple. At the same time, it can also ensure that its volume will not be too large to affect the valve implantation process.

[0102] 3. The working principle of the braided stent equipped with a detection device for detecting peripheral leakage is to find the detection device with abnormal output. It is only necessary to compare the output electrical signals such as current or voltage values. At the same time, the detection device is connected to the measurement circuit through a wire. If only the positioning of the peripheral leakage area is considered, the design of the measurement circuit is relatively simple.

[0103] 4. After the traction rope is used to retract the braided stent, the detection device is separated from the valve annulus, so it can be used as a blood pressure measurement device in the body, and can be used to confirm the size of the transvalvular pressure before withdrawal; in addition, the blood pressure values ​​in different areas can also be recorded during the withdrawal process.

[0104] In the several embodiments provided in this application, it should be understood that the disclosed devices and methods can be implemented in other ways. The device embodiments described above are merely schematic. For example, the division of the units is merely a logical function division. In actual implementation, there may be other division methods, such as: multiple units or components can be combined, or can be integrated into another system, or some features can be ignored or not executed. In addition, the coupling, direct coupling, or communication connection between the components shown or discussed can be through some interfaces, and the indirect coupling or communication connection of the devices or units can be electrical, mechanical or other forms.

[0105] The units described above as separate components may or may not be physically separated, and the components displayed as units may or may not be physical units, that is, they may be located in one place or distributed on multiple network units; some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0106] In addition, the functional units in the embodiments of the present application can all be integrated into one processing module, or each unit can be a separate unit, or two or more units can be integrated into one unit; the above-mentioned integrated unit can be implemented in the form of hardware or in the form of hardware plus software functional units. It can be understood by ordinary technicians in this field that all or part of the steps of the above-mentioned method embodiments can be completed by hardware related to program instructions, and the above-mentioned program can be stored in a computer-readable storage medium. When the program is executed, it executes the steps of the above-mentioned method embodiments; and the above-mentioned storage medium includes: mobile storage devices, read-only memory (ROM), random access memory (RAM), disks or optical disks, etc. Various media that can store program codes.

[0107] The methods disclosed in the several method embodiments provided in this application can be arbitrarily combined without conflict to obtain new method embodiments.

[0108] The features disclosed in the several product embodiments provided in this application can be arbitrarily combined without conflict to obtain new product embodiments.

[0109] The features disclosed in the several method or device embodiments provided in this application can be arbitrarily combined without conflict to obtain new method embodiments or device embodiments.

[0110] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in this application should be included in the scope of protection of this application. Therefore, the scope of protection of this application should be based on the scope of protection of the claims.

Claims

1. A method for manufacturing a braided stent, characterized in that: The method for manufacturing the braided stent comprises: forming a truncated cone mold, wherein the truncated cone mold comprises a base plate and a plurality of first bosses and a plurality of second bosses located on the base plate; the plurality of first bosses are located in a first circumferential region of the truncated cone mold, the plurality of second bosses are located in a second circumferential region of the truncated cone mold, and the first circumferential region and the second circumferential region have a height difference; A braided wire is wound along the plurality of first bosses and the plurality of second bosses to form a closed braided stent; wherein the portion of the braided stent wound around at least some of the first bosses is annular, and the portion of the braided stent wound around the plurality of second bosses is arc-shaped; Among them, in some grids of the braided stent, a detection device is mounted on the side wall close to the arc portion, and among all the detection signals output by the detection devices, a signal with abnormal fluctuations indicates paravalvular leakage near the detection device.

2. The method for manufacturing a braided stent according to claim 1, wherein: The braided wire is wound along the plurality of first bosses and the plurality of second bosses to form a closed braided stent, comprising: Winding one end of the braided wire along the first boss and the second boss according to a fixed winding trajectory until one end of the braided wire passes through each of the first bosses and each of the second bosses; One end of the braided wire and the other end of the braided wire are twisted together to form the closed braided stent.

3. The method for manufacturing a braided stent according to claim 2, characterized in that: The method of winding one end of the braided wire along the first boss and the second boss according to a fixed winding trajectory until the one end of the braided wire passes through each of the first boss and each of the second boss comprises: One end of the braided wire is wound along the first boss and the second boss in sequence according to a first fixed winding trajectory, wherein the adjacent first bosses and second bosses passed by the one end of the braided wire in sequence during the winding process are in different circumferential regions; Winding one end of the braided wire around the adjacent first boss in the same circumferential region as the first boss at the starting position; One end of the braided wire is turned in the opposite direction of symmetry with the middle boss of the truncated cone mold as the axis; One end of the braided wire is wound along the second boss and the first boss in sequence according to a second fixed winding trajectory, wherein the adjacent second bosses and the first bosses passed by the one end of the braided wire in sequence during the winding process are in different circumferential regions; Until one end of the braided wire passes through each of the first bosses and each of the second bosses.

4. The method for manufacturing a braided stent according to claim 3, characterized in that: A line segment formed by winding one end of the braided wire along the first boss and the second boss in sequence according to the first fixed winding trajectory, and a line segment formed by winding one end of the braided wire along the second boss and the first boss in sequence according to the second fixed winding trajectory form upper and lower intersection points when they intersect.

5. The method for manufacturing a braided stent according to claim 3, characterized in that: A line segment formed by winding one end of the braided wire along the second boss and the first boss in sequence according to the second fixed winding trajectory forms a winding point when the line segment intersects with a line segment formed by winding one end of the braided wire along the first boss and the second boss in sequence according to the first fixed winding trajectory.

6. The method for manufacturing a braided stent according to claim 1, wherein: After the braided wire is wound along the plurality of first bosses and the plurality of second bosses to form a closed braided stent, the method includes: The closed braided stent is shaped by adopting shaping technology.

7. The method for manufacturing a braided stent according to claim 1, wherein: The method of forming a truncated cone mold includes: forming the bottom plate of the frustum mold; Positioning the first circumferential area and the second circumferential area on the bottom plate by taking the height of the bottom area of ​​the valve stent as the height difference between the first circumferential area and the second circumferential area; A plurality of first bosses are provided in the first circumferential region, and a plurality of second bosses are provided in the second circumferential region.

8. The method for manufacturing a braided stent according to claim 7, wherein: The bottom plate forming the truncated cone mold includes: The bottom plate of the truncated cone mold is formed according to a preset fixed inclination angle; wherein, the angle formed by the bottom surface of the bottom plate close to the second boss and the side surface of the truncated cone mold is equal to the preset fixed inclination angle; the angle formed by the arc-shaped part of the woven bracket corresponding to the second boss and the radial cross-section of the woven bracket is equal to the preset fixed inclination angle.

9. The method for manufacturing a braided stent according to claim 1, wherein: After the braided wire is wound along the plurality of first bosses and the plurality of second bosses to form a closed braided stent, the method includes: bending a portion of the braided stent corresponding to the first boss inwardly; The bent braided stent is shaped using a shaping technology.

10. The method for manufacturing a braided stent according to claims 1 to 9, characterized in that: The method for manufacturing the braided stent further includes: The braided wire is formed of a metal wire; wherein the braided wire is a single wire including a single metal wire, or the braided wire is at least two wires composed of at least two metal wires.

11. A braided stent, characterized in that: The braided stent is manufactured using the method for manufacturing a braided stent according to claim 1, wherein a detection device is mounted on a side wall of a portion of the mesh of the braided stent near the arc-shaped portion; the detection device transmits a detection signal to an external receiving device via a wired or wireless method; The radial inner side and the radial outer side of the braided stent are both covered with a skirt section, wherein the skirt section is used to fix the detection device; Wherein, the detection device is used in the process of placing the valve stent, when the bottom area of ​​the valve stent is close to the valve ring area of ​​the detection object, the woven stent is aligned with the bottom area, and the detection device is aligned with the bottom grid of the valve stent, and the detection device outputs a detection signal to the external receiving device; wherein, among all the detection signals output by the detection devices, the signal with abnormal fluctuation indicates that paravalvular leakage occurs near the detection device.

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