Novel valve stent and novel valve device

Abstract

The invention discloses a novel valve stent and a novel valve device. The novel valve stent is a self-expansion stent, and comprises a stent main body which is a tubular grid skeleton; the outflow end release pieces are uniformly distributed at the outflow end of the stent main body in the circumferential direction; the positioning parts are uniformly distributed at the outflow end of the stent main body in the circumferential direction, and the two ends of each positioning part are connected to the two edge grids at the outflow end or the two adjacent outflow end release parts; the plurality of traction pieces are arranged in one-to-one correspondence with the plurality of positioning pieces; and in the direction from the outflow end to the inflow end of the opposite stent main body, the turning angle of the outflow end release piece or the edge grid to the connected positioning piece is an obtuse angle. By means of the mode, the novel valve support can effectively reduce breakage of the positioning piece, and the reliability of capturing the entering sinus by the positioning piece is improved.

Description

Technical Field

[0001] The present application relates to the technical field of interventional treatment devices for heart valve diseases, and in particular to a novel valve stent and a novel valve device. Background Art

[0002] With the aging of the population, the incidence of valvular heart disease has increased significantly. In recent years, transcatheter valve implantation / repair has gradually matured and been widely used, especially transcatheter aortic valve implantation (TAVR / TAVI), which has a more sufficient evidence-based basis and greatly reduces trauma. It is a milestone in the field of interventional treatment of heart valve disease.

[0003] With the improvement of instruments and the accumulation of experience, TAVI technology has been continuously improved. In clinical practice, the main artificial bioprosthetic valves used in TAVI are Edwards Sapien (Edwards, USA) with balloon expansion and CoreValve (Medtronic, USA) with self-expanding. TAVI technology has made remarkable progress internationally and has broad application prospects in China.

[0004] Data show that the proportion of Asians suffering from aortic valve regurgitation is higher than that of patients with severe stenosis in Europe and the United States. The balloon-expandable valve suitable for severe calcified stenosis is extremely demanding in the selection of annular area and calcification location, while the self-expanding valve suitable for regurgitation has higher compliance on the annular ring, which can reduce the uneven circular stress at the annular level and may improve long-term hemodynamic outcomes. Self-expanding valves At present, there are four domestically produced aortic valves approved by China's CFDA for marketing, namely Venus A of Venus Medtech, J valve of Suzhou Jiecheng, VitaFlow of MicroPort Cardiovascular, and TaurusElite of Peijia. However, no domestic company has an absolute leading advantage. Although they are all self-expanding stent designs, Venus A of Venus Medtech, VitaFlow of MicroPort Cardiovascular, and TaurusElite of Peijia adopt percutaneous approaches, mainly to solve the problem of aortic valve stenosis, and the stents have no significant anchoring device design, and only rely on the OVERSIZE of the main stent itself to fix the stent; Suzhou Jiecheng's J valve self-expanding stent design has three anchoring devices that can fix the stent to the bottom of the autologous valve leaflet, which can solve the problem of aortic regurgitation, but the main valve product that has obtained a registration certificate adopts a transapical route, which is more traumatic than the percutaneous route. At present, the percutaneous route product is still in the clinical stage and has not obtained a registration certificate. Its percutaneous route product still uses a transapical non-integrated cutting separate anchoring device. There are currently two other aortic valves on the market that use percutaneous approaches to treat aortic regurgitation. One is Trilogy from JenaValve, a company that cooperates with Peijia, and the other is PIONEER aortic valve from Kekai Life Sciences. The valve structures of the two companies are similar in design. Both are anchoring structures with only a small opening angle that are expanded on an integrated cutting structure. The hollow design of the outflow end also makes the radial bearing capacity of the stent insufficient.

[0005] In summary, the aortic valve products currently on the market in China all have certain limitations in treating diseases or have deficiencies in their own performance.

[0006] In the Chinese invention patent application with application number 202210473085.X, a self-expanding percutaneous aortic valve device with integrated cutting, bilateral locking, and automatic leaflet capture is provided to treat both regurgitation and stenosis. It has structural features such as a stent body, a positioning member, a release member, and a T-piece, which can well meet the needs of patients. After a large number of confirmatory preclinical actual uses, it is still found that there are technical problems that have not been solved, including:

[0007] 1) The positioning piece is easy to break; the root of the positioning piece is not designed on the same side, and needs to be flipped 180° to be fixed, which is easy to break, causing the position of the anchoring valve to shift, affecting the effect of treating reflux;

[0008] 2) The positioning piece is not easy to enter the sinus; limited by the umbrella-shaped opening fracture and the large arc expansion fracture of the positioning piece, the positioning piece has a single shape and is not easy to enter the sinus. Summary of the invention

[0009] The present application mainly provides a novel valve stent and a novel valve device to solve the problem that the positioning piece at the outflow end of the existing aortic valve device is prone to breakage and difficult to enter the sinus.

[0010] In order to solve the above technical problems, a technical solution adopted by the present application is to provide a new type of valve stent. The new type of valve stent is a self-expanding stent, comprising: a stent body, which is a tubular grid skeleton; a plurality of outflow end release members, which are evenly distributed along the circumference at the outflow end of the stent body; a plurality of positioning members, which are evenly distributed along the circumference at the outflow end of the stent body, and the two ends of the positioning members are connected to the two edge grids on the outflow end or the two adjacent outflow end release members; a plurality of traction members, which are arranged one by one corresponding to the plurality of positioning members; wherein, in the direction from the outflow end to the inflow end of the stent body opposite to the outflow end, the turning angle from the outflow end release member or the edge grid to the connected positioning member is an obtuse angle.

[0011] In some embodiments, the edge mesh includes two first ribs connected to each other, and the connection point of the two first ribs is a mesh vertex of the edge mesh;

[0012] The outflow end release member includes two second ribs connected to the grid vertices of the two edge grids, and a hanging ear connected to the other ends of the two second ribs;

[0013] The end of the positioning member is connected to a component formed by the first rib and the second rib on the outside.

[0014] In some embodiments, the positioning member includes a U-shaped portion and two connecting arms bent and connected to both ends of the U-shaped portion, the U-shaped portion is unfolded in an umbrella shape relative to the bracket body, the connecting arm is connected to the first rib or the second rib, and the turning angle is formed between the first rib or the second rib and the connecting arm.

[0015] In some embodiments, the bottom of the U-shaped portion is provided with the traction member facing the outflow end.

[0016] In some embodiments, the traction member includes a wire connection hole, and the wire connection hole is used to connect an external traction wire.

[0017] In some embodiments, the traction member is also used to insert a sheath tube disposed outside the traction wire.

[0018] In some embodiments, the traction member includes a support arm and a connecting buckle connected to each other, the support arm is connected between the connecting buckle and the bottom of the U-shaped portion, and a wire connecting hole is provided on the connecting buckle.

[0019] In some embodiments, the U-shaped portion includes a first folding sub-portion and a second folding sub-portion connected to each other, the first folding sub-portion and the second folding sub-portion are folded, the U-shaped end of the second folding sub-portion is close to the outflow end relative to the folded connection between the first folding sub-portion and the second folding sub-portion, and the U-shaped end of the second folding sub-portion serves as the traction member.

[0020] In order to solve the above technical problems, another technical solution adopted by the present application is to provide a novel valve device. The novel valve device includes the novel valve stent as described above.

[0021] The beneficial effects of the present application are as follows: Different from the prior art, the present application discloses a novel valve stent and a novel valve device. The two ends of the positioning member are connected to two adjacent outflow end release members or two edge grids, and the turning angle from the outflow end release member or the edge grid to the connected positioning member is an obtuse angle, and the positioning member is also provided with a corresponding traction member, so the same-side smooth design of the positioning member ensures that the positioning member is not easy to break, improves the safety of the operation and the prognosis and treatment effect, and at the same time, the positioning member can achieve a large opening angle, a large arc expansion and silk thread traction, which provides a favorable clinical effect guarantee for the anchoring of the physiological tissue and the capture of the sinus by the novel valve device. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work, among which:

[0023] Figure 1 is a schematic structural diagram of an aortic valve device in the background art;

[0024] Figure 2 Yes Figure 1 A schematic diagram of the structure of an active valve stent in the aortic valve device shown;

[0025] Figure 3 It is a structural schematic diagram of an embodiment of a novel valve device provided by the present application;

[0026] Figure 4 Yes Figure 3 A schematic structural diagram of another embodiment of an active valve stent in the novel valve device shown;

[0027] Figure 5 Yes Figure 3 A schematic diagram showing a structural comparison of a positioning member in a novel valve stent shown in FIG. 1 , which is changed from a non-ipsilateral smooth design (a) to an ipsilateral smooth design (b);

[0028] Figure 6 yes Figure 2 The schematic diagram of the local structure of the aortic valve stent shown is in a contracted state;

[0029] Figure 7 yes Figure 5 The schematic diagram of the local structure of the novel valve stent with same-side smooth design in the contracted state is shown;

[0030] Figure 8 yes Figure 7 A schematic structural diagram of an embodiment of a novel valve stent is shown;

[0031] Fig. 9 yes Figure 7 A schematic structural diagram of another embodiment of the novel valve stent shown;

[0032] Fig.10 yes Figure 7 A schematic structural diagram of another embodiment of the novel valve stent is shown. DETAILED DESCRIPTION

[0033] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0034] The terms "first", "second", "third" in the embodiments of the present application are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Thus, the features defined as "first", "second", "third" can expressly or implicitly include at least one of the features. In the description of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined. 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 comprising a series of steps or units is not limited to the listed steps or units, but optionally also includes steps or units that are not listed, or optionally also includes other steps or units inherent to these processes, methods, products or devices.

[0035] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0036] The aortic valve is one of the four valves in the heart, located between the left ventricle and the aorta. It is responsible for ensuring that blood flows from the left ventricle to the aorta in one direction and preventing blood from flowing back. The aortic valve is composed of three semilunar shaped leaflets (cusps or leaflets).

[0037] Normally, the aortic valve has three leaflets, each of which is like a small pocket whose edges touch each other and form a seal when closed. Each leaflet is made of a thin, tough layer of fibrous tissue covered by endothelial cells. The inside of the leaflet contains collagen and elastic fibers, which give the leaflet enough strength and elasticity to withstand the pressure changes during each heartbeat.

[0038] When the left ventricle contracts, the pressure increases and pushes the valve leaflets open, allowing blood to flow quickly into the aorta. When the left ventricle relaxes, the pressure drops and the valve leaflets close naturally, preventing blood from flowing back from the aorta to the left ventricle, ensuring the effectiveness of blood circulation.

[0039] Specifically, during systole (contraction), the pressure in the left ventricle increases, exceeding the pressure in the aorta, causing the aortic valve leaflets to be pushed open and blood to be ejected rapidly into the aorta. During diastole (relaxation), the pressure in the left ventricle decreases and the blood in the aorta tries to flow back, which causes the valve leaflets to close tightly, preventing blood from flowing back.

[0040] When the human aortic valve develops valvular diseases such as aortic stenosis or aortic regurgitation, it will be unable to perform its original function and can be treated with minimally invasive transcatheter aortic valve implantation (TAVI).

[0041] The core concept of TAVI is to deliver a new artificial aortic valve to the diseased site through a vascular pathway and deploy it in situ to replace the dysfunctional native valve. This process does not require opening the chest, so it is less traumatic and has a quick recovery.

[0042] The main surgical instruments of TAVI include a delivery system and a novel valve device 200. The delivery system is used to deliver the novel valve device 200 to the treatment position via a vascular path determined by a guidewire, and then release the novel valve device 200. After the release, the novel valve device 200 self-expands and captures the valve leaflets into the sinus, clinging to and fixing them at the native valve, wherein the valve leaflets on the novel valve device 200 replace the function of the native valve and restore normal heart blood flow.

[0043] When the novel valve device 200 is installed in the delivery system and before being released, it is in a contracted state to reduce its volume for easy delivery along the vascular pathway; after being delivered to the treatment site and released, it can return to its normal state, self-expand and unfold between the left ventricle and the aorta, and the positioning pieces on it capture the leaflets into the sinuses, so that the leaflets on it can replace the native valve.

[0044] See also Figure 1 and Figure 2 , Figure 1 is a schematic structural diagram of an aortic valve device in the background art, Figure 2 Yes Figure 1 Schematic diagram of the structure of the active valve stent in the aortic valve device shown.

[0045] The aortic valve device 01 in the background technology includes an aortic valve stent 02, a valve skirt 03 and a valve leaflet 04, wherein the valve skirt 03 is connected to the inner side of the aortic valve stent 02, and the valve leaflet 04 is connected to the inner side of the valve skirt 03, wherein the outflow end 021 of the aortic valve stent 02 adopts a fully continuous grid structure design, and its positioning piece 022 adopts a non-ipsilateral smooth design relative to the release piece 023, and the positioning piece 022 formed by cutting needs to be everted nearly 180 degrees and then heat-formed, and the positioning piece 022 needs to be turned back again to be straightened along the axial direction of the aortic valve stent 02 during transportation. These design features lead to some risks as described in the background technology.

[0046] The present application provides a novel valve device 200, see Figure 3 , Figure 3 It is a structural schematic diagram of an embodiment of a new valve device provided in the present application.

[0047] The novel valve device 200 includes a novel valve stent 100, a valve skirt 210 and a valve leaf 220, wherein the novel valve stent 100 includes a stent body 10, a plurality of outflow end release members 20 and a plurality of positioning members 30, the valve skirt 210 is connected to the inner side of the stent body 10, the valve leaf 220 is connected to the inner side of the valve skirt 210, and the valve leaf 220 is configured to allow blood to flow along the inflow end 14 of the stent body 10 to its outflow end 11, and to prevent blood from flowing along the outflow end 11 to the inflow end 14; wherein the plurality of outflow end release members 20 connected to the stent body 10 are used to be pulled and fixed in the conveying system, so as to be released in a controlled manner after being conveyed to the treatment position, so that the novel valve device 200 can be fixed at the treatment position; the plurality of positioning members 30 connected to the stent body 10 capture the valve leaf into the sinus after release.

[0048] The human aortic valve leaflet is in the shape of a half bowl, forming a bowl pocket with the aortic sinus wall, with its tip facing downward and its mouth facing upward. The positioning member 30 enters the bowl pocket of the human aortic valve leaflet from above, and can slide down to the bottom along the structure of the valve sinus that is larger at the top and smaller at the bottom. It can be guided to accurately enter the valve leaflet bowl pocket and capture the valve leaflet through perspective and ultrasound imaging. During the implantation process, the human body's own valve leaflet can be actively captured, providing accurate positioning for the doctor during the surgical operation, and can solve the problem of fixing the new valve stent to avoid movement toward the ventricle.

[0049] The present application provides a novel valve stent 100, Figures 3 to 5 ,in Figure 4 Yes Figure 3 The structure diagram of another embodiment of the active valve support in the novel valve device is shown. Figure 5 Yes Figure 3 Schematic diagram of structural comparison of the positioning member in the novel valve stent shown in FIG. 1 , which is changed from a non-ipsilateral smooth design (a) to an ipsilateral smooth design (b).

[0050] The novel valve stent 100 is a self-expanding stent, which includes a stent body 10, a plurality of outflow end release pieces 20 and a plurality of positioning pieces 30. The stent body 10 is a tubular grid skeleton, and the end edge of the outflow end 11 thereof includes a plurality of edge grids 12 and a plurality of grid gaps 13 cross-distributed along the circumferential direction; the plurality of outflow end release pieces 20 are evenly distributed along the circumferential direction at the outflow end 11 of the stent body 10, and are correspondingly connected to the edge grids 12; the plurality of positioning pieces 30 are evenly distributed along the circumferential direction at the outflow end 11 of the stent body 10, and are correspondingly arranged to the plurality of grid gaps 13, and the two ends of the positioning piece 30 are connected to two adjacent outflow end release pieces 20 or two edge grids 12; wherein, in the direction A from the outflow end 11 to the inflow end 14 of the opposite stent body 10, the turning angle a1 from the outflow end release piece 20 or the edge grid 12 to the connected positioning piece 30 is an obtuse angle.

[0051] The novel valve stent 100 is made of nickel-titanium alloy and is formed by laser cutting and heat setting. It is an integrated structure without any additional connection structure. In other words, the stent body 10 and the outflow end release members 20 and the positioning members 30 thereon are all formed by laser cutting.

[0052] like Figure 3 or Figure 4 As shown, the stent body 10 is a tubular grid skeleton, which includes an inflow end 14 and an outflow end 11, and its structure is mainly composed of ribs forming a diamond grid; Figures 6 to 10 As shown, when the novel valve stent 100 is in a contracted state, the ribs constituting the diamond-shaped grid are close to each other, so that the grid is eliminated; Figure 3 or Figure 4 As shown, after the novel valve stent 100 is released, self-expansion causes the eliminated mesh to re-expand.

[0053] In this embodiment, Figure 3 or Figure 4 As shown, the outflow end 11 of the stent body 10 has three edge grids 12 and three grid gaps 13 cross-distributed along the circumferential direction, the number of the outflow end release pieces 20 and the number of the positioning pieces 30 are both three, the outflow end release pieces 20 are arranged corresponding to the edge grids 12 at each location, and the positioning pieces 30 are arranged corresponding to the grid gaps 13 at each location, that is, the outflow end release pieces 20 and the positioning pieces 30 are also cross-distributed.

[0054] Optionally, the number of edge grids 12 and grid gaps 13 is the same as the number of outflow end release members 20 and positioning members 30 , and may be more than two, such as four, five or six.

[0055] Combined with reference Figure 2 and Figure 3 , or see Figure 2 and Figure 4 The area spanned by both ends of the positioning member 30 corresponds to the grid gap 13, and the grid gap 13 is formed by eliminating the originally existing edge grid 12.

[0056] The positioning member 30 is an extended structure of the stent body 10 and is relatively located outside the stent body 10. After heat setting, it forms a U-shaped structure that bends downward and can be elastically folded. In this embodiment, when the novel valve stent 100 is in a contracted state, the positioning members 30 are folded and accommodated in the grid gaps 13; and after the novel valve stent 100 is released, each positioning member 30 can be controlled to be elastically folded, thereby capturing the valve leaflets into the sinus.

[0057] Optionally, when the novel valve stent 100 is in a contracted state, each positioning member 30 can also be elastically folded to extend toward the outflow end 11 and to be retracted; and after the novel valve stent 100 is released, each positioning member 30 rebounds and returns to its original state, thereby capturing the valve leaflets into the sinus.

[0058] In this embodiment, the grid structures on the bracket body 10 are all diamond grids, wherein the diamond grids located at the edge of the outflow end 11 are edge grids 12, and the grid gaps 13 lack part of the diamond grids relative to the edge grids 12, for example, lack at least one layer of grid structure or lack at least two layers of grid structure.

[0059] Alternatively, if Figure 3 As shown, the grid gap 13 lacks a layer of grid structure relative to the edge grid 12, that is, the upper half layer of ribs that originally formed the diamond grid at the grid gap 13 is cancelled, and the lower half layer of ribs that constitute the original diamond grid is retained, which is equivalent to eliminating a layer of diamond grids. The eliminated layer of diamond grids may include two, three or four diamond grids.

[0060] Alternatively, if Figure 4 As shown, the grid gap 13 lacks two layers of grid structure relative to the edge grid 12, and the grid gap 13 is in the shape of an inverted pyramid, that is, the ribs that originally formed two layers of diamond grids at the grid gap 13 are all cancelled except for the ribs shared with the edge grid 12, which is equivalent to eliminating two layers of diamond grids. The eliminated two layers of diamond grids are in the shape of an inverted pyramid, for example, the upper layer of diamond grids includes three diamond grids, and the lower layer of diamond grids includes two diamond grids. This is determined by the grid structure characteristics of the bracket body 10.

[0061] Optionally, the grid gap 13 lacks a three-layer grid structure relative to the edge grid 12, and the grid gap 13 is in an inverted pyramid shape, that is, all the ribs that originally formed the three-layer diamond grid at the grid gap 13 are cancelled except for the ribs shared with the edge grid 12, which is equivalent to eliminating the three-layer diamond grid. For example, the first layer of the eliminated three-layer grid structure includes three grid structures, the second layer includes two grid structures, and the third layer includes one grid structure.

[0062] In other embodiments, due to different specifications of the bracket body 10 and the diamond grid thereon, the size and shape of the grid gap 13 and the edge grid 12 can be adaptively set to be different, and the present application does not impose specific limitations on this.

[0063] Combined with reference Figure 2 , Figure 5 and Figure 6 ,in Figure 5 Yes Figure 3 The schematic diagram of the structure comparison of the positioning member in the novel valve stent shown in the figure is changed from the non-ipsilateral smooth design (a) to the ipsilateral smooth design (b). Figure 6yes Figure 2 The schematic diagram of the local structure of the aortic valve stent shown is in a contracted state.

[0064] In the existing aortic valve stent 02, a section of tubular material is used to form the stent body 024 and the positioning member 022 by laser cutting, and the outflow end 021 thereof adopts a circumferentially continuous grid design, so that the positioning member 022 can only be formed by cutting the tubular material on the side of the outflow end 021 of the stent body 024 away from the inflow end 025, such as Figure 5 As shown, the turning angle formed between the end of the positioning member 022 and the outflow end release member 023 is an acute angle a2. At this time, the positioning member 022 is located on the side of the outflow end 021 away from the inflow end 025, and then the positioning member 022 formed by laser cutting needs to be turned nearly 180 degrees and then heat-formed to form a usable aortic valve stent 02. Because the turning angle of the positioning member 022 is too large and it is normally maintained in an open state after heat setting, the stress inside it causes the risk of the positioning member 022 breaking during use or after implantation in the body, which in turn causes the position of the anchoring failure valve to shift, affecting the treatment effect.

[0065] like Figure 6 As shown, the aortic valve stent 02 is in a contracted state when being transported, and the heat-set positioning piece 022 needs to be elastically flipped nearly 180 degrees again to stretch for easy transportation. In this process, the positioning piece 022 is folded once more, which further increases the risk of breakage.

[0066] Combined with reference Figure 4 , Figure 5 and Figure 7 ,in Figure 7 yes Figure 5 Shown is a schematic diagram of the local structure of a new valve stent with a same-side smooth design in a contracted state.

[0067] In the present application, due to the presence of the grid gap 13, at least a portion of the positioning member 30 can be cut and formed using the material originally located at the grid gap 13, and then the positioning member 30 can form a same-side smooth design relative to the outflow end release member 20 and / or the edge grid 12, that is, the root of the positioning member 30 (the end of the positioning member 30) adopts a same-side smooth design, so that the positioning member 30 does not need to be turned nearly 180 degrees relative to each other during heat setting, but only needs to be stretched outward at a small acute angle, for example, the positioning member 30 is heat-set after being turned outward at an angle of less than 60 degrees. Therefore, after heat setting, the stress formed in the normalized open state maintained therein is greatly reduced compared with the implementation method of the prior art, and the risk of the positioning member 30 breaking is also greatly reduced, which can greatly eliminate the risk of position displacement of the valve causing anchor failure, ensure reliable treatment effect and greatly improve the performance of the device itself, and the service life is also improved.

[0068] In this embodiment, Figure 5 and Figure 7 As shown, in the direction A from the outflow end 11 to the inflow end 14 of the opposite bracket body 10, the turning angle a1 from the outflow end release piece 20 or the edge grid 12 to the connected positioning piece 30 is an obtuse angle, so that the end of the positioning piece 30 forms a same-side smooth design relative to the outflow end release piece 20 or the edge grid 12.

[0069] Optionally, both ends of the positioning member 30 are connected to two adjacent outflow-end release members 20 , and a turning angle a1 from the component of the outflow-end release member 20 to the connected positioning member 30 is an obtuse angle.

[0070] Optionally, two ends of the positioning member 30 are connected to two edge grids 12 separated by a grid gap 13, and a turning angle a1 from the ribs of the edge grid 12 to the connected positioning member 30 is an obtuse angle.

[0071] Compared with the aortic valve stent 02 in the prior art, the end of the positioning member 30 in the present application is connected to the outflow end release member 20 or the edge grid 12, and the turning angle a1 formed is an obtuse angle, so that the end of the positioning member 30 is designed to be smooth on the same side relative to the outflow end release member 20 or the edge grid 12, and the positioning member 30 can be formed by cutting the material originally located at the grid notch 12, see Figure 7 In this case, the positioning member 30 may be completely located in the grid gap 12 or at least partially located in the grid gap 12; see Figure 7 And contrast Figure 5In (a) and (b), the positioning member 30 extends in the direction of the grid gap 12 relative to the outflow end release member 20, and the turning angle a1 is set to an obtuse angle. On the one hand, it is convenient for the positioning member 30 to be turned outward at a small angle during the subsequent heat setting, and on the other hand, it is possible to avoid the positioning member 30 causing an additional protrusion from the outflow end 11. Then, the positioning member 30 formed by cutting only needs to be turned outward at a small angle, which can be 15 to 60 degrees, and heat setting is performed to form a positioning member 30 that is normally opened at a certain angle relative to the bracket body 10.

[0072] In the present application, the positioning member 30 does not need to be flipped at a large angle for heat setting, but only needs to be everted at a small acute angle, and the end of the positioning member 30 forms a smooth design on the same side relative to the outflow end release member 20 or the edge grid 12. Therefore, the portion of the positioning member 30 protruding relative to the outflow end 11 is small and thin, which has less interference with the blood flow between the left ventricle and the aorta, and can reduce the risk of postoperative thrombosis. Furthermore, the outer dimensions formed by the positioning member 30 can be larger, so that the valve leaflets can be more easily captured into the sinus.

[0073] It has been verified by experiments, such as Figure 5 As shown, the waist dimension b2 of the positioning piece 022 in the aortic valve stent 02 in the prior art can reach 9 mm, and the waist dimension b1 of the positioning piece 30 in the novel valve stent 100 of the same specification in the present application can reach 15 mm. The positioning piece 30 of the present application has a larger unfolded size structure, which can be suitable for a wider group of people and can more easily capture the valve leaflets into the sinus.

[0074] In this embodiment, Figure 7 As shown, the positioning member 30 is basically formed by cutting the material originally located at the grid gap 13, so when the novel valve stent 100 is in a contracted state, the positioning member 30 can be accommodated in the grid gap 13. Therefore, the novel valve stent 100 in the present application can be formed by cutting a shorter length of tubular material, that is, the required material cost is lower.

[0075] When being transported by the delivery system, the novel valve stent 100 is in a contracted state, and the positioning piece 30 can be accommodated in the grid gap 13. Compared with the aortic valve stent 02 in the prior art, the novel valve stent 100 provided in the present application requires a shorter delivery space, and the positioning piece 30 does not need to be overlapped with the material on the stent body 10. Therefore, the outer diameter of the novel valve stent 100 in the contracted state is smaller, which is beneficial to reduce the relevant components of the delivery system so as to deliver it through smaller blood vessels; and this arrangement of the positioning piece 30 during transportation does not need to be flipped nearly 180 degrees to stretch, so the additional stress it is subjected to is almost not increased, thereby reducing the risk of breakage caused by keeping the positioning piece 30 folded at a large angle for a long time.

[0076] Optionally, when being transported by the delivery system, the positioning member 30 on the novel valve stent 100 may not be accommodated in the grid gap 13, but may be flipped nearly 180 degrees to extend in the opposite direction of direction A.

[0077] In this embodiment, refer to Figure 5 In the schematic diagram (b), the upper half structure of the edge grid 12 includes two first ribs 121 connected to each other, and the connection point of the two first ribs 121 is the grid vertex 120 of the edge grid 12; the outflow end release member 20 includes two second ribs 21 connected to the grid vertices 120 of the two edge grids 12, and a hanging ear 22 connected to the other ends of the two second ribs 21; the end of the positioning member 30 is connected to the component formed by the outer first ribs 121 and the second ribs 21.

[0078] The two second ribs 21 are connected to the grid vertices 120 of the two edge grids 12, thereby also forming a release grid 201, which can be used to sew part of the end of the leaflet 220; the ear 22 is used to connect to the delivery system, and when the ear 22 is disconnected from the delivery system, the new valve stent 100 can self-expand and unfold outward.

[0079] In this embodiment, the two second ribs 21 of the outflow end release member 20 connect two adjacent grid vertices 120, and the release grid 201 formed is also a diamond grid, which has basically the same structural dimensions as the edge grid 12. When the new valve stent 100 is in the expanded state, the first rib 121 and the second rib 21 are relatively inclined straight lines, and the end of the positioning member 30 can be connected to the straight member formed by the first rib 121 and the second rib 21.

[0080] Combined with reference Figure 5 and Figure 7 From another perspective, the grid gap 13 and the space between the two adjacent outflow end release pieces 20 together form a deep V-shaped space. The positioning piece 30 in the present application is formed by cutting the material originally existing in the deep V-shaped space. Therefore, when the two ends of the positioning piece 30 are connected to the second ribs 21 on the two adjacent outflow end release pieces 20, the length of the positioning piece 30 can be set relatively longer, and its set length can be guaranteed, so that the positioning piece 30 is not easy to break, and at the same time, the umbrella-shaped opening of the positioning piece 30 is guaranteed, and the waist size of the positioning piece 30 can be set larger, which can form a large arc expansion, so as to better play the role of the positioning piece 30 in anchoring the valve and capturing the sinus.

[0081] In this embodiment, Figure 7As shown, the positioning member 30 includes a U-shaped portion 31 and two connecting arms 32 bent and connected to the two ends of the U-shaped portion 31. The U-shaped portion 31 is unfolded in an umbrella shape relative to the bracket body 10. The connecting arm 32 is connected to the first rib rod 121 or the second rib rod 21. A turning angle a1 is formed between the first rib rod 121 or the second rib rod 21 and the connecting arm 32.

[0082] The ends of the connecting arm 32 and the U-shaped portion 31 are also bent to facilitate the U-shaped portion 31 to expand outward in an umbrella shape; a turning angle a1 is formed between the connecting arm 32 and the first rib rod 121 or the second rib rod 21, and the turning angle a1 is an obtuse angle, that is, the connecting arm 32 extends in the direction of the grid gap 13, that is, the portion of the positioning member 30 protruding from the outflow end 11 is very small, and when the connecting arm 32 is connected to the first rib rod 121, it has no portion protruding from the outflow end 11, so the portion of the positioning member 30 protruding from the outflow end 11 is relatively small, and the blood flow interference between the left ventricle and the aorta is relatively small, which can reduce the risk of thrombosis after surgery.

[0083] See also Figure 8 , Figure 8 yes Figure 7 A schematic diagram of the structure of an embodiment of the novel valve stent is shown. Further, a traction member 40 is provided at the bottom of the U-shaped portion 31 toward the outflow end 11, and the traction member 40 is used to connect a traction thread externally, and the thread can apply traction to control the deployment of the positioning member 30, thereby guiding the positioning member 30 to anchor the valve and capture the aorta.

[0084] A traction member 40 is disposed at the bottom center of the U-shaped portion 31 and at one side facing the outflow end. The traction member 40 is disposed at a position that is protected by the U-shaped portion 31 to prevent it from scratching blood vessels or ventricles in the human body.

[0085] If the new valve stent in the prior art is provided with a traction member 40 such as the one in the present application on the positioning member, it is very easy for the traction member 40 to scratch the blood vessels or ventricles in the human body, resulting in serious medical accidents. The traction member 40 cannot be installed on it, so the deployment of the positioning member is poorly uncontrolled and difficult to regulate, which increases the difficulty of the operation. In comparison, due to the arrangement of the positioning member 30 in the present application, it is possible to install the traction member 40 on the positioning member 30, so that the positioning member 30 can achieve better and more accurate capture of the sinus based on the traction member 40.

[0086] In this embodiment, the traction member 40 includes a wire connection hole 401, and the wire connection hole 401 is used to connect the external traction wire 101. During surgery, the traction wire 101 is passed through the wire connection hole 401 to establish a connection with the traction member 40, and the posture of the positioning member 30 is controlled by applying traction force to the traction member 40, and the positioning member 30 can be controlled to flip, thereby accurately capturing the sinus and anchoring the valve.

[0087] The traction member 40 includes a supporting arm 41 and a connecting buckle 42 connected to each other. The supporting arm 41 is connected between the connecting buckle 42 and the bottom of the U-shaped portion 31 . The connecting buckle 42 is provided with a wire connecting hole 401 .

[0088] See also Fig. 9 , Fig. 9 yes Figure 7 A schematic diagram of the structure of another embodiment of the novel valve stent is shown. Furthermore, the traction member 40 is also used to plug the sheath tube 102 arranged outside the traction wire 101. That is, the traction wire 101 is connected to the wire connection hole 401, and the sheath tube 102 is sleeved outside the traction wire 101 and one end is plugged into the traction member 40, wherein the support arm 41 and the connecting buckle 42 can provide the sheath tube 102 with a longer plug-in length, thereby improving the connection reliability. The sheath tube 102 provides protection for the traction wire 101, which can prevent the traction wire 101 from cutting the tissue in the body, further reducing the risk during the operation.

[0089] After the positioning member 30 is controlled to accurately capture the sinus, the traction wire can be untied from the wire connecting hole 401 , and the sheath tube can also be untied from the traction member 40 .

[0090] Optionally, the traction member 40 may also only include the connection buckle 42 as described above, that is, the connection buckle 42 is connected to the bottom of the U-shaped portion 31 .

[0091] Optionally, the traction member 40 may also be a T-shaped structure, and the traction wire is connected to the T-shaped structure.

[0092] See also Fig.10 , Fig.10 yes Figure 7 A schematic structural diagram of another embodiment of the novel valve stent is shown. In another embodiment, the U-shaped portion 31 includes a first folding sub-portion 312 and a second folding sub-portion 314 connected to each other, the first folding sub-portion 312 and the second folding sub-portion 314 are folded, the U-shaped end of the second folding sub-portion 314 is close to the outflow end 11 relative to the folded connection between the first folding sub-portion 312 and the second folding sub-portion 314, and the U-shaped end of the second folding sub-portion 314 serves as the traction member 40 as described above.

[0093] By configuring the U-shaped portion 31 to be a first folding sub-portion 312 and a second folding sub-portion 314 that are folded mutually, and utilizing the U-shaped end of the folded second folding sub-portion 314 as the traction member 40 as described above, it is avoided to configure an additional traction member 40, that is, the traction wire can be passed through the U-shaped end of the second folding sub-portion 314, so that a force can be applied to the positioning member 40 for precise regulation, so as to achieve a better and more accurate capture effect of the sinus.

[0094] Furthermore, the second folding sub-portion 314 does not extend beyond the outflow end 11 when received in the grid gap 13 , so as to eliminate the potential risk of thrombosis caused by it, that is, the positioning member 30 can be received in the grid gap 13 as a whole.

[0095] In this embodiment, the first folding sub-portion 312 and the second folding sub-portion 314 are substantially equal in length, so that the U-shaped end of the second folding sub-portion 314 can be substantially flush with the outflow end 11 when accommodated in the grid gap 13. Therefore, the connection point where the U-shaped end connects to the traction thread is equivalent to being flush with the outflow end 11. Therefore, the traction thread does not need to penetrate deep into the area of ​​the grid gap 13, and the positioning member 30 can be regulated relatively near the outflow end 11, thereby reducing the risk of tissue damage caused by the traction thread.

[0096] In the present application, the outflow end 11 of the stent body 10 includes a plurality of edge grids 12 and a plurality of grid gaps 13 cross-distributed along the circumferential direction. Compared with the circumferentially fully continuous grid design adopted at the outflow end of the original stent body, in the present application, part of the edge grids 12 equivalent to the outflow end 11 are cancelled to form a plurality of grid gaps 13 isolated by the edge grids 12. The outflow end 11 forms a circumferentially non-continuous grid design, which reduces the density of the ribs at the outflow end 11, that is, the number of the edge grids 12 at the outflow end 11 is reduced while the specifications remain unchanged, and the density of the ribs constituting the edge grids is also reduced. When the new valve device 200 is loaded in the delivery system, the required loading space can also be reduced, the loading difficulty is reduced, and the problem of increased friction caused by loading of the self-expanding valve is effectively solved, so that the valve can be reliably released, reducing the risk of surgical failure, and is also conducive to the development of a smaller diameter delivery system and expanding the patient user group through a thinner vascular path.

[0097] By configuring the outflow end 11 to include a plurality of edge grids 12 and a plurality of grid gaps 13 cross-distributed along the circumferential direction, it can adapt to a smaller loading space, so that the outer diameter of the loading area of ​​the delivery system does not need to be increased but can be reduced and optimized, thereby reducing the invasiveness of the device and effectively increasing the proportion of percutaneous interventions in patients with small or fragile blood vessels.

[0098] The loading space required at the outflow end 11 is relatively reduced, so more loading space can be reserved to accommodate the compressed leaflets 220, which greatly solves the problem that the compressed leaflets 220 have a greater risk of wrinkling and damage due to the small loading space. It is relatively easier and tends to select leaflets 220 close to the upper limit of thickness when screening the leaflet thickness, which can effectively increase the service life of the leaflets 220.

[0099] The formed grid gap 13 is equivalent to reducing part of the edge grid 12 of the outflow end 11. The leaflet 220 is partially sewn in the existing edge grid 12 or in the release grid 201 formed by the ribs of the edge grid 12 and the outflow end release piece 20. The grid ribs that were originally easily beaten by the free ends of the leaflets 220 are located in the area where the grid gap 13 is located. Therefore, the situation where the grid gap 13 beats against the edge of the free end of the leaflet 220, and an adverse factor that causes damage to the edge of the free end of the leaflet 220 is eliminated, so that the risk of damage to the free end of the leaflet 220 is reduced, and the reflux caused by the lax closure of the valve due to the damage of the free end is avoided, thereby effectively improving the treatment effect of the new valve device 200 and its service life is also improved.

[0100] Furthermore, because the outflow end 11 reduces part of the edge mesh 12 to form a mesh gap 13, the edge mesh 12 ribs that need to be covered during the endothelialization process are reduced, which is beneficial to the tissue endothelialization process after valve implantation and reduces the inflammatory effects.

[0101] Since a plurality of grid gaps 13 are provided, the number of edge grids 13 and grid vertices thereof is relatively reduced, so during the release of the inlet sinus manipulation, the risk of the grid vertices at the outflow end 11 piercing the aortic tissue can be effectively reduced, thereby improving the safety of the operation.

[0102] The plurality of grid gaps 13 also appropriately reduce the circumferential support of the outflow end 11. When encountering patients whose coronary artery orifices are close to the valve annulus, the outflow end 11 can appropriately contract when under pressure to avoid blocking the coronary artery orifice. Therefore, the new valve device 200 provided in the present application can be suitable for patients whose coronary artery orifices are close to the valve annulus.

[0103] Because the area spanned by both ends of the positioning member 30 corresponds to the grid gap 13, the grid vertices at the grid gap 13 are sunken relative to the grid vertices of the edge grid 12, thereby avoiding entanglement with the positioning member 20 and ensuring that the positioning member 30 can be freely unfolded after release, so that the valve traction and morphological implantation are not affected.

[0104] Since the outflow end 11 is provided with a plurality of mesh gaps 13, the metal mass ratio of the valve at the outflow end 11 is greatly reduced, thereby effectively reducing the release of metal ions such as nickel and reducing the risk of inflammatory problems such as metal ion sensitization.

[0105] The positioning member 30 is smoothly designed on the same side as the edge grid 12 and the outflow end release member 20, and its length can be guaranteed, that is, its length space is improved, so that the positioning member 30 is not easy to break, and the risk of breakage is effectively controlled. At the same time, the umbrella-shaped opening and large arc expansion of the positioning member 30 are guaranteed, so that it can better play its role in anchoring the valve and capturing the sinus.

[0106] In the present application, the outflow end 11 of the novel valve stent 100 adopts a discontinuous hollow grid design, which improves the effectiveness and reliability during valve loading and release, while reducing the risks of valve leaflet wrinkling, wall damage, entanglement between the positioning member 30 and the grid apex 120, puncture of tissue by the grid apex 120, and inflammatory response, thereby effectively improving the service life of the novel valve device 200 and reducing the probability of clinical adverse events.

[0107] The outflow end 11 of the novel valve stent 100 adopts a discontinuous hollow grid design, which provides ample space for the same-side smooth design, shape and size design of the positioning piece 30. The same-side smooth design of the positioning piece 30 ensures that the positioning piece 30 is not easy to break, thereby improving the safety of the operation and the prognosis and treatment effect. At the same time, the positioning piece 30 can achieve a large opening angle, large arc expansion and silk thread traction, which provides a favorable clinical effect guarantee for the novel valve device 200 to anchor physiological tissues and capture the sinus.

[0108] The above descriptions are merely embodiments of the present application and are not intended to limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A novel valve stent, which is a self-expanding stent, characterized in that: include: The main body of the stent is a tubular grid skeleton; A plurality of outflow end release members, uniformly distributed along the circumference at the outflow end of the stent body; A plurality of positioning members are evenly distributed along the circumferential direction at the outflow end of the stent body, and two ends of the positioning members are connected to two edge grids on the outflow end or two adjacent release members on the outflow end; A plurality of traction members, arranged one by one corresponding to the plurality of positioning members; Wherein, in the direction from the outflow end to the inflow end of the opposite support body, the turning angle from the outflow end release piece or the edge grid to the connected positioning piece is an obtuse angle.

2. The novel valve stent according to claim 1, characterized in that: The edge mesh includes two first ribs connected to each other, and the connection point of the two first ribs is a mesh vertex of the edge mesh; The outflow end release member includes two second ribs connected to the grid vertices of the two edge grids, and a hanging ear connected to the other ends of the two second ribs; The end of the positioning member is connected to a component formed by the first rib and the second rib on the outside.

3. The novel valve stent according to claim 2, characterized in that: The positioning member includes a U-shaped portion and two connecting arms bent and connected to the two ends of the U-shaped portion, the U-shaped portion is unfolded in an umbrella shape relative to the bracket body, the connecting arm is connected to the first rib or the second rib, and the turning angle is formed between the first rib or the second rib and the connecting arm.

4. The novel valve stent according to claim 3, characterized in that: The bottom of the U-shaped portion is provided with the traction member facing the outflow end.

5. The novel valve stent according to claim 4, characterized in that: The traction member comprises a wire connection hole, and the wire connection hole is used to connect an external traction wire.

6. The novel valve stent according to claim 5, characterized in that: The traction member is also used for inserting a sheath tube arranged outside the traction wire.

7. The novel valve stent according to claim 6, characterized in that: The traction member comprises a supporting arm and a connecting buckle connected to each other, the supporting arm is connected between the connecting buckle and the bottom of the U-shaped portion, and a wire connecting hole is provided on the connecting buckle.

8. The novel valve stent according to claim 3, characterized in that: The U-shaped portion includes a first folding sub-portion and a second folding sub-portion connected to each other, wherein the first folding sub-portion and the second folding sub-portion are folded, and the U-shaped end of the second folding sub-portion is close to the outflow end relative to the folded connection between the first folding sub-portion and the second folding sub-portion, and the U-shaped end of the second folding sub-portion serves as the traction member.

9. A novel valve device, characterized in that: Comprising a novel valve stent as described in any one of claims 1 to 8.

Images